10 CFR 72.176 - Audits.

Code of Federal Regulations, 2010 CFR

2010-01-01

... RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.176 Audits. The... assurance program and to determine the effectiveness of the program. The audits must be performed in... 10 Energy 2 2010-01-01 2010-01-01 false Audits. 72.176 Section 72.176 Energy NUCLEAR REGULATORY...

15 CFR 996.23 - Audit and decertification of hydrographic products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES Certification of a Hydrographic Product and Decertification. § 996.23 Audit and decertification of hydrographic products. (a) NOAA may audit...

15 CFR 996.23 - Audit and decertification of hydrographic products.

Code of Federal Regulations, 2013 CFR

2013-01-01

... ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES Certification of a Hydrographic Product and Decertification. § 996.23 Audit and decertification of hydrographic products. (a) NOAA may audit...

15 CFR 996.23 - Audit and decertification of hydrographic products.

Code of Federal Regulations, 2014 CFR

2014-01-01

... ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES Certification of a Hydrographic Product and Decertification. § 996.23 Audit and decertification of hydrographic products. (a) NOAA may audit...

15 CFR 996.23 - Audit and decertification of hydrographic products.

Code of Federal Regulations, 2012 CFR

2012-01-01

... ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES Certification of a Hydrographic Product and Decertification. § 996.23 Audit and decertification of hydrographic products. (a) NOAA may audit...

Exploring the links between quality assurance and laboratory resources. An audit-based study.

PubMed

Singh, Navjeevan; Panwar, Aru; Masih, Vipin Fazal; Arora, Vinod K; Bhatia, Arati

2003-01-01

To investigate and rectify the problems related to Ziehl-Neelsen (Z-N) staining in a cytology laboratory in the context of quality assurance. An audit based quality assurance study of 1,421 patients with clinical diagnoses of tubercular lymphadenopathy who underwent fine needle aspiration cytology. Data from 8 months were audited (group 1). Laboratory practices related to selection of smears for Z-N staining were studied. A 2-step corrective measure based on results of the audit was introduced for 2 months (group 2). Results were subjected to statistical analysis using the chi 2 test. Of 1,172 patients in group 1,368 had diagnoses other than tuberculosis. Overall acid-fast bacillus (AFB) positivity was 42%. AFB positivity in 249 patients in group 2 was 89% (P < .0001). Several issues in the laboratory are linked to quality assurance. Solving everyday problems can have far-reaching benefits for the performance of laboratory personnel, resources and work flow.

15 CFR 996.23 - Audit and decertification of hydrographic products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... hydrographic products it has certified. NOAA may conduct audits without advance notification. However, visits... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Audit and decertification of... ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES QUALITY ASSURANCE AND...

Single-Subject Evaluation: A Tool for Quality Assurance.

ERIC Educational Resources Information Center

Nuehring, Elane M.; Pascone, Anne B.

1986-01-01

The use of single-subject designs in peer review, in utilization review, and in other quality-assurance audits is encouraged. Presents an overview of the methodologies of single-subject designs and quality assurance, and provides examples of cases in which single-subject techniques furnished relevant quality assurance documentation. (Author/ABB)

Education for All in South Africa: Developing a National System for Quality Assurance.

ERIC Educational Resources Information Center

Smith, William J.; Ngoma-Maema, Wendy Yolisa

2003-01-01

Draws on international research, policy, and practice relevant to quality assurance systems to analyze the development of a national framework for educational quality assurance in South Africa. Describes an emerging framework for quality assurance that encompasses evaluation of student achievement, quality audits and reviews, program and service…

Audit of the informed consent process as a part of a clinical research quality assurance program.

PubMed

Lad, Pramod M; Dahl, Rebecca

2014-06-01

Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.

Quality Assurance in Higher Education: Proposals for Consultation.

ERIC Educational Resources Information Center

Higher Education Funding Council for England, Bristol.

This document sets out for consultation proposals for a revised method for quality assurance of teaching and learning in higher education. The proposals cover: (1) the objectives and principles of quality assurance; (2) an approach to quality assurance based on external audit principles; (3) the collection and publication of information; (4)…

Gynecologic Oncology Group quality assurance audits: analysis and initiatives for improvement.

PubMed

Blessing, John A; Bialy, Sally A; Whitney, Charles W; Stonebraker, Bette L; Stehman, Frederick B

2010-08-01

The Gynecologic Oncology Group (GOG) is a multi-institution, multi-discipline Cooperative Group funded by the National Cancer Institute (NCI) to conduct clinical trials which investigate the treatment, prevention, control, quality of survivorship, and translational science of gynecologic malignancies. In 1982, the NCI initiated a program of on-site quality assurance audits of participating institutions. Each is required to be audited at least once every 3 years. In GOG, the audit mandate is the responsibility of the GOG Quality Assurance Audit Committee and it is centralized in the Statistical and Data Center (SDC). Each component (Regulatory, Investigational Drug Pharmacy, Patient Case Review) is classified as Acceptable, Acceptable, follow-up required, or Unacceptable. To determine frequently occurring deviations and develop focused innovative solutions to address them. A database was created to examine the deviations noted at the most recent audit conducted at 57 GOG parent institutions during 2004-2007. Cumulatively, this involved 687 patients and 306 protocols. The results documented commendable performance: Regulatory (39 Acceptable, 17 Acceptable, follow-up, 1 Unacceptable); Pharmacy (41 Acceptable, 3 Acceptable, follow-up, 1 Unacceptable, 12 N/A): Patient Case Review (31 Acceptable, 22 Acceptable, follow-up, 4 Unacceptable). The nature of major and lesser deviations was analyzed to create and enhance initiatives for improvement of the quality of clinical research. As a result, Group-wide proactive initiatives were undertaken, audit training sessions have emphasized recurring issues, and GOG Data Management Subcommittee agendas have provided targeted instruction and training. The analysis was based upon parent institutions only; affiliate institutions and Community Clinical Oncology Program participants were not included, although it is assumed their areas of difficulty are similar. The coordination of the GOG Quality Assurance Audit program in the SDC has improved data quality by enhancing our ability to identify frequently occurring deviations and develop innovative solutions to avoid or minimize their occurrence in the future.

Development of an Instructional Quality Assurance Model in Nursing Science

ERIC Educational Resources Information Center

Ajpru, Haruthai; Pasiphol, Shotiga; Wongwanich, Suwimon

2011-01-01

The purpose of this study was to develop an instructional quality assurance model in nursing science. The study was divided into 3 phases; (1) to study the information for instructional quality assurance model development (2) to develop an instructional quality assurance model in nursing science and (3) to audit and the assessment of the developed…

Ten Years of External Quality Audit in Australia: Evaluating Its Effectiveness and Success

ERIC Educational Resources Information Center

Shah, Mahsood

2012-01-01

External quality audits are now being used in universities across the world to improve quality assurance, accountability for quality education and transparency of public funding of higher education. Some countries such as Australia, New Zealand, United Kingdom, Sweden and Denmark have had external quality audits for more than a decade but there…

Institutional Response to the Swedish Model of Quality Assurance.

ERIC Educational Resources Information Center

Nilsson, Karl-Axel; Wahlen, Staffan

2000-01-01

Evaluates the Swedish model of quality assurance of higher education by examining the response of institutions to 27 quality audits and 19 follow-up interviews. Discusses the relationship between top-down and bottom-up approaches to internal quality assurance and suggests that, with growing professionalization, more limited result-oriented audits…

76 FR 32333 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Revision to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-06

... duration of the timing of quality assurance audits performed by the Pennsylvania Department of...) Program--Quality Assurance Protocol for the Safety Inspection Program in Non-I/M Counties AGENCY... quality assurance program for its motor vehicle inspection and maintenance program (I/M program...

The Effectiveness of External Quality Audits: A Study of Australian Universities

ERIC Educational Resources Information Center

Shah, Mahsood

2013-01-01

External quality audits have been introduced in many countries as part of higher education reforms. This article is based on research on 30 Australian universities to assess the extent to which audits by the Australian Universities Quality Agency (AUQA) have improved quality assurance in the core and support areas of the universities. The article…

Taking It on Board: Quality Audit Findings for Higher Education Governance

ERIC Educational Resources Information Center

Baird, Jeanette

2007-01-01

An examination of the reports of quality audits of Australian universities is used to identify quality assurance issues which emerge as more or less important for governing bodies and academic boards respectively. For governing bodies, many issues identified in audit reports reflect established good practice, such as a need to evaluate the…

Audits for advanced treatment dosimetry

NASA Astrophysics Data System (ADS)

Ibbott, G. S.; Thwaites, D. I.

2015-01-01

Radiation therapy has advanced rapidly over the last few decades, progressing from 3D conformal treatment to image-guided intensity modulated therapy of several different flavors, both 3D and 4D and to adaptive radiotherapy. The use of intensity modulation has increased the complexity of quality assurance and essentially eliminated the physicist's ability to judge the validity of a treatment plan, even approximately, on the basis of appearance and experience. Instead, complex QA devices and procedures are required at the institutional level. Similarly, the assessment of treatment quality through remote and on-site audits also requires greater sophistication. The introduction of 3D and 4D dosimetry into external audit systems must follow, to enable quality assurance systems to perform meaningful and thorough audits.

Quality Assurance Reconsidered: A Case Study

ERIC Educational Resources Information Center

Gynnild, Vidar

2007-01-01

This article examines an external evaluation of the quality assurance system at the Norwegian University of Science and Technology (NTNU) conducted by The Norwegian Agency for Quality Assurance in Higher Education (NOKUT). The external audit report along with internal reports provided by the seven faculties of the university served as the major…

Expediting the Quest for Quality: The Role of IQAC in Academic Audit

ERIC Educational Resources Information Center

Nitonde, Rohidas

2016-01-01

Academic Audit is an important tool to control and maintain standards in academic sector. It has been found highly relevant by the experts across the world. Academic audit helps institutions to introspect and improve their quality. The present paper intends to probe into the possible role of Internal Quality Assurance Cell (IQAC) in Academic Audit…

GSFC Supplier Surveillance

NASA Technical Reports Server (NTRS)

Kelly, Michael P.

2011-01-01

Topics covered include: Develop Program/Project Quality Assurance Surveillance Plans The work activities performed by the developer and/or his suppliers are subject to evaluation and audit by government-designated representatives. CSO supports project by selecting on-site supplier representative s by one of several methods: (1) a Defense Contract Management Agency (DCMA) person via a Letter Of Delegation (LOD), (2) an independent assurance contractor (IAC) via a contract Audits, Assessments, and Assurance (A3) Contract Code 300 Mission Assurance Support Contract (MASC)

The role of field auditing in environmental quality assurance management.

PubMed

Claycomb, D R

2000-01-01

Environmental data quality improvement continues to focus on analytical laboratoryperformance with little, if any, attention given to improving the performance of field consultants responsible for sample collection. Many environmental professionals often assume that the primary opportunity for data error lies within the activities conducted by the laboratory. Experience in the evaluation of environmental data and project-wide quality assurance programs indicates that an often-ignored factor affecting environmental data quality is the manner in which a sample is acquired and handled in the field. If a sample is not properly collected, preserved, stored, and transported in the field, even the best laboratory practices and analytical methods cannot deliver accurate and reliable data (i.e., bad data in equals bad data out). Poor quality environmental data may result in inappropriate decisions regarding site characterization and remedial action. Field auditing is becoming an often-employed technique for examining the performance of the environmental sampling field team and how their performance may affect data quality. The field audits typically focus on: (1) verifying that field consultants adhere to project control documents (e.g., Work Plans and Standard Operating Procedures [SOPs]) during field operations; (2) providing third-party independent assurance that field procedures, quality assurance/ quality control (QA/QC)protocol, and field documentation are sufficient to produce data of satisfactory quality; (3) providing a defense in the event that field procedures are called into question; and (4) identifying ways to reduce sampling costs. Field audits are typically most effective when performed on a surprise basis; that is, the sampling contractor may be aware that a field audit will be conducted during some phase of sampling activities but is not informed of the specific day(s) that the audit will be conducted. The audit also should be conducted early on in the sampling program such that deficiencies noted during the audit can be addressed before the majority of field activities have been completed. A second audit should be performed as a follow-up to confirm that the recommended changes have been implemented. A field auditor is assigned to the project by matching, as closely as possible, the auditor's experience with the type of field activities being conducted. The auditor uses a project-specific field audit checklist developed from key information contained in project control documents. Completion of the extensive audit checklist during the audit focuses the auditor on evaluating each aspect of field activities being performed. Rather than examine field team performance after sampling, a field auditor can do so while the samples are being collected and can apply real-time corrective action as appropriate. As a result of field audits, responsible parties often observe vast improvements in their consultant's field procedures and, consequently, receive more reliable and representative field data at a lower cost. The cost savings and improved data quality that result from properly completed field audits make the field auditing process both cost-effective and functional.

Quality Control Review of Coopers & Lybrand L.L.P. Polytechnic University. Fiscal Year Ended June 30, 1996

DTIC Science & Technology

1998-05-18

The objective of a quality control review is to assure that the audit was conducted in accordance with applicable standards and meets the auditing...requirements of the OMB Circular A-I 33. As the cognizant Federal agency for the University, we conducted a quality control review of the audit working...papers. We focused our review on the following qualitative aspects of the audit : due professional care, planning, supervision, independence, quality

The Academic Quality Handbook: Enhancing Higher Education in Universities and Further Education Colleges.

ERIC Educational Resources Information Center

McGhee, Patrick

This book is intended as an introduction to the management of quality assurance and enhancement in higher education, particularly in England. The text focuses on the relationship between institutional quality assurance and the auditing authority of the British Quality Assurance Agency for Higher Education. The chapters of part 1, "The Quality…

Field Audit Checklist Tool (FACT)

EPA Pesticide Factsheets

Download EPA's The Field Audit Checklist Tool (FACT). FACT is intended to help auditors perform field audits, to easily view monitoring plan, quality assurance and emissions data and provides access to data collected under MATS.

The internal audit of clinical areas: a pilot of the internal audit methodology in a health service emergency department.

PubMed

Brown, Alison; Santilli, Mario; Scott, Belinda

2015-12-01

Governing bodies of health services need assurance that major risks to achieving the health service objectives are being controlled. Currently, the main assurance mechanisms generated within the organization are through the review of implementation of policies and procedures and review of clinical audits and quality data. The governing bodies of health services need more robust, objective data to inform their understanding of the control of clinical risks. Internal audit provides a methodological framework that provides independent and objective assurance to the governing body on the control of significant risks. The article describes the pilot of the internal audit methodology in an emergency unit in a health service. An internal auditor was partnered with a clinical expert to assess the application of clinical criteria based on best practice guidelines. The pilot of the internal audit of a clinical area was successful in identifying significant clinical risks that required further management. The application of an internal audit methodology to a clinical area is a promising mechanism to gain robust assurance at the governance level regarding the management of significant clinical risks. This approach needs further exploration and trial in a range of health care settings. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

A multihospital medication allergy audit: a means to quality assurance.

PubMed

Hoffmann, R P; Ellerbrock, M C; Lovett, J E

1982-04-01

Seventeen community hospitals within the 16 division of the Sisters of Mercy Health Corporation cooperatively participated in a medication allergy audit program. Initial and follow-up audits were conducted at each hospital to determine whether allergy information for penicillin- or aspirin-sensitive patients was appropriately communicated to the pharmacist. A total of 483 patient records were reviewed during each audit which corresponded to 12% of each hospital's average patient census. In the initial audit, the overall acceptance rate for the combined hospitals was 62.3%. Following the first audit, each hospital undertook corrective follow-up measures in an attempt to improve its results. In the second audit, the overall acceptance rate improved significantly to 78.9%. It is concluded that this auditing process followed by corrective follow-up measures was an effective mechanism for improving the communication of patient allergy information and is a means to quality assurance. Future audits will be necessary to determine whether the beneficial effects produced will be sustained or improved.

Audit, guidelines and standards: clinical governance for hip fracture care in Scotland.

PubMed

Currie, Colin T; Hutchison, James D

To report on experience of national-level audit, guidelines and standards for hip fracture care in Scotland. Scottish Hip Fracture Audit (from 1993) documents case-mix, process and outcomes of hip fracture care in Scotland. Evidence-based national guidelines on hip fracture care are available (1997, updated 2002). Hip fracture serves as a tracer condition by the health quality assurance authority for its work on older people, which reported in 2004. Audit data are used locally to document care and support and monitor service developments. Synergy between the guidelines and the audit provides a means of improving care locally and monitoring care nationally. External review by the quality assurance body shows to what extent guideline-based standards relating to A&E care, pre-operative delay, multidisciplinary care and audit participation are met. Three national-level initiatives on hip fracture care have delivered: Reliable and large-scale comparative information on case-mix, care and outcomes; evidence-based recommendations on care; and nationally accountable standards inspected and reported by the national health quality assurance authority. These developments are linked and synergistic, and enjoy both clinical and managerial support. They provide an evolving framework for clinical governance, with casemix-adjusted outcome assessment for hip fracture care as a next step.

Institutional Audits: A Comparison of the Experiences of Three South African Universities

ERIC Educational Resources Information Center

Botha, Jan; Favish, Judy; Stephenson, Sandra

2008-01-01

South Africa's external quality assurance agency, the Higher Education Quality Committee (HEQC), commenced its first cycle of institutional audits in 2004. During 2005, three public higher education institutions were audited, namely the University of Cape Town, the University of Stellenbosch and Rhodes University. The process of preparing for and…

Achieving quality assurance through clinical audit.

PubMed

Patel, Seraphim

2010-06-01

Audit is a crucial component of improvements to the quality of patient care. Clinical audits are undertaken to help ensure that patients can be given safe, reliable and dignified care, and to encourage them to self-direct their recovery. Such audits are undertaken also to help reduce lengths of patient stay in hospital, readmission rates and delays in discharge. This article describes the stages of clinical audit and the support required to achieve organisational core values.

Policy Development of Quality Assurance: A Critical Perspective on Past and Future Issues.

ERIC Educational Resources Information Center

van der Westhuizen, L. J.

2000-01-01

Provides an overview of the initiatives and development of policies to establish a workable quality assurance system for institutions of higher education in South Africa in the last decade. Notes challenges such as the government's emphasis on programs of study and its requirement that quality assurance systems include institutional auditing,…

KPMG Peat Marwick LLP GreatLakes Composites Consortium, Inc. Fiscal Year Ended December 31, 1995

DTIC Science & Technology

1997-06-25

The objective of a quality control review is to assure that the audit was conducted in accordance with applicable standards and meets the auditing...requirements of the OMB Circular A-133. As the cognizant agency for the Institute, we conducted a quality control review of the audit working papers. We...focused our review on the qualitative aspects of the audit : due professional care, planning, supervision, independence, quality control, internal

Quality Assurance in American and British Higher Education: A Comparison.

ERIC Educational Resources Information Center

Stanley, Elizabeth C.; Patrick, William J.

1998-01-01

Compares quality improvement and accountability processes in the United States and United Kingdom. For the United Kingdom, looks at quality audits, institutional assessment, standards-based quality assurance, and research assessment; in the United States, looks at regional and specialized accreditation, performance indicator systems, academic…

Assuring Quality in Education Evaluation.

ERIC Educational Resources Information Center

Trochim, William M. K.; Visco, Ronald J.

1986-01-01

A number of quality assurance educational evaluation methods are illustrated. Evaluation data obtained from the Providence, Rhode Island, school district are used. The methods are: (1) from auditing, internal control; (2) from accounting, double bookkeeping; and (3) from industrial quality control, acceptance sampling and cumulative percentage…

Current standards for infection control: audit assures compliance.

PubMed

Flanagan, Pauline

Having robust policies and procedures in place for infection control is fundamentally important. However, each organization has to go a step beyond this; evidence has to be provided that these policies and procedures are followed. As of 1 April 2009, with the introduction of the Care Quality Commission and The Health and Social Care Act 2008 Code of Practice for the NHS on the Prevention and Control of Healthcare-Associated Infections and Related Guidance, the assurance of robust infection control measures within any UK provider of health care became an even higher priority. Also, the commissioning of any service by the NHS must provide evidence that the provider has in place robust procedures for infection control. This article demonstrates how the clinical audit team at the Douglas Macmillan Hospice in North Staffordshire, UK, have used audit to assure high rates of compliance with the current national standards for infection control. Prior to the audit, hospice staff had assumed that the rates of compliance for infection control approached 100%. This article shows that a good quality audit tool can be used to identify areas of shortfall in infection control and the effectiveness of putting in place an action plan followed by re-audit.

A new quality assurance package for hospital palliative care teams: the Trent Hospice Audit Group model.

PubMed

Hunt, J; Keeley, V L; Cobb, M; Ahmedzai, S H

2004-07-19

Cancer patients in hospitals are increasingly cared for jointly by palliative care teams, as well as oncologists and surgeons. There has been a considerable growth in the number and range of hospital palliative care teams (HPCTs) in the United Kingdom. HPCTs can include specialist doctors and nurses, social workers, chaplains, allied health professionals and pharmacists. Some teams work closely with existing cancer multidisciplinary teams (MDTs) while others are less well integrated. Quality assurance and clinical governance requirements have an impact on the monitoring of such teams, but so far there is no standardised way of measuring the amount and quality of HPCTs' workload. Trent Hospice Audit Group (THAG) is a multiprofessional research group, which has been developing standards and audit tools for palliative care since the 1990s. These follow a format of structure-process-outcome for standards and measures. We describe a collaborative programme of work with HPCTs that has led to a new set of standards and audit tools. Nine HPCTs participated in three rounds of consultation, piloting and modification of standard statements and tools. The final pack of HPCT quality assurance tools covers: policies and documentation; medical notes review; questionnaires for ward-based staff. The tools measure the HPCT workload and casemix; the views of ward-based staff on the supportive role of the HPCT and the effectiveness of HPCT education programmes, particularly in changing practice. The THAG HPCT quality assurance pack is now available for use in cancer peer review.

NEVER AUDIT ALONE--THE CASE FOR AUDIT TEAMS

EPA Science Inventory

On-site audits conducted by technical and quality assurance (QA) experts at the data-gathering location are the core of an effective QA program. However, inadequate resources for such audits are the bane of a QA program, and the proposed solution frequently is to send only one au...

Higher Education as an International Commodity: Ensuring Quality in Partnerships.

ERIC Educational Resources Information Center

Hodson, Peter J.; Thomas, Harold G.

2001-01-01

Describes how overseas collaborative activity has been particularly popular with many United Kingdom higher education institutions over the past decade, with the Quality Assurance Agency creating an audit agenda to measure the quality of such partnerships. Asserts that existing collaborative audit approaches lack cultural sensitivity and are open…

Quality Assurance Plans under the Renewable Fuel Standard Program

EPA Pesticide Factsheets

Quality Assurance Plan or (QAP) is a voluntary program where independent third-parties may audit and verify that RINs have been properly generated and are valid for compliance purposes. RINs verified under a QAP may be purchased by regulated parties.

Criteria for internal auditing.

PubMed

Holder, W W; Clay, R J

1979-01-01

An effective, inclusive internal auditing endeavor should help assure hospital managements that (1) an adequate system of internal control exists to assure the safeguarding of assets and the reliability of data produced by the financial information system, (2) uneconomic operating practices are detected promptly so they can be remedied, and (3) program results and effectiveness levels are of sufficiently high quality to demonstrate managerial competence.

78 FR 69084 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-18

... quality assurance requirements in 40 CFR part 58, appendix A, require: ``2.6 Gaseous and Flow Rate Audit... Quality Assurance Regulations. These data and information are collected by state, local, and tribal air... ``EPA'' in any form of advertising.'' These requirements give assurance to end users that all specialty...

The quality assurance liaison: Combined technical and quality assurance support

NASA Astrophysics Data System (ADS)

Bolivar, S. L.; Day, J. L.

1993-03-01

The role of the quality assurance liaison, the responsibilities of this position, and the evolutionary changes in duties over the last six years are described. The role of the quality assurance liaison has had a very positive impact on the Los Alamos Yucca Mountain Site Characterization (YW) quality assurance program. Having both technical and quality assurance expertise, the quality assurance liaisons are able to facilitate communications with scientists on quality assurance issues and requirements, thereby generating greater productivity in scientific investigations. The quality assurance liaisons help ensure that the scientific community knows and implements existing requirements, is aware of new or changing regulations, and is able to conduct scientific work within Project requirements. The influence of the role of the quality assurance liaison can be measured by an overall improvement in attitude of the staff regarding quality assurance requirements and improved job performance, as well as a decrease in deficiencies identified during both internal and external audits and surveillances. This has resulted in a more effective implementation of quality assurance requirements.

Thermoluminescent dosimeters (TLD) quality assurance network in the Czech Republic.

PubMed

Kroutilķková, Daniela; Novotný, Josef; Judas, Libor

2003-02-01

The Czech thermoluminescent dosimeters (TLD) quality assurance network was established in 1997. Its aim is to pursue a regular independent quality audit in Czech radiotherapy centres and to support state supervision. The audit is realised via mailed TL dosimetry. The TLD system consists of encapsulated LiF:Mg,Ti powder (type MT-N) read with Harshaw manual reader model 4000. Basic mode of the TLD audit covers measurements under reference conditions, specifically beam calibration checks for all clinically used photon and electron beams. Advanced mode consists of measurements under both reference and non-reference conditions using a solid multipurpose phantom ('Leuven phantom') for photon beams. The radiotherapy centres are instructed to deliver to the TLD on central beam axis absorbed dose of 2 Gy calculated with their treatment planning system for a particular treatment set-up. The TLD measured doses are compared with the calculated ones. Deviations of +/-3% are considered acceptable for both basic and advanced mode of the audit. There are 34 radiotherapy centres in the Czech Republic. They undergo the basic mode of the TLD audit regularly every 2 years. If a centre shows a deviation outside the acceptance level, it is audited more often. Presently, most of the checked beams comply with the acceptance level. The advanced TLD audit has been implemented as a pilot study for the present. The results were mostly within the acceptance limit for the measurements on-axis, whereas for off-axis points they fell beyond the limit more frequently, especially for set-ups with inhomogeneities, oblique incidence and wedges. The results prove the importance of the national TLD quality assurance network. It has contributed to the improvement of clinical dosimetry in the Czech Republic. In addition, it helps the regulatory authority to monitor effectively and regularly radiotherapy centres.

External quality-assurance programs managed by the U.S. Geological Survey in support of the National Atmospheric Deposition Program/National Trends Network

USGS Publications Warehouse

Latysh, Natalie E.; Wetherbee, Gregory A.

2005-01-01

The U.S. Geological Survey, Branch of Quality Systems, operates the external quality-assurance programs for the National Atmospheric Deposition Program/National Trends Network (NADP/NTN). Beginning in 1978, six different programs have been implemented?the intersite-comparison program, the blind-audit program, the sample-handling evaluation program, the field-audit program, the interlaboratory-comparison program, and the collocated-sampler program. Each program was designed to measure error contributed by specific components in the data-collection process. The intersite-comparison program, which was discontinued in 2004, was designed to assess the accuracy and reliability of field pH and specific-conductance measurements made by site operators. The blind-audit and sample-handling evaluation programs, which also were discontinued in 2002 and 2004, respectively, assessed contamination that may result from sampling equipment and routine handling and processing of the wet-deposition samples. The field-audit program assesses the effects of sample handling, processing, and field exposure. The interlaboratory-comparison program evaluates bias and precision of analytical results produced by the contract laboratory for NADP, the Illinois State Water Survey, Central Analytical Laboratory, and compares its performance with the performance of international laboratories. The collocated-sampler program assesses the overall precision of wet-deposition data collected by NADP/NTN. This report documents historical operations and the operating procedures for each of these external quality-assurance programs. USGS quality-assurance information allows NADP/NTN data users to discern between actual environmental trends and inherent measurement variability.

NCQA implements new outcomes audit standards.

PubMed

1997-06-01

Faulty data gathering and auditing techniques have put in question the comparability of HEDIS outcomes standards. The National Center for Quality Assurance has moved to shore up its data's credibility with new auditing standards. A new class of certified auditors must be trained. Until then, the Health Care Financing Administration will have Medicare managed care organizations audited by independent firms.

Spinal cord testing: auditing for quality assurance.

PubMed

Marr, J A; Reid, B

1991-04-01

A quality assurance audit of spinal cord testing as documented by staff nurses was carried out. Twenty-five patient records were examined for accuracy of documented testing and compared to assessments performed by three investigators. A pilot study established interrater reliability of a tool that was designed especially for this study. Results indicated staff nurses failed to meet pre-established 100% standard in all categories of testing when compared with investigator's findings. Possible reasons for this disparity are discussed as well as indications for modifications in the spinal testing record, teaching program and preset standards.

A clinical audit programme for diagnostic radiology: the approach adopted by the International Atomic Energy Agency.

PubMed

Faulkner, K; Järvinen, H; Butler, P; McLean, I D; Pentecost, M; Rickard, M; Abdullah, B

2010-01-01

The International Atomic Energy Agency (IAEA) has a mandate to assist member states in areas of human health and particularly in the use of radiation for diagnosis and treatment. Clinical audit is seen as an essential tool to assist in assuring the quality of radiation medicine, particularly in the instance of multidisciplinary audit of diagnostic radiology. Consequently, an external clinical audit programme has been developed by the IAEA to examine the structure and processes existent at a clinical site, with the basic objectives of: (1) improvement in the quality of patient care; (2) promotion of the effective use of resources; (3) enhancement of the provision and organisation of clinical services; (4) further professional education and training. These objectives apply in four general areas of service delivery, namely quality management and infrastructure, patient procedures, technical procedures and education, training and research. In the IAEA approach, the audit process is initiated by a request from the centre seeking the audit. A three-member team, comprising a radiologist, medical physicist and radiographer, subsequently undertakes a 5-d audit visit to the clinical site to perform the audit and write the formal audit report. Preparation for the audit visit is crucial and involves the local clinical centre completing a form, which provides the audit team with information on the clinical centre. While all main aspects of clinical structure and process are examined, particular attention is paid to radiation-related activities as described in the relevant documents such as the IAEA Basic Safety Standards, the Code of Practice for Dosimetry in Diagnostic Radiology and related equipment and quality assurance documentation. It should be stressed, however, that the clinical audit does not have any regulatory function. The main purpose of the IAEA approach to clinical audit is one of promoting quality improvement and learning. This paper describes the background to the clinical audit programme and the IAEA clinical audit protocol.

40 CFR 96.72 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... quality assurance requirements of appendix B of part 75 of this chapter, data shall be substituted using...) Audit decertification. Whenever both an audit of a monitoring system and a review of the initial... certification or recertification application submission and at the time of the audit, the permitting authority...

78 FR 12157 - RFS Renewable Identification Number (RIN) Quality Assurance Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... conducting their own audits of renewable fuel production facilities. Given the time and effort to conduct... that invalid RINs are replaced with valid RINs. Requirements for audits of renewable fuel production... production and RIN generation. Most conduct some form of on-site audit including a review of production...

Development and Operation of a Voluntary Audit Program.

ERIC Educational Resources Information Center

Murphy, Jerome R.

This report describes a voluntary audit program implemented by the Educational Testing Service (ETS). The comprehensive audit program was developed to assure that all corporate programs adhere to the ETS Standards for Quality and Fairness. The standards address issues which relate to all ETS activities such as accountability, confidentiality of…

The Rockford School of Medicine Undergraduate Quality Assurance Program

ERIC Educational Resources Information Center

Barr, Daniel; And Others

1976-01-01

An undergraduate program of ambulatory care quality assurance is described which has been operational at the Rockford School of Medicine for three years. Focus is on involving students in peer review and related audit activities. Results of preliminary evaluation are reported and generalizations offered. (JT)

External audit of clinical practice and medical decision making in a new Asian oncology center: Results and implications for both developing and developed nations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Shakespeare, Thomas P.; Back, Michael F.; Lu, Jiade J.

2006-03-01

Purpose: The external audit of oncologist clinical practice is increasingly important because of the incorporation of audits into national maintenance of certification (MOC) programs. However, there are few reports of external audits of oncology practice or decision making. Our institution (The Cancer Institute, Singapore) was asked to externally audit an oncology department in a developing Asian nation, providing a unique opportunity to explore the feasibility of such a process. Methods and Materials: We audited 100 randomly selected patients simulated for radiotherapy in 2003, using a previously reported audit instrument assessing clinical documentation/quality assurance and medical decision making. Results: Clinical documentation/qualitymore » assurance, decision making, and overall performance criteria were adequate 74.4%, 88.3%, and 80.2% of the time, respectively. Overall 52.0% of cases received suboptimal management. Multivariate analysis revealed palliative intent was associated with improved documentation/clinical quality assurance (p = 0.07), decision making (p 0.007), overall performance (p = 0.003), and optimal treatment rates (p 0.07); non-small-cell lung cancer or central nervous system primary sites were associated with better decision making (p = 0.001), overall performance (p = 0.03), and optimal treatment rates (p = 0.002). Conclusions: Despite the poor results, the external audit had several benefits. It identified learning needs for future targeting, and the auditor provided facilitating feedback to address systematic errors identified. Our experience was also helpful in refining our national revalidation audit instrument. The feasibility of the external audit supports the consideration of including audit in national MOC programs.« less

Opportunity or Exploitation? Women and Quality Assurance in Higher Education

ERIC Educational Resources Information Center

Morley, Louise

2005-01-01

Based on interviews with 18 UK women academics and managers on quality and power in higher education, this article interrogates the impact of quality assurance discourses and practices on women in higher education. Micro-level analysis of the effects of audit and the evaluative state seem to suggest that hegemonic masculinities and gendered power…

75 FR 12559 - Statement of Organization, Functions and Delegations of Authority

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-16

... National, State and local professional organizations to promote quality assurance efforts and deter fraud... publishes State Board compliance reports; (3) conducts audits to ensure validity of data in the banks; (4) develops programs of research on trends in data, quality assurance, risk management, medical liability and...

Establishing Quality Assurance in the South African Context

ERIC Educational Resources Information Center

Strydom, A. H.; Strydom, J. F.

2004-01-01

This paper provides perspectives on the unique challenges and opportunities facing the national auditing and accreditation system in South African higher education. In doing so, the quality assurance contexts of developed countries, Africa and South Africa are considered and the issues of uncertainty and conformity are highlighted. This is…

The Dutch surgical colorectal audit.

PubMed

Van Leersum, N J; Snijders, H S; Henneman, D; Kolfschoten, N E; Gooiker, G A; ten Berge, M G; Eddes, E H; Wouters, M W J M; Tollenaar, R A E M; Bemelman, W A; van Dam, R M; Elferink, M A; Karsten, Th M; van Krieken, J H J M; Lemmens, V E P P; Rutten, H J T; Manusama, E R; van de Velde, C J H; Meijerink, W J H J; Wiggers, Th; van der Harst, E; Dekker, J W T; Boerma, D

2013-10-01

In 2009, the nationwide Dutch Surgical Colorectal Audit (DSCA) was initiated by the Association of Surgeons of the Netherlands (ASN) to monitor, evaluate and improve colorectal cancer care. The DSCA is currently widely used as a blueprint for the initiation of other audits, coordinated by the Dutch Institute for Clinical Auditing (DICA). This article illustrates key elements of the DSCA and results of three years of auditing. Key elements include: a leading role of the professional association with integration of the audit in the national quality assurance policy; web-based registration by medical specialists; weekly updated online feedback to participants; annual external data verification with other data sources; improvement projects. In two years, all Dutch hospitals participated in the audit. Case-ascertainment was 92% in 2010 and 95% in 2011. External data verification by comparison with the Netherlands Cancer Registry (NCR) showed high concordance of data items. Within three years, guideline compliance for diagnostics, preoperative multidisciplinary meetings and standardised reporting increased; complication-, re-intervention and postoperative mortality rates decreased significantly. The success of the DSCA is the result of effective surgical collaboration. The leading role of the ASN in conducting the audit resulted in full participation of all colorectal surgeons in the Netherlands. By integrating the audit into the ASNs' quality assurance policy, it could be used to set national quality standards. Future challenges include reduction of administrative burden; expansion to a multidisciplinary registration; and addition of financial information and patient reported outcomes to the audit data. Copyright © 2013 Elsevier Ltd. All rights reserved.

[Not Available].

PubMed

1996-03-01

The subject of audit can seem confusing to the uninitiated. A proliferation of jargon appears to have developed as issues of quality, quality assurance, value for money and effectiveness have become more prone to investigation through the audit cycle. It may also appear' that research and audit serve different masters, the researcher's altruistic aim of furthering the knowledge base of nursing (ultimately for the benefit of patients) seemingly at odds with the manager's obsession with saving money through audit. If that is the view held by many nurses then this issue of Nurse Researcher aims to clarify the picture and establish the real relationship between audit and research.

External Quality Assurance Programs Managed by the U.S. Geological Survey in Support of the National Atmospheric Deposition Program/Mercury Deposition Network

USGS Publications Warehouse

Latysh, Natalie E.; Wetherbee, Gregory A.

2007-01-01

The U.S. Geological Survey (USGS) Branch of Quality Systems operates external quality assurance programs for the National Atmospheric Deposition Program/Mercury Deposition Network (NADP/MDN). Beginning in 2004, three programs have been implemented: the system blank program, the interlaboratory comparison program, and the blind audit program. Each program was designed to measure error contributed by specific components in the data-collection process. The system blank program assesses contamination that may result from sampling equipment, field exposure, and routine handling and processing of the wet-deposition samples. The interlaboratory comparison program evaluates bias and precision of analytical results produced by the Mercury Analytical Laboratory (HAL) for the NADP/MDN, operated by Frontier GeoSciences, Inc. The HAL's performance is compared with the performance of five other laboratories. The blind audit program assesses bias and variability of MDN data produced by the HAL using solutions disguised as environmental samples to ascertain true laboratory performance. This report documents the implementation of quality assurance procedures for the NADP/MDN and the operating procedures for each of the external quality assurance programs conducted by the USGS. The USGS quality assurance information provides a measure of confidence to NADP/MDN data users that measurement variability is distinguished from environmental signals.

Monitoring Compliance to Promote Quality Assurance: Development of a Mental Health Clinical Chart Audit Tool in Belize, 2013.

PubMed

Winer, Rachel A; Bennett, Eleanor; Murillo, Illouise; Schuetz-Mueller, Jan; Katz, Craig L

2015-09-01

Belize trained psychiatric nurse practitioners (PNPs) in the early 1990s to provide mental health services throughout the country. Despite overwhelming success, the program is limited by lack of monitoring, evaluation, and surveillance. To promote quality assurance, we developed a chart audit tool to monitor mental healthcare delivery compliance for initial psychiatric assessment notes completed by PNPs. After reviewing the Belize Health Information System electronic medical record system, we developed a clinical audit tool to capture 20 essential components for initial assessment clinical notes. The audit tool was then piloted for initial assessment notes completed during July through September of 2013. One hundred and thirty-four initial psychiatric interviews were audited. The average chart score among all PNPs was 9.57, ranging from 3 to 15. Twenty-three charts-or 17.2%-had a score of 14 or higher and met a 70% compliance benchmark goal. Among indicators most frequently omitted included labs ordered and named (15.7%) and psychiatric diagnosis (21.6%). Explicit statement of medications initiated with dose and frequency occurred in 47.0% of charts. Our findings provide direction for training and improvement, such as emphasizing the importance of naming labs ordered, medications and doses prescribed, and psychiatric diagnoses in initial assessment clinical notes. We hope this initial assessment helps enhance mental health delivery compliance by prompting creation of BHIS templates, development of audits tools for revisit follow-up visits, and establishment of corrective actions for low-scoring practitioners. These efforts may serve as a model for implementing quality assurance programming in other low resource settings.

15 CFR 995.14 - Auditing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Auditing. 995.14 Section 995.14... AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION REQUIREMENTS FOR NOAA HYDROGRAPHIC PRODUCTS AND SERVICES CERTIFICATION REQUIREMENTS FOR DISTRIBUTORS OF NOAA...

Defense Contract Management Agency Santa Ana Quality Assurance Oversight Needs lmprovement

DTIC Science & Technology

2013-04-19

Management Agency Santa Ana Quality Assurance Oversight Needs Improvement What We Did We determined whether the Defense Contract Management Agency (DCMA...for critical safety items (CSIs). For this audit, we reviewed QA oversight of four contracts valued at about $278 million. What We Found The DCMA...limited assurance that 18,507 critical safety items, consisting of T-11 parachutes, oxygen masks, drone parachutes, and breathing apparatuses met

The role of dosimetry audit in lung SBRT multi-centre clinical trials.

PubMed

Clark, Catharine H; Hurkmans, Coen W; Kry, Stephen F

2017-12-01

Stereotactic Body Radiotherapy (SBRT) in the lung is a challenging technique which requires high quality clinical trials to answer the un-resolved clinical questions. Quality assurance of these clinical trials not only ensures the safety of the treatment of the participating patients but also minimises the variation in treatment, thus allowing the lowest number of patient treatments to answer the trial question. This review addresses the role of dosimetry audits in the quality assurance process and considers what can be done to ensure the highest accuracy of dose calculation and delivery and it's assessment in multi-centre trials. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Combining ISO/IEC 17025:2005 and European Commission Decision 2002/657 audit requirements: a practical way forward.

PubMed

Kay, Jack F

2012-08-01

Laboratories involved in the analyses of veterinary drug residues are under increasing pressure to demonstrate that they produce meaningful and reliable data. Quality assurance and quality control systems are implemented in laboratories to provide evidence of this and these are subject to external assessment to ensure that they are effective. Audits to ISO/IEC 17025:2005, an internationally accepted standard, and subsequent accreditation provide laboratories and their customers with a degree of assurance that the laboratories are operating in control and the data they report can be relied on. However, national or regional authorities may place additional requirements on laboratories to ensure quality data are reported. For example, in the European Union, all official control laboratories involved in veterinary drug residue analyses must also meet the requirements of European Commission Decision 2002/657/EC which sets performance criteria for analytical methods used in this area and these are subject to additional audits by national or regional authorities. All audits place considerable time and resource demands on laboratories and this paper discusses the burden audits place on laboratories and describes a UK initiative to combine these audits to the benefit of both the regulatory authority and the laboratory. © 2012 John Wiley & Sons, Ltd.

'Screening audit' as a quality assurance tool in good clinical practice compliant research environments.

PubMed

Park, Sinyoung; Nam, Chung Mo; Park, Sejung; Noh, Yang Hee; Ahn, Cho Rong; Yu, Wan Sun; Kim, Bo Kyung; Kim, Seung Min; Kim, Jin Seok; Rha, Sun Young

2018-04-25

With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice (GCP) and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed a simple auditing process (a screening audit) and evaluated its feasibility and effectiveness. The screening audit was developed using a routine audit checklist based on the Severance Hospital's Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. RESULTS: Investigator reply rates gradually increased, except for the first year (73% → 26% → 53% → 49% → 55%). The studies were graded as "critical," "major," "minor," and "not a finding" (11.9, 39.0, 42.9, and 6.3%, respectively), based on findings and number of deficiencies. The auditors' decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being "major" or "critical" (p = 0.002, < 0.0001, < 0.0001, respectively). Inappropriateness of documents, failure to obtain informed consent, inappropriateness of informed consent process, and failure to protect participants' personal information were associated with higher audit grade (p < 0.0001, p = 0.0001, p < 0.0001, p = 0.003). We were able to observe critical GCP violations in the routine internal audit results of post-screening audit compliance checks in "non-responding" and "critical" studies upon applying the screening audit. Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to ensure medical ethics. The tool also provides useful selection criteria for conducting routine audits.

AN AUDITING FRAMEWORK TO SUBSTANTIATE ELECTRONIC RECORDKEEPING PRACTICES

EPA Science Inventory

Quality assurance audits of computer systems help to ensure that the end data meet the needs of the user. Increasingly complex systems require the stepwise procedures outlined below.

The areas reviewed in this paper include both technical and evidentiary criteria. I...

Auditing the nutrition content of patient charts: one hospital's perspective.

PubMed

Skopelianos, S

1993-01-01

Chart audits are traditionally based on patient charts categorized by disease. An alternate approach, using categorization by four types of nutrition care intervention, has been developed by University Hospital. This paper describes the process followed, criteria developed and the results of two complete chart audits. It was shown that nutrition profile forms improved documentation. Overall norms increased significantly from 81.5% to 90% (p < .05). Discussion centres on the evolutionary process from quality assurance to continuous quality improvement.

Software quality assurance plan for GCS

NASA Technical Reports Server (NTRS)

Duncan, Stephen E.; Bailey, Elizabeth K.

1990-01-01

The software quality assurance (SQA) function for the Guidance and Control Software (GCS) project which is part of a software error studies research program is described. The SQA plan outlines all of the procedures, controls, and audits to be carried out by the SQA organization to ensure adherence to the policies, procedures, and standards for the GCS project.

The role of health informatics in clinical audit: part of the problem or key to the solution?

PubMed

Georgiou, Andrew; Pearson, Michael

2002-05-01

The concepts of quality assurance (for which clinical audit is an essential part), evaluation and clinical governance each depend on the ability to derive and record measurements that describe clinical performance. Rapid IT developments have raised many new possibilities for managing health care. They have allowed for easier collection and processing of data in greater quantities. These developments have encouraged the growth of quality assurance as a key feature of health care delivery. In the past most of the emphasis has been on hospital information systems designed predominantly for the administration of patients and the management of financial performance. Large, hi-tech information system capacity does not guarantee quality information. The task of producing information that can be confidently used to monitor the quality of clinical care requires attention to key aspects of the design and operation of the audit. The Myocardial Infarction National Audit Project (MINAP) utilizes an IT-based system to collect and process data on large numbers of patients and make them readily available to contributing hospitals. The project shows that IT systems that employ rigorous health informatics methodologies can do much to improve the monitoring and provision of health care.

Quality assurance audit: a prospective non-randomised trial of chemotherapy and radiotherapy for osteolymphoma (TROG 99.04/ALLG LY02).

PubMed

Christie, D; Le, T; Watling, K; Cornes, D; O'Brien, P; Hitchins, R

2009-04-01

A quality assurance (QA) audit of the Trans Tasman Radiation Oncology Group and Australasian Lymphoma and Leukaemia Group trial (TROG 99.04/ALLG LY02) began after accrual of 25 patients. The trial is a prospective non-randomized study of standard treatment for osteolymphoma. Data relating to informed consent, eligibility, chemotherapy and radiotherapy were reviewed. The audit showed a relatively low level of major variations from the protocol, with an overall rate of 3.6%. As this trial has accrued slowly over a long period, the concept of QA has also developed. Amendments were made to the protocol accordingly. In the future, QA procedures should be predetermined, conducted rapidly in real time, and appropriately funded in order to be relevant to the ongoing conduct of the trial.

What can we learn from a decade of database audits? The Duke Clinical Research Institute experience, 1997--2006.

PubMed

Rostami, Reza; Nahm, Meredith; Pieper, Carl F

2009-04-01

Despite a pressing and well-documented need for better sharing of information on clinical trials data quality assurance methods, many research organizations remain reluctant to publish descriptions of and results from their internal auditing and quality assessment methods. We present findings from a review of a decade of internal data quality audits performed at the Duke Clinical Research Institute, a large academic research organization that conducts data management for a diverse array of clinical studies, both academic and industry-sponsored. In so doing, we hope to stimulate discussions that could benefit the wider clinical research enterprise by providing insight into methods of optimizing data collection and cleaning, ultimately helping patients and furthering essential research. We present our audit methodologies, including sampling methods, audit logistics, sample sizes, counting rules used for error rate calculations, and characteristics of audited trials. We also present database error rates as computed according to two analytical methods, which we address in detail, and discuss the advantages and drawbacks of two auditing methods used during this 10-year period. Our review of the DCRI audit program indicates that higher data quality may be achieved from a series of small audits throughout the trial rather than through a single large database audit at database lock. We found that error rates trended upward from year to year in the period characterized by traditional audits performed at database lock (1997-2000), but consistently trended downward after periodic statistical process control type audits were instituted (2001-2006). These increases in data quality were also associated with cost savings in auditing, estimated at 1000 h per year, or the efforts of one-half of a full time equivalent (FTE). Our findings are drawn from retrospective analyses and are not the result of controlled experiments, and may therefore be subject to unanticipated confounding. In addition, the scope and type of audits we examine here are specific to our institution, and our results may not be broadly generalizable. Use of statistical process control methodologies may afford advantages over more traditional auditing methods, and further research will be necessary to confirm the reliability and usability of such techniques. We believe that open and candid discussion of data quality assurance issues among academic and clinical research organizations will ultimately benefit the entire research community in the coming era of increased data sharing and re-use.

Interobserver agreement between primary graders and an expert grader in the Bristol and Weston diabetic retinopathy screening programme: a quality assurance audit.

PubMed

Patra, S; Gomm, E M W; Macipe, M; Bailey, C

2009-08-01

To assess the quality and accuracy of primary grading in the Bristol and Weston diabetic retinopathy screening programme and to set standards for future interobserver agreement reports. A prospective audit of 213 image sets from six fully trained primary graders in the Bristol and Weston diabetic retinopathy screening programme was carried out over a 4-week period. All the images graded by the primary graders were regraded by an expert grader blinded to the primary grading results and the identity of the primary grader. The interobserver agreement between primary graders and the blinded expert grader and the corresponding Kappa coefficient was determined for overall grading, referable, non-referable and ungradable disease. The audit standard was set at 80% for interobserver agreement with a Kappa coefficient of 0.7. The interobserver agreement bettered the audit standard of 80% in all the categories. The Kappa coefficient was substantial (0.7) for the overall grading results and ranged from moderate to substantial (0.59-0.65) for referable, non-referable and ungradable disease categories. The main recommendation of the audit was to provide refresher training for the primary graders with focus on ungradable disease. The audit demonstrated an acceptable level of quality and accuracy of primary grading in the Bristol and Weston diabetic retinopathy screening programme and provided a standard against which future interobserver agreement can be measured for quality assurance within a screening programme. Diabet. Med. 26, 820-823 (2009).

Present and Future in Quality Assurance of Engineering Education in Japan

NASA Astrophysics Data System (ADS)

Aoki, Kyosuke; Nozawa, Tsunenori

The quality of engineering education in our country should be assured by the self-assessment of the institution that conducts education. Recent evaluation and/or accreditation are intended to assist and promote such achievement. The certified evaluation and accreditation for colleges of technology and the audit by the Japan Accreditation Board for Engineering Education (JABEE) have been carried out on the engineering education. In this article we will discuss the ways of accreditation of both systems and try to consider future for the quality assurance of the engineering education in Japan.

An institutional review board-based clinical research quality assurance program.

PubMed

Lad, Pramod M; Dahl, Rebecca

2013-01-01

Despite the acknowledged importance of quality assurance in the clinical research process, the problem of how such a program should be implemented at the level of an academic teaching hospital or a similar institution has not been addressed in the literature. Despite the fact that quality assurance is expected in programs which certify and accredit Institutional Review Boards (IRBs), very little is known about the role of the IRB in programs of clinical research quality assurance. In this article we consider the definition of clinical research quality assurance, and describe a program designed to achieve it. The key elements of such a program are education at the site level, which has both mandatory and voluntary components, and an auditing and monitoring program, which reinforces the education on quality assurance. The role of the IRB in achieving the program goals and the organizational placement of the quality assurance program within the IRB structure and function are important items of discussion.

30 CFR 74.9 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... registration under ISO Q9001-2000, American National Standard, Quality Management Systems-Requirements... ISO Q9001-2000, American National Standard, Quality Management Systems-Requirements. The Director of... management audits. Upon request, applicants or approval holders must allow NIOSH to inspect the quality...

Quality assurance in surgical practice through auditing.

PubMed

Wong, W T

1980-05-01

An efficient auditing method is presented which involves objective criteria-based numerical screening of medical process and treatment outcome by paramedical staff and detailed analysis of deviated cases by surgeons. If properly performed it requires the study of no more than 50 cases in a diagnostic category to provide sufficient information about the quality of care. Encouraging points as well as problems are communicated to the surgeons to induce the maintenance or improvement of the standard of care. Graphic documentation of case performance is possible, allowing surgeons to compare results with their colleagues. The general performance level of several consecutive studies can be compared at a glance. In addition, logical education programs to improve the medical process can be designed on the basis of the problems identified. As all the cases with an unacceptable outcome are traceable to inadequate medical process, improvement in this area will decrease outcome defects. With the use of auditing and the follow-up technique described, the quality of care in surgery may be assured.

40 CFR Appendix A to Part 58 - Quality Assurance Requirements for SLAMS, SPMs and PSD Air Monitoring

Code of Federal Regulations, 2011 CFR

2011-07-01

... in section 4.3.1 of this appendix. 3.2.7PM2.5 Performance Evaluation Program (PEP) Procedures. The... evaluation audit means that both the primary monitor and PEP audit concentrations are valid and above 3 µg/m3... Evaluation Program (PEP) Procedures. Each year, one performance evaluation audit, as described in section 3.2...

40 CFR Appendix A to Part 58 - Quality Assurance Requirements for SLAMS, SPMs and PSD Air Monitoring

Code of Federal Regulations, 2012 CFR

2012-07-01

... in section 4.3.1 of this appendix. 3.2.7PM2.5 Performance Evaluation Program (PEP) Procedures. The... evaluation audit means that both the primary monitor and PEP audit concentrations are valid and above 3 µg/m3... Evaluation Program (PEP) Procedures. Each year, one performance evaluation audit, as described in section 3.2...

Auditing radiation sterilization facilities

NASA Astrophysics Data System (ADS)

Beck, Jeffrey A.

The diversity of radiation sterilization systems available today places renewed emphasis on the need for thorough Quality Assurance audits of these facilities. Evaluating compliance with Good Manufacturing Practices is an obvious requirement, but an effective audit must also evaluate installation and performance qualification programs (validation_, and process control and monitoring procedures in detail. The present paper describes general standards that radiation sterilization operations should meet in each of these key areas, and provides basic guidance for conducting QA audits of these facilities.

Measuring Data Quality Through a Source Data Verification Audit in a Clinical Research Setting.

PubMed

Houston, Lauren; Probst, Yasmine; Humphries, Allison

2015-01-01

Health data has long been scrutinised in relation to data quality and integrity problems. Currently, no internationally accepted or "gold standard" method exists measuring data quality and error rates within datasets. We conducted a source data verification (SDV) audit on a prospective clinical trial dataset. An audit plan was applied to conduct 100% manual verification checks on a 10% random sample of participant files. A quality assurance rule was developed, whereby if >5% of data variables were incorrect a second 10% random sample would be extracted from the trial data set. Error was coded: correct, incorrect (valid or invalid), not recorded or not entered. Audit-1 had a total error of 33% and audit-2 36%. The physiological section was the only audit section to have <5% error. Data not recorded to case report forms had the greatest impact on error calculations. A significant association (p=0.00) was found between audit-1 and audit-2 and whether or not data was deemed correct or incorrect. Our study developed a straightforward method to perform a SDV audit. An audit rule was identified and error coding was implemented. Findings demonstrate that monitoring data quality by a SDV audit can identify data quality and integrity issues within clinical research settings allowing quality improvement to be made. The authors suggest this approach be implemented for future research.

A quality assurance audit: phase III trial of maximal androgen deprivation in prostate cancer (TROG 96.01).

PubMed

Steigler, A; Mameghan, H; Lamb, D; Joseph, D; Matthews, J; Franklin, I; Turner, S; Spry, N; Poulsen, M; North, J; Kovacev, O; Denham, J

2000-02-01

In 1997 the Trans-Tasman Radiation Oncology Group (TROG) performed a quality assurance (QA) audit of its phase III randomized clinical trial investigating the effectiveness of different durations of maximal androgen deprivation prior to and during definitive radiation therapy for locally advanced carcinoma of the prostate (TROG 96.01). The audit reviewed a total of 60 cases from 15 centres across Australia and New Zealand. In addition to verification of technical adherence to the protocol, the audit also incorporated a survey of centre planning techniques and a QA time/cost analysis. The present report builds on TROG's first technical audit conducted in 1996 for the phase III accelerated head and neck trial (TROG 91.01) and highlights the significant progress TROG has made in the interim period. The audit provides a strong validation of the results of the 96.01 trial, as well as valuable budgeting and treatment planning information for future trials. Overall improvements were detected in data quality and quantity, and in protocol compliance, with a reduction in the rate of unacceptable protocol violations from 10 to 4%. Audit design, staff education and increased data management resources were identified as the main contributing factors to these improvements. In addition, a budget estimate of $100 per patient has been proposed for conducting similar technical audits. The next major QA project to be undertaken by TROG during the period 1998-1999 is an intercentre dosimetry study. Trial funding and staff education have been targeted as the key major issues essential to the continued success and expansion of TROG's QA programme.

Redefining and expanding quality assurance.

PubMed

Robins, J L

1992-12-01

To meet the current standards of excellence necessary for blood establishments, we have learned from industry that a movement toward organization-wide quality assurance/total quality management must be made. Everyone in the organization must accept responsibility for participating in providing the highest quality products and services. Quality must be built into processes and design systems to support these quality processes. Quality assurance has been redefined to include a quality planning function described as the most effective way of designing quality into processes. A formalized quality planning process must be part of quality assurance. Continuous quality improvement has been identified as the strategy every blood establishment must support while striving for error-free processing as the long-term objective. The auditing process has been realigned to support and facilitate this same objective. Implementing organization-wide quality assurance/total quality management is one proven plan for guaranteeing the quality of the 20 million products that are transfused into 4 million patients each year and for moving toward the new order.

