'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�

[Quality assurance in occupational health services].

PubMed

Michalak, J

1996-01-01

The general conditions influencing the quality assurance and audit in Polish occupational health services are presented. The factors promoting or hampering the implementation of quality assurance and audits are also discussed. The major influence on the transformation of Polish occupational health services in exorted by employers who are committed to cover the costs of the obligatory prophylactic examination of their employees. This is the factor which also contributes to the improvement of quality if services. The definitions of the most important terms are reviewed to highlight their accordance with the needs of occupational health services in Poland. The examples of audit are presented and the elements of selected methods of auditing are suggested to be adopted in Poland.

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.

Auditor Independence: Beyond the Dilemma of Combining Auditing and Advisory Activities for the Development of Quality Assurance Systems in Agriculture

ERIC Educational Resources Information Center

Maxime, Francoise; Maze, Armelle

2006-01-01

This article aims to study the design and the organization of auditing systems to develop environmental or quality assurance schemes at the farm level and the role that extension services could play in these processes. It starts by discussing the issue of combining auditing and advisory activities and developing auditing competences. Empirical…

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.

Academic Staff Views on External Quality Audit: Post Audit Evaluation in a Private Higher Education College

ERIC Educational Resources Information Center

Shah, Mahsood; Nair, Chenicheri Sid; Stanford, Sue-Ann

2011-01-01

Governments in many countries have funded independent agencies to undertake quality audits of higher education institutions. Such agencies ensure that universities and other higher education providers have effective systems and processes to assure quality assurance in core and support areas. While external quality audits have been in place for a…

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.

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)

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)…

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…

Developing and Implementing a Quality Assurance Strategy for Electroconvulsive Therapy.

PubMed

Hollingsworth, Jessa; Baliko, Beverly; McKinney, Selina; Rosenquist, Peter

2018-04-17

The literature provides scant guidance in effective quality assurance strategies concerning the use of electroconvulsive therapy (ECT) for the treatment of psychiatric conditions. Numerous guidelines are published that provide guidance in the delivery of care; however, little has been done to determine how a program or facility might ensure compliance to best practice for safety, tolerability, and efficacy in performing ECT. The objective of this project was to create a quality assurance strategy specific to ECT. Determining standards for quality care and clarifying facility policy were key outcomes in establishing an effective quality assurance strategy. An audit tool was developed utilizing quality criteria derived from a systematic review of ECT practice guidelines, peer review, and facility policy. All ECT procedures occurring over a 2-month period of May to June 2017 were retrospectively audited and compared against target compliance rates set for the facility's ECT program. Facility policy was adapted to reflect quality standards, and audit findings were used to inform possible practice change initiatives, were used to create benchmarks for continuous quality monitoring, and were integrated into regular hospital quality meetings. Clarification on standards of care and the use of clinical auditing in ECT was an effective starting point in the development of a quality assurance strategy. Audit findings were successfully integrated into the hospital's overall quality program, and recognition of practice compliance informed areas for future quality development and policy revision in this small community-based hospital in the southeastern United States. This project sets the foundation for a quality assurance strategy that can be used to help monitor procedural safety and guide future improvement efforts in delivering ECT. Although it is just the first step in creating meaningful quality improvement, setting clear standards and identifying areas of greatest

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.

Quality audit--a review of the literature concerning delivery of continence care.

PubMed

Swaffield, J

1995-09-01

This paper outlines the role of quality audit within the framework of quality assurance, presenting the concurrent and retrospective approaches available. The literature survey provides a review of the limited audit tools available and their application to continence services and care delivery, as well as attempts to produce tools from national and local standard setting. Audit is part of a process; it can involve staff, patients and their relatives and the team of professionals providing care, as well as focusing on organizational and management levels. In an era of market delivery of services there is a need to justify why audit is important to continence advisors and managers. Effectiveness, efficiency and economics may drive the National Health Service, but quality assurance, which includes standards and audit tools, offers the means to ensure the quality of continence services and care to patients and auditing is also required in the purchaser/provider contracts for patient services. An overview and progress to date of published and other a projects in auditing continence care and service is presented. By outlining and highlighting the audit of continence service delivery and care as a basis on which to build quality assurance programmes, it is hoped that this knowledge will be shared through the setting up of a central auditing clearing project.

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…

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.

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.

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…

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…

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.

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…

Contract Quality Assurance and Pricing Practices for Patriot Missile Procurements

DTIC Science & Technology

1995-06-26

The audit objectives were to evaluate DoD and Raytheon quality assurance and pricing practices for Patriot missile circuit boards. We also evaluated the management control program as it applied to the audit objectives.

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.

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…

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.

[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.

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…

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…

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.

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…

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…

10 CFR 71.137 - Audits.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Audits. 71.137 Section 71.137 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71.137 Audits... planned and periodic audits to verify compliance with all aspects of the quality assurance program and to...

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.

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.

[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.

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,…

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 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.

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.

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).

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

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…

[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.

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.

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)

Statistical auditing of toxicology reports.

PubMed

Deaton, R R; Obenchain, R L

1994-06-01

Statistical auditing is a new report review process used by the quality assurance unit at Eli Lilly and Co. Statistical auditing allows the auditor to review the process by which the report was generated, as opposed to the process by which the data was generated. We have the flexibility to use different sampling techniques and still obtain thorough coverage of the report data. By properly implementing our auditing process, we can work smarter rather than harder and continue to help our customers increase the quality of their products (reports). Statistical auditing is helping our quality assurance unit meet our customers' need, while maintaining or increasing the quality of our regulatory obligations.

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.

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...

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…

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

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

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.

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

Surgical audit in the developing countries.

PubMed

Bankole, J O; Lawal, O O; Adejuyigbe, O

2003-01-01

Audit assures provision of good quality health service at affordable cost. To be complete therefore, surgical practice in the young developing countries, as elsewhere, must incorporate auditing. Peculiarities of the developing countries and insufficient understanding of auditing may be, however, responsible for its been little practised. This article, therefore, reviews the objectives, the commonly evaluated aspects, and the method of audit, and includes a simple model of audit cycle. It is hoped that it will kindle the idea of regular practice of quality assurance by surgeons working in the young developing nations and engender a sustainable interest.

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.

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.

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.

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.

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...

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.

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.

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.

Clinical audit: shining a light on good practice.

PubMed

Grainger, Angela

2010-07-01

Healthcare organisations undertake quality assurance to produce safe and effective patient care systems. Statutory quality assurance requirements are met through external reviews, monitoring and inspection processes, and each NHS trust must produce a corporate annual quality account. However, this can result in approaching audits as if they are 'tick-box activities'. This article discusses how organisations can avoid this trap by applying audit results to practice.

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.

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.

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.

College Quality Assurance Assurances. Mendip Papers 020.

ERIC Educational Resources Information Center

Sallis, E.; Hingley, P.

This paper discusses the increasing interest in quality assurance in British education including its measurement and management through the introduction of a quality assurance system. The reasons and benefits of beginning a quality assurance system are discussed, and questions of what constitutes quality, whether it is quality in fact…

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

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...

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.

Multinational Quality Assurance

ERIC Educational Resources Information Center

Kinser, Kevin

2011-01-01

Multinational colleges and universities pose numerous challenges to the traditional models of quality assurance that are designed to validate domestic higher education. When institutions cross international borders, at least two quality assurance protocols are involved. To guard against fraud and abuse, quality assurance in the host country is…

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.

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.

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

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...

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.

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.

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.

Quality Assurance.

ERIC Educational Resources Information Center

Massachusetts Career Development Inst., Springfield.

This booklet is one of six texts from a workplace literacy curriculum designed to assist learners in facing the increased demands of the workplace. The booklet contains five sections that cover the following topics: (1) importance of reliability; (2) meaning of quality assurance; (3) historical development of quality assurance; (4) statistical…

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...

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.

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

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.

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.

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.

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.

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.

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.

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

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.

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

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.

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.

Quality assurance in transition.

PubMed

Blumenfeld, S N

1993-06-01

This paper outlines the early approaches to quality assurance, and its transition from business to health care. It then describes the development of the more recent trends in quality assurance of Total Quality Management and Continuous Quality Improvement and discusses the strengths and weaknesses of these approaches. The paper then goes on to show how these approaches have been modified for application to peripheral health services in developing countries through the work of the Primary Health Care Operations Research Project and the Quality Assurance Project.

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.

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.

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

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.

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.

Saving Quality from Quality Assurance. Perspective

ERIC Educational Resources Information Center

Stephenson, Sandra L.

2004-01-01

The word 'quality' has become a 'central term in the lexicon of contemporary higher education and a major point of interest to various interest groups'. As quality assurance systems have developed around the world, certain assumptions are becoming alarmingly widespread: for example that quality assurance is new to higher education, that quality…

Quality Assurance for University Teaching.

ERIC Educational Resources Information Center

Ellis, Roger, Ed.

This book, written from a British perspective, presents 17 papers on quality assurance in teaching at the university level. The first eight papers address issues of assuring quality and include: (1) "Quality Assurance for University Teaching; Issues and Approaches" (Roger Ellis); (2) "A British Standard for University…

10 CFR 71.37 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance. 71.37 Section 71.37 Energy NUCLEAR... Package Approval § 71.37 Quality assurance. (a) The applicant shall describe the quality assurance program... quality assurance program that are applicable to the particular package design under consideration...

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.

Training, Quality Assurance Factors, and Tools Investigation: a Work Report and Suggestions on Software Quality Assurance

NASA Technical Reports Server (NTRS)

Lee, Pen-Nan

1991-01-01

Previously, several research tasks have been conducted, some observations were obtained, and several possible suggestions have been contemplated involving software quality assurance engineering at NASA Johnson. These research tasks are briefly described. Also, a brief discussion is given on the role of software quality assurance in software engineering along with some observations and suggestions. A brief discussion on a training program for software quality assurance engineers is provided. A list of assurance factors as well as quality factors are also included. Finally, a process model which can be used for searching and collecting software quality assurance tools is presented.

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

Read Code Quality Assurance

PubMed Central

Schulz, Erich; Barrett, James W.; Price, Colin

1998-01-01

As controlled clinical vocabularies assume an increasing role in modern clinical information systems, so the issue of their quality demands greater attention. In order to meet the resulting stringent criteria for completeness and correctness, a quality assurance system comprising a database of more than 500 rules is being developed and applied to the Read Thesaurus. The authors discuss the requirement to apply quality assurance processes to their dynamic editing database in order to ensure the quality of exported products. Sources of errors include human, hardware, and software factors as well as new rules and transactions. The overall quality strategy includes prevention, detection, and correction of errors. The quality assurance process encompasses simple data specification, internal consistency, inspection procedures and, eventually, field testing. The quality assurance system is driven by a small number of tables and UNIX scripts, with “business rules” declared explicitly as Structured Query Language (SQL) statements. Concurrent authorship, client-server technology, and an initial failure to implement robust transaction control have all provided valuable lessons. The feedback loop for error management needs to be short. PMID:9670131

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.

RAVEN Quality Assurance Activities

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

Cogliati, Joshua Joseph

2015-09-01

This report discusses the quality assurance activities needed to raise the Quality Level of Risk Analysis in a Virtual Environment (RAVEN) from Quality Level 3 to Quality Level 2. This report also describes the general RAVEN quality assurance activities. For improving the quality, reviews of code changes have been instituted, more parts of testing have been automated, and improved packaging has been created. For upgrading the quality level, requirements have been created and the workflow has been improved.

