CTEPP STANDARD OPERATING PROCEDURE FOR DETECTION AND QUANTIFICATION OF TARGET ANALYTES BY GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) (SOP-5.24)

EPA Science Inventory

This standard operating procedure describes the method used for the determination of target analytes in sample extracts and related quality assurance/quality control sample extracts generated in the CTEPP study.

U.S. Geological Survey Noble Gas Laboratory’s standard operating procedures for the measurement of dissolved gas in water samples

USGS Publications Warehouse

Hunt, Andrew G.

2015-08-12

This report addresses the standard operating procedures used by the U.S. Geological Survey’s Noble Gas Laboratory in Denver, Colorado, U.S.A., for the measurement of dissolved gases (methane, nitrogen, oxygen, and carbon dioxide) and noble gas isotopes (helium-3, helium-4, neon-20, neon-21, neon-22, argon-36, argon-38, argon-40, kryton-84, krypton-86, xenon-103, and xenon-132) dissolved in water. A synopsis of the instrumentation used, procedures followed, calibration practices, standards used, and a quality assurance and quality control program is presented. The report outlines the day-to-day operation of the Residual Gas Analyzer Model 200, Mass Analyzer Products Model 215–50, and ultralow vacuum extraction line along with the sample handling procedures, noble gas extraction and purification, instrument measurement procedures, instrumental data acquisition, and calculations for the conversion of raw data from the mass spectrometer into noble gas concentrations per unit mass of water analyzed. Techniques for the preparation of artificial dissolved gas standards are detailed and coupled to a quality assurance and quality control program to present the accuracy of the procedures used in the laboratory.

[Standard operating procedures in ethic committees].

PubMed

Czarkowski, Marek

2006-02-01

Polish ethic committees should have to work together in order to maintain and develop high quality standards in the protection of human subjects. Exchanging knowledge, know-how and information polish ethic committees should have to implement standard operating procedures. Procedures should improve quality and proficiency of all types of ethic committee's activities. Standard operating procedures should cover as important problems as conflict of interest, trial's insurance or elections of ethic committees. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting. Governmental initiatives and creation of forum for polish ethic committees are essential in the effective standardisation, coordination and implementation of procedures in regional ethic committees. These projects need support via public funding from our authorities.

40 CFR 131.20 - State review and revision of water quality standards.

Code of Federal Regulations, 2010 CFR

2010-07-01

... accordance with provisions of State law, EPA's water quality management regulation (40 CFR 130.3(b)(6)) and... quality standards. 131.20 Section 131.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality...

Basics of compounding: considerations for implementing United States pharmacopeia chapter 797 pharmaceutical compounding-sterile preparations, part 16: suggested standard operating procedures.

PubMed

Okeke, Claudia C; Allen, Loyd V

2009-01-01

The standard operating procedures suggested in this article are presented to compounding pharmacies to ensure the quality of the environment in which a CSP is prepared. Since United States Pharmacopeia Chapter 797 provides minimum standards, each facility should aim for best practice gold standard. The standard operating procedures should be tailored to meet the expectations and design of each facility. Compounding personnel are expected to know and understand each standard operating procedure to allow for complete execution of the procedures.

40 CFR 131.20 - State review and revision of water quality standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 22 2011-07-01 2011-07-01 false State review and revision of water quality standards. 131.20 Section 131.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality Standards § 131.20 State review and revision of...

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.

40 CFR 132.5 - Procedures for adoption and EPA review.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROGRAMS WATER QUALITY GUIDANCE FOR THE GREAT LAKES SYSTEM § 132.5 Procedures for adoption and EPA review... water quality standards that were derived, or are as protective as or more protective than could be... procedure by which water quality-based effluent limits and total maximum daily loads are developed using the...

Should Title 24 Ventilation Requirements Be Amended to include an Indoor Air Quality Procedure?

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

Dutton, Spencer M.; Mendell, Mark J.; Chan, Wanyu R.

Minimum outdoor air ventilation rates (VRs) for buildings are specified in standards, including California?s Title 24 standards. The ASHRAE ventilation standard includes two options for mechanically-ventilated buildings ? a prescriptive ventilation rate procedure (VRP) that specifies minimum VRs that vary among occupancy classes, and a performance-based indoor air quality procedure (IAQP) that may result in lower VRs than the VRP, with associated energy savings, if IAQ meeting specified criteria can be demonstrated. The California Energy Commission has been considering the addition of an IAQP to the Title 24 standards. This paper, based on a review of prior data and newmore » analyses of the IAQP, evaluates four future options for Title 24: no IAQP; adding an alternate VRP, adding an equivalent indoor air quality procedure (EIAQP), and adding an improved ASHRAE-like IAQP. Criteria were established for selecting among options, and feedback was obtained in a workshop of stakeholders. Based on this review, the addition of an alternate VRP is recommended. This procedure would allow lower minimum VRs if a specified set of actions were taken to maintain acceptable IAQ. An alternate VRP could also be a valuable supplement to ASHRAE?s ventilation standard.« less

42 CFR 493.1425 - Standard; Testing personnel responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... laboratory's quality control policies, document all quality control activities, instrument and procedural... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing Moderate Complexity Testing § 493.1425 Standard; Testing personnel...

[Procedure of seed quality testing and seed grading standard of Prunus humilis].

PubMed

Wen, Hao; Ren, Guang-Xi; Gao, Ya; Luo, Jun; Liu, Chun-Sheng; Li, Wei-Dong

2014-11-01

So far there exists no corresponding quality test procedures and grading standards for the seed of Prunus humilis, which is one of the important source of base of semen pruni. Therefor we set up test procedures that are adapt to characteristics of the P. humilis seed through the study of the test of sampling, seed purity, thousand-grain weight, seed moisture, seed viability and germination percentage. 50 cases of seed specimens of P. humilis tested. The related data were analyzed by cluster analysis. Through this research, the seed quality test procedure was developed, and the seed quality grading standard was formulated. The seed quality of each grade should meet the following requirements: for first grade seeds, germination percentage ≥ 68%, thousand-grain weight 383 g, purity ≥ 93%, seed moisture ≤ 5%; for second grade seeds, germination percentage ≥ 26%, thousand-grain weight ≥ 266 g, purity ≥ 73%, seed moisture ≤9%; for third grade seeds, germination percentage ≥ 10%, purity ≥ 50%, thousand-grain weight ≥ 08 g, seed moisture ≤ 13%.

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.

Air Pollution over the States

ERIC Educational Resources Information Center

Environmental Science and Technology, 1972

1972-01-01

State plans for implementing air quality standards are evaluated together with problems in modeling procedures and enforcement. Monitoring networks, standards, air quality regions, and industrial problems are also discussed. (BL)

US EPA Base Study Standard Operating Procedure for Data Processing and Data Management

EPA Pesticide Factsheets

The purpose of the Standard Operating Procedures (SOP) for data management and data processing is to facilitate consistent documentation and completion of data processing duties and management responsibilities in order to maintain a high standard of data quality.

40 CFR 131.21 - EPA review and approval of water quality standards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Act remains the applicable standard until EPA approves a change, deletion, or addition to that water... 40 Protection of Environment 23 2013-07-01 2013-07-01 false EPA review and approval of water... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality...

40 CFR 131.21 - EPA review and approval of water quality standards.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Act remains the applicable standard until EPA approves a change, deletion, or addition to that water... 40 Protection of Environment 22 2014-07-01 2013-07-01 true EPA review and approval of water... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality...

40 CFR 131.21 - EPA review and approval of water quality standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Act remains the applicable standard until EPA approves a change, deletion, or addition to that water... 40 Protection of Environment 23 2012-07-01 2012-07-01 false EPA review and approval of water... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality...

40 CFR 131.21 - EPA review and approval of water quality standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Act remains the applicable standard until EPA approves a change, deletion, or addition to that water... 40 Protection of Environment 22 2011-07-01 2011-07-01 false EPA review and approval of water... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality...

Developing Flowcharted Procedures Manuals for School District Administration within the ISO 9000 Context.

ERIC Educational Resources Information Center

Schoch, Robert

2002-01-01

Describes how the School District of Lancaster, Pennsylvania, implemented a districtwide quality-management system based on the Geneva-based International Standards Organization 9001, a major component of which is the documentation of procedures. Includes sections on implementation, procedure manuals, quality management, uniformity, formatting,…

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...

Evaluation of a new very low dose imaging protocol: feasibility and impact on X-ray dose levels in electrophysiology procedures

PubMed Central

Bourier, Felix; Reents, Tilko; Ammar-Busch, Sonia; Buiatti, Alessandra; Kottmaier, Marc; Semmler, Verena; Telishevska, Marta; Brkic, Amir; Grebmer, Christian; Lennerz, Carsten; Kolb, Christof; Hessling, Gabriele; Deisenhofer, Isabel

2016-01-01

Aims This study presents and evaluates the impact of a new lowest-dose fluoroscopy protocol (Siemens AG), especially designed for electrophysiology (EP) procedures, on X-ray dose levels. Methods and results From October 2014 to March 2015, 140 patients underwent an EP study on an Artis zee angiography system. The standard low-dose protocol was operated at 23 nGy (fluoroscopy) and at 120 nGy (cine-loop), the new lowest-dose protocol was operated at 8 nGy (fluoroscopy) and at 36 nGy (cine-loop). Procedural data, X-ray times, and doses were analysed in 100 complex left atrial and in 40 standard EP procedures. The resulting dose–area products were 877.9 ± 624.7 µGym² (n = 50 complex procedures, standard low dose), 199 ± 159.6 µGym² (n = 50 complex procedures, lowest dose), 387.7 ± 36.0 µGym² (n = 20 standard procedures, standard low dose), and 90.7 ± 62.3 µGym² (n = 20 standard procedures, lowest dose), P < 0.01. In the low-dose and lowest-dose groups, procedure times were 132.6 ± 35.7 vs. 126.7 ± 34.7 min (P = 0.40, complex procedures) and 72.3 ± 20.9 vs. 85.2 ± 44.1 min (P = 0.24, standard procedures), radiofrequency (RF) times were 53.8 ± 26.1 vs. 50.4 ± 29.4 min (P = 0.54, complex procedures) and 10.1 ± 9.9 vs. 12.2 ± 14.7 min (P = 0.60, standard procedures). One complication occurred in the standard low-dose and lowest-dose groups (P = 1.0). Conclusion The new lowest-dose imaging protocol reduces X-ray dose levels by 77% compared with the currently available standard low-dose protocol. From an operator standpoint, lowest X-ray dose levels create a different, reduced image quality. The new image quality did not significantly affect procedure or RF times and did not result in higher complication rates. Regarding radiological protection, operating at lowest-dose settings should become standard in EP procedures. PMID:26589627

CTEPP STANDARD OPERATING PROCEDURE FOR CONDUCTING INTERNAL FIELD AUDITS AND QUALITY CONTROL (SOP-2.25)

EPA Science Inventory

This SOP describes the method for conducting internal field audits and quality control procedures. Internal field audits will be conducted to ensure the collection of high quality data. Internal field audits will be conducted by Field Auditors (the Field QA Officer and the Field...

Economic Assessment and Budgetary Impact of a Telemedicine Procedure and Spirometry Quality Control in the Primary Care Setting.

PubMed

Marina, Nuria; Bayón, Juan Carlos; López de Santa María, Elena; Gutiérrez, Asunción; Inchausti, Marta; Bustamante, Victor; Gáldiz, Juan B

2016-01-01

To evaluate the economic impact of a telemedicine procedure designed to improve the quality of lung function testing (LFT) in primary care in a public healthcare system, compared with the standard method. The economic impact of 9,039 LFTs performed in 51 health centers (2010-2013) using telespirometry (TS) compared to standard spirometry (SS) was studied. TS costs more per unit than SS (€47.80 vs. €39.70) (2013), but the quality of the TS procedure is superior (84% good quality, compared to 61% using the standard procedure). Total cost of TS was €431,974 (compared with €358,306€ for SS), generating an economic impact of €73,668 (2013). The increase in cost for good quality LFT performed using TS was €34,030 (2010) and €144,295 (2013), while the costs of poor quality tests fell by €15,525 (2010) and 70,627€ (2013). The cost-effectiveness analysis concludes that TS is 23% more expensive and 46% more effective. Healthcare costs consequently fall as the number of LFTs performed by TS rises. Avoiding poor quality, invalid LFTs generates savings that compensate for the increased costs of performing LFTs with TS, making it a cost-effective method. Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR PREPARATION OF STANDARD OPERATING PROCEDURES (SOPS) (UA-G-1.0)

EPA Science Inventory

The purpose of this SOP is to establish a uniform format for the preparation of SOPs. Use of these protocols ensures consistent implementation of project tasks, documents the preparation and implementation of the procedures used, describes quality control measures and the limits...

Standard procedures and quality-control practices for the U.S. Geological Survey National Field Quality Assurance Program from 1982 through 1993

USGS Publications Warehouse

Stanley, D.L.

1995-01-01

The U.S. Geological Survey operates the National Field Quality Assurance Program to provide quality- assurance reference samples to field personnel who make water-quality field measurements. The program monitors the accuracy and precision of pH, specific conductance, and alkalinity field measurements. This report documents the operational procedures and quality-control techniques used in operating the quality-assurance program.

European Standards for Quality Assurance and Institutional Practices of Student Assessment in the UK, the Netherlands and the Czech Republic

ERIC Educational Resources Information Center

Kohoutek, Jan

2014-01-01

This article analyses the student assessment procedures of 12 universities in the UK, the Netherlands and the Czech Republic with respect to their alignment with the European standards and guidelines on the quality of assessing higher education students (European Standards and Guidelines for Quality Assurance [ESG] 1.3). Based on qualitative…

How to Improve the Quality of Screening Endoscopy in Korea: National Endoscopy Quality Improvement Program.

PubMed

Cho, Yu Kyung

2016-07-01

In Korea, gastric cancer screening, either esophagogastroduodenoscopy or upper gastrointestinal series (UGIS), is performed biennially for adults aged 40 years or older. Screening endoscopy has been shown to be associated with localized cancer detection and better than UGIS. However, the diagnostic sensitivity of detecting cancer is not satisfactory. The National Endoscopy Quality Improvement (QI) program was initiated in 2009 to enhance the quality of medical institutions and improve the effectiveness of the National Cancer Screening Program (NCSP). The Korean Society of Gastrointestinal Endoscopy developed quality standards through a broad systematic review of other endoscopic quality guidelines and discussions with experts. The standards comprise five domains: qualifications of endoscopists, endoscopic unit facilities and equipment, endoscopic procedure, endoscopy outcomes, and endoscopic reprocessing. After 5 years of the QI program, feedback surveys showed that the perception of QI and endoscopic practice improved substantially in all domains of quality, but the quality standards need to be revised. How to avoid missing cancer in endoscopic procedures in daily practice was reviewed, which can be applied to the mass screening endoscopy. To improve the quality and effectiveness of NCSP, key performance indicators, acceptable quality standards, regular audit, and appropriate reimbursement are necessary.

Standard operating procedures (SOPs): reason for, types of, adequacy, approval, and deviations from and revisions to.

PubMed

Isaman, V; Thelin, R

1995-09-01

Standard Operating Procedures (SOPs) are required in order to comply with the Good Laboratory Practice Standards (GLPS) as promulgated in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) 40 CFR Part 160. Paragraph 160.81 (a) states: "A testing facility shall have standard operating procedures in writing setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study." Types of SOPs include administrative and personnel, analyses, substances, quality assurance and records, test system, equipment, and field related. All SOPs must be adequate in scope to describe the function in sufficient detail such that the study data are reproducible. All SOPs must be approved by a management level as described in a corporate organization chart. Signatures for SOP responsibility, authorship, and Quality Assurance review adds strength and accountability to the SOP. In the event a procedure or method is performed differently from what is stated in the SOP, an SOP deviation is necessary. As methods and procedures are improved, SOP revisions are necessary to maintain SOP adequacy and applicability. The replaced SOP is put into a historical SOP file and all copies of the replaced SOPs are destroyed.

[Process-oriented quality management in the hospital].

PubMed

Wolters, H G

1998-03-01

Procedures and experiences concerning the implementation of quality management in a midsize hospital with 6 medical disciplines are described. Quality of infrastructure was checked with lists and the quality of medical performance assessed by means of standardized numerical audit with all professional groups. Weaknesses were identified by comparing the result to each quality indicator with target standards. As examples, causal relations and consequences of deficiencies in clinical care documentation, scheme of preoperative diagnosis, co-ordination of surgical procedures and handling of complications are given in more detail. Obstacles were rated depending on frequency and risk potential, sometimes cost effectiveness. Members of all professional groups and departments involved participated in trouble solving teams to which external expert assistance was provided. For example, interventions leading to improved co-ordination of surgical activities and their impacts are specified. Improving systematically the quality of clinical procedures is one gateway to establish quality management in hospitals continuously and thoroughly becoming an integrated part of the corporate culture. Investment of resources is necessary but justified by midrange benefits.

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE FOR PREPARATION OF STANDARD OPERATING PROCEDURES (SOPS) (UA-G-1.0)

EPA Science Inventory

The purpose of this SOP is to establish a uniform format for the preparation of SOPs. Use of these protocols ensures consistent implementation of project tasks, documents the preparation and implementation of the procedures used, describes quality control measures and the limits...

Using the Many-Facet Rasch Model to Evaluate Standard-Setting Judgments: Setting Performance Standards for Advanced Placement® Examinations

ERIC Educational Resources Information Center

Kaliski, Pamela; Wind, Stefanie A.; Engelhard, George, Jr.; Morgan, Deanna; Plake, Barbara; Reshetar, Rosemary

2012-01-01

The Many-Facet Rasch (MFR) Model is traditionally used to evaluate the quality of ratings on constructed response assessments; however, it can also be used to evaluate the quality of judgments from panel-based standard setting procedures. The current study illustrates the use of the MFR Model by examining the quality of ratings obtained from a…

21 CFR 58.35 - Quality assurance unit.

Code of Federal Regulations, 2013 CFR

2013-04-01

... the corrective actions taken. (5) Determine that no deviations from approved protocols or 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 procedures, and...

21 CFR 58.35 - Quality assurance unit.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the corrective actions taken. (5) Determine that no deviations from approved protocols or 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 procedures, and...

21 CFR 58.35 - Quality assurance unit.

Code of Federal Regulations, 2012 CFR

2012-04-01

... the corrective actions taken. (5) Determine that no deviations from approved protocols or 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 procedures, and...

21 CFR 58.35 - Quality assurance unit.

Code of Federal Regulations, 2011 CFR

2011-04-01

... the corrective actions taken. (5) Determine that no deviations from approved protocols or 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 procedures, and...