Pre-use anesthesia machine check; certified anesthesia technician based quality improvement audit.

PubMed

Al Suhaibani, Mazen; Al Malki, Assaf; Al Dosary, Saad; Al Barmawi, Hanan; Pogoku, Mahdhav

2014-01-01

Quality assurance of providing a work ready machine in multiple theatre operating rooms in a tertiary modern medical center in Riyadh. The aim of the following study is to keep high quality environment for workers and patients in surgical operating rooms. Technicians based audit by using key performance indicators to assure inspection, passing test of machine worthiness for use daily and in between cases and in case of unexpected failure to provide quick replacement by ready to use another anesthetic machine. The anesthetic machines in all operating rooms are daily and continuously inspected and passed as ready by technicians and verified by anesthesiologist consultant or assistant consultant. The daily records of each machines were collected then inspected for data analysis by quality improvement committee department for descriptive analysis and report the degree of staff compliance to daily inspection as "met" items. Replaced machine during use and overall compliance. Distractive statistic using Microsoft Excel 2003 tables and graphs of sums and percentages of item studied in this audit. Audit obtained highest compliance percentage and low rate of replacement of machine which indicate unexpected machine state of use and quick machine switch. The authors are able to conclude that following regular inspection and running self-check recommended by the manufacturers can contribute to abort any possibility of hazard of anesthesia machine failure during operation. Furthermore in case of unexpected reason to replace the anesthesia machine in quick maneuver contributes to high assured operative utilization of man machine inter-phase in modern surgical operating rooms.

40 CFR 89.511 - Suspension and revocation of certificates of conformity.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ENGINES Selective Enforcement Auditing § 89.511 Suspension and revocation of certificates of conformity... proposed quality control and/or quality assurance measures to be taken by the manufacturer to prevent...

40 CFR 90.511 - Suspension and revocation of certificates of conformity.

Code of Federal Regulations, 2010 CFR

2010-07-01

... KILOWATTS Selective Enforcement Auditing § 90.511 Suspension and revocation of certificates of conformity... proposed quality control and/or quality assurance measures to be taken by the manufacturer to prevent...

Quality assurance in the treatment of colorectal cancer: the EURECCA initiative.

PubMed

Breugom, A J; Boelens, P G; van den Broek, C B M; Cervantes, A; Van Cutsem, E; Schmoll, H J; Valentini, V; van de Velde, C J H

2014-08-01

Colorectal cancer is one of the most common cancers in Europe. Over the past few decades, important advances have been made in screening, staging and treatment of colorectal cancer. However, considerable variation between and within European countries remains, which implies that further improvements are possible. The most important remaining question now is: when are we, health care professionals, delivering the best available care to patients with colon or rectal cancer? Currently, quality assurance is a major issue in colorectal cancer care and quality assurance awareness is developing in almost all disciplines involved in the treatment of colorectal cancer patients. Quality assurance has shown to be effective in clinical trials. For example, standardisation and quality control were introduced in the Dutch TME trial and led to marked improvements of local control and survival in rectal cancer patients. Besides, audit structures can also be very effective in monitoring cancer management and national audits showed to further improve outcome in colorectal cancer patients. To reduce the differences between European countries, an international, multidisciplinary, outcome-based quality improvement programme, European Registration of Cancer Care (EURECCA), has been initiated. In the near future, the EURECCA dataset will perform research on subgroups as elderly patients or patients with comorbidities, which are often excluded from trials. For optimal colorectal cancer care, quality assurance in guideline formation and in multidisciplinary team management is also of great importance. The aim of this review was to create greater awareness and to give an overview of quality assurance in the management of colorectal cancer. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Audits of oncology units - an effective and pragmatic approach.

PubMed

Abratt, Raymond Pierre; Eedes, David; Bailey, Belinda; Salmon, Chris; Govender, Yogi; Oelofse, Ivan; Burger, Henriette

2017-05-24

Audits of oncology units are part of all quality-assurance programmes. However, they do not always come across as pragmatic and helpful to staff. To report on the results of an online survey on the usefulness and impact of an audit process for oncology units. Staff in oncology units who were part of the audit process completed the audit self-assessment form for the unit. This was followed by a visit to each unit by an assessor, and then subsequent personal contact, usually via telephone. The audit self-assessment document listed quality-assurance measures or items in the physical and functional areas of the oncology unit. There were a total of 153 items included in the audit. The online survey took place in October 2016. The invitation to participate was sent to 59 oncology units at which staff members had completed the audit process. The online survey was completed by 54 (41%) of the 132 potential respondents. The online survey found that the audit was very or extremely useful in maintaining personal professional standards in 89% of responses. The audit process and feedback was rated as very or extremely satisfactory in 80% and 81%, respectively. The self-assessment audit document was scored by survey respondents as very or extremely practical in 63% of responses. The feedback on the audit was that it was very or extremely helpful in formulating improvement plans in oncology units in 82% of responses. Major and minor changes that occurred as a result of the audit process were reported as 8% and 88%, respectively. The survey findings show that the audit process and its self- assessment document meet the aims of being helpful and pragmatic.

[Guideline compliance in hip fracture: results of an external quality-assurance program in North Rhine Westphalia: 2003-2005].

PubMed

Schulze Raestrup, U; Grams, A; Smektala, R

2008-02-01

Whereas the Scottish guidelines are audited annually, nobody evaluates guideline compliance in Germany. Thus, can external quality assurance data pursuant to section 137 of the German Social Code Book V be suitable for auditing guideline compliance? From North Rhine Westphalia, a total of 48,831 cases of femoral fractures near the hip joint were evaluated. Compliance with the guidelines was determined based on preoperative hospital stay, thrombosis, and antibiotic prophylaxis. Guideline rationale was reviewed in terms of mortality and thromboembolism rate. Sixty-four percent of the interventions were performed in a timely manner. Thrombosis prophylaxis was given in 99% of cases. Antibiotics were given as a single shot. There was no connection between mortality and thromboembolism rates or time to surgery. Guideline compliance is similar in German and Scotland. The external quality assurance data are suitable for evaluating guideline compliance. The literature recommends a short time to surgery. Given the short observation period, it was not possible to demonstrate any improvement in outcomes.

2008 Niday Perinatal Database quality audit: report of a quality assurance project.

PubMed

Dunn, S; Bottomley, J; Ali, A; Walker, M

2011-12-01

This quality assurance project was designed to determine the reliability, completeness and comprehensiveness of the data entered into Niday Perinatal Database. Quality of the data was measured by comparing data re-abstracted from the patient record to the original data entered into the Niday Perinatal Database. A representative sample of hospitals in Ontario was selected and a random sample of 100 linked mother and newborn charts were audited for each site. A subset of 33 variables (representing 96 data fields) from the Niday dataset was chosen for re-abstraction. Of the data fields for which Cohen's kappa statistic or intraclass correlation coefficient (ICC) was calculated, 44% showed substantial or almost perfect agreement (beyond chance). However, about 17% showed less than 95% agreement and a kappa or ICC value of less than 60% indicating only slight, fair or moderate agreement (beyond chance). Recommendations to improve the quality of these data fields are presented.

Quality assurance and the need to evaluate interventions and audit programme outcomes.

PubMed

Zhao, Min; Vaartjes, Ilonca; Klipstein-Grobusch, Kerstin; Kotseva, Kornelia; Jennings, Catriona; Grobbee, Diederick E; Graham, Ian

2017-06-01

Evidence-based clinical guidelines provide standards for the provision of healthcare. However, these guidelines have been poorly implemented in daily practice. Clinical audit is a quality improvement tool to promote quality of care in daily practice and to improve outcomes through the systematic review of care delivery and implementation of changes. A major priority in the management of subjects with cardiovascular disease (CVD) management is secondary prevention by controlling cardiovascular risk factors and providing appropriate medical treatment. Clinical audits can be applied to monitor modifiable risk factors and evaluate quality improvements of CVD management in daily practice. Existing clinical audits have provided an overview of the burden of risk factors in subjects with CVD and reflect real-world risk factor recording and management. However, consistent and representative data from clinic audits are still insufficient to fully monitor quality improvement of CVD management. Data are lacking in particular from low- and middle-income countries, limiting the evaluation of CVD management quality by clinical audit projects in many settings. To support the development of clinical standards, monitor daily practice performance, and improve quality of care in CVD management at national and international levels, more widespread clinical audits are warranted.

Value of audits in breast cancer screening quality assurance programmes.

PubMed

Geertse, Tanya D; Holland, Roland; Timmers, Janine M H; Paap, Ellen; Pijnappel, Ruud M; Broeders, Mireille J M; den Heeten, Gerard J

2015-11-01

Our aim was to retrospectively evaluate the results of all audits performed in the past and to assess their value in the quality assurance of the Dutch breast cancer screening programme. The audit team of the Dutch Reference Centre for Screening (LRCB) conducts triennial audits of all 17 reading units. During audits, screening outcomes like recall rates and detection rates are assessed and a radiological review is performed. This study investigates and compares the results of four audit series: 1996-2000, 2001-2005, 2003-2007 and 2010-2013. The analysis shows increased recall rates (from 0.66%, 1.07%, 1.22% to 1.58%), increased detection rates (from 3.3, 4.5, 4.8 to 5.4 per 1000) and increased sensitivity (from 64.5%, 68.7%, 70.5% to 71.6%), over the four audit series. The percentage of 'missed cancers' among interval cancers and advanced screen-detected cancers did not change (p = 0.4). Our audits not only provide an opportunity for assessing screening outcomes, but also provide moments of self-reflection with peers. For radiologists, an accurate understanding of their performance is essential to identify points of improvement. We therefore recommend a radiological review of screening examinations and immediate feedback as part of an audit. • Radiological review and immediate feedback are recommended as part of an audit. • For breast screening radiologists, audits provide moments of self-reflection with peers. • Radiological review of screening examinations provides insights in recall behaviour. • Accurate understanding of radiologists' performance is essential to identify points of improvement.

OASYS: a computerized auditing system for orthopaedic surgery.

PubMed

Stoodley, M A; Sikorski, J M

1991-11-01

Medical auditing based on individual diagnoses or specific therapies is well established. Auditing of all medical activity has an expanding role in quality assurance and research. In an attempt to overcome the limitations of existing auditing systems, a fundamentally different, flexible, high quality and easily accessible orthopaedic auditing system has been developed. This records a description of each component of patients' orthopaedic diagnoses, records treatment and complications, produces discharge letters and surgical log books and allows flexible and comprehensive audits. It has been in use in an orthopaedic service since January 1990 and has been successful in identifying problems and monitoring the effectiveness of changes. It is anticipated that the system will become more widely used and provide the basis for a 'user group' which will share the accumulated data and further development costs.

Flight Dynamics Mission Support and Quality Assurance Process

NASA Technical Reports Server (NTRS)

Oh, InHwan

1996-01-01

This paper summarizes the method of the Computer Sciences Corporation Flight Dynamics Operation (FDO) quality assurance approach to support the National Aeronautics and Space Administration Goddard Space Flight Center Flight Dynamics Support Branch. Historically, a strong need has existed for developing systematic quality assurance using methods that account for the unique nature and environment of satellite Flight Dynamics mission support. Over the past few years FDO has developed and implemented proactive quality assurance processes applied to each of the six phases of the Flight Dynamics mission support life cycle: systems and operations concept, system requirements and specifications, software development support, operations planing and training, launch support, and on-orbit mission operations. Rather than performing quality assurance as a final step after work is completed, quality assurance has been built in as work progresses in the form of process assurance. Process assurance activities occur throughout the Flight Dynamics mission support life cycle. The FDO Product Assurance Office developed process checklists for prephase process reviews, mission team orientations, in-progress reviews, and end-of-phase audits. This paper will outline the evolving history of FDO quality assurance approaches, discuss the tailoring of Computer Science Corporations's process assurance cycle procedures, describe some of the quality assurance approaches that have been or are being developed, and present some of the successful results.

Colonoscopy quality assurance in Ontario: Systematic review and clinical practice guideline

PubMed Central

Tinmouth, Jill; Kennedy, Erin B; Baron, David; Burke, Mae; Feinberg, Stanley; Gould, Michael; Baxter, Nancy; Lewis, Nancy

2014-01-01

Colonoscopy is fundamental to the diagnosis and management of digestive diseases and plays a key role in colorectal cancer (CRC) screening and diagnosis. Therefore, it is important to ensure that colonoscopy is of high quality. The present guidance document updates the evidence and recommendations in Cancer Care Ontario’s 2007 Colonoscopy Standards, and was conducted under the aegis of the Program in Evidence-Based Care. It is intended to support quality improvement for colonoscopies for all indications, including follow-up to a positive fecal occult blood test, screening for individuals who have a family history of CRC and those at average risk, investigation for symptomatic patients, and surveillance of those with a history of adenomatous polyps or CRC. A systematic review was performed to evaluate the existing evidence concerning the following three key aspects of colonoscopy: physician endoscopist training and maintenance of competency; institutional quality assurance parameters; and colonoscopy quality indicators and auditable outcomes. Where appropriate, indicators were designated quality indicators (where there was sufficient evidence to recommend a specific target) and auditable outcomes (insufficient evidence to recommend a specific target, but which should be monitored for quality assurance purposes). The guidance document may be used to support colonoscopy quality assurance programs to improve the quality of colonoscopy regardless of indication. Improvements in colonoscopy quality are anticipated to improve important outcomes in digestive diseases, such as reduction of the incidence of and mortality from CRC. PMID:24839621

Significant event auditing.

PubMed

Pringle, M

2000-12-01

Significant event auditing has been described for 5 years and it is slowly gaining credibility as an effective method of quality assurance in British general practice. This paper describes what it is, what its background is, how it is done and whether it is effective. While it needs a positive team culture - and therefore may not suit every practice - where it is used it appears to be a useful adjunct to a clinical audit programme.

77 FR 56178 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-12

... programs. FSIS will use the PEPRL-F-0008-04 form as a self assessment audit checklist to collect information related to the quality assurance/quality control procedures in place at in-plant and private...

European Quality--Adding to the Debate?

ERIC Educational Resources Information Center

Birtwistle, Tim

1996-01-01

Two pilot programs designed to improve and maintain quality in European higher education are described and compared: an audit of universities' procedures for quality assurance; and an assessment of programs of study, including teaching and learning, student characteristics, staff, facilities, and quality management. Both include institutional…

15 CFR 995.25 - Quality management system.

Code of Federal Regulations, 2010 CFR

2010-01-01

... expertise. (7) CEVAD shall conduct internal audits at planned intervals to determine whether the quality... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Quality management system. 995.25...) NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DEPARTMENT OF COMMERCE QUALITY ASSURANCE AND CERTIFICATION...

What can we learn from a decade of database audits? The Duke Clinical Research Institute experience, 1997–2006

PubMed Central

Rostami, Reza; Nahm, Meredith; Pieper, Carl F.

2011-01-01

Background Despite a pressing and well-documented need for better sharing of information on clinical trials data quality assurance methods, many research organizations remain reluctant to publish descriptions of and results from their internal auditing and quality assessment methods. Purpose We present findings from a review of a decade of internal data quality audits performed at the Duke Clinical Research Institute, a large academic research organization that conducts data management for a diverse array of clinical studies, both academic and industry-sponsored. In so doing, we hope to stimulate discussions that could benefit the wider clinical research enterprise by providing insight into methods of optimizing data collection and cleaning, ultimately helping patients and furthering essential research. Methods We present our audit methodologies, including sampling methods, audit logistics, sample sizes, counting rules used for error rate calculations, and characteristics of audited trials. We also present database error rates as computed according to two analytical methods, which we address in detail, and discuss the advantages and drawbacks of two auditing methods used during this ten-year period. Results Our review of the DCRI audit program indicates that higher data quality may be achieved from a series of small audits throughout the trial rather than through a single large database audit at database lock. We found that error rates trended upward from year to year in the period characterized by traditional audits performed at database lock (1997–2000), but consistently trended downward after periodic statistical process control type audits were instituted (2001–2006). These increases in data quality were also associated with cost savings in auditing, estimated at 1000 hours per year, or the efforts of one-half of a full time equivalent (FTE). Limitations Our findings are drawn from retrospective analyses and are not the result of controlled experiments, and may therefore be subject to unanticipated confounding. In addition, the scope and type of audits we examine here are specific to our institution, and our results may not be broadly generalizable. Conclusions Use of statistical process control methodologies may afford advantages over more traditional auditing methods, and further research will be necessary to confirm the reliability and usability of such techniques. We believe that open and candid discussion of data quality assurance issues among academic and clinical research organizations will ultimately benefit the entire research community in the coming era of increased data sharing and re-use. PMID:19342467

Quality assurance of radiotherapy in cancer treatment: toward improvement of patient safety and quality of care.

PubMed

Ishikura, Satoshi

2008-11-01

The process of radiotherapy (RT) is complex and involves understanding of the principles of medical physics, radiobiology, radiation safety, dosimetry, radiation treatment planning, simulation and interaction of radiation with other treatment modalities. Each step in the integrated process of RT needs quality control and quality assurance (QA) to prevent errors and to give high confidence that patients will receive the prescribed treatment correctly. Recent advances in RT, including intensity-modulated and image-guided RT, focus on the need for a systematic RTQA program that balances patient safety and quality with available resources. It is necessary to develop more formal error mitigation and process analysis methods, such as failure mode and effect analysis, to focus available QA resources optimally on process components. External audit programs are also effective. The International Atomic Energy Agency has operated both an on-site and off-site postal dosimetry audit to improve practice and to assure the dose from RT equipment. Several countries have adopted a similar approach for national clinical auditing. In addition, clinical trial QA has a significant role in enhancing the quality of care. The Advanced Technology Consortium has pioneered the development of an infrastructure and QA method for advanced technology clinical trials, including credentialing and individual case review. These activities have an impact not only on the treatment received by patients enrolled in clinical trials, but also on the quality of treatment administered to all patients treated in each institution, and have been adopted globally; by the USA, Europe and Japan also.

A VIRTUAL TECHNICAL SYSTEMS AUDIT OF RESEARCH QUALITY ASSURANCE AND RECORD MANAGEMENT SYSTEMS IN ORD, U.S EPA

EPA Science Inventory

NHEERL conducts technical systems audits (TSAs) on its research projects. The findings are reported by the QA Manager (QAM) to the Director of QA (DQA) as Exemplary Findings (things the QA Team liked); Corrective Actions (things that must be corrected immediately); and Areas for...

77 FR 65521 - Determination of Attainment for the San Francisco Bay Area Nonattainment Area for the 2006 Fine...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-29

...\\ EPA also concluded \\8\\ from its Technical System Audit of the BAAQMD Primary Quality Assurance..., Air Pollution Control Officer, BAAQMD, transmitting ``System Audit of the Ambient Monitoring Program... email. www.regulations.gov is an ``anonymous access'' system, and EPA will not know your identity or...

77 FR 65346 - Determination of Attainment for the Sacramento Nonattainment Area for the 2006 Fine Particle...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-26

... 7 EPA also concluded \\8\\ from its Technical System Audit of the CARB Primary Quality Assurance..., transmitting ``Technical System Audit of the California Environmental Protection Agency Air Resources Board... an ``anonymous access'' system, and EPA will not know your identity or contact information unless you...

Compliance/non-compliance with biosecurity rules specified in the Danish Quality Assurance system (KIK) and Campylobacter-positive broiler flocks 2012 and 2013.

PubMed

Sandberg, M; Dahl, J; Lindegaard, L L; Pedersen, J R

2017-01-01

One source for Campylobacter jejuni infections in humans could be consumption of broiler meat. Transmission of Campylobacter into broiler houses/flocks occurs via many routes. A number of biosecurity rules is specified in the Quality Assurance System in Danish Chicken Production (KIK) - for which the broiler producers annually are audited for compliance with, by bureau Veritas. Multivariable logistic regression models were used to investigated the association between Compliance/non-compliance with biosecurity rules and Campylobacter-positive flocks - on KIK data from 2012 and 2013. Month and before after audit period were also included in the models. KIK rules important to comply with were: no vegetation around houses, closed systems for feed storage and distribution, and division between clean and unclean zones within broiler houses. A Campylobacter-reducing effect was observed of audit visits (in itself), indicating that there is more focus on compliance with KIK at the time of an audit visit, and that adequate daily biosecurity behavior is important. © 2016 Poultry Science Association Inc.

Prolonged labour as indication for emergency caesarean section: a quality assurance analysis by criterion-based audit at two Tanzanian rural hospitals.

PubMed

Maaløe, N; Sorensen, B L; Onesmo, R; Secher, N J; Bygbjerg, I C

2012-04-01

To audit the quality of obstetric management preceding emergency caesarean sections for prolonged labour. A quality assurance analysis of a retrospective criterion-based audit supplemented by in-depth interviews with hospital staff. Two Tanzanian rural mission hospitals. Audit of 144 cases of women undergoing caesarean sections for prolonged labour; in addition, eight staff members were interviewed. Criteria of realistic best practice were established, and the case files were audited and compared with these. Hospital staff were interviewed about what they felt might be the causes for the audit findings. Prevalence of suboptimal management and themes emerging from an analysis of the transcripts. Suboptimal management was identified in most cases. Non-invasive interventions to potentially avoid operative delivery were inadequately used. When deciding on caesarean section, in 26% of the cases labour was not prolonged, and in 16% the membranes were still intact. Of the women with genuine prolonged labour, caesarean sections were performed with a fully dilated cervix in 36% of the cases. Vacuum extraction was not considered. Amongst the hospital staff interviewed, the awareness of evidence-based guidelines was poor. Word of mouth, personal experience, and fear, especially of HIV transmission, influenced management decisions. The lack of use and awareness of evidence-based guidelines led to misinterpretation of clinical signs, fear of simple interventions, and an excessive rate of emergency caesarean sections. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

A risk-based approach to scheduling audits.

PubMed

Rönninger, Stephan; Holmes, Malcolm

2009-01-01

The manufacture and supply of pharmaceutical products can be a very complex operation. Companies may purchase a wide variety of materials, from active pharmaceutical ingredients to packaging materials, from "in company" suppliers or from third parties. They may also purchase or contract a number of services such as analysis, data management, audit, among others. It is very important that these materials and services are of the requisite quality in order that patient safety and company reputation are adequately protected. Such quality requirements are ongoing throughout the product life cycle. In recent years, assurance of quality has been derived via audit of the supplier or service provider and by using periodic audits, for example, annually or at least once every 5 years. In the past, companies may have used an audit only for what they considered to be "key" materials or services and used testing on receipt, for example, as their quality assurance measure for "less important" supplies. Such approaches changed as a result of pressure from both internal sources and regulators to the time-driven audit for all suppliers and service providers. Companies recognised that eventually they would be responsible for the quality of the supplied product or service and audit, although providing only a "snapshot in time" seemed a convenient way of demonstrating that they were meeting their obligations. Problems, however, still occur with the supplied product or service and will usually be more frequent from certain suppliers. Additionally, some third-party suppliers will no longer accept routine audits from individual companies, as the overall audit load can exceed one external audit per working day. Consequently a different model is needed for assessing supplier quality. This paper presents a risk-based approach to creating an audit plan and for scheduling the frequency and depth of such audits. The approach is based on the principles and process of the Quality Risk Management guideline (ICH Q9) of the International Conference on Harmonisation (ICH). It proposes that if regulatory conditions allow, it may be possible to remove the need to conduct audits on the sole basis of time elapsed since the last audit, or at least to increase the time interval between such audits without compromising either patient safety or company reputation. The proposal is equally applicable to both large and small companies. Small companies may find it particularly useful in cases where they use a supplier that may have a monopoly position or that serves many other pharmaceutical companies. In such circumstances the supplier may be reluctant or even refuse to accept audits from some individual companies because of their low purchasing levels. A similar approach could be proposed for regulatory authorities for the scheduling of regulatory inspections.

Audit Cultures and Quality Assurance Mechanisms in England: A Study of Their Perceived Impact on the Work of Academics

ERIC Educational Resources Information Center

Cheng, Ming

2010-01-01

Proponents of the concept of the audit culture in UK higher education argue that from the late 1990s onward audit functioned as a form of power control and had a profound effect on academics and their work. Such arguments continued to be made into the early 2000s. Since then, however, the level of external scrutiny surrounding UK academics'…

Radiotherapy dosimetry audit: three decades of improving standards and accuracy in UK clinical practice and trials.

PubMed

Clark, Catharine H; Aird, Edwin G A; Bolton, Steve; Miles, Elizabeth A; Nisbet, Andrew; Snaith, Julia A D; Thomas, Russell A S; Venables, Karen; Thwaites, David I

2015-01-01

Dosimetry audit plays an important role in the development and safety of radiotherapy. National and large scale audits are able to set, maintain and improve standards, as well as having the potential to identify issues which may cause harm to patients. They can support implementation of complex techniques and can facilitate awareness and understanding of any issues which may exist by benchmarking centres with similar equipment. This review examines the development of dosimetry audit in the UK over the past 30 years, including the involvement of the UK in international audits. A summary of audit results is given, with an overview of methodologies employed and lessons learnt. Recent and forthcoming more complex audits are considered, with a focus on future needs including the arrival of proton therapy in the UK and other advanced techniques such as four-dimensional radiotherapy delivery and verification, stereotactic radiotherapy and MR linear accelerators. The work of the main quality assurance and auditing bodies is discussed, including how they are working together to streamline audit and to ensure that all radiotherapy centres are involved. Undertaking regular external audit motivates centres to modernize and develop techniques and provides assurance, not only that radiotherapy is planned and delivered accurately but also that the patient dose delivered is as prescribed.

Radiotherapy dosimetry audit: three decades of improving standards and accuracy in UK clinical practice and trials

PubMed Central

Aird, Edwin GA; Bolton, Steve; Miles, Elizabeth A; Nisbet, Andrew; Snaith, Julia AD; Thomas, Russell AS; Venables, Karen; Thwaites, David I

2015-01-01

Dosimetry audit plays an important role in the development and safety of radiotherapy. National and large scale audits are able to set, maintain and improve standards, as well as having the potential to identify issues which may cause harm to patients. They can support implementation of complex techniques and can facilitate awareness and understanding of any issues which may exist by benchmarking centres with similar equipment. This review examines the development of dosimetry audit in the UK over the past 30 years, including the involvement of the UK in international audits. A summary of audit results is given, with an overview of methodologies employed and lessons learnt. Recent and forthcoming more complex audits are considered, with a focus on future needs including the arrival of proton therapy in the UK and other advanced techniques such as four-dimensional radiotherapy delivery and verification, stereotactic radiotherapy and MR linear accelerators. The work of the main quality assurance and auditing bodies is discussed, including how they are working together to streamline audit and to ensure that all radiotherapy centres are involved. Undertaking regular external audit motivates centres to modernize and develop techniques and provides assurance, not only that radiotherapy is planned and delivered accurately but also that the patient dose delivered is as prescribed. PMID:26329469

77 FR 45965 - Determination of Attainment for the Paul Spur/Douglas PM10

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-02

... plans, and based on the findings of our technical system audit report, ADEQ's monitoring network meets... to EPA's Air Quality System (AQS) database as quality- assured. Next, we reviewed the ambient PM 10...

Development of a multihospital pharmacy quality assurance program.

PubMed

Hoffmann, R P; Ravin, R; Colaluca, D M; Gifford, R; Grimes, D; Grzegorczyk, R; Keown, F; Kuhr, F; McKay, R; Peyser, J; Ryan, R; Zalewski, C

1980-07-01

Seven community hospitals have worked cooperatively for 18 months to develop an initial hospital pharmacy quality assurance program. Auditing criteria were developed for nine service areas corresponding to the model program developed by the American Society of Hospital Pharmacists. Current plans are to implement and modify this program as required at each participating hospital. Follow-up programs will also be essential to a functional, ongoing program, and these will be developed in the future.

Design and implementation of an audit trail in compliance with US regulations.

PubMed

Jiang, Keyuan; Cao, Xiang

2011-10-01

Audit trails have been used widely to ensure quality of study data and have been implemented in computerized clinical trials data systems. Increasingly, there is a need to audit access to study participant identifiable information to provide assurance that study participant privacy is protected and confidentiality is maintained. In the United States, several federal regulations specify how the audit trail function should be implemented. To describe the development and implementation of a comprehensive audit trail system that meets the regulatory requirements of assuring data quality and integrity and protecting participant privacy and that is also easy to implement and maintain. The audit trail system was designed and developed after we examined regulatory requirements, data access methods, prevailing application architecture, and good security practices. Our comprehensive audit trail system was developed and implemented at the database level using a commercially available database management software product. It captures both data access and data changes with the correct user identifier. Documentation of access is initiated automatically in response to either data retrieval or data change at the database level. Currently, our system has been implemented only on one commercial database management system. Although our audit trail algorithm does not allow for logging aggregate operations, aggregation does not reveal sensitive private participant information. Careful consideration must be given to data items selected for monitoring because selection of all data items using our system can dramatically increase the requirements for computer disk space. Evaluating the criticality and sensitivity of individual data items selected can control the storage requirements for clinical trial audit trail records. Our audit trail system is capable of logging data access and data change operations to satisfy regulatory requirements. Our approach is applicable to virtually any data that can be stored in a relational database.

Auditing of chromatographic data.

PubMed

Mabie, J T

1998-01-01

During a data audit, it is important to ensure that there is clear documentation and an audit trail. The Quality Assurance Unit should review all areas, including the laboratory, during the conduct of the sample analyses. The analytical methodology that is developed should be documented prior to sample analyses. This is an important document for the auditor, as it is the instrumental piece used by the laboratory personnel to maintain integrity throughout the process. It is expected that this document will give insight into the sample analysis, run controls, run sequencing, instrument parameters, and acceptance criteria for the samples. The sample analysis and all supporting documentation should be audited in conjunction with this written analytical method and any supporting Standard Operating Procedures to ensure the quality and integrity of the data.

The hospital transfusion committee: a step towards improved quality assurance.

PubMed

Calder, L; Woodfield, G

1991-10-09

Quality assurance has an important contribution to make in the judicious use of scarce resources. Auckland Hospital has established a transfusion committee because there was an escalating usage of blood and blood products which are expensive prescription medicines. A pilot audit of red cell transfusions indicated that 29% of red cell transfusions may have been unnecessary. A wide range of initiatives at Auckland Hospital has reduced blood product usage. Inappropriate use of blood carries an opportunity cost and may subject patients to unnecessary risk of reactions, including potential disease transmission. Strategies which need to be employed by transfusion committees include the introduction of clinical audit, physician education, restrictions on availability, and clinical budgeting. It is recommended that transfusion committees be set up in all major hospitals.

From Lexical Regularities to Axiomatic Patterns for the Quality Assurance of Biomedical Terminologies and Ontologies.

PubMed

van Damme, Philip; Quesada-Martínez, Manuel; Cornet, Ronald; Fernández-Breis, Jesualdo Tomás

2018-06-13

Ontologies and terminologies have been identified as key resources for the achievement of semantic interoperability in biomedical domains. The development of ontologies is performed as a joint work by domain experts and knowledge engineers. The maintenance and auditing of these resources is also the responsibility of such experts, and this is usually a time-consuming, mostly manual task. Manual auditing is impractical and ineffective for most biomedical ontologies, especially for larger ones. An example is SNOMED CT, a key resource in many countries for codifying medical information. SNOMED CT contains more than 300000 concepts. Consequently its auditing requires the support of automatic methods. Many biomedical ontologies contain natural language content for humans and logical axioms for machines. The 'lexically suggest, logically define' principle means that there should be a relation between what is expressed in natural language and as logical axioms, and that such a relation should be useful for auditing and quality assurance. Besides, the meaning of this principle is that the natural language content for humans could be used to generate the logical axioms for the machines. In this work, we propose a method that combines lexical analysis and clustering techniques to (1) identify regularities in the natural language content of ontologies; (2) cluster, by similarity, labels exhibiting a regularity; (3) extract relevant information from those clusters; and (4) propose logical axioms for each cluster with the support of axiom templates. These logical axioms can then be evaluated with the existing axioms in the ontology to check their correctness and completeness, which are two fundamental objectives in auditing and quality assurance. In this paper, we describe the application of the method to two SNOMED CT modules, a 'congenital' module, obtained using concepts exhibiting the attribute Occurrence - Congenital, and a 'chronic' module, using concepts exhibiting the attribute Clinical course - Chronic. We obtained a precision and a recall of respectively 75% and 28% for the 'congenital' module, and 64% and 40% for the 'chronic' one. We consider these results to be promising, so our method can contribute to the support of content editors by using automatic methods for assuring the quality of biomedical ontologies and terminologies. Copyright © 2018. Published by Elsevier Inc.

Mercury Deposition Network Site Operator Training for the System Blank and Blind Audit Programs

USGS Publications Warehouse

Wetherbee, Gregory A.; Lehmann, Christopher M.B.

2008-01-01

The U.S. Geological Survey operates the external quality assurance project for the National Atmospheric Deposition Program/Mercury Deposition Network. The project includes the system blank and blind audit programs for assessment of total mercury concentration data quality for wet-deposition samples. This presentation was prepared to train new site operators and to refresh experienced site operators to successfully process and submit system blank and blind audit samples for chemical analysis. Analytical results are used to estimate chemical stability and contamination levels of National Atmospheric Deposition Program/Mercury Deposition Network samples and to evaluate laboratory variability and bias.

Gaining Control and Predictability of Software-Intensive Systems Development and Sustainment

DTIC Science & Technology

2015-02-04

implementation of the baselines, audits , and technical reviews within an overarching systems engineering process (SEP; Defense Acquisition University...warfighters’ needs. This management and metrics effort supplements and supports the system’s technical development through the baselines, audits and...other areas that could be researched and added into the nine-tier model. Areas including software metrics, quality assurance , software-oriented

Development of a data entry auditing protocol and quality assurance for a tissue bank database.

PubMed

Khushi, Matloob; Carpenter, Jane E; Balleine, Rosemary L; Clarke, Christine L

2012-03-01

Human transcription error is an acknowledged risk when extracting information from paper records for entry into a database. For a tissue bank, it is critical that accurate data are provided to researchers with approved access to tissue bank material. The challenges of tissue bank data collection include manual extraction of data from complex medical reports that are accessed from a number of sources and that differ in style and layout. As a quality assurance measure, the Breast Cancer Tissue Bank (http:\\\\www.abctb.org.au) has implemented an auditing protocol and in order to efficiently execute the process, has developed an open source database plug-in tool (eAuditor) to assist in auditing of data held in our tissue bank database. Using eAuditor, we have identified that human entry errors range from 0.01% when entering donor's clinical follow-up details, to 0.53% when entering pathological details, highlighting the importance of an audit protocol tool such as eAuditor in a tissue bank database. eAuditor was developed and tested on the Caisis open source clinical-research database; however, it can be integrated in other databases where similar functionality is required.

A Development of Automatic Audit System for Written Informed Consent using Machine Learning.

PubMed

Yamada, Hitomi; Takemura, Tadamasa; Asai, Takahiro; Okamoto, Kazuya; Kuroda, Tomohiro; Kuwata, Shigeki

2015-01-01

In Japan, most of all the university and advanced hospitals have implemented both electronic order entry systems and electronic charting. In addition, all medical records are subjected to inspector audit for quality assurance. The record of informed consent (IC) is very important as this provides evidence of consent from the patient or patient's family and health care provider. Therefore, we developed an automatic audit system for a hospital information system (HIS) that is able to evaluate IC automatically using machine learning.

Implementation of Quality Systems in Nuclear Medicine: Why It Matters. An Outcome Analysis (Quality Management Audits in Nuclear Medicine Part III).

PubMed

Dondi, Maurizio; Paez, Diana; Torres, Leonel; Marengo, Mario; Delaloye, Angelika Bischof; Solanki, Kishor; Van Zyl Ellmann, Annare; Lobato, Enrique Estrada; Miller, Rodolfo Nunez; Giammarile, Francesco; Pascual, Thomas

2018-05-01

The International Atomic Energy Agency (IAEA) developed a comprehensive program-Quality Management Audits in Nuclear Medicine (QUANUM). This program covers all aspects of nuclear medicine practices including, but not limited to, clinical practice, management, operations, and services. The QUANUM program, which includes quality standards detailed in relevant checklists, aims at introducing a culture of comprehensive quality audit processes that are patient oriented, systematic, and outcome based. This paper will focus on the impact of the implementation of QUANUM on daily routine practices in audited centers. Thirty-seven centers, which had been externally audited by experts under IAEA auspices at least 1 year earlier, were invited to run an internal audit using the QUANUM checklists. The external audits also served as training in quality management and the use of QUANUM for the local teams, which were responsible of conducting the internal audits. Twenty-five out of the 37 centers provided their internal audit report, which was compared with the previous external audit. The program requires that auditors score each requirement within the QUANUM checklists on a scale of 0-4, where 0-2 means nonconformance and 3-4 means conformance to international regulations and standards on which QUANUM is based. Our analysis covering both general and clinical areas assessed changes on the conformance status on a binary manner and the level of conformance scores. Statistical analysis was performed using nonparametric statistical tests. The evaluation of the general checklists showed a global improvement on both the status and the levels of conformances (P < 0.01). The evaluation of the requirements by checklist also showed a significant improvement in all, with the exception of Hormones and Tumor marker determinations, where changes were not significant. Of the 25 evaluated institutions, 88% (22 of 25) and 92% (23 of 25) improved their status and levels of conformance, respectively. Fifty-five requirements, on average, increased from nonconformance to conformance status. In 8 key areas, the number of improved requirements was well above the average: Administration & Management (checklist 2); Radiation Protection & Safety (checklist 4); General Quality Assurance system (checklist 6); Imaging Equipment Quality Assurance or Quality Control (checklist 7); General Diagnostic (checklist 9); General Therapeutic (checklist 12); Radiopharmacy Level 1 (checklist 14); and Radiopharmacy Level 2 (checklist 15). Analysis of results related to clinical activities showed an overall positive impact on both the status and the level of conformance to international standards. Similar results were obtained for the most frequently performed clinical imaging and therapeutic procedures. Our study shows that the implementation of a comprehensive quality management system through the IAEA QUANUM program has a positive impact on nuclear medicine practices. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

QA in Radiation Therapy: The RPC Perspective

NASA Astrophysics Data System (ADS)

Ibbott, G. S.

2010-11-01

The Radiological Physics Center (RPC) is charged with assuring the consistent delivery of radiation doses to patients on NCI-sponsored clinical trials. To accomplish this, the RPC conducts annual mailed audits of machine calibration, dosimetry audit visits to institutions, reviews of treatment records, and credentialing procedures requiring the irradiation of anthropomorphic phantoms. Through these measurements, the RPC has gained an understanding of the level of quality assurance practiced in this cohort of institutions, and a database of measurements of beam characteristics of a large number of treatment machines. The results of irradiations of phantoms have yielded insight into the delivery of advanced technology treatment procedures.

A Comparison of the Audit and Accreditation Tools Used By The Health Care Financing Administration, The Texas Department of Insurance, and The National Committee on Quality Assurance: The Cost of Multi-Agency Oversight on Medicare+Choice Plans in Texas

DTIC Science & Technology

2001-04-12

Comparison of Oversight Models in Managed Care 1 Running Head: Comparison of Oversight Models in Managed Care A Comparison of the Audit and...TITLE AND SUBTITLE A Comparison of the Audit and Accreditation Tools Used By The Health Care Financing Administration, The Texas Department of...Comparison of Oversight Models in Managed Care 5 A Comparison of the Audit and Accreditation Tools Used By The Health Care Financing

Advanced Hysteroscopic Surgery: Quality Assurance in Teaching Hospitals.

PubMed

Erian, Mark M S; McLaren, Glenda R; Erian, Anna-Marie

2017-01-01

Advanced hysteroscopic surgery (AHS) is a vitally important technique in the armamentarium for the management of many day-to-day clinical problems, such as menorrhagia, surgical excision of uterine myomata and septa in the management of female infertility, hysteroscopic excision of chronically retained products of conception (placenta accreta), and surgical removal of intramural ectopic pregnancy. In today's climate of accountability, it is necessary that gynecologists take a more active role in assuring the quality of their work. In this article, we discuss the quality assurance system from the point of view of the surgical audit meetings in some of the major teaching hospitals affiliated with the University of Queensland (Brisbane, Queensland, Australia).

Advanced Hysteroscopic Surgery: Quality Assurance in Teaching Hospitals

PubMed Central

McLaren, Glenda R.; Erian, Anna-Marie

2017-01-01

Advanced hysteroscopic surgery (AHS) is a vitally important technique in the armamentarium for the management of many day-to-day clinical problems, such as menorrhagia, surgical excision of uterine myomata and septa in the management of female infertility, hysteroscopic excision of chronically retained products of conception (placenta accreta), and surgical removal of intramural ectopic pregnancy. In today's climate of accountability, it is necessary that gynecologists take a more active role in assuring the quality of their work. In this article, we discuss the quality assurance system from the point of view of the surgical audit meetings in some of the major teaching hospitals affiliated with the University of Queensland (Brisbane, Queensland, Australia). PMID:28729781

Clinical governance: bridging the gap between managerial and clinical approaches to quality of care

PubMed Central

Buetow, S. A.; Roland, M.

1999-01-01

Clinical governance has been introduced as a new approach to quality improvement in the UK national health service. This article maps clinical governance against a discussion of the four main approaches to measuring and improving quality of care: quality assessment, quality assurance, clinical audit, and quality improvement (including continuous quality improvement). Quality assessment underpins each approach. Whereas clinical audit has, in general, been professionally led, managers have driven quality improvement initiatives. Quality assurance approaches have been perceived to be externally driven by managers or to involve professional inspection. It is discussed how clinical governance seeks to bridge these approaches. Clinical governance allows clinicians in the UK to lead a comprehensive strategy to improve quality within provider organisations, although with an expectation of greatly increased external accountability. Clinical governance aims to bring together managerial, organisational, and clinical approaches to improving quality of care. If successful, it will define a new type of professionalism for the next century. Failure by the professions to seize the opportunity is likely to result in increasingly detailed external control of clinical activity in the UK, as has occurred in some other countries. PMID:10847876

40 CFR 63.10 - Recordkeeping and reporting requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... alternative reporting arrangements, in advance, with the permitting authority in that State. Procedures... manufacturer(s) and model number(s); (G) The date of the latest CMS certification or audit; (H) The total..., nonmonitoring equipment malfunctions, quality assurance/quality control calibrations, other known causes, and...

Near-Real-Time Cloud Auditing for Rapid Response

DTIC Science & Technology

2013-10-01

cloud auditing , which provides timely evaluation results and rapid response, is the key to assuring the cloud. In this paper, we discuss security and...providers with possible automation of the audit , assertion, assessment, and assurance of their services. The Cloud Security Alliance (CSA [15]) was formed...monitoring tools, research literature, standards, and other resources related to IA (Information Assurance ) metrics and IT auditing . In the following

[Quality assurance in geriatric rehabilitation--approaches and methods].

PubMed

Deckenbach, B; Borchelt, M; Steinhagen-Thiessen, E

1997-08-01

It did not take the provisions of the 5th Book of the Social Code for quality assurance issues to gain significance in the field of geriatric rehabilitation as well. While in the surgical specialties, experience in particular with external quality assurance have already been gathered over several years now, suitable concepts and methods for the new Geriatric Rehabilitation specialty are still in the initial stages of development. Proven methods from the industrial and service sectors, such as auditing, monitoring and quality circles, can in principle be drawn on for devising geriatric rehabilitation quality assurance schemes; these in particular need to take into account the multiple factors influencing the course and outcome of rehabilitation entailed by multimorbidity and multi-drug use; the eminent role of the social environment; therapeutic interventions by a multidisciplinary team; as well as the multi-dimensional nature of rehabilitation outcomes. Moreover, the specific conditions of geriatric rehabilitation require development not only of quality standards unique to this domain but also of quality assurance procedures specific to geriatrics. Along with a number of other methods, standardized geriatric assessment will play a crucial role in this respect.

Nuchal translucency and first trimester risk assessment: a systematic review.

PubMed

Sheppard, Celeste; Platt, Lawrence D

2007-06-01

First-trimester risk assessment for fetal aneuploidy using nuchal translucency (NT) measurement is rapidly gaining popularity in the United States. In combination with maternal serum markers in the first trimester, the screening performance is exceptionally good, with detection rates of more than 80% at a screen positive rate of 5%. Recently, the method has been validated for screening for Down syndrome and other aneuploidies in multicenter trials in the United States and elsewhere. Compliance with established criteria for measurement of the NT is essential to achieve uniform reliability and high screening test sensitivity. There is an international consensus about the importance of specific training in the NT examination, conformity to standards of NT measurement, and regular audit for quality assurance. In the United States, the Nuchal Translucency Quality Review program has been developed to administer credentialing and quality review for registered practitioners. The Nuchal Translucency Quality Review credentials signify the proficiency of the sonographer or sonologist in NT measurement and participation in a regular quality assurance audit. We encourage accreditation of clinical sites offering first-trimester risk assessment to ensure the highest quality care.

Guidelines for quality assurance in multicenter trials: a position paper.

PubMed

Knatterud, G L; Rockhold, F W; George, S L; Barton, F B; Davis, C E; Fairweather, W R; Honohan, T; Mowery, R; O'Neill, R

1998-10-01

In the wake of reports of falsified data in one of the trials of the National Surgical Adjuvant Project for Breast and Bowel Cancer supported by the National Cancer Institute, clinical trials came under close scrutiny by the public, the press, and Congress. Questions were asked about the quality and integrity of the collected data and the analyses and conclusions of trials. In 1995, the leaders of the Society for Clinical Trials (the Chair of the Policy Committee, Dr. David DeMets, and the President of the Society, Dr. Sylvan Green) asked two members of the Society (Dr. Genell Knatterud and Dr. Frank Rockhold) to act as co-chairs of a newly formed subcommittee to discuss the issues of data integrity and auditing. In consultation with Drs. DeMets and Green, the co-chairs selected other members (Ms. Franca Barton, Dr. C.E. Davis, Dr. Bill Fairweather, Dr. Stephen George, Mr. Tom Honohan, Dr. Richard Mowery, and Dr. Robert O'Neill) to serve on the subcommittee. The subcommittee considered "how clean clinical trial data should be, to what extent auditing procedures are required, and who should conduct audits and how often." During the initial discussions, the subcommittee concluded that data auditing was insufficient to achieve data integrity. Accordingly, the subcommittee prepared this set of guidelines for standards of quality assurance for multicenter clinical trials. We include recommendations for appropriate action if problems are detected.

Auditing the standard of anaesthesia care in obstetric units.

PubMed

Mörch-Siddall, J; Corbitt, N; Bryson, M R

2001-04-01

We undertook an audit of 15 obstetric units in the north of England over a 10-month period to ascertain to what extent they conformed to the Obstetric Anaesthetists' Association 'Recommended Minimum Standards for Obstetric Anaesthetic Services' using a quality assurance approach. We demonstrated that all units conformed to the majority of standards but did not conform in at least one major and minor area.

Building the Joint Battlespace Infosphere. Volume 1: Summary

DTIC Science & Technology

1999-12-17

Integrity guarantees. The information staff will conduct audits and other routine procedures to ensure that the JBI platform and its clients are...delete the object; thereafter, the object will not be available to other JBI clients, but it will have been saved in an archive for auditing or...this project are maintaining multiyear, multilocation programs in nomadic networking and assuring quality of service in emerging networks. Dynamic

Randomized trials and quality assurance in gastric cancer surgery.

PubMed

Dikken, Johan L; Cats, Annemieke; Verheij, Marcel; van de Velde, Cornelis J H

2013-03-01

A D2 lymphadenectomy can be considered standard of surgical care for advanced resectable gastric cancer. Currently, several multimodality strategies are used, including postoperative monochemotherapy in Asia, postoperative chemoradiotherapy in the United States, and perioperative chemotherapy in Europe. As the majority of gastric cancer patients are treated outside the framework of clinical trials, quality assurance programs, including referral to high-volume centers and clinical auditing are needed to improve gastric cancer care on a nationwide level. Copyright © 2012 Wiley Periodicals, Inc.

Theorising Quality in Higher Education

ERIC Educational Resources Information Center

Morley, Louise

2004-01-01

Britain now has the most heavily regulated higher education system in the world and institutions must deliver best educational value. This book explores the political and psychic economy of quality assurance in higher education and interrogates the discourse and practices associated with the audit culture in Britain. Following Acknowledgements and…

Operative blood transfusion quality improvement audit.

PubMed

Al Sohaibani, Mazen; Al Malki, Assaf; Pogaku, Venumadhav; Al Dossary, Saad; Al Bernawi, Hanan

2014-01-01

To determine how current anesthesia team handless the identification of surgical anaesthetized patient (right patient). And the check of blood unit before collecting and immediately before blood administration (right blood) in operating rooms where nurses have minimal duties and responsibility to handle blood for transfusion in anaesthetized patients. To elicit the degree of anesthesia staff compliance with new policies and procedures for anaesthetized surgical patient the blood transfusion administration. A large tertiary care reference and teaching hospital. A prospective quality improvement. Elaboration on steps for administration of transfusion from policies and procedures to anaesthetized patients; and analysis of the audit forms for conducted transfusions. An audit form was used to get key performance indicators (KPIs) observed in all procedures involve blood transfusion and was ticked as item was met, partially met, not met or not applicable. Descriptive statistics as number and percentage Microsoft excel 2003. Central quality improvement committee presented the results in number percentage and graphs. The degree of compliance in performing the phases of blood transfusion by anesthesia staff reached high percentage which let us feel certain that the quality is assured that the internal policy and procedures (IPP) are followed in the great majority of all types of red cells and other blood products transfusion from the start of requesting the blood or blood product to the prescript of checking the patient in the immediate post-transfusion period. Specific problem area of giving blood transfusion to anaesthetized patient was checking KPI concerning the phases of blood transfusion was audited and assured the investigators of high quality performance in procedures of transfusion.

[Quality control in anesthesiology].

PubMed

Muñoz-Ramón, J M

1995-03-01

The process of quality control and auditing of anesthesiology allows us to evaluate care given by a service and solve problems that are detected. Quality control is a basic element of care giving and is only secondarily an area of academic research; it is therefore a meaningless effort if the information does not serve to improve departmental procedures. Quality assurance procedures assume certain infrastructural requirements and an initial period of implementation and adjustment. The main objectives of quality control are the reduction of morbidity and mortality due to anesthesia, assurance of the availability and proper management of resources and, finally, the well-being and safety of the patient.

Field Methods and Quality-Assurance Plan for Quality-of-Water Activities, U.S. Geological Survey, Idaho National Laboratory, Idaho

USGS Publications Warehouse

Knobel, LeRoy L.; Tucker, Betty J.; Rousseau, Joseph P.

2008-01-01

Water-quality activities conducted by the staff of the U.S. Geological Survey (USGS) Idaho National Laboratory (INL) Project Office coincide with the USGS mission of appraising the quantity and quality of the Nation's water resources. The activities are conducted in cooperation with the U.S. Department of Energy's (DOE) Idaho Operations Office. Results of the water-quality investigations are presented in various USGS publications or in refereed scientific journals. The results of the studies are highly regarded, and they are used with confidence by researchers, regulatory and managerial agencies, and interested civic groups. In its broadest sense, quality assurance refers to doing the job right the first time. It includes the functions of planning for products, review and acceptance of the products, and an audit designed to evaluate the system that produces the products. Quality control and quality assurance differ in that quality control ensures that things are done correctly given the 'state-of-the-art' technology, and quality assurance ensures that quality control is maintained within specified limits.

Improving quality: bridging the health sector divide.

PubMed

Pringle, Mike

2003-12-01

All too often, quality assurance looks at just one small part of the complex system that is health care. However, evidently each individual patient has one set of experiences and outcomes, often involving a range of health professionals in a number of settings across multiple sectors. In order to solve the problems of this complexity, we need to establish high-quality electronic recording in each of the settings. In the UK, primary care has been leading the way in adopting information technology and can now use databases for individual clinical care, for quality assurance using significant event and conventional auditing, and for research. Before we can understand and quality-assure the whole health care system, we need electronic patient records in all settings and good communication to build a summary electronic health record for each patient. Such an electronic health record will be under the control of the patient concerned, will be shared with the explicit consent of the patient, and will form the vehicle for quality assurance across all sectors of the health service.

Quality beyond compliance.

PubMed

Centanni, N; Monroe, M; White, L; Larson, R

1999-01-01

The service sector within the biopharmaceutical industry has experienced phenomenal growth over the past decade. In the highly regulated Good Laboratory Practices environment, the need for timely, high-quality service, accurate results, and on-time deliverables becomes paramount for the success and profitability of biopharmaceutical companies. The quality assurance process is a vital component of this drug product-development cycle and ensures compliance to the highest domestic and international regulatory standards. Quality-assurance professionals historically have held the role of independent auditors of the processes, who certify that results meet current standards of practice. Covance, a contract research organization that includes Good Laboratory Practices laboratories, reorganized and expanded the functional responsibilities of its quality assurance team in 1997. Auditors and quality assurance professionals have assumed roles beyond traditional compliance auditing and are forging new leadership and mentoring roles as process-improvement specialists. The results have been tangible, measurable benefits for clients and the Covance organization. This article provides an overview of this cultural change and the processes put in place to improve efficiency, productivity, and customer and employee satisfaction.

Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa

PubMed Central

Jaya, Ziningi; Drain, Paul K.

2017-01-01

Introduction Rapid HIV tests have improved access to HIV diagnosis and treatment by providing quick and convenient testing in rural clinics and resource-limited settings. In this study, we evaluated the quality management system for voluntary and provider-initiated point-of-care HIV testing in primary healthcare (PHC) clinics in rural KwaZulu-Natal (KZN), South Africa. Material and methods We conducted a quality assessment audit in eleven PHC clinics that offer voluntary HIV testing and counselling in rural KZN, South Africa from August 2015 to October 2016. All the participating clinics were purposively selected from the province-wide survey of diagnostic services. We completed an on-site monitoring checklist, adopted from the WHO guidelines for assuring accuracy and reliability of HIV rapid tests, to assess the quality management system for HIV rapid testing at each clinic. To determine clinic’s compliance to WHO quality standards for HIV rapid testing the following quality measure was used, a 3-point scale (high, moderate and poor). A high score was defined as a percentage rating of 90 to 100%, moderate was defined as a percentage rating of 70 to 90%, and poor was defined as a percentage rating of less than 70%. Clinic audit scores were summarized and compared. We employed Pearson pair wise correlation coefficient to determine correlations between clinics audit scores and clinic and clinics characteristics. Linear regression model was computed to estimate statistical significance of the correlates. Correlations were reported as significant at p ≤0.05. Results Nine out of 11 audited rural PHC clinics are located outside 20Km of the nearest town and hospital. Majority (18.2%) of the audited rural PHC clinics reported that HIV rapid test was performed by HIV lay counsellors. Overall, ten clinics were rated moderate, in terms of their compliance to the stipulated WHO guidelines. Audit results showed that rural PHC clinics’ average rating score for compliance to the WHO guidelines ranged between 64.4% (CI: 44%– 84%) and 89.2% (CI: 74%– 100%).Ten out of eleven of the clinics were rated as moderate (70–89%). All clinic have scored highest for the following audit component: equipment; process control and specimen management; and facility ad safety, with 100%. Clinics obtained the lowest scores for the assessment audit component followed by process improvement and organisation, with 40.9% (CI: 15.7–66.1%), 45.5% (CI: 10.4–80.5%) and 56.8% (CI: 31.8 81.8%), respectively. A statistically significant correlation was observed between the following: category of staff performing the HIV rapid tests in the audited clinics and service and satisfactory audit component; weekly average number of patients using the audited PHC clinics and service and satisfactory audit component; number of HIV lay counsellors in the audited clinics and quality control audit component with p<0.05. Discussion In the small audit of primary healthcare clinics located within the rural part of KwaZulu-Natal, results revealed an overall moderate rating of the quality management system for rapid HIV testing. Improvements in the organisation, quality control, process improvement and assessment components could enable a higher quality assurance rating for rural HIV testing in KwaZulu-Natal. PMID:28829801

Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa.