[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.

[Integrated quality assurance].

PubMed

Bögel, K; Stöhr, K

1994-07-01

The definition of terms and connotation of "Quality", "Quality Assurance" and "Integration" lead to an analysis and understanding of inhibiting and fostering factors of the "Health Triad" of people, animals and environment. Although "Quality" is largely or ultimately determined by the consumer, there are considerable differences as this term is applied by (a) the individual consumer, (b) the dynamic producer defending or gaining markets, (c) those engaged in traditional product manufacturing, or (d) governments setting (minimum) requirements for the sake of free trade. "Quality Assurance" offers cooperation of partners all along the food chain from "pasture to table". The managerial process turned into a continuum of responsibility and agreement on processes and product characteristics. This overcomes the disadvantages of strategies stressing distinct defense barriers. In practice this philosophy of a predominant role of defence barriers proved largely partnership destructive, in that it permitted to shift responsibilities for failures and to claim administrative competence according to momentary situations and interests. "Integrated Quality Assurance" means mutual agreement of two or more partners along the food chain (e. g. feed producers, farmers, animal health industry, veterinarians and food processors) on product characteristics and production methods. It involves essential system elements including facilities, materials, manpower, information, transport, management etc. Different principles and procedures of quality assurance have been introduced in practice, including agriculture and food processing. These different approaches are not mutually exclusive but largely of complementary nature.(ABSTRACT TRUNCATED AT 250 WORDS)

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…

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.

23 CFR 637.207 - Quality assurance program.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false Quality assurance program. 637.207 Section 637.207... CONSTRUCTION INSPECTION AND APPROVAL Quality Assurance Procedures for Construction § 637.207 Quality assurance program. (a) Each STD's quality assurance program shall provide for an acceptance program and an...

40 CFR 31.45 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Quality assurance. 31.45 Section 31.45... Requirements Reports, Records, Retention, and Enforcement § 31.45 Quality assurance. If the grantee's project... quality assurance practices consisting of policies, procedures, specifications, standards, and...

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…

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

10 CFR 72.140 - Quality assurance requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance requirements. 72.140 Section 72.140... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.140 Quality assurance requirements. (a) Purpose. This subpart describes quality assurance...

10 CFR 71.103 - Quality assurance organization.

Code of Federal Regulations, 2012 CFR

2012-01-01

... contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance organization. 71.103 Section 71.103... Quality Assurance § 71.103 Quality assurance organization. (a) The licensee, 2 certificate holder, and...

10 CFR 71.103 - Quality assurance organization.

Code of Federal Regulations, 2014 CFR

2014-01-01

... contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance organization. 71.103 Section 71.103... Quality Assurance § 71.103 Quality assurance organization. (a) The licensee, 2 certificate holder, and...

10 CFR 71.103 - Quality assurance organization.

Code of Federal Regulations, 2013 CFR

2013-01-01

... contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance organization. 71.103 Section 71.103... Quality Assurance § 71.103 Quality assurance organization. (a) The licensee, 2 certificate holder, and...

10 CFR 76.93 - Quality assurance.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each of...

10 CFR 76.93 - Quality assurance.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each of...

10 CFR 76.93 - Quality assurance.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each of...

10 CFR 76.93 - Quality assurance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each of...

10 CFR 76.93 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance. 76.93 Section 76.93 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.93 Quality assurance. The Corporation shall establish, maintain, and execute a quality assurance program satisfying each of...

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.

[Introduction of Quality Management System Audit in Medical Device Single Audit Program].

PubMed

Wen, Jing; Xiao, Jiangyi; Wang, Aijun

2018-01-30

The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.

30 CFR 74.9 - Quality assurance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Quality assurance. 74.9 Section 74.9 Mineral... DUST SAMPLING DEVICES Requirements for Continuous Personal Dust Monitors § 74.9 Quality assurance. (a) General requirements. The applicant shall establish and maintain a quality control system that assures...

40 CFR 30.54 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Quality assurance. 30.54 Section 30.54... NON-PROFIT ORGANIZATIONS Post-Award Requirements Reports and Records § 30.54 Quality assurance. If the... data generation, the grantee shall develop and implement quality assurance practices consisting of...

10 CFR 63.144 - Quality assurance program change.

Code of Federal Regulations, 2013 CFR

2013-01-01

... assurance program information that duplicates language in quality assurance regulatory guides and quality... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance program change. 63.144 Section 63.144... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Quality Assurance § 63.144 Quality assurance program change. Changes to...

10 CFR 63.144 - Quality assurance program change.

Code of Federal Regulations, 2014 CFR

2014-01-01

... assurance program information that duplicates language in quality assurance regulatory guides and quality... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance program change. 63.144 Section 63.144... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Quality Assurance § 63.144 Quality assurance program change. Changes to...

10 CFR 63.144 - Quality assurance program change.

Code of Federal Regulations, 2012 CFR

2012-01-01

... assurance program information that duplicates language in quality assurance regulatory guides and quality... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance program change. 63.144 Section 63.144... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Quality Assurance § 63.144 Quality assurance program change. Changes to...

Principles and Practices for Quality Assurance and Quality Control

USGS Publications Warehouse

Jones, Berwyn E.

1999-01-01

Quality assurance and quality control are vital parts of highway runoff water-quality monitoring projects. To be effective, project quality assurance must address all aspects of the project, including project management responsibilities and resources, data quality objectives, sampling and analysis plans, data-collection protocols, data quality-control plans, data-assessment procedures and requirements, and project outputs. Quality control ensures that the data quality objectives are achieved as planned. The historical development and current state of the art of quality assurance and quality control concepts described in this report can be applied to evaluation of data from prior projects.

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.

Thoughts on Internal and External Quality Assurance

ERIC Educational Resources Information Center

Zhang, Jianxin

2012-01-01

Quality assurance of higher education is made up of two parts: internal quality assurance (IQA) and external quality assurance (EQA). Both belong to a union of the coexistence and balance of yin and yang. But in reality there exists a paradox of "confusion of quality assurance (QA) subject consciousness, singularity of social QA and lack of QA…

40 CFR 194.22 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Quality assurance. 194.22 Section 194... General Requirements § 194.22 Quality assurance. (a)(1) As soon as practicable after April 9, 1996, the Department shall adhere to a quality assurance program that implements the requirements of ASME NQA-1-1989...

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...

Internal Quality Assurance--Enhancing Quality Culture. ENQA Workshop Report 16

ERIC Educational Resources Information Center

ENQA (European Association for Quality Assurance in Higher Education), 2010

2010-01-01

The European Association for Quality Assurance in Higher Education (ENQA), in cooperation with the Quality Assurance Agency (QAA, UK), organised a seminar on theme "Internal Quality Assurance--Enhancing quality culture" which was held on 8-9 June, 2010 in London, United Kingdom. The seminar marked the fourth annual meeting of the ENQA…

Modernization of software quality assurance

NASA Technical Reports Server (NTRS)

Bhaumik, Gokul

1988-01-01

The customers satisfaction depends not only on functional performance, it also depends on the quality characteristics of the software products. An examination of this quality aspect of software products will provide a clear, well defined framework for quality assurance functions, which improve the life-cycle activities of software development. Software developers must be aware of the following aspects which have been expressed by many quality experts: quality cannot be added on; the level of quality built into a program is a function of the quality attributes employed during the development process; and finally, quality must be managed. These concepts have guided our development of the following definition for a Software Quality Assurance function: Software Quality Assurance is a formal, planned approach of actions designed to evaluate the degree of an identifiable set of quality attributes present in all software systems and their products. This paper is an explanation of how this definition was developed and how it is used.

Improving patient safety through quality assurance.

PubMed

Raab, Stephen S

2006-05-01

Anatomic pathology laboratories use several quality assurance tools to detect errors and to improve patient safety. To review some of the anatomic pathology laboratory patient safety quality assurance practices. Different standards and measures in anatomic pathology quality assurance and patient safety were reviewed. Frequency of anatomic pathology laboratory error, variability in the use of specific quality assurance practices, and use of data for error reduction initiatives. Anatomic pathology error frequencies vary according to the detection method used. Based on secondary review, a College of American Pathologists Q-Probes study showed that the mean laboratory error frequency was 6.7%. A College of American Pathologists Q-Tracks study measuring frozen section discrepancy found that laboratories improved the longer they monitored and shared data. There is a lack of standardization across laboratories even for governmentally mandated quality assurance practices, such as cytologic-histologic correlation. The National Institutes of Health funded a consortium of laboratories to benchmark laboratory error frequencies, perform root cause analysis, and design error reduction initiatives, using quality assurance data. Based on the cytologic-histologic correlation process, these laboratories found an aggregate nongynecologic error frequency of 10.8%. Based on gynecologic error data, the laboratory at my institution used Toyota production system processes to lower gynecologic error frequencies and to improve Papanicolaou test metrics. Laboratory quality assurance practices have been used to track error rates, and laboratories are starting to use these data for error reduction initiatives.

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

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.

Material quality assurance risk assessment : [summary].

DOT National Transportation Integrated Search

2013-01-01

With the shift from quality control (QC) of materials and placement techniques : to quality assurance (QA) and acceptance over the years, the role of the Office : of Materials Technology (OMT) has been shifting towards assurance of : material quality...

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.

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.

222-S Laboratory Quality Assurance Plan. Revision 1

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

Meznarich, H.K.

1995-07-31

This Quality Assurance Plan provides,quality assurance (QA) guidance, regulatory QA requirements (e.g., 10 CFR 830.120), and quality control (QC) specifications for analytical service. This document follows the U.S Department of Energy (DOE) issued Hanford Analytical Services Quality Assurance Plan (HASQAP). In addition, this document meets the objectives of the Quality Assurance Program provided in the WHC-CM-4-2, Section 2.1. Quality assurance elements required in the Guidelines and Specifications for Preparing Quality Assurance Program Plans (QAMS-004) and Interim Guidelines and Specifications for Preparing Quality Assurance Project Plans (QAMS-005) from the US Environmental Protection Agency (EPA) are covered throughout this document. A qualitymore » assurance index is provided in the Appendix A. This document also provides and/or identifies the procedural information that governs laboratory operations. The personnel of the 222-S Laboratory and the Standards Laboratory including managers, analysts, QA/QC staff, auditors, and support staff shall use this document as guidance and instructions for their operational and quality assurance activities. Other organizations that conduct activities described in this document for the 222-S Laboratory shall follow this QA/QC document.« less

10 CFR 71.103 - Quality assurance organization.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance organization. 71.103 Section 71.103... Quality Assurance § 71.103 Quality assurance organization. (a) The licensee, 2 certificate holder, and... that are important to safety have been correctly performed. (c) The persons and organizations...

10 CFR 71.103 - Quality assurance organization.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance organization. 71.103 Section 71.103... Quality Assurance § 71.103 Quality assurance organization. (a) The licensee, 2 certificate holder, and... that are important to safety have been correctly performed. (c) The persons and organizations...

10 CFR 71.135 - Quality assurance records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance records. 71.135 Section 71.135 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71.135 Quality assurance records. The licensee, certificate holder, and applicant for a CoC...

49 CFR 180.505 - Quality assurance program.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 2 2010-10-01 2010-10-01 false Quality assurance program. 180.505 Section 180.505... MAINTENANCE OF PACKAGINGS Qualification and Maintenance of Tank Cars § 180.505 Quality assurance program. The quality assurance program requirements of § 179.7 of this subchapter apply. ...