21 CFR 58.35 - Quality assurance unit.

Code of Federal Regulations, 2014 CFR

2014-04-01

... the corrective actions taken. (5) Determine that no deviations from approved protocols or 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 procedures, and...

Evaluation of a new very low dose imaging protocol: feasibility and impact on X-ray dose levels in electrophysiology procedures.

PubMed

Bourier, Felix; Reents, Tilko; Ammar-Busch, Sonia; Buiatti, Alessandra; Kottmaier, Marc; Semmler, Verena; Telishevska, Marta; Brkic, Amir; Grebmer, Christian; Lennerz, Carsten; Kolb, Christof; Hessling, Gabriele; Deisenhofer, Isabel

2016-09-01

This study presents and evaluates the impact of a new lowest-dose fluoroscopy protocol (Siemens AG), especially designed for electrophysiology (EP) procedures, on X-ray dose levels. From October 2014 to March 2015, 140 patients underwent an EP study on an Artis zee angiography system. The standard low-dose protocol was operated at 23 nGy (fluoroscopy) and at 120 nGy (cine-loop), the new lowest-dose protocol was operated at 8 nGy (fluoroscopy) and at 36 nGy (cine-loop). Procedural data, X-ray times, and doses were analysed in 100 complex left atrial and in 40 standard EP procedures. The resulting dose-area products were 877.9 ± 624.7 µGym² (n = 50 complex procedures, standard low dose), 199 ± 159.6 µGym² (n = 50 complex procedures, lowest dose), 387.7 ± 36.0 µGym² (n = 20 standard procedures, standard low dose), and 90.7 ± 62.3 µGym² (n = 20 standard procedures, lowest dose), P < 0.01. In the low-dose and lowest-dose groups, procedure times were 132.6 ± 35.7 vs. 126.7 ± 34.7 min (P = 0.40, complex procedures) and 72.3 ± 20.9 vs. 85.2 ± 44.1 min (P = 0.24, standard procedures), radiofrequency (RF) times were 53.8 ± 26.1 vs. 50.4 ± 29.4 min (P = 0.54, complex procedures) and 10.1 ± 9.9 vs. 12.2 ± 14.7 min (P = 0.60, standard procedures). One complication occurred in the standard low-dose and lowest-dose groups (P = 1.0). The new lowest-dose imaging protocol reduces X-ray dose levels by 77% compared with the currently available standard low-dose protocol. From an operator standpoint, lowest X-ray dose levels create a different, reduced image quality. The new image quality did not significantly affect procedure or RF times and did not result in higher complication rates. Regarding radiological protection, operating at lowest-dose settings should become standard in EP procedures. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

24 CFR 200.954 - Supplementary specific requirements under the HUD building product standard and certification...

Code of Federal Regulations, 2012 CFR

2012-04-01

... shall also include the manufacturer's name, plant location, and shelf life. (c) Periodic tests and quality assurance. Under the procedures set forth in § 200.935(d)(8) concerning periodic tests and quality... administrator. (2) The administrator shall also review the quality assurance procedures twice a year to assure...

24 CFR 200.954 - Supplementary specific requirements under the HUD building product standard and certification...

Code of Federal Regulations, 2011 CFR

2011-04-01

... shall also include the manufacturer's name, plant location, and shelf life. (c) Periodic tests and quality assurance. Under the procedures set forth in § 200.935(d)(8) concerning periodic tests and quality... administrator. (2) The administrator shall also review the quality assurance procedures twice a year to assure...

US EPA Base Study Standard Operating Procedure for Continuous Monitoring of Outdoor Air

EPA Pesticide Factsheets

The procedure described is intended for monitoring continuously and simultaneously outdoor air quality parameters that are most commonly associated with indoor air quality: the concentrations of carbon dioxide (CO2) and carbon monoxide (CO), temperature, nd relative humidity (RH).

21 CFR 58.81 - Standard operating procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... quality and integrity of the data generated in the course of a study. All deviations in a study from... data. Significant changes in established standard operating procedures shall be properly authorized in... following: (1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling...

42 CFR 493.1495 - Standard; Testing personnel responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... samples are tested in the same manner as patient specimens; (3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived...

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.

UK key performance indicators and quality assurance standards for colonoscopy.

PubMed

Rees, Colin J; Thomas Gibson, Siwan; Rutter, Matt D; Baragwanath, Phil; Pullan, Rupert; Feeney, Mark; Haslam, Neil

2016-12-01

Colonoscopy should be delivered by endoscopists performing high quality procedures. The British Society of Gastroenterology, the UK Joint Advisory Group on GI Endoscopy, and the Association of Coloproctology of Great Britain and Ireland have developed quality assurance measures and key performance indicators for the delivery of colonoscopy within the UK. This document sets minimal standards for delivery of procedures along with aspirational targets that all endoscopists should aim for. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Using Quality Management Systems to Improve Test Development and Standards and to Promote Good Practice: A Case Study of Testing Italian as a Foreign Language

ERIC Educational Resources Information Center

Grego Bolli, Giuliana

2014-01-01

This article discusses the problem of quality in the production of language tests in the context of Italian language examinations. The concept of quality is closely related to the application of stated standards and related procedures. These standards, developed over the last thirty years, are mainly related to the concepts of the accountability…

Field guide for collecting and processing stream-water samples for the National Water-Quality Assessment Program

USGS Publications Warehouse

Shelton, Larry R.

1994-01-01

The U.S. Geological Survey's National Water-Quality Assessment program includes extensive data- collection efforts to assess the quality of the Nations's streams. These studies require analyses of stream samples for major ions, nutrients, sediments, and organic contaminants. For the information to be comparable among studies in different parts of the Nation, consistent procedures specifically designed to produce uncontaminated samples for trace analysis in the laboratory are critical. This field guide describes the standard procedures for collecting and processing samples for major ions, nutrients, organic contaminants, sediment, and field analyses of conductivity, pH, alkalinity, and dissolved oxygen. Samples are collected and processed using modified and newly designed equipment made of Teflon to avoid contamination, including nonmetallic samplers (D-77 and DH-81) and a Teflon sample splitter. Field solid-phase extraction procedures developed to process samples for organic constituent analyses produce an extracted sample with stabilized compounds for more accurate results. Improvements to standard operational procedures include the use of processing chambers and capsule filtering systems. A modified collecting and processing procedure for organic carbon is designed to avoid contamination from equipment cleaned with methanol. Quality assurance is maintained by strict collecting and processing procedures, replicate sampling, equipment blank samples, and a rigid cleaning procedure using detergent, hydrochloric acid, and methanol.

Recent progress in the development of ISO 19751

NASA Astrophysics Data System (ADS)

Farnand, Susan P.; Dalal, Edul N.; Ng, Yee S.

2006-01-01

A small number of general visual attributes have been recognized as essential in describing image quality. These include micro-uniformity, macro-uniformity, colour rendition, text and line quality, gloss, sharpness, and spatial adjacency or temporal adjacency attributes. The multiple-part International Standard discussed here was initiated by the INCITS W1 committee on the standardization of office equipment to address the need for unambiguously documented procedures and methods, which are widely applicable over the multiple printing technologies employed in office applications, for the appearance-based evaluation of these visually significant image quality attributes of printed image quality. 1,2 The resulting proposed International Standard, for which ISO/IEC WD 19751-1 3 presents an overview and an outline of the overall procedure and common methods, is based on a proposal that was predicated on the idea that image quality could be described by a small set of broad-based attributes. 4 Five ad hoc teams were established (now six since a sharpness team is in the process of being formed) to generate standards for one or more of these image quality attributes. Updates on the colour rendition, text and line quality, and gloss attributes are provided.

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.

40 CFR Appendix C to Part 61 - Quality Assurance Procedures

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 9 2014-07-01 2014-07-01 false Quality Assurance Procedures C Appendix C to Part 61 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS Pt. 61, App. C Appendix C to Part 61...

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2011-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

Applying policy and health effects of air pollution in South Korea: focus on ambient air quality standards

PubMed Central

Ha, Jongsik

2014-01-01

Objectives South Korea’s air quality standards are insufficient in terms of establishing a procedure for their management. The current system lacks a proper decision-making process and prior evidence is not considered. The purpose of this study is to propose a measure for establishing atmospheric environmental standards in South Korea that will take into consideration the health of its residents. Methods In this paper, the National Ambient Air Quality Standards (NAAQS) of the US was examined in order to suggest ways, which consider health effects, to establish air quality standards in South Korea. Up-to-date research on the health effects of air pollution was then reviewed, and tools were proposed to utilize the key results. This was done in an effort to ensure the reliability of the standards with regard to public health. Results This study showed that scientific research on the health effects of air pollution and the methodology used in the research have contributed significantly to establishing air quality standards. However, as the standards are legally binding, the procedure should take into account the effects on other sectors. Realistically speaking, it is impossible to establish standards that protect an entire population from air pollution. Instead, it is necessary to find a balance between what should be done and what can be done. Conclusions Therefore, establishing air quality standards should be done as part of an evidence-based policy that identifies the health effects of air pollution and takes into consideration political, economic, and social contexts. PMID:25300297

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

PubMed

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

2015-07-01

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

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR FORM QA/QC CHECKS (UA-C-2.0)

EPA Science Inventory

The purpose of this SOP is to outline the process of Field Quality Assurance and Quality Control checks. This procedure was followed to ensure consistent data retrieval during the Arizona NHEXAS project and the "Border" study. Keywords: custody; QA/QC; field checks.

The Nation...

Guidelines and standard procedures for studies of ground-water quality; selection and installation of wells, and supporting documentation

USGS Publications Warehouse

Lapham, W.W.; Wilde, F.D.; Koterba, M.T.

1997-01-01

This is the first of a two-part report to document guidelines and standard procedures of the U.S. Geological Survey for the acquisition of data in ground-water-quality studies. This report provides guidelines and procedures for the selection and installation of wells for water-quality studies/*, and the required or recommended supporting documentation of these activities. Topics include (1) documentation needed for well files, field folders, and electronic files; (2) criteria and information needed for the selection of water-supply and observation wells, including site inventory and data collection during field reconnaissance; and (3) criteria and preparation for installation of monitoring wells, including the effects of equipment and materials on the chemistry of ground-water samples, a summary of drilling and coring methods, and information concerning well completion, development, and disposition.

[Recommendations for the control of documents and the establishment of a documentary system].

PubMed

Vinner, E

2013-06-01

The quality management system that must be implemented in a MBL to meet the requirements of the standard NF EN ISO 15189 is based, among other things, on the creation and use by staff of a documentary system approved and updated. This documentary system is constituted by external documents (standards, suppliers' documents...) and internal documents (quality manual, procedures, instructions, technical and quality recordings...). A procedure of the documentary system control must be formalized. The documentary system should be modeled in order to identify the various procedures to be drafted and the incurred risks in the case a document would be missing in this system. Each document must be indexed in a unique way and document management must be carried out rigorously. The use of document management software is a great help to manage the life cycle of documents.

Emerging developments in the standardized chemical characterization of indoor air quality.

PubMed

Nehr, Sascha; Hösen, Elisabeth; Tanabe, Shin-Ichi

2017-01-01

Despite the fact that the special characteristics of indoor air pollution make closed environments quite different from outdoor environments, the conceptual ideas for assessing air quality indoors and outdoors are similar. Therefore, the elaboration of International Standards for air quality characterization in view of controlling indoor air quality should resort to this common basis. In this short review we describe the possibilities of standardization of tools dedicated to indoor air quality characterization with a focus on the tools permitting to study the indoor air chemistry. The link between indoor exposure and health as well as the critical processes driving the indoor air quality are introduced. Available International Standards for the assessment of indoor air quality are depicted. The standards comprise requirements for the sampling on site, the analytical procedures, and the determination of material emissions. To date, these standardized procedures assure that indoor air, settled dust and material samples are analyzed in a comparable manner. However, existing International Standards exclusively specify conventional, event-driven target-screening using discontinuous measurement methods for long-lived pollutants. Therefore, this review draws a parallel between physico-chemical processes in indoor and outdoor environments. The achievements in atmospheric sciences also improve our understanding of indoor environments. The community of atmospheric scientists can be both ideal and supporter for researchers in the area of indoor air quality characterization. This short review concludes with propositions for future standardization activities for the chemical characterization of indoor air quality. Future standardization efforts should focus on: (i) the elaboration of standardized measurement methods and measurement strategies for online monitoring of long-lived and short-lived pollutants, (ii) the assessment of the potential and the limitations of non-target screening, (iii) the paradigm shift from event-driven investigations to systematic approaches to characterize indoor environments, and (iv) the development of tools for policy implementation. Copyright © 2016 Elsevier Ltd. All rights reserved.

42 CFR 493.643 - Fee for determination of program compliance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... laboratory's scope and volume of testing (excluding tests performed for quality control, quality assurance... procedure or examination for a single analyte. (Tests performed for quality control, quality assurance, and... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Administration...

21 CFR Appendix E to Subpart A of... - Elements To Be Considered in Developing a Two-Way Alert System

Code of Federal Regulations, 2011 CFR

2011-04-01

... what circumstances an alert is required —Standard Operating Procedures (SOP's) —Mechanism of health... mechanisms 3. Enforcement Procedures —Followup mechanisms —Corrective action procedures 4. Quality Assurance...

21 CFR Appendix E to Subpart A of... - Elements To Be Considered in Developing a Two-Way Alert System

Code of Federal Regulations, 2012 CFR

2012-04-01

... what circumstances an alert is required —Standard Operating Procedures (SOP's) —Mechanism of health... mechanisms 3. Enforcement Procedures —Followup mechanisms —Corrective action procedures 4. Quality Assurance...

21 CFR Appendix E to Subpart A of... - Elements To Be Considered in Developing a Two-Way Alert System

Code of Federal Regulations, 2014 CFR

2014-04-01

... what circumstances an alert is required —Standard Operating Procedures (SOP's) —Mechanism of health... mechanisms 3. Enforcement Procedures —Followup mechanisms —Corrective action procedures 4. Quality Assurance...

21 CFR Appendix E to Subpart A of... - Elements To Be Considered in Developing a Two-Way Alert System

Code of Federal Regulations, 2013 CFR

2013-04-01

... what circumstances an alert is required —Standard Operating Procedures (SOP's) —Mechanism of health... mechanisms 3. Enforcement Procedures —Followup mechanisms —Corrective action procedures 4. Quality Assurance...

40 CFR 140.5 - Analytical procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 140.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) MARINE SANITATION DEVICE STANDARD § 140.5 Analytical procedures. In determining the composition and quality of effluent discharge from marine sanitation devices, the procedures contained in 40 CFR part 136...

Template for success: using a resident-designed sign-out template in the handover of patient care.

PubMed

Clark, Clancy J; Sindell, Sarah L; Koehler, Richard P

2011-01-01

Report our implementation of a standardized handover process in a general surgery residency program. The standardized handover process, sign-out template, method of implementation, and continuous quality improvement process were designed by general surgery residents with support of faculty and senior hospital administration using standard work principles and business models of the Virginia Mason Production System and the Toyota Production System. Nonprofit, tertiary referral teaching hospital. General surgery residents, residency faculty, patient care providers, and hospital administration. After instruction in quality improvement initiatives, a team of general surgery residents designed a sign-out process using an electronic template and standard procedures. The initial implementation phase resulted in 73% compliance. Using resident-driven continuous quality improvement processes, real-time feedback enabled residents to modify and improve this process, eventually attaining 100% compliance and acceptance by residents. The creation of a standardized template and protocol for patient handovers might eliminate communication failures. Encouraging residents to participate in this process can establish the groundwork for successful implementation of a standardized handover process. Integrating a continuous quality-improvement process into such an initiative can promote active participation of busy general surgery residents and lead to successful implementation of standard procedures. Copyright © 2011 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

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...

[Impact of 3 years of contract implementation on the quality of cataract surgery].

PubMed

Begiristain, J; Elizalde, B; Ibarluzea, J; Mendicute, J; Sola, C

1999-01-01

To assess the adequacy to clinical practice of cataract procedures contracted in the Gipuzkoa Health Area (in public as well as concerted hospitals) from 1995. A second aim is to identify the achievements obtained three years after its implementation comparing the data with those of 1994, a year before. Before its implementation a multidisciplinar team established the number of surgical procedures to be contracted each year by age and sex, as well as the technical and quality conditions (out-patient surgery, loco-regional anaesthetic, facoemulsification, etc.). Data used for the assessment: Cataracts Registry of the Ophthalmologic Unit, Patient Management Categories and surgical waiting lists. During the period studied, 8,073 cataract operations were performed, 9% higher than expected. The distribution by age and sex was as estimated. Technical and quality standards were fulfilled, except for the surgical waiting list, in at least 75% of the procedures. The surgical technique mainly used was facoenmulsification, increasing from 15% in 1994 to 76.5% in 1997. The contracting of cataract surgery has allowed the assessment, reordering, and establishment of standards of care for all the professionals involved in the process. There were improvements in clinical practice during the period studied. This has given raise to the homogenisation of care in all the units following technical and quality standards, meaning better equity for the patients in need of the procedure.

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.

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.

Quality-assurance plan for water-quality activities in the U.S. Geological Survey Washington Water Science Center

USGS Publications Warehouse

Conn, Kathleen E.; Huffman, Raegan L.; Barton, Cynthia

2017-05-08

In accordance with guidelines set forth by the Office of Water Quality in the Water Mission Area of the U.S. Geological Survey, a quality-assurance plan has been created for use by the Washington Water Science Center (WAWSC) in conducting water-quality activities. This qualityassurance plan documents the standards, policies, and procedures used by the WAWSC 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 complement the quality-assurance plans for surface-water and groundwater activities at the WAWSC.

British standard (BS) 5750--quality assurance?

PubMed

Pratt, D J

1995-04-01

BS5750 is the British Standard on "Quality Systems". Its equivalent in European Standards is EN29000 and in the International Standards Organisation ISO9000. This paper points out that these standards lay down formalised procedures and require documentation but do not ipso facto lead to quality assurance. The author points to the Japanese post-war industrial success as being an example of Total Quality Management within the framework provided by the philosophy of Dr. W. Edwards Deming (1988 and 1993). This philosophy on the management of "systems" to provide high quality products and services is briefly outlined. The author argues that improvement in prosthetic and orthotic services will not be reached through implementation of BS5750 but rather through radical rethinking and the adoption and application of the Deming philosophy.

Data Quality Assurance and Control for AmeriFlux Network at CDIAC, ORNL

NASA Astrophysics Data System (ADS)

Shem, W.; Boden, T.; Krassovski, M.; Yang, B.