PubMed

Jaya, Ziningi; Drain, Paul K; Mashamba-Thompson, Tivani P

2017-01-01

Rapid HIV tests have improved access to HIV diagnosis and treatment by providing quick and convenient testing in rural clinics and resource-limited settings. In this study, we evaluated the quality management system for voluntary and provider-initiated point-of-care HIV testing in primary healthcare (PHC) clinics in rural KwaZulu-Natal (KZN), South Africa. We conducted a quality assessment audit in eleven PHC clinics that offer voluntary HIV testing and counselling in rural KZN, South Africa from August 2015 to October 2016. All the participating clinics were purposively selected from the province-wide survey of diagnostic services. We completed an on-site monitoring checklist, adopted from the WHO guidelines for assuring accuracy and reliability of HIV rapid tests, to assess the quality management system for HIV rapid testing at each clinic. To determine clinic's compliance to WHO quality standards for HIV rapid testing the following quality measure was used, a 3-point scale (high, moderate and poor). A high score was defined as a percentage rating of 90 to 100%, moderate was defined as a percentage rating of 70 to 90%, and poor was defined as a percentage rating of less than 70%. Clinic audit scores were summarized and compared. We employed Pearson pair wise correlation coefficient to determine correlations between clinics audit scores and clinic and clinics characteristics. Linear regression model was computed to estimate statistical significance of the correlates. Correlations were reported as significant at p ≤0.05. Nine out of 11 audited rural PHC clinics are located outside 20Km of the nearest town and hospital. Majority (18.2%) of the audited rural PHC clinics reported that HIV rapid test was performed by HIV lay counsellors. Overall, ten clinics were rated moderate, in terms of their compliance to the stipulated WHO guidelines. Audit results showed that rural PHC clinics' average rating score for compliance to the WHO guidelines ranged between 64.4% (CI: 44%- 84%) and 89.2% (CI: 74%- 100%).Ten out of eleven of the clinics were rated as moderate (70-89%). All clinic have scored highest for the following audit component: equipment; process control and specimen management; and facility ad safety, with 100%. Clinics obtained the lowest scores for the assessment audit component followed by process improvement and organisation, with 40.9% (CI: 15.7-66.1%), 45.5% (CI: 10.4-80.5%) and 56.8% (CI: 31.8 81.8%), respectively. A statistically significant correlation was observed between the following: category of staff performing the HIV rapid tests in the audited clinics and service and satisfactory audit component; weekly average number of patients using the audited PHC clinics and service and satisfactory audit component; number of HIV lay counsellors in the audited clinics and quality control audit component with p<0.05. In the small audit of primary healthcare clinics located within the rural part of KwaZulu-Natal, results revealed an overall moderate rating of the quality management system for rapid HIV testing. Improvements in the organisation, quality control, process improvement and assessment components could enable a higher quality assurance rating for rural HIV testing in KwaZulu-Natal.

The Contradictory Managerialism of University Quality Assurance

ERIC Educational Resources Information Center

Reid, Ian C.

2009-01-01

This paper investigates how Australian universities are being disciplined to behave as commercial enterprises by the Australian Universities Quality Agency (AUQA). The manual produced by AUQA, for the purpose of conducting audits of Australian universities, is analysed. I use an analytical framework that provides a means by which a text from the…

40 CFR 97.632 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

40 CFR 97.732 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

40 CFR 97.632 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2013 CFR

2013-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

40 CFR 97.732 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

40 CFR 97.632 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2012 CFR

2012-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

40 CFR 97.732 - Monitoring system out-of-control periods.

Code of Federal Regulations, 2014 CFR

2014-07-01

.... Whenever any monitoring system fails to meet the quality-assurance and quality-control requirements or data validation requirements of part 75 of this chapter, data shall be substituted using the applicable missing data procedures in subpart D or appendix D to part 75 of this chapter. (b) Audit decertification...

Quality assurance of clinical transfusion practice by implementation of the privilege of blood prescription and computerized prospective audit of blood requests.

PubMed

Marconi, M; Almini, D; Pizzi, M N; Riccardi, D; Bergamaschi, W; Giovanetti, A M; Rebulla, P; Sirchia, G

1996-03-01

Guidelines, algorithms and recommendations have been issued in the attempt to ensure appropriateness of transfusion practice, but the results are less than satisfactory, mainly due to the difficulty to turn paper procedures into actual practice. In our hospital we have tried to overcome this difficulty through the implementation of a quality assurance programme which includes giving the privilege of nonurgent blood prescription to a limited number of physicians and a computerized prospective audit of blood requests. The latter is performed through verification of the compliance of blood requests, which are designed to include a patient's laboratory and clinical data, with hospital guidelines for the proper use of blood. In the 12 months since implementation of the computerized prospective audit the transfusion service has evaluated 7884 requests. Of these, 63.4% (n = 4998) were for red blood cells, 21.1% (n = 1664) for platelets and 15.5% (n = 1222) for fresh frozen plasma. The prospective audit showed that 96.8% and 98.1% of requests for red units and platelets were appropriate, respectively. Conversely, approximately 27% of plasma requests did not comply with guidelines, mainly because the evidence of coagulopathy was missing. However, inappropriateness of plasma requests for elective general surgery decreased from 39% at the onset of the programme to 14% in the last trimester considered. Moreover, the evaluation by retrospective audit of the proportion of patients transfused with both red blood cells and plasma in the perioperative period out of those transfused with red blood cells only, as an indicator of unwanted reconstitution of whole blood, showed that this proportion decreased from 47.6% (320/672) in the 12 months before implementation of computerized audit to 37.8% (244/646) in the following 12 months (difference = -9.8%, 95% confidence interval of the difference from -4.5% to -15.1%; P < 0.005 by chi 2 test). Our initial experience, together with the present system, shows that (1) the restriction of nonurgent blood prescription to a group of clinicians more educated in transfusion medicine than average clinicians practicing in a large multispecialty hospital is feasible; (2) prospective audit is a useful tool for assuring the quality of blood requesting.

78 FR 54643 - Proposed Information Collection Request; Comment Request; Laboratory Quality Assurance Evaluation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-05

... certification responsibilities for the chemistry and microbiology laboratories that they oversee in their...--including an assessment of Proficiency Test results; and on-site audits at least triennially). Whereas 40...

40 CFR 86.612-97 - Suspension and revocation of certificates of conformity.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ENGINES (CONTINUED) Selective Enforcement Auditing of New Light-Duty Vehicles, Light-Duty Trucks, and... control and/or quality assurance measures to be taken by the manufacturer to prevent the future occurrence...

Quality assurance in road traffic analyses in Switzerland.

PubMed

Briellmann, Thomas A; Sigrist, Thomas; Augsburger, Marc; Favrat, Bernard; Oestreich, Andrea; Deom, André

2010-05-20

Swiss laboratories performing toxicological road traffic analyses have been authorized for many years by the Swiss Federal Roads Office (FEDRO). In 2003 FEDRO signed a contract with the Swiss Society of Legal Medicine (SSLM) to organize the complete quality management concerning road traffic analyses. For this purpose a multidisciplinary working group was established under the name of "road traffic commission (RTC)". RTC has to organize external quality control, to interpret the results of these controls, to perform audits in the laboratories and to report all results to FEDRO. Furthermore the working group can be mandated for special tasks by FEDRO. As an independent organization the Swiss Center for Quality Control (CSCQ) in Geneva manages the external quality controls in the laboratory over the past years. All tested drugs and psychoactive substances are listed in a federal instruction. The so-called 'zero tolerance substances' (THC, morphine, cocaine, amphetamine, methamphetamine, MDMA and MDEA) and their metabolites have to be tested once a year, all other substances (benzodiazepines, zolpidem, phenobarbital, etc.) periodically. Results over the last years show that all laboratories are generally within the confidence interval of +/-30% of the mean value. In cases of non-conformities measures have to be taken immediately and reported to the working group. External audits are performed triennially but accredited laboratories can combine this audit with the approval of the Swiss Accreditation Service (SAS). During the audits a special checklist filled in by the laboratory director is assessed. Non-conformities have to be corrected. During the process of establishing a new legislation, RTC had an opportunity of advising FEDRO. In collaboration with FEDRO, RTC and hence SSLM can work actively on improving of quality assurance in road traffic toxicological analyses, and has an opportunity to bring its professional requests to the federal authorities.

When Somebody's Watching: Researching the Workplace Impact of Academic Audit. AIR 2002 Forum Paper.

ERIC Educational Resources Information Center

Palermo, Josephine

The proposed quality assurance framework for higher education in Australia will, for the first time since the early 1990s, introduce a process of external quality monitoring through the auspices of the Australian Universities Quality Agency. There is little research that evaluates the impact of external monitoring on the experiences of staff,…

Quality assurance in surgical oncology. Colorectal cancer as an example.

PubMed

Gunnarsson, Ulf

2003-02-01

Quality assurance in surgical oncology is a field of growing importance. National, regional and local systems have been built up in many countries. Often the quality assurance projects are linked to different registers. The advantage of such a link is the possibility of obtaining population-based data from unselected health care institutions. Few discussions of results from such projects have been published. Quality assurance of colorectal cancer surgery implies the development and use of systems for improvement all the way from detection of the cancer to the outcome as survival and patient satisfaction. To achieve this we must know what methods are being used and the outcome of our treatments. Designing processes for improvement necessitates careful planning, including decisions about end-points. Some crucial issues are discussed step-by-step in the present paper. In addition to auditing and providing collegial feedback, quality assurance is a tool for closing the gap between clinical practice and evidence based medicine and for creating new evidences as well as monitoring the introduction of new techniques and their effects.

Standardized development of computer software. Part 2: Standards

NASA Technical Reports Server (NTRS)

Tausworthe, R. C.

1978-01-01

This monograph contains standards for software development and engineering. The book sets forth rules for design, specification, coding, testing, documentation, and quality assurance audits of software; it also contains detailed outlines for the documentation to be produced.

Concept of Draft International Standard for a Unified Approach to Space Program Quality Assurance

NASA Astrophysics Data System (ADS)

Stryzhak, Y.; Vasilina, V.; Kurbatov, V.

2002-01-01

For want of the unified approach to guaranteed space project and product quality assurance, implementation of many international space programs has become a challenge. Globalization of aerospace industry and participation of various international ventures with diverse quality assurance requirements in big international space programs requires for urgent generation of unified international standards related to this field. To ensure successful fulfillment of space missions, aerospace companies should design and process reliable and safe products with properties complying or bettering User's (or Customer's) requirements. Quality of the products designed or processed by subcontractors (or other suppliers) should also be in compliance with the main user (customer)'s requirements. Implementation of this involved set of unified requirements will be made possible by creating and approving a system (series) of international standards under a generic title Space Product Quality Assurance based on a system consensus principle. Conceptual features of the baseline standard in this system (series) should comprise: - Procedures for ISO 9000, CEN and ECSS requirements adaptation and introduction into space product creation, design, manufacture, testing and operation; - Procedures for quality assurance at initial (design) phases of space programs, with a decision on the end product made based on the principle of independence; - Procedures to arrange incoming inspection of products delivered by subcontractors (including testing, audit of supplier's procedures, review of supplier's documentation), and space product certification; - Procedures to identify materials and primary products applied; - Procedures for quality system audit at the component part, primary product and materials supplier facilities; - Unified procedures to form a list of basic performances to be under configuration management; - Unified procedures to form a list of critical space product components, and unified procedures to define risks related to the specific component application and evaluate safety for the entire program implementation. In the eyes of the authors, those features together with a number of other conceptual proposals should constitute a unified standard-technical basis for implementing international space programs.

Structural methodologies for auditing SNOMED.

PubMed

Wang, Yue; Halper, Michael; Min, Hua; Perl, Yehoshua; Chen, Yan; Spackman, Kent A

2007-10-01

SNOMED is one of the leading health care terminologies being used worldwide. As such, quality assurance is an important part of its maintenance cycle. Methodologies for auditing SNOMED based on structural aspects of its organization are presented. In particular, automated techniques for partitioning SNOMED into smaller groups of concepts based primarily on relationships patterns are defined. Two abstraction networks, the area taxonomy and p-area taxonomy, are derived from the partitions. The high-level views afforded by these abstraction networks form the basis for systematic auditing. The networks tend to highlight errors that manifest themselves as irregularities at the abstract level. They also support group-based auditing, where sets of purportedly similar concepts are focused on for review. The auditing methodologies are demonstrated on one of SNOMED's top-level hierarchies. Errors discovered during the auditing process are reported.

Emergency recompression: clinical audit of service delivery at a national level.

PubMed

Ross, John As; Sayer, Martin Dj

2009-03-01

Clinical audit is an essential element to the maintenance or improvement of delivery of any medical service. During the development phase of a National Recompression Registration Service for Scotland, clinical audit was initiated to provide a standardised tool to monitor the quality of outcome with respect to the severity of presentation. A functional audit process was an essential consideration for planned future measurement of treatment efficacy at local (single hyperbaric unit) and national (multiple hyperbaric units) scales. The audit process was designed to be undemanding, robust and informative, irrespective of the experience of treatment centre and of the clinician in charge of treatment. The clinical records from 104 cases of divers with decompression illness were used to derive and evaluate measures of severity and clinical outcome that could be used for audit and quality assurance. The various measures of disease severity were examined against clinical outcome and days spent in care after admission to a hyperbaric unit. An initial version of the clinical audit format that was developed from this process is presented.

Installation Restoration Program (IRP) Stage 7, Remedial Investigation/ Feasibility Study Comprehensive CERCLA Work PLan for McClellan AFB/EM, McClellan AFB, California

DTIC Science & Technology

1991-07-01

Systems Audits ; Preventive Maintenance; Data Assessment Procedures; Corrective Action; Quality Assurance Reports; and Site Management. General Data Quality...for verification and quality control audits . A copy of the QAPP will be in the possession of field sampling teams for all sampling efforts...L cc- acca C wi w-C P-3-- C I- usu 2; - at C4~~2 Q (( c ccc c-c C- 0L U -C 3- au S - - C3 . - acu tr - -a CL.43 C LU -C2 -C ul 0it S w- -C u Ocw - z i

[Quality assurance in interventional cardiology].

PubMed

Gülker, H

2009-10-01

Quality assurance in clinical studies aiming at approval of pharmaceutical products is submitted to strict rules, controls and auditing regulations. Comparative instruments to ensure quality in diagnostic and therapeutic procedures are not available in interventional cardiology, likewise in other fields of cardiovascular medicine. Quality assurance simply consists of "quality registers" with basic data not externally controlled. Based on the experiences of clinical studies and their long history of standardization it is assumed that these data may be severely flawed thus being inappropriate to set standards for diagnostic and therapeutic strategies. The precondition for quality assurance are quality data. In invasive coronary angiography and intervention medical indications, the decision making process interventional versus surgical revascularization, technical performance and after - care are essential aspects affecting quality of diagnostics and therapy. Quality data are externally controlled data. To collect quality data an appropriate infrastructure is a necessary precondition which is not existent. For an appropriate infrastructure investments have to be done both to build up as well as to sustain the necessary preconditions. As long as there are no infrastructure and no investments there will be no "quality data". There exist simply registers of data which are not proved to be a basis for significant assurance and enhancement in quality in interventional coronary cardiology. Georg Thieme Verlag KG Stuttgart, New York.

A quality-assurance assessment for constituents reported by the national atmospheric deposition program and the national trends network

NASA Astrophysics Data System (ADS)

See, Randolph B.; Schroder, LeRoy J.; Willoughby, Timothy C.

A continuing quality-assurance program has been operated by the U.S. Geological Survey to evaluate any bias introduced by routine handling, shipping, and laboratory analyses of wet-deposition samples collected in the National Atmospheric Deposition Program (NADP) and National Trends Network (NTN). Blind-audit samples having a variety of constituent concentrations and values were selected. Only blind-audit samples with constituent concentrations and values less than the 95th-percentile concentration for natural wet-deposition samples were included in the analysis. Of the major ions, there was a significant increase of Ca 2+, Mg 2+, Na 2+, K +, SO 42- and Cl -1 in samples handled according to standard protocols and shipped in NADP/NTN sample-collection buckets. For 1979-1987, graphs of smoothed data showing the estimated contamination in blind-audit samples indicate a decrease in the median concentration and ranges of Ca 2+, Mg 2+ and SO 42- contamination of blind-audit samples shipped in sample-collection buckets. Part of the contamination detected in blind-audit samples can be attributed to contact with the sample-collection bucket and lid; however, additional sources also seem to contaminate the blind-audit sample. Apparent decreases in the magnitude and range of sample contamination may be caused by differences in sample-collection bucket- and lid-washing procedures by the NADP/NTN Central Analytical Laboratory. Although the degree of bias is minimal for most constituents, summaries of the NADP/NTN data base may contain overestimates of Ca 2+, Mg 2+, Na -, K + and SO 42- and Cl - concentrations, and underestimates of H + concentrations.

A quality-assurance assessment for constituents reported by the National Atmospheric Deposition Program and the National Trends Network

USGS Publications Warehouse

See, R.B.; Schroder, L.J.; Willoughby, T.C.

1989-01-01

A continuing quality-assurance program has been operated by the U.S. Geographical Survey to evaluate any bias introduced by routine handling, shipping, and laboratory analyses of wet-deposition samples collected in the National Atmospheric Deposition Program (NADP) and National Trends Network (NTN). Blind-audit samples having a variety of constituent concentrations and values were selected. Only blind-audit samples with constituent concentrations and values less than the 95th-percentile concentration for natural wet-deposition samples were included in the analysis. Of the major ions, there was a significant increase of Ca2+, Mg2+, K+ SO42+ and Cl- in samples handled according to standard protocols and shipped in NADP/NTN sample-collection buckets. For 1979-1987, graphs of smoothed data showing the estimated contaminations in blind-audit samples indicate a decrease in the median concentration and ranges of Ca2+, Mg2+ and SO42- contamination of blind-audit samples shipped in sample-collection buckets. Part of the contamination detected in blind-audit samples can be attributed to contact with the sample-collection bucket and lid; however, additional sources also seem to contaminate the blind-audit sample. Apparent decreases in the magnitude and range of sample contamination may be caused by differences in sample-collection bucket- and lid-washing procedures by the NADP/NTN Central Analytical Laboratory. Although the degree of bias is minimal for most constituents, summaries of the NADP/NTN data base may contain overestimates of Ca2+, Mg2+, Na-, K+, SO42- and Cl- concentrations, and underestimates of H+ concentrations.

Local audit of diagnostic surgical pathology as a tool for quality assurance.

PubMed

Malami, Sani Abubakar; Iliyasu, Yawale

2008-01-01

Internal audit has been rarely done for quality assurance of histology laboratories in Nigeria. We reviewed the steps involved in the production of reports with a view to assessing the performance of the histopathology laboratory of Aminu Kano Teaching Hospital, Nigeria. A randomly selected 2 per cent sample of the total histology workload of the center for the year ending December 2005 amounting to 2877 cases was systematically reviewed. Analysis of the accumulated data showed a concordance rate of 94.8% between the original and review histological diagnoses, comparable to other published studies. Significant defects were observed to be due to missing demographic information on request forms (22.8%), poor technical quality of slide sections (18.4%) and typographical errors by typists (12.3%) In a minority of cases microscopic description was inadequate or inappropriate (7.0%) and some were inaccurate (2.7%). The turnaround time ranged from 2 to 16 days (mean 6.2 days) with results of 75.8 per cent of the specimens completed within 7 days. From the study we have shown that local audit is feasible in Nigerian laboratories and is an excellent method for detecting errors and improving performance in Surgical Pathology to optimize the scarce resources available to patient care in our country.

Product asssurance requirements for micro VCM-apparatus and associated equipment

NASA Astrophysics Data System (ADS)

1982-10-01

The rules for performing Micro VCM-tests (vacuum tests) on materials for European Space Agency projects are presented. Formal guidelines for initial audits along with annual and special quality assurance reviews are summarized. Inspection forms are displayed.

21 CFR 26.1 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN... regulatory systems means that the systems are sufficiently comparable to assure that the process of... require that the respective regulatory systems have identical procedures. (c) Good Manufacturing Practices...

7 CFR 91.1 - General.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES... administrative rules of the Science and Technology of the Agricultural Marketing Service for conducting the analytical testing and laboratory audits with quality assurance reviews. It also contains the fees, charges...

7 CFR 91.1 - General.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES... administrative rules of the Science and Technology of the Agricultural Marketing Service for conducting the analytical testing and laboratory audits with quality assurance reviews. It also contains the fees, charges...

7 CFR 91.1 - General.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES... administrative rules of the Science and Technology of the Agricultural Marketing Service for conducting the analytical testing and laboratory audits with quality assurance reviews. It also contains the fees, charges...

7 CFR 91.1 - General.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS SERVICES... administrative rules of the Science and Technology of the Agricultural Marketing Service for conducting the analytical testing and laboratory audits with quality assurance reviews. It also contains the fees, charges...

Auditing Orthopaedic Audit

PubMed Central

Guryel, E; Acton, K; Patel, S

2008-01-01

INTRODUCTION Clinical audit plays an important role in the drive to improve the quality of patient care and thus forms a cornerstone of clinical governance. Assurance that the quality of patient care has improved requires completion of the audit cycle. A considerable sum of money and time has been spent establishing audit activity in the UK. Failure to close the loop undermines the effectiveness of the audit process and wastes resources. PATIENTS AND METHODS We analysed the effectiveness of audit in trauma and orthopaedics at a local hospital by comparing audit projects completed over a 6-year period to criteria set out in the NHS National Audit and Governance report. RESULTS Of the 25 audits performed since 1999, half were presented to the relevant parties and only 20% completed the audit cycle. Only two of these were audits against national standards and 28% were not based on any standards at all. Only a third of the audits led by junior doctors resulted in implementation of their action plan compared to 75% implementation for consultant-led and 67% for nurse-led audits. CONCLUSIONS A remarkably large proportion of audits included in this analysis failed to meet accepted criteria for effective audit. Audits completed by junior doctors were found to be the least likely to complete the cycle. This may relate to the lack of continuity in modern medical training and little incentive to complete the cycle. Supervision by permanent medical staff, principally consultants, and involvement of the audit department may play the biggest role in improving implementation of change. PMID:18828963

Auditing orthopaedic audit.

PubMed

Guryel, E; Acton, K; Patel, S

2008-11-01

Clinical audit plays an important role in the drive to improve the quality of patient care and thus forms a cornerstone of clinical governance. Assurance that the quality of patient care has improved requires completion of the audit cycle. A considerable sum of money and time has been spent establishing audit activity in the UK. Failure to close the loop undermines the effectiveness of the audit process and wastes resources. We analysed the effectiveness of audit in trauma and orthopaedics at a local hospital by comparing audit projects completed over a 6-year period to criteria set out in the NHS National Audit and Governance report. Of the 25 audits performed since 1999, half were presented to the relevant parties and only 20% completed the audit cycle. Only two of these were audits against national standards and 28% were not based on any standards at all. Only a third of the audits led by junior doctors resulted in implementation of their action plan compared to 75% implementation for consultant-led and 67% for nurse-led audits. A remarkably large proportion of audits included in this analysis failed to meet accepted criteria for effective audit. Audits completed by junior doctors were found to be the least likely to complete the cycle. This may relate to the lack of continuity in modern medical training and little incentive to complete the cycle. Supervision by permanent medical staff, principally consultants, and involvement of the audit department may play the biggest role in improving implementation of change.

Are we monitoring the quality of cataract surgery services? A qualitative situation analysis of attitudes and practices in a large city in South Africa.

PubMed

Haastrup, Oluwatosin O O; Buchan, John C; Cassels-Brown, Andy; Cook, Colin

2015-01-01

To evaluate the current quality "assurance" and "improvement" mechanisms, the knowledge, attitudes and practices of cataract surgeons in a large South African city. A total of 17 in-depth semi-structured interviews were conducted with ophthalmologists in June 2012 at 2 tertiary institutions in the Republic of South Africa. Recruitment of the purposive sample was supplemented by snowball sampling. The study participants were 5 general ophthalmologists and 2 pediatric ophthalmologists; 4 senior and 4 junior registrars and a medical officer. Participants were interviewed by a trained qualitative interviewer. The interview lasted between 20 and 60 min. The interviews were recorded, transcribed verbatim and analyzed for thematic content. Mechanisms for quality assurance were trainee logbooks and subjective senior staff observation. Clinicians were encouraged, but not obliged to self-audit. Quality improvement is incentivized by personal integrity and ambition. Poorly performing departments are inconspicuous, especially nationally, and ophthalmologists rely on the impression to gauge the quality of service provided by colleagues. Currently, word of mouth is the method for determining the better cataract surgical centers. The quality assurance mechanisms were dependent on insight and integrity of the individual surgeons. No structures were described that would ensure the detection of surgeons with higher than expected complication rates. Currently, audits are not enforced, and surgical outcomes are not well monitored due to concerns that this may lead to lack of openness among ophthalmologists.

The challenge of designing a database for auditing surgical in-patients.

PubMed

Branday, J M; Crandon, I; Carpenter, R; Rhoden, A; Meeks-Aitken, N

1999-12-01

Surgical audit is imperative in modern practice, particularly in the developing world where resources are limited and efficient allocation important. The structure, process and outcome of surgical care can be determined for quality assurance or for research. Improved efficiency and reduction of morbidity and mortality are additional goals which may be accomplished. However, computerization, medical staff cooperation and the availability of dedicated staff are among the hurdles which may be encountered. We report the challenge of designing and establishing a database for auditing surgical inpatients in a developing country and the difficulties which were encountered.

Field methods and quality-assurance plan for water-quality activities and water-level measurements, U.S. Geological Survey, Idaho National Laboratory, Idaho

USGS Publications Warehouse

Bartholomay, Roy C.; Maimer, Neil V.; Wehnke, Amy J.

2014-01-01

Water-quality activities and water-level measurements by the personnel of the U.S. Geological Survey (USGS) Idaho National Laboratory (INL) Project Office coincide with the USGS mission of appraising the quantity and quality of the Nation’s water resources. The activities are carried out in cooperation with the U.S. Department of Energy (DOE) Idaho Operations Office. Results of the water-quality and hydraulic head investigations are presented in various USGS publications or in refereed scientific journals and the data are stored in the National Water Information System (NWIS) database. The results of the studies are used by researchers, regulatory and managerial agencies, and interested civic groups. In the broadest sense, quality assurance refers to doing the job right the first time. It includes the functions of planning for products, review and acceptance of the products, and an audit designed to evaluate the system that produces the products. Quality control and quality assurance differ in that quality control ensures that things are done correctly given the “state-of-the-art” technology, and quality assurance ensures that quality control is maintained within specified limits.

Findings From a Nursing Care Audit Based on the Nursing Process: A Descriptive Study.

PubMed

Poortaghi, Sarieh; Salsali, Mahvash; Ebadi, Abbas; Rahnavard, Zahra; Maleki, Farzaneh

2015-09-01

Although using the nursing process improves nursing care quality, few studies have evaluated nursing performance in accordance with nursing process steps either nationally or internationally. This study aimed to audit nursing care based on a nursing process model. This was a cross-sectional descriptive study in which a nursing audit checklist was designed and validated for assessing nurses' compliance with nursing process. A total of 300 nurses from various clinical settings of Tehran university of medical sciences were selected. Data were analyzed using descriptive and inferential statistics, including frequencies, Pearson correlation coefficient and independent samples t-tests. The compliance rate of nursing process indicators was 79.71 ± 0.87. Mean compliance scores did not significantly differ by education level and gender. However, overall compliance scores were correlated with nurses' age (r = 0.26, P = 0.001) and work experience (r = 0.273, P = 0.001). Nursing process indicators can be used to audit nursing care. Such audits can be used as quality assurance tools.

Medical Physics Challenges for the Implementation of Quality Assurance Programmes in Radiation Oncology.

PubMed

Meghzifene, A

2017-02-01

The importance of quality assurance in radiation therapy, as well as its positive consequences on patient treatment outcome, is well known to radiation therapy professionals. In low- and middle-income countries, the implementation of quality assurance in radiation therapy is especially challenging, due to a lack of staff training, a lack of national guidelines, a lack of quality assurance equipment and high patient daily throughput. According to the International Atomic Energy Agency (IAEA) Directory of Radiotherapy Centres, the proportion of linear accelerators compared with Co-60 machines has increased significantly in recent years in low- and middle-income countries. However, this increase in the proportion of relatively more demanding technology is not always accompanied with the necessary investment in staff training and quality assurance. The IAEA provides supports to low- and middle-income countries to develop and strengthen quality assurance programmes at institutional and national level. It also provides guidance, through its publications, on quality assurance and supports implementation of comprehensive clinical audits to identify gaps and makes recommendations for quality improvement in radiation therapy. The new AAPM TG100 report suggests a new approach to quality management in radiation therapy. If implemented, it will lead to improved cost-effectiveness of radiation therapy in all income settings. Low- and middle-income countries could greatly benefit from this new approach as it will help direct their scarce resources to areas where they can produce the optimum impact on patient care, without compromising patient safety. Copyright © 2016. Published by Elsevier Ltd.

48 CFR 4.803 - Contents of contract files.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Cost or price analysis. (20) Audit reports or reasons for waiver. (21) Record of negotiation. (22... them. (13) Documents supporting advance or progress payments. (14) Progressing, expediting, and production surveillance records. (15) Quality assurance records. (16) Property administration records. (17...

41 CFR 102-118.410 - Can GSA suspend my agency's prepayment audit program?

Code of Federal Regulations, 2011 CFR

2011-01-01

... conduct a quality assurance review. (b) A systematic or a multitude of individual failures will result in... on his or her determination of a systematic or frequent failure of the program to: (1) Conduct an...

FORTRAN tools

NASA Technical Reports Server (NTRS)

Presser, L.

1978-01-01

An integrated set of FORTRAN tools that are commercially available is described. The basic purpose of various tools is summarized and their economic impact highlighted. The areas addressed by these tools include: code auditing, error detection, program portability, program instrumentation, documentation, clerical aids, and quality assurance.

The pre-audit assessment: A homework assignment for auditors

DOE Office of Scientific and Technical Information (OSTI.GOV)

Marschman, S.C.

1993-02-01

The role of the quality assurance audit is evolving from compliance verification to a much broader assessment of programmatic and management performance. In the past, audits were poorly understood and caused fear and trepidation. Auditees turned an audit into a cat-and-mouse game using coverup strategies and decoy discrepancies. These games were meant to ``give the auditors what they want, namely a few findings that could later be easily corrected. At Pacific Northwest Laboratory (PNL), I observed auditing become a spectator sport. Matching a compliance-oriented auditor against a crafty group of scientists provided hours of entertainment. As a program manager, itmore » was clear these games were neither productive useful nor cost effective. Fortunately, over the past few years several concepts embraced by ``total quality management` have begun to emerge at PNL. These concepts are being adopted by most successful organizations, and based on these concepts new tools and ideas are emerging to help organizations improve productivity and quality. Successful organizations have been and are continuing to develop management strategies that rely on participative approaches to their operations. These approaches encourage the empowerment of organization staff at all levels, with the goal of instilling ownership of quality in every staff member. As management philosophies are changing, so are the responsibilities and expectations of managers. Managers everywhere are experimenting with new tools to help them improve their operations and competitiveness. As the quality audit evolves, managers and other customers of the audit process have developed expectations for the auditing process that never existed in years past. These expectations have added complexity to the audit process. It is no longer adequate to prepare a checklist, perform the audit, and document the results. When viewed as a tool for verifying performance, a quality audit becomes more than a compliance checklist.« less

The pre-audit assessment: A homework assignment for auditors

DOE Office of Scientific and Technical Information (OSTI.GOV)

Marschman, S.C.

1993-02-01

The role of the quality assurance audit is evolving from compliance verification to a much broader assessment of programmatic and management performance. In the past, audits were poorly understood and caused fear and trepidation. Auditees turned an audit into a cat-and-mouse game using coverup strategies and decoy discrepancies. These games were meant to give the auditors what they want, namely a few findings that could later be easily corrected. At Pacific Northwest Laboratory (PNL), I observed auditing become a spectator sport. Matching a compliance-oriented auditor against a crafty group of scientists provided hours of entertainment. As a program manager, itmore » was clear these games were neither productive useful nor cost effective. Fortunately, over the past few years several concepts embraced by total quality management' have begun to emerge at PNL. These concepts are being adopted by most successful organizations, and based on these concepts new tools and ideas are emerging to help organizations improve productivity and quality. Successful organizations have been and are continuing to develop management strategies that rely on participative approaches to their operations. These approaches encourage the empowerment of organization staff at all levels, with the goal of instilling ownership of quality in every staff member. As management philosophies are changing, so are the responsibilities and expectations of managers. Managers everywhere are experimenting with new tools to help them improve their operations and competitiveness. As the quality audit evolves, managers and other customers of the audit process have developed expectations for the auditing process that never existed in years past. These expectations have added complexity to the audit process. It is no longer adequate to prepare a checklist, perform the audit, and document the results. When viewed as a tool for verifying performance, a quality audit becomes more than a compliance checklist.« less

UK national audit against the key performance indicators in the British Association for Sexual Health and HIV Medical Foundation for AIDS and Sexual Health Sexually Transmitted Infections Management Standards.

PubMed

McClean, H; Sullivan, A K; Carne, C A; Warwick, Z; Menon-Johansson, A; Clutterbuck, D

2012-10-01

A national audit of practice performance against the key performance indicators in the British Association for Sexual Health and HIV (BASHH) and HIV Medical Foundation for AIDS Sexual Health Standards for the Management of Sexually Transmitted Infections (STIs) was conducted in 2011. Approximately 60% and 8% of level 3 and level 2 services, respectively, participated. Excluding partner notification performance, the five lowest areas of performance for level 3 clinics were the STI/HIV risk assessment, care pathways linking care in level 2 clinics to local level 3 services, HIV test offer to patients with concern about STIs, information governance and receipt of chlamydial test results by clinicians within seven working days (the worst area of performance). The five lowest areas of performance for level 2 clinics were participating in audit, having an audit plan for the management of STIs for 2009-2010, the STI/HIV risk assessment, HIV test offer to patients with concern about STIs and information governance. The results are discussed with regard to the importance of adoption of the standards by commissioners of services because of their relevance to other national quality assurance drivers, and the need for development of a national system of STI management quality assurance measurement and reporting.

The National Health Service Breast Screening Programme and British Association of Surgical Oncology audit of quality assurance in breast screening 1996-2001.

PubMed

Sauven, P; Bishop, H; Patnick, J; Walton, J; Wheeler, E; Lawrence, G

2003-01-01

The National Health Service Breast Screening Programme (NHSBSP) is an example of a nationally coordinated quality assurance programme in which all the professional groups involved participate. Surgeons, radiologists and pathologists defined the clinical outcome measures against which they would subsequently be audited. The NHSBSP and the Association of Breast Surgery at BASO are jointly responsible for coordinating an annual audit of all surgical activities undertaken within the NHSBSP. The trends for key outcome measures between 1996 and 2001 are provided. The preoperative diagnosis rate (minimum standard 70 per cent or more) improved from 63 to 87 per cent. This rise was mirrored by an increase in the use of core biopsy in preference to fine-needle cytology. The proportion of patients in whom lymph node status was recorded improved from 81 to 93 per cent. There was no significant change in the number of women treated by low case-load surgeons and waiting times for surgery increased through the study interval. The BASO-NHSBSP Breast Audit has recorded major changes in clinical practice over 5 years. A key feature has been the dissemination of good practice through feedback of the results at local and national level. Copyright 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons Ltd

The Path to Excellence: Quality Assurance in Higher Education. ASHE-ERIC Higher Education Research Reports, No. 1. FYI Executive Summary.

ERIC Educational Resources Information Center

Marcus, Lawrence R.; And Others

There is an increasing interest by government in accountability for higher education. Efforts such as performance budgeting, performance auditing, and state review of academic programs are becoming more common. Opponents of government involvement assert that regional accreditation reviews are sufficient to maintain quality standards. However,…

Transforming an EPA QA/R-2 quality management plan into an ISO 9002 quality management system.

PubMed

Kell, R A; Hedin, C M; Kassakhian, G H; Reynolds, E S

2001-01-01

The Environmental Protection Agency's (EPA) Office of Emergency and Remedial Response (OERR) requires environmental data of known quality to support Superfund hazardous waste site projects. The Quality Assurance Technical Support (QATS) Program is operated by Shaw Environmental and Infrastructure, Inc. to provide EPA's Analytical Operations Center (AOC) with performance evaluation samples, reference materials, on-site laboratory auditing capabilities, data audits (including electronic media data audits), methods development, and other support services. The new QATS contract awarded in November 2000 required that the QATS Program become ISO 9000 certified. In a first for an EPA contractor, the QATS staff and management successfully transformed EPA's QA/R-2 type Quality Management Plan into a Quality Management System (QMS) that complies with the requirements of the internationally recognized ISO 9002 standard and achieved certification in the United States, Canada, and throughout Europe. The presentation describes how quality system elements of ISO 9002 were implemented on an already existing quality system. The psychological and organizational challenges of the culture change in QATS' day-to-day operations will be discussed for the benefit of other ISO 9000 aspirants.

Dosimetry for audit and clinical trials: challenges and requirements

NASA Astrophysics Data System (ADS)

Kron, T.; Haworth, A.; Williams, I.

2013-06-01

Many important dosimetry audit networks for radiotherapy have their roots in clinical trial quality assurance (QA). In both scenarios it is essential to test two issues: does the treatment plan conform with the clinical requirements and is the plan a reasonable representation of what is actually delivered to a patient throughout their course of treatment. Part of a sound quality program would be an external audit of these issues with verification of the equivalence of plan and treatment typically referred to as a dosimetry audit. The increasing complexity of radiotherapy planning and delivery makes audits challenging. While verification of absolute dose delivered at a reference point was the standard of external dosimetry audits two decades ago this is often deemed inadequate for verification of treatment approaches such as Intensity Modulated Radiation Therapy (IMRT) and Volumetric Modulated Arc Therapy (VMAT). As such, most dosimetry audit networks have successfully introduced more complex tests of dose delivery using anthropomorphic phantoms that can be imaged, planned and treated as a patient would. The new challenge is to adapt this approach to ever more diversified radiotherapy procedures with image guided/adaptive radiotherapy, motion management and brachytherapy being the focus of current research.

Multicentre dose audit for clinical trials of radiation therapy in Asia

PubMed Central

Fukuda, Shigekazu; Fukumura, Akifumi; Nakamura, Yuzuru-Kutsutani; Jianping, Cao; Cho, Chul-Koo; Supriana, Nana; Dung, To Anh; Calaguas, Miriam Joy; Devi, C.R. Beena; Chansilpa, Yaowalak; Banu, Parvin Akhter; Riaz, Masooma; Esentayeva, Surya; Kato, Shingo; Karasawa, Kumiko; Tsujii, Hirohiko

2017-01-01

Abstract A dose audit of 16 facilities in 11 countries has been performed within the framework of the Forum for Nuclear Cooperation in Asia (FNCA) quality assurance program. The quality of radiation dosimetry varies because of the large variation in radiation therapy among the participating countries. One of the most important aspects of international multicentre clinical trials is uniformity of absolute dose between centres. The National Institute of Radiological Sciences (NIRS) in Japan has conducted a dose audit of participating countries since 2006 by using radiophotoluminescent glass dosimeters (RGDs). RGDs have been successfully applied to a domestic postal dose audit in Japan. The authors used the same audit system to perform a dose audit of the FNCA countries. The average and standard deviation of the relative deviation between the measured and intended dose among 46 beams was 0.4% and 1.5% (k = 1), respectively. This is an excellent level of uniformity for the multicountry data. However, of the 46 beams measured, a single beam exceeded the permitted tolerance level of ±5%. We investigated the cause for this and solved the problem. This event highlights the importance of external audits in radiation therapy. PMID:27864507

An efficient, large-scale, non-lattice-detection algorithm for exhaustive structural auditing of biomedical ontologies.

PubMed

Zhang, Guo-Qiang; Xing, Guangming; Cui, Licong

2018-04-01

One of the basic challenges in developing structural methods for systematic audition on the quality of biomedical ontologies is the computational cost usually involved in exhaustive sub-graph analysis. We introduce ANT-LCA, a new algorithm for computing all non-trivial lowest common ancestors (LCA) of each pair of concepts in the hierarchical order induced by an ontology. The computation of LCA is a fundamental step for non-lattice approach for ontology quality assurance. Distinct from existing approaches, ANT-LCA only computes LCAs for non-trivial pairs, those having at least one common ancestor. To skip all trivial pairs that may be of no practical interest, ANT-LCA employs a simple but innovative algorithmic strategy combining topological order and dynamic programming to keep track of non-trivial pairs. We provide correctness proofs and demonstrate a substantial reduction in computational time for two largest biomedical ontologies: SNOMED CT and Gene Ontology (GO). ANT-LCA achieved an average computation time of 30 and 3 sec per version for SNOMED CT and GO, respectively, about 2 orders of magnitude faster than the best known approaches. Our algorithm overcomes a fundamental computational barrier in sub-graph based structural analysis of large ontological systems. It enables the implementation of a new breed of structural auditing methods that not only identifies potential problematic areas, but also automatically suggests changes to fix the issues. Such structural auditing methods can lead to more effective tools supporting ontology quality assurance work. Copyright © 2018 Elsevier Inc. All rights reserved.

[5th Report of the German Association of Cardiologists in Private Practice (BNK) on Quality Assurance in Cardiac Catheterization and Coronary Intervention 2003-2005].

PubMed

Levenson, B; Albrecht, A; Göhring, St; Haerer, W; Herholz, H; Reifart, N; Sauer, G; Troger, B

2007-02-01

On behalf of the German Association of Cardiologists in Private Practice (BNK) the Steering Committee of the QuIK Registry reports on the results of the voluntary quality assurance in invasive cardiology in 2003-2005 and compares it to other data collections. In 2005 more than 70% of diagnostic (LHK) and 78% of therapeutic (PCI) cardiac catheterization procedures in private practice were entered into the registry. Altogether 229,462 LHK and 64,818 PCI were documented over the 3 years. In the reported period age of patients, percentage of acute coronary syndromes and three-vessel coronary artery disease increased in LHK as well as in PCI while consumption of contrast media and fluoroscopy time decreased. By implemented possibility of follow-up, a high rate of external auditing (monitoring) and certification QuIK remains a worldwide unique quality assurance project in cardiology. On a stable data basis over 10 years the QuIK Registry enables the implementation of quality indicators for future quality assurance purposes.

Introducing quality assurance and medical audit into the UCSF medical center curriculum.

PubMed

Barbaccia, J C

1976-05-01

The experience gained by a medical school faculty in developing and piloting a course for undergraduate medical students in medical care evaluation led to a similar effort for house staff. It is recognized that if the profession is to fulfill the demand by society for social accountability in the use of resources for health care, medical care assessment and quality assurance mechanisms must become an intimate part of the clinical experience of medical students and house officers. Teaching these subjects requires a theoretical framework; introduction of content and skills appropriate to the level of the student and continuation of progressively more advanced training throughout medical education; use of assessment and quality assurance techniques by clinician-teachers themselves to provide models for the student; and continued evolution of pedagogic approach and course content based on developments in the area.

[Contribution to the establishment of quality assurance in five medical microbiology departments in Togo].

PubMed

Katawa, G; Kpotsra, A; Karou, D S; Eklou, M; Tayi, K E; de Souza, C

2011-02-01

In Togo, as in many other developing countries, there is a lack of data on quality control and assurance of laboratories. The present study aimed to access for the quality management system in five medical bacteriology laboratories in Togo. The study was conducted from May to August 2006. Data were recorded by an audit on the reliability of results and the technical organization of laboratories. The standard ISO 15189:2003, the Togolese guide of good laboratory practices (GBEA-Togo) and the WHO medical bacteriology standards were used as references. The results of the audit showed a lack of culture media in laboratories, inappropriate choice of culture media, partial identification of some microorganisms, variability of identification procedures, a lack of diagnostic reagents and an inability to identify some potentially pathogenic bacteria. Concerning the technical organization of laboratories, compliance average ranging from 25.8 to 54.8 % was recorded. This indicates a limited organization of such laboratories. The issue of this study showed that laboratories must be equipped, their technical organization should be improved and they must establish a program of equipment maintenance.

[Quality assurance in ENT tumor surgery].

PubMed

Eckel, H E; Streppel, M; Schmalenbach, K; Volling, P; Schrappe, M; Dietz, A; Bootz, F

2000-12-01

Quality control is of special importance in head and neck oncology since the quality of medical care constitutes a vital parameter for the diseased patient. In contrast to other medical specialties, no quality assurance program for head and neck cancer patients has yet been established in Germany. Therefore, a survey was conducted to assess the quality assurance instruments that are in use today in otorhinolaryngology-head and neck (ORL-HNS) centers. In a nationwide survey, questionnaires were sent out to 146 German ORL-HNS departments (the return rate was 75%). 56% of all departments apply dedicated quality assurance processes, and 38% have appointed a formal quality assurance officer. Interdisciplinary oncological conferences are held in the vast majority of all departments with the participation of radiation oncologists in 86 (78%), medical oncologists in 84 (76%), diagnostic radiologists in 82 (74%), and pathologists in 73 (66%). Morbidity-mortality conferences are held in seven departments (6%). A standardized follow-up of oncological patients is carried out in 95 units (86%), and 53 departments use computer-assisted data bases to organize their follow-up data (48%). A wide variety of documentation systems is in use throughout the country: 78 units (71%) offer formal follow-up to their oncological patients. This survey documents a wide-spread interest in quality assurance procedures. Many individual efforts are being undertaken. However, no uniform quality assurance or auditing system is currently in use in Germany nor is a commonly accepted data base available. The ability to offer oncological follow-up within the national social security system is generally considered indispensable for the maintenance of high-quality oncological care in ORL-HNS departments.

On the need for quality assurance in superficial kilovoltage radiotherapy.

PubMed

Austerlitz, C; Mota, H; Gay, H; Campos, D; Allison, R; Sibata, C

2008-01-01

External auditing of beam output and energy qualities of four therapeutic X-ray machines were performed in three radiation oncology centres in northeastern Brazil. The output and half-value layers (HVLs) were determined using a parallel-plate ionisation chamber and high-purity aluminium foils, respectively. The obtained values of absorbed dose to water and energy qualities were compared with those obtained by the respective institutions. The impact on the prescribed dose was analysed by determining the half-value depth (D(1/2)). The beam outputs presented percent differences ranging from -13 to +25%. The ratio between the HVL in use by the institution and the measurements obtained in this study ranged from 0.75 to 2.33. Such deviations in HVL result in percent differences in dose at D(1/2) ranging from -52 to +8%. It was concluded that dosimetric quality audit programmes in radiation therapy should be expanded to include dermatological radiation therapy and such audits should include HVL verification.

Ada Software Design Methods Formulation.

DTIC Science & Technology

1982-10-01

aside for one-to-one, non -judgemental discussions between SofTech and the design teams. SofTech’s role in the meetings was to address any Ada-specific...assurance 1.0 prepare version audits 1.0 monitoring contracts 1.0 library control 1.0 other development 1.0 correspondence 1.0 conduct support design ...quality assurance 2.0 Control Board update training manuals 2.0 participation 2.5 being trained 2.0 formulation of policy 2.5 functional system design

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sailer, S.J.

This Quality Assurance Project Plan (QAPJP) specifies the quality of data necessary and the characterization techniques employed at the Idaho National Engineering Laboratory (INEL) to meet the objectives of the Department of Energy (DOE) Waste Isolation Pilot Plant (WIPP) Transuranic Waste Characterization Quality Assurance Program Plan (QAPP) requirements. This QAPJP is written to conform with the requirements and guidelines specified in the QAPP and the associated documents referenced in the QAPP. This QAPJP is one of a set of five interrelated QAPjPs that describe the INEL Transuranic Waste Characterization Program (TWCP). Each of the five facilities participating in the TWCPmore » has a QAPJP that describes the activities applicable to that particular facility. This QAPJP describes the roles and responsibilities of the Idaho Chemical Processing Plant (ICPP) Analytical Chemistry Laboratory (ACL) in the TWCP. Data quality objectives and quality assurance objectives are explained. Sample analysis procedures and associated quality assurance measures are also addressed; these include: sample chain of custody; data validation; usability and reporting; documentation and records; audits and 0385 assessments; laboratory QC samples; and instrument testing, inspection, maintenance and calibration. Finally, administrative quality control measures, such as document control, control of nonconformances, variances and QA status reporting are described.« less

Diagnostic image quality in gynaecological ultrasound: Who should measure it, what should we measure and how?

PubMed Central

Knapp, Karen

2013-01-01

Assessment of diagnostic image quality in gynaecological ultrasound is an important aspect of imaging department quality assurance. This may be addressed through audit, but who should undertake the audit, what should be measured and how, remains contentious. The aim of this study was to identify whether peer audit is a suitable method of assessing the diagnostic quality of gynaecological ultrasound images. Nineteen gynaecological ultrasound studies were independently assessed by six sonographers utilising a pilot version of an audit tool. Outcome measures were levels of inter-rater agreement using different data collection methods (binary scores, Likert scale, continuous scale), effect of ultrasound study difficulty on study score and whether systematic differences were present between reviewers of different clinical grades and length of experience. Inter-rater agreement ranged from moderate to good depending on the data collection method. A continuous scale gave the highest level of inter-rater agreement with an intra-class correlation coefficient of 0.73. A strong correlation (r = 0.89) between study difficulty and study score was yielded. Length of clinical experience between reviewers had no effect on the audit scores, but individuals of a higher clinical grade gave significantly lower scores than those of a lower grade (p = 0.04). Peer audit is a promising tool in the assessment of ultrasound image quality. Continuous scales seem to be the best method of data collection implying a strong element of heuristically driven decision making by reviewing ultrasound practitioners. PMID:27433192

QUALITY ASSURANCE PERFORMANCE AUDIT REPORT FOR THE SECRETARIA DEL MEDIO AMBIENTE CIUDAD DE MEXICO, DF, MEXICO RED AUTOMATICA DE MONITOREO ATMOSFERICO (RAMA) AIR QUALITY MONITORING STATIONS

EPA Science Inventory

The United States Environmental Protection Agency (U.S. EPA) conducted this evaluation of the air monitoring network, known as RAM (Red Automatica de Monitoreo Atmosferico) at the request of the Mexico City Secretariat of the Environment on October 16-27, 2000. This evaluation...

Environmental auditing in hospitals: approach and implementation in an university hospital.

PubMed

Dettenkofer, M; Kümmerer, K; Schuster, A; Mühlich, M; Scherrer, M; Daschner, F D

1997-05-01

Medical audit in infection control today is accepted as an important element in the quality assurance of health care. In contrast, environmental auditing, which was approved in 1993 by the Council of the European Communities for industry ("Eco-Management and Audit Scheme-EMAS), has not so far been used as a tool to control and reduce environmental pollution caused by medical care in hospitals. The aim of this study was to investigate, whether environmental auditing in hospitals is useful. This process should also be cost effective. In this paper, methodological and organizational issues are described. Initially an environmental review of activities at the University Hospital, Freiburg and an eco-analysis of the input and output were performed. The first results of the study and a critical discussion will be presented in another paper.

Audit of the Federal Energy Regulatory Commission`s Office of Chief Accountant

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1995-04-07

The Federal Energy Regulatory Commission`s (Commission) mission is to oversee America`s natural gas and oil pipeline transportation, electric utility, and hydroelectric power industries to ensure that consumers receive adequate energy supplies at just and reasonable rates. To carry out this mission, the Commission issues regulations covering the accounting, reporting, and rate-making requirements of the regulated utility companies. The Commission`s Office of Chief Accountant performs financial related audits at companies to ensure compliance with these regulations. The purpose of this audit was to evaluate the office of Chief Accountant`s audit performance. Specifically, the objectives were to determine if the most appropriatemore » audit approach was used and if a quality assurance process was in place to ensure reports were accurate and supported by the working papers.« less

External quality assurance performance of clinical research laboratories in sub-saharan Africa.

PubMed

Amukele, Timothy K; Michael, Kurt; Hanes, Mary; Miller, Robert E; Jackson, J Brooks

2012-11-01

Patient Safety Monitoring in International Laboratories (JHU-SMILE) is a resource at Johns Hopkins University that supports and monitors laboratories in National Institutes of Health-funded international clinical trials. To determine the impact of the JHU-SMILE quality assurance scheme in sub-Saharan African laboratories, we reviewed 40 to 60 months of external quality assurance (EQA) results of the College of American Pathologists (CAP) in these laboratories. We reviewed the performance of 8 analytes: albumin, alanine aminotransferase, creatinine, sodium, WBC, hemoglobin, hematocrit, and the human immunodeficiency virus antibody rapid test. Over the 40- to 60-month observation period, the sub-Saharan laboratories had a 1.63% failure rate, which was 40% lower than the 2011 CAP-wide rate of 2.8%. Seventy-six percent of the observed EQA failures occurred in 4 of the 21 laboratories. These results demonstrate that a system of remote monitoring, feedback, and audits can support quality in low-resource settings, even in places without strong regulatory support for laboratory quality.

ISO 9000: The Librarian's Role.

ERIC Educational Resources Information Center

Dobson, Chris; Ernst, Carolyn

1999-01-01

Describes the special library's role in implementing ISO 9000 (i.e., a series of international quality-assurance standards developed by the International Organization of Standards). Topics discussed include document and data control, keeping the standards current, documentation of procedures, the ISO 9000 audit, and benefits for the library. (MES)

Findings From a Nursing Care Audit Based on the Nursing Process: A Descriptive Study

PubMed Central

Poortaghi, Sarieh; Salsali, Mahvash; Ebadi, Abbas; Rahnavard, Zahra; Maleki, Farzaneh

2015-01-01

Background: Although using the nursing process improves nursing care quality, few studies have evaluated nursing performance in accordance with nursing process steps either nationally or internationally. Objectives: This study aimed to audit nursing care based on a nursing process model. Patients and Methods: This was a cross-sectional descriptive study in which a nursing audit checklist was designed and validated for assessing nurses’ compliance with nursing process. A total of 300 nurses from various clinical settings of Tehran university of medical sciences were selected. Data were analyzed using descriptive and inferential statistics, including frequencies, Pearson correlation coefficient and independent samples t-tests. Results: The compliance rate of nursing process indicators was 79.71 ± 0.87. Mean compliance scores did not significantly differ by education level and gender. However, overall compliance scores were correlated with nurses’ age (r = 0.26, P = 0.001) and work experience (r = 0.273, P = 0.001). Conclusions: Nursing process indicators can be used to audit nursing care. Such audits can be used as quality assurance tools. PMID:26576448

Melbourne vascular surgical association audit.

PubMed

Beiles, C Barry

2003-01-01

The formation of the Melbourne Vascular Surgical Association has led to the establishment of a vascular surgical audit programme that commenced in January 1999. This has allowed establishment of a benchmark for quality assurance in vascular surgery in Australia. A consultative process allowed widespread adoption of the audit across all public hospital vascular units in Melbourne and the two largest regional centres in Victoria. Data were collected at two points during admission: at operation and at discharge. Risk stratification, using logistic regression and risk-adjusted ratios for adverse events was assessed for comparison of outcomes between units for the first 3 years of data collection. There is regular contact with all participants for data feedback and quality control. The standard of vascular surgery across Victoria is consistent, and there has been excellent compliance by all academic vascular units. Private practice data are less complete, and only half of the vascular surgeons have participated. A statewide audit process is feasible and viable. Coordination by the Melbourne Vascular Surgical Association is crucial for its continued success.

Pharmaceutical quality assurance of local private distributors: a secondary analysis in 13 low-income and middle-income countries.

PubMed

Van Assche, Kerlijn; Nebot Giralt, Ariadna; Caudron, Jean Michel; Schiavetti, Benedetta; Pouget, Corinne; Tsoumanis, Achilleas; Meessen, Bruno; Ravinetto, Raffaella

2018-01-01

The rapid globalisation of the pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private pharmaceutical distributors. This descriptive study uses secondary data derived from the audits conducted by the QUAMED group at 60 local private pharmaceutical distributors in 13 LMICs. We assessed the distributors' compliance with good distribution practices (GDP), general quality requirements (GQR) and cold chain management (CCM), based on an evaluation tool inspired by the WHO guidelines 'Model Quality Assurance System (MQAS) for procurement agencies'. Descriptive statistics describe the compliance for the whole sample, for distributors in sub-Saharan Africa (SSA) versus those in non-SSA, and for those in low-income countries (LICs) versus middle-income countries (MICs). Local private pharmaceutical distributors in our sample were non-compliant, very low-compliant or low-compliant for GQR (70%), GDP (60%) and CCM (41%). Only 7/60 showed good to full compliance for at least two criteria. Observed compliance varies by geographical region and by income group: maximum values are higher in non-SSA versus SSA and in MICs versus LICs, while minimum values are the same across different groups. The poor compliance with WHO quality standards observed in our sample indicates a concrete risk that patients in LMICs are exposed to poor-quality or degraded medicines. Significant investments are needed to strengthen the regulatory supervision, including on private pharmaceutical distributors. An adapted standardised evaluation tool inspired by the WHO MQAS would be helpful for self-evaluation, audit and inspection purposes.

Reference dosimeter system of the iaea

NASA Astrophysics Data System (ADS)

Mehta, Kishor; Girzikowsky, Reinhard

1995-09-01

Quality assurance programmes must be in operation at radiation processing facilities to satisfy national and international Standards. Since dosimetry has a vital function in these QA programmes, it is imperative that the dosimetry systems in use at these facilities are well calibrated with a traceability to a Primary Standard Dosimetry Laboratory. As a service to the Member States, the International Atomic Energy Agency operates the International Dose Assurance Service (IDAS) to assist in this process. The transfer standard dosimetry system that is used for this service is based on ESR spectrometry. The paper describes the activities undertaken at the IAEA Dosimetry Laboratory to establish the QA programme for its reference dosimetry system. There are four key elements of such a programme: quality assurance manual; calibration that is traceable to a Primary Standard Dosimetry Laboratory; a clear and detailed statement of uncertainty in the dose measurement; and, periodic quality audit.