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

48 CFR 37.604 - Quality assurance surveillance plans.

Code of Federal Regulations, 2013 CFR

2013-10-01

... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan or...

48 CFR 37.604 - Quality assurance surveillance plans.

Code of Federal Regulations, 2014 CFR

2014-10-01

... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan or...

48 CFR 37.604 - Quality assurance surveillance plans.

Code of Federal Regulations, 2010 CFR

2010-10-01

... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan or...

48 CFR 37.604 - Quality assurance surveillance plans.

Code of Federal Regulations, 2012 CFR

2012-10-01

... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan or...

48 CFR 37.604 - Quality assurance surveillance plans.

Code of Federal Regulations, 2011 CFR

2011-10-01

... surveillance plans. 37.604 Section 37.604 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION... assurance surveillance plans. Requirements for quality assurance and quality assurance surveillance plans are in Subpart 46.4. The Government may either prepare the quality assurance surveillance plan or...

42 CFR 441.585 - Quality assurance system.

Code of Federal Regulations, 2012 CFR

2012-10-01

... provides information about the provisions of quality improvement and assurance to each individual receiving... 42 Public Health 4 2012-10-01 2012-10-01 false Quality assurance system. 441.585 Section 441.585...) § 441.585 Quality assurance system. (a) States must establish and maintain a comprehensive, continuous...

10 CFR 71.105 - Quality assurance program.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance program. 71.105 Section 71.105 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71.105 Quality assurance program. (a) The licensee, certificate holder, and applicant for a CoC...

10 CFR 72.174 - Quality assurance records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance records. 72.174 Section 72.174 Energy... NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.174 Quality assurance records. The licensee, applicant for a license, certificate holder, and...

10 CFR 72.144 - Quality assurance program.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance program. 72.144 Section 72.144 Energy... NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.144 Quality assurance program. (a) The licensee, applicant for a license, certificate holder...

10 CFR 72.174 - Quality assurance records.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance records. 72.174 Section 72.174 Energy... NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.174 Quality assurance records. The licensee, applicant for a license, certificate holder, and...

10 CFR 72.174 - Quality assurance records.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance records. 72.174 Section 72.174 Energy... NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.174 Quality assurance records. The licensee, applicant for a license, certificate holder, and...

10 CFR 72.174 - Quality assurance records.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance records. 72.174 Section 72.174 Energy... NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.174 Quality assurance records. The licensee, applicant for a license, certificate holder, and...

['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.

Quality assurance in forensic odontology

PubMed

Solheim, T

2018-05-30

Quality assurance or quality control is a term and concept coming from the industry. Here it is most important. All products must have a minimum quality and variation in size, for example, must be kept within certain strict limits. There must be a system to control this. May be not every single product is controlled, but spot tests must be taken. Measures must be taken to improve the quality if it is not good enough. This concept has been transferred to medicine, odontology, and consequently also to forensic odontology. These areas have in common with industry the production of that certain products. However, they are usually handmade and not produced in an industrial process. In addition, dentistry is a great deal of art and judgement and quality control of these factors may be difficult. In this paper, I will focus on forensic odontology. What are the problems? What can we do and cannot do? In addition, how can we assure the quality of the work, the assessment and conclusion, and the report? I have some personal opinions on that and I will give some suggestions. Quality assurance on an international level is difficult. Conditions and juridical systems are different in different countries. Especially forensic odontologists are different and have different opinions. This presentation will be relevant to the ongoing discussion and attempts at revising the IOFOS' guidelines for quality assurance.

Process audits versus product quality monitoring of bulk milk.

PubMed

Velthuis, A G J; van Asseldonk, M A P M

2011-01-01

Assessment of milk quality is based on bulk milk testing and farm certification on process quality audits. It is unknown to what extent dairy farm audits improve milk quality. A statistical analysis was conducted to quantify possible associations between bulk milk testing and dairy farm audits. The analysis comprised 64.373 audit outcomes on 26,953 dairy farms, which were merged with all conducted laboratory tests of bulk milk samples 12 mo before the audit. Each farm audit record included 271 binary checklist items and 52 attention point variables (given to farmers if serious deviations were observed), both indicating possible deviations from the desired farm situation. Test results included somatic cell count (SCC), total bacterial count (TBC), antimicrobial drug residues (ADR), level of butyric acid spores (BAB), freezing point depression (FPD), level of free fatty acid (FFA), and milk sediment (SED). Results show that numerous audit variables were related to bulk milk test results, although the goodness of fit of the models was generally low. Cow hygiene, clean cubicles, hygiene of milking parlor, and utility room were positively correlated with superior product quality, mainly with respect to SCC, TBC, BAB, FPD, FFA, and SED. Animal health or veterinary drugs management (i.e., drug treatment recording, marking of treated animals, and storage of veterinary drugs) related to SCC, FPD, FFA, and SED. The availability of drinking water was related to TBC, BAB, FFA, and SED, whereas maintenance of the milking equipment was related mainly to SCC, FPD, and FFA. In summary, bulk milk quality and farm audit outcomes are, to some degree, associated: if dairy farms are assessed negatively on specific audit aspects, the bulk milk quality is more likely to be inferior. However, the proportion of the total variance in milk test results explained by audits ranged between 4 and 13% (depending on the specific bulk milk test), showing that auditing dairy farms provides

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.

Opinion of gastroenterologists towards quality assurance in endoscopy.

PubMed

de Jonge, Vincent; Kuipers, Ernst J; van Leerdam, Monique E

2011-03-01

Quality assurance has become an important issue. Many societies are adopting quality assurance programs in order to monitor and improve quality of care. To assess the opinion of gastroenterologists towards quality assurance on the endoscopy department. A survey was sent to all gastroenterologists (n=319) in the Netherlands. It assessed their opinion on a quality assurance program for endoscopy units, including its design, logistics, and content. 200 gastroenterologists (63%) completed the questionnaire. 95% had a positive opinion towards quality assurance and 67% supposed an increase in quality. 28% assumed a negative impact on the time available for patient contact by introducing a quality assurance program and 35% that the capacity would decrease. A negative attitude towards disclosure of results to insurance companies (23%) and media (53%) was reported. Female gastroenterologists were less positive to share the results with other stakeholders (p<0.05). Most important quality measurements were assessment of complications (97%), standardised reporting (96%), and adequate patient information (95%). Gastroenterologists have a positive attitude towards quality assurance. However, concerns do exist about time investment and disclosure of results to others. Information provision and procedure characteristics were considered the most important aspects of quality assurance. Copyright © 2010 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

7 CFR 652.7 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 6 2010-01-01 2010-01-01 false Quality assurance. 652.7 Section 652.7 Agriculture... AGRICULTURE SUPPORT ACTIVITIES TECHNICAL SERVICE PROVIDER ASSISTANCE General Provisions § 652.7 Quality assurance. (a) NRCS will review, in consultation with the Farm Service Agency, as appropriate, the quality...

Recent Trends in Quality Assurance

ERIC Educational Resources Information Center

Amaral, Alberto; Rosa, Maria Joao

2010-01-01

In this paper we present a brief description of the evolution of quality assurance in Europe, paying particular attention to its relationship to the rising loss of trust in higher education institutions. We finalise by analysing the role of the European Commission in the setting up of new quality assurance mechanisms that tend to promote…

48 CFR 246.470 - Government contract quality assurance actions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... quality assurance actions. 246.470 Section 246.470 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 246.470 Government contract quality assurance actions. ...

SWiFT Software Quality Assurance Plan.

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

Berg, Jonathan Charles

This document describes the software development practice areas and processes which contribute to the ability of SWiFT software developers to provide quality software. These processes are designed to satisfy the requirements set forth by the Sandia Software Quality Assurance Program (SSQAP). APPROVALS SWiFT Software Quality Assurance Plan (SAND2016-0765) approved by: Department Manager SWiFT Site Lead Dave Minster (6121) Date Jonathan White (6121) Date SWiFT Controls Engineer Jonathan Berg (6121) Date CHANGE HISTORY Issue Date Originator(s) Description A 2016/01/27 Jon Berg (06121) Initial release of the SWiFT Software Quality Assurance Plan

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.

40 CFR 75.21 - Quality assurance and quality control requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Quality assurance and quality control... PROGRAMS (CONTINUED) CONTINUOUS EMISSION MONITORING Operation and Maintenance Requirements § 75.21 Quality assurance and quality control requirements. (a) Continuous emission monitoring systems. The owner or...

The quality assurance-risk management interface.

PubMed

Little, N

1992-08-01

Involvement with both risk management and quality assurance programs has led many authors to the conclusion that the fundamental differences between these activities are, in fact, very small. "At the point of overlap, it is almost impossible to distinguish the purposes and methods of both functions from one another." "Good risk management includes real improvement in patient care through organized quality assurance activities." The interface between a proactive risk management program and a quality assurance program is dynamic and can serve the legitimate interests of both. There is little to be gained by thinking of them as separate entities and much to be gained by sharing the lessons of both. If one thinks of risk management in terms of "risk" to quality patient care, and that "assuring quality" is the most productive type of risk management, then there is no practical reason to separate one from the other.

Software Quality Assurance Metrics

NASA Technical Reports Server (NTRS)

McRae, Kalindra A.

2004-01-01

Software Quality Assurance (SQA) is a planned and systematic set of activities that ensures conformance of software life cycle processes and products conform to requirements, standards and procedures. In software development, software quality means meeting requirements and a degree of excellence and refinement of a project or product. Software Quality is a set of attributes of a software product by which its quality is described and evaluated. The set of attributes includes functionality, reliability, usability, efficiency, maintainability, and portability. Software Metrics help us understand the technical process that is used to develop a product. The process is measured to improve it and the product is measured to increase quality throughout the life cycle of software. Software Metrics are measurements of the quality of software. Software is measured to indicate the quality of the product, to assess the productivity of the people who produce the product, to assess the benefits derived from new software engineering methods and tools, to form a baseline for estimation, and to help justify requests for new tools or additional training. Any part of the software development can be measured. If Software Metrics are implemented in software development, it can save time, money, and allow the organization to identify the caused of defects which have the greatest effect on software development. The summer of 2004, I worked with Cynthia Calhoun and Frank Robinson in the Software Assurance/Risk Management department. My task was to research and collect, compile, and analyze SQA Metrics that have been used in other projects that are not currently being used by the SA team and report them to the Software Assurance team to see if any metrics can be implemented in their software assurance life cycle process.

7 CFR 90.102 - Quality assurance review.

Code of Federal Regulations, 2011 CFR

2011-01-01

... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

7 CFR 90.102 - Quality assurance review.

Code of Federal Regulations, 2012 CFR

2012-01-01

... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

7 CFR 90.102 - Quality assurance review.

Code of Federal Regulations, 2013 CFR

2013-01-01

... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

7 CFR 90.102 - Quality assurance review.

Code of Federal Regulations, 2014 CFR

2014-01-01

... INTRODUCTION Quality Assurance § 90.102 Quality assurance review. (a) Each laboratory performing tests and... review of the adequacy of quality control measures taken by the laboratory for the standardized method of...

10 CFR 830.121 - Quality Assurance Program (QAP).

Code of Federal Regulations, 2013 CFR

2013-01-01

... changes continue to satisfy the quality assurance requirements. (4) Conduct work in accordance with the... 10 Energy 4 2013-01-01 2013-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality...