2014-12-01

The Carbon Dioxide Information Analysis Center (CDIAC) at the Oak Ridge National Laboratory (ORNL) serves as the long-term data repository for the AmeriFlux network. Datasets currently available include hourly or half-hourly meteorological and flux observations, biological measurement records, and synthesis data products. Currently there is a lack of standardized nomenclature and specifically designed procedures for data quality assurance/control in processing and handling micrometeorological and ecological data at individual flux sites. CDIAC's has bridged this gap by providing efficient and accurate procedures for data quality control and standardization of the results for easier assimilation by the models used in climate science. In this presentation we highlight the procedures we have put in place to scrutinize continuous flux and meteorological data within Ameriflux network. We itemize some basic data quality issues that we have observed over the past years and include some examples of typical data quality issues. Such issues, e.g., incorrect time-stamping, poor calibration or maintenance of instruments, missing or incomplete metadata and others that are commonly over-looked by PI's, invariably impact the time-series observations.

Beam uniformity of flat top lasers

NASA Astrophysics Data System (ADS)

Chang, Chao; Cramer, Larry; Danielson, Don; Norby, James

2015-03-01

Many beams that output from standard commercial lasers are multi-mode, with each mode having a different shape and width. They show an overall non-homogeneous energy distribution across the spot size. There may be satellite structures, halos and other deviations from beam uniformity. However, many scientific, industrial and medical applications require flat top spatial energy distribution, high uniformity in the plateau region, and complete absence of hot spots. Reliable standard methods for the evaluation of beam quality are of great importance. Standard methods are required for correct characterization of the laser for its intended application and for tight quality control in laser manufacturing. The International Organization for Standardization (ISO) has published standard procedures and definitions for this purpose. These procedures have not been widely adopted by commercial laser manufacturers. This is due to the fact that they are unreliable because an unrepresentative single-pixel value can seriously distort the result. We hereby propose a metric of beam uniformity, a way of beam profile visualization, procedures to automatically detect hot spots and beam structures, and application examples in our high energy laser production.

24 CFR 200.935 - Administrator qualifications and procedures for HUD building products certification programs.

Code of Federal Regulations, 2011 CFR

2011-04-01

... guidelines in any quality assurance review: (1) ASQC Q9000-1-1994 Quality Management and Quality Assurance... Systems—Model for Quality Assurance in Final Inspection and Test; (5) ASQC Q9004-1-1994 Quality Management... in interpreting testing standards, test methods, evaluating test reports and quality control programs...

The effect of column purification on cDNA indirect labelling for microarrays

PubMed Central

Molas, M Lia; Kiss, John Z

2007-01-01

Background The success of the microarray reproducibility is dependent upon the performance of standardized procedures. Since the introduction of microarray technology for the analysis of global gene expression, reproducibility of results among different laboratories has been a major problem. Two of the main contributors to this variability are the use of different microarray platforms and different laboratory practices. In this paper, we address the latter question in terms of how variation in one of the steps of a labelling procedure affects the cDNA product prior to microarray hybridization. Results We used a standard procedure to label cDNA for microarray hybridization and employed different types of column chromatography for cDNA purification. After purifying labelled cDNA, we used the Agilent 2100 Bioanalyzer and agarose gel electrophoresis to assess the quality of the labelled cDNA before its hybridization onto a microarray platform. There were major differences in the cDNA profile (i.e. cDNA fragment lengths and abundance) as a result of using four different columns for purification. In addition, different columns have different efficiencies to remove rRNA contamination. This study indicates that the appropriate column to use in this type of protocol has to be experimentally determined. Finally, we present new evidence establishing the importance of testing the method of purification used during an indirect labelling procedure. Our results confirm the importance of assessing the quality of the sample in the labelling procedure prior to hybridization onto a microarray platform. Conclusion Standardization of column purification systems to be used in labelling procedures will improve the reproducibility of microarray results among different laboratories. In addition, implementation of a quality control check point of the labelled samples prior to microarray hybridization will prevent hybridizing a poor quality sample to expensive micorarrays. PMID:17597522

The effect of column purification on cDNA indirect labelling for microarrays.

PubMed

Molas, M Lia; Kiss, John Z

2007-06-27

The success of the microarray reproducibility is dependent upon the performance of standardized procedures. Since the introduction of microarray technology for the analysis of global gene expression, reproducibility of results among different laboratories has been a major problem. Two of the main contributors to this variability are the use of different microarray platforms and different laboratory practices. In this paper, we address the latter question in terms of how variation in one of the steps of a labelling procedure affects the cDNA product prior to microarray hybridization. We used a standard procedure to label cDNA for microarray hybridization and employed different types of column chromatography for cDNA purification. After purifying labelled cDNA, we used the Agilent 2100 Bioanalyzer and agarose gel electrophoresis to assess the quality of the labelled cDNA before its hybridization onto a microarray platform. There were major differences in the cDNA profile (i.e. cDNA fragment lengths and abundance) as a result of using four different columns for purification. In addition, different columns have different efficiencies to remove rRNA contamination. This study indicates that the appropriate column to use in this type of protocol has to be experimentally determined. Finally, we present new evidence establishing the importance of testing the method of purification used during an indirect labelling procedure. Our results confirm the importance of assessing the quality of the sample in the labelling procedure prior to hybridization onto a microarray platform. Standardization of column purification systems to be used in labelling procedures will improve the reproducibility of microarray results among different laboratories. In addition, implementation of a quality control check point of the labelled samples prior to microarray hybridization will prevent hybridizing a poor quality sample to expensive micorarrays.

Using the Many-Faceted Rasch Model to Evaluate Standard Setting Judgments: An Illustration with the Advanced Placement Environmental Science Exam

ERIC Educational Resources Information Center

Kaliski, Pamela K.; Wind, Stefanie A.; Engelhard, George, Jr.; Morgan, Deanna L.; Plake, Barbara S.; Reshetar, Rosemary A.

2013-01-01

The many-faceted Rasch (MFR) model has been used to evaluate the quality of ratings on constructed response assessments; however, it can also be used to evaluate the quality of judgments from panel-based standard setting procedures. The current study illustrates the use of the MFR model for examining the quality of ratings obtained from a standard…

Quality-Assurance Plan for Water-Quality Activities of the U.S. Geological Survey Montana Water Science Center

USGS Publications Warehouse

Lambing, John H.

2006-01-01

In accordance with guidelines set forth by the Office of Water Quality in the Water Resources Discipline of the U.S. Geological Survey (USGS), a quality-assurance plan has been created for use by the USGS Montana Water Science Center in conducting water-quality activities. This quality-assurance plan documents the standards, policies, and procedures used by the USGS Montana Water Science Center for activities related to the collection, processing, storage, analysis, and publication of water-quality data. The policies and procedures presented in this quality-assurance plan for water-quality activities complement the quality-assurance plans for surface-water and ground-water activities and suspended-sediment analysis.

40 CFR Appendix K to Part 75 - Quality Assurance and Operating Procedures for Sorbent Trap Monitoring Systems

Code of Federal Regulations, 2010 CFR

2010-07-01

... until the leak check is passed. Post-test leak check ≤4% of average sampling rate After sampling ** See... the test site. The sorbent media must be obtained from a source that can demonstrate the quality...-traceable calibration gas standards and reagents shall be used for the tests and procedures required under...

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE FOR FORM QA AND QC CHECKS (UA-C-2.0)

EPA Science Inventory

The purpose of this SOP is to outline the process of field quality assurance and quality control checks. This procedure was followed to ensure consistent data retrieval during the Arizona NHEXAS project and the Border study. Keywords: custody; QA/QC; field checks.

The U.S.-Mex...

WHO expert committee on specifications for pharmaceutical preparations.

PubMed

2013-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Release procedure for International Chemical Reference Substances; WHO guidelines on quality risk management; WHO guidelines on variations to a prequalified product; and the Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products.

42 CFR 493.1232 - Standard: Specimen identification and integrity.

Code of Federal Regulations, 2011 CFR

2011-10-01

... AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing General Laboratory Systems § 493.1232 Standard: Specimen identification and integrity. The laboratory must establish and follow written policies and procedures that ensure positive identification and...

Revised version of quality guidelines for presurgical epilepsy evaluation and surgical epilepsy therapy issued by the Austrian, German, and Swiss working group on presurgical epilepsy diagnosis and operative epilepsy treatment.

PubMed

Rosenow, Felix; Bast, Thomas; Czech, Thomas; Feucht, Martha; Hans, Volkmar H; Helmstaedter, Christoph; Huppertz, Hans-Jürgen; Noachtar, Soheyl; Oltmanns, Frank; Polster, Tilman; Seeck, Margitta; Trinka, Eugen; Wagner, Kathrin; Strzelczyk, Adam

2016-08-01

The definition of minimal standards remains pivotal as a basis for a high standard of care and as a basis for staff allocation or reimbursement. Only limited publications are available regarding the required staffing or methodologic expertise in epilepsy centers. The executive board of the working group (WG) on presurgical epilepsy diagnosis and operative epilepsy treatment published the first guidelines in 2000 for Austria, Germany, and Switzerland. In 2014, revised guidelines were published and the WG decided to publish an unaltered English translation in this report. Because epilepsy surgery is an elective procedure, quality standards are particularly high. As detailed in the first edition of these guidelines, quality control relates to seven different domains: (1) establishing centers with a sufficient number of sufficiently and specifically trained personnel, (2) minimum technical standards and equipment, (3) continuous medical education of employees, (4) surveillance by trained personnel during video electroencephalography (EEG) monitoring (VEM), (5) systematic acquisition of clinical and outcome data, (6) the minimum number of preoperative evaluations and epilepsy surgery procedures, and (7) the cooperation of epilepsy centers. These standards required the certification of the different professions involved and minimum numbers of procedures. In the subsequent decade, quite a number of colleagues were certified by the trinational WG; therefore, the executive board of the WG decided in 2013 to make these standards obligatory. This revised version is particularly relevant given that the German procedure classification explicitly refers to the guidelines of the WG with regard to noninvasive/invasive preoperative video-EEG monitoring and invasive intraoperative diagnostics in epilepsy. Wiley Periodicals, Inc. © 2016 International League Against Epilepsy.

Quality assurance tendering and awarding contracts

NASA Astrophysics Data System (ADS)

1994-12-01

Standards relating to quality control can be significantly useful when tendering for and awarding contracts. However, because it is sometimes difficult to express these standards in palpable economic terms, they can (practically) never be applied as criteria for awarding contracts in accordance with U.A.R. (Uniform General Standards) 1986. Therefore it would be advisable in the future to regard the availability of a (certified) system of quality control as being a standard requirement. To this end, a paragraph setting requirements for a quality control plan should be included in the specification. A quality control plan will be required on awarding a contract. This envisaged scenario can best achieved through a transitional phase. During this period there will be opportunity enough for removing any shortcomings in the wording and for considering standards to be required and assessment procedures.

14 CFR 21.607 - Quality system.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Quality system. 21.607 Section 21.607... PROCEDURES FOR PRODUCTS AND PARTS Technical Standard Order Approvals § 21.607 Quality system. Each applicant for or holder of a TSO authorization must establish a quality system that meets the requirements of...

Parameter Trending, Geolocation Quality Control and the Procedures to Support Preparation of Next Versions of the TRMM Reprocessing Algorithm

NASA Technical Reports Server (NTRS)

Stocker, Erich Franz

2004-01-01

TRMM has been an imminently successful mission from an engineering standpoint but even more from a science standpoint. An important part of this science success has been the careful quality control of the TRMM standard products. This paper will present the quality monitoring efforts that the TRMM Science Data and Information System (TSDIS) conducts on a routine basis. The paper will detail parameter trending, geolocation quality control and the procedures to support the preparation of next versions of the algorithm used for reprocessing.

40 CFR 75.35 - Missing data procedures for CO2.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 16 2011-07-01 2011-07-01 false Missing data procedures for CO2. 75.35... (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.35 Missing data... the 720 quality-assured monitor operating hours preceding implementation of the standard missing data...

40 CFR 75.35 - Missing data procedures for CO2.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Missing data procedures for CO2. 75.35... (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.35 Missing data... the 720 quality-assured monitor operating hours preceding implementation of the standard missing data...

40 CFR 75.35 - Missing data procedures for CO 2.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 17 2013-07-01 2013-07-01 false Missing data procedures for CO 2. 75... (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.35 Missing data... the 720 quality-assured monitor operating hours preceding implementation of the standard missing data...

40 CFR 75.35 - Missing data procedures for CO2.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 17 2012-07-01 2012-07-01 false Missing data procedures for CO2. 75.35... (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.35 Missing data... the 720 quality-assured monitor operating hours preceding implementation of the standard missing data...

40 CFR 75.35 - Missing data procedures for CO 2.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 17 2014-07-01 2014-07-01 false Missing data procedures for CO 2. 75... (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.35 Missing data... the 720 quality-assured monitor operating hours preceding implementation of the standard missing data...

EPA Geospatial Quality Council Promoting Quality Assurance in the Geospatial Coummunity

EPA Science Inventory

After establishing a foundation for the EPA National Geospatial Program, the EPA Geospatial Quality Council (GQC) is, in part, focusing on improving administrative efficiency in the geospatial community. To realize this goal, the GQC is developing Standard Operating Procedures (S...

Standard Reference Specimens in Quality Control of Engineering Surfaces

PubMed Central

Song, J. F.; Vorburger, T. V.

1991-01-01

In the quality control of engineering surfaces, we aim to understand and maintain a good relationship between the manufacturing process and surface function. This is achieved by controlling the surface texture. The control process involves: 1) learning the functional parameters and their control values through controlled experiments or through a long history of production and use; 2) maintaining high accuracy and reproducibility with measurements not only of roughness calibration specimens but also of real engineering parts. In this paper, the characteristics, utilizations, and limitations of different classes of precision roughness calibration specimens are described. A measuring procedure of engineering surfaces, based on the calibration procedure of roughness specimens at NIST, is proposed. This procedure involves utilization of check specimens with waveform, wavelength, and other roughness parameters similar to functioning engineering surfaces. These check specimens would be certified under standardized reference measuring conditions, or by a reference instrument, and could be used for overall checking of the measuring procedure and for maintaining accuracy and agreement in engineering surface measurement. The concept of “surface texture design” is also suggested, which involves designing the engineering surface texture, the manufacturing process, and the quality control procedure to meet the optimal functional needs. PMID:28184115

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.

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 clinical need were crucial beginning for this hospital's growing program.

The Standardized Letter of Recommendation: Implications for Selection. Research Report. ETS RR-07-38

ERIC Educational Resources Information Center

Liu, Ou Lydia; Minsky, Jennifer; Ling, Guangming; Kyllonen, Patrick

2007-01-01

In an effort to standardize academic application procedures, the Standardized Letter of Recommendation (SLR) was developed to capture important cognitive and noncognitive qualities of graduate school candidates. The SLR consists of seven scales ("knowledge," "analytical skills," "communication skills,"…

77 FR 34221 - Air Quality Designations for the 2008 Ozone National Ambient Air Quality Standards for Several...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-11

... Regulatory Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E... preamble. APA Administrative Procedure Act CAA Clean Air Act CFR Code of Federal Regulations D.C. District... Authority Rule U.S. United States U.S.C. United States Code VCS Voluntary Consensus Standards VOC Volatile...

Optimizing ACS NSQIP modeling for evaluation of surgical quality and risk: patient risk adjustment, procedure mix adjustment, shrinkage adjustment, and surgical focus.

PubMed

Cohen, Mark E; Ko, Clifford Y; Bilimoria, Karl Y; Zhou, Lynn; Huffman, Kristopher; Wang, Xue; Liu, Yaoming; Kraemer, Kari; Meng, Xiangju; Merkow, Ryan; Chow, Warren; Matel, Brian; Richards, Karen; Hart, Amy J; Dimick, Justin B; Hall, Bruce L

2013-08-01

The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) collects detailed clinical data from participating hospitals using standardized data definitions, analyzes these data, and provides participating hospitals with reports that permit risk-adjusted comparisons with a surgical quality standard. Since its inception, the ACS NSQIP has worked to refine surgical outcomes measurements and enhance statistical methods to improve the reliability and validity of this hospital profiling. From an original focus on controlling for between-hospital differences in patient risk factors with logistic regression, ACS NSQIP has added a variable to better adjust for the complexity and risk profile of surgical procedures (procedure mix adjustment) and stabilized estimates derived from small samples by using a hierarchical model with shrinkage adjustment. New models have been developed focusing on specific surgical procedures (eg, "Procedure Targeted" models), which provide opportunities to incorporate indication and other procedure-specific variables and outcomes to improve risk adjustment. In addition, comparative benchmark reports given to participating hospitals have been expanded considerably to allow more detailed evaluations of performance. Finally, procedures have been developed to estimate surgical risk for individual patients. This article describes the development of, and justification for, these new statistical methods and reporting strategies in ACS NSQIP. Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Technical standards and guidelines: molecular genetic testing for ultra-rare disorders.

PubMed

Maddalena, Anne; Bale, Sherri; Das, Soma; Grody, Wayne; Richards, Sue

2005-10-01

These standards and guidelines are designed primarily as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines does not necessarily ensure a successful medical outcome. These standards and guidelines should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, the clinical molecular geneticist should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen. It may be prudent, however, to document in the laboratory record the rationale for any significant deviation from these standards and guidelines.

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR RECEIPT OF EQUIPMENT AND IMPLEMENTATION SUPPLIES (UA-G-5.0)

EPA Science Inventory

The purpose of this SOP is to outline procedures for the receipt of equipment and field implementation supplies at the NHEXAS Arizona research project. This procedure was followed to ensure consistent data custody, storage, transfer, and analysis of a high quality during the Ari...

40 CFR 132.1 - Scope, purpose, and availability of documents.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PROGRAMS WATER QUALITY GUIDANCE FOR THE GREAT LAKES SYSTEM § 132.1 Scope, purpose, and availability of documents. (a) This part constitutes the Water Quality Guidance for the Great Lakes System (Guidance... identifies minimum water quality standards, antidegradation policies, and implementation procedures for the...

40 CFR 132.1 - Scope, purpose, and availability of documents.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROGRAMS WATER QUALITY GUIDANCE FOR THE GREAT LAKES SYSTEM § 132.1 Scope, purpose, and availability of documents. (a) This part constitutes the Water Quality Guidance for the Great Lakes System (Guidance... identifies minimum water quality standards, antidegradation policies, and implementation procedures for the...

40 CFR 132.1 - Scope, purpose, and availability of documents.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PROGRAMS WATER QUALITY GUIDANCE FOR THE GREAT LAKES SYSTEM § 132.1 Scope, purpose, and availability of documents. (a) This part constitutes the Water Quality Guidance for the Great Lakes System (Guidance... identifies minimum water quality standards, antidegradation policies, and implementation procedures for the...