Auditing an Online Self-reported Interventional Radiology Adverse Event Database for Compliance and Accuracy.

PubMed

Burch, Ezra A; Shyn, Paul B; Chick, Jeffrey F; Chauhan, Nikunj R

2017-04-01

The purpose of this study was to determine whether auditing an online self-reported interventional radiology quality assurance database improves compliance with record entry or improves the accuracy of adverse event (AE) reporting and grading. Physicians were trained in using the database before the study began. An audit of all database entries for the first 3 months, or the first quarter, was performed, at which point physicians were informed of the audit process; entries for the subsequent 3 months, or the second quarter, were again audited. Results between quarters were compared. Compliance with record entry improved from the first to second quarter, but reminders were necessary to ensure 100% compliance with record entry. Knowledge of the audit process did not significantly improve self-reporting of AE or accuracy of AE grading. However, auditing significantly changed the final AE reporting rates and grades. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

A survey of medical quality assurance programs in Ontario hospitals.

PubMed Central

Barrable, B

1992-01-01

OBJECTIVE: To determine the prevalence and types of medical quality assurance practices in Ontario hospitals. DESIGN: Survey. SETTING: All teaching, community, chronic care, rehabilitation and psychiatric hospitals that were members of the Ontario Hospital Association as of May 1990. PARTICIPANTS: The person deemed by the chief executive officer of each hospital to be most responsible for medical administration. INTERVENTION: A questionnaire to obtain information on each hospital's use of criteria audit, indicators inventory, occurrence screening and reporting, and utilization review and management (URM) activities. OUTCOME MEASURES: Prevalence of the use of the quality assurance activities, the people responsible for the activities and the relative success of the URM program in modifying physicians' performance. RESULTS: Of the 245 member hospitals participants from 179 (73%) responded. Criteria audits were performed in 136 (76%), indicators inventory in 43 (24%), occurrence screening in 44 (25%), occurrence reporting in 61 (34%) and URM in 123 (69%). In-hospital deaths were reviewed in 157 (88%) of the hospitals. In all, 87 (55%) of the respondents from hospitals that had a URM program or were developing one indicated that their program was successful in modifying physicians' practices, and 29 (18%) reported that it was not successful; 26 (16%) stated that the effect was still unknown, and 16 (10%) did not respond. Seventy (40%) stated that results of tissue reviews were reported at least 10 times per year and 94 (83%) that medical record reviews were reported at least as often. The differences in the prevalence of the quality assurance activities between the hospitals were not found to be significant. CONCLUSIONS: Many Ontario hospitals are conducting a wide variety of quality assurance activities. Further study is required to determine whether the differences in prevalence of these activities between hospitals would be significant in a larger, perhaps national, sample. Strategies are needed to ensure universal involvement and participation in the improvement of the quality of care and the assessment of the cost-effectiveness of health care treatments. Recommendations to achieve these objectives are suggested. PMID:1735040

Quality assurance for respiratory care services: a computer-assisted program.

PubMed

Elliott, C G

1993-01-01

At present, the principal advantage of computer-assisted quality assurance is the acquisition of quality assurance date without resource-consuming chart reviews. A surveillance program like the medical director's alert may reduce morbidity and mortality. Previous research suggests that inadequate oxygen therapy or failures in airway management are important causes of preventable deaths in hospitals. Furthermore, preventable deaths tend to occur among patients who have lower severity-of-illness scores and who are not in ICUs. Thus, surveillance of the entire hospital, as performed by the HIS medical director's alert, may significantly impact hospital mortality related to respiratory care. Future research should critically examine the potential of such computerized systems to favorably change the morbidity and mortality of hospitalized patients. The departments of respiratory care and medical informatics at LDS Hospital have developed a computer-assisted approach to quality assurance monitoring of respiratory care services. This system provides frequent and consistent samples of a variety of respiratory care data. The immediate needs of patients are addressed through a daily surveillance system (medical director's alert). The departmental quality assurance program utilizes a separate program that monitors clinical indicators of staff performance in terms of stated departmental policies and procedures (rate-based clinical indicators). The availability of an integrated patient database allows these functions to be performed without labor-intensive chart audits.

Sessional Academic Success: A Distributed Framework for Academic Support and Development

ERIC Educational Resources Information Center

Hamilton, Jillian; Fox, Michelle; McEwan, Mitchell

2013-01-01

With approximately half of Australian university teaching now performed by Sessional Academics, there has been growing recognition of the contribution they make to student learning. At the same time, sector-wide research and institutional audits continue to raise concerns about academic development, quality assurance, recognition and belonging…

NATIONAL PERFORMANCE AUDIT PROGRAM: 1979 PROFICIENCY SURVEYS FOR SULFUR DIOXIDE, NITROGEN DIOXIDE, CARBON MONOXIDE, SULFATE, NITRATE, LEAD AND HIGH VOLUME FLOW

EPA Science Inventory

The Quality Assurance Division of the Environmental Monitoring Systems Laboratory, Research Triangle Park, North Carolina, administers semiannual Surveys of Analytical Proficiency for sulfur dioxide, nitrogen dioxide, carbon monoxide, sulfate, nitrate and lead. Sample material, s...

Assessment Relationships in Higher Education: The Tension of Process and Practice

ERIC Educational Resources Information Center

Crook, Charles; Gross, Harriet; Dymott, Roy

2006-01-01

It is argued that the auditing demands of quality assurance have encouraged a greater proceduralisation of university coursework assessment. Interviews with academics from a cross-section of Psychology departments illustrated how assessment had acquired the tightly scripted character of an organisational process. Yet undergraduate focus group…

Multicentre dose audit for clinical trials of radiation therapy in Asia.

PubMed

Mizuno, Hideyuki; Fukuda, Shigekazu; Fukumura, Akifumi; Nakamura, Yuzuru-Kutsutani; Jianping, Cao; Cho, Chul-Koo; Supriana, Nana; Dung, To Anh; Calaguas, Miriam Joy; Devi, C R Beena; Chansilpa, Yaowalak; Banu, Parvin Akhter; Riaz, Masooma; Esentayeva, Surya; Kato, Shingo; Karasawa, Kumiko; Tsujii, Hirohiko

2017-05-01

A dose audit of 16 facilities in 11 countries has been performed within the framework of the Forum for Nuclear Cooperation in Asia (FNCA) quality assurance program. The quality of radiation dosimetry varies because of the large variation in radiation therapy among the participating countries. One of the most important aspects of international multicentre clinical trials is uniformity of absolute dose between centres. The National Institute of Radiological Sciences (NIRS) in Japan has conducted a dose audit of participating countries since 2006 by using radiophotoluminescent glass dosimeters (RGDs). RGDs have been successfully applied to a domestic postal dose audit in Japan. The authors used the same audit system to perform a dose audit of the FNCA countries. The average and standard deviation of the relative deviation between the measured and intended dose among 46 beams was 0.4% and 1.5% (k = 1), respectively. This is an excellent level of uniformity for the multicountry data. However, of the 46 beams measured, a single beam exceeded the permitted tolerance level of ±5%. We investigated the cause for this and solved the problem. This event highlights the importance of external audits in radiation therapy. © The Author 2016. Published by Oxford University Press on behalf of The Japan Radiation Research Society and Japanese Society for Radiation Oncology.

Audit feedback on reading performance of screening mammograms: An international comparison.

PubMed

Hofvind, S; Bennett, R L; Brisson, J; Lee, W; Pelletier, E; Flugelman, A; Geller, B

2016-09-01

Providing feedback to mammography radiologists and facilities may improve interpretive performance. We conducted a web-based survey to investigate how and why such feedback is undertaken and used in mammographic screening programmes. The survey was sent to representatives in 30 International Cancer Screening Network member countries where mammographic screening is offered. Seventeen programmes in 14 countries responded to the survey. Audit feedback was aimed at readers in 14 programmes, and facilities in 12 programmes. Monitoring quality assurance was the most common purpose of audit feedback. Screening volume, recall rate, and rate of screen-detected cancers were typically reported performance measures. Audit reports were commonly provided annually, but more frequently when target guidelines were not reached. The purpose, target audience, performance measures included, form and frequency of the audit feedback varied amongst mammographic screening programmes. These variations may provide a basis for those developing and improving such programmes. © The Author(s) 2016.

Comprehensive Auditing in Nuclear Medicine Through the International Atomic Energy Agency Quality Management Audits in Nuclear Medicine Program. Part 2: Analysis of Results.

PubMed

Dondi, Maurizio; Torres, Leonel; Marengo, Mario; Massardo, Teresa; Mishani, Eyal; Van Zyl Ellmann, Annare; Solanki, Kishor; Bischof Delaloye, Angelika; Lobato, Enrique Estrada; Miller, Rodolfo Nunez; Ordonez, Felix Barajas; Paez, Diana; Pascual, Thomas

2017-11-01

The International Atomic Energy Agency has developed a program, named Quality Management Audits in Nuclear Medicine (QUANUM), to help its Member States to check the status of their nuclear medicine practices and their adherence to international reference standards, covering all aspects of nuclear medicine, including quality assurance/quality control of instrumentation, radiopharmacy (further subdivided into levels 1, 2, and 3, according to complexity of work), radiation safety, clinical applications, as well as managerial aspects. The QUANUM program is based on both internal and external audits and, with specifically developed Excel spreadsheets, it helps assess the level of conformance (LoC) to those previously defined quality standards. According to their level of implementation, the level of conformance to requested standards; 0 (absent) up to 4 (full conformance). Items scored 0, 1, and 2 are considered non-conformance; items scored 3 and 4 are considered conformance. To assess results of the audit missions performed worldwide over the last 8 years, a retrospective analysis has been run on reports from a total of 42 audit missions in 39 centers, three of which had been re-audited. The analysis of all audit reports has shown an overall LoC of 73.9 ± 8.3% (mean ± standard deviation), ranging between 56.6% and 87.9%. The highest LoC has been found in the area of clinical services (83.7% for imaging and 87.9% for therapy), whereas the lowest levels have been found for Radiopharmacy Level 2 (56.6%); Computer Systems and Data Handling (66.6%); and Evaluation of the Quality Management System (67.6%). Prioritization of non-conformances produced a total of 1687 recommendations in the final audit report. Depending on the impact on safety and daily clinical activities, they were further classified as critical (requiring immediate action; n = 276; 16% of the total); major (requiring action in relatively short time, typically from 3 to 6 months; n = 604; 36%); whereas the remaining 807 (48%) were classified as minor, that is, to be addressed whenever possible. The greatest proportion of recommendations has been found in the category "Managerial, Organization and Documentation" (26%); "Staff Radiation Protection and Safety" (17.3%); "Radiopharmaceuticals Preparation, Dispensing and Handling" (15.8%); and "Quality Assurance/Quality Control" and "Management of Equipment and Software" (11.4%). The lowest level of recommendations belongs to the item "Human Resources" (4%). The QUANUM program proved applicable to a wide variety of institutions, from small practices to larger centers with PET/CT and cyclotrons. Clinical services rendered to patients showed a good compliance with international standards, whereas issues related to radiation protection of both staff and patients will require a higher degree of attention. This is a relevant feedback for the International Atomic Energy Agency with regard to the effective translation of safety recommendations into routine practice. Training on drafting and application of standard operating procedures should also be considered a priority. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Holding up a mirror: changing obstetric practice through criterion-based clinical audit in developing countries.

PubMed

Wagaarachchi, P T; Graham, W J; Penney, G C; McCaw-Binns, A; Yeboah Antwi, K; Hall, M H

2001-08-01

The objective of the study described is to assess the feasibility and effectiveness of using a criterion-based clinical audit to measure and improve the quality of obstetric care at the district hospital level in developing countries. The focus is on the management of five life-threatening obstetric complications--hemorrhage, eclampsia, genital tract infection, obstructed labor and uterine rupture was audited using a "before and after" design. The five steps of the audit cycle were followed: establish criteria of good quality care; measure current practice (Review I); feedback findings and set targets; take action to change practice; and re-evaluate practice (Review II). Systematic literature review, panel discussions and pilot work led to the development of 31 audit criteria. Review I included 555 life-threatening complications occurring over 66 hospital-months; Review II included 342 complications over 42 hospital-months. Many common areas for improvement were identified across the four hospitals. Agreed mechanisms for achieving these improvements included clinical protocols, reviews of staffing, and training workshops. Some aspects of clinical monitoring, drug use and record keeping improved significantly between Reviews I and II. Criterion-based clinical audit in four typical district hospitals in Ghana and Jamaica is a feasible and acceptable method for quality assurance and appears to have improved the management of life-threatening obstetric complications.

Quality Assurance and Control Considerations in Environmental Measurements and Monitoring

NASA Astrophysics Data System (ADS)

Sedlet, Jacob

1982-06-01

Quality assurance and quality control have become accepted as essential parts of all environmental surveillance, measurements, and monitoring programs, both nuclear and non-nuclear. The same principles and details apply to each. It is primarily the final measurement technique that differs. As the desire and need to measure smaller amounts of pollutants with greater accuracy has increased, it has been recognized that quality assurance and control programs are cost-effective in achieving the expected results. Quality assurance (QA) consists of all the actions necessary to provide confidence in the results. Quality control (QC) is a part of QA, and consists of those actions and activities that permit the control of the individual steps in the environmental program. The distinction between the two terms is not always clearly defined, but a sharp division is not necessary. The essential principle of QA and QC is a commitment to high quality results. The essential components of a QA and QC program are a complete, written procedures manual for all parts of the environmental program, the use of standard or validated procedures, participation in applicable interlaboratory comparison or QA programs, replicate analysis and measurement, training of personnel, and a means of auditing or checking that the QA and QC programs are properly conducted. These components are discussed below in some detail.

Random safety auditing, root cause analysis, failure mode and effects analysis.

PubMed

Ursprung, Robert; Gray, James

2010-03-01

Improving quality and safety in health care is a major concern for health care providers, the general public, and policy makers. Errors and quality issues are leading causes of morbidity and mortality across the health care industry. There is evidence that patients in the neonatal intensive care unit (NICU) are at high risk for serious medical errors. To facilitate compliance with safe practices, many institutions have established quality-assurance monitoring procedures. Three techniques that have been found useful in the health care setting are failure mode and effects analysis, root cause analysis, and random safety auditing. When used together, these techniques are effective tools for system analysis and redesign focused on providing safe delivery of care in the complex NICU system. Copyright 2010 Elsevier Inc. All rights reserved.

NASA Case Sensitive Review and Audit Approach

NASA Astrophysics Data System (ADS)

Lee, Arthur R.; Bacus, Thomas H.; Bowersox, Alexandra M.; Newman, J. Steven

2005-12-01

As an Agency involved in high-risk endeavors NASA continually reassesses its commitment to engineering excellence and compliance to requirements. As a component of NASA's continual process improvement, the Office of Safety and Mission Assurance (OSMA) established the Review and Assessment Division (RAD) [1] to conduct independent audits to verify compliance with Agency requirements that impact safe and reliable operations. In implementing its responsibilities, RAD benchmarked various approaches for conducting audits, focusing on organizations that, like NASA, operate in high-risk environments - where seemingly inconsequential departures from safety, reliability, and quality requirements can have catastrophic impact to the public, NASA personnel, high-value equipment, and the environment. The approach used by the U.S. Navy Submarine Program [2] was considered the most fruitful framework for the invigorated OSMA audit processes. Additionally, the results of benchmarking activity revealed that not all audits are conducted using just one approach or even with the same objectives. This led to the concept of discrete, unique "audit cases."

23 CFR 140.805 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Audit Expense § 140.805 Definitions. (a) Project related audits. Audits which directly benefit Federal-aid highway projects. Audits performed in accordance with the requirements of 23 CFR part 12, audits of third party contract costs, and other audits providing assurance that a recipient has complied...

Quantification, Risk, and the Rhetoric of Higher Education Management

ERIC Educational Resources Information Center

Dale, Leigh

2012-01-01

This essay is a contribution to the literature of critique of higher education policy and management. It offers a general discussion of problems arising from the proliferation of mechanisms of audit and quality assurance within the context of concerns about dependence on quantitative measures of values. It argues that uncritical dependence on…

NATIONAL PERFORMANCE AUDIT PROGRAM: 1980 PROFICIENCY SURVEY FOR SULFUR DIOXIDE, NITROGEN DIOXIDE, CARBON MONOXIDE, SULFATE, NITRATE, LEAD AND HIGH VOLUME FLOW

EPA Science Inventory

Based on authority granted by provisions of the Clean Air Act (42 U.S.C 7410, et seq.), the Quality Assurance Division of the Environmental Monitoring Systems Laboratory, Research Triangle Park, NC administers periodic surveys of analytical proficiency for sulfur dioxide, nitroge...

40 CFR 51.363 - Quality assurance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... performing all tests and other required functions. Performance audits shall be of two types: overt and covert... least twice per year for each lane or test bay and shall include: (i) A check for the observance of... the use of aids such as binoculars or video cameras, at least once per year per inspector in high...

40 CFR 51.363 - Quality assurance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... performing all tests and other required functions. Performance audits shall be of two types: overt and covert... least twice per year for each lane or test bay and shall include: (i) A check for the observance of... the use of aids such as binoculars or video cameras, at least once per year per inspector in high...

40 CFR 63.8075 - What reports must I submit and when?

Code of Federal Regulations, 2010 CFR

2010-07-01

... demonstrations to verify that control devices subject to § 63.8000(d)(3) are operating as designed. (3) A... procedures and quality assurance procedures. (iii) Descriptions of monitoring devices, monitoring frequencies...) Identification of the CMS. (J) The date of the latest CMS certification or audit. (K) The operating day or...

Project Quality Assurance Plan for research and development services provided by Oak Ridge National Laboratory in support of the Westinghouse Materials Company of Ohio Operable Unit 1 Stabilization Development and Treatability Studies Program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gilliam, T.M.

1991-05-01

This Project Quality Assurance Plan (PQAP) sets forth the quality assurance (QA) requirements that are applied to those elements of the Westinghouse Materials Company of Ohio (WMCO) Operable Unit 1 support at Oak Ridge National Laboratory (ORNL) project that involve research and development (R D) performed at ORNL. This is in compliance with the applicable criteria of 10 CFR Part 50, Appendix B, ANSI/ASME NQA-1, as specified by Department of Energy (DOE) Oak Ridge Operations (ORO) Order 5700.6B. For this application, NQA-1 is the core QA Program requirements document. QA policy, normally found in the requirements document, is contained herein.more » The requirements of this PQAP apply to project activities that affect the quality and reliability/credibility of research, development, and investigative data and documentation. These activities include the functions of attaining quality objectives and assuring that an appropriate QA program scope is established. The scope of activities affecting quality includes organization; personnel training and qualifications; design control; procurement; material handling and storage; operating procedures; testing, surveillance, and auditing; R D investigative activities and documentation; deficiencies; corrective actions; and QA record keeping. 12 figs.« less

Using the RxNorm web services API for quality assurance purposes.

PubMed

Peters, Lee; Bodenreider, Olivier

2008-11-06

Auditing large, rapidly evolving terminological systems is still a challenge. In the case of RxNorm, a standardized nomenclature for clinical drugs, we argue that quality assurance processes can benefit from the recently released application programming interface (API) provided by RxNav. We demonstrate the usefulness of the API by performing a systematic comparison of alternative paths in the RxNorm graph, over several thousands of drug entities. This study revealed potential errors in RxNorm, currently under review. The results also prompted us to modify the implementation of RxNav to navigate the RxNorm graph more accurately. The RxNav web services API used in this experiment is robust and fast.

Using the RxNorm Web Services API for Quality Assurance Purposes

PubMed Central

Peters, Lee; Bodenreider, Olivier

2008-01-01

Auditing large, rapidly evolving terminological systems is still a challenge. In the case of RxNorm, a standardized nomenclature for clinical drugs, we argue that quality assurance processes can benefit from the recently released application programming interface (API) provided by RxNav. We demonstrate the usefulness of the API by performing a systematic comparison of alternative paths in the RxNorm graph, over several thousands of drug entities. This study revealed potential errors in RxNorm, currently under review. The results also prompted us to modify the implementation of RxNav to navigate the RxNorm graph more accurately. The RxNorm web services API used in this experiment is robust and fast. PMID:18999038

Development of a flattening filter free multiple source model for use as an independent, Monte Carlo, dose calculation, quality assurance tool for clinical trials.

PubMed

Faught, Austin M; Davidson, Scott E; Popple, Richard; Kry, Stephen F; Etzel, Carol; Ibbott, Geoffrey S; Followill, David S

2017-09-01

The Imaging and Radiation Oncology Core-Houston (IROC-H) Quality Assurance Center (formerly the Radiological Physics Center) has reported varying levels of compliance from their anthropomorphic phantom auditing program. IROC-H studies have suggested that one source of disagreement between institution submitted calculated doses and measurement is the accuracy of the institution's treatment planning system dose calculations and heterogeneity corrections used. In order to audit this step of the radiation therapy treatment process, an independent dose calculation tool is needed. Monte Carlo multiple source models for Varian flattening filter free (FFF) 6 MV and FFF 10 MV therapeutic x-ray beams were commissioned based on central axis depth dose data from a 10 × 10 cm 2 field size and dose profiles for a 40 × 40 cm 2 field size. The models were validated against open-field measurements in a water tank for field sizes ranging from 3 × 3 cm 2 to 40 × 40 cm 2 . The models were then benchmarked against IROC-H's anthropomorphic head and neck phantom and lung phantom measurements. Validation results, assessed with a ±2%/2 mm gamma criterion, showed average agreement of 99.9% and 99.0% for central axis depth dose data for FFF 6 MV and FFF 10 MV models, respectively. Dose profile agreement using the same evaluation technique averaged 97.8% and 97.9% for the respective models. Phantom benchmarking comparisons were evaluated with a ±3%/2 mm gamma criterion, and agreement averaged 90.1% and 90.8% for the respective models. Multiple source models for Varian FFF 6 MV and FFF 10 MV beams have been developed, validated, and benchmarked for inclusion in an independent dose calculation quality assurance tool for use in clinical trial audits. © 2017 American Association of Physicists in Medicine.

10 CFR 603.645 - Periodic audits and award-specific audits of for-profit participants.

Code of Federal Regulations, 2010 CFR

2010-01-01

... amounts or adjusts performance outcomes. The periodic audit provides some assurance that the reported... 10 Energy 4 2010-01-01 2010-01-01 false Periodic audits and award-specific audits of for-profit... Financial Matters § 603.645 Periodic audits and award-specific audits of for-profit participants. The...

Quality control and assurance in hematopoietic stem cell transplantation data registries in Japan and other countries.

PubMed

Kuwatsuka, Yachiyo

2016-01-01

Observational studies from national and international registries with large volumes of patients are commonly performed to identify superior strategies for hematopoietic stem cell transplantation. Major international and national stem cell transplant registries collect outcome data using electronic data capture systems, and a systematic study support process has been developed. Statistical support for studies is available from some major international registries, and international and national registries also mutually collaborate to promote stem cell transplant outcome studies and transplant-related activities. Transplant registries additionally take measures to improve data quality to further improve the quality of outcome studies by utilizing data capture systems and manual data management. Data auditing can potentially even further improve data quality; however, human and budgetary resources can be limiting factors in system construction and audits of the Japanese transplant registry are not currently performed.

Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

PubMed

Gass, Jonathon D; Misra, Anamika; Yadav, Mahendra Nath Singh; Sana, Fatima; Singh, Chetna; Mankar, Anup; Neal, Brandon J; Fisher-Bowman, Jennifer; Maisonneuve, Jenny; Delaney, Megan Marx; Kumar, Krishan; Singh, Vinay Pratap; Sharma, Narender; Gawande, Atul; Semrau, Katherine; Hirschhorn, Lisa R

2017-09-07

There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial. We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model. The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p = 0.0004) increase in accuracy throughout consecutive audits. The DQMIS was successful, despite an increase from 20 to 130 data collectors. In the absence of widely disseminated data quality methods and standards for large RCT interventions in limited-resource settings, we developed an integrated DQA system, combining auditing, rapid data feedback, and supportive supervision, which ensured high-quality data and could serve as a model for future health systems research trials. Future efforts should focus on standardization of DQA processes for health systems research. ClinicalTrials.gov identifier, NCT02148952 . Registered on 13 February 2014.

Initial experience with a novel pre-sign-out quality assurance tool for review of random surgical pathology diagnoses in a subspecialty-based university practice.

PubMed

Owens, Scott R; Wiehagen, Luke T; Kelly, Susan M; Piccoli, Anthony L; Lassige, Karen; Yousem, Samuel A; Dhir, Rajiv; Parwani, Anil V

2010-09-01

We recently implemented a novel pre-sign-out quality assurance tool in our subspecialty-based surgical pathology practice at the University of Pittsburgh Medical Center. It randomly selects an adjustable percentage of cases for review by a second pathologist at the time the originating pathologist's electronic signature is entered and requires that the review be completed within 24 hours, before release of the final report. The tool replaced a retrospective audit system and it has been in successful use since January 2009. We report our initial experience for the first 14 months of its service. During this time, the disagreement numbers and levels were similar to those identified using the retrospective system, case turnaround time was not significantly affected, and the number of case amendments generated decreased. The tool is a useful quality assurance instrument and its prospective nature allows for the potential prevention of some serious errors.

75 FR 61143 - Financial Management and Assurance; Government Auditing Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-04

... GOVERNMENT ACCOUNTABILITY OFFICE Financial Management and Assurance; Government Auditing Standards Correction In notice document 2010-23374 beginning on page 57274 in the issue of Monday, September 20, 2010 make the following corrections: 1. On page 57275, in the first column, under the ADDRESSES section, in...

Impact of the introduction of weekly radiotherapy quality assurance meetings at one UK cancer centre

PubMed Central

Brammer, C V; Allerton, R; Churn, M; Joseph, M; Koh, P; Sayers, I; King, M

2014-01-01

Objective: The complexity of radiotherapy planning is increasing rapidly. Delivery and planning is subject to detailed quality assurance (QA) checks. The weakest link is often the oncologists' delineation of the clinical target volume (CTV). Weekly departmental meetings for radiotherapy QA (RTQA) were introduced into the Royal Wolverhampton Hospital, Wolverhampton, UK, in October 2011. This article describes the impact of this on patient care. Methods: CTVs for megavoltage photon radiotherapy courses for all radical, adjuvant and palliative treatments longer than five fractions (with the exception of two field tangential breast treatments not enrolled into clinical trials) were reviewed in the RTQA meeting. Audits were carried out in January 2012 (baseline) and September 2013, each over a 4-week period. Adherence to departmental contouring protocols was assessed and the number of major and minor alterations following peer review were determined. Results: There was no statistically significant difference for major alterations between the two study groups; 8 alterations in 80 patients (10%) for the baseline audit vs 3 alterations from 72 patients (4.2%) in the second audit (p = 0.17). A trend towards a reduction in alterations following peer review was observed. There has, however, been a change in practice resulting in a reduction in variation in CTV definition within our centre and greater adherence to protocols. There is increasing confidence in the quality and constancy of care delivered. Conclusion: Introduction of a weekly QA meeting for target volume definition has facilitated consensus and adoption of departmental clinical guidelines within the unit. Advances in knowledge: The weakest areas in radiotherapy are patient selection and definition of the CTV. Engagement in high-quality RTQA is paramount. This article describes the impact of this in one UK cancer centre. PMID:25251520

Impact of the introduction of weekly radiotherapy quality assurance meetings at one UK cancer centre.

PubMed

Brammer, C V; Pettit, L; Allerton, R; Churn, M; Joseph, M; Koh, P; Sayers, I; King, M

2014-11-01

The complexity of radiotherapy planning is increasing rapidly. Delivery and planning is subject to detailed quality assurance (QA) checks. The weakest link is often the oncologists' delineation of the clinical target volume (CTV). Weekly departmental meetings for radiotherapy QA (RTQA) were introduced into the Royal Wolverhampton Hospital, Wolverhampton, UK, in October 2011. This article describes the impact of this on patient care. CTVs for megavoltage photon radiotherapy courses for all radical, adjuvant and palliative treatments longer than five fractions (with the exception of two field tangential breast treatments not enrolled into clinical trials) were reviewed in the RTQA meeting. Audits were carried out in January 2012 (baseline) and September 2013, each over a 4-week period. Adherence to departmental contouring protocols was assessed and the number of major and minor alterations following peer review were determined. There was no statistically significant difference for major alterations between the two study groups; 8 alterations in 80 patients (10%) for the baseline audit vs 3 alterations from 72 patients (4.2%) in the second audit (p = 0.17). A trend towards a reduction in alterations following peer review was observed. There has, however, been a change in practice resulting in a reduction in variation in CTV definition within our centre and greater adherence to protocols. There is increasing confidence in the quality and constancy of care delivered. Introduction of a weekly QA meeting for target volume definition has facilitated consensus and adoption of departmental clinical guidelines within the unit. The weakest areas in radiotherapy are patient selection and definition of the CTV. Engagement in high-quality RTQA is paramount. This article describes the impact of this in one UK cancer centre.

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

Quality Assurance Specifications for Planetary Protection Assays

NASA Astrophysics Data System (ADS)

Baker, Amy

As the European Space Agency planetary protection (PP) activities move forward to support the ExoMars and other planetary missions, it will become necessary to increase staffing of labo-ratories that provide analyses for these programs. Standardization of procedures, a comprehen-sive quality assurance program, and unilateral training of personnel will be necessary to ensure that the planetary protection goals and schedules are met. The PP Quality Assurance/Quality Control (QAQC) program is designed to regulate and monitor procedures performed by labora-tory personnel to ensure that all work meets data quality objectives through the assembly and launch process. Because personnel time is at a premium and sampling schedules are often de-pendent on engineering schedules, it is necessary to have flexible staffing to support all sampling requirements. The most productive approach to having a competent and flexible work force is to establish well defined laboratory procedures and training programs that clearly address the needs of the program and the work force. The quality assurance specification for planetary protection assays has to ensure that labora-tories and associated personnel can demonstrate the competence to perform assays according to the applicable standard AD4. Detailed subjects included in the presentation are as follows: • field and laboratory control criteria • data reporting • personnel training requirements and certification • laboratory audit criteria. Based upon RD2 for primary and secondary validation and RD3 for data quality objectives, the QAQC will provide traceable quality assurance safeguards by providing structured laboratory requirements for guidelines and oversight including training and technical updates, standardized documentation, standardized QA/QC checks, data review and data archiving.

[Quality of mental health services: a self audit in the South Verona mental health service].

PubMed

Allevi, Liliana; Salvi, Giovanni; Ruggeri, Mirella

2006-01-01

To start a process of Continuous Quality Improvement (CQI) in an Italian Community Mental Health Service by using a quality assurance questionnaire in a self audit exercise. The questionnaire was administered to 14 key workers and clinical managers with different roles and seniority. One senior manager's evaluation was used as a benchmark for all the others. Changes were introduced in the service practice according to what emerged from the evaluation. Meetings were scheduled to monitor those changes and renew the CQI process. There was a wide difference in the key workers' answers. Overall, the senior manager's evaluation was on the 60th percentile of the distribution of the other evaluations. Those areas that required prompt intervention were risk management, personnel development, and CQI. The CQI process was followed up for one year: some interventions were carried out to change the practice of the service. A self audit exercise in Community Mental Health Services was both feasible and useful. The CQI process was easier to start than to carry on over the long term.

Are We Monitoring the Quality of Cataract Surgery Services? A Qualitative Situation Analysis of Attitudes and Practices in a Large City in South Africa

PubMed Central

Haastrup, Oluwatosin O. O.; Buchan, John C.; Cassels-Brown, Andy; Cook, Colin

2015-01-01

Purpose: To evaluate the current quality “assurance” and “improvement” mechanisms, the knowledge, attitudes and practices of cataract surgeons in a large South African city. Methodology: A total of 17 in-depth semi-structured interviews were conducted with ophthalmologists in June 2012 at 2 tertiary institutions in the Republic of South Africa. Recruitment of the purposive sample was supplemented by snowball sampling. The study participants were 5 general ophthalmologists and 2 pediatric ophthalmologists; 4 senior and 4 junior registrars and a medical officer. Participants were interviewed by a trained qualitative interviewer. The interview lasted between 20 and 60 min. The interviews were recorded, transcribed verbatim and analyzed for thematic content. Results: Mechanisms for quality assurance were trainee logbooks and subjective senior staff observation. Clinicians were encouraged, but not obliged to self-audit. Quality improvement is incentivized by personal integrity and ambition. Poorly performing departments are inconspicuous, especially nationally, and ophthalmologists rely on the impression to gauge the quality of service provided by colleagues. Currently, word of mouth is the method for determining the better cataract surgical centers. Conclusion: The quality assurance mechanisms were dependent on insight and integrity of the individual surgeons. No structures were described that would ensure the detection of surgeons with higher than expected complication rates. Currently, audits are not enforced, and surgical outcomes are not well monitored due to concerns that this may lead to lack of openness among ophthalmologists. PMID:25949081

Quality-assurance procedures: Method 5G determination of particulate emissions from wood heaters from a dilution tunnel sampling location

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ward, T.E.; Hartman, M.W.; Olin, R.C.

1989-06-01

Quality-assurance procedures are contained in this comprehensive document intended to be used as an aid for wood-heater manufacturers and testing laboratories in performing particulate matter sampling of wood heaters according to EPA protocol, Method 5G. These procedures may be used in research and development, and as an aid in auditing and certification testing. A detailed, step-by-step quality assurance guide is provided to aid in the procurement and assembly of testing apparatus, to clearly describe the procedures, and to facilitate data collection and reporting. Suggested data sheets are supplied that can be used as an aid for both recordkeeping and certificationmore » applications. Throughout the document, activity matrices are provided to serve as a summary reference. Checklists are also supplied that can be used by testing personnel. Finally, for the purposes of ensuring data quality, procedures are outlined for apparatus operation, maintenance, and traceability. These procedures combined with the detailed description of the sampling and analysis protocol will help ensure the accuracy and reliability of Method 5G emission-testing results.« less

Pharmaceutical quality assurance of local private distributors: a secondary analysis in 13 low-income and middle-income countries

PubMed Central

Caudron, Jean Michel; Schiavetti, Benedetta; Pouget, Corinne; Tsoumanis, Achilleas; Meessen, Bruno; Ravinetto, Raffaella

2018-01-01

Introduction The rapid globalisation of the pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private pharmaceutical distributors. Methods This descriptive study uses secondary data derived from the audits conducted by the QUAMED group at 60 local private pharmaceutical distributors in 13 LMICs. We assessed the distributors’ compliance with good distribution practices (GDP), general quality requirements (GQR) and cold chain management (CCM), based on an evaluation tool inspired by the WHO guidelines ’Model Quality Assurance System (MQAS) for procurement agencies'. Descriptive statistics describe the compliance for the whole sample, for distributors in sub-Saharan Africa (SSA) versus those in non-SSA, and for those in low-income countries (LICs) versus middle-income countries (MICs). Results Local private pharmaceutical distributors in our sample were non-compliant, very low-compliant or low-compliant for GQR (70%), GDP (60%) and CCM (41%). Only 7/60 showed good to full compliance for at least two criteria. Observed compliance varies by geographical region and by income group: maximum values are higher in non-SSA versus SSA and in MICs versus LICs, while minimum values are the same across different groups. Conclusion The poor compliance with WHO quality standards observed in our sample indicates a concrete risk that patients in LMICs are exposed to poor-quality or degraded medicines. Significant investments are needed to strengthen the regulatory supervision, including on private pharmaceutical distributors. An adapted standardised evaluation tool inspired by the WHO MQAS would be helpful for self-evaluation, audit and inspection purposes. PMID:29915671

42 CFR 457.236 - Audits.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Audits. 457.236 Section 457.236 Public Health...-Reviews and Audits; Withholding for Failure to Comply; Deferral and Disallowance of Claims; Reduction of Federal Medical Payments § 457.236 Audits. The CHIP agency must assure appropriate audit of records on...

Radiological safety status and quality assurance audit of medical X-ray diagnostic installations in India.

PubMed

Sonawane, A U; Singh, Meghraj; Sunil Kumar, J V K; Kulkarni, Arti; Shirva, V K; Pradhan, A S

2010-10-01

We conducted a radiological safety and quality assurance (QA) audit of 118 medical X-ray diagnostic machines installed in 45 major hospitals in India. The main objective of the audit was to verify compliance with the regulatory requirements stipulated by the national regulatory body. The audit mainly covered accuracy check of accelerating potential (kVp), linearity of tube current (mA station) and timer, congruence of radiation and optical field, and total filtration; in addition, we also reviewed medical X-ray diagnostic installations with reference to room layout of X-ray machines and conduct of radiological protection survey. A QA kit consisting of a kVp Test-O-Meter (ToM) (Model RAD/FLU-9001), dose Test-O-Meter (ToM) (Model 6001), ionization chamber-based radiation survey meter model Gun Monitor and other standard accessories were used for the required measurements. The important areas where there was noncompliance with the national safety code were: inaccuracy of kVp calibration (23%), lack of congruence of radiation and optical field (23%), nonlinearity of mA station (16%) and timer (9%), improper collimator/diaphragm (19.6%), faulty adjustor knob for alignment of field size (4%), nonavailability of warning light (red light) at the entrance of the X-ray room (29%), and use of mobile protective barriers without lead glass viewing window (14%). The present study on the radiological safety status of diagnostic X-ray installations may be a reasonably good representation of the situation in the country as a whole. The study contributes significantly to the improvement of radiological safety by the way of the steps already taken and by providing a vital feed back to the national regulatory body.

Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05).

PubMed

Roos, Daniel E; Davis, Sidney R; Turner, Sandra L; O'Brien, Peter C; Spry, Nigel A; Burmeister, Bryan H; Hoskin, Peter J; Ball, David L

2003-05-01

Trans-Tasman Radiation Oncology Group 96.05 is a prospective randomized controlled trial comparing a single 8 Gy with 20 Gy in five fractions of radiotherapy (RT) for neuropathic pain due to bone metastases. This paper summarizes the quality assurance (QA) activities for the first 234 patients (accrual target 270). Independent audits to assess compliance with eligibility/exclusion criteria and appropriateness of treatment of the index site were conducted after each cohort of approximately 45 consecutive patients. Reported serious adverse events (SAEs) in the form of cord/cauda equina compression or pathological fracture developing at the index site were investigated and presented in batches to the Independent Data Monitoring Committee. Finally, source data verification of the RT prescription page and treatment records was undertaken for each of the first 234 patients to assess compliance with the protocol. Only one patient was found conclusively not to have genuine neuropathic pain, and there were no detected 'geographical misses' with RT fields. The overall rate of detected infringements for other eligibility criteria over five audits (225 patients) was 8% with a dramatic improvement after the first audit. There has at no stage been a statistically significant difference in SAEs by randomization arm. There was a 22% rate of RT protocol variations involving ten of the 14 contributing centres, although the rate of major dose violations (more than +/-10% from protocol dose) was only 6% with no statistically significant difference by randomization arm (P=0.44). QA auditing is an essential but time-consuming component of RT trials, including those assessing palliative endpoints. Our experience confirms that all aspects should commence soon after study activation.

Beam Output Audit results within the EORTC Radiation Oncology Group network.

PubMed

Hurkmans, Coen W; Christiaens, Melissa; Collette, Sandra; Weber, Damien Charles

2016-12-15

Beam Output Auditing (BOA) is one key process of the EORTC radiation therapy quality assurance program. Here the results obtained between 2005 and 2014 are presented and compared to previous results.For all BOA reports the following parameters were scored: centre, country, date of audit, beam energies and treatment machines audited, auditing organisation, percentage of agreement between stated and measured dose.Four-hundred and sixty-one BOA reports were analyzed containing the results of 1790 photon and 1366 electron beams, delivered by 755 different treatment machines. The majority of beams (91.1%) were within the optimal limit of ≤ 3%. Only 13 beams (0.4%; n = 9 electrons; n = 4 photons), were out of the range of acceptance of ≤ 5%. Previous reviews reported a much higher percentage of 2.5% or more of the BOAs with >5% deviation.The majority of EORTC centres present beam output variations within the 3% tolerance cutoff value and only 0.4% of audited beams presented with variations of more than 5%. This is an important improvement compared to previous BOA results.

Breast imaging. A practical look at its capabilities and its limitations.

PubMed

Clark, R; Nemec, L; Love, N

1992-10-01

The film-screen technique is evolving as the standard for mammography. Sonography is the only other method that currently has a defined role in breast imaging. Mammography should be performed at facilities that have received American College of Radiology accreditation or its equivalent, because technical quality assurance is an important part of mammographic practice. Interpretive quality may be assured by outcome audits performed by mammography facilities. Primary care physicians are best suited to encouraging eligible women to undergo screening studies and should consider these recommendations: Refer patients for screening mammography to accredited facilities according to established guidelines. Educate patients about the need for regular screening. Provide annual breast physical examination. Refresh your knowledge on breast health and the techniques of physical examination if necessary. Teach patients breast self-examination techniques. Demand low-cost, high-quality screening mammography; be aware of local variability of charges and quality.

Audit of prostate cancer: lessons learnt for current clinical practice, surrogates for quality of care and standardisation and quality assurance.

PubMed

Silcocks, P; Needham, P; Hemsley, F

1999-07-01

Two-hundred and fifty-one prostate cancer patients first registered during 1994 were sampled from a Regional Cancer Registry. In the six months after diagnosis, 39% received drug treatment alone, while 37% had no active treatment. Eighty-one percent of cases were histologically proven. Seventy-six percent had a prostate specific antigen (PSA) test and in 3% the PSA test was the basis for diagnosis. Of histologically proven cases 29% had a Gleason grade. None were staged by clinicians. Key lessons were: The result was a snapshot of current clinical practice which suggested other possible surrogates for quality of care, such as basis of stage and timing of investigations; There is a need for standardisation and quality assurance of the content of pathology reports; Standard treatment protocols would aid recording and comparison of treatments.

Identifying problematic concepts in SNOMED CT using a lexical approach.

PubMed

Agrawal, Ankur; Perl, Yehoshua; Elhanan, Gai

2013-01-01

SNOMED CT (SCT) has been endorsed as a premier clinical terminology by many organizations with a perceived use within electronic health records and clinical information systems. However, there are indications that, at the moment, SCT is not optimally structured for its intended use by healthcare practitioners. A study is conducted to investigate the extent of inconsistencies among the concepts in SCT. A group auditing technique to improve the quality of SCT is introduced that can help identify problematic concepts with a high probability. Positional similarity sets are defined, which are groups of concepts that are lexically similar and the position of the differing word in the fully specified name of the concepts of a set that correspond to each other. A manual auditing of a sample of such sets found 38% of the sets exhibiting one or more inconsistent concepts. Group auditing techniques such as this can thus be very helpful to assure the quality of SCT, which will help expedite its adoption as a reference terminology for clinical purposes.

Using RUFDATA to guide a logic model for a quality assurance process in an undergraduate university program.

PubMed

Sherman, Paul David

2016-04-01

This article presents a framework to identify key mechanisms for developing a logic model blueprint that can be used for an impending comprehensive evaluation of an undergraduate degree program in a Canadian university. The evaluation is a requirement of a comprehensive quality assurance process mandated by the university. A modified RUFDATA (Saunders, 2000) evaluation model is applied as an initiating framework to assist in decision making to provide a guide for conceptualizing a logic model for the quality assurance process. This article will show how an educational evaluation is strengthened by employing a RUFDATA reflective process in exploring key elements of the evaluation process, and then translating this information into a logic model format that could serve to offer a more focussed pathway for the quality assurance activities. Using preliminary program evaluation data from two key stakeholders of the undergraduate program as well as an audit of the curriculum's course syllabi, a case is made for, (1) the importance of inclusivity of key stakeholders participation in the design of the evaluation process to enrich the authenticity and accuracy of program participants' feedback, and (2) the diversification of data collection methods to ensure that stakeholders' narrative feedback is given ample exposure. It is suggested that the modified RUFDATA/logic model framework be applied to all academic programs at the university undergoing the quality assurance process at the same time so that economies of scale may be realized. Copyright © 2015 Elsevier Ltd. All rights reserved.

Assessing the practice of biomedical ontology evaluation: Gaps and opportunities.

PubMed

Amith, Muhammad; He, Zhe; Bian, Jiang; Lossio-Ventura, Juan Antonio; Tao, Cui

2018-04-01

With the proliferation of heterogeneous health care data in the last three decades, biomedical ontologies and controlled biomedical terminologies play a more and more important role in knowledge representation and management, data integration, natural language processing, as well as decision support for health information systems and biomedical research. Biomedical ontologies and controlled terminologies are intended to assure interoperability. Nevertheless, the quality of biomedical ontologies has hindered their applicability and subsequent adoption in real-world applications. Ontology evaluation is an integral part of ontology development and maintenance. In the biomedicine domain, ontology evaluation is often conducted by third parties as a quality assurance (or auditing) effort that focuses on identifying modeling errors and inconsistencies. In this work, we first organized four categorical schemes of ontology evaluation methods in the existing literature to create an integrated taxonomy. Further, to understand the ontology evaluation practice in the biomedicine domain, we reviewed a sample of 200 ontologies from the National Center for Biomedical Ontology (NCBO) BioPortal-the largest repository for biomedical ontologies-and observed that only 15 of these ontologies have documented evaluation in their corresponding inception papers. We then surveyed the recent quality assurance approaches for biomedical ontologies and their use. We also mapped these quality assurance approaches to the ontology evaluation criteria. It is our anticipation that ontology evaluation and quality assurance approaches will be more widely adopted in the development life cycle of biomedical ontologies. Copyright © 2018 Elsevier Inc. All rights reserved.

Can hospital audit teams identify case management problems, analyse their causes, identify and implement improvements? A cross-sectional process evaluation of obstetric near-miss case reviews in Benin.

PubMed

Borchert, Matthias; Goufodji, Sourou; Alihonou, Eusèbe; Delvaux, Thérèse; Saizonou, Jacques; Kanhonou, Lydie; Filippi, Véronique

2012-10-11

Obstetric near-miss case reviews are being promoted as a quality assurance intervention suitable for hospitals in low income countries. We introduced such reviews in five district, regional and national hospitals in Benin, West Africa. In a cross-sectional study we analysed the extent to which the hospital audit teams were able to identify case management problems (CMPs), analyse their causes, agree on solutions and put these solutions into practice. We analysed case summaries, women's interview transcripts and audit minutes produced by the audit teams for 67 meetings concerning one woman with near-miss complications each. We compared the proportion of CMPs identified by an external assessment team to the number found by the audit teams. For the latter, we described the CMP causes identified, solutions proposed and implemented by the audit teams. Audit meetings were conducted regularly and were well attended. Audit teams identified half of the 714 CMPs; they were more likely to find managerial ones (71%) than the ones relating to treatment (30%). Most identified CMPs were valid. Almost all causes of CMPs were plausible, but often too superficial to be of great value for directing remedial action. Audit teams suggested solutions, most of them promising ones, for 38% of the CMPs they had identified, but recorded their implementation only for a minority (8.5%). The importance of following-up and documenting the implementation of solutions should be stressed in future audit interventions. Tools facilitating the follow-up should be made available. Near-miss case reviews hold promise, but their effectiveness to improve the quality of care sustainably and on a large scale still needs to be established.

Can hospital audit teams identify case management problems, analyse their causes, identify and implement improvements? A cross-sectional process evaluation of obstetric near-miss case reviews in Benin

PubMed Central

2012-01-01

Background Obstetric near-miss case reviews are being promoted as a quality assurance intervention suitable for hospitals in low income countries. We introduced such reviews in five district, regional and national hospitals in Benin, West Africa. In a cross-sectional study we analysed the extent to which the hospital audit teams were able to identify case management problems (CMPs), analyse their causes, agree on solutions and put these solutions into practice. Methods We analysed case summaries, women’s interview transcripts and audit minutes produced by the audit teams for 67 meetings concerning one woman with near-miss complications each. We compared the proportion of CMPs identified by an external assessment team to the number found by the audit teams. For the latter, we described the CMP causes identified, solutions proposed and implemented by the audit teams. Results Audit meetings were conducted regularly and were well attended. Audit teams identified half of the 714 CMPs; they were more likely to find managerial ones (71%) than the ones relating to treatment (30%). Most identified CMPs were valid. Almost all causes of CMPs were plausible, but often too superficial to be of great value for directing remedial action. Audit teams suggested solutions, most of them promising ones, for 38% of the CMPs they had identified, but recorded their implementation only for a minority (8.5%). Conclusions The importance of following-up and documenting the implementation of solutions should be stressed in future audit interventions. Tools facilitating the follow-up should be made available. Near-miss case reviews hold promise, but their effectiveness to improve the quality of care sustainably and on a large scale still needs to be established. PMID:23057707

Sample survey methods as a quality assurance tool in a general practice immunisation audit.

PubMed

Cullen, R

1994-04-27

In a multidoctor family practice there are often just too many sets of patients records to make it practical to repeat an audit by census of even an age band of the practice on a regular basis. This paper attempts to demonstrate how sample survey methodology can be incorporated into the quality assurance cycle. A simple random sample (with replacement) of 120 from 580 children with permanent records who were aged between 6 weeks and 2 years old from an Auckland general practice was performed, with sample size selected to give a predetermined precision. The survey was then repeated after 4 weeks. Both surveys were able to be completed within the course of a normal working day. An unexpectedly low level of under 2 years olds that were recorded as not overdue for any immunisations was found (22.5%) with only a modest improvement after a standard telephone/letter catch up campaign. Seventy-two percent of the sample held a group one community services card. The advantages of properly conducted sample surveys in producing useful estimates of known precision without disrupting office routines excessively were demonstrated. Through some attention to methodology, the trauma of a practice census can be avoided.

Quality, management, and the interplay of self-assessment, process assessments, and performance-based observations

NASA Astrophysics Data System (ADS)

Willett, D. J.

1993-04-01

In this document, the author presents his observations on the topic of quality assurance (QA). Traditionally the focus of quality management has been on QA organizations, manuals, procedures, audits, and assessments; quality was measured by the degree of conformance to specifications or standards. Today quality is defined as satisfying user needs and is measured by user satisfaction. The author proposes that quality is the responsibility of line organizations and staff and not the responsibility of the QA group. This work outlines an effective Conduct of Operations program. The author concludes his observations with a discussion of how quality is analogous to leadership.

Assessment of national dosimetry quality audits results for teletherapy machines from 1989 to 2015.

PubMed

Muhammad, Wazir; Ullah, Asad; Mahmood, Khalid; Matiullah

2016-01-01

The purpose of this study was to ensure accuracy in radiation dose delivery, external dosimetry quality audit has an equal importance with routine dosimetry performed at clinics. To do so, dosimetry quality audit was organized by the Secondary Standard Dosimetry Laboratory (SSDL) of Pakistan Institute of Nuclear Science and Technology (PINSTECH) at the national level to investigate and minimize uncertainties involved in the measurement of absorbed dose, and to improve the accuracy of dose measurement at different radiotherapy hospitals. A total of 181 dosimetry quality audits (i.e., 102 of Co-60 and 79 of linear accelerators) for teletherapy units installed at 22 different sites were performed from 1989 to 2015. The percent deviation between users’ calculated/stated dose and evaluated dose (in the result of on-site dosimetry visits) were calculated and the results were analyzed with respect to the limits of ± 2.5% (ICRU "optimal model") ± 3.0% (IAEA on-site dosimetry visits limit) and ± 5.0% (ICRU minimal or "lowest acceptable" model). The results showed that out of 181 total on-site dosimetry visits, 20.44%, 16.02%, and 4.42% were out of acceptable limits of ± 2.5% ± 3.0%, and ± 5.0%, respectively. The importance of a proper ongoing quality assurance program, recommendations of the followed protocols, and properly calibrated thermometers, pressure gauges, and humidity meters at radiotherapy hospitals are essential in maintaining consistency and uniformity of absorbed dose measurements for precision in dose delivery.

49 CFR 385.313 - Who will conduct the safety audit?

Code of Federal Regulations, 2010 CFR

2010-10-01

... FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.313 Who will conduct the safety audit? An individual certified under the FMCSA regulations to perform safety audits will conduct the safety audit. ... 49 Transportation 5 2010-10-01 2010-10-01 false Who will conduct the safety audit? 385.313 Section...

7 CFR 1773.9 - Disclosure of fraud, illegal acts, and other noncompliance.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., the auditor must design the audit to provide reasonable assurance of detecting fraud that is material... UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE (CONTINUED) POLICY ON AUDITS OF RUS BORROWERS RUS Audit... statements, auditors should apply audit procedures specifically directed to ascertaining whether an illegal...

28 CFR 31.201 - Audit.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Audit. 31.201 Section 31.201 Judicial Administration DEPARTMENT OF JUSTICE OJJDP GRANT PROGRAMS Formula Grants General Requirements § 31.201 Audit. The State must assure that it adheres to the audit requirements enumerated in the “Financial and...

Benchmarking and audit of breast units improves quality of care

PubMed Central

van Dam, P.A.; Verkinderen, L.; Hauspy, J.; Vermeulen, P.; Dirix, L.; Huizing, M.; Altintas, S.; Papadimitriou, K.; Peeters, M.; Tjalma, W.

2013-01-01

Quality Indicators (QIs) are measures of health care quality that make use of readily available hospital inpatient administrative data. Assessment quality of care can be performed on different levels: national, regional, on a hospital basis or on an individual basis. It can be a mandatory or voluntary system. In all cases development of an adequate database for data extraction, and feedback of the findings is of paramount importance. In the present paper we performed a Medline search on “QIs and breast cancer” and “benchmarking and breast cancer care”, and we have added some data from personal experience. The current data clearly show that the use of QIs for breast cancer care, regular internal and external audit of performance of breast units, and benchmarking are effective to improve quality of care. Adherence to guidelines improves markedly (particularly regarding adjuvant treatment) and there are data emerging showing that this results in a better outcome. As quality assurance benefits patients, it will be a challenge for the medical and hospital community to develop affordable quality control systems, which are not leading to excessive workload. PMID:24753926

42 CFR 447.202 - Audits.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Audits. 447.202 Section 447.202 Public Health... ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment Methods: General Provisions § 447.202 Audits. The Medicaid agency must assure appropriate audit of records if payment is based on costs of services or on a fee plus...

10 CFR 26.415 - Audits.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Audits. 26.415 Section 26.415 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS FFD Program for Construction § 26.415 Audits. (a) Licensees and other entities who implement an FFD program under this subpart shall ensure that audits are performed to assure...

[The QuIK-Registry of the German Society of Cardiologists in private practice: countrywide and benchmarking quality assurance in invasive cardiology].

PubMed

Albrecht, A; Levenson, B; Göhring, S; Haerer, W; Reifart, N; Ringwald, G; Troger, B

2009-10-01

QuIK is the German acronym for QUality Assurance in Invasive Cardiology. It describes the continuous project of an electronic data collection in Cardiac catheterization laboratories all over Germany. Mainly members of the German Society of Cardiologists in Private Practice (BNK) participate in this computer based project. Since 1996 data of diagnostic and interventional procedures are collected and send to a registry-center where a regular benchmarking analysis of the results is performed. Part of the project is a yearly auditing process including an on-site visit to the cath lab to guarantee for the reliability of information collected. Since 1996 about one million procedures have been documented. Georg Thieme Verlag KG Stuttgart , New York.

[Quality assurance of fine-needle aspiration cytology of the organized mammography screening].

PubMed

Bak, Mihály; Konyár, Eva; Schneider, Ferenc; Bidlek, Mária; Szabó, Eva; Nyári, Tibor; Godény, Mária; Kásler, Miklós

2010-08-08

The National Public Health Program has established the organized mammography screening in Hungary. The aim of our study was to determine the quality assurance of breast aspiration cytology. Cytology results were rated to 5 categories (C1, C2, C3, C4 and C5). All cytology reports were compared with the final histology diagnosis. 1361 women had aspiration cytology diagnosis performed from a total of 47718 mammography non-negative lesions. There were 805 (59.1%) benign and 187 (13.7%) malignant alterations. Sensitivity was 91%, specificity 88%, positive predictive value 96.6% and negative predictive value turned to be 71% (p<0.001). The auditing values of fine needle aspiration cytology in our laboratory meet, or in certain aspects exceed the proposed minimum threshold values.

QUALITY ASSURANCE PROGRAM FOR WET DEPOSITION SAMPLING AND CHEMICAL ANALYSES FOR THE NATIONAL TRENDS NETWORK.

USGS Publications Warehouse

Schroder, LeRoy J.; Malo, Bernard A.; ,

1985-01-01

The purpose of the National Trends Network is to delineate the major inorganic constituents in the wet deposition in the United States. The approach chosen to monitor the Nation's wet deposition is to install approximately 150 automatic sampling devices with at least one collector in each state. Samples are collected at one week intervals, removed from collectors, and transported to an analytical laboratory for chemical analysis. The quality assurance program has divided wet deposition monitoring into 5 parts: (1) Sampling site selection, (2) sampling device, (3) sample container, (4) sample handling, and (5) laboratory analysis. Each of these five components is being examined using existing designs or new designs. Each existing or proposed sampling site is visited and a criteria audit is performed.