10 CFR 830.121 - Quality Assurance Program (QAP).

Code of Federal Regulations, 2012 CFR

2012-01-01

... changes continue to satisfy the quality assurance requirements. (4) Conduct work in accordance with the... 10 Energy 4 2012-01-01 2012-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality...

10 CFR 830.121 - Quality Assurance Program (QAP).

Code of Federal Regulations, 2011 CFR

2011-01-01

... changes continue to satisfy the quality assurance requirements. (4) Conduct work in accordance with the... 10 Energy 4 2011-01-01 2011-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality...

10 CFR 830.121 - Quality Assurance Program (QAP).

Code of Federal Regulations, 2014 CFR

2014-01-01

... changes continue to satisfy the quality assurance requirements. (4) Conduct work in accordance with the... 10 Energy 4 2014-01-01 2014-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality...

48 CFR 2453.246 - Quality Assurance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Quality Assurance. 2453.246 Section 2453.246 Federal Acquisition Regulations System DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT CLAUSES AND FORMS FORMS Prescription of Forms 2453.246 Quality Assurance. ...

78 FR 7816 - Quality Assurance Program Requirements (Operations)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-04

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0021] Quality Assurance Program Requirements (Operations...), DG-1300, ``Quality Assurance Program Requirements (Operations).'' DATES: Submit comments by April 1... CFR Part 50, Appendix B, ``Quality Assurance Criteria for Nuclear power Plants and Fuel Reprocessing...

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.

10 CFR 72.142 - Quality assurance organization.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance organization. 72.142 Section 72.142... Assurance § 72.142 Quality assurance organization. (a) The licensee, applicant for a license, certificate... writing the authority and duties of persons and organizations performing activities affecting the...

10 CFR 72.142 - Quality assurance organization.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Quality assurance organization. 72.142 Section 72.142... Assurance § 72.142 Quality assurance organization. (a) The licensee, applicant for a license, certificate... writing the authority and duties of persons and organizations performing activities affecting the...

78 FR 37850 - Quality Assurance Program Requirements (Operations)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-24

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0021] Quality Assurance Program Requirements (Operations... Regulatory Commission (NRC) is issuing a revision to Regulatory Guide (RG) 1.33, ``Quality Assurance Program... managerial and administrative Quality Assurance (QA) controls for nuclear power plants during operations...

10 CFR 830.121 - Quality Assurance Program (QAP).

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Quality Assurance Program (QAP). 830.121 Section 830.121 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Quality Assurance Requirements § 830.121 Quality... the Quality Assurance criteria in § 830.122. (b) The contractor responsible for a DOE nuclear facility...

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

Quality Audit in the Fastener Industry

NASA Technical Reports Server (NTRS)

Reagan, John R.

1995-01-01

Both the financial and quality communities rely on audits to verify customers records. The financial community is highly structured around three categories of risk, INHERENT RISK, CONTROL RISK, and DETECTION RISK. Combined, the product of these three categories constitute the AUDIT RISK. The financial community establishes CONTROL RISK based in large part on a systems level understanding of the process flow. This system level understanding is best expressed in a flowchart. The quality community may be able to adopt this structure and thereby reduce cost while maintaining and enhancing quality. The quality community should attempt to flowchart the systems level quality process before beginning substantive testing. This theory needs to be applied in several trial cases to prove or disprove this hypothesis

Quality audit in the fastener industry

NASA Astrophysics Data System (ADS)

Reagan, John R.

1995-09-01

Both the financial and quality communities rely on audits to verify customers records. The financial community is highly structured around three categories of risk, INHERENT RISK, CONTROL RISK, and DETECTION RISK. Combined, the product of these three categories constitute the AUDIT RISK. The financial community establishes CONTROL RISK based in large part on a systems level understanding of the process flow. This system level understanding is best expressed in a flowchart. The quality community may be able to adopt this structure and thereby reduce cost while maintaining and enhancing quality. The quality community should attempt to flowchart the systems level quality process before beginning substantive testing. This theory needs to be applied in several trial cases to prove or disprove this hypothesis

21 CFR 820.22 - Quality audit.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Quality audit. 820.22 Section 820.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... reports shall be reviewed by management having responsibility for the matters audited. The dates and...

Quality Assurance in Chinese Higher Education

ERIC Educational Resources Information Center

Li, Yuan

2010-01-01

Quality assurance has been integrated into the fabric of higher education in China, with the issue of quality in higher education--how to evaluate it and how to enhance it--now taking centre stage in Chinese higher education. In the past decade, the development of quality assurance in Chinese higher education has covered a broad spectrum of…

Quality Assurance and School Monitoring in Hong Kong

ERIC Educational Resources Information Center

Mok, Magdalena Mo Ching

2007-01-01

This study reports on the Hong Kong education quality assurance and school monitoring system. Three research questions were addressed: (1) Who controls the quality of school education in Hong Kong? (2) What strategies are used in the Hong Kong school education quality assurance process? (3) Agenda for Future Research on quality assurance and…

Quality Assurance and Quality Control, Part 2.

PubMed

Akers, Michael J

2015-01-01

The tragedy surrounding the New England Compounding Center and contaminated steroid syringe preparations clearly points out what can happen if quality-assurance and quality-control procedures are not strictly practiced in the compounding of sterile preparations. This article is part 2 of a two-part article on requirements to comply with United States Pharmacopeia general chapters <797> and <1163> with respect to quality assurance of compounded sterile preparations. Part 1 covered documentation requirements, inspection procedures, compounding accuracy checks, and part of a discussion on bacterial endotoxin testing. Part 2 covers sterility testing, the completion from part 1 on bacterial endotoxin testing, a brief dicussion of United States Pharmacopeia <1163>, and advances in pharmaceutical quality systems.

[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.

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

21 CFR 892.1940 - Radiologic quality assurance instrument.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radiologic quality assurance instrument. 892.1940... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1940 Radiologic quality assurance instrument. (a) Identification. A radiologic quality assurance instrument is a device intended for medical...

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.

Quality assurance for health and environmental chemistry: 1990

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

Gautier, M.A.; Gladney, E.S.; Koski, N.L.

1991-10-01

This report documents the continuing quality assurance efforts of the Health and Environmental Chemistry Group (HSE-9) at the Los Alamos National Laboratory. The philosophy, methodology, computing resources, and laboratory information management system used by the quality assurance program to encompass the diversity of analytical chemistry practiced in the group are described. Included in the report are all quality assurance reference materials used, along with their certified or consensus concentrations, and all analytical chemistry quality assurance measurements made by HSE-9 during 1990.

10 CFR 63.144 - Quality assurance program change.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance program change. 63.144 Section 63.144 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN A GEOLOGIC... assurance program information that duplicates language in quality assurance regulatory guides and quality...

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…

Academic Achievement Standards and Quality Assurance

ERIC Educational Resources Information Center

Sadler, D. Royce

2017-01-01

Quality assurance processes have been applied to many aspects of higher education, including teaching, learning and assessment. At least in the latter domain, quality assurance needs its fundamental tenets critically scrutinised. A common but inadequate approach has been to identify and promote learning environment changes "likely to…

30 CFR 7.7 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 7.7 Section 7.7 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.7 Quality assurance. Applicants granted...

[Quality assurance of emergency medical work].

PubMed

Sunde, H G

1995-03-30

Patients attending a casualty department often have diseases or injuries needing urgent medical attention. Early and correct diagnosis and treatment may be of major importance for the medical outcome. The continuity of staff is often low, with many doctors and nurses working part time. This may represent a threat to the quality of the medical work. Quality assurance at a casualty department through good training, introduction of written rules, a good flow of information to the staff and local licensing of doctors are factors which can assure that the quality of the medical service remains the best. This paper presents the work done at The Tromsø Municipal Casualty Department to assure the quality of the medical service to the population.

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

Assuring quality in high-consequence engineering

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

Hoover, Marcey L.; Kolb, Rachel R.

2014-03-01

In high-consequence engineering organizations, such as Sandia, quality assurance may be heavily dependent on staff competency. Competency-dependent quality assurance models are at risk when the environment changes, as it has with increasing attrition rates, budget and schedule cuts, and competing program priorities. Risks in Sandia's competency-dependent culture can be mitigated through changes to hiring, training, and customer engagement approaches to manage people, partners, and products. Sandia's technical quality engineering organization has been able to mitigate corporate-level risks by driving changes that benefit all departments, and in doing so has assured Sandia's commitment to excellence in high-consequence engineering and national service.

Quality Assurance in Sub-Saharan Africa

ERIC Educational Resources Information Center

Materu, Peter; Righetti, Petra

2010-01-01

This article assesses the status and practice of higher education quality assurance in sub-Saharan Africa, focusing on degree-granting tertiary institutions. A main finding is that structured national-level quality assurance processes in African higher education are a very recent phenomenon and that most countries face major capacity constraints.…

30 CFR 14.8 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 14.8 Section 14.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... Quality assurance. Applicants granted an approval or an extension of approval under this Part must: (a) In...

30 CFR 15.8 - Quality assurance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Quality assurance. 15.8 Section 15.8 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF... § 15.8 Quality assurance. (a) Applicants granted an approval or an extension of approval under this...

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.

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...

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...

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...

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

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.

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.

10 CFR 72.142 - Quality assurance organization.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., or consultants, the work of establishing and executing the quality assurance program, but the... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance organization. 72.142 Section 72.142... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality...

10 CFR 72.142 - Quality assurance organization.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., or consultants, the work of establishing and executing the quality assurance program, but the... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance organization. 72.142 Section 72.142... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality...

10 CFR 72.142 - Quality assurance organization.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., or consultants, the work of establishing and executing the quality assurance program, but the... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance organization. 72.142 Section 72.142... SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality...

Informatics Futures in Dental Education and Research: Quality Assurance.

ERIC Educational Resources Information Center

Crall, James J.

1991-01-01

The paper addresses the potential of informatics to patient care quality assurance curricula, focusing on (1) terminology and developments related to quality of care evaluations; (2) criticisms of traditional approaches; (3) limitations of existing data sources for quality assurance in dentistry; and (4) quality assurance considerations in…

[Quality assurance and total quality management in residential home care].

PubMed

Nübling, R; Schrempp, C; Kress, G; Löschmann, C; Neubart, R; Kuhlmey, A

2004-02-01

Quality, quality assurance, and quality management have been important topics in residential care homes for several years. However, only as a result of reform processes in the German legislation (long-term care insurance, care quality assurance) is a systematic discussion taking place. Furthermore, initiatives and holistic model projects, which deal with the assessment and improvement of service quality, were developed in the field of care for the elderly. The present article gives a critical overview of essential developments. Different comprehensive approaches such as the implementation of quality management systems, nationwide expert-based initiatives, and developments towards professionalizing care are discussed. Empirically based approaches, especially those emphasizing the assessment of outcome quality, are focused on in this work. Overall, the authors conclude that in the past few years comprehensive efforts have been made to improve the quality of care. However, the current situation still requires much work to establish a nationwide launch and implementation of evidence-based quality assurance and quality management.

[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.

Quality Assurance in the European Higher Education Area: The Emergence of a German Market for Quality Assurance Agencies

ERIC Educational Resources Information Center

Serrano-Velarde, Kathia E.

2008-01-01

Most European countries have introduced systematic quality assurance as part of an overall governance reform aimed at enhancing universities' autonomy. Researchers and economic entrepreneurs tend, however, to underestimate the political dimension of accreditation and evaluation when they consider the contribution of quality assurance to the…

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.

[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.

[Quality assurance and quality management in intensive care].