40 CFR 132.1 - Scope, purpose, and availability of documents.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PROGRAMS WATER QUALITY GUIDANCE FOR THE GREAT LAKES SYSTEM § 132.1 Scope, purpose, and availability of documents. (a) This part constitutes the Water Quality Guidance for the Great Lakes System (Guidance... identifies minimum water quality standards, antidegradation policies, and implementation procedures for the...

ISO 9000: The Librarian's Role.

ERIC Educational Resources Information Center

Dobson, Chris; Ernst, Carolyn

1999-01-01

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

Water-quality sampling by the U.S. Geological Survey-Standard protocols and procedures

USGS Publications Warehouse

Wilde, Franceska D.

2010-01-01

Thumbnail of and link to report PDF (1.0 MB) The U.S. Geological Survey (USGS) develops the sampling procedures and collects the data necessary for the accurate assessment and wise management of our Nation's surface-water and groundwater resources. Federal and State agencies, water-resource regulators and managers, and many organizations and interested parties in the public and private sectors depend on the reliability, timeliness, and integrity of the data we collect and the scientific soundness and impartiality of our data assessments and analysis. The standard data-collection methods uniformly used by USGS water-quality personnel are peer reviewed, kept up-to-date, and published in the National Field Manual for the Collection of Water-Quality Data (http://pubs.water.usgs.gov/twri9A/).

Laminar-airflow equipment certification: what the pharmacist needs to know.

PubMed

Bryan, D; Marback, R C

1984-07-01

The basic information pharmacy practitioners need to determine the suitability and applicability of laminar-airflow equipment test standards and procedures is presented. The operative guideline for any laminar-flow clean bench (LFCB) certification is the cleanroom and work station requirements for controlled environments as defined by the federal government under Federal Standard 209b (FS 209b). FS 209b outlines the tests, test procedures, and acceptable performance ranges for all LFCB equipment. National Sanitation Foundation Standard Number 49 (NSF 49) is used in the certification of biological-safety cabinets (BSCs). NSF 49 covers those aspects of safety, maintenance, performance, and testing that are unique BSCs. To monitor certification properly, practitioners should be familiar with these standards and the air-velocity profile, high-efficiency particulate air filter performance, noise output, light, and electrical test procedures. A review of the requisite knowledge, experience, and reputation of certifying agents is presented, along with an outline of all the necessary procedures, equipment, and documentation to be used in the process. A thorough test report should be issued upon unit certification. As pharmacy practitioners are responsible for all other aspects of quality assurance, they should also be capable of auditing these certifications to ensure the aseptic quality of products compounded in the laminar-airflow environment.

Instrument Quality Control.

PubMed

Jayakody, Chatura; Hull-Ryde, Emily A

2016-01-01

Well-defined quality control (QC) processes are used to determine whether a certain procedure or action conforms to a widely accepted standard and/or set of guidelines, and are important components of any laboratory quality assurance program (Popa-Burke et al., J Biomol Screen 14: 1017-1030, 2009). In this chapter, we describe QC procedures useful for monitoring the accuracy and precision of laboratory instrumentation, most notably automated liquid dispensers. Two techniques, gravimetric QC and photometric QC, are highlighted in this chapter. When used together, these simple techniques provide a robust process for evaluating liquid handler accuracy and precision, and critically underpin high-quality research programs.

Surface Water Quality-Assurance Plan for the North Florida Program Office of the U.S. Geological Survey

USGS Publications Warehouse

Franklin, Marvin A.

2000-01-01

The U.S. Geological Survey, Water Resources Division, has a policy that requires each District office to prepare a Surface Water Quality-Assurance Plan. The plan for each District describes the policies and procedures that ensure high quality in the collection, processing, analysis, computer storage, and publication of surface-water data. The North Florida Program Office Surface Water Quality-Assurance Plan documents the standards, policies, and procedures used by the North Florida Program office for activities related to the collection, processing, storage, analysis, and publication of surface-water data.

Guidelines for the processing and quality assurance of benthic invertebrate samples collected as part of the National Water-Quality Assessment Program

USGS Publications Warehouse

Cuffney, T.F.; Gurtz, M.E.; Meador, M.R.

1993-01-01

Benthic invertebrate samples are collected as part of the U.S. Geological Survey's National Water-Quality Assessment Program. This is a perennial, multidisciplinary program that integrates biological, physical, and chemical indicators of water quality to evaluate status and trends and to develop an understanding of the factors controlling observed water quality. The Program examines water quality in 60 study units (coupled ground- and surface-water systems) that encompass most of the conterminous United States and parts of Alaska and Hawaii. Study-unit teams collect and process qualitative and semi-quantitative invertebrate samples according to standardized procedures. These samples are processed (elutriated and subsampled) in the field to produce as many as four sample components: large-rare, main-body, elutriate, and split. Each sample component is preserved in 10-percent formalin, and two components, large-rare and main-body, are sent to contract laboratories for further processing. The large-rare component is composed of large invertebrates that are removed from the sample matrix during field processing and placed in one or more containers. The main-body sample component consists of the remaining sample materials (sediment, detritus, and invertebrates) and is subsampled in the field to achieve a volume of 750 milliliters or less. The remaining two sample components, elutriate and split, are used for quality-assurance and quality-control purposes. Contract laboratories are used to identify and quantify invertebrates from the large-rare and main-body sample components according to the procedures and guidelines specified within this document. These guidelines allow the use of subsampling techniques to reduce the volume of sample material processed and to facilitate identifications. These processing procedures and techniques may be modified if the modifications provide equal or greater levels of accuracy and precision. The intent of sample processing is to determine the quantity of each taxon present in the semi-quantitative samples or to list the taxa present in qualitative samples. The processing guidelines provide standardized laboratory forms, sample labels, detailed sample processing flow charts, standardized format for electronic data, quality-assurance procedures and checks, sample tracking standards, and target levels for taxonomic determinations. The contract laboratory (1) is responsible for identifications and quantifications, (2) constructs reference collections, (3) provides data in hard copy and electronic forms, (4) follows specified quality-assurance and quality-control procedures, and (5) returns all processed and unprocessed portions of the samples. The U.S. Geological Survey's Quality Management Group maintains a Biological Quality-Assurance Unit, located at the National Water-Quality Laboratory, Arvada, Colorado, to oversee the use of contract laboratories and ensure the quality of data obtained from these laboratories according to the guidelines established in this document. This unit establishes contract specifications, reviews contractor performance (timeliness, accuracy, and consistency), enters data into the National Water Information System-II data base, maintains in-house reference collections, deposits voucher specimens in outside museums, and interacts with taxonomic experts within and outside the U.S. Geological Survey. This unit also modifies the existing sample processing and quality-assurance guidelines, establishes criteria and testing procedures for qualifying potential contract laboratories, identifies qualified taxonomic experts, and establishes voucher collections.

What European gynaecologists need to master: Consensus on medical expertise outcomes of pan-European postgraduate training in obstetrics & gynaecology.

PubMed

van der Aa, Jessica E; Tancredi, Annalisa; Goverde, Angelique J; Velebil, Petr; Feyereisl, Jaroslav; Benedetto, Chiara; Teunissen, Pim W; Scheele, Fedde

2017-09-01

European harmonisation of training standards in postgraduate medical education in Obstetrics and Gynaecology is needed because of the increasing mobility of medical specialists. Harmonisation of training will provide quality assurance of training and promote high quality care throughout Europe. Pan-European training standards should describe medical expertise outcomes that are required from the European gynaecologist. This paper reports on consensus development on the medical expertise outcomes of pan-European training in Obstetrics and Gynaecology. A Delphi procedure was performed amongst European gynaecologists and trainees in Obstetrics & Gynaecology, to develop consensus on outcomes of training. The consensus procedure consisted of two questionnaire rounds, followed by a consensus meeting. To ensure reasonability and feasibility for implementation of the training standards in Europe, implications of the outcomes were considered in a working group thereafter. We invited 142 gynaecologists and trainees in Obstetrics & Gynaecology for participation representing a wide range of European countries. They were selected through the European Board & College of Obstetrics and Gynaecology and the European Network of Trainees in Obstetrics & Gynaecology. Sixty people participated in round 1 and 2 of the consensus procedure, 38 (63.3%) of whom were gynaecologists and 22 (36.7%) were trainees in Obstetrics & Gynaecology. Twenty-eight European countries were represented in this response. Round 3 of the consensus procedure was performed in a consensus meeting with six experts. Implications of the training outcomes were discussed in a working group meeting, to ensure reasonability and feasibility of the material for implementation in Europe. The entire consensus procedure resulted in a core content of training standards of 188 outcomes, categorised in ten topics. European consensus was developed regarding the medical expertise outcomes of pan-European training in Obstetrics and Gynaecology. The outcomes will be described in core trainings standards, aimed at harmonising training in Obstetrics and Gynaecology in Europe to promote high quality care. Copyright © 2017 Elsevier B.V. All rights reserved.

INTERIM GUIDANCE FOR DEVELOPING GLOBAL POSITIONING SYSTEM DATA COLLECTION STANDARD OPERATING PROCEDURES AND QUALITY ASSURANCE PROJECT PLANS

EPA Science Inventory

The United States Environmental Protection Agency Geospatial Quality Council developed this document to harmonize the process of collecting, editing, and exporting spatial data of known quality using the Global Positioning System (GPS). Each organizational entity may adopt this d...

Merging Quality Processes & Tools with DACUM.

ERIC Educational Resources Information Center

McLennan, Krystyna S.

This paper explains how merging DACUM (Developing a Curriculum) analysis with quality initiatives can reduce waste, increase job efficiency, assist in development of standard operating procedures, and involve employees in positive job improvement methods. In the first half of the paper, the following principles of total quality management (TQM)…

42 CFR 493.1251 - Standard: Procedure manual.

Code of Federal Regulations, 2013 CFR

2013-10-01

... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... intervals (normal values). (11) Imminently life-threatening test results, or panic or alert values. (12... reporting patient results including, when appropriate, the protocol for reporting imminently life...

42 CFR 493.1251 - Standard: Procedure manual.

Code of Federal Regulations, 2014 CFR

2014-10-01

... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... intervals (normal values). (11) Imminently life-threatening test results, or panic or alert values. (12... reporting patient results including, when appropriate, the protocol for reporting imminently life...

42 CFR 493.1251 - Standard: Procedure manual.

Code of Federal Regulations, 2010 CFR

2010-10-01

... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... intervals (normal values). (11) Imminently life-threatening test results, or panic or alert values. (12... reporting patient results including, when appropriate, the protocol for reporting imminently life...

Guidelines and standard procedures for continuous water-quality monitors: Site selection, field operation, calibration, record computation, and reporting

USGS Publications Warehouse

Wagner, Richard J.; Mattraw, Harold C.; Ritz, George F.; Smith, Brett A.

2000-01-01

The U.S. Geological Survey uses continuous water-quality monitors to assess variations in the quality of the Nation's surface water. A common system configuration for data collection is the four-parameter water-quality monitoring system, which collects temperature, specific conductance, dissolved oxygen, and pH data, although systems can be configured to measure other properties such as turbidity or chlorophyll. The sensors that are used to measure these water properties require careful field observation, cleaning, and calibration procedures, as well as thorough procedures for the computation and publication of final records. Data from sensors can be used in conjunction with collected samples and chemical analyses to estimate chemical loads. This report provides guidelines for site-selection considerations, sensor test methods, field procedures, error correction, data computation, and review and publication processes. These procedures have evolved over the past three decades, and the process continues to evolve with newer technologies.

NHEXAS PHASE I ARIZONA STUDY--LIST OF STANDARD OPERATING PROCEDURES

EPA Science Inventory

This document lists available protocols and SOPs for the NHEXAS Phase I Arizona study. It identifies protocols and SOPs for the following study components: (1) Sample collection and field operations, (2) Sample analysis, (3) General laboratory procedures, (4) Quality Assurance, (...

Impacts of Climate Policy on Regional Air Quality, Health, and Air Quality Regulatory Procedures

NASA Astrophysics Data System (ADS)

Thompson, T. M.; Selin, N. E.

2011-12-01

Both the changing climate, and the policy implemented to address climate change can impact regional air quality. We evaluate the impacts of potential selected climate policies on modeled regional air quality with respect to national pollution standards, human health and the sensitivity of health uncertainty ranges. To assess changes in air quality due to climate policy, we couple output from a regional computable general equilibrium economic model (the US Regional Energy Policy [USREP] model), with a regional air quality model (the Comprehensive Air Quality Model with Extensions [CAMx]). USREP uses economic variables to determine how potential future U.S. climate policy would change emissions of regional pollutants (CO, VOC, NOx, SO2, NH3, black carbon, and organic carbon) from ten emissions-heavy sectors of the economy (electricity, coal, gas, crude oil, refined oil, energy intensive industry, other industry, service, agriculture, and transportation [light duty and heavy duty]). Changes in emissions are then modeled using CAMx to determine the impact on air quality in several cities in the Northeast US. We first calculate the impact of climate policy by using regulatory procedures used to show attainment with National Ambient Air Quality Standards (NAAQS) for ozone and particulate matter. Building on previous work, we compare those results with the calculated results and uncertainties associated with human health impacts due to climate policy. This work addresses a potential disconnect between NAAQS regulatory procedures and the cost/benefit analysis required for and by the Clean Air Act.

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE FOR RECEIPT OF EQUIPMENT AND FIELD IMPLEMENTATION SUPPLIES (UA-G-5.0)

EPA Science Inventory

The purpose of this SOP is to outline procedures for the receipt of equipment and field implementation supplies for the Arizona Border Study. This procedure was followed to ensure consistent data custody, storage, transfer, and analysis of a high quality during the Arizona NHEXA...

NHEXAS PHASE I REGION 5 STUDY--STANDARD OPERATING PROCEDURE--NHEXAS FILTER HANDLING, WEIGHING AND ARCHIVING PROCEDURES FOR AEROSOL SAMPLES (RTI/ACS-AP-209-011)

EPA Science Inventory

This protocol describes the procedures for weighing, handling, and archiving aerosol filters and for managing the associated analytical and quality assurance data. Filter samples were weighed for aerosol mass at RTI laboratory, with only the automated field sampling data transfer...

Guidelines and standard procedures for continuous water-quality monitors: Station operation, record computation, and data reporting

USGS Publications Warehouse

Wagner, Richard J.; Boulger, Robert W.; Oblinger, Carolyn J.; Smith, Brett A.

2006-01-01

The U.S. Geological Survey uses continuous water-quality monitors to assess the quality of the Nation's surface water. A common monitoring-system configuration for water-quality data collection is the four-parameter monitoring system, which collects temperature, specific conductance, dissolved oxygen, and pH data. Such systems also can be configured to measure other properties, such as turbidity or fluorescence. Data from sensors can be used in conjunction with chemical analyses of samples to estimate chemical loads. The sensors that are used to measure water-quality field parameters require careful field observation, cleaning, and calibration procedures, as well as thorough procedures for the computation and publication of final records. This report provides guidelines for site- and monitor-selection considerations; sensor inspection and calibration methods; field procedures; data evaluation, correction, and computation; and record-review and data-reporting processes, which supersede the guidelines presented previously in U.S. Geological Survey Water-Resources Investigations Report WRIR 00-4252. These procedures have evolved over the past three decades, and the process continues to evolve with newer technologies.

Assessment of the NASA Flight Assurance Review Program

NASA Technical Reports Server (NTRS)

Holmes, J.; Pruitt, G.

1983-01-01

The NASA flight assurance review program to develop minimum standard guidelines for flight assurance reviews was assessed. Documents from NASA centers and NASA headquarters to determine current design review practices and procedures were evaluated. Six reviews were identified for the recommended minimum. The practices and procedures used at the different centers to incorporate the most effective ones into the minimum standard review guidelines were analyzed and guidelines for procedures, personnel and responsibilies, review items/data checklist, and feedback and closeout were defined. The six recommended reviews and the minimum standards guidelines developed for flight assurance reviews are presented. Observations and conclusions for further improving the NASA review and quality assurance process are outlined.

Landsat Image Map Production Methods at the U. S. Geological Survey

USGS Publications Warehouse

Kidwell, R.D.; Binnie, D.R.; Martin, S.

1987-01-01

To maintain consistently high quality in satellite image map production, the U. S. Geological Survey (USGS) has developed standard procedures for the photographic and digital production of Landsat image mosaics, and for lithographic printing of multispectral imagery. This paper gives a brief review of the photographic, digital, and lithographic procedures currently in use for producing image maps from Landsat data. It is shown that consistency in the printing of image maps is achieved by standardizing the materials and procedures that affect the image detail and color balance of the final product. Densitometric standards are established by printing control targets using the pressplates, inks, pre-press proofs, and paper to be used for printing.

The importance of production standard operating procedure in a family business company

NASA Astrophysics Data System (ADS)

Hongdiyanto, C.

2017-12-01

Plastic industry is a growing sector, therefore UD X which engage in this business has a great potential to grow as well. The problem faced by this family business company is that no standard operating procedure is used and it lead to problem in the quality and quantity produced. This research is aim to create a production standard operating procedure for UD X. Semistructure interview is used to gather information from respondent to help writer create the SOP. There are four SOP’s created, namely: classifying SOP, sorting SOP, milling SOP and packing SOP. Having SOP will improve the effectiveness of production because employees already know how to work in each stages of production process.

Surface-Water Quality-Assurance Plan for the USGS Wisconsin Water Science Center

USGS Publications Warehouse

Garn, H.S.

2007-01-01

This surface-water quality-assurance plan documents the standards, policies, and procedures used by the Wisconsin Water Science Center of the U.S. Geological Survey, Water Resources Discipline, for activities related to the collection, processing, storage, analysis, management, and publication of surface-water data. The roles and responsibilities of Water Science Center personnel in following these policies and procedures including those related to safety and training are presented.

Surface-water quality-assurance plan for the Wisconsin district of the U. S. Geological Survey, Water Resources Division

USGS Publications Warehouse

Garn, H.S.

2002-01-01

This surface-water quality-assurance plan documents the standards, policies, and procedures used by the Wisconsin District of the U.S. Geological Survey, Water Resources Division, for activities related to the collection, processing, storage, analysis, management, and publication of surface-water data. The roles and responsibilities of District personnel in following these policies and procedures including those related to safety and training are presented.