Assessing the work of medical audit advisory groups in promoting audit in general practice.

PubMed

Baker, R; Hearnshaw, H; Cooper, A; Cheater, F; Robertson, N

1995-12-01

Objectives--To determine the role of medical audit advisory groups in audit activities in general practice. Design--Postal questionnaire survey. Subjects--All 104 advisory groups in England and Wales in 1994. Main measures--Monitoring audit: the methods used to classify audits, the methods used by the advisory group to collect data on audits from general practices, the proportion of practices undertaking audit. Directing and coordinating audits: topics and number of practices participating in multipractice audits. Results--The response rate was 86-5%. In 1993-4, 54% of the advisory groups used the Oxfordshire or Kirklees methods for classifying audits, or modifications of them. 99% of the advisory groups collected data on audit activities at least once between 1991-2 and 1993-4. Visits, questionnaires, and other methods were used to collect information from all or samples of practices in each of the advisory group's areas. Some advisory groups used different methods in different years. In 1991-2, 57% of all practices participated in some audit, in 1992-3, 78%, and in 1993-4, 86%. 428 multipractice audits were identified. The most popular topic was diabetes. Conclusions--Advisory groups have been active in monitoring audit in general practice. However, the methods used to classify and collect information about audits in general practices varied widely. The number of practices undertaking audit increased between 1991-2 and 1993 1. The large number of multipractice audits supports the view that the advisory groups have directed and coordinated audit activities. This example of a national audit programme for general practice may be helpful in other countries in which the introduction of quality assurance is being considered.

Herbicide Orange Site Characterization Study Naval Construction Battalion Center

DTIC Science & Technology

1987-01-01

U.S. Testing Laboratories for analysis. Over 200 additional analyses were performed for a variety of quality assurance criteria. The resultant data...TABLE 9. NCBC PERFORMANCE AUDIT SAMPLE ANALYSIS SUNMARYa (SERIES 1) TCDD Sppb ) Reported Detection Relative b Sample Number Concentration Limit...limit rather than estimating the variance of the results. The sample results were transformed using the natural logarithm. The Shapiro-Wilk W test

Complex overlapping concepts: An effective auditing methodology for families of similarly structured BioPortal ontologies.

PubMed

Zheng, Ling; Chen, Yan; Elhanan, Gai; Perl, Yehoshua; Geller, James; Ochs, Christopher

2018-05-28

In previous research, we have demonstrated for a number of ontologies that structurally complex concepts (for different definitions of "complex") in an ontology are more likely to exhibit errors than other concepts. Thus, such complex concepts often become fertile ground for quality assurance (QA) in ontologies. They should be audited first. One example of complex concepts is given by "overlapping concepts" (to be defined below.) Historically, a different auditing methodology had to be developed for every single ontology. For better scalability and efficiency, it is desirable to identify family-wide QA methodologies. Each such methodology would be applicable to a whole family of similar ontologies. In past research, we had divided the 685 ontologies of BioPortal into families of structurally similar ontologies. We showed for four ontologies of the same large family in BioPortal that "overlapping concepts" are indeed statistically significantly more likely to exhibit errors. In order to make an authoritative statement concerning the success of "overlapping concepts" as a methodology for a whole family of similar ontologies (or of large subhierarchies of ontologies), it is necessary to show that "overlapping concepts" have a higher likelihood of errors for six out of six ontologies of the family. In this paper, we are demonstrating for two more ontologies that "overlapping concepts" can successfully predict groups of concepts with a higher error rate than concepts from a control group. The fifth ontology is the Neoplasm subhierarchy of the National Cancer Institute thesaurus (NCIt). The sixth ontology is the Infectious Disease subhierarchy of SNOMED CT. We demonstrate quality assurance results for both of them. Furthermore, in this paper we observe two novel, important, and useful phenomena during quality assurance of "overlapping concepts." First, an erroneous "overlapping concept" can help with discovering other erroneous "non-overlapping concepts" in its vicinity. Secondly, correcting erroneous "overlapping concepts" may turn them into "non-overlapping concepts." We demonstrate that this may reduce the complexity of parts of the ontology, which in turn makes the ontology more comprehensible, simplifying maintenance and use of the ontology. Copyright © 2018. Published by Elsevier Inc.

A collaborative computer auditing system under SOA-based conceptual model

NASA Astrophysics Data System (ADS)

Cong, Qiushi; Huang, Zuoming; Hu, Jibing

2013-03-01

Some of the current challenges of computer auditing are the obstacles to retrieving, converting and translating data from different database schema. During the last few years, there are many data exchange standards under continuous development such as Extensible Business Reporting Language (XBRL). These XML document standards can be used for data exchange among companies, financial institutions, and audit firms. However, for many companies, it is still expensive and time-consuming to translate and provide XML messages with commercial application packages, because it is complicated and laborious to search and transform data from thousands of tables in the ERP databases. How to transfer transaction documents for supporting continuous auditing or real time auditing between audit firms and their client companies is a important topic. In this paper, a collaborative computer auditing system under SOA-based conceptual model is proposed. By utilizing the widely used XML document standards and existing data transformation applications developed by different companies and software venders, we can wrap these application as commercial web services that will be easy implemented under the forthcoming application environments: service-oriented architecture (SOA). Under the SOA environments, the multiagency mechanism will help the maturity and popularity of data assurance service over the Internet. By the wrapping of data transformation components with heterogeneous databases or platforms, it will create new component markets composed by many software vendors and assurance service companies to provide data assurance services for audit firms, regulators or third parties.

Quality of clinical trials: A moving target

PubMed Central

Bhatt, Arun

2011-01-01

Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122

International Perspectives on Quality Assurance and New Techniques in Radiation Medicine: Outcomes of an IAEA Conference

DOE Office of Scientific and Technical Information (OSTI.GOV)

Shortt, Ken; Davidsson, Lena; Hendry, Jolyon

2008-05-01

The International Atomic Energy Agency organized an international conference called, 'Quality Assurance and New Techniques in Radiation Medicine' (QANTRM). It dealt with quality assurance (QA) in all aspects of radiation medicine (diagnostic radiology, nuclear medicine, and radiotherapy) at the international level. Participants discussed QA issues pertaining to the implementation of new technologies and the need for education and staff training. The advantage of developing a comprehensive and harmonized approach to QA covering both the technical and the managerial issues was emphasized to ensure the optimization of benefits to patient safety and effectiveness. The necessary coupling between medical radiation imaging andmore » radiotherapy was stressed, particularly for advanced technologies. However, the need for a more systematic approach to the adoption of advanced technologies was underscored by a report on failures in intensity-modulated radiotherapy dosimetry auditing tests in the United States, which could imply inadequate implementation of QA for these new technologies. A plenary session addressed the socioeconomic impact of introducing advanced technologies in resource-limited settings. How shall the dual gaps, one in access to basic medical services and the other in access to high-quality modern technology, be addressed?.« less

International perspectives on quality assurance and new techniques in radiation medicine: outcomes of an IAEA conference.

PubMed

Shortt, Ken; Davidsson, Lena; Hendry, Jolyon; Dondi, Maurizio; Andreo, Pedro

2008-01-01

The International Atomic Energy Agency organized an international conference called, "Quality Assurance and New Techniques in Radiation Medicine" (QANTRM). It dealt with quality assurance (QA) in all aspects of radiation medicine (diagnostic radiology, nuclear medicine, and radiotherapy) at the international level. Participants discussed QA issues pertaining to the implementation of new technologies and the need for education and staff training. The advantage of developing a comprehensive and harmonized approach to QA covering both the technical and the managerial issues was emphasized to ensure the optimization of benefits to patient safety and effectiveness. The necessary coupling between medical radiation imaging and radiotherapy was stressed, particularly for advanced technologies. However, the need for a more systematic approach to the adoption of advanced technologies was underscored by a report on failures in intensity-modulated radiotherapy dosimetry auditing tests in the United States, which could imply inadequate implementation of QA for these new technologies. A plenary session addressed the socioeconomic impact of introducing advanced technologies in resource-limited settings. How shall the dual gaps, one in access to basic medical services and the other in access to high-quality modern technology, be addressed?

Criterion-based clinical audit in obstetrics: bridging the quality gap?

PubMed

Graham, W J

2009-06-01

The Millennium Development Goal 5 - reducing maternal mortality by 75% - is unlikely to be met globally and for the majority of low-income countries. At this time of heightened concern to scale-up services for mothers and babies, it is crucial that not only shortfalls in the quantity of care - in terms of location and financial access - are addressed, but also the quality. Reductions in maternal and perinatal mortality in the immediate term depend in large part on the timely delivery of effective practices in the management of life-threatening complications. Such practices require a functioning health system - including skilled and motivated providers engaged with the women and communities whom they serve. Assuring the quality of this system, the services and the care that women receive requires many inputs, including effective and efficient monitoring mechanisms. The purpose of this article is to summarise the practical steps involved in applying one such mechanism, criterion-based clinical audit (CBCA), and to highlight recent lessons from its application in developing countries. Like all audit tools, the ultimate worth of CBCA relates to the action it stimulates in the health system and among providers.

Approaches to quality management and accreditation in a genetic testing laboratory

PubMed Central

Berwouts, Sarah; Morris, Michael A; Dequeker, Elisabeth

2010-01-01

Medical laboratories, and specifically genetic testing laboratories, provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health and medical-legal instances, referral laboratories and authoritative bodies. All expect results that are accurate and obtained in an efficient and effective manner, within a suitable time frame and at acceptable cost. There are different ways of achieving the end results, but compliance with International Organization for Standardization (ISO) 15189, the international standard for the accreditation of medical laboratories, is becoming progressively accepted as the optimal approach to assuring quality in medical testing. We present recommendations and strategies designed to aid genetic testing laboratories with the implementation of a quality management system, including key aspects such as document control, external quality assessment, internal quality control, internal audit, management review, validation, as well as managing the human side of change. The focus is on pragmatic approaches to attain the levels of quality management and quality assurance required for accreditation according to ISO 15189, within the context of genetic testing. Attention is also given to implementing efficient and effective quality improvement. PMID:20720559

[Certification of an ambulatory gastroenterologic service fulfilling ISO Law 9001--criteria and national guidelines of the Gastroenterologic Association].

PubMed

Birkner, B

2000-09-01

The objectives of certification and accreditation are the deployment and examination of quality improvement measures in health care services. The quality management system of the ISO 9001 is created to install measures and tools leading to assured and improved quality in health care. Only some experiences with certification fulfilling ISO 9001 criteria exist in the German health care system. Evidence-based clinical guidelines can serve as references for the development of standards in quality measurement. Only little data exists on the implementation strategy of guidelines and evaluation, respectively. A pilot quality management system in consistence with ISO 9001 criteria was developed for ambulatory, gastroenterological services. National guidelines of the German Society of Gastroenterology and Metabolism and the recommendations of the German Association of Physicians for quality assurance of gastrointestinal endoscopy were included in the documentation and internal auditing. This pilot quality management system is suitable for the first steps in the introduction of quality management in ambulatory health care. This system shows validity for accreditation and certification of gastrointestinal health care units as well.

32 CFR 37.645 - Must I require periodic audits, as well as award-specific audits, of for-profit participants?

Code of Federal Regulations, 2010 CFR

2010-07-01

... amounts or adjusts performance outcomes. The periodic audit provides some assurance that the reported... 32 National Defense 1 2010-07-01 2010-07-01 false Must I require periodic audits, as well as award-specific audits, of for-profit participants? 37.645 Section 37.645 National Defense Department of Defense...

Breast cancer mammographic diagnosis performance in a public health institution: a retrospective cohort study.

PubMed

Mello, Juliana M R B; Bittelbrunn, Fernando P; Rockenbach, Marcio A B C; May, Guilherme G; Vedolin, Leonardo M; Kruger, Marilia S; Soldatelli, Matheus D; Zwetsch, Guilherme; de Miranda, Gabriel T F; Teixeira, Saone I P; Arruda, Bruna S

2017-12-01

To evaluate the quality assurance of mammography results at a reference institution for the diagnosis and treatment of breast cancer in southern Brazil, based on the BIRADS (Breast Imaging Reporting and Data System) 5th edition recommendations for auditing purposes. Retrospective cohort and cross-sectional study with 4502 patients (9668 mammographies)) who underwent at least one or both breast mammographies throughout 2013 at a regional public hospital, linked to a federal public university. The results were followed until 31 December 2014, including true positives (TPs), true negatives (TNs), false positives (FPs), false negatives (FNs), positive predictive values (PPVs), negative predictive value (NPV), sensitivity and specificity, with a confidence interval of 95%. The study showed high quality assurance, particularly regarding sensitivity (90.22%) and specificity (92.31%). The overall positive predictive value (PPV) was 65.35%, and the negative predictive value (NPV) was 98.32%. The abnormal interpretation rate (recall rate) was 12.26%. The results are appropriate when compared to the values proposed by the BIRADS 5th edition. Additionally, the study provided self-reflection considering our radiological practice, which is essential for improvements and collaboration regarding breast cancer detection. It may stimulate better radiological practice performance and continuing education, despite possible infrastructure and facility limitations. • Accurate quality performance rates are possible despite financial and governmental limitations. • Low-income institutions should develop standardised teamwork to improve radiological practice. • Regular mammography audits may help to increase the quality of public health systems.

Validating dose rate calibration of radiotherapy photon beams through IAEA/WHO postal audit dosimetry service.

PubMed

Jangda, Abdul Qadir; Hussein, Sherali

2012-05-01

In external beam radiation therapy (EBRT), the quality assurance (QA) of the radiation beam is crucial to the accurate delivery of the prescribed dose to the patient. One of the dosimetric parameters that require monitoring is the beam output, specified as the dose rate on the central axis under reference conditions. The aim of this project was to validate dose rate calibration of megavoltage photon beams using the International Atomic Energy Agency (IAEA)/World Health Organisation (WHO) postal audit dosimetry service. Three photon beams were audited: a 6 MV beam from the low-energy linac and 6 and 18 MV beams from a dual high-energy linac. The agreement between our stated doses and the IAEA results was within 1% for the two 6 MV beams and within 2% for the 18 MV beam. The IAEA/WHO postal audit dosimetry service provides an independent verification of dose rate calibration protocol by an international facility.

The surveillance of nursing standards: an organisational case study.

PubMed

Cooke, Hannah

2006-11-01

Quality assurance has acquired increasing prominence in contemporary healthcare systems and there has been an 'explosion' of audit activity. Some authors have begun to investigate the impact of audit activity on organisational and professional cultures. This paper considers data from a wider study of the management of the 'problem' nurse. Nurses and managers had contrasting perceptions of the value of different methods of assessing ward standards and their views are presented here. The study involved organisational case studies in three healthcare Trusts in the north of England. The fieldwork for this study was funded by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting under their research scholarship programme. Multiple methods were employed including observation, interviewing and documentary analysis. A total of 144 informal interviews were carried out with ward nurses and their managers. The study demonstrated different viewpoints regarding the surveillance of nursing standards at top management, middle management and ward levels. The paper considers the discrepancies between these different viewpoints. None of the participants placed a high value on audit as a method of assessing ward standards. Complaints data and informal methods were more highly valued by managers. Ward nurses stressed the importance of presence and vigilance in assuring high standards of nursing care.

24 CFR 570.495 - Reviews and audits response.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 3 2010-04-01 2010-04-01 false Reviews and audits response. 570... Development Block Grant Program § 570.495 Reviews and audits response. (a) If HUD's review and audit under... information or assurances will be required before acceptance of one or more of the certifications required for...

75 FR 10496 - Tribal Self-Governance Program Planning Cooperative Agreement; Announcement Type: New Funding...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-08

... SF-424 and all necessary assurances and certifications. Audits being sent separately must be received... as no uncorrected significant and material audit exceptions in the required annual audit of the.... Applicants are required to submit complete annual audit reports for the three fiscal years prior to the year...

49 CFR 385.315 - Where will the safety audit be conducted?

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.315 Where will the safety audit be conducted? The safety audit will generally be conducted at the new entrant's business premises. ... 49 Transportation 5 2010-10-01 2010-10-01 false Where will the safety audit be conducted? 385.315...

49 CFR 385.319 - What happens after completion of the safety audit?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false What happens after completion of the safety audit... REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.319 What happens after completion of the safety audit? (a) Upon completion of the safety audit, the auditor will review the findings...

[Audits across state borders for medical consulting agencies within the German healthcare insurance system].

PubMed

Schneider, T; Sommerfeld, W; Möller, J

2003-06-01

The Medizinischer Dienst der Krankenversicherung (MDK) is a non-profit medical consulting organisation serving the German Healthcare Insurance System. Despite its uniform commission throughout Germany, organisation and structure differ considerably between Provincial States which is reflected by differing results. A common nationwide system of key figures and indicators aims at analysing results and learning from one another. Development of an audit concept for analysing key figures and indicators within the MDK aiming at quality improvement. Development of a system of key figures and indicators covering five spheres (products, staff, costs, data analysis, structure). Analysis by means of audits carried out across provincial state borders in five steps (audit manual, training of auditors, visitation, audit report, repetition audit). The system of key figures and indicators assures relevant and comparable data. Audit manual, training of auditors, visitation, and audit report meet the needs of all people and institutions involved. Preparation of auditors as well as openness, and flow of information within audited organisations offer areas for improvement. There is as yet no assessment of the cost-benefit ratio of audits. The concept presented in this article consists of two parts: A system of key figures and indicators as well as a concept for audits. The concept is suitable for a) generating and analysing relevant key figures and indicators for each MDK, and b) providing information for benchmarking between different MDK. Further development of the concept to a comprehensive management concept is necessary.

Telemedicine-based system for quality management and peer review in radiology.

PubMed

Morozov, Sergey; Guseva, Ekaterina; Ledikhova, Natalya; Vladzymyrskyy, Anton; Safronov, Dmitry

2018-06-01

Quality assurance is the key component of modern radiology. A telemedicine-based quality assurance system helps to overcome the "scoring" approach and makes the quality control more accessible and objective. A concept for quality assurance in radiology is developed. Its realization is a set of strategies, actions, and tools. The latter is based on telemedicine-based peer review of 23,199 computed tomography (CT) and magnetic resonance imaging (MRI) images. The conception of the system for quality management in radiology represents a chain of actions: "discrepancies evaluation - routine support - quality improvement activity - discrepancies evaluation". It is realized by an audit methodology, telemedicine, elearning, and other technologies. After a year of systemic telemedicine-based peer reviews, the authors have estimated that clinically significant discrepancies were detected in 6% of all cases, while clinically insignificant ones were found in 19% of cases. Most often, problems appear in musculoskeletal records; 80% of the examinations have diagnostic or technical imperfections. The presence of routine telemedicine support and personalized elearning allowed improving the diagnostics quality. The level of discrepancies has decreased significantly (p < 0.05). The telemedicine-based peer review system allows improving radiology departments' network effectiveness. • "Scoring" approach to radiologists' performance assessment must be changed. • Telemedicine peer review and personalized elearning significantly decrease the number of discrepancies. • Teleradiology allows linking all primary-level hospitals to a common peer review network.

Development of an audit instrument for nursing care plans in the patient record

PubMed Central

Bjorvell, C; Thorell-Ekstrand, I; Wredling, R

2000-01-01

Objectives—To develop, validate, and test the reliability of an audit instrument that measures the extent to which patient records describe important aspects of nursing care. Material—Twenty records from each of three hospital wards were collected and audited. The auditors were registered nurses with a knowledge of nursing documentation in accordance with the VIPS model—a model designed to structure nursing documentation. (VIPS is an acronym formed from the Swedish words for wellbeing, integrity, prevention, and security.) Methods—An audit instrument was developed by determining specific criteria to be met. The audit questions were aimed at revealing the content of the patient for nursing assessment, nursing diagnosis, planned interventions, and outcome. Each of the 60 records was reviewed by the three auditors independently and the reliability of the instrument was tested by calculating the inter-rater reliability coefficient. Content validity was tested by using an expert panel and calculating the content validity ratio. The criterion related validity was estimated by the correlation between the score of the Cat-ch-Ing instrument and the score of an earlier developed and used audit instrument. The results were then tested by using Pearson's correlation coefficient. Results—The new audit instrument, named Cat-ch-Ing, consists of 17 questions designed to judge the nursing documentation. Both quantity and quality variables are judged on a rating scale from zero to three, with a maximum score of 80. The inter-rater reliability coefficients were 0.98, 0.98, and 0.92, respectively for each group of 20 records, the content validity ratio ranged between 0.20 and 1.0 and the criterion related validity showed a significant correlation of r = 0.68 (p< 0.0001, 95% CI 0.57 to 0.76) between the two audit instruments. Conclusion—The Cat-ch-Ing instrument has proved to be a valid and reliable audit instrument for nursing records when the VIPS model is used as the basis of the documentation. (Quality in Health Care 2000;9:6–13) Key Words: audit instrument; nursing care plans; quality assurance PMID:10848373

Reduced Circumferential Resection Margin Involvement in Rectal Cancer Surgery: Results of the Dutch Surgical Colorectal Audit.

PubMed

Gietelink, Lieke; Wouters, Michel W J M; Tanis, Pieter J; Deken, Marion M; Ten Berge, Martijn G; Tollenaar, Rob A E M; van Krieken, J Han; de Noo, Mirre E

2015-09-01

The circumferential resection margin (CRM) is a significant prognostic factor for local recurrence, distant metastasis, and survival after rectal cancer surgery. Therefore, availability of this parameter is essential. Although the Dutch total mesorectal excision trial raised awareness about CRM in the late 1990s, quality assurance on pathologic reporting was not available until the Dutch Surgical Colorectal Audit (DSCA) started in 2009. The present study describes the rates of CRM reporting and involvement since the start of the DSCA and analyzes whether improvement of these parameters can be attributed to the audit. Data from the DSCA (2009-2013) were analyzed. Reporting of CRM and CRM involvement was plotted for successive years, and variations of these parameters were analyzed in a funnelplot. Predictors of CRM involvement were determined in univariable analysis and the independent influence of year of registration on CRM involvement was analyzed in multivariable analysis. A total of 12,669 patients were included for analysis. The mean percentage of patients with a reported CRM increased from 52.7% to 94.2% (2009-2013) and interhospital variation decreased. The percentage of patients with CRM involvement decreased from 14.2% to 5.6%. In multivariable analysis, the year of DSCA registration remained a significant predictor of CRM involvement. After the introduction of the DSCA, a dramatic improvement in CRM reporting and a major decrease of CRM involvement after rectal cancer surgery have occurred. This study suggests that a national quality assurance program has been the driving force behind these achievements. Copyright © 2015 by the National Comprehensive Cancer Network.

Implementation of quality management systems and progress towards accreditation of National Tuberculosis Reference Laboratories in Africa

PubMed Central

de Dieu Iragena, Jean; Kao, Kekeletso; Erni, Donatelle; Mekonen, Teferi

2017-01-01

Background Laboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Enabling access to quality services is a challenge in low-resource settings. Implementation of a strong quality management system (QMS) and laboratory accreditation are key to improving patient care. Objectives The study objective was to determine the status of QMS implementation and progress towards accreditation of National Tuberculosis Reference Laboratories (NTRLs) in the African Region. Method An online questionnaire was administered to NTRL managers in 47 World Health Organization Regional Office for Africa member states in the region, between February and April 2015, regarding the knowledge of QMS tools and progress toward implementation to inform strategies for tuberculosis diagnostic services strengthening in the region. Results A total of 21 laboratories (43.0%) had received SLMTA/TB-SLMTA training, of which 10 had also used the Global Laboratory Initiative accreditation tool. However, only 36.7% of NTRLs had received a laboratory audit, a first step in quality improvement. Most NTRLs participated in acid-fast bacilli microscopy external quality assurance (95.8%), although external quality assurance for other techniques was lower (60.4% for first-line drug susceptibility testing, 25.0% for second-line drug susceptibility testing, and 22.9% for molecular testing). Barriers to accreditation included lack of training and accreditation programmes. Only 28.6% of NTRLs had developed strategic plans and budgets which included accreditation. Conclusion Good foundations are in place on the continent from which to scale up accreditation efforts. Laboratory audits should be conducted as a first step in developing quality improvement action plans. Political commitment and strong leadership are needed to drive accreditation efforts; advocacy will require clear evidence of patient impact and cost-benefit. PMID:28879161

Web Implementation of Quality Assurance (QA) for X-ray Units in Balkanic Medical Institutions.

PubMed

Urošević, Vlade; Ristić, Olga; Milošević, Danijela; Košutić, Duško

2015-08-01

Diagnostic radiology is the major contributor to the total dose of the population from all artificial sources. In order to reduce radiation exposure and optimize diagnostic x-ray image quality, it is necessary to increase the quality and efficiency of quality assurance (QA) and audit programs. This work presents a web application providing completely new QA solutions for x-ray modalities and facilities. The software gives complete online information (using European standards) with which the corresponding institutions and individuals can evaluate and control a facility's Radiation Safety and QA program. The software enables storage of all data in one place and sharing the same information (data), regardless of whether the measured data is used by an individual user or by an authorized institution. The software overcomes the distance and time separation of institutions and individuals who take part in QA. Upgrading the software will enable assessment of the medical exposure level to ionizing radiation.

MRT fuel element inspection at Dounreay

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gibson, J.

1997-08-01

To ensure that their production and inspection processes are performed in an acceptable manner, ie. auditable and traceable, the MTR Fuel Element Fabrication Plant at Dounreay operates to a documented quality system. This quality system, together with the fuel element manufacturing and inspection operations, has been independently certified to ISO9002-1987, EN29002-1987 and BS5750:Pt2:1987 by Lloyd`s Register Quality Assurance Limited (LRQA). This certification also provides dual accreditation to the relevant German, Dutch and Australian certification bodies. This paper briefly describes the quality system, together with the various inspection stages involved in the manufacture of MTR fuel elements at Dounreay.

A preliminary study into performing routine tube output and automatic exposure control quality assurance using radiology information system data.

PubMed

Charnock, P; Jones, R; Fazakerley, J; Wilde, R; Dunn, A F

2011-09-01

Data are currently being collected from hospital radiology information systems in the North West of the UK for the purposes of both clinical audit and patient dose audit. Could these data also be used to satisfy quality assurance (QA) requirements according to UK guidance? From 2008 to 2009, 731 653 records were submitted from 8 hospitals from the North West England. For automatic exposure control QA, the protocol from Institute of Physics and Engineering in Medicine (IPEM) report 91 recommends that milliamperes per second can be monitored for repeatability and reproducibility using a suitable phantom, at 70-81 kV. Abdomen AP and chest PA examinations were analysed to find the most common kilovoltage used with these records then used to plot average monthly milliamperes per second with time. IPEM report 91 also recommends that a range of commonly used clinical settings is used to check output reproducibility and repeatability. For each tube, the dose area product values were plotted over time for two most common exposure factor sets. Results show that it is possible to do performance checks of AEC systems; however more work is required to be able to monitor tube output performance. Procedurally, the management system requires work and the benefits to the workflow would need to be demonstrated.

Quality assurance for patients with head injuries admitted to a regional trauma unit.

PubMed

Schwartz, M L; Sharkey, P W; Andersen, J A

1991-07-01

The efficacy of trauma systems in reducing preventable deaths has been established but the methods of auditing care are still evolving. Various "audit filters" to identify which patients' charts should be reviewed have been proposed. An analysis of all patients admitted to the Regional Trauma Unit (RTU) over a 19-month period was conducted. Of 729 patients, 135 were identified as having suffered a traumatic intracranial hemorrhage (TICH). On review, neither delay in transfer from the emergency room to the operating room nor increasing time from the incident to the operating room correlated with increasing mortality. In contrast to delay, the Glasgow Coma Scale (GCS) score on admission correlated well with outcome. The charts of patients with anomalous outcomes based on admission GCS score were reviewed, and two possibly preventable deaths were identified. There were 48 patients with TICH who had no operations but there were no deaths attributable to a missed operation. There were 76 patients for whom the GCS score at the referring hospital and the GCS score on admission to the RTU were available. Seven of 19 patients who worsened on transfer declined because of significant pulmonary injuries. Anomalous outcomes based on admission GCS score and declining GCS scores are recommended as quality assurance filters.

The role of quality assurance in future midwifery practice.

PubMed

Dawson, J

1993-08-01

Recent recommendations have been made which would give midwives a more central role in maternity care and a greater degree of independence than they currently enjoy. This paper argues that midwives' current attitudes to quality assurance are incompatible with this enhanced role. Research conducted in three health districts is described, which explored the perceptions of nurses, midwives and managers towards quality assurance. The findings indicate that quality assurance (in whatever form that concept is operationalized) is a demonstration of accountability. For managers this accountability is primarily for the service as a whole, whilst nurses and midwives view their accountability as being owed to patients/clients. The main methodology which the study identified as being used for monitoring nursing care was the development and auditing of explicit standards. This approach has been actively promoted by the Royal College of Nursing, enabling nurses to regain control of the purely professional aspects of the nursing profession. Midwives in the study districts showed a marked reluctance to adopt such a strategy, taking the view that as independent practitioners consensus standards would be unacceptable. It is argued that this attitude is inconsistent with the basic principle that professionals are accountable for both demonstrating and developing the quality of professional practice. It is further suggested that midwives currently have an opportunity to regain professional control of midwifery practice, which will be lost unless they are prepared to take responsibility for evaluating the standards for which they are accountable.

49 CFR 385.311 - What will the safety audit consist of?

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.311 What will the safety audit consist of? The safety audit will consist of a review of the new entrant's safety management systems and a... 49 Transportation 5 2010-10-01 2010-10-01 false What will the safety audit consist of? 385.311...

49 CFR 385.309 - What is the purpose of the safety audit?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false What is the purpose of the safety audit? 385.309... SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.309 What is the purpose of the safety audit? The purpose of a safety audit is to: (a) Provide educational and technical assistance to...

External quality-assurance results for the National Atmospheric Deposition Program/National Trends Network, 2002-03

USGS Publications Warehouse

Wetherbee, Gregory A.; Latysh, Natalie E.; Burke, Kevin P.

2005-01-01

Six external quality-assurance programs were operated by the U.S. Geological Survey (USGS) External Quality-Assurance (QA) Project for the National Atmospheric Deposition Program/National Trends Network (NADP/NTN) from 2002 through 2003. Each program measured specific components of the overall error inherent in NADP/NTN wet-deposition measurements. The intersite-comparison program assessed the variability and bias of pH and specific conductance determinations made by NADP/NTN site operators twice per year with respect to accuracy goals. The percentage of site operators that met the pH accuracy goals decreased from 92.0 percent in spring 2002 to 86.3 percent in spring 2003. In these same four intersite-comparison studies, the percentage of site operators that met the accuracy goals for specific conductance ranged from 94.4 to 97.5 percent. The blind-audit program and the sample-handling evaluation (SHE) program evaluated the effects of routine sample handling, processing, and shipping on the chemistry of weekly NADP/NTN samples. The blind-audit program data indicated that the variability introduced by sample handling might be environmentally significant to data users for sodium, potassium, chloride, and hydrogen ion concentrations during 2002. In 2003, the blind-audit program was modified and replaced by the SHE program. The SHE program was designed to control the effects of laboratory-analysis variability. The 2003 SHE data had less overall variability than the 2002 blind-audit data. The SHE data indicated that sample handling buffers the pH of the precipitation samples and, in turn, results in slightly lower conductivity. Otherwise, the SHE data provided error estimates that were not environmentally significant to data users. The field-audit program was designed to evaluate the effects of onsite exposure, sample handling, and shipping on the chemistry of NADP/NTN precipitation samples. Field-audit results indicated that exposure of NADP/NTN wet-deposition samples to onsite conditions tended to neutralize the acidity of the samples by less than 1.0 microequivalent per liter. Onsite exposure of the sampling bucket appeared to slightly increase the concentration of most of the analytes but not to an extent that was environmentally significant to NADP data users. An interlaboratory-comparison program was used to estimate the analytical variability and bias of the NADP Central Analytical Laboratory (CAL) during 2002-03. Bias was identified in the CAL data for calcium, magnesium, sodium, potassium, ammonium, chloride, nitrate, sulfate, hydrogen ion, and specific conductance, but the absolute value of the bias was less than analytical minimum detection limits for all constituents except magnesium, nitrate, sulfate, and specific conductance. Control charts showed that CAL results were within statistical control approximately 90 percent of the time. Data for the analysis of ultrapure deionized-water samples indicated that CAL did not have problems with laboratory contamination. During 2002-03, the overall variability of data from the NADP/NTN precipitation-monitoring system was estimated using data from three collocated monitoring sites. Measurement differences of constituent concentration and deposition for paired samples from the collocated samplers were evaluated to compute error terms. The medians of the absolute percentage errors (MAEs) for the paired samples generally were larger for cations (approximately 8 to 50 percent) than for anions (approximately 3 to 33 percent). MAEs were approximately 16 to 30 percent for hydrogen-ion concentration, less than 10 percent for specific conductance, less than 5 percent for sample volume, and less than 8 percent for precipitation depth. The variability attributed to each component of the sample-collection and analysis processes, as estimated by USGS quality-assurance programs, varied among analytes. Laboratory analysis variability accounted for approximately 2 percent of the

43 CFR 12.51 - State plans.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Lands: Interior Office of the Secretary of the Interior ADMINISTRATIVE AND AUDIT REQUIREMENTS AND COST...) Assurances. In each plan the State will include an assurance that the State shall comply with all applicable.... For this assurance and other assurances required in the plan, the State may: (1) Cite by number the...

Quality assurance audits of medical surveillance programs for hazardous waste workers.

PubMed

Udasin, I G; Buckler, G; Gochfeld, M

1991-11-01

The Occupational Safety and Health Administration (OSHA) Hazardous Waste Operations and Emergency Response Regulation (29 CFR 1910.120) requires medical surveillance examinations for hazardous waste workers. We investigated the consistency and appropriateness of the services provided under OSHA 29 CFR 1910.120 as part of a quality control audit. Our study revealed that in most cases the required paperwork including fitness for duty and restrictions or limitations was completed. However, it is also apparent that many of the components of a complete occupational history were not performed. Spirometric examinations often were performed incorrectly. Documentation of baseline tests was not uniformly done, nor were patients always informed of the findings of their examinations. Our study indicated there may be a lack of education, training, and experience of occupational health providers. This suggests that further efforts should be made to educate physicians and nurses providing medical surveillance and other services to hazardous waste workers.

[Quality assurance of hospital medical records as a risk management tool].

PubMed

Terranova, Giuseppina; Cortesi, Elisabetta; Briani, Silvia; Giannini, Raffaella

2006-01-01

A retrospective analysis of hospital medical records was performed jointly by the Medicolegal department of the Pistoia Local Health Unit N. 3 and by the management of the SS. Cosma and Damiano di Pescia Hospital. Evaluation was based on ANDEM criteria, JCAHO standards, and the 1992 discharge abstract guidelines of the Italian Health Ministry. In the first phase of the study, data were collected and processed for each hospital ward and then discussed with clinicians and audited. After auditing, appropriate actions were agreed upon for correcting identified problems. Approximately one year later a second smaller sample of medical records was evaluated and a higher compliance rate with the established corrective actions was found in all wards for all data categories. In this study the evaluation of medical records can be considered in the wider context of risk management, a multidisciplinary process directed towards identifying and monitoring risk through the use of appropriate quality indicators.

Assessing the dosimetric and geometric accuracy of stereotactic radiosurgery

NASA Astrophysics Data System (ADS)

Dimitriadis, Alexis

Stereotactic radiosurgery (SRS) is a non-invasive treatment predominantly used for the management of malignant and benign brain tumours. The treatment can be delivered by various platforms in a single fraction where a high dose of radiation is delivered to the target whilst the surrounding healthy tissue is spared. This requires a high degree of accuracy in terms of the dose level delivered but also in terms of geometric precision. The purpose of this work was to identify the variations of SRS practice in the UK and develop a novel method compatible with all practices, capable of assessing the accuracy of delivery. The motivation behind this effort was to contribute to safety in SRS delivery, provide confidence through a quality assurance audit and form a basis to support standardisation in SRS. A national survey was performed to investigate SRS practices in the UK and to help guide the methodology of this thesis. This resulted to the development of a method for an end-to-end audit of SRS. This was based on an anthropomorphic head phantom with a medium sized target located centrally in the brain, in close proximity to the brainstem. This realistic patient scenario was presented to all 26 radiosurgery centres in the UK who were asked to treat it with SRS. The dose delivered was assessed using two novel commercially available radiation detectors, a plastic scintillator and radiochromic film. These detectors were characterised for measuring the dose delivered in SRS. Another established dosimetry system, alanine, was also used alongside these detectors to assess the accuracy of each delivery. The results allowed the assessment of SRS practices in the UK and the comparison of all centres that participated in the audit. The results were also used to evaluate the performance of the dosimeters used for the purposes of quality assurance measurements and audit.

49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 5 2013-10-01 2013-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...

49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 5 2012-10-01 2012-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...

49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 5 2014-10-01 2014-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...

49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...

49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...

Quality assurance in melanoma surgery: The evolving experience at a large tertiary referral centre.

PubMed

Read, R L; Pasquali, S; Haydu, L; Thompson, J F; Stretch, J R; Saw, R P M; Quinn, M J; Shannon, K; Spillane, A J

2015-07-01

The quality of melanoma surgery needs to be assessed by oncological outcome and complication rates. There is no published consensus on complication rates for common melanoma surgeries, namely wide excision (WE), sentinel node biopsy (SNB) and regional lymph node dissection (RLND). Consequently there are no agreed standards by which surgeons can audit their practices. Surgical standards were proposed in 2008 following review of the literature and from expert opinion. Melanoma Institute Australia (MIA) self-reported audit data from 2011 and 2012 were compared with these standards. To quality check the self-reported audit, RLND data were extracted from the MIA database. Six surgeons performed a mean of 568 surgeries each quarter; with a mean of 106 major procedures. Following WE with primary closure or flap repair, wound infection or dehiscence occurred in <1% of cases. When skin grafting was required non-take of >20% of the grafted area was observed in 5.9% of cases. Following SNB wound infection and significant seroma occurred in 1.8% of cases. RLND node counts were below the 90% standard in 4 of 409 procedures. In comparison, data extraction identified 405 RLNDs, with node counts below the 90% standard in eight procedures. Two of these patients had previously undergone surgery removing nodes from the field and two had gross coalescing disease with extensive extra-nodal spread. The quality standards proposed in 2008 have been validated long-term by high volume caseloads. The data presented provide standards by which melanoma surgeons can audit their surgical performance. Copyright © 2015 Elsevier Ltd. All rights reserved.

Federal Managers’ Financial Integrity Act: FY 1993 Statement of Assurance

DTIC Science & Technology

1993-01-01

BASED ON YOUR MANAGEMENT REVIEWS AND NOT JUST AUDIT RESULTS, THAT OUR SYSTEMS OF INTERNAL CONTROL AM EFECTIVE IN9 SA.EGUARDING OUR ASSETS AND...coordinating the development and integration of the two processes/programs using the principles of Total Quality Leadership . A prototype was designed...Inventories. Department of the Navy (DON) activities did not screen non-Defense Business Operations Fund (DBOF) ("sponsor") material on receipt, purge

40 CFR 97.72 - Out of control periods.

Code of Federal Regulations, 2010 CFR

2010-07-01

... assurance or data validation requirements of part 75 of this chapter, data shall be substituted using the...) Audit decertification. Whenever both an audit of an emission monitoring system and a review of the... certification or recertification application submission and at the time of the audit, the Administrator will...

Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

PubMed

Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella

2014-07-01

The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.

10 CFR 455.61 - Eligibility.

Code of Federal Regulations, 2010 CFR

2010-01-01

... energy audit has been performed, give assurance that it has implemented all energy conservation... Plan as described in subpart B of this part; (c) Have conducted an energy audit or an energy use...

Clinical audit and peer review scheme for the South West post-new 2006 dental contract: a report on progress so far.

PubMed

Howard-Williams, P

2009-01-10

With the introduction of personal dental services (PDS) into the South West the Local Assessment Panel (LAP) devised a new scheme consisting of 'cookbook' audits and piloted the scheme amongst the PDS dentists of South and West Devon, Somerset and Avon in 2005/2006. When the new contracting arrangements came into force, and in the absence of guidance from above, the LAP in consultation with the PCTs decided to consolidate the successful pilot audit scheme for PDS dentists and extend the new scheme to all the participating PCTs and their performers. The current scheme covers Devon, Somerset, Avon and Gloucester PCTs and is administrated by Mrs Jackie Derrick on behalf of Somerset PCT. All the audits showed improvement with the exception of the patient satisfaction survey where the first audit cycle showed an average patient satisfaction rating of 99% which cannot be improved on. We have redesigned this audit to try and make it more challenging and informative. The improvement in clinical record keeping was particularly marked. With the advent of new contractual arrangements in April 2009 it is essential that practitioners are able to demonstrate quality assurance in their practice and we believe that the South West scheme is a dentist friendly scheme, relevant to everyday dental practice.

Ten-year results of quality assurance in radiotherapy chart round.

PubMed

Taghavi Bayat, Bardia; Gill, Suki; Siva, Shankar; Tai, Keen Hun; Joon, Michael Lim; Foroudi, Farshad

2013-04-23

The Royal Australian and New Zealand College of Radiologists (RANZCR) initiated a unique instrument to audit the quality of patient notes and radiotherapy prescriptions. We present our experience collected over ten years from the use of the RANZCR audit instrument. In this study, the results of data collected prospectively from January 1999 to June 2009 through the audit instrument were assessed. Radiotherapy chart rounds were held weekly in the uro-oncology tumour stream and real time feedback was provided. Electronic medical records were retrospectively assessed in September 2009 to see if any omissions were subsequently corrected. In total 2597 patients were audited. One hundred and thirty seven (5%) patients had one hundred and ninety nine omissions in documentation or radiotherapy prescription. In 79% of chart rounds no omissions were found at all, in 12% of chart rounds one omission was found and in 9% of chart rounds two or more omissions were found. Out of 199 omissions, 95% were of record keeping and 2% were omissions in the treatment prescription. Of omissions, 152 (76%) were unfiled investigation results of which 77 (51%) were subsequently corrected. Real-time audit with feedback is an effective tool in assessing the standards of radiotherapy documentation in our department, and also probably contributed to the high level of attentiveness. A large proportion of omissions were investigation results, which highlights the need for an improved system of retrieval of investigation results in the radiation oncology department.

Quality assurance in head and neck surgical oncology: EORTC 24954 trial on larynx preservation.

PubMed

Leemans, C R; Tijink, B M; Langendijk, J A; Andry, G; Hamoir, M; Lefebvre, J L

2013-09-01

The Head and Neck Cancer Group (HNCG) of the EORTC conducted a quality assurance program in the EORTC 24954 trial on larynx preservation. In this multicentre study, patients with resectable advanced squamous cell carcinoma of the larynx or hypopharynx were randomly assigned for treatment with sequential or alternating chemoradiation. The need for a quality assurance program is the evaluation and prevention of differences in treatments between centres in this multidisciplinary study. The surgical subcommittee of the HNCG prepared a questionnaire, and clinical records of all patients were verified during audits of independent teams. Data relating institutional practices were collected during a face to face interview with members of the local team. 271 clinical records from the nine main contributing centres were reviewed. The main difference between centres was the time interval between first consultation and treatment initiation, with a mean of 45 days. On the pathology report the nodal involvement was described by level in 36% of the cases according to the American Academy of Otolaryngology-Head and Neck Surgery classification. Extranodal spread was not always described in neck dissection specimens. The EORTC 24954 trial on larynx preservation was the first prospective trial with a quality assurance program in head and neck surgical oncology. The analysis shows similarities in practices, but also points out some important differences between centres. Operation reports were fairly complete, but uniformity in pathology reports should be improved. Copyright © 2013 Elsevier Ltd. All rights reserved.

External quality-assurance results for the National Atmospheric Deposition Program and the National Trends Network during 1986

USGS Publications Warehouse

See, Randolph B.; Schroder, LeRoy J.; Willoughby, Timothy C.

1988-01-01

During 1986, the U.S. Geological Survey operated three programs to provide external quality-assurance monitoring of the National Atmospheric Deposition Program and National Trends Network. An intersite-comparison program was used to assess the accuracy of onsite pH and specific-conductance determinations at quarterly intervals. The blind-audit program was used to assess the effect of routine sample handling on the precision and bias of program and network wet-deposition data. Analytical results from four laboratories, which routinely analyze wet-deposition samples, were examined to determine if differences existed between laboratory analytical results and to provide estimates of the analytical precision of each laboratory. An average of 78 and 89 percent of the site operators participating in the intersite-comparison met the network goals for pH and specific conductance. A comparison of analytical values versus actual values for samples submitted as part of the blind-audit program indicated that analytical values were slightly but significantly (a = 0.01) larger than actual values for pH, magnesium, sodium, and sulfate; analytical values for specific conductance were slightly less than actual values. The decreased precision in the analyses of blind-audit samples when compared to interlaboratory studies indicates that a large amount of uncertainty in network deposition data may be a result of routine field operations. The results of the interlaboratory comparison study indicated that the magnitude of the difference between laboratory analyses was small for all analytes. Analyses of deionized, distilled water blanks by participating laboratories indicated that the laboratories had difficulty measuring analyte concentrations near their reported detection limits. (USGS)

Auditor recommendations resulting from three clinical audit rounds in Finnish radiology units.

PubMed

Miettunen, Kirsi; Metsälä, Eija

2017-06-01

Background The purpose of clinical audits performed in radiology units is to reduce the radiation dose of patients and staff and to implement evidence-based best practices. Purpose To describe auditor recommendations in three Finnish clinical audit rounds performed in 2002-2014, and to determine if auditor recommendations have had any impact on improving medical imaging practice. Material and Methods The retrospective observational study was performed in radiology units holding a radiation safety license issued by the Finnish Radiation and Nuclear Safety Authority. The data comprised a systematic sample (n = 120) of auditor reports produced in three auditing rounds in these units during the years 2002-2014. The data were analyzed by descriptive methods and by using the Friedman two-way ANOVA test. Results The number of auditor recommendations given varied between clinical audit rounds and according to the type of imaging unit, as well as according to calculation method. Proportionally, the most recommendations in all three clinical audit rounds were given about defining and using quality assurance functions and about guidelines and practices for carrying out procedures involving radiation exposure. Demanding radiology units improved their practices more than basic imaging units towards the third round. Conclusion Auditor recommendations help to address the deficiencies in imaging practices. There is a need to develop uniform guidelines and to provide tutoring for clinical auditors in order to produce comparable clinical audit results.

Developing policy, standard orders, and quality-assurance monitoring for palliative sedation therapy.

PubMed

Ghafoor, Virginia L; Silus, Lauren S

2011-03-15

The development of a policy, evidence-based standard orders, and monitoring for palliative sedation therapy (PST) is described. Concerns regarding PST at the University of Minnesota Medical Center (UMMC) arose and needed to be addressed in a formal process. A multidisciplinary group consisting of palliative care physicians, nurse practitioners, clinical nurse specialists, and clinical pharmacy specialists reached consensus on the practice model and medications to be used for PST. Major elements of the plan included the development and implementation of an institutional policy for palliative sedation; standard orders for patient care, sedation, and monitoring; education for staff, patients, and patients' family members; and quality-assurance monitoring. A literature review was performed to identify research and guidelines defining the practice of PST. Policy content includes the use of a standard order set linking patient care, medication administration, the monitoring of sedation, and symptom management. Approval of the policy involved several UMMC committees. An evaluation matrix was used to determine critical areas for PST monitoring and to guide development of a form to monitor quality. A retrospective chart audit using the quality-assurance monitoring form assessed baseline sedation medication and patient outcomes. Assessment of compliance began in the fall of 2008, after the policy and standard orders were approved by the UMMC medical executive committee. In 2008, two cases of PST were monitored using the standardized form. PST cases will be continually monitored and analyzed. Development of policy, standard orders, and quality-assurance monitoring for PST required a formal multidisciplinary process. A process-improvement process is critical to defining institutional policy, educational goals, and outcome metrics for PST.

78 FR 67211 - Notice of Request for the Extension of a Currently Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-08

... Certifications and Assurances, that they will comply with pre-award and post-delivery audit requirements for..., Post-Delivery Audit Requirements Under Buy America DATES: Comments must be submitted before January 7... through Friday, except federal holidays. FOR FURTHER INFORMATION CONTACT: Pre-Award, Post-Delivery Audit...

How participation in surgical mortality audit impacts surgical practice.

PubMed

Lui, Chi-Wai; Boyle, Frances M; Wysocki, Arkadiusz Peter; Baker, Peter; D'Souza, Alisha; Faint, Sonya; Rey-Conde, Therese; North, John B

2017-04-19

Surgical mortality audit is an important tool for quality assurance and professional development but little is known about the impact of such activity on professional practice at the individual surgeon level. This paper reports the findings of a survey conducted with a self-selected cohort of surgeons in Queensland, Australia, on their experience of participating in the audit and its impact on their professional practice, as well as implications for hospital systems. The study used a descriptive cross-sectional survey design. All surgeons registered in Queensland in 2015 (n = 919) were invited to complete an anonymous online questionnaire between September and October 2015. 184 surgeons completed and returned the questionnaire at a response rate of 20%. Thirty-nine percent of the participants reported that involvement in the audit process affected their clinical practice. This was particularly the case for surgeons whose participation included being an assessor. Thirteen percent of the participants had perceived improvement to hospital practices or advancement in patient care and safety as a result of audit recommendations. Analysis of the open-ended responses suggested the audit experience had led surgeons to become more cautious, reflective in action and with increased confidence in best practice, and recognise the importance of effective communication and clear documentation. This is the first study to examine the impact of participation in a mortality audit process on the professional practice of surgeons. The findings offer evidence for surgical mortality audit as an effective strategy for continuous professional development and for improving patient safety initiatives.

Department of Defense Annual Statement of Assurance, Volume II for Fiscal Year 1996.

DTIC Science & Technology

1996-12-01

FY 1996. US Army Audit Agency (USAAA) conducted a multilocation audit of contract security requirements at the request of the US Army Contracting...corrective action(s) are certified by the responsible components upon completion and reviewed through on-site verification, subsequent audit . inspection...requirement for processing Navy pricing inquiries received by DLA inventory control points. 9/97 Verification: Subsequent on-site verification. audit

Quality Assurance in Trichiasis Surgery: a methodology

PubMed Central

Buchan, John C; Limburg, Hans; Burton, Matthew J

2013-01-01

SUMMARY Trachoma remains a significant cause of blindness in many parts of the world. The major route to blindness involves upper lid entropion leading to trachomatous trichiasis (TT) which promotes progressive corneal opacification. The provision of surgery to correct TT in the populations most severely affected is a major challenge for the global effort to eliminate Trachoma blindness by the year 2020. Most attention has been paid to increasing the quantity of TT surgery performed, and large numbers of non-doctor operators have been trained to this end. Surgical audit by those performing TT surgery is not a routine part of any national trachoma control programme, and no effective mechanism exists for identifying surgeons experiencing poor outcomes. We propose a methodology for surgical audit at the level of the individual surgeon based on Lot Quality Assurance. A set number of patients operated on previously for upper eyelid TT are examined to detect the recurrence of TT. The number of recurrent cases found will lead to categorisation of the TT surgeon to either “high recurrence” or “low recurrence” with reasonable confidence. The threshold of unacceptability can be set by individual programmes according to previous local studies of recurrence rates or those from similar settings. Identification of surgeons delivering unacceptably high levels of recurrent TT will guide managers on the need for remedial intervention such as re-training. PMID:20881027

Quality assurance and quality control for thermal/optical analysis of aerosol samples for organic and elemental carbon.

PubMed

Chow, Judith C; Watson, John G; Robles, Jerome; Wang, Xiaoliang; Chen, L-W Antony; Trimble, Dana L; Kohl, Steven D; Tropp, Richard J; Fung, Kochy K

2011-12-01

Accurate, precise, and valid organic and elemental carbon (OC and EC, respectively) measurements require more effort than the routine analysis of ambient aerosol and source samples. This paper documents the quality assurance (QA) and quality control (QC) procedures that should be implemented to ensure consistency of OC and EC measurements. Prior to field sampling, the appropriate filter substrate must be selected and tested for sampling effectiveness. Unexposed filters are pre-fired to remove contaminants and acceptance tested. After sampling, filters must be stored in the laboratory in clean, labeled containers under refrigeration (<4 °C) to minimize loss of semi-volatile OC. QA activities include participation in laboratory accreditation programs, external system audits, and interlaboratory comparisons. For thermal/optical carbon analyses, periodic QC tests include calibration of the flame ionization detector with different types of carbon standards, thermogram inspection, replicate analyses, quantification of trace oxygen concentrations (<100 ppmv) in the helium atmosphere, and calibration of the sample temperature sensor. These established QA/QC procedures are applicable to aerosol sampling and analysis for carbon and other chemical components.

34 CFR 303.123 - Prohibition against commingling.

Code of Federal Regulations, 2010 CFR

2010-07-01

... assurance in this section is satisfied by the use of an accounting system that includes an “audit trail” of... TODDLERS WITH DISABILITIES State Application for a Grant Statement of Assurances § 303.123 Prohibition against commingling. The statement must include an assurance satisfactory to the Secretary that funds made...

Dosimetry audits and intercomparisons in radiotherapy: A Malaysian profile

NASA Astrophysics Data System (ADS)

M. Noor, Noramaliza; Nisbet, A.; Hussein, M.; Chu S, Sarene; Kadni, T.; Abdullah, N.; Bradley, D. A.

2017-11-01

Quality audits and intercomparisons are important in ensuring control of processes in any system of endeavour. Present interest is in control of dosimetry in teletherapy, there being a need to assess the extent to which there is consistent radiation dose delivery to the patient. In this study we review significant factors that impact upon radiotherapy dosimetry, focusing upon the example situation of radiotherapy delivery in Malaysia, examining existing literature in support of such efforts. A number of recommendations are made to provide for increased quality assurance and control. In addition to this study, the first level of intercomparison audit i.e. measuring beam output under reference conditions at eight selected Malaysian radiotherapy centres is checked; use being made of 9 μm core diameter Ge-doped silica fibres (Ge-9 μm). The results of Malaysian Secondary Standard Dosimetry Laboratory (SSDL) participation in the IAEA/WHO TLD postal dose audit services during the period between 2011 and 2015 will also been discussed. In conclusion, following review of the development of dosimetry audits and the conduct of one such exercise in Malaysia, it is apparent that regular periodic radiotherapy audits and intercomparison programmes should be strongly supported and implemented worldwide. The programmes to-date demonstrate these to be a good indicator of errors and of consistency between centres. A total of ei+ght beams have been checked in eight Malaysian radiotherapy centres. One out of the eight beams checked produced an unacceptable deviation; this was found to be due to unfamiliarity with the irradiation procedures. Prior to a repeat measurement, the mean ratio of measured to quoted dose was found to be 0.99 with standard deviation of 3%. Subsequent to the repeat measurement, the mean distribution was 1.00, and the standard deviation was 1.3%.

ANIMAL BEHAVIOR AND WELL-BEING SYMPOSIUM: The Common Swine Industry Audit: Future steps to assure positive on-farm animal welfare utilizing validated, repeatable and feasible animal-based measures.

PubMed

Pairis-Garcia, M; Moeller, S J

2017-03-01

The Common Swine Industry Audit (CSIA) was developed and scientifically evaluated through the combined efforts of a task force consisting of university scientists, veterinarians, pork producers, packers, processers, and retail and food service personnel to provide stakeholders throughout the pork chain with a consistent, reliable, and verifiable system to ensure on-farm swine welfare and food safety. The CSIA tool was built from the framework of the Pork Quality Assurance Plus (PQA Plus) site assessment program with the purpose of developing a single, common audit platform for the U.S. swine industry. Twenty-seven key aspects of swine care are captured and evaluated in CSIA and cover the specific focal areas of animal records, animal observations, facilities, and caretakers. Animal-based measures represent approximately 50% of CSIA evaluation criteria and encompass critical failure criteria, including observation of willful acts of abuse and determination of timely euthanasia. Objective, science-based measures of animal well-being parameters (e.g., BCS, lameness, lesions, hernias) are assessed within CSIA using statistically validated sample sizes providing a detection ability of 1% with 95% confidence. The common CSIA platform is used to identify care issues and facilitate continuous improvement in animal care through a validated, repeatable, and feasible animal-based audit process. Task force members provide continual updates to the CSIA tool with a specific focus toward 1) identification and interpretation of appropriate animal-based measures that provide inherent value to pig welfare, 2) establishment of acceptability thresholds for animal-based measures, and 3) interpretation of CSIA data for use and improvement of welfare within the U.S. swine industry.

Safety Assurances at Space Test Centres: Lessons Learned

NASA Astrophysics Data System (ADS)

Alarcon Ruiz, Raul; O'Neil, Sean; Valls, Rafel Prades

2010-09-01

The European Space Agency’s(ESA) experts in quality, cleanliness and contamination control, safety, test facilities and test methods have accumulated valuable experience during the performance of dedicated audits of space test centres in Europe over a period of 10 years. This paper is limited to a summary of the safety findings and provides a valuable reference to the lessons learned, identifying opportunities for improvement in the areas of risk prevention measures associated to the safety of all test centre personnel, the test specimen, the test facilities and associated infrastructure. Through the analysis of the audit results the authors present what are the main lessons learned, and conclude how an effective safety management system will contribute to successful test campaigns and have a positive impact on the cost and schedule of space projects.