PubMed

Notz, K; Dubb, R; Kaltwasser, A; Hermes, C; Pfeffer, S

2015-11-01

Treatment success in hospitals, particularly in intensive care units, is directly tied to quality of structure, process, and outcomes. Technological and medical advancements lead to ever more complex treatment situations with highly specialized tasks in intensive care nursing. Quality criteria that can be used to describe and correctly measure those highly complex multiprofessional situations have only been recently developed and put into practice.In this article, it will be shown how quality in multiprofessional teams can be definded and assessed in daily clinical practice. Core aspects are the choice of a nursing theory, quality assurance measures, and quality management. One possible option of quality assurance is the use of standard operating procedures (SOPs). Quality can ultimately only be achieved if professional groups think beyond their boundaries, minimize errors, and establish and live out instructions and SOPs.

The Concepts of Quality, Quality Assurance and Quality Enhancement

ERIC Educational Resources Information Center

Elassy, Noha

2015-01-01

Purpose: This paper aims to critically review and discuss different definitions of the concepts of quality, quality assurance (QA) and quality enhancement (QE) in higher education (HE) with presenting critical perspectives of the literature. Design/methodology/approach: The paper looks at literature concerns with the meaning of quality, QA and QE,…

Assuring quality in narrative analysis.

PubMed

Bailey, P H

1996-04-01

Many nurse-researchers using qualitative strategies have been concerned with assuring quality in their work. The early literature reveals that the concepts of validity and reliability, as understood from the positivist perspective, are somehow inappropriate and inadequate when applied to interpretive research. More recent literature suggests that because of the positivist and interpretive paradigms are epistemologically divergent, the transfer of quality criteria from one perspective to the other is not automatic or even reasonable. The purpose of this article, therefore, is to clarify what the terms quality, trustworthiness, credibility, authenticity, and goodness mean in qualitative research findings. The process of assuring quality, validation, in qualitative research will be discussed within the context of the interpretive method, narrative analysis. A brief review of quality in narrative analysis nursing research will also be presented.

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

15 CFR 996.31 - Termination of the Quality Assurance Program.

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 Other Quality Assurance Program Matters § 996.31 Termination of the Quality Assurance Program. (a) NOAA reserves the right to terminate the...

15 CFR 996.31 - Termination of the Quality Assurance Program.

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 Other Quality Assurance Program Matters § 996.31 Termination of the Quality Assurance Program. (a) NOAA reserves the right to terminate the...

15 CFR 996.31 - Termination of the Quality Assurance Program.

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 Other Quality Assurance Program Matters § 996.31 Termination of the Quality Assurance Program. (a) NOAA reserves the right to terminate the...

15 CFR 996.31 - Termination of the Quality Assurance Program.

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 Other Quality Assurance Program Matters § 996.31 Termination of the Quality Assurance Program. (a) NOAA reserves the right to terminate the...

2015 International PV Quality Assurance Task Force (PVQAT) Workshop |

Science.gov Websites

Photovoltaic Research | NREL International PV Quality Assurance Task Force (PVQAT) Workshop 2015 International PV Quality Assurance Task Force (PVQAT) Workshop Wednesday, February 25, 2015 Chairs : Tony Sample and Masaaki Yamamichi The 2015 International PV Quality Assurance Task Force (PVQAT

Quality assurance program plan for radionuclide airborne emissions monitoring

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

Boom, R.J.

1995-12-01

This Quality Assurance Program Plan identifies quality assurance program requirements and addresses the various Westinghouse Hanford Company organizations and their particular responsibilities in regards to sample and data handling of radiological airborne emissions. This Quality Assurance Program Plan is prepared in accordance with and to written requirements.

Quality assurance and quality improvement in U.S. clinical molecular genetic laboratories.

PubMed

Chen, Bin; Richards, C Sue; Wilson, Jean Amos; Lyon, Elaine

2011-04-01

A robust quality-assurance program is essential for laboratories that perform molecular genetic testing to maintain high-quality testing and be able to address challenges associated with performance or delivery of testing services as the use of molecular genetic tests continues to expand in clinical and public health practice. This unit discusses quality-assurance and quality-improvement considerations that are critical for molecular genetic testing performed for heritable diseases and conditions. Specific discussion is provided on applying regulatory standards and best practices in establishing/verifying test performance, ensuring quality of the total testing process, monitoring and maintaining personnel competency, and continuing quality improvement. The unit provides a practical reference for laboratory professionals to use in recognizing and addressing essential quality-assurance issues in human molecular genetic testing. It should also provide useful information for genetics researchers, trainees, and fellows in human genetics training programs, as well as others who are interested in quality assurance and quality improvement for molecular genetic testing. 2011 by John Wiley & Sons, Inc.

7 CFR 90.102 - Quality assurance review.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Quality assurance review. 90.102 Section 90.102 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) COMMODITY LABORATORY TESTING PROGRAMS INTRODUCTION Quality Assurance §...

42 CFR 441.474 - Quality assurance and improvement plan.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Quality assurance and improvement plan. 441.474... SERVICES Optional Self-Directed Personal Assistance Services Program § 441.474 Quality assurance and improvement plan. (a) The State must provide a quality assurance and improvement plan that describes the State...

42 CFR 441.474 - Quality assurance and improvement plan.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Quality assurance and improvement plan. 441.474... SERVICES Optional Self-Directed Personal Assistance Services Program § 441.474 Quality assurance and improvement plan. (a) The State must provide a quality assurance and improvement plan that describes the State...

42 CFR 441.474 - Quality assurance and improvement plan.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Quality assurance and improvement plan. 441.474... SERVICES Optional Self-Directed Personal Assistance Services Program § 441.474 Quality assurance and improvement plan. (a) The State must provide a quality assurance and improvement plan that describes the State...

42 CFR 441.474 - Quality assurance and improvement plan.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Quality assurance and improvement plan. 441.474... SERVICES Optional Self-Directed Personal Assistance Services Program § 441.474 Quality assurance and improvement plan. (a) The State must provide a quality assurance and improvement plan that describes the State...

42 CFR 441.474 - Quality assurance and improvement plan.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Quality assurance and improvement plan. 441.474... SERVICES Optional Self-Directed Personal Assistance Services Program § 441.474 Quality assurance and improvement plan. (a) The State must provide a quality assurance and improvement plan that describes the State...

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.

Audit activity and quality of completed audit projects in primary care in Staffordshire.

PubMed Central

Chambers, R; Bowyer, S; Campbell, I

1995-01-01

OBJECTIVES--To survey audit activity in primary care and determine which practice factors are associated with completed audit; to survey the quality of completed audit projects. DESIGN--From April 1992 to June 1993 a team from the medical audit advisory group visited all general practices; a research assistant visited each practice to study the best audit project. Data were collected in structured interviews. SETTING--Staffordshire, United Kingdom. SUBJECTS--All 189 general practices. MAIN MEASURES--Audit activity using Oxford classification system. Quality of best audit project by assessing choice of topic; participation of practice staff; setting of standards; methods of data collection and presentation of results; whether a plan to make changes resulted from the audit; and whether changes led to the set standards being achieved. RESULTS--Audit information was available from 169 practices (89%). 44(26%) practices had carried out at least one full audit; 40(24%) had not started audit. Mean scores with the Oxford classification system were significantly higher with the presence of a practice manager (2.7(95% confidence interval 2.4 to 2.9) v 1.2(0.7 to 1.8), p < 0.0001) and with computerisation (2.8(2.5 to 3.1) v 1.4 (0.9 to 2.0), p < 0.0001), organised notes (2.6(2.1 to 3.0) v 1.7(7.2 to 2.2), p = 0.03), being a training practice (3.5(3.2 to 3.8) v 2.1(1.8 to 2.4), p < 0.0001), and being a partnership (2.8(2.6 to 3.0) v 1.5(1.1 to 2.0), p < 0.0001). Standards had been set in 62 of the 71 projects reviewed. Data were collected prospectively in 36 projects and retrospectively in 35. 16 projects entailed taking samples from a study population and 55 from the whole population. 50 projects had a written summary. Performance was less than the standards set or expected in 56 projects. 62 practices made changes as a result of the audit. 35 of the 53 that had reviewed the changes found that the original standards had been reached. CONCLUSIONS--Evaluation of audit in

10 CFR 71.101 - Quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... quality assurance actions related to control of the physical characteristics and quality of the material... through 71.137 and satisfying any specific provisions that are applicable to the licensee's activities... assurance requirement's importance to safety. (c) Approval of program. (1) Before the use of any package for...

42 CFR 441.585 - Quality assurance system.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Quality assurance system. 441.585 Section 441.585 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... provides information about the provisions of quality improvement and assurance to each individual receiving...

42 CFR 441.585 - Quality assurance system.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Quality assurance system. 441.585 Section 441.585 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... provides information about the provisions of quality improvement and assurance to each individual receiving...

Savannah River Laboratory quality assurance manual. Revision 2

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

Not Available

1985-02-01

The SRL quality assurance program is a management activity that verifies that the results of our research and development are adequate for their intended use and that our facilities function properly. The program is based on Savannah River Quality Assurance Plan (DPW-82-111-2, Rev 0) as applied through Quality Assurance Procedures and Divisional Plans (following section). The AED policy states that ''all activities shall be conducted to achieve a high quality of product and performance...'' The policy contains 18 considerations to be applied ''proportional to needs, based on the technical and professional judgment of responsible Du Pont employees.'' Quality is themore » responsibility of each individual and his line organization, as is safety. To ensure that quality is being considered for all SRL activities, all research programs are reviewed, and all facilities are assessed. These assessments and reviews are the nucleus of the Quality Assurance program.« 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

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

Quality assurance: Importance of systems and standard operating procedures

PubMed Central

Manghani, Kishu

2011-01-01

It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company. PMID:21584180

Quality assurance: Importance of systems and standard operating procedures.

PubMed

Manghani, Kishu

2011-01-01

It is mandatory for sponsors of clinical trials and contract research organizations alike to establish, manage and monitor their quality control and quality assurance systems and their integral standard operating procedures and other quality documents to provide high-quality products and services to fully satisfy customer needs and expectations. Quality control and quality assurance systems together constitute the key quality systems. Quality control and quality assurance are parts of quality management. Quality control is focused on fulfilling quality requirements, whereas quality assurance is focused on providing confidence that quality requirements are fulfilled. The quality systems must be commensurate with the Company business objectives and business model. Top management commitment and its active involvement are critical in order to ensure at all times the adequacy, suitability, effectiveness and efficiency of the quality systems. Effective and efficient quality systems can promote timely registration of drugs by eliminating waste and the need for rework with overall financial and social benefits to the Company.

A New Tool for Quality: The Internal Audit.

PubMed

Haycock, Camille; Schandl, Annette

As health care systems aspire to improve the quality and value for the consumers they serve, quality outcomes must be at the forefront of this value equation. As organizations implement evidence-based practices, electronic records to standardize processes, and quality improvement initiatives, many tactics are deployed to accelerate improvement and care outcomes. This article describes how one organization utilized a formal clinical audit process to identify gaps and/or barriers that may be contributing to underperforming measures and outcomes. This partnership between quality and audit can be a powerful tool and produce insights that can be scaled across a large health care system.