Cost Effective, Ultra Sensitive Groundwater Monitoring for Site Remediation and Management: Standard Operating Procedures with QA/QC

DTIC Science & Technology

2015-05-01

in consultation with the site management . 4.0 DATA TYPES AND QUALITY CONTROL A sampling plan must account for the collection, handling, and...GUIDANCE DOCUMENT Cost-Effective, Ultra-Sensitive Groundwater Monitoring for Site Remediation and Management : Standard Operating Procedures...Groundwater Monitoring for Site Remediation and Management 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Halden, R.U., Roll, I.B. 5d

Stormwater Characterization and Lagoon Sediment Analysis, Grand Forks Air Force Base, North Dakota

DTIC Science & Technology

1990-08-01

tetrachloroethylene, and 0.0026 mg/l ethyl benzene. Analyses showed no pesticides . 4. Extraction Procedure (EP) Analysis. An AFOEHL contractor performed EP extraction ...runoff met North Dakota state stream standards. Lagoon sediment did not contain Extraction Procedure hazardous chemicals. Stormwater runoff exceeded...Standards for Water Quality for the State of North Dakota ( Extracts ) 39 D Site/Analysis Summary 69 E Lift Station Flow Records 73 F Wastewater

[Standard Operating Procedures in Clinical Medicine].

PubMed

Miljak, Tomislav; Zaar, Peter

2017-09-01

Standard operating procedures (SOP) in hospital care have the potential to improve treatment quality and transparency. However, after arriving at the decision to generate a SOP for the own hospital or ward, the upcoming question is often, how to start?The present article tries to give some interdisciplinary guidance about reasonable structures and contents of SOPs that could be understood as a basic matrix for individual work. © Georg Thieme Verlag KG Stuttgart · New York.

Human Connectome Project Informatics: quality control, database services, and data visualization

PubMed Central

Marcus, Daniel S.; Harms, Michael P.; Snyder, Abraham Z.; Jenkinson, Mark; Wilson, J Anthony; Glasser, Matthew F.; Barch, Deanna M.; Archie, Kevin A.; Burgess, Gregory C.; Ramaratnam, Mohana; Hodge, Michael; Horton, William; Herrick, Rick; Olsen, Timothy; McKay, Michael; House, Matthew; Hileman, Michael; Reid, Erin; Harwell, John; Coalson, Timothy; Schindler, Jon; Elam, Jennifer S.; Curtiss, Sandra W.; Van Essen, David C.

2013-01-01

The Human Connectome Project (HCP) has developed protocols, standard operating and quality control procedures, and a suite of informatics tools to enable high throughput data collection, data sharing, automated data processing and analysis, and data mining and visualization. Quality control procedures include methods to maintain data collection consistency over time, to measure head motion, and to establish quantitative modality-specific overall quality assessments. Database services developed as customizations of the XNAT imaging informatics platform support both internal daily operations and open access data sharing. The Connectome Workbench visualization environment enables user interaction with HCP data and is increasingly integrated with the HCP's database services. Here we describe the current state of these procedures and tools and their application in the ongoing HCP study. PMID:23707591

The role of standards in the development and implementation of clinical laboratory tests: a domestic and global perspective.

PubMed

Michaud, Ginette Y

2005-01-01

In the field of clinical laboratory medicine, standardization is aimed at increasing the trueness and reliability of measured values. Standardization relies on the use of written standards, reference measurement procedures and reference materials. These are important tools for the design and validation of new tests, and for establishing the metrological traceability of diagnostic assays. Their use supports the translation of research technologies into new diagnostic assays and leads to more rapid advances in science and medicine, as well as improvements in the quality of patient care. The various standardization tools are described, as are the procedures by which written standards, reference procedures and reference materials are developed. Recent efforts to develop standards for use in the field of molecular diagnostics are discussed. The recognition of standardization tools by the FDA and other regulatory authorities is noted as evidence of their important role in ensuring the safety and performance of in vitro diagnostic devices.

Tracking and Reporting Outcomes Of Procedural Sedation (TROOPS): Standardized Quality Improvement and Research Tools from the International Committee for the Advancement of Procedural Sedation.

PubMed

Roback, M G; Green, S M; Andolfatto, G; Leroy, P L; Mason, K P

2018-01-01

Many hospitals, and medical and dental clinics and offices, routinely monitor their procedural-sedation practices-tracking adverse events, outcomes, and efficacy in order to optimize the sedation delivery and practice. Currently, there exist substantial differences between settings in the content, collection, definition, and interpretation of such sedation outcomes, with resulting widespread reporting variation. With the objective of reducing such disparities, the International Committee for the Advancement of Procedural Sedation has herein developed a multidisciplinary, consensus-based, standardized tool intended to be applicable for all types of sedation providers in all locations worldwide. This tool is amenable for inclusion in either a paper or an electronic medical record. An additional, parallel research tool is presented to promote consistency and standardized data collection for procedural-sedation investigations. Copyright © 2017. Published by Elsevier Ltd.

42 CFR 493.1423 - Standard; Testing personnel qualifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical... stability and storage; (F) The skills required to implement the quality control policies and procedures of... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived...

[Discussion on research thinking of traditional Chinese medicine standardization system based on whole process quality control].

PubMed

Dong, Ling; Sun, Yu; Pei, Wen-Xuan; Dai, Jun-Dong; Wang, Zi-Yu; Pan, Meng; Chen, Jiang-Peng; Wang, Yun

2017-12-01

The concept of "Quality by design" indicates that good design for the whole life cycle of pharmaceutical production enables the drug to meet the expected quality requirements. Aiming at the existing problems of the traditional Chinese medicine (TCM) industry, the TCM standardization system was put forward in this paper from the national strategic level, under the guidance by the idea of quality control in international manufacturing industry and with considerations of TCM industry's own characteristics and development status. The connotation of this strategy was to establish five interrelated systems: multi-indicators system based on tri-indicators system, quality standard and specification system of TCM herbal materials and decoction pieces, quality traceability system, data monitoring system based on whole-process quality control, and whole-process quality management system of TCM, and achieve the whole process systematic and scientific study in TCM industry through "top-level design-implement in steps-system integration" workflow. This article analyzed the correlation between the quality standards of all links, established standard operating procedures of each link and whole process, and constructed a high standard overall quality management system for TCM industry chains, in order to provide a demonstration for the establishment of TCM whole-process quality control system and provide systematic reference and basis for standardization strategy in TCM industry. Copyright© by the Chinese Pharmaceutical Association.

Quality Assurance in Breast Health Care and Requirement for Accreditation in Specialized Units

PubMed Central

Güler, Sertaç Ata; Güllüoğlu, Bahadır M.

2014-01-01

Breast health is a subject of increasing importance. The statistical increase in the frequency of breast cancer and the consequent increase in death rate increase the importance of quality of services to be provided for breast health. For these reasons, the minimum standards and optimum quality metrics of breast care provided to the community are determined. The quality parameters for breast care service include the results, the structure and the operation of services. Within this group, the results of breast health services are determined according to clinical results, patient satisfaction and financial condition. The structure of quality services should include interdisciplinary meetings, written standards for specific procedures and the existence of standardized reporting systems. Establishing breast centers that adopt integrated multidisciplinary working principles and their cost-effective maintenance are important in terms of operation of breast health services. The importance of using a “reviewing/auditing” procedure that checks if all of these functions existing in the health system are carried out at the desired level and an “accreditation” system indicating that the working breast units/centers provide minimum quality adequacy in all aspects, is undeniable. Currently, the accreditation system for breast centers is being used in the European Union and the United States for the last 5–10 years. This system is thought to provide standardization in breast care services, and is accepted as one of the important factors that resulted in reduction in mortality associated with breast cancer. PMID:28331658

Quality Assurance in Breast Health Care and Requirement for Accreditation in Specialized Units.

PubMed

Güler, Sertaç Ata; Güllüoğlu, Bahadır M

2014-07-01

Breast health is a subject of increasing importance. The statistical increase in the frequency of breast cancer and the consequent increase in death rate increase the importance of quality of services to be provided for breast health. For these reasons, the minimum standards and optimum quality metrics of breast care provided to the community are determined. The quality parameters for breast care service include the results, the structure and the operation of services. Within this group, the results of breast health services are determined according to clinical results, patient satisfaction and financial condition. The structure of quality services should include interdisciplinary meetings, written standards for specific procedures and the existence of standardized reporting systems. Establishing breast centers that adopt integrated multidisciplinary working principles and their cost-effective maintenance are important in terms of operation of breast health services. The importance of using a "reviewing/auditing" procedure that checks if all of these functions existing in the health system are carried out at the desired level and an "accreditation" system indicating that the working breast units/centers provide minimum quality adequacy in all aspects, is undeniable. Currently, the accreditation system for breast centers is being used in the European Union and the United States for the last 5-10 years. This system is thought to provide standardization in breast care services, and is accepted as one of the important factors that resulted in reduction in mortality associated with breast cancer.

The study of surgical image quality evaluation system by subjective quality factor method

NASA Astrophysics Data System (ADS)

Zhang, Jian J.; Xuan, Jason R.; Yang, Xirong; Yu, Honggang; Koullick, Edouard

2016-03-01

GreenLightTM procedure is an effective and economical way of treatment of benign prostate hyperplasia (BPH); there are almost a million of patients treated with GreenLightTM worldwide. During the surgical procedure, the surgeon or physician will rely on the monitoring video system to survey and confirm the surgical progress. There are a few obstructions that could greatly affect the image quality of the monitoring video, like laser glare by the tissue and body fluid, air bubbles and debris generated by tissue evaporation, and bleeding, just to name a few. In order to improve the physician's visual experience of a laser surgical procedure, the system performance parameter related to image quality needs to be well defined. However, since image quality is the integrated set of perceptions of the overall degree of excellence of an image, or in other words, image quality is the perceptually weighted combination of significant attributes (contrast, graininess …) of an image when considered in its marketplace or application, there is no standard definition on overall image or video quality especially for the no-reference case (without a standard chart as reference). In this study, Subjective Quality Factor (SQF) and acutance are used for no-reference image quality evaluation. Basic image quality parameters, like sharpness, color accuracy, size of obstruction and transmission of obstruction, are used as subparameter to define the rating scale for image quality evaluation or comparison. Sample image groups were evaluated by human observers according to the rating scale. Surveys of physician groups were also conducted with lab generated sample videos. The study shows that human subjective perception is a trustworthy way of image quality evaluation. More systematic investigation on the relationship between video quality and image quality of each frame will be conducted as a future study.

Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group.

PubMed

Tuck, Melissa K; Chan, Daniel W; Chia, David; Godwin, Andrew K; Grizzle, William E; Krueger, Karl E; Rom, William; Sanda, Martin; Sorbara, Lynn; Stass, Sanford; Wang, Wendy; Brenner, Dean E

2009-01-01

Specimen collection is an integral component of clinical research. Specimens from subjects with various stages of cancers or other conditions, as well as those without disease, are critical tools in the hunt for biomarkers, predictors, or tests that will detect serious diseases earlier or more readily than currently possible. Analytic methodologies evolve quickly. Access to high-quality specimens, collected and handled in standardized ways that minimize potential bias or confounding factors, is key to the "bench to bedside" aim of translational research. It is essential that standard operating procedures, "the how" of creating the repositories, be defined prospectively when designing clinical trials. Small differences in the processing or handling of a specimen can have dramatic effects in analytical reliability and reproducibility, especially when multiplex methods are used. A representative working group, Standard Operating Procedures Internal Working Group (SOPIWG), comprised of members from across Early Detection Research Network (EDRN) was formed to develop standard operating procedures (SOPs) for various types of specimens collected and managed for our biomarker discovery and validation work. This report presents our consensus on SOPs for the collection, processing, handling, and storage of serum and plasma for biomarker discovery and validation.

A Double Standard and Dubious Ethics in Determining Quality Teaching

ERIC Educational Resources Information Center

Reardon, R. Martin

2016-01-01

"Double Standard" was created by the actors who appeared in the accompanying video in spring 2014, as part fulfillment of the requirements for a master's-level class highlighting ethics in education for future educational administrators. A double standard comes into focus as an incoming middle school principal establishes procedures she…

Application of QC_DR software for acceptance testing and routine quality control of direct digital radiography systems: initial experiences using the Italian Association of Physicist in Medicine quality control protocol.

PubMed

Nitrosi, Andrea; Bertolini, Marco; Borasi, Giovanni; Botti, Andrea; Barani, Adriana; Rivetti, Stefano; Pierotti, Luisa

2009-12-01

Ideally, medical x-ray imaging systems should be designed to deliver maximum image quality at an acceptable radiation risk to the patient. Quality assurance procedures are employed to ensure that these standards are maintained. A quality control protocol for direct digital radiography (DDR) systems is described and discussed. Software to automatically process and analyze the required images was developed. In this paper, the initial results obtained on equipment of different DDR manufacturers were reported. The protocol was developed to highlight even small discrepancies in standard operating performance.

Standardisation of DNA quantitation by image analysis: quality control of instrumentation.

PubMed

Puech, M; Giroud, F

1999-05-01

DNA image analysis is frequently performed in clinical practice as a prognostic tool and to improve diagnosis. The precision of prognosis and diagnosis depends on the accuracy of analysis and particularly on the quality of image analysis systems. It has been reported that image analysis systems used for DNA quantification differ widely in their characteristics (Thunissen et al.: Cytometry 27: 21-25, 1997). This induces inter-laboratory variations when the same sample is analysed in different laboratories. In microscopic image analysis, the principal instrumentation errors arise from the optical and electronic parts of systems. They bring about problems of instability, non-linearity, and shading and glare phenomena. The aim of this study is to establish tools and standardised quality control procedures for microscopic image analysis systems. Specific reference standard slides have been developed to control instability, non-linearity, shading and glare phenomena and segmentation efficiency. Some systems have been controlled with these tools and these quality control procedures. Interpretation criteria and accuracy limits of these quality control procedures are proposed according to the conclusions of a European project called PRESS project (Prototype Reference Standard Slide). Beyond these limits, tested image analysis systems are not qualified to realise precise DNA analysis. The different procedures presented in this work determine if an image analysis system is qualified to deliver sufficiently precise DNA measurements for cancer case analysis. If the controlled systems are beyond the defined limits, some recommendations are given to find a solution to the problem.

Quality Management and Key Performance Indicators in Oncologic Esophageal Surgery.

PubMed

Gockel, Ines; Ahlbrand, Constantin Johannes; Arras, Michael; Schreiber, Elke Maria; Lang, Hauke

2015-12-01

Ranking systems and comparisons of quality and performance indicators will be of increasing relevance for complex "high-risk" procedures such as esophageal cancer surgery. The identification of evidence-based standards relevant for key performance indicators in esophageal surgery is essential for establishing monitoring systems and furthermore a requirement to enhance treatment quality. In the course of this review, we analyze the key performance indicators case volume, radicality of resection, and postoperative morbidity and mortality, leading to continuous quality improvement. Ranking systems established on this basis will gain increased relevance in highly complex procedures within the national and international comparison and furthermore improve the treatment of patients with esophageal carcinoma.

Tear cytokine profile as a noninvasive biomarker of inflammation for ocular surface diseases: standard operating procedures.

PubMed

Wei, Yi; Gadaria-Rathod, Neha; Epstein, Seth; Asbell, Penny

2013-12-23

To provide standard operating procedures (SOPs) for measuring tear inflammatory cytokine concentrations and to validate the resulting profile as a minimally invasive objective metric and biomarker of ocular surface inflammation for use in multicenter clinical trials on dry eye disease (DED). Standard operating procedures were established and then validated with cytokine standards, quality controls, and masked tear samples collected from local and distant clinical sites. The concentrations of the inflammatory cytokines in tears were quantified using a high-sensitivity human cytokine multiplex kit. A panel of inflammatory cytokines was initially investigated, from which four key inflammatory cytokines (IL-1β, IL-6, INF-γ, and TNF-α) were chosen. Results with cytokine standards statistically satisfied the manufacturer's quality control criteria. Results with pooled tear samples were highly reproducible and reliable with tear volumes ranging from 4 to 10 μL. Incorporation of the SOPs into clinical trials was subsequently validated. Tear samples were collected at a distant clinical site, stored, and shipped to our Biomarker Laboratory, where a masked analysis of the four tear cytokines was successfully performed. Tear samples were also collected from a feasibility study on DED. Inflammatory cytokine concentrations were decreased in tears of subjects who received anti-inflammatory treatment. Standard operating procedures for human tear cytokine assessment suitable for multicenter clinical trials were established. Tear cytokine profiling using these SOPs may provide objective metrics useful for diagnosing, classifying, and analyzing treatment efficacy in inflammatory conditions of the ocular surface, which may further elucidate the mechanisms involved in the pathogenesis of ocular surface disease.

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE--COMPENDIUM OF METHODS FOR ANALYSIS OF TRACE METALS AND PESTICIDES IN DIETARY SAMPLES USING TOTAL DIET STUDY PROCEDURES (FDA-COMPENDIUM)

EPA Science Inventory

This compendium contains seven SOPs developed by Food and Drug Administration (FDA) laboratories for methods of analyzing trace metals in dietary samples collected using Total Diet study procedures. The SOPs include the following: (1) Quality Control for Analysis of NHEXAS Food o...

29 CFR 1910.7 - Definition and requirements for a nationally recognized testing laboratory.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., written testing procedures, and calibration and quality control programs) to perform: (i) Testing and... test standards; or (ii) Experimental testing and examining of equipment and materials for workplace..., labeled, or accepted, the following controls or services: (i) Implements control procedures for...

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--LIST OF STANDARD OPERATING PROCEDURES

EPA Science Inventory

This document lists available protocols and SOPs for the U.S.-Mexico Border Program study. It identifies protocols and SOPs for the following study components: (1) Sample collection and field operations, (2) Sample analysis, (3) General laboratory procedures, (4) Quality Assuranc...

40 CFR 63.2382 - What notifications must I submit and when and what information should be submitted?

Code of Federal Regulations, 2010 CFR

2010-07-01

... sampling and analysis procedures and quality assurance procedures. (iii) Descriptions of monitoring devices... ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS... compliance assessments, inspections and repairs, and calculations used to demonstrate initial compliance...

Quality management of Body Donation Program at the University of Padova.

PubMed

Porzionato, Andrea; Macchi, Veronica; Stecco, Carla; Mazzi, Anna; Rambaldo, Anna; Sarasin, Gloria; Parenti, Anna; Scipioni, Antonio; De Caro, Raffaele

2012-01-01

Quality management improvement has become a recent focus of attention in medical education. The program for the donation of bodies and body parts (Body Donation Program) at the University of Padova has recently been subjected to a global quality management standard, the ISO 9001:2008 certification. The aim of the present work is to show how the above standard is useful in enhancing the efficiency of body donation procedures and the quality and output of medical education. The program is managed by means of the following interlinked procedures: the collection of body donations, death certificates, data, and body parts from living donors; the transportation and identification of cadavers; the management of bodies, body parts, equipment, instruments, purchasing of necessary materials, and setting up anatomical training sessions; the management of preventive and corrective actions; the management of documents and registration; the management of internal and external quality audits; and the review of outcomes and improvement planning. Monitoring indicators are identified in the numbers of donors and of donated body parts per year, education sessions, and satisfaction of learners and donors, as evaluated by questionnaires. The process management approach, the integrated involvement of medical, technical, and administrative staff in defining procedures, and the application of monitoring indicators allow quality improvement in all aspects of the Body Donation Program. Copyright © 2012 American Association of Anatomists.