Q methodology, risk training and quality management.

PubMed

McKeown, M; Hinks, M; Stowell-Smith, M; Mercer, D; Forster, J

1999-01-01

The results of a Q methodological study of professional understandings of the notion of risk in mental health services within the UK are discussed in relation to the relevance for staff training and quality assurance. The study attempted to access the diversity of understandings of risk issues amongst a multi-professional group of staff (n = 60) attending inter-agency risk training workshops in 1998. Q methodology is presented as both an appropriate means for such inquiry and as a novel experiential technique for training purposes. A tentative argument is advanced that the qualitative accounts generated by Q research could assist in systematic reviews of quality, complementing the singularly quantitative approaches typically represented in the audit process.

[Audit of general hospitals and private surgical clinics in Israel].

PubMed

Freund, Ruth; Dor, Michael; Lotan, Yoram; Haver, Eitan

2007-12-01

Supervision and inspection of medical facilities are among the responsibilities of the Ministry of Health (MOH) anchored in the "Public Health Act 1940". In order to implement the law, the General Medical Division of the MOH began the process of auditing hospitals and private surgical clinics prior to considering the reissue of their license. The audit aimed to implement the law, activate supervision on general hospitals and private surgical clinics, provide feed-back to the audited institution and upgrade quality assurance, regulate medical activities according to the activities elaborated in the license and recommend the license renewal. Prior to the audits, 20 areas of activity were chosen for inspection. For each activity a check list was developed as a tool for inspection. Each area was inspected during a 4-5 hour visit by a MOH expert, accompanied by the local service manager in the institution under inspection. A comprehensive report, summarizing the findings was sent to the medical institute, requesting correction in those areas where improvements were needed. Recommendation for license renewal was sent to the Director of Licensing Division Ministry of Health. Between June 2003 and July 2006, 91 structured audits took place. A total of 47 general hospitals and 24 private surgical clinics were visited at least once. Most general hospitals were found abiding, functioning according to the required standards and eligible for license renewal. Licenses of institutions that complied with the standards determined by the audit teams, were renewed. Two private hospitals in central Israel, that were given an overall poor evaluation, were issued with a temporary license and subsequently re-audited 4 times over the next two years. Generally, the standards in private surgical clinics were lower than those found in general public hospitals. In one clinic the license was not renewed, and in another an order was issued to cease surgical procedures requiring general anesthesia. The evaluations were mainly qualitative, deliberately avoiding numerical rating. In order to improve the process in the future and facilitate common scale rating to establish an equitable comparison system between institutions, it will be necessary to develop more quality measures and compulsory standards, based on the measures used during the first round of audits. Publication of the results of such comparisons, will elevate medical performance, and ultimately improve the quality of services and medical care in Israel.

The malaria testing and treatment market in Kinshasa, Democratic Republic of the Congo, 2013.

PubMed

Mpanya, Godéfroid; Tshefu, Antoinette; Likwela, Joris Losimba

2017-02-28

The Democratic Republic of Congo (DRC) is one of the two most leading contributors to the global burden of disease due to malaria. This paper describes the malaria testing and treatment market in the nation's capital province of Kinshasa, including availability of malaria testing and treatment and relative anti-malarial market share for the public and private sector. A malaria medicine outlet survey was conducted in Kinshasa province in 2013. Stratified multi-staged sampling was used to select areas for the survey. Within sampled areas, all outlets with the potential to sell or distribute anti-malarials in the public and private sector were screened for eligibility. Among outlets with anti-malarials or malaria rapid diagnostic tests (RDT) in stock, a full audit of all available products was conducted. Information collected included product information (e.g. active ingredients, brand name), amount reportedly distributed to patients in the past week, and retail price. In total, 3364 outlets were screened for inclusion across Kinshasa and 1118 outlets were eligible for the study. Among all screened outlets in the private sector only about one in ten (12.1%) were stocking quality-assured Artemisinin-based Combination Therapy (ACT) medicines. Among all screened public sector facilities, 24.5% had both confirmatory testing and quality-assured ACT available, and 20.2% had sulfadoxine-pyrimethamine (SP) available for intermittent preventive therapy during pregnancy (IPTp). The private sector distributed the majority of anti-malarials in Kinshasa (96.7%), typically through drug stores (89.1% of the total anti-malarial market). Non-artemisinin therapies were the most commonly distributed anti-malarial (50.1% of the total market), followed by non quality-assured ACT medicines (38.5%). The median price of an adult quality-assured ACT was $6.59, and more expensive than non quality-assured ACT ($3.71) and SP ($0.44). Confirmatory testing was largely not available in the private sector (1.1%). While the vast majority of anti-malarial medicines distributed to patients in Kinshasa province are sold within the private sector, availability of malaria testing and appropriate treatment for malaria is alarmingly low. There is a critical need to improve access to confirmatory testing and quality-assured ACT in the private sector. Widespread availability and distribution of non quality-assured ACT and non-artemisinin therapies must be addressed to ensure effective malaria case management.

An Audit of Second-Trimester Fetal Anomaly Scans Based on a Novel Image-Scoring Method in the Southwest Region of the Netherlands.

PubMed

Ursem, Nicolette T C; Peters, Ingrid A; Kraan-van der Est, Mieke N; Reijerink-Verheij, Jacqueline C I Y; Knapen, Maarten F C M; Cohen-Overbeek, Titia E

2017-06-01

Since 2007 the second-trimester fetal anomaly scan is offered to all pregnant women as part of the national prenatal screening program in the Netherlands. Dutch population-based screening programs generally have a well-described system to achieve quality assurance. Because of the absence of a uniform system to monitor the actual performance of the fetal anomaly scan in 2012, we developed a standardized image-scoring method. The aim of this study was to evaluate the scanning performance of all sonographers in the southwestern region of the Netherlands using this image-scoring method. Each sonographer was requested to set up a digital portfolio. A portfolio consists of five logbooks from five different pregnant women, each containing 25 fetal anatomical structures and six biometric measures of randomly selected fetal anomaly scans. During the study period, 425 logbooks of 85 sonographers were assessed as part of the audit process. Seventy-three out of 85 sonographers (86%) met the criteria in the primary audit, and 12 sonographers required individual hands-on training. A successful assessment was achieved for 11 sonographers in the re-audit and one sonographer ceased her contract. Moreover, 2.1% of the required images were not digitally stored and therefore could not be reviewed. Quality assessment using the image-scoring method demonstrated that most of the sonographers met the expectations of the audit process, but those who had subpar performance met the expectations after retraining. © 2017 by the American Institute of Ultrasound in Medicine.

Assessment of Quality Assurance Measures for Radioactive Material Transport Packages not Requiring Competent Authority Design Approval - 13282

DOE Office of Scientific and Technical Information (OSTI.GOV)

Komann, Steffen; Groeke, Carsten; Droste, Bernhard

The majority of transports of radioactive materials are carried out in packages which don't need a package design approval by a competent authority. Low-active radioactive materials are transported in such packages e.g. in the medical and pharmaceutical industry and in the nuclear industry as well. Decommissioning of NPP's leads to a strong demand for packages to transport low and middle active radioactive waste. According to IAEA regulations the 'non-competent authority approved package types' are the Excepted Packages and the Industrial Packages of Type IP-1, IP-2 and IP-3 and packages of Type A. For these types of packages an assessment bymore » the competent authority is required for the quality assurance measures for the design, manufacture, testing, documentation, use, maintenance and inspection (IAEA SSR 6, Chap. 306). In general a compliance audit of the manufacturer of the packaging is required during this assessment procedure. Their regulatory level in the IAEA regulations is not comparable with the 'regulatory density' for packages requiring competent authority package design approval. Practices in different countries lead to different approaches within the assessment of the quality assurance measures in the management system as well as in the quality assurance program of a special package design. To use the package or packaging in a safe manner and in compliance with the regulations a management system for each phase of the life of the package or packaging is necessary. The relevant IAEA-SSR6 chap. 801 requires documentary verification by the consignor concerning package compliance with the requirements. (authors)« less

Physician's Breakout Session

NASA Technical Reports Server (NTRS)

Barry, William

2001-01-01

Dr. William Barry, Manager, NASA Occupational Health Program, moderated this session. As in one of the opening sessions, he re-iterated that the overall theme for the next year will be facilitating and implementing NIAT-1 (NASA Integrated Action Team - Action 1). He presented a candidate list of topics for consideration and discussion: (1) NIAT-1; (2) Skin cancer detection and the NASA Solar Safe Program; (3) Weapons of mass destruction; (4) Quality assurance; (5) Audits; (6) Environment of care; (7) Infection control; (8) Medication management; and (9) Confidentiality of medical records.

A Study to Determine the Cost of Quality Assurance to the Department of Surgery at US Army Medical Department Activity. Fort Benning, Georgia

DTIC Science & Technology

1984-07-01

to make maximum use of available time. General Surgery averaged ninety-six operative procedures per month during 1983, ophthalmology averaged fifteen...health care providers 2. Document evaluation of: a) Surgical care review (tissue review) b) Blood utilization c) Antibiotics utilization d) Pharmacy and...21. Number Surgical Procedures Performed 470 470 on Patients Undergoing all Types of Surgery APPENDIX L EXAMPLES OF AUDIT CRITERIA 103 SERVICE MONTH

Final Quality Assurance Plan for the Remedial Investigations and Feasibility Studies of the Helicopter Hangar Area and the Fire Training Area at Fort George G. Meade, Maryland

DTIC Science & Technology

1995-05-05

impoundment for a metal products manufacturer in Florida. During the site investigation, evidence of offsite contamination was found to be migrating onto...equipment, cross contamination through improper storage of samples) " Audit sampling documentation and procedures to ensure that samples are labeled...characterization of the occurrence and distribution of chemical contamination and site characteristics that are likely to influence human exposure or remediation

How reliable are national surveillance data? Findings from an audit of Canadian methicillin-resistant Staphylococcus aureus surveillance data.

PubMed

Forrester, Leslie; Collet, Jun Chen; Mitchell, Robyn; Pelude, Linda; Henderson, Elizabeth; Vayalumkal, Joseph; Leduc, Stephanie; Ghahreman, Saeed; Weir, Christine; Gravel, Denise

2012-03-01

The Canadian Nosocomial Infection Surveillance Program (CNISP) has conducted surveillance for incident cases of methicillin-resistant Staphylococcus aureus (MRSA) in sentinel hospitals since 1995. In 2007, a reliability audit of the 2005 data was conducted. In 2005, 5,652 cases were submitted to the CNISP from 43 hospitals. A proportional sample of submitted forms (up to 25) from each site were randomly selected. Stratified random sampling was used to obtain the comparison data. The original data were compared with the reabstracted data for congruence on 7 preselected variables. Reabstracted data were received from 30 out of 43 hospitals (70%), providing 443 of the 598 case forms requested (74%). Of these, 397 (90%) had matching case identification numbers. Overall, the percentage of discordant responses was 7.0%, ranging from 3.5% for sex and up to 23.7% for less well-defined variables (eg, where MRSA was acquired). Our findings suggest that, in general, the 2005 MRSA data are reliable. However to improve reliability a data quality framework with quality assurance practices, including ongoing auditing should be integrated into the CNISP's surveillance programs. Providing training to data collectors and standard definitions with practical examples may help to improve data quality, especially for those variables that require clinical judgment. Crown Copyright © 2012. Published by Mosby, Inc. All rights reserved.

45 CFR 2519.400 - What must an applicant include in an application for a grant?

Code of Federal Regulations, 2010 CFR

2010-10-01

... information and assurances specified by the Corporation in the grant application package. (c) Assurances that... to the program as may be required for fiscal audits and program evaluation; (2) Comply with the... and protect the rights of those employees; and (4) Comply with any other assurances that the...

49 CFR 385.321 - What failures of safety management practices disclosed by the safety audit will result in a...

Code of Federal Regulations, 2010 CFR

2010-10-01

... disclosed by the safety audit will result in a notice to a new entrant that its USDOT new entrant... MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.321 What failures of safety management practices disclosed by the safety audit will result in a notice...

Auditing the auditors.

PubMed

Pallarito, K

1998-09-21

An independent auditor's opinion is supposed to be the gold standard in healthcare accounting. Such audits provide reasonable assurance that financial statements are accurate, which is particularly important in not-for-profit healthcare because most organizations don't have shareholder oversight. But the recent firing of a Big Five accounting firm by a major healthcare system in bankruptcy reorganization raises questions about the credibility of external audits.

Dosimetry quality audit of high energy photon beams in greek radiotherapy centers.

PubMed

Hourdakis, Constantine J; Boziari, A

2008-04-01

Dosimetry quality audits and intercomparisons in radiotherapy centers is a useful tool in order to enhance the confidence for an accurate therapy and to explore and dissolve discrepancies in dose delivery. This is the first national comprehensive study that has been carried out in Greece. During 2002--2006 the Greek Atomic Energy Commission performed a dosimetry quality audit of high energy external photon beams in all (23) Greek radiotherapy centers, where 31 linacs and 13 Co-60 teletherapy units were assessed in terms of their mechanical performance characteristics and relative and absolute dosimetry. The quality audit in dosimetry of external photon beams took place by means of on-site visits, where certain parameters of the photon beams were measured, calculated and assessed according to a specific protocol and the IAEA TRS 398 dosimetry code of practice. In each radiotherapy unit (Linac or Co-60), certain functional parameters were measured and the results were compared to tolerance values and limits. Doses in water under reference and non reference conditions were measured and compared to the stated values. Also, the treatment planning systems (TPS) were evaluated with respect to irradiation time calculations. The results of the mechanical tests, dosimetry measurements and TPS evaluation have been presented in this work and discussed in detail. This study showed that Co-60 units had worse performance mechanical characteristics than linacs. 28% of all irradiation units (23% of linacs and 42% of Co-60 units) exceeded the acceptance limit at least in one mechanical parameter. Dosimetry accuracy was much worse in Co60 units than in linacs. 61% of the Co60 units exhibited deviations outside +/-3% and 31% outside +/-5%. The relevant percentages for the linacs were 24% and 7% respectively. The results were grouped for each hospital and the sources of errors (functional and human) have been investigated and discussed in details. This quality audit proved to be a useful tool for the improvement of quality in radiotherapy. It succeeded to disseminate the IAEA TRS-398 protocol in nearly all radiotherapy centers achieving homogenization and consistency of dosimetry within the country. Also, it detected discrepancies in dosimetry and provided guidance and recommendations to eliminate sources of errors. Finally, it proved that quality assurance programs, periodic quality control tests, maintenance and service play an important role for achieving accuracy and safe operation in radiotherapy.

External quality-assurance results for the National Atmospheric Deposition Program/National Trends Network, 1997-99

USGS Publications Warehouse

Gordon, John D.; Latysh, Natalie E.; Lindholm, Sandy J.

2003-01-01

Five external quality-assurance programs were operated by the U.S. Geological Survey for the National Atmospheric Deposition Program/ National Trends Network (NADP/NTN) during 1997 through 1999: the intersite-comparison program, the blind-audit program, the field- audit program, the interlaboratory-comparison program, and the collocated-sampler program. The intersite-comparison program assesses the accuracy of pH and specific-conductance determinations made by NADP/NTN site operators. In two 1997 intersite-comparison studies, 83.7 and 85.8 percent of the pH determinations met the NADP/NTN accuracy goals, whereas 97.3 and 92.4 percent of the specific-conductance determinations met the NADP/NTN accuracy goals. The percentage of pH and specific-conductance determinations that met the accuracy goals in 1998 were, for the most part, higher than in 1997. In two 1998 studies, 90.9 and 90.3 percent of the pH determinations met the accuracy goals compared to 94.7 and 96.0 percent of the specific- conductance measurements meeting the accuracy goals. In one 1999 intersite-comparison study, 89.5 percent and 99.4 percent of pH and specific- conductance determinations, respectively, met the NADP/NTN accuracy goals. The blind-audit program evaluates the effects of routine sample handling, processing, and shipping on the analytical bias and precision of weekly precipitation samples. A portion of the blind-audit sample subject to the normal onsite handling and processing of a weekly precipitation sample is referred to as the bucket portion, whereas the portion receiving only minimal handling is referred to as the bottle portion. Positive bias in regard to blind-audit results indicates that the bucket portion has a higher concentration than the bottle portion. The paired t-test for the 1997 through 1999 blind- audit data indicates that routine sample handling, processing, and shipping introduced a positive bias (a=0.05) for calcium and chloride and a negative bias (cz=0.05) for hydrogen ion. During 1997 through 1999, the median paired differences between the bucket and bottle portions ranged from 0.00 milligram per liter for nitrate and ammonium to +0.010 milligram per liter for both chloride and sulfate. The median paired difference between the bucket and bottle portions for hydrogen ion was -1.086 microequivalents per liter, whereas for specific conductance, the median paired difference between the bucket and bottle portions was -0.200 microsiemen per centimeter during 1997 through 1999. Surface-chemistry effects due to variable amounts of precipitation contacting prewashed sample-collection and shipping-container surfaces were studied in the blind-audit program by using three different sample volumes. The sample- collection and shipping containers used for the blind-audit study were obtained from the site operator's supply and could have been used for precipitation samples. Results of a Kruskal-Wallis analysis of variance test of the relation between paired blind-audit sample differences in units of concentration and sample volume were statistically significant for magnesium, chloride, sulfate, and hydrogen ion during 1997 through 1999. Before 1994, at least 5 of the 10 analytes displayed a statistically significant difference between paired blind-audit differences in units of concentration and sample volume, supporting the premise that chemical reactions between the 13-liter bucket shipping container (primarily the butadiene o-ring lid of the shipping container) and the sample, which resulted in an increasing loss of hydrogen ion with increasing volume, have been eliminated by the new l-liter bottle sample- shipping protocol. The field-audit program measures the effects of field exposure, handling, and processing on the chemistry of NADP/NTN precipitation samples. In the field-audit program, the site operator is instructed to process and submit a quality- control sample following a standard 7-day, Tuesday-to-Tuesday sampling period with no

Results of external quality-assurance program for the National Atmospheric Deposition Program and National Trends Network during 1985

USGS Publications Warehouse

Brooks, M.H.; Schroder, L.J.; Willoughby, T.C.

1988-01-01

External quality assurance monitoring of the National Atmospheric Deposition Program (NADP) and National Trends Network (NTN) was performed by the U.S. Geological Survey during 1985. The monitoring consisted of three primary programs: (1) an intersite comparison program designed to assess the precision and accuracy of onsite pH and specific conductance measurements made by NADP and NTN site operators; (2) a blind audit sample program designed to assess the effect of routine field handling on the precision and bias of NADP and NTN wet deposition data; and (3) an interlaboratory comparison program designed to compare analytical data from the laboratory processing NADP and NTN samples with data produced by other laboratories routinely analyzing wet deposition samples and to provide estimates of individual laboratory precision. An average of 94% of the site operators participated in the four voluntary intersite comparisons during 1985. A larger percentage of participating site operators met the accuracy goal for specific conductance measurements (average, 87%) than for pH measurements (average, 67%). Overall precision was dependent on the actual specific conductance of the test solution and independent of the pH of the test solution. Data for the blind audit sample program indicated slight positive biases resulting from routine field handling for all analytes except specific conductance. These biases were not large enough to be significant for most data users. Data for the blind audit sample program also indicated that decreases in hydrogen ion concentration were accompanied by decreases in specific conductance. Precision estimates derived from the blind audit sample program indicate that the major source of uncertainty in wet deposition data is the routine field handling that each wet deposition sample receives. Results of the interlaboratory comparison program were similar to results of previous years ' evaluations, indicating that the participating laboratories produced comparable data when they analyzed identical wet deposition samples, and that the laboratory processing NADP and NTN samples achieved the best analyte precision of the participating laboratories. (Author 's abstract)

Meeting the requirements of importing countries: practice and policy for on-farm approaches to food safety.

PubMed

Dagg, P J; Butler, R J; Murray, J G; Biddle, R R

2006-08-01

In light of the increasing consumer demand for safe, high-quality food and recent public health concerns about food-borne illness, governments and agricultural industries are under pressure to provide comprehensive food safety policies and programmes consistent with international best practice. Countries that export food commodities derived from livestock must meet both the requirements of the importing country and domestic standards. It is internationally accepted that end-product quality control, and similar methods aimed at ensuring food safety, cannot adequately ensure the safety of the final product. To achieve an acceptable level of food safety, governments and the agricultural industry must work collaboratively to provide quality assurance systems, based on sound risk management principles, throughout the food supply chain. Quality assurance systems on livestock farms, as in other parts of the food supply chain, should address food safety using hazard analysis critical control point principles. These systems should target areas including biosecurity, disease monitoring and reporting, feedstuff safety, the safe use of agricultural and veterinary chemicals, the control of potential food-borne pathogens and traceability. They should also be supported by accredited training programmes, which award certification on completion, and auditing programmes to ensure that both local and internationally recognised guidelines and standards continue to be met. This paper discusses the development of policies for on-farm food safety measures and their practical implementation in the context of quality assurance programmes, using the Australian beef industry as a case study.

A national survey of cardiac rehabilitation services in New Zealand: 2015.

PubMed

Kira, Geoff; Doolan-Noble, Fiona; Humphreys, Grace; Williams, Gina; O'Shaughnessy, Helen; Devlin, Gerry

2016-05-27

Guidelines for cardiac rehabilitation (CR) programmes inform best practice. In Aotearoa NewZealand, little information exists about the structure and services provided by CR programmes and there is a poor understanding of how existing CR programmes are delivered with respect to evidence-based national guidelines. All 46 CR providers in New Zealand were invited to participate in a national survey in 2015. The survey sought information on the following: unit structure; referral processes; patient assessment; audit (including quality assurance activity); Phase 2 CR content; and support for special populations. Simple descriptive analysis of the responses was conducted, involving forming counts and percentages. Thirty-six distinct units completed the survey and 94% provided Phase 2. Assessment tools, Phase 2 educational components, and the methods of providing the exercise component varied. Most units audited their services, 25% audited their programme six-monthly or more frequently. Just over half of the units (56%) reported key performance indicators. The survey identified variations in delivery and content of CR in New Zealand, with poor understanding of the impact on patient outcomes. This is likely due to the absence of standardised audit practices and routine collection of key performance indicators on a national basis.

Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

PubMed

Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

2008-08-01

To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.

Quality Assurance and Improvement in Head and Neck Cancer Surgery: From Clinical Trials to National Healthcare Initiatives.

PubMed

Simon, Christian; Caballero, Carmela

2018-05-24

It is without question in the best interest of our patients, if we can identify ways to improve the quality of care we deliver to them. Great progress has been made within the last 25 years in terms of development and implementation of quality-assurance (QA) platforms and quality improvement programs for surgery in general, and within this context for head and neck surgery. As of now, we have successfully identified process indicators that impact outcome of our patients and the quality of care we deliver as surgeons. We have developed risk calculators to determine the risk for complications of individual surgical patients. We have created perioperative guidelines for complex head and neck procedures. We have in Europe and North America created audit registries that can gather and analyze data from institutions across the world to better understand which processes need change to obtain good outcomes and improve quality of care. QA platforms can be tested within the clearly defined environment of prospective clinical trials. If positive, such programs could be rolled out within national healthcare systems, if feasible. Testing quality programs in clinical trials could be a versatile tool to help head neck cancer patients benefit directly from such initiatives on a global level.

40 CFR 92.503 - General Requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Production Line Testing and Audit Programs § 92.503 General Requirements. (a) Manufacturers (and... locomotives and locomotive engines shall conduct audits pursuant to the requirements of § 92.511 to ensure... alternate production line testing program provides equivalent assurance that the locomotives and locomotive...

Trust, but verify - Accuracy of clinical commercial radiation Treatment Planning Systems

NASA Astrophysics Data System (ADS)

Lehmann, J.; Kenny, J.; Lye, J.; Dunn, L.; Williams, I.

2014-03-01

Computer based Treatment Planning Systems (TPS) are used worldwide to design and calculate treatment plans for treating radiation therapy patients. TPS are generally well designed and thoroughly tested by their developers and local physicists prior to clinical use. However, the wide-reaching impact of their accuracy warrants ongoing vigilance. This work reviews the findings of the Australian national audit system and provides recommendations for checks of TPS. The Australian Clinical Dosimetry Service (ACDS) has designed and implemented a national system of audits, currently in a three year test phase. The Level III audits verify the accuracy of a beam model of a facility's TPS through a comparison of measurements with calculation at selected points in an anthropomorphic phantom. The plans are prescribed by the ACDS and all measurement equipment is brought in for independent onsite measurements. In this first version of audits, plans are comparatively simple, involving asymmetric fields, wedges and inhomogeneities. The ACDS has performed 14 Level III audits to-date. Six audits returned at least one measurement at Action Level, indicating that the measured dose differed more than 3.3% (but less than 5%) from the planned dose. Two audits failed (difference >5%). One fail was caused by a data transmission error coupled with quality assurance (QA) not being performed. The second fail was investigated and reduced to Action Level with the onsite audit team finding phantom setup at treatment a contributing factor. The Action Level results are attributed to small dose calculation deviations within the TPS, which are investigated and corrected by the facilities. Small deviations exist in clinical TPS which can add up and can combine with output variations to result in unacceptable variations. Ongoing checks and independent audits are recommended.

49 CFR 385.337 - What happens if a new entrant refuses to permit a safety audit to be performed on its operations?

Code of Federal Regulations, 2010 CFR

2010-10-01

... safety audit to be performed on its operations? 385.337 Section 385.337 Transportation Other Regulations... TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.337 What happens if a new entrant refuses to permit a safety audit to be performed on its...

External audit on the clinical practice and medical decision-making at the departments of radiotherapy in Budapest and Vienna.

PubMed

Esik, O; Seitz, W; Lövey, J; Knocke, T H; Gaudi, I; Németh, G; Pötter, R

1999-04-01

To present an example of how to study and analyze the clinical practice and the quality of medical decision-making under daily routine working conditions in a radiotherapy department, with the aims of detecting deficiencies and improving the quality of patient care. Two departments, each with a divisional organization structure and an established internal audit system, the University Clinic of Radiotherapy and Radiobiology in Vienna (Austria), and the Department of Radiotherapy at the National Institute of Oncology in Budapest (Hungary), conducted common external audits. The descriptive parameters of the external audit provided information on the auditing (auditor and serial number of the audit), the cohorts (diagnosis, referring institution, serial number and intention of radiotherapy) and the staff responsible for the treatment (division and physician). During the ongoing external audits, the qualifying parameters were (1) the sound foundation of the indication of radiotherapy, (2) conformity to the institution protocol (3), the adequacy of the choice of radiation equipment, (4) the appropriateness of the treatment plan, and the correspondence of the latter with (5) the simulation and (6) verification films. Various degrees of deviation from the treatment principles were defined and scored on the basis of the concept of Horiot et al. (Horiot JC, Schueren van der E. Johansson KA, Bernier J, Bartelink H. The program of quality assurance of the EORTC radiotherapy group. A historical overview. Radiother. Oncol. 1993,29:81-84), with some modifications. The action was regarded as adequate (score 1) in the event of no deviation or only a small deviation with presumably no alteration of the desired end-result of the treatment. A deviation adversely influencing the result of the therapy was considered a major deviation (score 3). Cases involving a minor deviation (score 2) were those only slightly affecting the therapeutic end-results, with effects between those of cases with scores 1 and 3. Non-performance of the necessary radiotherapeutic procedures was penalized by the highest score of 4. Statistical evaluation was performed with the BMDP software package, using variance analysis. Bimonthly audits (six with a duration of 4-6 h in each institution) were carried out by three auditors from the evaluating departments; they reviewed a total of 452 cases in Department A, and 265 cases in Department B. Despite the comparable staffing and instrumental conditions, a markedly higher number (1.5 times) of new cases were treated in Department A, but with a lower quality of radiotherapy, as adequate values of qualifying parameters (1-6) were more frequent for the cases treated in Department B (85.3%, 94%, 83.4%, 28.3%, 41.9% and 81.1%) than for those in Department A (67%, 83.4%, 87.8%, 26.1%, 33.2% and 17.7%). The responsible division (including staff and instrumentation), the responsible physician and the type of the disease each exerted a highly significant effect on the quality level of the treatment. Statistical analysis revealed a positive influence of the curative (relative to the palliative/symptomatic) intention of the treatment on the level of quality, but the effect of the first radiotherapy (relative to the second or further one) was statistically significant in only one department. At the same time, the quality parameters did not vary with the referring institution, the auditing person or the serial number of the audit. The external audit relating to the provision of radiotherapeutic care proved feasible with the basic conformity and compliance of the staff and resulted in valuable information to take correction measures.

Whither surgical quality assurance of breast cancer surgery (surgical margins and local recurrence) after paterson.

PubMed

Bundred, N J; Thomas, J; Dixon, J M J

2017-10-01

The Kennedy report into the actions of the disgraced Breast Surgeon, Paterson focussed on issues of informed consent for mastectomy, management of surgical margins and raised concerns about local recurrence rates and the increasing emphasis on cosmesis after mastectomy for breast cancer. This article assesses whether Kennedy's recommendations apply to the UK as a whole and how to address these issues. New GMC advice on consent and newer nonevidenced innovations in immediate reconstruction have altered the level of informed consent required. Patients deserve a better understanding of the issues of oncological versus cosmetic outcomes on which to base their decisions. Involvement of the whole multidisciplinary team including Oncologists is necessary in surgical planning. Failure to obtain clear microscopic margins at mastectomy leads to an increased local recurrence, yet has received little attention in the UK. Whereas, other countries have used surgical quality assurance audits to reduce local recurrence; local recurrence rates are not available and the extent of variation across the UK in margin involvement after surgery, its management and relationship to local recurrence needs auditing prospectively to reduce unnecessary morbidity. To reassure public, patients and the NHS management, an accreditation system with more rigour than NHSBSP QA and peer review is now required. Resource and efforts to support its introduction will be necessary from the Royal College of Surgeons and the Association of Breast Surgeons. New innovations require careful evaluation before their backdoor introduction to the NHS. Private Hospitals need to have the same standards imposed.

Deriving an Abstraction Network to Support Quality Assurance in OCRe

PubMed Central

Ochs, Christopher; Agrawal, Ankur; Perl, Yehoshua; Halper, Michael; Tu, Samson W.; Carini, Simona; Sim, Ida; Noy, Natasha; Musen, Mark; Geller, James

2012-01-01

An abstraction network is an auxiliary network of nodes and links that provides a compact, high-level view of an ontology. Such a view lends support to ontology orientation, comprehension, and quality-assurance efforts. A methodology is presented for deriving a kind of abstraction network, called a partial-area taxonomy, for the Ontology of Clinical Research (OCRe). OCRe was selected as a representative of ontologies implemented using the Web Ontology Language (OWL) based on shared domains. The derivation of the partial-area taxonomy for the Entity hierarchy of OCRe is described. Utilizing the visualization of the content and structure of the hierarchy provided by the taxonomy, the Entity hierarchy is audited, and several errors and inconsistencies in OCRe’s modeling of its domain are exposed. After appropriate corrections are made to OCRe, a new partial-area taxonomy is derived. The generalizability of the paradigm of the derivation methodology to various families of biomedical ontologies is discussed. PMID:23304341

[4th report of German Association of Cardiologists in private practice (BNK) on quality assurance in cardiac catheterization and coronary intervention 1999-2002].

PubMed

Levenson, Benny; Albrecht, Alexander; Göhring, Stefan; Haerer, Winfried; Herholz, Harald; Kaltenbach, Martin; Reifart, Nicolaus; Sauer, Gregor; Silber, Sigmund; Troger, Bernhard

2003-06-01

The Society of German Cardiologists in private practice (BNK) reports about its project on quality assurance in invasive cardiology (QuIK). Results of a computerized data collection and analysis of cardiac catheterizations and interventions in the years 1999-2002 are presented. These results are compared with other registries. The QuIK-project is done voluntarily by 70% of the society's cardiologists who perform invasive methods. A total of 225,562 diagnostic and 64,895 interventional procedures are documented over the 4 years. Patient characteristics and procedural data kept unchanged. Complication rates were low (< 2%), MACE < 0.5%. There was a rising number of patients referred with acute myocardial infarction. Less time was used to complete procedures from 1 year to another. Two out of three of the centers underwent a monitoring/auditing process in 2002. The desirable post-interventional follow-up after discharge in all cases appears to be impossible to fulfill under the given economical circumstances.

Prenatal nutrition services: a cost analysis.

PubMed

Splett, P L; Caldwell, H M; Holey, E S; Alton, I R

1987-02-01

The scarcity of information about program costs in relation to quality care prompted a cost analysis of prenatal nutrition services in two urban settings. This study examined prenatal nutrition services in terms of total costs, per client costs, per visit costs, and cost per successful outcome. Standard cost-accounting principles were used. Outcome measures, based on written quality assurance criteria, were audited using standard procedures. In the studied programs, nutrition services were delivered for a per client cost of $72 in a health department setting and $121 in a hospital-based prenatal care program. Further analysis illustrates that total and per client costs can be misleading and that costs related to successful outcomes are much higher. The three levels of cost analysis reported provide baseline data for quantifying the costs of providing prenatal nutrition services to healthy pregnant women. Cost information from these cost analysis procedures can be used to guide adjustments in service delivery to assure successful outcomes of nutrition care. Accurate cost and outcome data are necessary prerequisites to cost-effectiveness and cost-benefit studies.

7 CFR 3052.300 - Auditee responsibilities.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., DEPARTMENT OF AGRICULTURE AUDITS OF STATES, LOCAL GOVERNMENTS, AND NON-PROFIT ORGANIZATIONS Auditees § 3052... that provides reasonable assurance that the auditee is managing Federal awards in compliance with laws... audits required by this part are properly performed and submitted when due. When extensions to the report...

40 CFR 1033.305 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... CONTROL OF EMISSIONS FROM LOCOMOTIVES Manufacturer and Remanufacturer Production Line Testing and Audit... locomotives. (b) Remanufacturers are required to conduct audits according to the requirements of § 1033.335 to... request, you must show us that the alternate program gives equal assurance that your engines meet the...

75 FR 57274 - Financial Management and Assurance; Government Auditing Standards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-20

... contained in the 2010 Exposure Draft update GAGAS to reflect major developments in the accountability and audit profession and emphasize specific considerations applicable to the government environment. In addition, this proposed revision modernizes GAGAS, with updates to reflect major developments in the...

Quality Assurance for Clinical Trials

PubMed Central

Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

2013-01-01

Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

A multicentre 'end to end' dosimetry audit of motion management (4DCT-defined motion envelope) in radiotherapy.

PubMed

Palmer, Antony L; Nash, David; Kearton, John R; Jafari, Shakardokht M; Muscat, Sarah

2017-12-01

External dosimetry audit is valuable for the assurance of radiotherapy quality. However, motion management has not been rigorously audited, despite its complexity and importance for accuracy. We describe the first end-to-end dosimetry audit for non-SABR (stereotactic ablative body radiotherapy) lung treatments, measuring dose accumulation in a moving target, and assessing adequacy of target dose coverage. A respiratory motion lung-phantom with custom-designed insert was used. Dose was measured with radiochromic film, employing triple-channel dosimetry and uncertainty reduction. The host's 4DCT scan, outlining and planning techniques were used. Measurements with the phantom static and then moving at treatment delivery separated inherent treatment uncertainties from motion effects. Calculated and measured dose distributions were compared by isodose overlay, gamma analysis, and we introduce the concept of 'dose plane histograms' for clinically relevant interpretation of film dosimetry. 12 radiotherapy centres and 19 plans were audited: conformal, IMRT (intensity modulated radiotherapy) and VMAT (volumetric modulated radiotherapy). Excellent agreement between planned and static-phantom results were seen (mean gamma pass 98.7% at 3% 2 mm). Dose blurring was evident in the moving-phantom measurements (mean gamma pass 88.2% at 3% 2 mm). Planning techniques for motion management were adequate to deliver the intended moving-target dose coverage. A novel, clinically-relevant, end-to-end dosimetry audit of motion management strategies in radiotherapy is reported. Copyright © 2017 Elsevier B.V. All rights reserved.

38 CFR 41.300 - Auditee responsibilities.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) AUDITS OF STATES, LOCAL GOVERNMENTS, AND NON-PROFIT ORGANIZATIONS Auditees § 41.300 Auditee... reasonable assurance that the auditee is managing Federal awards in compliance with laws, regulations, and... schedule of expenditures of Federal awards in accordance with § 41.310. (e) Ensure that the audits required...

29 CFR 99.300 - Auditee responsibilities.

Code of Federal Regulations, 2010 CFR

2010-07-01

... of the Secretary of Labor AUDITS OF STATES, LOCAL GOVERNMENTS, AND NON-PROFIT ORGANIZATIONS Auditees... that provides reasonable assurance that the auditee is managing Federal awards in compliance with laws... the schedule of expenditures of Federal awards in accordance with § 99.310. (e) Ensure that the audits...

40 CFR 56.7 - State agency performance audits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... which grantees use Federal monies, to assure that an adequate evaluation of each State's performance in... 40 Protection of Environment 5 2010-07-01 2010-07-01 false State agency performance audits. 56.7 Section 56.7 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED...

External quality-assurance project report for the National Atmospheric Deposition Program/National Trends Network and Mercury Deposition Network, 2009-2010

USGS Publications Warehouse

Wetherbee, Gregory A.; Martin, RoseAnn; Rhodes, Mark F.; Chesney, Tanya A.

2014-01-01

The U.S. Geological Survey operated six distinct programs to provide external quality-assurance monitoring for the National Atmospheric Deposition Program/National Trends Network (NTN) and Mercury Deposition Network (MDN) during 2009–2010. The field-audit program assessed the effects of onsite exposure, sample handling, and shipping on the chemistry of NTN samples; a system-blank program assessed the same effects for MDN. Two interlaboratory-comparison programs assessed the bias and variability of the chemical analysis data from the Central Analytical Laboratory (CAL) and Mercury (Hg) Analytical Laboratory (HAL). The blind-audit program was also implemented for the MDN to evaluate analytical bias in total Hg concentration data produced by the HAL. The co-located-sampler program was used to identify and quantify potential shifts in NADP data resulting from replacement of original network instrumentation with new electronic recording rain gages (E-gages) and precipitation collectors that use optical sensors. The results indicate that NADP data continue to be of sufficient quality for the analysis of spatial distributions and time trends of chemical constituents in wet deposition across the United States. Results also suggest that retrofit of the NADP networks with the new precipitation collectors could cause –8 to +14 percent shifts in NADP annual precipitation-weighted mean concentrations and total deposition values for ammonium, nitrate, sulfate, and hydrogen ion, and larger shifts (+13 to +74 percent) for calcium, magnesium, sodium, potassium, and chloride. The prototype N-CON Systems bucket collector is more efficient in the catch of precipitation in winter than Aerochem Metrics Model 301 collector, especially for light snowfall.

U.S. Geological Survey external quality-assurance project report for the National Atmospheric Deposition Program / National Trends Network and Mercury Deposition Network, 2011-2012

USGS Publications Warehouse

Wetherbee, Gregory A.; Martin, RoseAnn

2014-01-01

The U.S. Geological Survey operated six distinct programs to provide external quality-assurance monitoring for the National Atmospheric Deposition Program (NADP) / National Trends Network (NTN) and Mercury Deposition Network (MDN) during 2011–2012. The field-audit program assessed the effects of onsite exposure, sample handling, and shipping on the chemistry of NTN samples; a system-blank program assessed the same effects for MDN. Two interlaboratory-comparison programs assessed the bias and variability of the chemical analysis data from the Central Analytical Laboratory and Mercury Analytical Laboratory (HAL). A blind-audit program was implemented for the MDN during 2011 to evaluate analytical bias in HAL total mercury concentration data. The co-located–sampler program was used to identify and quantify potential shifts in NADP data resulting from the replacement of original network instrumentation with new electronic recording rain gages and precipitation collectors that use optical precipitation sensors. The results indicate that NADP data continue to be of sufficient quality for the analysis of spatial distributions and time trends of chemical constituents in wet deposition across the United States. Co-located rain gage results indicate -3.7 to +6.5 percent bias in NADP precipitation-depth measurements. Co-located collector results suggest that the retrofit of the NADP networks with the new precipitation collectors could cause +10 to +36 percent shifts in NADP annual deposition values for ammonium, nitrate, and sulfate; -7.5 to +41 percent shifts for hydrogen-ion deposition; and larger shifts (-51 to +52 percent) for calcium, magnesium, sodium, potassium, and chloride. The prototype N-CON Systems bucket collector typically catches more precipitation than the NADP-approved Aerochem Metrics Model 301 collector.

Frequency and reliability of oestrogen receptor, progesterone receptor and HER2 in breast carcinoma determined by immunohistochemistry in Australasia: results of the RCPA Quality Assurance Program

PubMed Central

Francis, Glenn D; Dimech, Margaret; Giles, Leanne; Hopkins, Alison

2007-01-01

Background and Aims Immunohistochemistry (IHC) has replaced radioligand binding assay for the determination of oestrogen receptor (ER) status in breast carcinoma. IHC is also used for assessment of progesterone receptor (PR) and HER2. The Royal College of Pathologists of Australasia (RCPA) Quality Assurance Program (QAP) introduced a breast markers module in 2003 to evaluate the performance of laboratories with IHC for ER, PR and HER2. Methods An audit of laboratories reporting breast carcinomas was performed in 2005 and 2006 to evaluate in‐house results. Laboratories were asked to submit the hormone receptor and HER2 status on each invasive breast carcinoma for the previous 6 month period up to a maximum of 100 cases. The time periods were 1 July 2004 to 31 December 2004, and 1 July 2005 to 31 December 2005. A total of 55 laboratories returned information for 2004 and 67 for 2005. Results Complete data on 8128 patients was returned for both surveys, 3353 cases for 2004 and 4775 for 2005. The results were similar for both surveys. Of the 8128 cases, 59.0% were ER+/PR+, 15.9% ER+/PR−, 2.4% ER−/PR+ and 22.7% ER−/PR−. HER2 data were submitted for a total of 6512 patients (excludes 52 patients with incomplete data sets); 17.1% were reported as 3+ positive on IHC, 12.5% as 2+ and 70.4% as negative. Conclusions A laboratory audit was introduced into the RCPA QAP for breast markers due to concerns raised by participating laboratories about technical differences in supplied tissues for testing. This audit indicates that overall the results for ER, PR and HER2 fall inside established parameters. However, a number of individual laboratories do not meet the target values and variation in results would impact on patient treatment decisions. PMID:17259294

DOE Office of Scientific and Technical Information (OSTI.GOV)

Carlsbad Field Office

The Performance Demonstration Program (PDP) for headspace gases distributes blind audit samples in a gas matrix for analysis of volatile organic compounds (VOCs). Participating measurement facilities (i.e., fixed laboratories, mobile analysis systems, and on-line analytical systems) are located across the United States. Each sample distribution is termed a PDP cycle. These evaluation cycles provide an objective measure of the reliability of measurements performed for transuranic (TRU) waste characterization. The primary documents governing the conduct of the PDP are the Quality Assurance Program Document (QAPD) (DOE/CBFO-94-1012) and the Waste Isolation Pilot Plant (WIPP) Waste Analysis Plan (WAP) contained in the Hazardousmore » Waste Facility Permit (NM4890139088-TSDF) issued by the New Mexico Environment Department (NMED). The WAP requires participation in the PDP; the PDP must comply with the QAPD and the WAP. This plan implements the general requirements of the QAPD and the applicable requirements of the WAP for the Headspace Gas (HSG) PDP. Participating measurement facilities analyze blind audit samples of simulated TRU waste package headspace gases according to the criteria set by this PDP Plan. Blind audit samples (hereafter referred to as PDP samples) are used as an independent means to assess each measurement facility’s compliance with the WAP quality assurance objectives (QAOs). To the extent possible, the concentrations of VOC analytes in the PDP samples encompass the range of concentrations anticipated in actual TRU waste package headspace gas samples. Analyses of headspace gases are required by the WIPP to demonstrate compliance with regulatory requirements. These analyses must be performed by measurement facilities that have demonstrated acceptable performance in this PDP. These analyses are referred to as WIPP analyses and the TRU waste package headspace gas samples on which they are performed are referred to as WIPP samples in this document. Participating measurement facilities must analyze PDP samples using the same procedures used for routine waste characterization analyses of WIPP samples.« less

Frequency and reliability of oestrogen receptor, progesterone receptor and HER2 in breast carcinoma determined by immunohistochemistry in Australasia: results of the RCPA Quality Assurance Program.

PubMed

Francis, Glenn D; Dimech, Margaret; Giles, Leanne; Hopkins, Alison

2007-11-01

Immunohistochemistry (IHC) has replaced radioligand binding assay for the determination of oestrogen receptor (ER) status in breast carcinoma. IHC is also used for assessment of progesterone receptor (PR) and HER2. The Royal College of Pathologists of Australasia (RCPA) Quality Assurance Program (QAP) introduced a breast markers module in 2003 to evaluate the performance of laboratories with IHC for ER, PR and HER2. An audit of laboratories reporting breast carcinomas was performed in 2005 and 2006 to evaluate in-house results. Laboratories were asked to submit the hormone receptor and HER2 status on each invasive breast carcinoma for the previous 6 month period up to a maximum of 100 cases. The time periods were 1 July 2004 to 31 December 2004, and 1 July 2005 to 31 December 2005. A total of 55 laboratories returned information for 2004 and 67 for 2005. Complete data on 8128 patients was returned for both surveys, 3353 cases for 2004 and 4775 for 2005. The results were similar for both surveys. Of the 8128 cases, 59.0% were ER+/PR+, 15.9% ER+/PR-, 2.4% ER-/PR+ and 22.7% ER-/PR-. HER2 data were submitted for a total of 6512 patients (excludes 52 patients with incomplete data sets); 17.1% were reported as 3+ positive on IHC, 12.5% as 2+ and 70.4% as negative. A laboratory audit was introduced into the RCPA QAP for breast markers due to concerns raised by participating laboratories about technical differences in supplied tissues for testing. This audit indicates that overall the results for ER, PR and HER2 fall inside established parameters. However, a number of individual laboratories do not meet the target values and variation in results would impact on patient treatment decisions.

Quality assessment of malaria laboratory diagnosis in South Africa.

PubMed

Dini, Leigh; Frean, John

2003-01-01

To assess the quality of malaria diagnosis in 115 South African laboratories participating in the National Health Laboratory Service Parasitology External Quality Assessment Programme we reviewed the results from 7 surveys from January 2000 to August 2002. The mean percentage incorrect result rate was 13.8% (95% CI 11.3-16.9%), which is alarmingly high, with about 1 in 7 blood films being incorrectly interpreted. Most participants with incorrect blood film interpretations had acceptable Giemsa staining quality, indicating that there is less of a problem with staining technique than with blood film interpretation. Laboratories in provinces in which malaria is endemic did not necessarily perform better than those in non-endemic areas. The results clearly suggest that malaria laboratory diagnosis throughout South Africa needs strengthening by improving laboratory standardization and auditing, training, quality assurance and referral resources.

An analysis of multi-type relational interactions in FMA using graph motifs with disjointness constraints.

PubMed

Zhang, Guo-Qiang; Luo, Lingyun; Ogbuji, Chime; Joslyn, Cliff; Mejino, Jose; Sahoo, Satya S

2012-01-01

The interaction of multiple types of relationships among anatomical classes in the Foundational Model of Anatomy (FMA) can provide inferred information valuable for quality assurance. This paper introduces a method called Motif Checking (MOCH) to study the effects of such multi-relation type interactions for detecting logical inconsistencies as well as other anomalies represented by the motifs. MOCH represents patterns of multi-type interaction as small labeled (with multiple types of edges) sub-graph motifs, whose nodes represent class variables, and labeled edges represent relational types. By representing FMA as an RDF graph and motifs as SPARQL queries, fragments of FMA are automatically obtained as auditing candidates. Leveraging the scalability and reconfigurability of Semantic Web Technology, we performed exhaustive analyses of a variety of labeled sub-graph motifs. The quality assurance feature of MOCH comes from the distinct use of a subset of the edges of the graph motifs as constraints for disjointness, whereby bringing in rule-based flavor to the approach as well. With possible disjointness implied by antonyms, we performed manual inspection of the resulting FMA fragments and tracked down sources of abnormal inferred conclusions (logical inconsistencies), which are amendable for programmatic revision of the FMA. Our results demonstrate that MOCH provides a unique source of valuable information for quality assurance. Since our approach is general, it is applicable to any ontological system with an OWL representation.

An Analysis of Multi-type Relational Interactions in FMA Using Graph Motifs with Disjointness Constraints

PubMed Central

Zhang, Guo-Qiang; Luo, Lingyun; Ogbuji, Chime; Joslyn, Cliff; Mejino, Jose; Sahoo, Satya S

2012-01-01

The interaction of multiple types of relationships among anatomical classes in the Foundational Model of Anatomy (FMA) can provide inferred information valuable for quality assurance. This paper introduces a method called Motif Checking (MOCH) to study the effects of such multi-relation type interactions for detecting logical inconsistencies as well as other anomalies represented by the motifs. MOCH represents patterns of multi-type interaction as small labeled (with multiple types of edges) sub-graph motifs, whose nodes represent class variables, and labeled edges represent relational types. By representing FMA as an RDF graph and motifs as SPARQL queries, fragments of FMA are automatically obtained as auditing candidates. Leveraging the scalability and reconfigurability of Semantic Web Technology, we performed exhaustive analyses of a variety of labeled sub-graph motifs. The quality assurance feature of MOCH comes from the distinct use of a subset of the edges of the graph motifs as constraints for disjointness, whereby bringing in rule-based flavor to the approach as well. With possible disjointness implied by antonyms, we performed manual inspection of the resulting FMA fragments and tracked down sources of abnormal inferred conclusions (logical inconsistencies), which are amendable for programmatic revision of the FMA. Our results demonstrate that MOCH provides a unique source of valuable information for quality assurance. Since our approach is general, it is applicable to any ontological system with an OWL representation. PMID:23304382

Got ACTs? Availability, price, market share and provider knowledge of anti-malarial medicines in public and private sector outlets in six malaria-endemic countries.

PubMed

O'Connell, Kathryn A; Gatakaa, Hellen; Poyer, Stephen; Njogu, Julius; Evance, Illah; Munroe, Erik; Solomon, Tsione; Goodman, Catherine; Hanson, Kara; Zinsou, Cyprien; Akulayi, Louis; Raharinjatovo, Jacky; Arogundade, Ekundayo; Buyungo, Peter; Mpasela, Felton; Adjibabi, Chérifatou Bello; Agbango, Jean Angbalu; Ramarosandratana, Benjamin Fanomezana; Coker, Babajide; Rubahika, Denis; Hamainza, Busiku; Chapman, Steven; Shewchuk, Tanya; Chavasse, Desmond

2011-10-31

Artemisinin-based combination therapy (ACT) is the first-line malaria treatment throughout most of the malaria-endemic world. Data on ACT availability, price and market share are needed to provide a firm evidence base from which to assess the current situation concerning quality-assured ACT supply. This paper presents supply side data from ACTwatch outlet surveys in Benin, the Democratic Republic of Congo (DRC), Madagascar, Nigeria, Uganda and Zambia. Between March 2009 and June 2010, nationally representative surveys of outlets providing anti-malarials to consumers were conducted. A census of all outlets with the potential to provide anti-malarials was conducted in clusters sampled randomly. 28,263 outlets were censused, 51,158 anti-malarials were audited, and 9,118 providers interviewed. The proportion of public health facilities with at least one first-line quality-assured ACT in stock ranged between 43% and 85%. Among private sector outlets stocking at least one anti-malarial, non-artemisinin therapies, such as chloroquine and sulphadoxine-pyrimethamine, were widely available (> 95% of outlets) as compared to first-line quality-assured ACT (< 25%). In the public/not-for-profit sector, first-line quality-assured ACT was available for free in all countries except Benin and the DRC (US$1.29 [Inter Quartile Range (IQR): $1.29-$1.29] and $0.52[IQR: $0.00-$1.29] per adult equivalent dose respectively). In the private sector, first-line quality-assured ACT was 5-24 times more expensive than non-artemisinin therapies. The exception was Madagascar where, due to national social marketing of subsidized ACT, the price of first-line quality-assured ACT ($0.14 [IQR: $0.10, $0.57]) was significantly lower than the most popular treatment (chloroquine, $0.36 [IQR: $0.36, $0.36]). Quality-assured ACT accounted for less than 25% of total anti-malarial volumes; private-sector quality-assured ACT volumes represented less than 6% of the total market share. Most anti-malarials were distributed through the private sector, but often comprised non-artemisinin therapies, and in the DRC and Nigeria, oral artemisinin monotherapies. Provider knowledge of the first-line treatment was significantly lower in the private sector than in the public/not-for-profit sector. These standardized, nationally representative results demonstrate the typically low availability, low market share and high prices of ACT, in the private sector where most anti-malarials are accessed, with some exceptions. The results confirm that there is substantial room to improve availability and affordability of ACT treatment in the surveyed countries. The data will also be useful for monitoring the impact of interventions such as the Affordable Medicines Facility for malaria.

Got ACTs? Availability, price, market share and provider knowledge of anti-malarial medicines in public and private sector outlets in six malaria-endemic countries

PubMed Central

2011-01-01

Background Artemisinin-based combination therapy (ACT) is the first-line malaria treatment throughout most of the malaria-endemic world. Data on ACT availability, price and market share are needed to provide a firm evidence base from which to assess the current situation concerning quality-assured ACT supply. This paper presents supply side data from ACTwatch outlet surveys in Benin, the Democratic Republic of Congo (DRC), Madagascar, Nigeria, Uganda and Zambia. Methods Between March 2009 and June 2010, nationally representative surveys of outlets providing anti-malarials to consumers were conducted. A census of all outlets with the potential to provide anti-malarials was conducted in clusters sampled randomly. Results 28,263 outlets were censused, 51,158 anti-malarials were audited, and 9,118 providers interviewed. The proportion of public health facilities with at least one first-line quality-assured ACT in stock ranged between 43% and 85%. Among private sector outlets stocking at least one anti-malarial, non-artemisinin therapies, such as chloroquine and sulphadoxine-pyrimethamine, were widely available (> 95% of outlets) as compared to first-line quality-assured ACT (< 25%). In the public/not-for-profit sector, first-line quality-assured ACT was available for free in all countries except Benin and the DRC (US$1.29 [Inter Quartile Range (IQR): $1.29-$1.29] and $0.52[IQR: $0.00-$1.29] per adult equivalent dose respectively). In the private sector, first-line quality-assured ACT was 5-24 times more expensive than non-artemisinin therapies. The exception was Madagascar where, due to national social marketing of subsidized ACT, the price of first-line quality-assured ACT ($0.14 [IQR: $0.10, $0.57]) was significantly lower than the most popular treatment (chloroquine, $0.36 [IQR: $0.36, $0.36]). Quality-assured ACT accounted for less than 25% of total anti-malarial volumes; private-sector quality-assured ACT volumes represented less than 6% of the total market share. Most anti-malarials were distributed through the private sector, but often comprised non-artemisinin therapies, and in the DRC and Nigeria, oral artemisinin monotherapies. Provider knowledge of the first-line treatment was significantly lower in the private sector than in the public/not-for-profit sector. Conclusions These standardized, nationally representative results demonstrate the typically low availability, low market share and high prices of ACT, in the private sector where most anti-malarials are accessed, with some exceptions. The results confirm that there is substantial room to improve availability and affordability of ACT treatment in the surveyed countries. The data will also be useful for monitoring the impact of interventions such as the Affordable Medicines Facility for malaria. PMID:22039838

Introduction of a qualitative perinatal audit at Muhimbili National Hospital, Dar es Salaam, Tanzania

PubMed Central

Kidanto, Hussein L; Mogren, Ingrid; van Roosmalen, Jos; Thomas, Angela N; Massawe, Siriel N; Nystrom, Lennarth; Lindmark, Gunilla

2009-01-01

Background Perinatal death is a devastating experience for the mother and of concern in clinical practice. Regular perinatal audit may identify suboptimal care related to perinatal deaths and thus appropriate measures for its reduction. The aim of this study was to perform a qualitative perinatal audit of intrapartum and early neonatal deaths and propose means of reducing the perinatal mortality rate (PMR). Methods From 1st August, 2007 to 31st December, 2007 we conducted an audit of perinatal deaths (n = 133) with birth weight 1500 g or more at Muhimbili National Hospital (MNH). The audit was done by three obstetricians, two external and one internal auditors. Each auditor independently evaluated the cases narratives. Suboptimal factors were identified in the antepartum, intrapartum and early neonatal period and classified into three levels of delay (community, infrastructure and health care). The contribution of each suboptimal factor to adverse perinatal outcome was identified and the case graded according to possible avoidability. Degree of agreement between auditors was assessed by the kappa coefficient. Results The PMR was 92 per 1000 total births. Suboptimal factors were identified in 80% of audited cases and half of suboptimal factors were found to be the likely cause of adverse perinatal outcome and were preventable. Poor foetal heart monitoring during labour was indirectly associated with over 40% of perinatal death. There was a poor to fair agreement between external and internal auditors. Conclusion There are significant areas of care that need improvement. Poor monitoring during labour was a major cause of avoidable perinatal mortality. This type of audit was a good starting point for quality assurance at MNH. Regular perinatal audits to identify avoidable causes of perinatal deaths with feed back to the staff may be a useful strategy to reduce perinatal mortality. PMID:19765312

ENVIRONMENTAL AUDITING: Environmental Auditing in Hospitals: First Results in a University Hospital.