Perspectives on Quality Assurance in Higher Education in Norway

ERIC Educational Resources Information Center

Lycke, Kirsten Hofgaard

2004-01-01

Quality assurance is well known internationally but the notion is relatively new in Norway. To understand some of the issues and dilemmas that emerge in the Norwegian reception of quality assurance in higher education, this article traces how quality assurance is gaining its form and how international trends are understood, transposed and adopted…

Quality Assurance in Postgraduate Education. ENQA Workshop Report 12

ERIC Educational Resources Information Center

Bitusikova, Alexandra; Bohrer, Janet; Borosic, Ivana; Costes, Nathalie; Edinsel, Kerim; Hollander, Karoline; Jacobsson, Gunilla; Jakopovic, Ivan Filip; Kearney, Mary-Louise; Mulder, Fred; Negyesi, Judith; Pietzonka, Manuel

2010-01-01

The present report follows an ENQA (European Association for Quality Assurance in Higher Education) Workshop on Quality Assurance and Postgraduate Education, hosted by the Romanian Agency for Quality Assurance in Higher Education (ARACIS) in Brasov, Romania on 12-13 March 2009. The workshop was an excellent opportunity for ENQA members to exchange…

Quality Assurance of Quality Assurance Agencies from an Asian Perspective: Regulation, Autonomy and Accountability

ERIC Educational Resources Information Center

Hou, Angela Yung-Chi; Ince, Martin; Tsai, Sandy; Chiang, Chung Lin

2015-01-01

As quality guardians of higher education, quality assurance agencies are required to guarantee the credibility of the review process and to ensure the objectivity and transparency of their decisions and recommendations. These agencies are therefore expected to use a range of internal and external approaches to prove the quality of their review…

Exploring Quality Assurance in Sixth Form Colleges

ERIC Educational Resources Information Center

Stoten, David William

2012-01-01

Purpose: This paper aims to focus on the changing nature of quality assurance systems within the sixth form college sector. Design/methodology/approach: Ten sixth form colleges were surveyed across England and staff from varying levels within college hierarchies questioned about how quality assurance systems were implemented. Research involved…

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...

AUDIT OF THE AUDITS.

PubMed

Alam, Malik Mahmood

2015-01-01

Audits play an important role in improving the services to patient care. Our department was involved in carrying out Audits by the trainees on regular basis as suggested by the Royal college and each House officer or the Registrar rotating through was doing an Audit in his/her tenure. Ninteen Audits were done in 3 years in the Pediatric department. We used the criteria suggested for evaluating the quality of Audits and put into the category of full Audits, Partial Audits, Potential Audits and planning Audits. Six of our Audits were full Audits, eleven were partial Audits, two were Potential Audits and none were Planning Audits. We think that as a general trend we had similar shortcomings in quality of our Audits which need to be improved by involving seniors specially in implementing the changes suggested in the Audits otherwise it will not fulfill the Aims and objectives.

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.

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

[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 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

Now & Then: Ingrid Proctor-Fridia: Quality Assurance Representative.

ERIC Educational Resources Information Center

Barnes, Sue; Michalowicz, Karen Dee

1995-01-01

Describes the use of geometry now by a U.S. Department of Defense quality assurance representative and in ancient times by the Egyptians and Babylonians. Includes reproducible student worksheets on quality assurance. (MKR)

Quality-Assurance Plan for Water-Quality Activities in the USGS Ohio Water Science Center

USGS Publications Warehouse

Francy, Donna S.; Shaffer, Kimberly H.

2008-01-01

In accordance with guidelines set forth by the Office of Water Quality in the Water Resources Discipline of the U.S. Geological Survey, a quality-assurance plan has been written for use by the Ohio Water Science Center in conducting water-quality activities. This quality-assurance plan documents the standards, policies, and procedures used by the Ohio Water Science Center for activities related to the collection, processing, storage, analysis, and publication of water-quality data. The policies and procedures documented in this quality-assurance plan for water-quality activities are meant to complement the Ohio Water Science Center quality-assurance plans for water-quality monitors, the microbiology laboratory, and surface-water and ground-water activities.

Quality Assurance in Continuing Professional Education. An Analysis.

ERIC Educational Resources Information Center

Tovey, Philip

Based on research conducted in and around universities in the United Kingdom, this book analyzes quality assurance in continuing professional education (CPE). An introduction provides a close look at the terms "quality,""quality assurance," and "CPE." Part I deals with context. Chapter 1 looks at theoretical…

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.

Quality Assurance 1992-2012

ERIC Educational Resources Information Center

Brown, Roger

2012-01-01

As the author's contribution to a series marking the Golden Jubilee of the Association of University Administrators, he reflects on changes in quality assurance over the past twenty years and speculates on what the future may hold for quality as the association moves into a new and very different competitive regime. He begins by discussing the…

Highly Integrated Quality Assurance – An Empirical Case

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

Drake Kirkham; Amy Powell; Lucas Rich

2011-02-01

Highly Integrated Quality Assurance – An Empirical Case Drake Kirkham1, Amy Powell2, Lucas Rich3 1Quality Manager, Radioisotope Power Systems (RPS) Program, Idaho National Laboratory, P.O. Box 1625 M/S 6122, Idaho Falls, ID 83415-6122 2Quality Engineer, RPS Program, Idaho National Laboratory 3Quality Engineer, RPS Program, Idaho National Laboratory Contact: Voice: (208) 533-7550 Email: Drake.Kirkham@inl.gov Abstract. The Radioisotope Power Systems Program of the Idaho National Laboratory makes an empirical case for a highly integrated Quality Assurance function pertaining to the preparation, assembly, testing, storage and transportation of 238Pu fueled radioisotope thermoelectric generators. Case data represents multiple campaigns including the Pluto/New Horizons mission,more » the Mars Science Laboratory mission in progress, and other related projects. Traditional Quality Assurance models would attempt to reduce cost by minimizing the role of dedicated Quality Assurance personnel in favor of either functional tasking or peer-based implementations. Highly integrated Quality Assurance adds value by placing trained quality inspectors on the production floor side-by-side with nuclear facility operators to enhance team dynamics, reduce inspection wait time, and provide for immediate, independent feedback. Value is also added by maintaining dedicated Quality Engineers to provide for rapid identification and resolution of corrective action, enhanced and expedited supply chain interfaces, improved bonded storage capabilities, and technical resources for requirements management including data package development and Certificates of Inspection. A broad examination of cost-benefit indicates highly integrated Quality Assurance can reduce cost through the mitigation of risk and reducing administrative burden thereby allowing engineers to be engineers, nuclear operators to be nuclear operators, and the cross-functional team to operate more efficiently. Applicability of this

New challenges in assuring vaccine quality.

PubMed Central

Dellepiane, N.; Griffiths, E.; Milstien, J. B.

2000-01-01

In the past, quality control of vaccines depended on use of a variety of testing methods to ensure that the products were safe and potent. These methods were developed for vaccines whose safety and efficacy were based on several years worth of data. However, as vaccine production technologies have developed, so have the testing technologies. Tests are now able to detect potential hazards with a sensitivity not possible a few years ago, and an increasing array of physicochemical methods allows a much better characterization of the product. In addition to sophisticated tests, vaccine regulation entails a number of other procedures to ensure safety. These include characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by national regulatory authorities, and enhanced pre- and post-marketing surveillance for possible adverse events following immunization. These procedures help assure vaccine efficacy and safety, and some examples are given in this article. However, some contaminants of vaccines that can be detected by newer assays raise theoretical safety concerns but their presence may be less hazardous than not giving the vaccines. Thus risk-benefit decisions must be well informed and based on scientific evidence. PMID:10743279

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?

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.

Ontario's Quality Assurance Framework: A Critical Response

ERIC Educational Resources Information Center

Heap, James

2013-01-01

Ontario's Quality Assurance Framework (QAF) is reviewed and found not to meet all five criteria proposed for a strong quality assurance system focused on student learning. The QAF requires a statement of student learning outcomes and a method and means of assessing those outcomes, but it does not require that data on achievement of intended…

48 CFR 246.402 - Government contract quality assurance at source.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 3 2011-10-01 2011-10-01 false Government contract... ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 246.402 Government contract quality assurance at source. Do not require...

Revision 2 of the Enbridge Quality Assurance Project Plan

EPA Pesticide Factsheets

This Quality Assurance Project Plan (QAPP) presents Revision 2 of the organization, objectives, planned activities, and specific quality assurance/quality control (QA/QC) procedures associated with the Enbridge Marshall Pipeline Release Project.

Quality assurance and organizational effectiveness in hospitals.

PubMed Central

Hetherington, R W

1982-01-01

The purpose of this paper is to explore some aspects of a general theoretical model within which research on the organizational impacts of quality assurance programs in hospitals may be examined. Quality assurance is conceptualized as an organizational control mechanism, operating primarily through increased formalization of structures and specification of procedures. Organizational effectiveness is discussed from the perspective of the problem-solving theory of organizations, wherein effective organizations are those which maintain at least average performance in all four system problem areas simultaneously (goal-attainment, integration, adaptation and pattern-maintenance). It is proposed that through the realization of mutual benefits for both professionals and the bureaucracy, quality assurance programs can maximize such effective performance in hospitals. PMID:7096096

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 2146.270 FEGLI Program quality assurance requirements. (a) The... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false FEGLI Program quality...

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 2146.270 FEGLI Program quality assurance requirements. (a) The... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false FEGLI Program quality...

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 2146.270 FEGLI Program quality assurance requirements. (a) The... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false FEGLI Program quality...

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 2146.270 FEGLI Program quality assurance requirements. (a) The... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false FEGLI Program quality...

48 CFR 2146.270 - FEGLI Program quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT QUALITY ASSURANCE Contract Quality Requirements 2146.270 FEGLI Program quality assurance requirements. (a) The... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true FEGLI Program quality...

Material quality assurance risk assessment.

DOT National Transportation Integrated Search

2013-01-01

Over the past two decades the role of SHA has shifted from quality control (QC) of materials and : placement techniques to quality assurance (QA) and acceptance. The role of the Office of Materials : Technology (OMT) has been shifting towards assuran...

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.

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

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."

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...

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.

U.S. Geological Survey quality-assurance plan for continuous water-quality monitoring in Kansas, 2014

USGS Publications Warehouse

Bennett, Trudy J.; Graham, Jennifer L.; Foster, Guy M.; Stone, Mandy L.; Juracek, Kyle E.; Rasmussen, Teresa J.; Putnam, James E.

2014-01-01

A quality-assurance plan for use in conducting continuous water-quality monitoring activities has been developed for the Kansas Water Science Center in accordance with guidelines set forth by the U.S. Geological Survey. This quality-assurance plan documents the standards, policies, and procedures used by the U.S. Geological Survey in Kansas for activities related to the collection, processing, storage, analysis, and release of continuous water-quality monitoring data. The policies and procedures that are documented in this quality-assurance plan for continuous water-quality monitoring activities complement quality-assurance plans for surface-water and groundwater activities in Kansas.

48 CFR 846.408 - Single-agency assignments of Government contract quality assurance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... of Government contract quality assurance. 846.408 Section 846.408 Federal Acquisition Regulations System DEPARTMENT OF VETERANS AFFAIRS CONTRACT MANAGEMENT QUALITY ASSURANCE Government Contract Quality Assurance 846.408 Single-agency assignments of Government contract quality assurance. ...

HANDBOOK: QUALITY ASSURANCE/QUALITY CONTROL (QA/QC) PROCEDURES FOR HAZARDOUS WASTE INCINERATION

EPA Science Inventory

Resource Conservation and Recovery Act regulations for hazardous waste incineration require trial burns by permit applicants. uality Assurance Project Plan (QAPjP) must accompany a trial burn plan with appropriate quality assurance/quality control procedures. uidance on the prepa...