Chapter A10. Lakes and reservoirs: Guidelines for study design and sampling

USGS Publications Warehouse

Green, William R.; Robertson, Dale M.; Wilde, Franceska D.

2015-09-29

Within this chapter are references to other chapters of the NFM that provide more detailed guidelines related to specific topics and more detailed protocols for the quality assurance and assessment of the lake and reservoir data. Protocols and procedures to address and document the quality of lake and reservoir investigations are adapted from, or referenced to, the protocols and standard operating procedures contained in related chapters of this National Field Manual.

Carpal tunnel syndrome: Analysis of online patient information with the EQIP tool.

PubMed

Frueh, F S; Palma, A F; Raptis, D A; Graf, C P; Giovanoli, P; Calcagni, M

2015-06-01

Patients suffering from carpal tunnel syndrome (CTS) actively search for medical information on the Internet. The World Wide Web represents the main source of patient information. The aim of this study was to systematically assess the quality of patient information about CTS in the Internet. A qualitative and quantitative assessment of websites was performed with the modified Ensuring Quality Information for Patients (EQIP) tool that contains 36 standardized items. Five hundred websites with information on CTS treatment options were identified through Google, Bing, Yahoo, Ask.com and AOL. Duplicates and irrelevant websites were excluded. One hundred and ten websites were included. Only five websites addressed more than 20 items; quality scores were not significantly different between the various providing groups. A median of 15 EQIP items was found, with the top website addressing 26 out of 36 items. Major complications such as median nerve injury were reported in 27% of the websites and their treatment in only 3%. This analysis revealed several critical shortcomings in the quality of the information provided to patients suffering from CTS. There is a collective need to provide interactive, informative and educational websites for standard procedures in hand surgery. These websites should be compatible with international quality standards for hand surgery procedures. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Multicenter Cell Processing for Cardiovascular Regenerative Medicine Applications - The Cardiovascular Cell Therapy Research Network (CCTRN) Experience

PubMed Central

Gee, Adrian P.; Richman, Sara; Durett, April; McKenna, David; Traverse, Jay; Henry, Timothy; Fisk, Diann; Pepine, Carl; Bloom, Jeannette; Willerson, James; Prater, Karen; Zhao, David; Koç, Jane Reese; Ellis, Steven; Taylor, Doris; Cogle, Christopher; Moyé, Lemuel; Simari, Robert; Skarlatos, Sonia

2013-01-01

Background Aims Multi-center cellular therapy clinical trials require the establishment and implementation of standardized cell processing protocols and associated quality control mechanisms. The aims here were to develop such an infrastructure in support of the Cardiovascular Cell Therapy Research Network (CCTRN) and to report on the results of processing for the first 60 patients. Methods Standardized cell preparations, consisting of autologous bone marrow mononuclear cells, prepared using the Sepax device were manufactured at each of the five processing facilities that supported the clinical treatment centers. Processing staff underwent centralized training that included proficiency evaluation. Quality was subsequently monitored by a central quality control program that included product evaluation by the CCTRN biorepositories. Results Data from the first 60 procedures demonstrate that uniform products, that met all release criteria, could be manufactured at all five sites within 7 hours of receipt of the bone marrow. Uniformity was facilitated by use of the automated systems (the Sepax for processing and the Endosafe device for endotoxin testing), standardized procedures and centralized quality control. Conclusions Complex multicenter cell therapy and regenerative medicine protocols can, where necessary, successfully utilize local processing facilities once an effective infrastructure is in place to provide training, and quality control. PMID:20524773

7 CFR 1710.408 - Quality assurance plan.

Code of Federal Regulations, 2014 CFR

2014-01-01

... AGRICULTURE GENERAL AND PRE-LOAN POLICIES AND PROCEDURES COMMON TO ELECTRIC LOANS AND GUARANTEES Energy... accordance with quality assurance plans meeting standards designed to achieve the purposes of this subpart... pump) the new system must be designed and installed by certified and insured professionals acceptable...

US EPA Base Study Standard Operating Procedure for Continuous Monitoring of Indoor Air

EPA Pesticide Factsheets

The procedure described is intended for monitoring continuously and simultaneously, at selected work sites, parameters that are most commonly associated with the quality of indoor environments: the concentrations of carbon dioxide (CO2), carbon monoxide (CO), temperature, relative humidity (RH), illumination, and noise.

40 CFR 160.81 - Standard operating procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

... methods that management is satisfied are adequate to insure the quality and integrity of the data... authorized by the study director and shall be documented in the raw data. Significant changes in established... procedures shall be established for, but not limited to, the following: (1) Test system area preparation. (2...

40 CFR 160.81 - Standard operating procedures.

Code of Federal Regulations, 2011 CFR

2011-07-01

... methods that management is satisfied are adequate to insure the quality and integrity of the data... authorized by the study director and shall be documented in the raw data. Significant changes in established... procedures shall be established for, but not limited to, the following: (1) Test system area preparation. (2...

NHEXAS PHASE I REGION 5 STUDY--STANDARD OPERATING PROCEDURE--HANDLING QUALITY CONTROL SAMPLES IN THE FIELD (RTI/ACS-AP-209-090)

EPA Science Inventory

This protocol describes how quality control samples should be handled in the field, and was designed as a quick reference source for the field staff. The protocol describes quality control samples for air-VOCs, air-particles, water samples, house dust, soil, urine, blood, hair, a...

ISO 9002 as Literacy Practice: Coping with Quality-Control Documents in a High-Tech Company

ERIC Educational Resources Information Center

Kleifgen, Jo Anne

2005-01-01

This study describes the process by which a circuit board manufacturing company became certified in an international quality control program known as ISO 9002. Particular attention is paid to how quality documents were made and used in actual practice and to the relationship between these standardized procedures (official literacies) and…

[How to establish a good acupuncture-moxibustion standard?].

PubMed

Wu, Xiao-dong; Xiao, Hui

2014-10-01

At the beginning of a standard item, the standardized objects and involved contents should be demonstrated thoroughly, which is the precondition of establishing a good standard. After the proposal of this standard, a high-level drafting group should be built, led by top specialists who also draft the standard, which is essential to guarantee the quality of the standard. Before drafting the standard, literature regarding this standard should be searched completely, and Directives for Standardization should be learned to understand the basic requirements of establishing a standard; in the meanwhile, selections on standardized contents and quantitative boundaries of technical indices should be comprehensively and deeply studied. At the stage of consultation, focus should be paid on the scope of the consultation departments, level and personnel quality. As for standard review, it should be precise and truth-seeking. At the stage of submitting and authorization, it is necessary to have timely communication. Only by full cooperations of all parties, and by strictly following the procedure, method and rule of standard establishment, can a high-quality acupuncture-moxibustion standard be established.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2009-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new standards and guidelines were adopted and recommended for use: the current list of available International Chemical Reference Substances and International Infrared Reference Spectra; guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products; procedure for prequalification of pharmaceutical products; and the procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products.

77 FR 64333 - Relocation of Transmission Lines for the U.S. 93 Boulder City Bypass Project, Boulder County, NV...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-19

... Standard 13 ``Environmental Quality Protection.'' Long-term operations of the transmission line will follow Western's standard operating procedures and will not be affected by this action. In addition to Construction Standard 13, the following measures apply to the modifications that will be made to Western's...

Methodological Choices in the Content Analysis of Textbooks for Measuring Alignment with Standards

ERIC Educational Resources Information Center

Polikoff, Morgan S.; Zhou, Nan; Campbell, Shauna E.

2015-01-01

With the recent adoption of the Common Core standards in many states, there is a need for quality information about textbook alignment to standards. While there are many existing content analysis procedures, these generally have little, if any, validity or reliability evidence. One exception is the Surveys of Enacted Curriculum (SEC), which has…

40 CFR 75.21 - Quality assurance and quality control requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., as defined in § 72.2, k=2) of plus or minus 1.0 percent (calculated combined standard uncertainty of... system according to the quality assurance and quality control procedures in appendix B of this part. (2... requirements of Method 2, 6C, 7E, or 3A in Appendices A-1, A-2 and A-4 to part 60 of this chapter (supplemented...

Certification standards transfer: from committee to laboratory.

PubMed

Lehmann, H P

1998-12-01

The ISO 9000 Standards series were developed to provide the international manufacturing industry with a framework to ensure purchased products meet quality criteria. Section 4 of ISO 9001, Quality System Model for Quality Assurance in Design, Development, Production, Installation and Servicing, contains 20 aspects of a quality system that must be addressed by an organization in order to receive ISO 9001 certification. This concept is extended to the clinical laboratory, where a quality system program establishes for the customer (patient/clinician) that the purchased product (requested information on a submitted specimen-test result) meets established quality norms. In order to satisfy the customer, the providing organization must have policies and procedures in place that ensure a quality product, and be certified. To become certified the organization must, through an inspection process, demonstrate to an independent accrediting agency that it meets defined standards. In the United States, the government through the Clinical Laboratory Improvement Amendment (CLIA) 1988 established quality standards for the clinical laboratory. The College of American Pathologists (CAP), through its Laboratory Accreditation Program (LAP), serves as an independent agency that certifies that laboratories meet standards. To demonstrate the applicability of an established clinical laboratory accreditation program to ISO 9001 certification, the standards and checklists of CLIA 1988 and the CAP LAP will be examined to determine their conformance to ISO 9001, Section 4.

The standardization of urine particle counting in medical laboratories--a Polish experience with the EQA programme.

PubMed

Cwiklińska, Agnieszka; Kąkol, Judyta; Kuchta, Agnieszka; Kortas-Stempak, Barbara; Pacanis, Anastasis; Rogulski, Jerzy; Wróblewska, Małgorzata

2012-02-01

Given the common problems with the standardization of urine particle counting methods and the great variability in the results obtained by Polish laboratories under international Labquality External Quality Assessment (EQA), we initiated educational recovery activities. Detailed instructions on how to perform the standardized examination were sent to EQA participants, as was a questionnaire forms which enabled information to be gathered in respect to the procedures being applied. Laboratory results were grouped according to the method declared on the EQA 'Result' form or according to a manual examination procedure established on the basis of the questionnaire. The between-laboratory CVs for leukocyte and erythrocyte counts were calculated for each group and compared using the Mann-Whitney test. Significantly lower between-laboratory CVs (p = 0.03) were achieved for leukocyte counting among the laboratories that analysed control specimens in accordance with standardized procedures as compared with those which used non-standardized procedures. We also observed a visible lower variability for erythrocyte counting. Unfortunately despite our activities, only a few of the Polish laboratories applied the standardized examination procedures, and only 29% of the results could have been considered to be standardized (16% - manual methods, 13% - automated systems). The standardization of urine particle counting methods continues to be a significant problem in medical laboratories and requires further recovery activities which can be conducted using the EQA scheme.

Procedures for establishing and maintaining consistent air-kerma strength standards for low-energy, photon-emitting brachytherapy sources: recommendations of the Calibration Laboratory Accreditation Subcommittee of the American Association of Physicists in Medicine.

PubMed

DeWerd, Larry A; Huq, M Saiful; Das, Indra J; Ibbott, Geoffrey S; Hanson, William F; Slowey, Thomas W; Williamson, Jeffrey F; Coursey, Bert M

2004-03-01

Low dose rate brachytherapy is being used extensively for the treatment of prostate cancer. As of September 2003, there are a total of thirteen 125I and seven 103Pd sources that have calibrations from the National Institute of Standards and Technology (NIST) and the Accredited Dosimetry Calibration Laboratories (ADCLs) of the American Association of Physicists in Medicine (AAPM). The dosimetry standards for these sources are traceable to the NIST wide-angle free-air chamber. Procedures have been developed by the AAPM Calibration Laboratory Accreditation Subcommittee to standardize quality assurance and calibration, and to maintain the dosimetric traceability of these sources to ensure accurate clinical dosimetry. A description of these procedures is provided to the clinical users for traceability purposes as well as to provide guidance to the manufacturers of brachytherapy sources and ADCLs with regard to these procedures.

Measuring the quality of melanoma surgery - Highlighting issues with standardization and quality assurance of care in surgical oncology.

PubMed

Pasquali, S; Sommariva, A; Spillane, A J; Bilimoria, K Y; Rossi, C R

2017-03-01

In an attempt to ensure high standards of cancer care, there is increasing interest in determining and monitoring the quality of interventions in surgical oncology. In recent years, this has been particularly the case for melanoma surgery. The vast majority of patients with melanoma undergo surgery. Usually, this is with combinations of wide excision, sentinel lymph node biopsy and lymphadenectomy. The indications for these procedures evolved during a time when no effective systemic adjuvant therapy was available, and whilst the rationale has been sound, the justification for differences in extent and thoroughness has generally been supported by inadequate or low-level evidence. This has led to a substantial variation among melanoma centres or even among surgeons within a centre in how these procedures are done. With recent rapid progress in the efficacy of systemic treatments that are impacting on overall survival, the prospect of long-term survival in these previously high risk patients means that more than ever long-term locoregional control of melanoma is imperative. Furthermore, the understanding of effects of systemic therapy on locoregional disease will only be interpretable if surgeons use standardized, high quality techniques. This article focuses on standardization and evolution of quality indicators for melanoma surgery and how these might have a positive impact on patient care. Copyright © 2016 Elsevier Ltd, BASO ~ the Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Report of the FELASA Working Group on evaluation of quality systems for animal units.

PubMed

Howard, B; van Herck, H; Guillen, J; Bacon, B; Joffe, R; Ritskes-Hoitinga, M

2004-04-01

This report compares and considers the merits of existing, internationally available quality management systems suitable for implementation in experimental animal facilities. These are: the Good Laboratory Practice Guidelines, ISO 9000:2000 (International Organization for Standardization) and AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International). Good laboratory practice (GLP) is a legal requirement for institutions undertaking non-clinical health and environmental studies for the purpose of registering or licensing for use and which have to be 'GLP-compliant'. GLP guidelines are often only relevant for and obtainable by those institutions. ISO is primarily an external business standard, which provides a management tool to master and optimize a business activity; it aims to implement and enhance 'customer satisfaction'. AAALAC is primarily a peer-reviewed system of accreditation which evaluates the organization and procedures in programmes of animal care and use to ensure the appropriate use of animals, safeguard animal well-being (ensuring state-of-the-art housing, management, procedural techniques, etc.) as well as the management of health and safety of staff. Management needs to determine, on the basis of a facility's specific goals, whether benefits would arise from the introduction of a quality system and, if so, which system is most appropriate. The successful introduction of a quality system confers peer-recognition against an independent standard, thereby providing assurance of standards of animal care and use, improving the quality of animal studies, and contributing to the three Rs-reduction, refinement and replacement.

[Nursing service certification. Norm UNE-EN-ISO 9001-2008].

PubMed

Salazar de la Guerra, R; Ferrer Arnedo, C; Labrador Domínguez, M J; Sangregorio Matesanz, A

2014-01-01

To certify the nursing services using a quality management system, taking an international standard as a reference, and based on a continuous improvement process. The standard was revised, and the Quality Management System documentation was updated, consisting of a Quality Manual and 7 control procedures. All the existing procedures were coded in accordance with the documentation control process. Each operational procedure was associated with a set of indicators which permitted to know the results obtained, analyze the deviations and to implement further improvements. The system was implemented successfully. Twenty-eight care procedures and eleven procedures concerning techniques were incorporated into the management system. Thirty indicators were established that allowed the whole process to be monitored. All patients were assigned to a nurse in their clinical notes and all of them had a personalized Care Plan according to planning methodology using North American Nursing Diagnosis Association (NANDA), Nursing Interventions Classification (NIC) and Nursing Outcomes Classification (NOC) international rankings. The incidence of falls, as well as the incidence of chronic skin wounds, was low, taking into account the characteristics of the patient and the duration of the stay (mean=35.87 days). The safety indicators had a high level of compliance, with 90% of patients clearly identified and 100% with hygiene protocol. The confidence rating given to the nurses was 91%. The certification enabled the quality of the service to be improved using a structured process, analyzing the results, dealing with non-conformities and introducing improvements. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

38 CFR 36.4348 - Servicer Appraisal Processing Program.

Code of Federal Regulations, 2012 CFR

2012-07-01

... requirement, routine reviews of SAPP cases will be made by VA staff based upon quality control procedures..., that its activities do not deviate from high standards of integrity. The quality control system must include frequent, periodic audits that specifically address the appraisal review activity. These audits...

38 CFR 36.4348 - Servicer Appraisal Processing Program.

Code of Federal Regulations, 2014 CFR

2014-07-01

... requirement, routine reviews of SAPP cases will be made by VA staff based upon quality control procedures..., that its activities do not deviate from high standards of integrity. The quality control system must include frequent, periodic audits that specifically address the appraisal review activity. These audits...

38 CFR 36.4348 - Servicer Appraisal Processing Program.

Code of Federal Regulations, 2013 CFR

2013-07-01

... requirement, routine reviews of SAPP cases will be made by VA staff based upon quality control procedures..., that its activities do not deviate from high standards of integrity. The quality control system must include frequent, periodic audits that specifically address the appraisal review activity. These audits...

38 CFR 36.4348 - Servicer Appraisal Processing Program.

Code of Federal Regulations, 2011 CFR

2011-07-01

... requirement, routine reviews of SAPP cases will be made by VA staff based upon quality control procedures..., that its activities do not deviate from high standards of integrity. The quality control system must include frequent, periodic audits that specifically address the appraisal review activity. These audits...

76 FR 9025 - Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-16

... consumer protection, the Agency issued GLP regulations. The regulations specify minimum standards for the proper conduct of safety testing and contain sections on facilities, personnel, equipment, standard operating procedures (SOPs), test and control articles, quality assurance, protocol and conduct of a safety...

Effects of modifying the World Health Organization standard operating procedures for malaria microscopy to improve surveillance in resource poor settings.