PubMed

Dettenkofer; Kuemmerer; Schuster; Mueller; Muehlich; S; Daschner

2000-01-01

/ While medical audit in infection control today is one important element in the quality assurance of health care, environmental auditing, approved in 1993 by the Council of the European Communities for the industrial sector, so far has not been used as a tool to control and reduce environmental pollution caused by medical care. The aim of this study was to investigate whether environmental auditing according to the European Eco-Management and Audit Scheme (EMAS) can be implemented in hospitals as a process of improvement in protection of the environment. In a prior publication the methodological issues and the organizational steps that had to be taken were described. An environmental review of the activities of the Freiburg University Hospital and an ecoanalysis of the input and output were performed. The results of this analysis, published in an environmental report, provide a fundamental data set for the consumption of energy, water, materials, and the burdens of major pollutants and waste. Regarding the organizational structure of the hospital, the first steps towards an integrating environmental management system as demanded by EMAS could be taken. Beside supporting advantages, e.g., improvement of environmental safety, public image and staff contentment, and potential economic benefits such as less cost to be paid for energy and water consumption, there are important restrictions of environmental auditing in hospitals. Examples are the lack of basic environmental data, staff motivation (especially of physicians), cooperation of the organizational substructures, and funds for prefinancing urgently needed improvements in ecology. Based on the study findings, a textbook on environmental auditing in hospitals, including checklists covering all important environmental objectives, has been published to support hospitals in their efforts to achieve an optimized and sustainable practice of providing health care.

Quality indicators for eye bank.

PubMed

Acharya, Manisha; Biswas, Saurabh; Das, Animesh; Mathur, Umang; Dave, Abhishek; Singh, Ashok; Dubey, Suneeta

2018-03-01

The aim of this study is to identify quality indicators of the eye bank and validate their effectivity. Adverse reaction rate, discard rate, protocol deviation rate, and compliance rate were defined as Quality Indicators of the eye bank. These were identified based on definition of quality that captures two dimensions - "result quality" and "process quality." The indicators were measured and tracked as part of quality assurance (QA) program of the eye bank. Regular audits were performed to validate alignment of standard operating procedures (SOP) with regulatory and surgeon acceptance standards and alignment of activities performed in the eye bank with the SOP. Prospective study of the indicators was performed by comparing their observed values over the period 2011-2016. Adverse reaction rate decreased more than 8-fold (from 0.61% to 0.07%), discard rate decreased and stabilized at 30%, protocol deviation rate decreased from 1.05% to 0.08%, and compliance rate reported by annual quality audits improved from 59% to 96% at the same time. In effect, adverse reaction rate, discard rate, and protocol deviation rate were leading indicators, and compliance rate was the trailing indicator. These indicators fulfill an important gap in available literature on QA in eye banking. There are two ways in which these findings can be meaningful. First, eye banks which are new to quality measurement can adopt these indicators. Second, eye banks which are already deeply engaged in quality improvement can test these indicators in their eye bank, thereby incorporating them widely and improving them over time.

Quality assurance and gastrointestinal endoscopy: an audit of 500 colonoscopic procedures.

PubMed

Denis, Bernard; Weiss, Anne-Marie; Peter, André; Bottlaender, Jacques; Chiappa, Pascale

2004-12-01

The aim of this study was to assess the quality of colonoscopic procedures in our endoscopy unit with the goal of improving performance. We prospectively audited 500 consecutive colonoscopic procedures and assessed sixty-two process or outcome indicators for each procedure. Most of the measured indicators were within standard limits: cecal intubation rate (92%), inadequate bowel preparations (24%), inappropriate procedures (9.7%), normal procedures (54%), yield for neoplasia (32%), morbidity (0.4%), and overall patient satisfaction (95.8%). Some indicators were outside standard limits suggesting our practices should be modified: endoscopy withdrawal time less than 6 minutes (78%), forceps removal of polyps (31%), resected polyps not recovered for pathological examination (12%), adenomas with villous elements (22%), patients unsatisfied because of time spent waiting for the procedure (19%), patients unsatisfied because of inadequate explanations (10%). There was no standard for a few indicators: patient discomfort (6.9%), diagnostic success (89%), therapeutic success (92%). Three new indicators were proposed: proportion of patients aged<50 years, number of normal colonoscopic procedures to perform to detect one advanced adenoma or cancer, and proportion of colonoscopic procedures causing discomfort. The diagnostic yield of colonoscopy was dependent on age, gender, indication and appropriateness of indication but not on the prescriber. This audit allowed us to evaluate our endoscopic practices and to detect certain shortcomings and deviations from standards. It enabled us to change some of our practices with the goal of improving the quality of our colonoscopic procedures.

Audit of acute asthma management at the Paediatric Emergency Department at Wad Madani Children’s Hospital, Sudan

PubMed Central

Haroun, Huda M.; Ali, Hassan M.; Tag Eldeen, Imad Eldeen M.

2012-01-01

This audit of hospital care of acute wheeze and asthma aimed to assess the degree of adherence of the acute care of the asthma patients to the published international guidelines. Information was collected in six key areas: patient demographics; initial asthma severity assessment; in-hospital treatment; asthma prophylaxis; asthma education and emergency planning; and follow-up arrangements. The area of initial asthma severity assessment showed defciencies in the clinical measures currently used to verify case severity. In- hospital treatment on the other hand was consistent with recommendations in the use of the inhaled β-2 agonist salbutamol as bronchodilator, the discrete use of aminophylline and the small number of patients ordered chest X-ray. However, the treatment was incoherent with recommendations in the delivery method used for inhaled bronchodilator in relation to the age group of treated patients, absence of ipratropium bromide as a bronchodilator in the management and the large use of antibiotics. Assessment of the areas of asthma prophylaxis, asthma education and emergency- planning and follow-up arrangements illustrated that little efforts were made to assure safe discharge, although these measures have been shown to reduce morbidity after the exacerbation and reduce relapse rates and signifcantly reduce hospitalizations, unscheduled acute visits, missed work days, as well as improving quality of life. This audit emphasizes the need for the adoption of a management protocol for acute asthma care in the emergency department based on published international guidelines and the assurance of its implementation, monitoring and evaluation using the right tools to improve patient care. PMID:27493337

Lessons from an audit of psychoeducation at an older adolescent inpatient unit.

PubMed

Swadi, Harith; Bobier, Candace; Price, Lisa; Craig, Brian

2010-02-01

The aim of this paper was to determine if patients undergoing treatment at an older adolescent inpatient unit receive psychoeducation according to the unit philosophy of providing timely and pertinent information regarding illness/diagnosis, medication, diet, outpatient follow-up, and alcohol/ drug use. Data were gathered prospectively as part of a quality assurance initiative at the Christchurch Youth Inpatient Unit. Patients were interviewed by a registered nurse using a structured audit tool. Participants reported receiving adequate information on medication and illness, and most received information on outpatient follow-up and alcohol and drug use. However, the majority reported a lack of information/ advice about diet. Patients' reported awareness of relapse prevention and the relationship of alcohol and other drugs use to medication and treatment was lower than expected. The audit highlighted areas of discrepancy between information staff believed they had delivered and information youth perceived as received. Psychiatric staff working with young people need be aware of the timing, language and mode of delivery of psychoeducation to enable their patients to 'take in' the information provided.

49 CFR 350.313 - How are MCSAP funds allocated?

Code of Federal Regulations, 2010 CFR

2010-10-01

... may be distributed for safety audits of New Entrant motor carriers under the New Entrant Safety Assurance Program at the discretion of the Administrator. (3) The remaining funds will be allocated among... able to use government employees to conduct New Entrant motor carrier audits, the Administrator may use...

38 CFR 18a.4 - Duties of the Director, Contract Compliance Service.

Code of Federal Regulations, 2010 CFR

2010-07-01

... periodic audits, reviews and evaluations; (c) Attempt to secure voluntary compliance by conciliatory or... assurance of compliance, or other source indicates noncompliance with Title VI; and report to the Chief... investigations, audits, reviews and evaluations or the results of attempts to secure voluntary compliance. [35 FR...

49 CFR 385.319 - What happens after completion of the safety audit?

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false What happens after completion of the safety audit...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.319 What happens after...

7 CFR 735.402 - Providers of other electronic documents.

Code of Federal Regulations, 2010 CFR

2010-01-01

... and maximum deductible amounts and applicability of other forms of financial assurances as set forth...) Submit a current review or an audit level financial statement prepared according to generally accepted...) Financial requirements; (9) Terms of insurance policies or assurances; (10) Provider's integrity statement...

Producing and marketing a specialty egg.

PubMed

Michella, S M; Slaugh, B T

2000-07-01

Eggland's Best, Inc. markets premium quality shell eggs under the Eggland's Best (EB) brand name. The company, started in 1988, is comprised of a franchise network of established egg producers and covers most of the United States. Eggland's Best provides its franchisees with marketing and technical support. The franchisees produce, process, and distribute EB eggs according to the strict program established and monitored by EB. Production follows the all-natural vegetarian feed program in accordance with the company's US patent entitled "Eggs Compatible with a Cholesterol Reducing Diet and Method of Producing the Same." The EB program excludes animal fat and other animal byproducts. Eggland's Best eggs have seven times the generic level of vitamin E, nearly three times more omega-3 fatty acids and iodine, and 25% less saturated fat than regular generic eggs. Eggland's Best has one of the finest shell egg quality assurance programs anywhere. Eggland's Best franchisees submit weekly egg samples that are analyzed for shell quality, interior quality, vitamin E, iodine, cholesterol and fatty acids. Samples of feed and the EB-patented feed supplement are also analyzed. Approximately 28,000 total laboratory tests are conducted annually. Nationwide product and display retail evaluations are contracted through an outside audit company (40 to 50 cities evaluated four times per year). All EB eggs are USDA graded according to EB's strict quality standards. Producers must follow a food safety quality assurance program (United Egg Producers Association 5-Star or equivalent state or company program). Each egg is stamped "EB" as assurance of meeting EB's highest standards of flavor, quality, and nutrition. Eggland's Best has enjoyed record sales growth for the past 3 yr.

Development and implementation of a quality assurance program for a hormonal contraceptive implant.

PubMed

Owen, Derek H; Jenkins, David; Cancel, Aida; Carter, Eli; Dorflinger, Laneta; Spieler, Jeff; Steiner, Markus J

2013-04-01

The importance of the distribution of safe, effective and cost-effective pharmaceutical products in resource-constrained countries is the subject of increasing attention. FHI 360 has developed a program aimed at evaluating the quality of a contraceptive implant manufactured in China, while the product is being registered in an increasing number of countries and distributed by international procurement agencies. The program consists of (1) independent product testing; (2) ongoing evaluation of the manufacturing facility through audits and inspections; and (3) post-marketing surveillance. This article focuses on the laboratory testing of the product. The various test methods were chosen from the following test method compendia, the United States Pharmacopeia (USP), British Pharmacopeia (BP), International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), or lot release tests mandated by Chinese regulatory requirements. Each manufactured lot is independently tested prior to its distribution to countries supported by this program. In addition, a more detailed annual testing program includes evaluation of the active ingredient (levonorgestrel), the final product and the packaging material. Over the first 4 years of this 5-year project, all tested lots met the established quality criteria. The quality assurance program developed for this contraceptive implant has helped ensure that a safe product was being introduced into developing country family planning programs. This program provides a template for establishing quality assurance programs for other cost-effective pharmaceutical products that have not yet received stringent regulatory approval and are being distributed in resource-poor settings. Copyright © 2013 Elsevier Inc. All rights reserved.

Geomorphic analysis of large alluvial rivers

NASA Astrophysics Data System (ADS)

Thorne, Colin R.

2002-05-01

Geomorphic analysis of a large river presents particular challenges and requires a systematic and organised approach because of the spatial scale and system complexity involved. This paper presents a framework and blueprint for geomorphic studies of large rivers developed in the course of basic, strategic and project-related investigations of a number of large rivers. The framework demonstrates the need to begin geomorphic studies early in the pre-feasibility stage of a river project and carry them through to implementation and post-project appraisal. The blueprint breaks down the multi-layered and multi-scaled complexity of a comprehensive geomorphic study into a number of well-defined and semi-independent topics, each of which can be performed separately to produce a clearly defined, deliverable product. Geomorphology increasingly plays a central role in multi-disciplinary river research and the importance of effective quality assurance makes it essential that audit trails and quality checks are hard-wired into study design. The structured approach presented here provides output products and production trails that can be rigorously audited, ensuring that the results of a geomorphic study can stand up to the closest scrutiny.

Never audit alone--the case for audit teams.

PubMed

Adams, N H

1999-01-01

On-site audits, conducted by technical and quality assurance (QA) experts at the data-gathering location, are the core of an effective QA program. However, inadequate resources for such audits are the bane of a QA program and, frequently, the proposed solution is to send only one auditor to the study site. There are several reasons why audits should be performed by more than one person: 1. Audits of EPA projects frequently involve hazardous chemicals or other environmental hazards. They also often involve working after normal work hours in remote locations with dangerous equipment. It is unsafe to work alone under such conditions. 2. Skills: Many of EPA's projects are multidisciplinary, involving multiple measurements systems, several environmental media, and complex automated data collection and analysis systems. It is unlikely that one auditor would have the requisite skills to assess all of these operations. 3. Separateness: Two auditors can provide two (sometimes differing) perspectives on problems encountered during an audit. Two auditors can provide complementary expertise and work experience. Two auditors can provide twice the surveillance power. 4. Support: The operations that need to be assessed are sometimes in different parts of a site, requiring two auditing devices or considerable commuting time. Also, auditors are occasionally diverted by managers wishing to show their best efforts rather than the whole operation; if two auditors are on-site, one can interview managers while the other talks with technical staff. If there is a dispute, one auditor can support the other in verifying observations. 5. Savings: Although sending one auditor is perceived to be a cost-saving measure, it may be more economical to send two auditors. Time on site (lodging, food) is decreased, more of the project is assessed in one visit, less pre-audit training is required, and report preparation is accelerated. In summary, sending more than one auditor on a field audit is smarter, safer and more effective, and can be less expensive in the long run.

Rural anaesthetic audit 2006 to 2010.

PubMed

Mills, P D; Newbury, J

2012-03-01

In order to review anaesthetic morbidity in our remote rural hospital, a retrospective audit of all anaesthetic records was undertaken for a five-year period between 2006 and 2010. Eight hundred and eighty-nine anaesthetic records were reviewed. The patients were all American Society of Anaesthesiologists physical status I to III. Ninety-eight percent of the anaesthetics were performed by general practitioner (non-specialist) anaesthetists. There were no anaesthetic deaths or serious adverse outcomes reported over this period. Sixteen intraoperative and seven postoperative problems were documented, but all were resolved uneventfully. The most common problems documented were difficult intubation (n=9) and respiratory depression (n=3). Within the limitations of this retrospective audit, these findings indicate that general practitioner anaesthetists provided safe anaesthesia in a remote rural hospital. It is our opinion that the case selection, prior experience of anaesthetic and theatre staff, stable nursing workforce and the use of protocols were important factors in determining the low rate of adverse events. However, we caution against over-interpretation of the data, given its retrospective nature, relatively small sample size, reliance on case records and the absence of agreed definitions for adverse events. We would also like to encourage all anaesthetic services, however remote, to audit their results as part of ongoing quality assurance.

Leveraging OpenStudio's Application Programming Interfaces: Preprint

DOE Office of Scientific and Technical Information (OSTI.GOV)

Long, N.; Ball, B.; Goldwasser, D.

2013-11-01

OpenStudio development efforts have been focused on providing Application Programming Interfaces (APIs) where users are able to extend OpenStudio without the need to compile the open source libraries. This paper will discuss the basic purposes and functionalities of the core libraries that have been wrapped with APIs including the Building Model, Results Processing, Advanced Analysis, UncertaintyQuantification, and Data Interoperability through Translators. Several building energy modeling applications have been produced using OpenStudio's API and Software Development Kits (SDK) including the United States Department of Energy's Asset ScoreCalculator, a mobile-based audit tool, an energy design assistance reporting protocol, and a portfolio scalemore » incentive optimization analysismethodology. Each of these software applications will be discussed briefly and will describe how the APIs were leveraged for various uses including high-level modeling, data transformations from detailed building audits, error checking/quality assurance of models, and use of high-performance computing for mass simulations.« less

The West Midlands breast cancer screening status algorithm - methodology and use as an audit tool.

PubMed

Lawrence, Gill; Kearins, Olive; O'Sullivan, Emma; Tappenden, Nancy; Wallis, Matthew; Walton, Jackie

2005-01-01

To illustrate the ability of the West Midlands breast screening status algorithm to assign a screening status to women with malignant breast cancer, and its uses as a quality assurance and audit tool. Breast cancers diagnosed between the introduction of the National Health Service [NHS] Breast Screening Programme and 31 March 2001 were obtained from the West Midlands Cancer Intelligence Unit (WMCIU). Screen-detected tumours were identified via breast screening units, and the remaining cancers were assigned to one of eight screening status categories. Multiple primaries and recurrences were excluded. A screening status was assigned to 14,680 women (96% of the cohort examined), 110 cancers were not registered at the WMCIU and the cohort included 120 screen-detected recurrences. The West Midlands breast screening status algorithm is a robust simple tool which can be used to derive data to evaluate the efficacy and impact of the NHS Breast Screening Programme.

Performance audits and laboratory comparisons for SCOS97-NARSTO measurements of speciated volatile organic compounds

NASA Astrophysics Data System (ADS)

Fujita, Eric M.; Harshfield, Gregory; Sheetz, Laurence

Performance audits and laboratory comparisons were conducted as part of the quality assurance program for the 1997 Southern California Ozone Study (SCOS97-NARSTO) to document potential measurement biases among laboratories measuring speciated nonmethane hydrocarbons (NMHC), carbonyl compounds, halogenated compounds, and biogenic hydrocarbons. The results show that measurements of volatile organic compounds (VOC) made during SCOS97-NARSTO are generally consistent with specified data quality objectives. The hydrocarbon comparison involved nine laboratories and consisted of two sets of collocated ambient samples. The coefficients of variation among laboratories for the sum of the 55 PAM target compounds and total NMHC ranged from ±5 to 15 percent for ambient samples from Los Angeles and Azusa. Abundant hydrocarbons are consistently identified by all laboratories, but discrepancies occur for olefins greater than C 4 and for hydrocarbons greater than C 8. Laboratory comparisons for halogenated compounds and biogenic hydrocarbons consisted of both concurrent ambient sampling by different laboratories and round-robin analysis of ambient samples. The coefficients of variation among participating laboratories were about 10-20 percent. Performance audits were conducted for measurement of carbonyl compounds involving sampling from a standard mixture of carbonyl compounds. The values reported by most of the laboratories were within 10-20 percent of those of the reference laboratory. Results of field measurement comparisons showed larger variations among the laboratories ranging from 20 to 40 percent for C 1-C 3 carbonyl compounds. The greater variations observed in the field measurement comparison may reflect potential sampling artifacts, which the performance audits did not address.

Results from the Australasian Vascular Surgical Audit: the inaugural year.

PubMed

Beiles, C Barry; Bourke, Bernie; Thomson, Ian

2012-03-01

The Australian and New Zealand Society for Vascular Surgery has incorporated a constitutional change to administer a self-funded compulsory vascular surgery audit since January 2010. This is a bi-national quality assurance activity that captures all procedures performed in both countries. Data is collected at two points in the clinical admission; at operation and at discharge and data entry is via the Internet. Security is stringent and confidentiality is guaranteed by Commonwealth privilege. Data privacy is maximized by encryption. The application is flexible and administered by a dedicated administrator with a help-desk facility. Reports are available to provide real-time feedback of user performance compared with the peer group data in key categories of arterial surgery. A structured hierarchy for data management has been established to assess four main categories of performance: mortality after aortic surgery, stroke and death after carotid surgery, patency and limb salvage after infrainguinal bypass and patency after arteriovenous access for haemodialysis. Data is analysed using risk-adjustment techniques and an algorithm for management of underperformance has been followed. Data validation has been performed. The outcomes in all categories have been of a high standard and correction of erroneous data in a single statistical outlier has negated underperformance. The audit has captured only 65% of the estimated procedures in Australia in the first year, but data quality is good. The feasibility of a complete compulsory bi-national audit has now been established and will be the benchmark for other craft groups in the current environment of accountability. © 2012 The Authors. ANZ Journal of Surgery © 2012 Royal Australasian College of Surgeons.

The ethical aspects of regulating production.

PubMed

Swanson, J C

2008-02-01

Polls and surveys conducted within the United States show general agreement that there is public support for the protection of farm livestock and poultry. Concurrent with the growing public sentiment is the recent adoption of socially responsible corporate policies by major food retailers relative to animal welfare. The animal welfare assurance and audit programs developed by the private sector are an attempt to assure consumers that best practice measures and independent oversight result in a reasonable quality of life for food-producing animals. These programs represent voluntary self-regulation and arguably a market-based approach to secure the welfare of food-producing animals. Animal advocacy organizations historically seek regulatory oversight of animal care practice. Legislative routes that require government promulgation and enforcement of animal care regulations represent an involuntary form of animal welfare assurance. There are ethical considerations concerning the employment of voluntary or involuntary regulation of the welfare of food-producing animals. For example, degree of public endangerment, economic impact, viability of small to medium producers, food price, food quality, and food security are prominent among the ethical considerations in deliberating whether to impose regulatory mandates on production. In either regulatory approach, the public must be convinced that the welfare of food-producing animals can be secured in a transparent and convincing manner.

Auditing Safety of Compounding and Reconstituting of Intravenous Medicines on Hospital Wards in Finland.

PubMed

Suvikas-Peltonen, Eeva; Palmgren, Joni; Häggman, Verner; Celikkayalar, Ercan; Manninen, Raija; Airaksinen, Marja

2017-01-01

On the hospital wards in Finland, nurses generally reconstitute intravenous medicines, such as antibiotics, analgesics, and antiemetics prescribed by doctors. Medicine reconstitution is prone to many errors. Therefore, it is important to identify incorrect practices in the reconstitution of medicine to improve patient safety in hospitals. The aim of this study was to audit the compounding and reconstituting of intravenous medicines on hospital wards in a secondary-care hospital in Finland by using an assessment tool and microbiological testing for identifying issues posing patient safety risks. A hospital pharmacist conducted an external audit by using a validated 65-item assessment tool for safe-medicine compounding practices on 20 wards of the selected hospital. Also, three different microbiological samples were collected to assure the aseptics. Practices were evaluated using a four-point rating scale of "never performed," "rarely performed," "often performed," and "always performed," and were based on observation and interviews with nurses or ward pharmacists. In addition, glove-, settle plate-, and media fill-tests were collected. Associations between microbial sample results and audit-tool results were discussed. Altogether, only six out of the 65 items were fully implemented in all wards; these were related to logistic practices and quality assurance. More than half of the wards used incorrect practices ("rarely performed" or "never performed") for five items. Most of these obviated practices related to aseptic practices. All media-fill tests were clean but the number of colony forming units in glove samples and settle- plate samples varied from 0 to >100. More contamination was found in wards where environmental conditions were inadequate or the use of gloves was incorrect. Compounding practices were [mostly] quite well adapted, but the aseptic practices needed improvement. Attention should have been directed particularly to good aseptic techniques and compounding environment on the wards. These results can be used for updating the guidelines and for training nurses involved in compounding. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

32 CFR 37.1010 - What substantive issues should my award document address?

Code of Federal Regulations, 2010 CFR

2010-07-01

... advances. For an expenditure-based TIA, your payment provision must require the return of interest should... § 37.830. (l) Audits. If your TIA is an expenditure-based award, you must include an audit provision... through 37.905. (p) Assurances for applicable national policy requirements. You must incorporate...

Improving the Business Communication Skills of Postgraduate Internal Audit Students: A South African Teaching Innovation

ERIC Educational Resources Information Center

Plant, Kato; Slippers, Jana

2015-01-01

This article reports on the introduction of a business communication course in the curriculum of postgraduate internal audit students at a higher education institution in South Africa. Internal auditors should have excellent verbal and written communication skills in performing value-adding assurance and consulting services to their engagement…

40 CFR Appendix A to Part 31 - Audit Requirements for State and Local Government Recipients

Code of Federal Regulations, 2014 CFR

2014-07-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and evaluation must be made whether or not the auditor intends to...

40 CFR Appendix A to Part 31 - Audit Requirements for State and Local Government Recipients

Code of Federal Regulations, 2011 CFR

2011-07-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and evaluation must be made whether or not the auditor intends to...

40 CFR Appendix A to Part 31 - Audit Requirements for State and Local Government Recipients

Code of Federal Regulations, 2010 CFR

2010-07-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and evaluation must be made whether or not the auditor intends to...

40 CFR Appendix A to Part 31 - Audit Requirements for State and Local Government Recipients

Code of Federal Regulations, 2012 CFR

2012-07-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and evaluation must be made whether or not the auditor intends to...

40 CFR Appendix A to Part 31 - Audit Requirements for State and Local Government Recipients

Code of Federal Regulations, 2013 CFR

2013-07-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and evaluation must be made whether or not the auditor intends to...

Controversies in prostate cancer staging implementation at a tertiary cancer center.

PubMed

Sexton, Tracy; Rodrigues, George; Brecevic, Ed; Boyce, Laura; Parrack, Denise; Lock, Michael; D'Souza, David

2006-12-01

To assess accuracy of recorded prostate cancer stage after implementation of a quality assurance staging improvement plan. Genitourinary multidisciplinary TNM staging guidelines were prospectively implemented. Educational programs for health records technicians (HRT) and clinicians preceded implementation of the new guidelines. Patient stage information was entered into the Oncology Patient Information System (OPIS) as part of the usual operations of the cancer center by an HRT. Physician and HRT auditors performed a subsequent quality assurance audit on 97 prostate cancer patients seen over a 2-month period. Assessment of staging accuracy and reasons for discrepancies between the OPIS stage and auditor stage were analyzed and reported. Fifty-four (52%) charts showed discrepancies between auditors. Of the fifty-four, twelve (22%) had discrepancies between OPIS and auditor, thirty (56%) showed discrepancies between auditors, and twelve (22%) had discrepancies between OPIS, physician auditor, and HRT auditor. Forty-three (41%) cases had no discrepancies. Reasons for discrepancies included: misinterpretation of the digital rectal examination (16/54), inappropriate use of TRUS/MRI (9/54) in staging, stage not assigned at initial diagnosis (9/54), misinterpretation of pathology (7/54), TNM staging confusion (4/54), OPIS update not performed (3/54), inappropriate use of biopsy data (3/54), disagreement between consultants (2/54), and misinterpretation of TURP result (1/54). Overall staging accuracy was 76% for OPIS, 65% for the physician auditor and 62% for the HRT auditor. Despite guidelines and educational interventions, computer registry staging accuracy remains an issue. On-going audit procedures are proposed to identify and correct both published and institutional staging guidelines.

Accuracy and reliability of Chile's National Air Quality Information System for measuring particulate matter: Beta attenuation monitoring issue.

PubMed

Toro A, Richard; Campos, Claudia; Molina, Carolina; Morales S, Raul G E; Leiva-Guzmán, Manuel A

2015-09-01

A critical analysis of Chile's National Air Quality Information System (NAQIS) is presented, focusing on particulate matter (PM) measurement. This paper examines the complexity, availability and reliability of monitoring station information, the implementation of control systems, the quality assurance protocols of the monitoring station data and the reliability of the measurement systems in areas highly polluted by particulate matter. From information available on the NAQIS website, it is possible to confirm that the PM2.5 (PM10) data available on the site correspond to 30.8% (69.2%) of the total information available from the monitoring stations. There is a lack of information regarding the measurement systems used to quantify air pollutants, most of the available data registers contain gaps, almost all of the information is categorized as "preliminary information" and neither standard operating procedures (operational and validation) nor assurance audits or quality control of the measurements are reported. In contrast, events that cause saturation of the monitoring detectors located in northern and southern Chile have been observed using beta attenuation monitoring. In these cases, it can only be concluded that the PM content is equal to or greater than the saturation concentration registered by the monitors and that the air quality indexes obtained from these measurements are underestimated. This occurrence has been observed in 12 (20) public and private stations where PM2.5 (PM10) is measured. The shortcomings of the NAQIS data have important repercussions for the conclusions obtained from the data and for how the data are used. However, these issues represent opportunities for improving the system to widen its use, incorporate comparison protocols between equipment, install new stations and standardize the control system and quality assurance. Copyright © 2015 Elsevier Ltd. All rights reserved.

U.S. Geological Survey external quality-assurance project report to the National Atmospheric Deposition Program / National Trends Network and Mercury Deposition Network, 2007-08

USGS Publications Warehouse

Wetherbee, Gregory A.; Latysh, Natalie E.; Chesney, Tanya A.

2010-01-01

The U.S. Geological Survey (USGS) used six distinct programs to provide external quality-assurance monitoring for the National Atmospheric Deposition Program / National Trends Network (NTN) and Mercury Deposition Network (MDN) during 2007-08. The field-audit program assessed the effects of onsite exposure, sample handling, and shipping on the chemistry of NTN samples, and a system-blank program assessed the same effects for MDN. Two interlaboratory-comparison programs assessed the bias and variability of the chemical analysis data from the Central Analytical Laboratory (CAL), Mercury (Hg) Analytical Laboratory (HAL), and 12 other participating laboratories. A blind-audit program was also implemented for the MDN to evaluate analytical bias in HAL total Hg concentration data. A co-located-sampler program was used to identify and quantify potential shifts in NADP data resulting from replacement of original network instrumentation with new electronic recording rain gages (E-gages) and prototype precipitation collectors. The results indicate that NADP data continue to be of sufficient quality for the analysis of spatial distributions and time trends of chemical constituents in wet deposition across the U.S. NADP data-quality objectives continued to be achieved during 2007-08. Results also indicate that retrofit of the NADP networks with the new E-gages is not likely to create step-function type shifts in NADP precipitation-depth records, except for sites where annual precipitation depth is dominated by snow because the E-gages tend to catch more snow than the original NADP rain gages. Evaluation of prototype precipitation collectors revealed no difference in sample volumes and analyte concentrations between the original NADP collectors and modified, deep-bucket collectors, but the Yankee Environmental Systems, Inc. (YES) collector obtained samples of significantly higher volumes and analyte concentrations than the standard NADP collector.

Quality assurance: The 10-Group Classification System (Robson classification), induction of labor, and cesarean delivery.

PubMed

Robson, Michael; Murphy, Martina; Byrne, Fionnuala

2015-10-01

Quality assurance in labor and delivery is needed. The method must be simple and consistent, and be of universal value. It needs to be clinically relevant, robust, and prospective, and must incorporate epidemiological variables. The 10-Group Classification System (TGCS) is a simple method providing a common starting point for further detailed analysis within which all perinatal events and outcomes can be measured and compared. The system is demonstrated in the present paper using data for 2013 from the National Maternity Hospital in Dublin, Ireland. Interpretation of the classification can be easily taught. The standard table can provide much insight into the philosophy of care in the population of women studied and also provide information on data quality. With standardization of audit of events and outcomes, any differences in either sizes of groups, events or outcomes can be explained only by poor data collection, significant epidemiological variables, or differences in practice. In April 2015, WHO proposed that the TGCS (also known as the Robson classification) is used as a global standard for assessing, monitoring, and comparing cesarean delivery rates within and between healthcare facilities. Copyright © 2015. Published by Elsevier Ireland Ltd.

Dosimetric verification of radiotherapy treatment planning systems in Serbia: national audit

PubMed Central

2012-01-01

Background Independent external audits play an important role in quality assurance programme in radiation oncology. The audit supported by the IAEA in Serbia was designed to review the whole chain of activities in 3D conformal radiotherapy (3D-CRT) workflow, from patient data acquisition to treatment planning and dose delivery. The audit was based on the IAEA recommendations and focused on dosimetry part of the treatment planning and delivery processes. Methods The audit was conducted in three radiotherapy departments of Serbia. An anthropomorphic phantom was scanned with a computed tomography unit (CT) and treatment plans for eight different test cases involving various beam configurations suggested by the IAEA were prepared on local treatment planning systems (TPSs). The phantom was irradiated following the treatment plans for these test cases and doses in specific points were measured with an ionization chamber. The differences between the measured and calculated doses were reported. Results The measurements were conducted for different photon beam energies and TPS calculation algorithms. The deviation between the measured and calculated values for all test cases made with advanced algorithms were within the agreement criteria, while the larger deviations were observed for simpler algorithms. The number of measurements with results outside the agreement criteria increased with the increase of the beam energy and decreased with TPS calculation algorithm sophistication. Also, a few errors in the basic dosimetry data in TPS were detected and corrected. Conclusions The audit helped the users to better understand the operational features and limitations of their TPSs and resulted in increased confidence in dose calculation accuracy using TPSs. The audit results indicated the shortcomings of simpler algorithms for the test cases performed and, therefore the transition to more advanced algorithms is highly desirable. PMID:22971539

Dosimetric verification of radiotherapy treatment planning systems in Serbia: national audit.

PubMed

Rutonjski, Laza; Petrović, Borislava; Baucal, Milutin; Teodorović, Milan; Cudić, Ozren; Gershkevitsh, Eduard; Izewska, Joanna

2012-09-12

Independent external audits play an important role in quality assurance programme in radiation oncology. The audit supported by the IAEA in Serbia was designed to review the whole chain of activities in 3D conformal radiotherapy (3D-CRT) workflow, from patient data acquisition to treatment planning and dose delivery. The audit was based on the IAEA recommendations and focused on dosimetry part of the treatment planning and delivery processes. The audit was conducted in three radiotherapy departments of Serbia. An anthropomorphic phantom was scanned with a computed tomography unit (CT) and treatment plans for eight different test cases involving various beam configurations suggested by the IAEA were prepared on local treatment planning systems (TPSs). The phantom was irradiated following the treatment plans for these test cases and doses in specific points were measured with an ionization chamber. The differences between the measured and calculated doses were reported. The measurements were conducted for different photon beam energies and TPS calculation algorithms. The deviation between the measured and calculated values for all test cases made with advanced algorithms were within the agreement criteria, while the larger deviations were observed for simpler algorithms. The number of measurements with results outside the agreement criteria increased with the increase of the beam energy and decreased with TPS calculation algorithm sophistication. Also, a few errors in the basic dosimetry data in TPS were detected and corrected. The audit helped the users to better understand the operational features and limitations of their TPSs and resulted in increased confidence in dose calculation accuracy using TPSs. The audit results indicated the shortcomings of simpler algorithms for the test cases performed and, therefore the transition to more advanced algorithms is highly desirable.

An audit of the nature and impact of clinical coding subjectivity variability and error in otolaryngology.

PubMed

Nouraei, S A R; Hudovsky, A; Virk, J S; Chatrath, P; Sandhu, G S

2013-12-01

To audit the accuracy of clinical coding in otolaryngology, assess the effectiveness of previously implemented interventions, and determine ways in which it can be further improved. Prospective clinician-auditor multidisciplinary audit of clinical coding accuracy. Elective and emergency ENT admissions and day-case activity. Concordance between initial coding and the clinician-auditor multi-disciplinary teams (MDT) coding in respect of primary and secondary diagnoses and procedures, health resource groupings health resource groupings (HRGs) and tariffs. The audit of 3131 randomly selected otolaryngology patients between 2010 and 2012 resulted in 420 instances of change to the primary diagnosis (13%) and 417 changes to the primary procedure (13%). In 1420 cases (44%), there was at least one change to the initial coding and 514 (16%) health resource groupings changed. There was an income variance of £343,169 or £109.46 per patient. The highest rates of health resource groupings change were observed in head and neck surgery and in particular skull-based surgery, laryngology and within that tracheostomy, and emergency admissions, and specially, epistaxis management. A randomly selected sample of 235 patients from the audit were subjected to a second audit by a second clinician-auditor multi-disciplinary team. There were 12 further health resource groupings changes (5%) and at least one further coding change occurred in 57 patients (24%). These changes were significantly lower than those observed in the pre-audit sample, but were also significantly greater than zero. Asking surgeons to 'code in theatre' and applying these codes without further quality assurance to activity resulted in an health resource groupings error rate of 45%. The full audit sample was regrouped under health resource groupings 3.5 and was compared with a previous audit of 1250 patients performed between 2007 and 2008. This comparison showed a reduction in the baseline rate of health resource groupings change from 16% during the first audit cycle to 9% in the current audit cycle (P < 0.001). Otolaryngology coding is complex and susceptible to subjectivity, variability and error. Coding variability can be improved, but not eliminated through regular education supported by an audit programme. © 2013 John Wiley & Sons Ltd.

[Quality assurance of rapid on-site evaluation of CT-guided fine-needle aspiration cytology of lung nodules].

PubMed

Bak, Mihály; Hidvégi, Judit; Andi, Judit; Bahéry, Mária; Kovács, Eszter; Schneider, Ferenc; Kostic, Szilárd; Rényi-Vámos, Ferenc; Szőke, János; Nyári, Tibor; Gődény, Mária; Kásler, Miklós

2013-01-06

The methods available for the diagnosis of lung cancer include radiologic, cytologic and pathologic procedures. The aim of this study was to determine the quality assurance of CT guided fine needle aspiration cytology of lung nodules. Cytology results were rated to 4 categories (positive; suspicious; negative; not representative). All cytology reports were compared with the final histology diagnosis. A total of 128 patients underwent CT-guided percutaneous fine-needle aspiration biopsy cytology (63 males; 65 females; mean age 62.8 years). Smears were adequate in 99 cases and inadequate in 29 cases. The average diameter of the nodules was 3.28 cm. Thirty three (25.6%) of the cases were histologically verified and 2 falsely negative and 2 falsely positive cases were detected. The sensitivity and the positive predictive value were 88.8% and 88.8%, respectively. Pneumothorax developed in 7 (5.4%) cases. These results suggest that CT-guided transthoracic fine needle aspiration cytology has a high diagnostic accuracy and an acceptable complication rate. The auditing valves of the results meet the proposed threshold values.

Development and evaluation of an instantaneous atmospheric corrosion rate monitor

NASA Astrophysics Data System (ADS)

Mansfeld, F.; Jeanjaquet, S. L.; Kendig, M. W.; Roe, D. K.

1985-06-01

A research program was carried out in which a new instantaneous atmospheric corrosion rate monitor (ACRM) was developed and evaluated, and equipment was constructed which will allow the use of many sensors in an economical way in outdoor exposures. In the first task, the ACRM was developed and tested in flow chambers in which relative humidity and gaseous and particulate pollutant levels can be controlled. Diurnal cycles and periods of rain were simulated. The effects of aerosols were studied. A computerized system was used for collection, storage, and analysis of the electrochemical data. In the second task, a relatively inexpensive electronics system for control of the ACRM and measurement of atmospheric corrosion rates was designed and built. In the third task, calibration of deterioration rates of various metallic and nonmetallic materials with the response of the ACRMs attached to these materials was carried out under controlled environmental conditions using the system developed in the second task. A Quality Assurance project plan was prepared with inputs from the Rockwell International Environmental Monitoring and Service Center and Quality Assurance System audits were performed.

7 CFR 226.4 - Payments to States and use of funds.

Code of Federal Regulations, 2010 CFR

2010-01-01

... are available for that State or on the basis of estimates by FNS. (h) Funding assurance. FNS shall... providing start-up, expansion and advance payments in accordance with this part. (i) Rate adjustments. FNS.... (j) Audit funds. For the expense of conducting audits and reviews under § 226.8, funds shall be made...

49 CFR 385.307 - What happens after a motor carrier begins operations as a new entrant?

Code of Federal Regulations, 2010 CFR

2010-10-01

... MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385... controls that are operating effectively. (b) A safety audit will be conducted on the new entrant, once it... records and documents required for the safety audit shall be made available for inspection upon request by...

7 CFR Appendix B to Part 3015 - OMB Circular A-128, “Audits of State and Local Governments”

Code of Federal Regulations, 2010 CFR

2010-01-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... regulations. a. Internal control review. In order to provide this assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and...

21 CFR Appendix A to Part 1403 - OMB Circular A-128, “Audits of State and Local Governments”

Code of Federal Regulations, 2010 CFR

2010-04-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and evaluation must be made whether or not the auditor intends to...

21 CFR Appendix A to Part 1403 - OMB Circular A-128, “Audits of State and Local Governments”

Code of Federal Regulations, 2013 CFR

2013-04-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and evaluation must be made whether or not the auditor intends to...

21 CFR Appendix A to Part 1403 - OMB Circular A-128, “Audits of State and Local Governments”

Code of Federal Regulations, 2014 CFR

2014-04-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and evaluation must be made whether or not the auditor intends to...

21 CFR Appendix A to Part 1403 - OMB Circular A-128, “Audits of State and Local Governments”

Code of Federal Regulations, 2011 CFR

2011-04-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and evaluation must be made whether or not the auditor intends to...

21 CFR Appendix A to Part 1403 - OMB Circular A-128, “Audits of State and Local Governments”

Code of Federal Regulations, 2012 CFR

2012-04-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and evaluation must be made whether or not the auditor intends to...

7 CFR Appendix B to Part 3015 - OMB Circular A-128, “Audits of State and Local Governments”

Code of Federal Regulations, 2011 CFR

2011-01-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... regulations. a. Internal control review. In order to provide this assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and...

7 CFR Appendix B to Part 3015 - OMB Circular A-128, “Audits of State and Local Governments”

Code of Federal Regulations, 2014 CFR

2014-01-01

... operations. A series of audits of individual departments, agencies, and establishments for the same fiscal... regulations. a. Internal control review. In order to provide this assurance the auditor must make a study and evaluation of internal control systems used in administering Federal assistance programs. The study and...

34 CFR 381.31 - What are the requirements pertaining to the protection, use, and release of personal information?

Code of Federal Regulations, 2011 CFR

2011-07-01

... interpreted by the courts of the United States, except that, for purposes of any periodic audit, report, or..., notwithstanding paragraph (d)(1) of this section, if an audit, monitoring review, State plan assurance review... personally identifiable information (i.e., name, address, telephone number, social security number, or other...

Quality assurance of chemical ingredient classification for the National Drug File - Reference Terminology.

PubMed

Zheng, Ling; Yumak, Hasan; Chen, Ling; Ochs, Christopher; Geller, James; Kapusnik-Uner, Joan; Perl, Yehoshua

2017-09-01

The National Drug File - Reference Terminology (NDF-RT) is a large and complex drug terminology consisting of several classification hierarchies on top of an extensive collection of drug concepts. These hierarchies provide important information about clinical drugs, e.g., their chemical ingredients, mechanisms of action, dosage form and physiological effects. Within NDF-RT such information is represented using tens of thousands of roles connecting drugs to classifications. In previous studies, we have introduced various kinds of Abstraction Networks to summarize the content and structure of terminologies in order to facilitate their visual comprehension, and support quality assurance of terminologies. However, these previous kinds of Abstraction Networks are not appropriate for summarizing the NDF-RT classification hierarchies, due to its unique structure. In this paper, we present the novel Ingredient Abstraction Network (IAbN) to summarize, visualize and support the audit of NDF-RT's Chemical Ingredients hierarchy and its associated drugs. A common theme in our quality assurance framework is to use characterizations of sets of concepts, revealed by the Abstraction Network structure, to capture concepts, the modeling of which is more complex than for other concepts. For the IAbN, we characterize drug ingredient concepts as more complex if they belong to IAbN groups with multiple parent groups. We show that such concepts have a statistically significantly higher rate of errors than a control sample and identify two especially common patterns of errors. Copyright © 2017 Elsevier Inc. All rights reserved.

Quality control and assurance for validation of DOS/I measurements

NASA Astrophysics Data System (ADS)

Cerussi, Albert; Durkin, Amanda; Kwong, Richard; Quang, Timothy; Hill, Brian; Tromberg, Bruce J.; MacKinnon, Nick; Mantulin, William W.

2010-02-01

Ongoing multi-center clinical trials are crucial for Biophotonics to gain acceptance in medical imaging. In these trials, quality control (QC) and assurance (QA) are key to success and provide "data insurance". Quality control and assurance deal with standardization, validation, and compliance of procedures, materials and instrumentation. Specifically, QC/QA involves systematic assessment of testing materials, instrumentation performance, standard operating procedures, data logging, analysis, and reporting. QC and QA are important for FDA accreditation and acceptance by the clinical community. Our Biophotonics research in the Network for Translational Research in Optical Imaging (NTROI) program for breast cancer characterization focuses on QA/QC issues primarily related to the broadband Diffuse Optical Spectroscopy and Imaging (DOS/I) instrumentation, because this is an emerging technology with limited standardized QC/QA in place. In the multi-center trial environment, we implement QA/QC procedures: 1. Standardize and validate calibration standards and procedures. (DOS/I technology requires both frequency domain and spectral calibration procedures using tissue simulating phantoms and reflectance standards, respectively.) 2. Standardize and validate data acquisition, processing and visualization (optimize instrument software-EZDOS; centralize data processing) 3. Monitor, catalog and maintain instrument performance (document performance; modularize maintenance; integrate new technology) 4. Standardize and coordinate trial data entry (from individual sites) into centralized database 5. Monitor, audit and communicate all research procedures (database, teleconferences, training sessions) between participants ensuring "calibration". This manuscript describes our ongoing efforts, successes and challenges implementing these strategies.

A tiered quality assurance review process for clinical data management standard operating procedures in an academic health center.

PubMed

Ittenbach, Richard F; Baker, Cynthia L; Corsmo, Jeremy J

2014-05-01

Standard operating procedures (SOPs) were once considered the province of the pharmaceutical industry but are now viewed as a key component of quality assurance programs. To address variability and increase the rigor of clinical data management (CDM) operations, the Cincinnati Children's Hospital Medical Center (CCHMC) decided to create CDM SOPs. In response to this challenge, and as part of a broader institutional initiative, the CCHMC leadership established an executive steering committee to oversee the development and implementation of CDM SOPs. This resulted in the creation of a quality assurance review process with three review panels: an SOP development team (16 clinical data managers and technical staff members), a faculty review panel (8 senior faculty and administrators), and an expert advisory panel (3 national CDM experts). This innovative, tiered review process helped ensure that the new SOPs would be created and implemented in accord with good CDM practices and standards. Twelve fully vetted, institutionally endorsed SOPs and one CDM template resulted from the intensive, iterative 10-month process (December 2011 to early October 2012). Phased implementation, which incoporated the CDM SOPs into the existing audit process for certain types of clinical research studies, was on schedule at the time of this writing. Once CCHMC researchers have had the opportunity to use the SOPs over time and across a broad range of research settings and conditions, the SOPs will be revisited and revalidated.

Laboratory audit as part of the quality assessment of a primary HPV-screening program.

PubMed

Hortlund, Maria; Sundström, Karin; Lamin, Helena; Hjerpe, Anders; Dillner, Joakim

2016-02-01

As primary HPV screening programs are rolled out, methods are needed for routine quality assurance of HPV laboratory analyzes. To explore the use of similar design for audit as currently used in cytology-based screening, to estimate the clinical sensitivity to identify women at risk for CIN 3 or worse (CIN3+). Population-based cohort study conducted within the cervical screening program in Stockholm, Sweden, in 2011-2012. All women with histopathologically confirmed CIN3+ in the following two years were identified by registry analysis. Primary HPV and cytology screening results were collected. For women who had not been HPV tested, biobanked cytology samples were HPV-tested. If the original HPV result had been negative, the sample and subsequent biopsies were analyzed with broad HPV typing (general primer PCR and Luminex). 154 women had a biobanked prediagnostic cytology sample taken up to 2 years before a histopathologically confirmed CIN3+. The high-risk HPV-positivity was 97% (148/154 women), whereas 143/154 (94%) women had had a cytological abnormality. Among the six HPV-negative samples, one sample was HPV 33 positive in repeat testing whereas the other five cases were HPV-negative also on repeat testing, but HPV-positive in the subsequent tumor tissue. A sensitivity of the HPV test that is higher than the sensitivity of cytology suggests adequate quality of the testing. Regular audits of clinical sensitivity, similar to those of cytology-based screening, should be used also in HPV-based screening programs, in order to continuously monitor the performance of the analyzes. Copyright © 2015 Elsevier B.V. All rights reserved.

76 FR 48943 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-09

... association may obtain a satisfactory written assurance from a seller or lessor that, within a reasonable time... purchaser or lessee. The bank or savings association must retain a record of the written assurance from the... loan. Compliance monitoring and auditing to ensure compliance requires 20 minutes per loan. Training...

Successful control of intractable nausea and vomiting requiring combined ondansetron and haloperidol in a patient with advanced cancer.

PubMed

Cole, R M; Robinson, F; Harvey, L; Trethowan, K; Murdoch, V

1994-01-01

Chemically induced nausea and vomiting is a common symptom of advanced cancer effected through stimulation of dopamine (D2) or serotonin (5-HT3) receptors located in the chemoreceptor trigger zone (CTZ). These may be blocked by therapeutic doses of haloperidol and ondansetron, respectively. This case, reporting on a single patient acting as her own control, establishes that combined blockade of these receptors is sometimes required to relieve intractable nausea and vomiting. It also demonstrates the value of clinical review, audit of care, and quality assurance in the palliative care setting.

Applicability of Topaz Composites to Electron Dosimetry

NASA Astrophysics Data System (ADS)

Bomfim, K. S.; Souza, D. N.

2010-11-01

Thermoluminescent dosimetric topaz properties have been investigated and the results have shown that this mineral presents characteristics of a good dosimeter mainly in doses evaluation in radiotherapy with photons beams in radiotherapy. Typical applications of thermoluminescent dosimeters in radiotherapy are: in vivo dosimetry on patients (either as a routine quality assurance procedure or for dose monitoring in special cases); verification of treatment techniques; dosimetry audits; and comparisons among hospitals. The mean aim of this work was to evaluate the efficiency of topaz-Teflon pellets as thermoluminescent dosimeters in high-energy electron beams used to radiotherapy. Topaz-Teflon pellets were used as TLD.

Effect of Audit Immunity/Privilege Laws on State's Ability to Enforce Title V Requirements

EPA Pesticide Factsheets

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

Quality Assurance Practices in Obstetric Care: A Survey of Hospitals in California.

PubMed

Lundsberg, Lisbet S; Lee, Henry C; Dueñas, Grace Villarin; Gregory, Kimberly D; Grossetta Nardini, Holly K; Pettker, Christian M; Illuzzi, Jessica L; Xu, Xiao

2018-02-01

To assess hospital practices in obstetric quality management activities and identify institutional characteristics associated with utilization of evidence-supported practices. Data for this study came from a statewide survey of obstetric hospitals in California regarding their organization and delivery of perinatal care. We analyzed responses from 185 hospitals that completed quality assurance sections of the survey to assess their practices in a broad spectrum of quality enhancement activities. The association between institutional characteristics and adoption of evidence-supported practices (ie, those supported by prior literature or recommended by professional organizations as beneficial for improving birth outcome or patient safety) was examined using bivariate analysis and appropriate statistical tests. Most hospitals regularly audited adherence to written protocols regarding critical areas of care; however, 77.7% and 16.8% reported not having written guidelines on diagnosis of labor arrest and management of abnormal fetal heart rate, respectively. Private nonprofit hospitals were more likely to have a written protocol for management of abnormal fetal heart rate (P=.002). One in 10 hospitals (9.7%) did not regularly review cases with significant morbidity or mortality, and only 69.0% regularly tracked indications for cesarean delivery. Moreover, 26.3%, 14.3%, and 8.7% of the hospitals reported never performing interprofessional simulations for eclampsia, shoulder dystocia, or postpartum hemorrhage, respectively. Teaching status was associated with more frequent simulations in these three areas (P≤.04 for all), while larger volume was associated with more frequent simulations for eclampsia (P=.04). Hospitals in California engage in a wide range of practices to assure or improve quality of obstetric care, but substantial variation in practice exists among hospitals. There is opportunity for improvement in adoption of evidence-supported practices.

Moving beyond quality control in diagnostic radiology and the role of the clinically qualified medical physicist.

PubMed

Delis, H; Christaki, K; Healy, B; Loreti, G; Poli, G L; Toroi, P; Meghzifene, A

2017-09-01

Quality control (QC), according to ISO definitions, represents the most basic level of quality. It is considered to be the snapshot of the performance or the characteristics of a product or service, in order to verify that it complies with the requirements. Although it is usually believed that "the role of medical physicists in Diagnostic Radiology is QC", this, not only limits the contribution of medical physicists, but is also no longer adequate to meet the needs of Diagnostic Radiology in terms of Quality. In order to assure quality practices more organized activities and efforts are required in the modern era of diagnostic radiology. The complete system of QC is just one element of a comprehensive quality assurance (QA) program that aims at ensuring that the requirements of quality of a product or service will consistently be fulfilled. A comprehensive Quality system, starts even before the procurement of any equipment, as the need analysis and the development of specifications are important components under the QA framework. Further expanding this framework of QA, a comprehensive Quality Management System can provide additional benefits to a Diagnostic Radiology service. Harmonized policies and procedures and elements such as mission statement or job descriptions can provide clarity and consistency in the services provided, enhancing the outcome and representing a solid platform for quality improvement. The International Atomic Energy Agency (IAEA) promotes this comprehensive quality approach in diagnostic imaging and especially supports the field of comprehensive clinical audits as a tool for quality improvement. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

NASA Audit Follow-up Handbook

NASA Technical Reports Server (NTRS)

1990-01-01

This NASA Audit Follow-up Handbook is issued pursuant to the requirements of the Office of Management and Budget (OMB) Circular A-50, Audit Follow-up, dated September 29, 1982. It sets forth policy, uniform performance standards, and procedural guidance to NASA personnel for use when considering reports issued by the Office of Inspector General (OIG), other executive branch audit organizations, the Defense Contract Audit Agency (DCAA), and the General Accounting Office (GAO). It is intended to: specify principal roles; strengthen the procedures for management decisions (resolution) on audit findings and corrective action on audit report recommendations; emphasize the importance of monitoring agreed upon corrective actions to assure actual accomplishment; and foster the use of audit reports as effective tools of management. A flow chart depicting the NASA audit and management decision process is in Appendix A. This handbook is a controlled handbook issued in loose-leaf form and will be revised by page changes. Additional copies for internal use may be obtained through normal distribution channels.

Determination of Energy of a Clinical Electron Beam as Part of a Routine Quality Assurance and Audit System

NASA Astrophysics Data System (ADS)

Hernández-Bello, Jimmy; D'Souza, Derek; Rossenberg, Ivan

2002-08-01

A method to determine the electron beam energy and an electron audit based on the current IPEM electron Code of Practice has been devised. During the commissioning on the new Varian 2100CD linear accelerator in The Middlesex Hospital, two methods were devised for the determination of electron energy. The first method involves the use of a two-depth method, whereby the ratio of ionisation (presented as a percentage) measured by an ion chamber at two depths in solid water is used to compare against the baseline ionisation depth value for that energy. The second method involves the irradiation of an X-ray film in solid water to obtain a depth dose curve and, hence determine the half value depth and practical range of the electrons. The results showed that the two-depth method has a better accuracy, repeatability, reliability and consistency than the X-ray method. The results for the electron audit showed that electron absolute outputs are obtained from ionisation measurements in solid water, where the energy-range parameters such as practical range and the depth at which ionisation is 50% of that at the maximum for the depth-ionisation curve are determined.

External audits of electron beams using mailed TLD dosimetry: preliminary results.

PubMed

Gomola, I; Van Dam, J; Isern-Verdum, J; Verstraete, J; Reymen, R; Dutreix, A; Davis, B; Huyskens, D

2001-02-01

A feasibility study has been performed to investigate the possibility of using mailed thermoluminescence dosimetry (TLD) for external audits of clinical electron beams in Europe. In the frame of the EC Network Project for Quality Assurance in Radiotherapy, instruction sheets and mailing procedures have been defined for mailed TLD dosimetry using the dedicated holder developed by a panel of experts of the International Atomic Energy Agency (IAEA). Three hundred and thirty electron beam set-ups have been checked in the reference centres and some local centres of the EC Network Project and in addition through the centres participating to the EORTC Radiotherapy Group trial 22922. The mean ratio of measured dose to stated dose is 0.2% and the standard deviation of measured dose to stated dose is 3.2%. In seven beam set-ups, deviations greater than 10% were observed (max. 66%), showing the usefulness of these checks. The results of this feasibility study (instruction sheets, mailing procedures, holder) are presently endorsed by the EQUAL-ESTRO structure in order to offer in the future to all ESTRO members the possibility to request external audits of clinical electron beams.

Clinical Implications of TiGRT Algorithm for External Audit in Radiation Oncology.