48 CFR 2152.246-70 - Quality assurance requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Quality assurance... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CLAUSES AND FORMS PRECONTRACT PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 2152.246-70 Quality assurance...

48 CFR 2152.246-70 - Quality assurance requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Quality assurance... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CLAUSES AND FORMS PRECONTRACT PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 2152.246-70 Quality assurance...

48 CFR 2152.246-70 - Quality assurance requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Quality assurance... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CLAUSES AND FORMS PRECONTRACT PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 2152.246-70 Quality assurance...

48 CFR 2152.246-70 - Quality assurance requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Quality assurance... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CLAUSES AND FORMS PRECONTRACT PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 2152.246-70 Quality assurance...

48 CFR 2152.246-70 - Quality assurance requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Quality assurance... MANAGEMENT, FEDERAL EMPLOYEES GROUP LIFE INSURANCE FEDERAL ACQUISITION REGULATION CLAUSES AND FORMS PRECONTRACT PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 2152.246-70 Quality assurance...

QUALITY ASSURANCE IN RESEARCH LABORATORIES: RULES AND REASON

EPA Science Inventory

Quality Assurance in Research Laboratories: Rules and Reason

Ron Rogers, Quality Assurance and Records Manager, Environmental Carcinogenesis Division, NHEERL/ORD/US EPA, Research Triangle Park, NC, 27709

To anyone who has actively participated in research, as I have...

Managerialism and the Risky Business of Quality Assurance in Universities

ERIC Educational Resources Information Center

Davis, Annemarie

2017-01-01

Purpose: This paper aims to identify what is needed to enhance academic quality assurance in a university, with specific efforts to reduce the risks associated with ritualised quality assurance practices. Design/methodology/approach: The aspects to enhance academic quality assurance efforts in managerial universities are identified through a…

Quality Assurance in Higher Education: A Review of Literature

ERIC Educational Resources Information Center

Ryan, Tricia

2015-01-01

This paper examines the literature surrounding quality assurance in global higher education. It provides an overview of accreditation as a mechanism to ensure quality in higher education, examines models of QA, and explores the concept of quality (including definitions of quality and quality assurance). In addition, this paper provides a review of…

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.

Radiographic Film Processing Quality Assurance: A Self-Teaching Workbook. Quality Assurance Series.

ERIC Educational Resources Information Center

Goldman, Lee W.

This workbook has been designed for use in conjunction with the manual, "Photographic Quality Assurance in Diagnostic Radiology, Nuclear Medicine and Radiation Therapy." Presented are several typical problems arising from the existence of variability and fluctuations in the automatic processing of radiographs, which unless corrected, can…

Clinical audit and quality improvement - time for a rethink?

PubMed

Bowie, Paul; Bradley, Nicholas A; Rushmer, Rosemary

2012-02-01

Evidence of the benefits of clinical audit to patient care is limited, despite its longevity. Additionally, numerous attitudinal, professional and organizational barriers impede its effectiveness. Yet, audit remains a favoured quality improvement (QI) policy lever. Growing interest in QI techniques suggest it is timely to re-examine audit. Clinical audit advisors assist health care teams, so hold unique cross-cutting perspectives on the strategic and practical application of audit in NHS organizations. We aimed to explore their views and experiences of their role in supporting health care teams in the audit process. Qualitative study using semi-structured and focus group interviews. Participants were purposively sampled (n = 21) across health sectors in two large Scottish NHS Boards. Interviews were audio-taped, transcribed and a thematic analysis performed. Work pressure and lack of protected time were cited as audit barriers, but these hide other reasons for non-engagement. Different professions experience varying opportunities to participate. Doctors have more opportunities and may dominate or frustrate the process. Audit is perceived as a time-consuming, additional chore and a managerially driven exercise with no associated professional rewards. Management failure to support and resource changes fuels low motivation and disillusionment. Audit is regarded as a 'political' tool stifled by inter-professional differences and contextual constraints. The findings echo previous studies. We found limited evidence that audit as presently defined and used is meeting policy makers' aspirations. The quality and safety improvement focus is shifting towards 'alternative' systems-based QI methods, but research to suggest that these will be any more impactful is also lacking. Additionally, identified professional, educational and organizational barriers still need to be overcome. A debate on how best to overcome the limitations of audit and its place alongside other approaches

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.

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…

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

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.

Technology Transfer Program (TTP). Quality Assurance System. Volume 2. Appendices

DTIC Science & Technology

1980-03-03

LSCo Report No. - 2X23-5.1-4-I TECHNOLOGY TRANSFER PROGRAM (TTP) FINAL REPORT QUALITY ASSURANCE SYSTEM Appendix A Accuracy Control System QUALITY...4-1 TECHNOLOGY TRANSFER PROGRAM (TTP) FINAL REPORT QUALITY ASSURANCE SYSTEM Appendix A Accuracy Control System QUALITY ASSURANCE VOLUME 2 APPENDICES...prepared by: Livingston Shipbuilding Company Orange, Texas March 3, 1980 APPENDIX A ACCURACY CONTROL SYSTEM . IIII MARINE TECHNOLOGY. INC. HP-121

In pursuit of quality by viable quality assurance system: the controllers' perceptions.

PubMed

Aziz, Anwar

2011-01-01

Patients, families and communities expect safe, competent and compassionate nursing care that has always been a core value of nursing. To meet these expectations, a valid and reliable quality assurance (QA) system is crucial to ensure that nurse-graduates are competent, confident and fit to practice. The QA approach is seen to be fundamental for quality improvement, it would be appropriate to consider its influence in the nursing education in Pakistan as the current situation is evident of non-existence of such a system to assure its quality. The data is drawn from a qualitative case study conducted in 2004. Among a purposive sample of 71 nurses inclusive of a group of Controllers were interviewed on one-to-one basis. Interviews were audio taped to reduce the risk of any misinterpretation and to facilitate the exact description of data as it was said. The non-directive, semi-structured and open-ended questionnaire was used to collect data. Thematic analysis of verbatim transcripts of the interviews was done. The study findings reveal a unanimous desire of the nurses to gauge quality of nurse education through efficient and effective quality assurance system. A crucial need is felt to develop a viable quality assurance system to ensure approved level of quality in nursing education to deliver the right care to the right patient at the right time, every time. The continuous quality assurance and improvement (CQAI) framework based on Deming Quality Cycle (Plan, Do, Check and Act) could facilitate appropriate designing and development of mechanism.

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

Quality Assurance in Online Content Literacy Methods Courses

ERIC Educational Resources Information Center

Marsh, Josephine P.; Lammers, Jayne C.; Alvermann, Donna E.

2012-01-01

As institutions offer more online courses in their teacher certification and literacy master's programs, research is needed to address issues of quality assurance in online instruction. This multicase study analyzes qualitatively elements for addressing quality assurance of the implementation of an online content literacy teacher education course…

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.

LOVE CANAL MONITORING PROGRAM. GCA QA/QC (QUALITY ASSURANCE/QUALITY CONTROL) SUMMARY REPORT

EPA Science Inventory

One of the most important responsibilities of the Love Canal prime contractor was the institution and maintenance of a quality assurance program. An important objective of the quality assurance program was to alert the subcontractors to the importance of high quality work on thei...

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...

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

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.

Operational excellence (six sigma) philosophy: Application to software quality assurance

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

Lackner, M.

1997-11-01

This report contains viewgraphs on operational excellence philosophy of six sigma applied to software quality assurance. This report outlines the following: goal of six sigma; six sigma tools; manufacturing vs administrative processes; Software quality assurance document inspections; map software quality assurance requirements document; failure mode effects analysis for requirements document; measuring the right response variables; and questions.

Quality Assurance of Assessment and Moderation Discourses Involving Sessional Staff

ERIC Educational Resources Information Center

Grainger, Peter; Adie, Lenore; Weir, Katie

2016-01-01

Quality assurance is a major agenda in tertiary education. The casualisation of academic work, especially in teaching, is also a quality assurance issue. Casual or sessional staff members teach and assess more than 50% of all university courses in Australia, and yet the research in relation to the role sessional staff play in quality assurance of…

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

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...

Understanding Quality Assurance: A Cross Country Case Study

ERIC Educational Resources Information Center

Choon Boey Lim, Fion

2008-01-01

Purpose: The purpose of this paper is to examine the level of understanding between an Australian university and its offshore partner institution, on quality assurance. It attempts to highlight the dynamics of quality assurance policy implementation within and across institutions for an offshore degree. Design/methodology/approach: The study used…

Policy of Quality Assurance in Hong Kong Preschools

ERIC Educational Resources Information Center

Dora, Ho Choi-wa

2007-01-01

This article discusses the sources, processes and impact of the quality assurance policy implemented in Hong Kong preschools. Regarded as a sort of policy alignment between the subsystems of pre-primary, primary and secondary education, the introduction of a quality assurance policy has been directly and indirectly transforming the settlements in…

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

Quality assurance paradigms for artificial intelligence in modelling and simulation

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

Oren, T.I.

1987-04-01

New classes of quality assurance concepts and techniques are required for the advanced knowledge-processing paradigms (such as artificial intelligence, expert systems, or knowledge-based systems) and the complex problems that only simulative systems can cope with. A systematization of quality assurance problems as well as examples are given to traditional and cognizant quality assurance techniques in traditional and cognizant modelling and simulation.

The Landscape of Quality Assurance in Distance Education

ERIC Educational Resources Information Center

Scull, W. Reed; Kendrick, David; Shearer, Rick; Offerman, Dana

2011-01-01

Distance education permeates the field of professional and continuing education to such an extent that quality assurance (QA) is a topic no distance educator or administrator should avoid. Quality assurance is an issue not just for continuing education but also for higher education generally. Given the disruptive impact of distance education and…

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...

Employer-Led Quality Assurance

ERIC Educational Resources Information Center

Tyszko, Jason A.

2017-01-01

Recent criticism of higher education accreditation has prompted calls for reform and sparked interest in piloting alternative quality assurance methods that better address student learning and employment outcomes. Although this debate has brought much needed attention to improving the outcomes of graduates and safeguarding federal investment in…

Quality assurance program for isotopic power systems

NASA Astrophysics Data System (ADS)

Hannigan, R. L.; Harnar, R. R.

1982-12-01

The Sandia National Laboratories Quality Assurance Program that applies to non-weapon (reimbursable) Radioisotopic Thermoelectric Generators is summarized. The program was implemented over the past 16 years on power supplies used in various space and terrestrial systems. The quality assurance (QA) activity of the program is in support of the Department of Energy, Office of Space Nuclear Projects. Basic elements of the program are described and examples of program documentation are presented.

An introduction to quality assurance.

PubMed

Riggs, D G

1989-10-01

Although initially applied within the manufacturing sectors of industry the benefits of quality assurance to both specifiers and customers alike are rapidly being realised by all sectors of business and industry.

Internal Quality Assurance Benchmarking. ENQA Workshop Report 20

ERIC Educational Resources Information Center

Blackstock, Douglas; Burquel, Nadine; Comet, Nuria; Kajaste, Matti; dos Santos, Sergio Machado; Marcos, Sandra; Moser, Marion; Ponds, Henri; Scheuthle, Harald; Sixto, Luis Carlos Velon

2012-01-01

The Internal Quality Assurance group of ENQA (IQA Group) has been organising a yearly seminar for its members since 2007. The main objective is to share experiences concerning the internal quality assurance of work processes in the participating agencies. The overarching theme of the 2011 seminar was how to use benchmarking as a tool for…

23 CFR 637.207 - Quality assurance program.

Code of Federal Regulations, 2012 CFR

2012-04-01

... program. (a) Each STD's quality assurance program shall provide for an acceptance program and an independent assurance (IA) program consisting of the following: (1) Acceptance program. (i) Each STD's... STD shall establish a dispute resolution system. The dispute resolution system shall address the...