PubMed

Fernando, Sumadhya D; Ihalamulla, Ratnasiri L; Wickremasinghe, Renu; de Silva, Nipun L; Thilakarathne, Janani H; Wijeyaratne, Pandu; Premaratne, Risintha G

2014-03-15

Individuals with fever are screened for malaria in specially-established malaria diagnostic laboratories set up in rural hospitals in the Northern and Eastern Provinces of Sri Lanka. Large numbers of blood smears negative for malaria parasites are being screened daily. Good quality smears are essential to maintain a high diagnostic competency among the technical staff. The modifications made to the World Health Organization (WHO) standard operating procedures to improve the quality of smears have been studied. A blinded, controlled, interventional study was conducted in 22 intervention and 21 control malaria diagnostic laboratories. Changes were made to the WHO standard operating procedure protocols to prepare, stain and examine blood smears for malaria parasite detection which were implemented in intervention laboratories. These included wipe-cleaning slides, preparing both thick and thin smears on the same slide, reversing the order of collecting blood for thick and thin smears, dry fixing thick smear for 20-25 minutes under table lamp, polishing the edge of spreader slide with sand paper and fixing the thin smear with methanol if not stained within four hours. Parameters with respect to quality of the smear as per WHO criteria were studied using randomly selected slides, and time taken for the report to be issued was recorded in both groups before and after the intervention. There were no significant differences observed in the parameters studied at baseline between the two groups or pre and post intervention in the control group. In the intervention group streak formation in thin smears was reduced from 29.4% to 5.0%. The average fixing time of thick smears was reduced from 2.4 hours to 20 minutes. Inappropriate thickness of thick smears reduced from 18.3% to 1.5%. Overall quality of thick smears and thin smears increased from 76.1% to 98.0% and 81.7% to 87.0%, respectively. The quality of slides bearing both thick and thin smears increased from 60.0% to 87.0%. New protocols with amendments to the WHO standard technical procedures ensure that good quality blood smears are prepared rapidly to diagnose malaria and the time required to issue the reports was reduced.

Standardization and quantification in FDG-PET/CT imaging for staging and restaging of malignant disease.

PubMed

Gámez-Cenzano, Cristina; Pino-Sorroche, Francisco

2014-04-01

There is a growing interest in using quantification in FDG-PET/CT in oncology, especially for evaluating response to therapy. Complex full quantitative procedures with blood sampling and dynamic scanning have been clinically replaced by the use of standardized uptake value measurements that provide an index of regional tracer uptake normalized to the administered dose of FDG. Some approaches have been proposed for assessing quantitative metabolic response, such as EORTC and PERCIST criteria in solid tumors. When using standardized uptake value in clinical routine and multicenter trials, standardization of protocols and quality control procedures of instrumentation is required. Copyright © 2014 Elsevier Inc. All rights reserved.

The uses and implications of standards in general practice consultations.

PubMed

Lippert, Maria Laura; Reventlow, Susanne; Kousgaard, Marius Brostrøm

2017-01-01

Quality standards play an increasingly important role in primary care through their inscription in various technologies for improving professional practice. While 'hard' biomedical standards have been the most common and debated, current quality development initiatives increasingly seek to include standards for the 'softer' aspects of care. This article explores the consequences of both kinds of quality standards for chronic care consultations. The article presents findings from an explorative qualitative field study in Danish general practice where a standardized technology for quality development has been introduced. Data from semi-structured interviews and observations among 17 general practitioners were analysed using an iterative analytical approach, which served to identify important variations in the uses and impacts of the technology. The most pronounced impact of the technology was observed among general practitioners who strictly adhered to the procedural standards on the interactional aspects of care. Thus, when allowed to function as an overall frame for consultations, those standards supported adherence to general recommendations regarding which elements to be included in chronic disease consultations. However, at the same time, adherence to those standards was observed to narrow the focus of doctor-patient dialogues and to divert general practitioners' attention from patients' personal concerns. Similar consequences of quality standards have previously been framed as manifestations of an inherent conflict between principles of patient-centredness and formal biomedical quality standards. However, this study suggests that standards on the 'softer' aspects of care may just as well interfere with a clinical approach relying on situated and attentive interactions with patients.

Conversion of School Nurse Policy and Procedure Manual to Electronic Format

ERIC Educational Resources Information Center

Randall, Joellyn; Knee, Rachel; Galemore, Cynthia

2006-01-01

Policy and procedure manuals are essential to establishing standards of practice and ensuring quality of care to students and families. The Olathe District Schools (Kansas) Technology Department created the Virtual File Cabinet to provide online access to employee policies, school board policies, forms, and other documents. A task force of school…

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR ANALYSIS OF PASSIVE FORMALDEHYDE SAMPLERS (BCO-L-16.0)

EPA Science Inventory

The purpose of this SOP is to describe the methodology used by Air Quality Research (Research Triangle Park, NC) for the analysis of the PF-1 passive formaldehyde samplers using a colorimetric method and chromotropic acid. This procedure was followed to ensure consistent data re...

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR ISOLATION OF MALFUNCTIONING OR DAMAGED EQUIPMENT (UA-G-2.0)

EPA Science Inventory

The purpose of this SOP is to identify and isolate malfunctioning or damaged equipment for the NHEXAS Arizona research project. This procedure was followed to ensure consistent data custody, storage, transfer and analysis of a high quality during the Arizona NHEXAS project and t...

Quality Procedures in the European Higher Education Area and Beyond--Second ENQA Survey. ENQA Occasional Papers 14

ERIC Educational Resources Information Center

Costes, Nathalie; Crozier, Fiona; Cullen, Peter; Grifoll, Josep; Harris, Nick; Helle, Emmi; Hopbach, Achim; Kekalainen, Helka; Knezevic, Bozana; Sits, Tanel; Sohm, Kurt

2008-01-01

Quality assurance for higher education in Europe has developed significantly since 2002, and has increasingly influenced, and been influenced by, the Bologna Process. A major step in the Bologna Process was taken at the ministerial meeting in Bergen in May 2005, with the adoption of the Standards and Guidelines for Quality Assurance in the…

Avoiding Assessment Anarchy. Quality Test Administration Strategies: Communicate Expectations, Reduce Variation, Increase Quality, Improve Relationships, Reward Excellence, Recognize Success.

ERIC Educational Resources Information Center

Matter, M. Kevin

This paper presents strategies that address the needs of the school district assessment office for standardized procedures to support reliable and efficient test processing and reporting and that meet the needs of school staff for test administration guidelines. The key to test administration and processing quality is a knowledgeable test…

U.S. Geological Survey quality-assurance plan for surface-water activities in Kansas, 2015

USGS Publications Warehouse

Painter, Colin C.; Loving, Brian L.

2015-01-01

This Surface Water Quality-Assurance Plan documents the standards, policies, and procedures used by the Kansas Water Science Center (KSWSC) of the U.S. Geological Survey (USGS) for activities related to the collection, processing, storage, analysis, and publication of surface-water data.

76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-19

... assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic... considerations for standardization of image acquisition, image interpretation methods, and other procedures to help ensure imaging data quality. The draft guidance describes two categories of image acquisition and...

Laboratory validation of four black carbon measurement methods for the determination of non-volatile particulate matter (PM) mass emissions . . .

EPA Science Inventory

A laboratory-scale experimental program was designed to standardize each of four black carbon measurement methods, provide appropriate quality assurance/control procedures for these techniques, and compare measurements made by these methods to a NIST traceable standard (filter gr...

40 CFR 260.11 - References.

Code of Federal Regulations, 2012 CFR

2012-07-01

...). (7) ASTM E 168-88, “Standard Practices for General Techniques of Infrared Quantitative Analysis,” IBR...-Visible Quantitative Analysis,” IBR approved for § 264.1063. (9) ASTM E 260-85, “Standard Practice for..., Research Triangle Park, NC. (1) “Screening Procedures for Estimating the Air Quality Impact of Stationary...

40 CFR 260.11 - References.

Code of Federal Regulations, 2014 CFR

2014-07-01

...). (7) ASTM E 168-88, “Standard Practices for General Techniques of Infrared Quantitative Analysis,” IBR...-Visible Quantitative Analysis,” IBR approved for § 264.1063. (9) ASTM E 260-85, “Standard Practice for..., Research Triangle Park, NC. (1) “Screening Procedures for Estimating the Air Quality Impact of Stationary...

40 CFR 260.11 - References.

Code of Federal Regulations, 2013 CFR

2013-07-01

...). (7) ASTM E 168-88, “Standard Practices for General Techniques of Infrared Quantitative Analysis,” IBR...-Visible Quantitative Analysis,” IBR approved for § 264.1063. (9) ASTM E 260-85, “Standard Practice for..., Research Triangle Park, NC. (1) “Screening Procedures for Estimating the Air Quality Impact of Stationary...

NREL: International Activities - Country Programs

Science.gov Websites

for use of mini-grid quality assurance and design standards and advising on mini-grid business models communities of practice and technical collaboration across countries on mini-grid development, modeling and interconnection standards and procedures, and with strengthening mini-grids and energy access programs. NREL is

Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

PubMed

McCarty, Lynn S; Borgert, Christopher J; Mihaich, Ellen M

2012-07-01

There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

Standard operating procedure changed pre-hospital critical care anaesthesiologists’ behaviour: a quality control study

PubMed Central

2013-01-01

Introduction The ability of standard operating procedures to improve pre-hospital critical care by changing pre-hospital physician behaviour is uncertain. We report data from a prospective quality control study of the effect on pre-hospital critical care anaesthesiologists’ behaviour of implementing a standard operating procedure for pre-hospital controlled ventilation. Materials and methods Anaesthesiologists from eight pre-hospital critical care teams in the Central Denmark Region prospectively registered pre-hospital advanced airway-management data according to the Utstein-style template. We collected pre-intervention data from February 1st 2011 to January 31st 2012, implemented the standard operating procedure on February 1st 2012 and collected post intervention data from February 1st 2012 until October 31st 2012. We included transported patients of all ages in need of controlled ventilation treated with pre-hospital endotracheal intubation or the insertion of a supraglottic airways device. The objective was to evaluate whether the development and implementation of a standard operating procedure for controlled ventilation during transport could change pre-hospital critical care anaesthesiologists’ behaviour and thereby increase the use of automated ventilators in these patients. Results The implementation of a standard operating procedure increased the overall prevalence of automated ventilator use in transported patients in need of controlled ventilation from 0.40 (0.34-0.47) to 0.74 (0.69-0.80) with a prevalence ratio of 1.85 (1.57-2.19) (p = 0.00). The prevalence of automated ventilator use in transported traumatic brain injury patients in need of controlled ventilation increased from 0.44 (0.26-0.62) to 0.85 (0.62-0.97) with a prevalence ratio of 1.94 (1.26-3.0) (p = 0.0039). The prevalence of automated ventilator use in patients transported after return of spontaneous circulation following pre-hospital cardiac arrest increased from 0.39 (0.26-0.48) to 0.69 (0.58-0.78) with a prevalence ratio of 1.79 (1.36-2.35) (p = 0.00). Conclusion We have shown that the implementation of a standard operating procedure for pre-hospital controlled ventilation can significantly change pre-hospital critical care anaesthesiologists’ behaviour. PMID:24308781

[Study on quality standards of decoction pieces of salt Alpinia].

PubMed

Li, Wenbing; Hu, Changjiang; Long, Lanyan; Huang, Qinwan; Xie, Xiuqiong

2010-12-01

To establish the quality criteria for decoction pieces of salt Alpinia. Decoction pieces of salt Alpinia were measured with moisture, total ash, acid-insoluble ash, water-extract and volatile oils according to the procedures recorded in the Chinese Pharmacopoeia 2010. The content of Nootkatone was determined by HPLC, and NaCl, by chloridion electrode method. We obtained results of total ash, acid-insoluble ash, water-extract and volatile oils of 10 batches of decoction pieces of salt Alpinia moisture; Meanwhile we set the HPLC and chloridion electrode method. This research established a fine quality standard for decoction pieces of salt Alpinia.

Preparation method and quality control of multigamma volume sources with different matrices.

PubMed

Listkowska, A; Lech, E; Saganowski, P; Tymiński, Z; Dziel, T; Cacko, D; Ziemek, T; Kołakowska, E; Broda, R

2018-04-01

The aim of the work was to develop new radioactive standard sources based on epoxy resins. The optimal proportions of the components and the homogeneity of the matrices were determined. The activity of multigamma sources prepared in Marinelli beakers was determined with reference to the National Standard of Radionuclides Activity in Poland. The difference of radionuclides activity values determined using calibrated gamma spectrometer and the activity of standard solutions used are in most cases significantly lower than measurement uncertainty limits. Sources production method and quality control procedure have been developed. Copyright © 2017 Elsevier Ltd. All rights reserved.

Quality-assurance plan for water-quality activities in the North Florida Program Office, Florida District

USGS Publications Warehouse

Berndt, Marian P.; Katz, Brian G.

2000-01-01

In accordance with guidelines set forth by the Office of Water Quality in the Water Resources Division of the U.S. Geological Survey, a quality-assurance plan was created for use by the Florida District's North Florida Program Office in conducting water-quality activities. This plan documents the standards, policies, and procedures used by the North Florida Program Office for activities related to the collection, processing, storage, analysis, and publication of water-quality data.

In view of standardization: comparison and analysis of initial management of severely burned patients in Germany, Austria and Switzerland.

PubMed

Münzberg, Matthias; Ziegler, Benjamin; Fischer, Sebastian; Wölfl, Christoph Georg; Grützner, Paul Alfred; Kremer, Thomas; Kneser, Ulrich; Hirche, Christoph

2015-02-01

Initial treatment of severely injured patients in German speaking trauma centers follows precise sequences. Several guidelines and training courses ensure a constant quality in providing evidence-based treatment for these patients. Similar standards, algorithms and guidelines for the treatment of severely burned patients are lacking. This raises the question about the current standard of care for burn victims in German speaking burn centers. In order to achieve standardization, as a first step this study surveys principles of burn room organization and management in these burn centers. A questionnaire including 40 questions regarding burn room organization, personnel structure and qualification, infrastructural conditions and quality management was developed and sent to 21 level one burn centers in Germany, Austria and Switzerland. The rate of returned questionnaires was 81%. The analysis revealed varying personnel and infrastructural conditions in participating burn centers. Indications for admission to the burn room and admission procedures itself are different throughout surveyed hospitals. Individual standard operating procedure (SOP) for burn trauma admissions was available in most burn centers and nearly all participants register their burn trauma cases using an in-house burn register. The survey suggests a lack of standardization in personnel structure, infrastructure and treatment approach for the initial clinical care of severely burned patients in burn centers across the German speaking countries. Further evaluation of existing protocols and international standards in burn care is inevitable to develop standardized guidelines for burn care and to improve quality of care. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

Quality-assurance plan and field methods for quality-of-water activities, U.S. Geological Survey, Idaho National Engineering Laboratory, Idaho

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

Mann, L.J.

1996-10-01

Water-quality activities at the Idaho National Engineering Laboratory (INEL) Project Office are part of the US Geological Survey`s (USGS) Water Resources Division (WRD) mission of appraising the quantity and quality of the Nation`s water resources. The purpose of the Quality Assurance Plan (QAP) for water-quality activities performed by the INEL Project Office is to maintain and improve the quality of technical products, and to provide a formal standardization, documentation, and review of the activities that lead to these products. The principles of this plan are as follows: (1) water-quality programs will be planned in a competent manner and activities willmore » be monitored for compliance with stated objectives and approaches; (2) field, laboratory, and office activities will be performed in a conscientious and professional manner in accordance with specified WRD practices and procedures by qualified and experienced employees who are well trained and supervised, if or when, WRD practices and procedures are inadequate, data will be collected in a manner that its quality will be documented; (3) all water-quality activities will be reviewed for completeness, reliability, credibility, and conformance to specified standards and guidelines; (4) a record of actions will be kept to document the activity and the assigned responsibility; (5) remedial action will be taken to correct activities that are deficient.« less

NASA Glenn's Acoustical Testing Laboratory Awarded Accreditation by the National Voluntary Laboratory Accreditation Program

NASA Technical Reports Server (NTRS)

Akers, James C.; Cooper, Beth A.

2004-01-01

NASA Glenn Research Center's Acoustical Testing Laboratory (ATL) provides a comprehensive array of acoustical testing services, including sound pressure level, sound intensity level, and sound-power-level testing per International Standards Organization (ISO)1 3744. Since its establishment in September 2000, the ATL has provided acoustic emission testing and noise control services for a variety of customers, particularly microgravity space flight hardware that must meet International Space Station acoustic emission requirements. The ATL consists of a 23- by 27- by 20-ft (height) convertible hemi/anechoic test chamber and a separate sound-attenuating test support enclosure. The ATL employs a personal-computer-based data acquisition system that provides up to 26 channels of simultaneous data acquisition with real-time analysis (ref. 4). Specialized diagnostic tools, including a scanning sound-intensity system, allow the ATL's technical staff to support its clients' aggressive low-noise design efforts to meet the space station's acoustic emission requirement. From its inception, the ATL has pursued the goal of developing a comprehensive ISO 17025-compliant quality program that would incorporate Glenn's existing ISO 9000 quality system policies as well as ATL-specific technical policies and procedures. In March 2003, the ATL quality program was awarded accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) for sound-power-level testing in accordance with ISO 3744. The NVLAP program is administered by the National Institutes of Standards and Technology (NIST) of the U.S. Department of Commerce and provides third-party accreditation for testing and calibration laboratories. There are currently 24 NVLAP-accredited acoustical testing laboratories in the United States. NVLAP accreditation covering one or more specific testing procedures conducted in accordance with established test standards is awarded upon successful completion of an intensive onsite assessment that includes proficiency testing and documentation review. The ATL NVLAP accreditation currently applies specifically to its ISO 3744 soundpower- level determination procedure (see the photograph) and supporting ISO 17025 quality system, although all ATL operations are conducted in accordance with its quality system. The ATL staff is currently developing additional procedures to adapt this quality system to the testing of space flight hardware in accordance with International Space Station acoustic emission requirements.<

Microbial ecology laboratory procedures manual NASA/MSFC

NASA Technical Reports Server (NTRS)

Huff, Timothy L.

1990-01-01

An essential part of the efficient operation of any microbiology laboratory involved in sample analysis is a standard procedures manual. The purpose of this manual is to provide concise and well defined instructions on routine technical procedures involving sample analysis and methods for monitoring and maintaining quality control within the laboratory. Of equal importance is the safe operation of the laboratory. This manual outlines detailed procedures to be followed in the microbial ecology laboratory to assure safety, analytical control, and validity of results.

Standardized Transportation of Human Islets: An Islet Cell Resource Center Study of More Than 2,000 Shipments

PubMed Central

Kaddis, John S.; Hanson, Matthew S.; Cravens, James; Qian, Dajun; Olack, Barbara; Antler, Martha; Papas, Klearchos K.; Iglesias, Itzia; Barbaro, Barbara; Fernandez, Luis; Powers, Alvin C.; Niland, Joyce C.