PubMed

Shahbazi-Gahrouei, Daryoush; Saeb, Mohsen; Monadi, Shahram; Jabbari, Iraj

2017-01-01

Performing audits play an important role in quality assurance program in radiation oncology. Among different algorithms, TiGRT is one of the common application software for dose calculation. This study aimed to clinical implications of TiGRT algorithm to measure dose and compared to calculated dose delivered to the patients for a variety of cases, with and without the presence of inhomogeneities and beam modifiers. Nonhomogeneous phantom as quality dose verification phantom, Farmer ionization chambers, and PC-electrometer (Sun Nuclear, USA) as a reference class electrometer was employed throughout the audit in linear accelerators 6 and 18 MV energies (Siemens ONCOR Impression Plus, Germany). Seven test cases were performed using semi CIRS phantom. In homogeneous regions and simple plans for both energies, there was a good agreement between measured and treatment planning system calculated dose. Their relative error was found to be between 0.8% and 3% which is acceptable for audit, but in nonhomogeneous organs, such as lung, a few errors were observed. In complex treatment plans, when wedge or shield in the way of energy is used, the error was in the accepted criteria. In complex beam plans, the difference between measured and calculated dose was found to be 2%-3%. All differences were obtained between 0.4% and 1%. A good consistency was observed for the same type of energy in the homogeneous and nonhomogeneous phantom for the three-dimensional conformal field with a wedge, shield, asymmetric using the TiGRT treatment planning software in studied center. The results revealed that the national status of TPS calculations and dose delivery for 3D conformal radiotherapy was globally within acceptable standards with no major causes for concern.

Clinical Implications of TiGRT Algorithm for External Audit in Radiation Oncology

PubMed Central

Shahbazi-Gahrouei, Daryoush; Saeb, Mohsen; Monadi, Shahram; Jabbari, Iraj

2017-01-01

Background: Performing audits play an important role in quality assurance program in radiation oncology. Among different algorithms, TiGRT is one of the common application software for dose calculation. This study aimed to clinical implications of TiGRT algorithm to measure dose and compared to calculated dose delivered to the patients for a variety of cases, with and without the presence of inhomogeneities and beam modifiers. Materials and Methods: Nonhomogeneous phantom as quality dose verification phantom, Farmer ionization chambers, and PC-electrometer (Sun Nuclear, USA) as a reference class electrometer was employed throughout the audit in linear accelerators 6 and 18 MV energies (Siemens ONCOR Impression Plus, Germany). Seven test cases were performed using semi CIRS phantom. Results: In homogeneous regions and simple plans for both energies, there was a good agreement between measured and treatment planning system calculated dose. Their relative error was found to be between 0.8% and 3% which is acceptable for audit, but in nonhomogeneous organs, such as lung, a few errors were observed. In complex treatment plans, when wedge or shield in the way of energy is used, the error was in the accepted criteria. In complex beam plans, the difference between measured and calculated dose was found to be 2%–3%. All differences were obtained between 0.4% and 1%. Conclusions: A good consistency was observed for the same type of energy in the homogeneous and nonhomogeneous phantom for the three-dimensional conformal field with a wedge, shield, asymmetric using the TiGRT treatment planning software in studied center. The results revealed that the national status of TPS calculations and dose delivery for 3D conformal radiotherapy was globally within acceptable standards with no major causes for concern. PMID:28989910

49 CFR 385.333 - What happens at the end of the 18-month safety monitoring period?

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.333 What happens at the end of the 18-month safety monitoring period? (a) If a safety audit has been performed within... the same basis as any other carrier. (d) If a safety audit or compliance review has not been performed...

77 FR 49384 - FMCSA Policy on the Timeliness of New Entrant Corrective Action Submissions

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-16

... 15 days of the date of a new entrant safety audit failure notice or within 10 days of the date of an... 20, 2012 for safety audit failure notices. FOR FURTHER INFORMATION CONTACT: Thomas Kelly, Office of... FMCSA's New Entrant Safety Assurance Program, 49 CFR Part 385, subpart D, applies to new entrant motor...

Assessment of three medical and research laboratories using WHO AFRO_SLIPTA Quality Standards in Southwestern Uganda: a long way to go.

PubMed

Taremwa, Ivan Mugisha; Ampaire, Lucas; Iramiot, Jacob; Muhwezi, Obed; Matte, Aloysius; Itabangi, Herbert; Mbabazi, Hope; Atwebembeire, Jeninah; Kamwine, Monicah; Katawera, Victoria; Mbalibulha, Yona; Orikiriza, Patrick; Boum, Yap

2017-01-01

While the laboratory represents more than 70% of clinical diagnosis and patient management, access to reliable and quality laboratory diagnostics in sub-Saharan Africa remains a challenge. To gain knowledge and suggest evidence based interventions towards laboratory improvement in Southwestern Uganda, we assessed the baseline laboratory quality standards in three medical and research laboratories in Southwestern Uganda. We conducted a cross sectional survey from October, 2013 to April, 2014. Selected laboratories, including one private research, one private for profit and one public laboratory, were assessed using the WHO AFRO_SLIPTA checklist and baseline scores were determined. The three laboratories assessed met basic facility requirements, had trained personnel, and safety measures in place. Sample reception was properly designed and executed with a well designated chain of custody. All laboratories had sufficient equipment for the nature of work they were involved in. However, we found that standard operating procedures were incomplete in all three laboratories, lack of quality audit schemes by two laboratories and only one laboratory enrolled into external quality assurance schemes. The SLIPTA scores were one star for the research laboratory and no star for both the public and private-for-profit laboratories. While most of the laboratory systems were in place, the low scores obtained by the assessed laboratories reflect the need for improvement to reach standards of quality assured diagnostics in the region. Therefore, routine mentorship and regional supportive supervision are necessary to increase the quality of laboratory services.

Australasian brachytherapy audit: results of the 'end-to-end' dosimetry pilot study.

PubMed

Haworth, Annette; Wilfert, Lisa; Butler, Duncan; Ebert, Martin A; Todd, Stephen; Bucci, Joseph; Duchesne, Gillian M; Joseph, David; Kron, Tomas

2013-08-01

We present the results of a pilot study to test the feasibility of a brachytherapy dosimetry audit. The feasibility study was conducted at seven sites from four Australian states in both public and private centres. A purpose-built cylindrical water phantom was imaged using the local imaging protocol and a treatment plan was generated to deliver 1 Gy to the central (1 of 3) thermoluminescent dosimeter (TLD) from six dwell positions. All centres completed the audit, consisting of three consecutive irradiations, within a 2-h time period, with the exception of one centre that uses a pulsed dose rate brachytherapy unit. All TLD results were within 4.5% of the predicted value, with the exception of one subset where the dwell position step size was incorrectly applied. While the limited data collected in the study demonstrated considerable heterogeneity in clinical practice, the study proved a brachytherapy dosimetry audit to be feasible. Future studies should include verification of source strength using a Standard Dosimetry Laboratory calibrated chamber, a phantom that more closely mimics the clinical situation, a more comprehensive review of safety and quality assurance (QA) procedures including source dwell time and position accuracy, and a review of patient treatment QA procedures such as applicator position verification. © 2013 The Authors. Journal of Medical Imaging and Radiation Oncology © 2013 The Royal Australian and New Zealand College of Radiologists.

Audit unto others{hor_ellipsis}

DOE Office of Scientific and Technical Information (OSTI.GOV)

Maday, J.H. Jr.

1992-05-01

My first encounter with a quality assurance auditor is reminiscent of an old Dodge commercial. You remember? The old sheriff, masked in mirrored sunglasses, paunch hanging over his gun belt, prophesying, ``You`re in a heap o` trouble boy!`` Well, my auditor could have been kin to the sheriff; they had the same posture, attitude, and mirrored sunglasses. Plus, my auditor wore a black leather vest and sported a ``Buffalo Bill`` goatee. While certainly memorable, both gentlemen were far from pleasant. I`m fairly certain that the compliance auditor of old deserved this perceived association with his law enforcement counterpart. Both believedmore » in enforcing the letter of the law, or their interpretations of it. Neither seemed capable of exercising interpretive powers, but instead relied on winning through intimidation, possibly with an eye toward claiming some version of a monthly Quota Award. Is the auditor of today any better perceived? Because this ``first encounter of the worst kind`` made a lasting impression on me, I have dedicated considerable time and effort trying to avoid being perceived as another sheriff when I conduct audits. In my auditing career, I am determined to capitalize on each opportunity to turn negative situations, as experienced by the auditee, into meaningful opportunities for improved performance. I want to treat the auditee the way I want to be treated when I am being audited. (author)« less

Audit unto others hor ellipsis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Maday, J.H. Jr.

1992-05-01

My first encounter with a quality assurance auditor is reminiscent of an old Dodge commercial. You remember The old sheriff, masked in mirrored sunglasses, paunch hanging over his gun belt, prophesying, You're in a heap o' trouble boy '' Well, my auditor could have been kin to the sheriff; they had the same posture, attitude, and mirrored sunglasses. Plus, my auditor wore a black leather vest and sported a Buffalo Bill'' goatee. While certainly memorable, both gentlemen were far from pleasant. I'm fairly certain that the compliance auditor of old deserved this perceived association with his law enforcement counterpart. Bothmore » believed in enforcing the letter of the law, or their interpretations of it. Neither seemed capable of exercising interpretive powers, but instead relied on winning through intimidation, possibly with an eye toward claiming some version of a monthly Quota Award. Is the auditor of today any better perceived Because this first encounter of the worst kind'' made a lasting impression on me, I have dedicated considerable time and effort trying to avoid being perceived as another sheriff when I conduct audits. In my auditing career, I am determined to capitalize on each opportunity to turn negative situations, as experienced by the auditee, into meaningful opportunities for improved performance. I want to treat the auditee the way I want to be treated when I am being audited. (author)« less

Delivering a quality-assured fracture liaison service in a UK teaching hospital-is it achievable?

PubMed

Shipman, K E; Stammers, J; Doyle, A; Gittoes, N

2016-10-01

To determine whether new national guidance on the specifications of a fracture liaison service are realistically deliverable, 1 year of data on the performance of such a service were audited. Audit targets were mostly met. This audit demonstrates that these standards are deliverable in a real world setting. UK service specifications for a fracture liaison service (FLS) have been produced (National Osteoporosis Society, NOS) to promote effective commissioning and delivery of the highest quality care to patients with fragility fractures. How deliverable these standards are has not as yet been methodically reported. Our FLS was modelled on the ten NOS standards; performance was audited after 1 year to determine whether these standards could be delivered and to describe the lessons learnt. Performance was audited against the NOS FLS Service Standards, with management based on the Fracture Risk Assessment Tool (FRAX®), the four-item Falls Risk Assessment Tool (FRAT), National Institute for Health and Care Excellence (NICE) and the National Osteoporosis Guideline Groups (NOGG) guidance. Data were recorded prospectively on a database. The FLS commenced in May 2014, was fully operational in August 2014 and data were captured from 1 September 2014 to 1 September 2015. The FLS detected 1773 patients and standards were largely achieved. Most, 94 %, patients were seen within 6 weeks, 533 DXA requests were generated, 804 outpatient FRAT assessments were recorded (134 required falls intervention) and 773 patients had bone treatments started. On follow-up at 3 months, between 78-79 % were still taking medication. Preliminary evaluation of a FLS implemented according to UK NOS standards demonstrates that the model is practical to apply to a large teaching hospital population. Collection and review of outcome and cost effectiveness data is required to determine the performance of this model in comparison with existing models.

Want independent validation and assurance? Ask for a SAS-70.

PubMed

Boutin, Christopher C

2008-08-01

The AICPA's Statement on Auditing Standards No.70, Service Organizations addresses CPA audits of service providers conducted to verify that a provider has adequate controls over its operations. Hospitals should request a SAS-70, the report produced by such an audit, from all of their third-party service providers. SAS-70s can be issued for a specific date or for a six-month period, and they typically consist of three sections: a CPA opinion, a description of controls, and information about the design of the controls.

Molecular Auditing: An Evaluation of Unsuspected Tissue Specimen Misidentification.

PubMed

Demetrick, Douglas J

2018-06-18

Context Specimen misidentification is the most significant error in laboratory medicine, potentially accounting for hundreds of millions of dollars in extra health care expenses and significant morbidity in patient populations in the United States alone. New technology allows the unequivocal documentation of specimen misidentification or contamination; however, the value of this technology currently depends on suspicion of the specimen integrity by a pathologist or other health care worker. Objective To test the hypothesis that there is a detectable incidence of unsuspected tissue specimen misidentification among cases submitted for routine surgical pathology examination. Design To test this hypothesis, we selected specimen pairs that were obtained at different times and/or different hospitals from the same patient, and compared their genotypes using standardized microsatellite markers used commonly for forensic human DNA comparison in order to identify unsuspected mismatches between the specimen pairs as a trial of "molecular auditing." We preferentially selected gastrointestinal, prostate, and skin biopsies because we estimated that these types of specimens had the greatest potential for misidentification. Results Of 972 specimen pairs, 1 showed an unexpected discordant genotype profile, indicating that 1 of the 2 specimens was misidentified. To date, we are unable to identify the etiology of the discordance. Conclusions These results demonstrate that, indeed, there is a low level of unsuspected tissue specimen misidentification, even in an environment with careful adherence to stringent quality assurance practices. This study demonstrates that molecular auditing of random, routine biopsy specimens can identify occult misidentified specimens, and may function as a useful quality indicator.

INFORMATION: Audit Report on "Accounting and Reporting for the American Recovery and Reinvestment Act by the Department of Energy's Funding Recipients"

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

2010-04-01

The American Recovery and Reinvestment Act of 2009 (Recovery Act) was established to jumpstart the U.S. economy, create or save millions of jobs, and invest in the Nation's energy future. The Department of Energy received approximately $37 billion through the Recovery Act to support a variety of science, energy and environmental initiatives. The Office of Management and Budget (OMB) issued guidance for carrying out stimulus-related activities which requires, among other things, that recipients ensure funds provided by the Recovery Act are clearly distinguishable from non-Recovery Act funds in all reporting systems and that recipients' actions are transparent to the public.more » To meet these requirements, the Department's recipients must clearly and accurately track and report on 18 separate data elements. In addition, the Department was to develop and implement a process to ensure that recipient information reported to the public was free from material omissions and significant reporting errors. Our recent report (OAS-RA-10-01, October 2009) noted that the Department had developed a quality assurance process to facilitate the quarterly reviews of recipient data and planned to test it during the first quarterly reporting cycle. To determine whether the Department's quality assurance process was effective, we examined information reported by recipients of Departmental funding as of September 30, 2009. We also sought to determine whether the Department's prime contractors were prepared to track and report on Recovery Act activities. The Department had taken a number of actions designed to ensure the accuracy and transparency of reported Recovery Act results. This process identified potential anomalies with information reported by 1,113 of 2,038, or 55 percent of recipients. We view the Department's data quality assurance efforts as both timely and significant. As noted by our audit testing, however, opportunities exist to strengthen the process. In particular: (1) Site officials did not always ensure that anomalies, once identified during the quality assurance process, were actually resolved. For example, the Department's process identified that about 740 of the approximately 10,000 jobs reported in the first quarter of Fiscal Year 2010 as created/retained were for projects reported as having no funds spent. Although these problems were referred to site officials for follow-up and/or correction, the information was never actually changed; (2) The Department did not always utilize the correct basis when evaluating the accuracy of 'funds provided' data submitted by grant recipients. For example, in its analysis process, the Department used data reflecting 'funds obligated' rather than the correct amount of 'total grant awards'. This generated a number of potential false positives; and, (3) Duplicate reports by certain recipients, resulting in overstatements of as much as $137 million of the more than $18 billion obligated, were not corrected. We observed that the Department had taken prompt action to ensure that its prime facility management contractors could properly report Recovery Act information. Notably, the seven contractors in this category included in our review had modified their accounting systems, as necessary, to ensure that they could accurately track and report on Recovery Act activities. The systems at each of these entities had been restructured so that they: (i) could separate Recovery Act and non-Recovery Act funds; and, (ii) had adequate processing capacity to handle the projected increase in transactions. We found the Department's decision to limit its reviews to the four elements that it considered to be critical (award amount, invoiced amount, jobs created/retained, and project status) to be reasonable. We concluded, however, other elements or dependent relationships should not be completely excluded from review. Beyond its initial development and implementation of its quality assurance process, the Department had taken steps to improve its ability to ensure that Recovery Act information was both accurate and transparent to the public. Specifically, officials changed the quality assurance plan based on initial data reviews. Department officials also informed us that they are in the process of updating their quality assurance process to meet new OMB requirements. For example, recent guidance directed agencies to focus on certain data elements, such as award number and recipient name, during their quality assurance reviews. In addition, subsequent to our review, the Department added two more data elements and comparisons to its quarterly assurance process, including an analysis of costs/expenditures and a comparison of the recipient reported project status to the Department's data contained in its financial system.« less

['Clinical auditing', a novel tool for quality assessment in surgical oncology].

PubMed

van Leersum, Nicoline J; Kolfschoten, Nikki E; Klinkenbijl, Jean H G; Tollenaar, Rob A E M; Wouters, Michel W J M

2011-01-01

To determine whether systematic audit and feedback of information about the process and outcomes improve the quality of surgical care. Systematic literature review. Embase, PubMed, and Web of Science databases were searched for publications on 'quality assessment' and 'surgery'. The references of the publications found were examined as well. Publications were included in the review if the effect of auditing on the quality of surgical care had been investigated. In the databases 2415 publications were found. After selection, 28 publications describing the effect of auditing, whether or not combined with a quality improvement project, on guideline adherence or indications of outcomes of care were included. In 21 studies, a statistically significant positive effect of auditing was reported. In 5 studies a positive effect was found, but this was either not significant or statistical significance was not determined. In 2 studies no effect was observed. 5 studies compared the combination of auditing with a quality improvement project with auditing alone; 4 of these reported an additional effect of the quality improvement project. Audit and feedback of quality information seem to have a positive effect on the quality of surgical care. The use of quality information from audits for the purpose of a quality improvement project can enhance the positive effect of the audit.

7 CFR 1421.406 - Reporting requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... review of the financial statement conducted by an independent Certified Public Accountant. The accountant's report of audit or review shall include the accountant's certifications, assurances, opinions...

Accuracy requirements and uncertainties in radiotherapy: a report of the International Atomic Energy Agency.

PubMed

van der Merwe, Debbie; Van Dyk, Jacob; Healy, Brendan; Zubizarreta, Eduardo; Izewska, Joanna; Mijnheer, Ben; Meghzifene, Ahmed

2017-01-01

Radiotherapy technology continues to advance and the expectation of improved outcomes requires greater accuracy in various radiotherapy steps. Different factors affect the overall accuracy of dose delivery. Institutional comprehensive quality assurance (QA) programs should ensure that uncertainties are maintained at acceptable levels. The International Atomic Energy Agency has recently developed a report summarizing the accuracy achievable and the suggested action levels, for each step in the radiotherapy process. Overview of the report: The report seeks to promote awareness and encourage quantification of uncertainties in order to promote safer and more effective patient treatments. The radiotherapy process and the radiobiological and clinical frameworks that define the need for accuracy are depicted. Factors that influence uncertainty are described for a range of techniques, technologies and systems. Methodologies for determining and combining uncertainties are presented, and strategies for reducing uncertainties through QA programs are suggested. The role of quality audits in providing international benchmarking of achievable accuracy and realistic action levels is also discussed. The report concludes with nine general recommendations: (1) Radiotherapy should be applied as accurately as reasonably achievable, technical and biological factors being taken into account. (2) For consistency in prescribing, reporting and recording, recommendations of the International Commission on Radiation Units and Measurements should be implemented. (3) Each institution should determine uncertainties for their treatment procedures. Sample data are tabulated for typical clinical scenarios with estimates of the levels of accuracy that are practically achievable and suggested action levels. (4) Independent dosimetry audits should be performed regularly. (5) Comprehensive quality assurance programs should be in place. (6) Professional staff should be appropriately educated and adequate staffing levels should be maintained. (7) For reporting purposes, uncertainties should be presented. (8) Manufacturers should provide training on all equipment. (9) Research should aid in improving the accuracy of radiotherapy. Some example research projects are suggested.

Analysis of regional radiotherapy dosimetry audit data and recommendations for future audits

PubMed Central

Palmer, A; Mzenda, B; Kearton, J; Wills, R

2011-01-01

Objectives Regional interdepartmental dosimetry audits within the UK provide basic assurances of the dosimetric accuracy of radiotherapy treatments. Methods This work reviews several years of audit results from the South East Central audit group including megavoltage (MV) and kilovoltage (kV) photons, electrons and iodine-125 seeds. Results Apart from some minor systematic errors that were resolved, the results of all audits have been within protocol tolerances, confirming the long-term stability and agreement of basic radiation dosimetric parameters between centres in the audit region. There is some evidence of improvement in radiation dosimetry with the adoption of newer codes of practice. Conclusion The value of current audit methods and the limitations of peer-to-peer auditing is discussed, particularly the influence of the audit schedule on the results obtained, where no “gold standard” exists. Recommendations are made for future audits, including an essential requirement to maintain the monitoring of basic fundamental dosimetry, such as MV photon and electron output, but audits must also be developed to include new treatment technologies such as image-guided radiotherapy and address the most common sources of error in radiotherapy. PMID:21159805

Quality audit of colonoscopy reports amongst patients screened or surveilled for colorectal neoplasia.

PubMed

Beaulieu, Daphnée; Barkun, Alan; Martel, Myriam

2012-07-21

To complete a quality audit using recently published criteria from the Quality Assurance Task Group of the National Colorectal Cancer Roundtable. Consecutive colonoscopy reports of patients at average/high risk screening, or with a prior colorectal neoplasia (CRN) by endoscopists who perform 11 000 procedures yearly, using a commercial computerized endoscopic report generator. A separate institutional database providing pathological results. Required documentation included patient demographics, history, procedure indications, technical descriptions, colonoscopy findings, interventions, unplanned events, follow-up plans, and pathology results. Reports abstraction employed a standardized glossary with 10% independent data validation. Sample size calculations determined the number of reports needed. Two hundreds and fifty patients (63.2 ± 10.5 years, female: 42.8%, average risk: 38.5%, personal/family history of CRN: 43.3%/20.2%) were scoped in June 2009 by 8 gastroenterologists and 3 surgeons (mean practice: 17.1 ± 8.5 years). Procedural indication and informed consent were always documented. 14% provided a previous colonoscopy date (past polyp removal information in 25%, but insufficient in most to determine surveillance intervals appropriateness). Most procedural indicators were recorded (exam date: 98.4%, medications: 99.2%, difficulty level: 98.8%, prep quality: 99.6%). All reports noted extent of visualization (cecum: 94.4%, with landmarks noted in 78.8% - photodocumentation: 67.2%). No procedural times were recorded. One hundred and eleven had polyps (44.4%) with anatomic location noted in 99.1%, size in 65.8%, morphology in 62.2%; removal was by cold biopsy in 25.2% (cold snare: 18%, snare cautery: 31.5%, unrecorded: 20.7%), 84.7% were retrieved. Adenomas were noted in 24.8% (advanced adenomas: 7.6%, cancer: 0.4%) in this population with varying previous colonic investigations. This audit reveals lacking reported items, justifying additional research to optimize quality of reporting.

Quality audit of colonoscopy reports amongst patients screened or surveilled for colorectal neoplasia

PubMed Central

Beaulieu, Daphnée; Barkun, Alan; Martel, Myriam

2012-01-01

AIM: To complete a quality audit using recently published criteria from the Quality Assurance Task Group of the National Colorectal Cancer Roundtable. METHODS: Consecutive colonoscopy reports of patients at average/high risk screening, or with a prior colorectal neoplasia (CRN) by endoscopists who perform 11 000 procedures yearly, using a commercial computerized endoscopic report generator. A separate institutional database providing pathological results. Required documentation included patient demographics, history, procedure indications, technical descriptions, colonoscopy findings, interventions, unplanned events, follow-up plans, and pathology results. Reports abstraction employed a standardized glossary with 10% independent data validation. Sample size calculations determined the number of reports needed. RESULTS: Two hundreds and fifty patients (63.2 ± 10.5 years, female: 42.8%, average risk: 38.5%, personal/family history of CRN: 43.3%/20.2%) were scoped in June 2009 by 8 gastroenterologists and 3 surgeons (mean practice: 17.1 ± 8.5 years). Procedural indication and informed consent were always documented. 14% provided a previous colonoscopy date (past polyp removal information in 25%, but insufficient in most to determine surveillance intervals appropriateness). Most procedural indicators were recorded (exam date: 98.4%, medications: 99.2%, difficulty level: 98.8%, prep quality: 99.6%). All reports noted extent of visualization (cecum: 94.4%, with landmarks noted in 78.8% - photodocumentation: 67.2%). No procedural times were recorded. One hundred and eleven had polyps (44.4%) with anatomic location noted in 99.1%, size in 65.8%, morphology in 62.2%; removal was by cold biopsy in 25.2% (cold snare: 18%, snare cautery: 31.5%, unrecorded: 20.7%), 84.7% were retrieved. Adenomas were noted in 24.8% (advanced adenomas: 7.6%, cancer: 0.4%) in this population with varying previous colonic investigations. CONCLUSION: This audit reveals lacking reported items, justifying additional research to optimize quality of reporting. PMID:22826619

NOTE: Monte Carlo simulation of correction factors for IAEA TLD holders

NASA Astrophysics Data System (ADS)

Hultqvist, Martha; Fernández-Varea, José M.; Izewska, Joanna

2010-03-01

The IAEA standard thermoluminescent dosimeter (TLD) holder has been developed for the IAEA/WHO TLD postal dose program for audits of high-energy photon beams, and it is also employed by the ESTRO-QUALity assurance network (EQUAL) and several national TLD audit networks. Factors correcting for the influence of the holder on the TL signal under reference conditions have been calculated in the present work from Monte Carlo simulations with the PENELOPE code for 60Co γ-rays and 4, 6, 10, 15, 18 and 25 MV photon beams. The simulation results are around 0.2% smaller than measured factors reported in the literature, but well within the combined standard uncertainties. The present study supports the use of the experimentally obtained holder correction factors in the determination of the absorbed dose to water from the TL readings; the factors calculated by means of Monte Carlo simulations may be adopted for the cases where there are no measured data.

The 1979 Southeastern Virginia Urban Plume Study (SEV-UPS): Surface and airborne studies

NASA Technical Reports Server (NTRS)

White, J. H.; Eaton, W. C.; Saeger, M. L.; Strong, R. B.; Tommerdahl, J. B.

1980-01-01

The operation of two surface monitoring stations (one in downtown Norfolk, Virginia, one south of the city near the Great Dismal Swamp) and the collection of 40 hours of airborne measurements is described. Surface site measurements of ozone, oxides of nitrogen, sulfur dioxide, temperature, dew point, b sub seat, and condensation nuclei were made. Instrument calibrations, quality assurance audits, and preliminary data analysis in support of the Urban Plume Study were also made. The air pollution problems that were addressed are discussed. Data handling procedures followed for the surface stations are presented. The operation of the aircraft sampling platform is described. Aircraft sampling procedures are discussed. A preliminary descriptive analysis of the aircraft data is given along with data or plots for surface sites, airborne studies, hydrocarbon species, and instrument performance audits. Several of the aircraft flights clearly show the presence of an urban ozone plume downwind of Norfolk in the direction of the mean wind flow.

Is audit research? The relationships between clinical audit and social-research.

PubMed

Hughes, Rhidian

2005-01-01

Quality has an established history in health care. Audit, as a means of quality assessment, is well understood and the existing literature has identified links between audit and research processes. This paper reviews the relationships between audit and research processes, highlighting how audit can be improved through the principles and practice of social research. The review begins by defining the audit process. It goes on to explore salient relationships between clinical audit and research, grouped into the following broad themes: ethical considerations, highlighting responsibilities towards others and the need for ethical review for audit; asking questions and using appropriate methods, emphasising transparency in audit methods; conceptual issues, including identifying problematic concepts, such as "satisfaction", and the importance of reflexivity within audit; emphasising research in context, highlighting the benefits of vignettes and action research; complementary methods, demonstrating improvements for the quality of findings; and training and multidisciplinary working, suggesting the need for closer relationships between researchers and clinical practitioners. Audit processes cannot be considered research. Both audit and research processes serve distinct purposes. Attention to the principles of research when conducting audit are necessary to improve the quality of audit and, in turn, the quality of health care.

Quality Assurance Program for Molecular Medicine Laboratories

PubMed Central

Hajia, M; Safadel, N; Samiee, S Mirab; Dahim, P; Anjarani, S; Nafisi, N; Sohrabi, A; Rafiee, M; Sabzavi, F; Entekhabi, B

2013-01-01

Background: Molecular diagnostic methods have played and continuing to have a critical role in clinical laboratories in recent years. Therefore, standardization is an evolutionary process that needs to be upgrade with increasing scientific knowledge, improvement of the instruments and techniques. The aim of this study was to design a quality assurance program in order to have similar conditions for all medical laboratories engaging with molecular tests. Methods: We had to design a plan for all four elements; required space conditions, equipments, training, and basic guidelines. Necessary guidelines was prepared and confirmed by the launched specific committee at the Health Reference Laboratory. Results: Several workshops were also held for medical laboratories directors and staffs, quality control manager of molecular companies, directors and nominees from universities. Accreditation of equipments and molecular material was followed parallel with rest of program. Now we are going to accredit medical laboratories and to evaluate the success of the program. Conclusion: Accreditation of medical laboratory will be succeeding if its basic elements are provided in advance. Professional practice guidelines, holding training and performing accreditation the molecular materials and equipments ensured us that laboratories are aware of best practices, proper interpretation, limitations of techniques, and technical issues. Now, active external auditing can improve the applied laboratory conditions toward the defined standard level. PMID:23865028

Quality assurance program for molecular medicine laboratories.

PubMed

Hajia, M; Safadel, N; Samiee, S Mirab; Dahim, P; Anjarani, S; Nafisi, N; Sohrabi, A; Rafiee, M; Sabzavi, F; Entekhabi, B

2013-01-01

Molecular diagnostic methods have played and continuing to have a critical role in clinical laboratories in recent years. Therefore, standardization is an evolutionary process that needs to be upgrade with increasing scientific knowledge, improvement of the instruments and techniques. The aim of this study was to design a quality assurance program in order to have similar conditions for all medical laboratories engaging with molecular tests. We had to design a plan for all four elements; required space conditions, equipments, training, and basic guidelines. Necessary guidelines was prepared and confirmed by the launched specific committee at the Health Reference Laboratory. Several workshops were also held for medical laboratories directors and staffs, quality control manager of molecular companies, directors and nominees from universities. Accreditation of equipments and molecular material was followed parallel with rest of program. Now we are going to accredit medical laboratories and to evaluate the success of the program. Accreditation of medical laboratory will be succeeding if its basic elements are provided in advance. Professional practice guidelines, holding training and performing accreditation the molecular materials and equipments ensured us that laboratories are aware of best practices, proper interpretation, limitations of techniques, and technical issues. Now, active external auditing can improve the applied laboratory conditions toward the defined standard level.

Normalizing Heterogeneous Medical Imaging Data to Measure the Impact of Radiation Dose.

PubMed

Silva, Luís A Bastião; Ribeiro, Luís S; Santos, Milton; Neves, Nuno; Francisco, Dulce; Costa, Carlos; Oliveira, José Luis

2015-12-01

The production of medical imaging is a continuing trend in healthcare institutions. Quality assurance for planned radiation exposure situations (e.g. X-ray, computer tomography) requires examination-specific set-ups according to several parameters, such as patient's age and weight, body region and clinical indication. These data are normally stored in several formats and with different nomenclatures, which hinder the continuous and automatic monitoring of these indicators and the comparison between several institutions and equipment. This article proposes a framework that aggregates, normalizes and provides different views over collected indicators. The developed tool can be used to improve the quality of radiologic procedures and also for benchmarking and auditing purposes. Finally, a case study and several experimental results related to radiation exposure and productivity are presented and discussed.

A case management tool for occupational health nurses: development, testing, and application.

PubMed

Mannon, J A; Conrad, K M; Blue, C L; Muran, S

1994-08-01

1. Case management is a process of coordinating an individual client's health care services to achieve optimal, quality care delivered in a cost effective manner. The case manager establishes a provider network, recommends treatment plans that assure quality and efficacy while controlling costs, monitors outcomes, and maintains a strong communication link among all the parties. 2. Through development of audit tools such as the one presented in this article, occupational health nurses can document case management activities and provide employers with measurable outcomes. 3. The Case Management Activity Checklist was tested using data from 61 firefighters' musculoskeletal injury cases. 4. The activities on the checklist are a step by step process: case identification/case disposition; assessment; return to work plan; resource identification; collaborative communication; and evaluation.

Using the Abstraction Network in Complement to Description Logics for Quality Assurance in Biomedical Terminologies - A Case Study in SNOMED CT

PubMed Central

Wei, Duo; Bodenreider, Olivier

2015-01-01

Objectives To investigate errors identified in SNOMED CT by human reviewers with help from the Abstraction Network methodology and examine why they had escaped detection by the Description Logic (DL) classifier. Case study; Two examples of errors are presented in detail (one missing IS-A relation and one duplicate concept). After correction, SNOMED CT is reclassified to ensure that no new inconsistency was introduced. Conclusions DL-based auditing techniques built in terminology development environments ensure the logical consistency of the terminology. However, complementary approaches are needed for identifying and addressing other types of errors. PMID:20841848

Using the abstraction network in complement to description logics for quality assurance in biomedical terminologies - a case study in SNOMED CT.

PubMed

Wei, Duo; Bodenreider, Olivier

2010-01-01

To investigate errors identified in SNOMED CT by human reviewers with help from the Abstraction Network methodology and examine why they had escaped detection by the Description Logic (DL) classifier. Case study; Two examples of errors are presented in detail (one missing IS-A relation and one duplicate concept). After correction, SNOMED CT is reclassified to ensure that no new inconsistency was introduced. DL-based auditing techniques built in terminology development environments ensure the logical consistency of the terminology. However, complementary approaches are needed for identifying and addressing other types of errors.

The Perceived Impact of Quality Audit on the Work of Academics

ERIC Educational Resources Information Center

Cheng, Ming

2011-01-01

Quality audit has become the dominant means of assessing the quality of university teaching and learning. This paper addresses this international trend through the analysis of academics' perception of quality audit. It presents a new way to understand quality audit through the interpretation of how frontline academics in England perceived and…

Implementing Laboratory Quality Management Systems in Mozambique: The Becton Dickinson-US President's Emergency Plan for AIDS Relief Public-Private Partnership Initiative.

PubMed

Skaggs, Beth; Pinto, Isabel; Masamha, Jessina; Turgeon, David; Gudo, Eduardo Samo

2016-04-15

Mozambique's ministry of health (MOH) recognized the need to establish a national laboratory quality assurance (NLQA) program to improve the reliability and accuracy of laboratory testing. The Becton Dickinson-US President's Emergency Plan for AIDS Relief Public-Private Partnership (PPP) was used to garner MOH commitment and train a cadre of local auditors and managers to support sustainability and country ownership of a NLQA program. From January 2011 to April 2012, the World Health Organization Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist and the Strengthening Laboratory Management Towards Accreditation (SLMTA) curriculum were used in 6 MOH laboratories. PPP volunteers provided training and mentorship to build the capacity of local auditors and program managers to promote institutionalization and sustainability of the program within the MOH. SLIPTA was launched in 6 MOH laboratories, and final audits demonstrated improvements across the 13 quality system essentials, compared with baseline. Training and mentorship of MOH staff by PPP volunteers resulted in 18 qualified auditors and 28 managers/quality officers capacitated to manage the improvement process in their laboratories. SLIPTA helps laboratories improve the quality and reliability of their service even in the absence of full accreditation. Local capacity building ensures sustainability by creating country buy-in, reducing costs of audits, and institutionalizing program management. Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

49 CFR 385.329 - May a new entrant that has had its USDOT new entrant registration revoked and its operations...

Code of Federal Regulations, 2010 CFR

2010-10-01

... New Entrant Safety Assurance Program § 385.329 May a new entrant that has had its USDOT new entrant... new entrant registration was revoked because of a failed safety audit, the new entrant must do all of... because FMCSA found that the new entrant had failed to submit to a safety audit, it must do all of the...

49 CFR 385.335 - If the FMCSA conducts a compliance review on a new entrant, will the new entrant also be subject...

Code of Federal Regulations, 2010 CFR

2010-10-01

... entrant, will the new entrant also be subject to a safety audit? 385.335 Section 385.335 Transportation... Safety Assurance Program § 385.335 If the FMCSA conducts a compliance review on a new entrant, will the new entrant also be subject to a safety audit? If the FMCSA conducts a compliance review on a new...

Naval Logistics Integration Through Interoperable Supply Systems

DTIC Science & Technology

2014-06-13

having large stocks of materials in-theater has proven to be no assurance that the combat forces will get the supplies they need, when they need them...must maintain an auditable record of all life cycle events. Individual property records must be maintained for each asset managed in the APSR...requisitions input, requisition status, requisition audit , shipment status, file/text upload, batch queries, order list, PIR/Backorders, MILSTRIP templates

[Further development and validation of a clinical auditing procedure for rehabilitation facilities].

PubMed

Meixner, K; Lubenow, B; Brückner, U; Gerdes, N

2006-06-01

Visitations (audits) are considered an instrument of external quality assurance by which the structural and organizational set-up of health facilities can be assessed on site by external experts. The Deutsche Rentenversicherung Bund (including the former Bundesversicherungsanstalt für Angestellte, BfA, the statutory pension insurance agency for white collar employees) is the largest body responsible for rehabilitation in Germany, and it regularly carries out visitations in the approximately 650 rehab centres it sends its patients to. The project presented in this article aimed at developing a manual with detailed descriptions of the procedures and criteria of the assessment, as well as at checking the inter-rater-reliability of the assessment. The manual was developed in cooperation with experts of the Deutsche Rentenversicherung Bund. It contains a description of the areas to be assessed during a visitation as well as leading questions and criteria for the evaluation of single features. The manual was examined in "test visitations" in 10 centres, each of which was visited by three visitation teams (1 medical and 1 administrative expert) simultaneously. When the resulting 30 assessments were compared, the criterion "overall quality of the centre" (which was assessed on a 10-point scale) showed precise agreement in 47 %, and a deviation by 1 point in 33 % of the cases. Single features assessed on a three-point scale (no improvement needed/improvement recommended/immediate improvement obligatory) resulted in precise agreement in between 80 % ("medical and therapeutic processes") and 86 % ("structural features") of the cases. Two-point scales (condition fulfilled or not fulfilled) showed an agreement between 89 % ("internal quality management") and 97 % ("single structural features"). In order to maintain and further develop this good inter-rater-reliability, the visitors of Deutsche Rentenversicherung Bund are continually trained in applying the visitation manual. In addition to transferring knowledge, these internal training courses are aimed at exchanging views and experience in order to enhance consensus among the visitors. This approach of Deutsche Rentenversicherung Bund could be regarded as "internal quality assurance" of its visitation procedure.

Assessing the quality of pharmacist answers to telephone drug information questions.

PubMed

Woodward, C T; Stevenson, J G; Poremba, A

1990-04-01

A quality assurance (QA) program is described in which frontline pharmacists were asked test drug information questions via anonymous telephone calls. The program was instituted at a university hospital that began providing decentralized pharmaceutical services in 1985. Questions were developed on the basis of a pilot study conducted to determine the types and complexity of drug information questions received by frontline pharmacists at the hospital. Data on departmental clinical productivity were used to determine the number of questions that would be posed during each shift in the various service areas. The questions were posed during a 10-day period; the pharmacists were aware of the program, but the callers did not identify their affiliation with it. In response to 105 questions asked, 86 were judged to have been answered correctly, 13 answers were deemed incomplete, and 6 were judged incorrect. Pharmacists were more likely to respond incorrectly to complex questions and questions posed during the night shift. As a result of the audit, staff members with advanced clinical knowledge were asked to help less experienced pharmacists, the position of assistant director for drug information and staff development was created, and educational programs were instituted. The QA audit has been repeated twice. Posing test drug information questions via anonymous telephone calls is effective in assessing the quality of drug information provided by pharmacists in patient-care areas.

An audit of a hospital-based Doppler ultrasound quality control protocol using a commercial string Doppler phantom.

PubMed

Cournane, S; Fagan, A J; Browne, J E

2014-05-01

Results from a four-year audit of a Doppler quality assurance (QA) program using a commercially available Doppler string phantom are presented. The suitability of the phantom was firstly determined and modifications were made to improve the reliability and quality of the measurements. QA of Doppler ultrasound equipment is very important as data obtained from these systems is used in patient management. It was found that if the braided-silk filament of the Doppler phantom was exchanged with an O-ring rubber filament and the velocity range below 50 cm/s was avoided for Doppler quality control (QC) measurements, then the maximum velocity accuracy (MVA) error and intrinsic spectral broadening (ISB) results obtained using this device had a repeatability of 18 ± 3.3% and 19 ± 3.5%, respectively. A consistent overestimation of the MVA of between 12% and 56% was found for each of the tested ultrasound systems. Of more concern was the variation of the overestimation within each respective transducer category: MVA errors of the linear, curvilinear and phased array probes were in the range 12.3-20.8%, 32.3-53.8% and 27-40.7%, respectively. There is a dearth of QA data for Doppler ultrasound; it would be beneficial if a multicentre longitudinal study was carried out using the same Doppler ultrasound test object to evaluate sensitivity to deterioration in performance measurements. Copyright © 2013 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Special Report on Review of "The Department of Energy's Quality Assurance Process for Prime Recipients' Reporting for the American Recovery and Reinvestment Act"

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

2009-10-01

The American Recovery and Reinvestment Act of 2009 (Recovery Act) was established to jumpstart the U.S. economy, create or save millions of jobs, spur technological advances in health and science, and invest in the Nation's energy future. The Department of Energy (Department) will receive an unprecedented $37 billion in Recovery Act funding to support a variety of science, energy, and environmental initiatives. The majority of the funding received by the Department will be allocated to various recipients through grants, cooperative agreements, contracts, and other financial instruments. To ensure transparency and accountability, the Office of Management and Budget (OMB) requires thatmore » recipients report on their receipt and use of Recovery Act funds on a quarterly basis to FederalReporting.gov. OMB also specifies that Federal agencies should develop and implement formal procedures to help ensure the quality of recipient reported information. Data that must be reported by recipients includes total funding received; funds expended or obligated; projects or activities for which funds were obligated or expended; and the number of jobs created and/or retained. OMB requires that Federal agencies perform limited data quality reviews of recipient data to identify material omissions and/or significant reporting errors and notify the recipients of the need to make appropriate and timely changes to erroneous reports. As part of a larger audit of recipient Recovery Act reporting and performance measurement and in support of a Government-wide review sponsored by the Recovery Accountability and Transparency Board, we completed an interim review to determine whether the Department had established a process to ensure the quality and accuracy of recipient reports. Our review revealed that the Department had developed a quality assurance process to facilitate the quarterly reviews of recipient data. The process included procedures to compare existing information from the Department's financial information systems with that reported to FederalReporting.gov by recipients. In addition, plans were in place to notify recipients of anomalies and/or errors exposed by the quality assurance process. While the Department has made a good deal of progress in this area, we did, however, identify several issues which could, if not addressed, impact the effectiveness of the quality assurance process.« less

A national audit of retail lamb loin quality in Australia.

PubMed

Safari, E; Channon, H A; Hopkins, D L; Hall, D G; van de Ven, R

2002-07-01

A retail audit of lamb loin tenderness was conducted over a 12-month period to determine the variation in tenderness of Australian lamb. Tenderness was objectively measured using Warner-Bratzler (WB) shear force. Muscle pH and cooking loss were determined on all samples and colour was measured on a sub-sample of loins. A total of 909 midloins from retail butcher shops and supermarkets located in four Australian capital cities (Sydney, Canberra, Melbourne, and Perth) were evaluated at four sampling times (December 1997 and March, June, and October 1998). Overall, 20.3% of all midloins purchased had a WB shear force value above the threshold level of 5 kg. Generic samples from Melbourne butcher shops were similar for WB shear force on average to the generic samples from Canberra and Sydney, whereas those from Melbourne supermarkets had significantly (P<0.001) higher WB shear force and were in line with generic samples from Perth. In both Canberra and Perth, alliance (branded) lamb had a greater WB shear force (P<0.05) than generic lamb. No relationship was found between price per kg and shear force (r=0.02) for loins purchased in Sydney (n=220). Price per kg differed between months (P<0.001) and suburbs (P<0.001), but not between retail butcher shops and supermarkets. Of the midloins tested, 10.3% had a pH above the critical point of 5.8. Midloins from the December 1997 sampling had a lower pH (P<0.01) than those sampled at other months. Those sampled in Melbourne and Perth had a similar mean pH, which were lower (P<0.001) than Canberra and Sydney samples. The findings from this quality audit suggest that there is room to improve the tenderness of Australian lamb sold in the domestic market. A lamb eating quality assurance system, based on set protocols, is one approach that is currently being investigated in Australia to ensure the supply of consistently high eating quality lamb to consumers.

34 CFR 364.35 - What records must be maintained?

Code of Federal Regulations, 2010 CFR

2010-07-01

... requirements, the State plan must include satisfactory assurances that all recipients of financial assistance... (b) Other records that the Secretary determines to be appropriate to facilitate an effective audit...

Quality of pathology reports for advanced ovarian cancer: are we missing essential information? An audit of 479 pathology reports from the EORTC-GCG 55971/NCIC-CTG OV13 neoadjuvant trial.

PubMed

Verleye, Leen; Ottevanger, Petronella B; Kristensen, Gunnar B; Ehlen, Tom; Johnson, Nick; van der Burg, Maria E L; Reed, Nick S; Verheijen, René H M; Gaarenstroom, Katja N; Mosgaard, Berit; Seoane, Jose M; van der Velden, Jacobus; Lotocki, Robert; van der Graaf, Winette; Penninckx, Björn; Coens, Corneel; Stuart, Gavin; Vergote, Ignace

2011-01-01

To assess the quality of surgical pathology reports of advanced stage ovarian, fallopian tube and primary peritoneal cancer. This quality assurance project was performed within the EORTC-GCG 55971/NCIC-CTG OV13 study comparing primary debulking surgery followed by chemotherapy with neoadjuvant chemotherapy and interval debulking surgery. Four hundred and seventy nine pathology reports from 40 institutions in 11 different countries were checked for the following quality indicators: macroscopic description of all specimens, measuring and weighing of major specimens, description of tumour origin and differentiation. All specimens were macroscopically described in 92.3% of the reports. All major samples were measured and weighed in 59.9% of the reports. A description of the origin of the tumour was missing in 20.5% of reports of the primary debulking group and in 23.4% of the interval debulking group. Assessment of tumour differentiation was missing in 10% of the reports after primary debulking and in 20.8% of the reports after interval debulking. Completeness of reports is positively correlated with accrual volume and adversely with hospital volume or type of hospital (academic versus non-academic). Quality of reports differs significantly by country. This audit of ovarian cancer pathology reports reveals that in a substantial number of reports basic pathologic data are missing, with possible adverse consequences for the quality of cancer care. Specialisation by pathologists and the use of standardised synoptic reports can lead to improved quality of reporting. Further research is needed to better define pre- and post-operative diagnostic criteria for ovarian cancer treated with neoadjuvant chemotherapy. Copyright © 2010 Elsevier Ltd. All rights reserved.

DoD Did Not Negotiate Rates With Overseas Health Care Providers and Generally Paid Claims as Billed

DTIC Science & Technology

2014-04-01

Amy J. Frontz Principal Assistant Inspector General for Auditing INSPECTOR GENERAL DEPARTMENT OF DEFENSE 4800 MARK CENTER DRIVE...Introduction 2 │ DODIG-2014-052 Prior Audit Report Showed Need for Additional Controls in TRICARE Overseas Program DoD Inspector General (DoD IG) Report...controls that provides reasonable assurance that programs are operating as intended and to evaluate the effectiveness of the controls. We identified

Data Quality: 1979 Southeastern Virginia Urban Plume Study (SEV-UPS): Surface and Airborne studies

NASA Technical Reports Server (NTRS)

White, J. H.; Strong, R. B.; Saeger, M. L.; Eaton, W. C.; Lommerdahl, J. B.

1981-01-01

The SEV-UPS field study conducted during August 1979 involved the coordinated air quality data collection efforts of three different organizations operating a total of four aircraft and 12 ground stations. Incorporated into plans for that program were numerous quality assurance activities designed to identify potential hazards for data quality in time for their correction and to take data to allow assessment of the consistency of the data from different stations. The purpose of this study was to document QA procedures that were performed by participating agencies and revise data from all platforms for mutual compatibility. For the latter effort, cases were identified on 21 occasions on seven different days where two or more monitoring systems were operating in the same location at nearly the same time. Data from the systems involved were tabulated in 200 m altitude segments, averaged and compared to detect any bias between measurements made from different systems. The results of these comparisons along with the results of independent performance audits are presented.

[Local groups as a tool for quality assurance of community health services].

PubMed

Mjell, J; Hjortdahl, P

2001-05-30

The aim of this study was to assess the use of local interprofessional or audit groups as a tool of quality enhancement. Fifty-six doctors, physiotherapists and nurses attended nine local interprofessional groups. The aim was to improve the quality of each professional's practice and to improve communication between the professions. The groups had a total of 62 meetings with each professional attending on average 5.7 meetings. All groups initiated quality enhancement projects. Initially the groups were very active and showed great initiative, but there were few final results. However, many groups reported improved communication and cooperation between the participating professionals. The experience from this project may be summarised as follows: The professionals within one and the same group should have more or less the same background and specialty. We recommend caution with organising interprofessional groups unless their participants work in the same practice. Interprofessional groups should spend adequate time for the members to get to know each other, and they should be guided by an experienced leader.

Clinical laboratory accreditation in India.

PubMed

Handoo, Anil; Sood, Swaroop Krishan

2012-06-01

Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.

An external dosimetry audit programme to credential static and rotational IMRT delivery for clinical trials quality assurance.

PubMed

Eaton, David J; Tyler, Justine; Backshall, Alex; Bernstein, David; Carver, Antony; Gasnier, Anne; Henderson, Julia; Lee, Jonathan; Patel, Rushil; Tsang, Yatman; Yang, Huiqi; Zotova, Rada; Wells, Emma

2017-03-01

External dosimetry audits give confidence in the safe and accurate delivery of radiotherapy. The RTTQA group have performed an on-site audit programme for trial recruiting centres, who have recently implemented static or rotational IMRT, and those with major changes to planning or delivery systems. Measurements of reference beam output were performed by the host centre, and by the auditor using independent equipment. Verification of clinical plans was performed using the ArcCheck helical diode array. A total of 54 measurement sessions were performed between May 2014 and June 2016 at 28 UK institutions, reflecting the different combinations of planning and delivery systems used at each institution. Average ratio of measured output between auditor and host was 1.002±0.006. Average point dose agreement for clinical plans was -0.3±1.8%. Average (and 95% lower confidence intervals) of gamma pass rates at 2%/2mm, 3%/2mm and 3%/3mm respectively were: 92% (80%), 96% (90%) and 98% (94%). Moderately significant differences were seen between fixed gantry angle and rotational IMRT, and between combination of planning systems and linac manufacturer, but not between anatomical treatment site or beam energy. An external audit programme has been implemented for universal and efficient credentialing of IMRT treatments in clinical trials. Good agreement was found between measured and expected doses, with few outliers, leading to a simple table of optimal and mandatory tolerances for approval of dosimetry audit results. Feedback was given to some centres leading to improved clinical practice. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

A risk-based auditing process for pharmaceutical manufacturers.

PubMed

Vargo, Susan; Dana, Bob; Rangavajhula, Vijaya; Rönninger, Stephan

2014-01-01

The purpose of this article is to share ideas on developing a risk-based model for the scheduling of audits (both internal and external). Audits are a key element of a manufacturer's quality system and provide an independent means of evaluating the manufacturer's or the supplier/vendor's compliance status. Suggestions for risk-based scheduling approaches are discussed in the article. Pharmaceutical manufacturers are required to establish and implement a quality system. The quality system is an organizational structure defining responsibilities, procedures, processes, and resources that the manufacturer has established to ensure quality throughout the manufacturing process. Audits are a component of the manufacturer's quality system and provide a systematic and an independent means of evaluating the manufacturer's overall quality system and compliance status. Audits are performed at defined intervals for a specified duration. The intention of the audit process is to focus on key areas within the quality system and may not cover all relevant areas during each audit. In this article, the authors provide suggestions for risk-based scheduling approaches to aid pharmaceutical manufacturers in identifying the key focus areas for an audit.

Assessing data quality and the variability of source data verification auditing methods in clinical research settings.

PubMed

Houston, Lauren; Probst, Yasmine; Martin, Allison

2018-05-18

Data audits within clinical settings are extensively used as a major strategy to identify errors, monitor study operations and ensure high-quality data. However, clinical trial guidelines are non-specific in regards to recommended frequency, timing and nature of data audits. The absence of a well-defined data quality definition and method to measure error undermines the reliability of data quality assessment. This review aimed to assess the variability of source data verification (SDV) auditing methods to monitor data quality in a clinical research setting. The scientific databases MEDLINE, Scopus and Science Direct were searched for English language publications, with no date limits applied. Studies were considered if they included data from a clinical trial or clinical research setting and measured and/or reported data quality using a SDV auditing method. In total 15 publications were included. The nature and extent of SDV audit methods in the articles varied widely, depending upon the complexity of the source document, type of study, variables measured (primary or secondary), data audit proportion (3-100%) and collection frequency (6-24 months). Methods for coding, classifying and calculating error were also inconsistent. Transcription errors and inexperienced personnel were the main source of reported error. Repeated SDV audits using the same dataset demonstrated ∼40% improvement in data accuracy and completeness over time. No description was given in regards to what determines poor data quality in clinical trials. A wide range of SDV auditing methods are reported in the published literature though no uniform SDV auditing method could be determined for "best practice" in clinical trials. Published audit methodology articles are warranted for the development of a standardised SDV auditing method to monitor data quality in clinical research settings. Copyright © 2018. Published by Elsevier Inc.

How to conduct a clinical audit and quality improvement project.

PubMed

Limb, Christopher; Fowler, Alex; Gundogan, Buket; Koshy, Kiron; Agha, Riaz

2017-07-01

Audits and quality improvement projects are vital aspects of clinical governance and continual service improvement in medicine. In this article we describe the process of clinical audit and quality improvement project. Guidance is also provided on how to design an effective audit and bypass barriers encountered during the process.

External Quality Control Review of the Defense Information Systems Agency Audit Organization

DTIC Science & Technology

2012-08-07

We are providing this report for your information and use. We have reviewed the system of quality control for the audit organization of the Defense...audit organization encompasses the audit organization’s leadership, emphasis on performing high quality work, and policies and procedures established

CTEPP STANDARD OPERATING PROCEDURE FOR CONDUCTING INTERNAL FIELD AUDITS AND QUALITY CONTROL (SOP-2.25)

EPA Science Inventory

This SOP describes the method for conducting internal field audits and quality control procedures. Internal field audits will be conducted to ensure the collection of high quality data. Internal field audits will be conducted by Field Auditors (the Field QA Officer and the Field...

Surgery has a key role for quality assurance of colorectal cancer screening programs: impact of the third level multidisciplinary team on lymph nodal staging.

PubMed

Bianco, Francesco; De Franciscis, Silvia; Belli, Andrea; Di Lena, Maria; Avallone, Antonio; Bianco, Maria Antonia; Di Marzo, Sabato; Gigli, Letizia; Rotondano, Gianluca; Spena, Silvana Russo; Tatangelo, Fabiana; Tempesta, Alfonso; Romano, Giovanni Maria

2016-03-01

From 2011 to 2013 in the area of the Naples 3 public health district (ASL-NA3), a colorectal cancer screening program (CCSP) was developed. In order to stress the need of quality assurance procedures for surgery and pathology, a third level oncologic pathway was added and set up at a referral colorectal cancer center (RC). Lymph nodal (LN) harvesting, as a process indicator, and nodal positivity were adopted for an interim analysis. The program was implemented by a series of audit meetings and a double type of multidisciplinary team (MDT): "horizontal" and "vertical." Three hundred and forty colorectal cancer (CRC) patients underwent surgery: 119 chose to be operated at the RC (Gr In), 65 were operated at 22 district hospitals (DH) (Gr Out), and 156 symptomatic not screened patients were operated at the RC (Gr Sym). Statistical analysis revealed differences between Gr In and Gr Out colon groups both for LN harvesting (median of 26 and 11, respectively, P = 0.0001), and for nodal positivity after the first screening round (34.78 and 19.45%, respectively, P = 0.0169). Results were all the more significant in a subset analysis on early T stage colon subgroups (In vs Out) both for LN harvesting (P < 0.0001) and nodal positivity (P < 0.0001). xSignificant differences between RC and DHs were found, particularly for early-stage CRC patients. LN harvesting should be considered as a surrogate marker of quality assurance for at least screening hospitals for "minimum best" standard of care. This should lead to set up a third level in any CCSP.