23 CFR 637.207 - Quality assurance program.

Code of Federal Regulations, 2014 CFR

2014-04-01

... program. (a) Each STD's quality assurance program shall provide for an acceptance program and an independent assurance (IA) program consisting of the following: (1) Acceptance program. (i) Each STD's... STD shall establish a dispute resolution system. The dispute resolution system shall address the...

23 CFR 637.207 - Quality assurance program.

Code of Federal Regulations, 2013 CFR

2013-04-01

... program. (a) Each STD's quality assurance program shall provide for an acceptance program and an independent assurance (IA) program consisting of the following: (1) Acceptance program. (i) Each STD's... STD shall establish a dispute resolution system. The dispute resolution system shall address the...

40 CFR 160.35 - Quality assurance unit.

Code of Federal Regulations, 2012 CFR

2012-07-01

... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

40 CFR 160.35 - Quality assurance unit.

Code of Federal Regulations, 2010 CFR

2010-07-01

... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

40 CFR 160.35 - Quality assurance unit.

Code of Federal Regulations, 2014 CFR

2014-07-01

... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

40 CFR 160.35 - Quality assurance unit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

40 CFR 160.35 - Quality assurance unit.

Code of Federal Regulations, 2011 CFR

2011-07-01

... standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating... LABORATORY PRACTICE STANDARDS Organization and Personnel § 160.35 Quality assurance unit. (a) A testing...

The evolution of clinical audit as a tool for quality improvement.

PubMed

Berk, Michael; Callaly, Thomas; Hyland, Mary

2003-05-01

Clinical auditing practices are recognized universally as a useful tool in evaluating and improving the quality of care provided by a health service. External auditing is a regular activity for mental health services in Australia but internal auditing activities are conducted at the discretion of each service. This paper evaluates the effectiveness of 6 years of internal auditing activities in a mental health service. A review of the scope, audit tools, purpose, sampling and design of the internal audits and identification of the recommendations from six consecutive annual audit reports was completed. Audit recommendations were examined, as well as levels of implementation and reasons for success or failure. Fifty-seven recommendations were identified, with 35% without action, 28% implemented and 33.3% still pending or in progress. The recommendations were more likely to be implemented if they relied on activity, planning and action across a selection of service areas rather than being restricted to individual departments within a service, if they did not involve non-mental health service departments and if they were not reliant on attitudinal change. Tools used, scope and reporting formats have become more sophisticated as part of the evolutionary nature of the auditing process. Internal auditing in the Barwon Health Mental Health Service has been effective in producing change in the quality of care across the organization. A number of evolutionary changes in the audit process have improved the efficiency and effectiveness of the audit.

Quality assurance programs for pressure ulcers.

PubMed

Xakellis, G C

1997-08-01

Traditional medical quality assurance programs are beginning to incorporate the principles of continuous quality improvement pioneered by Juran and Deming. Strategies for incorporating these principles into a long-term care facility are described, and two examples of successful implementation of continuous quality improvement programs for pressure ulcers are presented.

Quality Assurance Planning for Region 9

EPA Pesticide Factsheets

The ultimate success of an environmental program or project depends on the quality of the environmental data collected and used in decision-making. EPA has developed guidances to help state and tribal governments develop Quality Assurance Program Plans.

Quality assurance of qualitative research: a review of the discourse

PubMed Central

2011-01-01

Background Increasing demand for qualitative research within global health has emerged alongside increasing demand for demonstration of quality of research, in line with the evidence-based model of medicine. In quantitative health sciences research, in particular clinical trials, there exist clear and widely-recognised guidelines for conducting quality assurance of research. However, no comparable guidelines exist for qualitative research and although there are long-standing debates on what constitutes 'quality' in qualitative research, the concept of 'quality assurance' has not been explored widely. In acknowledgement of this gap, we sought to review discourses around quality assurance of qualitative research, as a first step towards developing guidance. Methods A range of databases, journals and grey literature sources were searched, and papers were included if they explicitly addressed quality assurance within a qualitative paradigm. A meta-narrative approach was used to review and synthesise the literature. Results Among the 37 papers included in the review, two dominant narratives were interpreted from the literature, reflecting contrasting approaches to quality assurance. The first focuses on demonstrating quality within research outputs; the second focuses on principles for quality practice throughout the research process. The second narrative appears to offer an approach to quality assurance that befits the values of qualitative research, emphasising the need to consider quality throughout the research process. Conclusions The paper identifies the strengths of the approaches represented in each narrative and recommend these are brought together in the development of a flexible framework to help qualitative researchers to define, apply and demonstrate principles of quality in their research. PMID:22182674

The Columbia River Protection Supplemental Technologies Quality Assurance Project Plan

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

Fix, N. J.

The U.S. Department of Energy (DOE) has conducted interim groundwater remedial activities on the Hanford Site since the mid-1990s for several groundwater contamination plumes. DOE established the Columbia River Protection Supplemental Technologies Project (Technologies Project) in 2006 to evaluate alternative treatment technologies. The objectives for the technology project are as follows: develop a 300 Area polyphosphate treatability test to immobilize uranium, design and test infiltration of a phosphate/apatite technology for Sr-90 at 100-N, perform carbon tetrachloride and chloroform attenuation parameter studies, perform vadose zone chromium characterization and geochemistry studies, perform in situ biostimulation of chromium studies for a reducing barriermore » at 100-D, and perform a treatability test for phytoremediation for Sr-90 at 100-N. This document provides the quality assurance guidelines that will be followed by the Technologies Project. This Quality Assurance Project Plan is based on the quality assurance requirements of DOE Order 414.1C, Quality Assurance, and 10 CFR 830, Subpart A--Quality Assurance Requirements as delineated in Pacific Northwest National Laboratory’s Standards-Based Management System. In addition, the technology project is subject to the Environmental Protection Agency (EPA) Requirements for Quality Assurance Project Plans (EPA/240/B-01/003, QA/R-5). The Hanford Analytical Services Quality Assurance Requirements Documents (HASQARD, DOE/RL-96-68) apply to portions of this project and to the subcontractors. HASQARD requirements are discussed within applicable sections of this plan.« less

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

References on EPA Quality Assurance Project Plans

EPA Pesticide Factsheets

Provides requirements for the conduct of quality management practices, including quality assurance (QA) and quality control (QC) activities, for all environmental data collection and environmental technology programs performed by or for this Agency.

Illinois' Forests, 2005: Statistics, Methods, and Quality Assurance

Treesearch

Susan J. Crocker; Charles J. Barnett; Mark A. Hatfield

2013-01-01

The first full annual inventory of Illinois' forests was completed in 2005. This report contains 1) descriptive information on methods, statistics, and quality assurance of data collection, 2) a glossary of terms, 3) tables that summarize quality assurance, and 4) a core set of tabular estimates for a variety of forest resources. A detailed analysis of inventory...

[Quality assurance of rehabilitation by the German pension insurance: an overview].

PubMed

Klosterhuis, H; Baumgarten, E; Beckmann, U; Erbstösser, S; Lindow, B; Naumann, B; Widera, T; Zander, J

2010-12-01

The German pension insurance has in recent years developed a comprehensive programme for quality assurance in rehabilitation, and has implemented the programme into routine practice. Different aspects of rehabilitation are evaluated with differentiated instruments. Issues dealt with inter alia include the quality of rehabilitative care in a narrower sense, the structure and organisation of the rehabilitation centres, as well as quality from the patients' perspective. On the whole, positive results predominate. Big differences in quality however have been found between the rehabilitation centres. The data collections and data evaluations carried out make a continuous process of quality assurance reporting possible for use by rehabilitation centres and pension insurance agencies. This will enable targeted initiatives for quality improvement. The methods and procedures of quality assurance are enhanced at regular intervals, and the scope of quality assurance is extended. Thus, rehab quality assurance is also expanded to cover ambulant rehabilitation or rehabilitation of children and young people. © Georg Thieme Verlag KG Stuttgart · New York.

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

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…

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

[Quality assurance in dentistry--past, present and future].

PubMed

Vered, Y; Schwartz, N; Babayoff, I

2003-01-01

Quality assurance involves the cycle of quality assessment, formal identification of problems, developing a strategy for resolving problems and implementation of changes. Historically, the term "first do not harm" can be considered as the first step in quality assurance. Patients' high expectations from the outcomes of dental treatment, new technology and cost containment changed the perspectives completely. We are facing a new era of an increasing demand for patients' involvement as well as an increasing demand for accountability of the members of the profession. The article describes the development of the issue of quality assurance during the last thirty years and highlights the difficulties encountered by the profession in adjusting the changes due to lack of education, experience, knowledge and absence of a definition for accepted criteria for action. Developing criteria for appropriateness of dental treatment, developing mechanisms for assessing the art of care, development of large data bases and development of consumers' surveys are some of the leading suggestions for future action. The responsibility for quality and quality assurance lies in the hands of the dental profession. Organized dentistry possesses a social and ethical commitment for the society, as well as professional obligation for the members of the profession. Although cost containment gave rise to the issue of quality, quality assurance should not be measured in financial terms, but in terms of accepting responsibility and working for continuous improvement. Steps in the right direction will, hopefully, lead to a better and more efficient utilization of the available resources and will increase the trust of the public in the profession of dentistry. Therefore, organized dentistry should not leave this important issue to be dealt by non-dental professions or commercial organizations.

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.

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.

Italian quality assurance in mental health.

PubMed

Rossi, Giovanni; Agnetti, Germana; Bosio, Roberto; De Luca, Pasquale; Erlicher, Arcadio; Morganti, Carla; Neri, Giovanni; Re, Edoardo; Semisa, Domenico; Fioritti, Angelo

2014-06-01

Since the radical changes in Italian mental health law in the 1970s, quality assurance models have gained consensus as the most suitable service assessment tool. In the 1990s, the whole Italian National Health System changed into a corporate model, and an accreditation system was implemented.The Italian Association for Quality and Accreditation in Mental Health (Associazione Italiana per la Qualità e l'Accreditamento in Salute Mentale [QUASM]) was founded in 1984, and since then, it offers consultation and support for Mental Health Departments and Regional Governments to help them to develop psychiatric programs, self-evaluation, educational programs, and professional peer-model accreditation. The QUASM accreditation manual has now gone through several revisions, the last in 2008. Until 2008, QUASM was successful in promoting quality and facilitating both institutional and professional accreditation. However, radical changes triggered by financial crisis have jeopardized quality assurance implementation. Nowadays, the challenge for QUASM is to maintain quality and accreditation geared to excellence against prevailing leveling trends.

An In-Depth Study on the Impact of External Quality Assurance

ERIC Educational Resources Information Center

Stensaker, Bjorn; Langfeldt, Liv; Harvey, Lee; Huisman, Jeroen; Westerheijden, Don

2011-01-01

After more than two decades of external quality assurance, there is an increasing interest in questions concerning the impact and effects of this activity. Following an external evaluation of NOKUT--the Norwegian quality assurance agency, this article studies the impact of external quality assurance in detail by analysing quantitative and…

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

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