2013-01-01

Preservation of cell quality during shipment of human pancreatic islets for use in laboratory research is a crucial, but neglected, topic. Mammalian cells, including islets, have been shown to be adversely affected by temperature changes in vitro and in vivo, yet protocols that control for thermal fluctuations during cell transport are lacking. To evaluate an optimal method of shipping human islets, an initial assessment of transportation conditions was conducted using standardized materials and operating procedures in 48 shipments sent to a central location by 8 pancreas-processing laboratories using a single commercial airline transporter. Optimization of preliminary conditions was conducted, and human islet quality was then evaluated in 2,338 shipments pre- and post-implementation of a finalized transportation container and standard operating procedures. The initial assessment revealed that the outside temperature ranged from a mean of −4.6±10.3°C to 20.9±4.8°C. Within-container temperature drops to or below 15°C occurred in 16 shipments (36%), while the temperature was found to be stabilized between 15–29°C in 29 shipments (64%). Implementation of an optimized transportation container and operating procedure reduced the number of within-container temperature drops (≤15°C) to 13% (n=37 of 289 winter shipments), improved the number desirably maintained between 15–29°C to 86% (n=250), but also increased the number reaching or exceeding 29°C to 1% (n=2; overall p<0.0001). Additionally, post-receipt quality ratings of excellent to good improved pre- vs. post- implementation of the standardized protocol, adjusting for pre-shipment purity/viability levels (p<0.0001). Our results show that extreme temperature fluctuations during transport of human islets, occurring when using a commercial airline transporter for long distance shipping, can be controlled using standardized containers, materials, and operating procedures. This cost-effective and pragmatic standardized protocol for the transportation of human islets can potentially be adapted for use with other mammalian cell systems, and is available online at: http://iidp.coh.org/sops.aspx. PMID:22889479

Federal standards and procedures for the National Watershed Boundary Dataset (WBD)

USGS Publications Warehouse

,; ,; ,

2009-03-11

Terminology, definitions, and procedural information are provided to ensure uniformity in hydrologic unit boundaries, names, and numerical codes. Detailed standards and specifications for data are included. The document also includes discussion of objectives, communications required for revising the data resolution in the United States and the Caribbean, as well as final review and data-quality criteria. Instances of unusual landforms or artificial features that affect the hydrologic units are described with metadata standards. Up-to-date information and availability of the hydrologic units are listed athttp://www.nrcs.usda.gov/wps/portal/nrcs/detail/national/technical/nra/dma/?&cid=nrcs143_021630/.

12 CFR 1815.104 - Specific responsibilities of the designated Fund official.

Code of Federal Regulations, 2010 CFR

2010-01-01

... and maintain working relationships with relevant government agencies (including Federal, state and... standards, procedures, and working relationships for protection and enhancement of environmental quality and...

Developing an automated database for monitoring ultrasound- and computed tomography-guided procedure complications and diagnostic yield.

PubMed

Itri, Jason N; Jones, Lisa P; Kim, Woojin; Boonn, William W; Kolansky, Ana S; Hilton, Susan; Zafar, Hanna M

2014-04-01

Monitoring complications and diagnostic yield for image-guided procedures is an important component of maintaining high quality patient care promoted by professional societies in radiology and accreditation organizations such as the American College of Radiology (ACR) and Joint Commission. These outcome metrics can be used as part of a comprehensive quality assurance/quality improvement program to reduce variation in clinical practice, provide opportunities to engage in practice quality improvement, and contribute to developing national benchmarks and standards. The purpose of this article is to describe the development and successful implementation of an automated web-based software application to monitor procedural outcomes for US- and CT-guided procedures in an academic radiology department. The open source tools PHP: Hypertext Preprocessor (PHP) and MySQL were used to extract relevant procedural information from the Radiology Information System (RIS), auto-populate the procedure log database, and develop a user interface that generates real-time reports of complication rates and diagnostic yield by site and by operator. Utilizing structured radiology report templates resulted in significantly improved accuracy of information auto-populated from radiology reports, as well as greater compliance with manual data entry. An automated web-based procedure log database is an effective tool to reliably track complication rates and diagnostic yield for US- and CT-guided procedures performed in a radiology department.

Recommendations for fluorescence instrument qualification: the new ASTM Standard Guide.

PubMed

DeRose, Paul C; Resch-Genger, Ute

2010-03-01

Aimed at improving quality assurance and quantitation for modern fluorescence techniques, ASTM International (ASTM) is about to release a Standard Guide for Fluorescence, reviewed here. The guide's main focus is on steady state fluorometry, for which available standards and instrument characterization procedures are discussed along with their purpose, suitability, and general instructions for use. These include the most relevant instrument properties needing qualification, such as linearity and spectral responsivity of the detection system, spectral irradiance reaching the sample, wavelength accuracy, sensitivity or limit of detection for an analyte, and day-to-day performance verification. With proper consideration of method-inherent requirements and limitations, many of these procedures and standards can be adapted to other fluorescence techniques. In addition, procedures for the determination of other relevant fluorometric quantities including fluorescence quantum yields and fluorescence lifetimes are briefly introduced. The guide is a clear and concise reference geared for users of fluorescence instrumentation at all levels of experience and is intended to aid in the ongoing standardization of fluorescence measurements.

Pros and Cons of 3D Image Fusion in Endovascular Aortic Repair: A Systematic Review and Meta-analysis.

PubMed

Goudeketting, Seline R; Heinen, Stefan G H; Ünlü, Çağdaş; van den Heuvel, Daniel A F; de Vries, Jean-Paul P M; van Strijen, Marco J; Sailer, Anna M

2017-08-01

To systematically review and meta-analyze the added value of 3-dimensional (3D) image fusion technology in endovascular aortic repair for its potential to reduce contrast media volume, radiation dose, procedure time, and fluoroscopy time. Electronic databases were systematically searched for studies published between January 2010 and March 2016 that included a control group describing 3D fusion imaging in endovascular aortic procedures. Two independent reviewers assessed the methodological quality of the included studies and extracted data on iodinated contrast volume, radiation dose, procedure time, and fluoroscopy time. The contrast use for standard and complex endovascular aortic repairs (fenestrated, branched, and chimney) were pooled using a random-effects model; outcomes are reported as the mean difference with 95% confidence intervals (CIs). Seven studies, 5 retrospective and 2 prospective, involving 921 patients were selected for analysis. The methodological quality of the studies was moderate (median 17, range 15-18). The use of fusion imaging led to an estimated mean reduction in iodinated contrast of 40.1 mL (95% CI 16.4 to 63.7, p=0.002) for standard procedures and a mean 70.7 mL (95% CI 44.8 to 96.6, p<0.001) for complex repairs. Secondary outcome measures were not pooled because of potential bias in nonrandomized data, but radiation doses, procedure times, and fluoroscopy times were lower, although not always significantly, in the fusion group in 6 of the 7 studies. Compared with the control group, 3D fusion imaging is associated with a significant reduction in the volume of contrast employed for standard and complex endovascular aortic procedures, which can be particularly important in patients with renal failure. Radiation doses, procedure times, and fluoroscopy times were reduced when 3D fusion was used.

Laboratory and quality assurance protocols for the analysis of herbicides in ground water from the Management Systems Evaluation Area, Princeton, Minnesota

USGS Publications Warehouse

Larson, S.J.; Capel, P.D.; VanderLoop, A.G.

1996-01-01

Laboratory and quality assurance procedures for the analysis of ground-water samples for herbicides at the Management Systems Evaluation Area near Princeton, Minnesota are described. The target herbicides include atrazine, de-ethylatrazine, de-isopropylatrazine, metribuzin, alachlor, 2,6-diethylaniline, and metolachlor. The analytical techniques used are solid-phase extraction, and analysis by gas chromatography with mass-selective detection. Descriptions of cleaning procedures, preparation of standard solutions, isolation of analytes from water, sample transfer methods, instrumental analysis, and data analysis are included.

Methodological approach for the assessment of ultrasound reproducibility of cardiac structure and function: a proposal of the study group of Echocardiography of the Italian Society of Cardiology (Ultra Cardia SIC) Part I

PubMed Central

2011-01-01

When applying echo-Doppler imaging for either clinical or research purposes it is very important to select the most adequate modality/technology and choose the most reliable and reproducible measurements. Quality control is a mainstay to reduce variability among institutions and operators and must be obtained by using appropriate procedures for data acquisition, storage and interpretation of echo-Doppler data. This goal can be achieved by employing an echo core laboratory (ECL), with the responsibility for standardizing image acquisition processes (performed at the peripheral echo-labs) and analysis (by monitoring and optimizing the internal intra- and inter-reader variability of measurements). Accordingly, the Working Group of Echocardiography of the Italian Society of Cardiology decided to design standardized procedures for imaging acquisition in peripheral laboratories and reading procedures and to propose a methodological approach to assess the reproducibility of echo-Doppler parameters of cardiac structure and function by using both standard and advanced technologies. A number of cardiologists experienced in cardiac ultrasound was involved to set up an ECL available for future studies involving complex imaging or including echo-Doppler measures as primary or secondary efficacy or safety end-points. The present manuscript describes the methodology of the procedures (imaging acquisition and measurement reading) and provides the documentation of the work done so far to test the reproducibility of the different echo-Doppler modalities (standard and advanced). These procedures can be suggested for utilization also in non referall echocardiographic laboratories as an "inside" quality check, with the aim at optimizing clinical consistency of echo-Doppler data. PMID:21943283

U.S.-MEXICO BORDER PROGRAM ARIZONA BORDER STUDY--STANDARD OPERATING PROCEDURE FOR ISOLATION OF MALFUNCTIONING OR DAMAGED EQUIPMENT (UA-G-2.0)

EPA Science Inventory

The purpose of this SOP is to identify and isolate malfunctioning or damaged equipment for the Arizona Border Study. This procedure was followed to ensure consistent data custody, storage, transfer and analysis of a high quality during the Arizona NHEXAS project and the Border s...

Policies and Procedures for the Operation of Vocational-Technical Education in the State of New Mexico.

ERIC Educational Resources Information Center

New Mexico Occupational Research and Development Coordinating Unit, Santa Fe.

This manual, developed after a number of statewide meetings, sets forth standards to provide a minimum regulation base upon which quality vocational education programs can be built. Policies and procedures are given for: (1) Agricultural Education, (2) Distributive Education, (3) Health Occupations Education, (4) Home Economics Education, (5)…

40 CFR Appendix C to Part 50 - Measurement Principle and Calibration Procedure for the Measurement of Carbon Monoxide in the...

Code of Federal Regulations, 2014 CFR

2014-07-01

... Procedure for the Measurement of Carbon Monoxide in the Atmosphere (Non-Dispersive Infrared Photometry) C Appendix C to Part 50 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS NATIONAL PRIMARY AND SECONDARY AMBIENT AIR QUALITY STANDARDS Pt. 50, App. C Appendix C to Part 50...

40 CFR Appendix C to Part 50 - Measurement Principle and Calibration Procedure for the Measurement of Carbon Monoxide in the...

Code of Federal Regulations, 2012 CFR

2012-07-01

... Procedure for the Measurement of Carbon Monoxide in the Atmosphere (Non-Dispersive Infrared Photometry) C Appendix C to Part 50 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS NATIONAL PRIMARY AND SECONDARY AMBIENT AIR QUALITY STANDARDS Pt. 50, App. C Appendix C to Part 50...

Raising the quality of rheumatology management recommendations: lessons from the EULAR process 10 years after provision of standard operating procedures.

PubMed

Colebatch-Bourn, Alexandra N; Conaghan, Philip G; Arden, Nigel K; Cooper, Cyrus; Dougados, Maxime; Edwards, Christopher J

2015-08-01

To increase understanding of how to raise the quality of rheumatology guidelines by reviewing European League Against Rheumatism (EULAR) management recommendations, using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, 10 years after publication of the EULAR standardized operating procedures (SOP) for the production of recommendations. It was hoped that this work could help inform improvements in guideline development by other societies and organizations. The SOP were published in 2004 to ensure the quality of EULAR-endorsed recommendations. We reviewed 27 published EULAR recommendations for management using the AGREE II tool. This provides a framework to assess the quality of guidelines across six broad domains using 23 specific questions. Overall the EULAR recommendations reviewed have been performed to a high standard. There are particular strengths in the methodology and presentation of the guidelines; however, the results indicate areas for development in future recommendations: in particular, stakeholder involvement and applicability of the recommendations. Improvements in quality were evident in recent years, with patient representation in 9 of 15 (60.0%) recommendations published 2010-14 compared with 4 of 12 (33.3%) published 2000-09. In the last 10 years the overall quality of recommendations was good, with standards improving over the decade following publication of the SOP. However, this review process has identified potential areas for improvement, especially in patient representation and provision of implementation tools. The lessons from this work can be applied to the development of rheumatology guidelines by other societies and organizations. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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

Spickett, Jeffery, E-mail: J.Spickett@curtin.edu.au; Faculty of Health Sciences, School of Public Health, Curtin University, Perth, Western Australia; Katscherian, Dianne

The approaches used for setting or reviewing air quality standards vary from country to country. The purpose of this research was to consider the potential to improve decision-making through integration of HIA into the processes to review and set air quality standards used in Australia. To assess the value of HIA in this policy process, its strengths and weaknesses were evaluated aligned with review of international processes for setting air quality standards. Air quality standard setting programmes elsewhere have either used HIA or have amalgamated and incorporated factors normally found within HIA frameworks. They clearly demonstrate the value of amore » formalised HIA process for setting air quality standards in Australia. The following elements should be taken into consideration when using HIA in standard setting. (a) The adequacy of a mainly technical approach in current standard setting procedures to consider social determinants of health. (b) The importance of risk assessment criteria and information within the HIA process. The assessment of risk should consider equity, the distribution of variations in air quality in different locations and the potential impacts on health. (c) The uncertainties in extrapolating evidence from one population to another or to subpopulations, especially the more vulnerable, due to differing environmental factors and population variables. (d) The significance of communication with all potential stakeholders on issues associated with the management of air quality. In Australia there is also an opportunity for HIA to be used in conjunction with the NEPM to develop local air quality standard measures. The outcomes of this research indicated that the use of HIA for air quality standard setting at the national and local levels would prove advantageous. -- Highlights: • Health Impact Assessment framework has been applied to a policy development process. • HIA process was evaluated for application in air quality standard setting. • Advantages of HIA in the air quality standard setting process are demonstrated.« less

Change in quality of malnutrition surveys between 1986 and 2015.

PubMed

Grellety, Emmanuel; Golden, Michael H

2018-01-01

Representative surveys collecting weight, height and MUAC are used to estimate the prevalence of acute malnutrition. The results are then used to assess the scale of malnutrition in a population and type of nutritional intervention required. There have been changes in methodology over recent decades; the objective of this study was to determine if these have resulted in higher quality surveys. In order to examine the change in reliability of such surveys we have analysed the statistical distributions of the derived anthropometric parameters from 1843 surveys conducted by 19 agencies between 1986 and 2015. With the introduction of standardised guidelines and software by 2003 and their more general application from 2007 the mean standard deviation, kurtosis and skewness of the parameters used to assess nutritional status have each moved to now approximate the distribution of the WHO standards when the exclusion of outliers from analysis is based upon SMART flagging procedure. Where WHO flags, that only exclude data incompatible with life, are used the quality of anthropometric surveys has improved and the results now approach those seen with SMART flags and the WHO standards distribution. Agencies vary in their uptake and adherence to standard guidelines. Those agencies that fully implement the guidelines achieve the most consistently reliable results. Standard methods should be universally used to produce reliable data and tests of data quality and SMART type flagging procedures should be applied and reported to ensure that the data are credible and therefore inform appropriate intervention. Use of SMART guidelines has coincided with reliable anthropometric data since 2007.

Standardization and quality management in next-generation sequencing.

PubMed

Endrullat, Christoph; Glökler, Jörn; Franke, Philipp; Frohme, Marcus

2016-09-01

DNA sequencing continues to evolve quickly even after > 30 years. Many new platforms suddenly appeared and former established systems have vanished in almost the same manner. Since establishment of next-generation sequencing devices, this progress gains momentum due to the continually growing demand for higher throughput, lower costs and better quality of data. In consequence of this rapid development, standardized procedures and data formats as well as comprehensive quality management considerations are still scarce. Here, we listed and summarized current standardization efforts and quality management initiatives from companies, organizations and societies in form of published studies and ongoing projects. These comprise on the one hand quality documentation issues like technical notes, accreditation checklists and guidelines for validation of sequencing workflows. On the other hand, general standard proposals and quality metrics are developed and applied to the sequencing workflow steps with the main focus on upstream processes. Finally, certain standard developments for downstream pipeline data handling, processing and storage are discussed in brief. These standardization approaches represent a first basis for continuing work in order to prospectively implement next-generation sequencing in important areas such as clinical diagnostics, where reliable results and fast processing is crucial. Additionally, these efforts will exert a decisive influence on traceability and reproducibility of sequence data.

A Framework for a Quality Control System for Vendor/Processor Contracts.

ERIC Educational Resources Information Center

Advanced Technology, Inc., Reston, VA.

A framework for monitoring quality control (QC) of processor contracts administered by the Department of Education's Office of Student Financial Assistance (OSFA) is presented and applied to the Pell Grant program. Guidelines for establishing QC measures and standards are included, and the uses of a sampling procedure in the QC system are…

An improved method of electrode placement in configuration Lead II for the reliable ECG recording by telemetry in the conscious rat.

PubMed

Tontodonati, Marcello; Fasdelli, Nicola; Dorigatti, Roberto

2011-01-01

Telemetry represents the gold standard technique for the acquisition of animal haemodynamic signals in the pharmaceutical preclinical development of new chemical entities. In terms of electrocardiographic signal recording, the quality is well established in large animals, mainly dog, non human primates and minipig, whereas it is still lacking in terms of satisfactory results in rodents (mouse and rat in particular). In very recent times, an increasing interest in early safety prediction for the reduction of cardiovascular attrition has been raised in all the major pharmaceutical companies, focusing in particular, on in vivo models. Crl:CD(SD) and Wistar Han rats (Crl:WI[Han], Charles River) underwent surgery for the implantation of telemetry devices (Data Science International, USA) for the acquisition of blood pressure and electrocardiogram (ECG). A group of male CD rats (N=6) was implanted using the standard procedure as described by DSI technical documentation; another male CD group (N=3) was implanted using the technique described by Sgoifo et al. (1996); a third group (total of N=46, N=26 male CD rats, and N=10 male WI and N=10 female WI) was implanted using an alternative approach developed in our laboratory. The new surgical procedure was analysed based on technical difficulties, time to complete the surgery, time to recover, animal care, survival time after surgery and quality of telemetry signal recordings. Although a quantitative and qualitative comparison with other techniques described in literature was beyond the scope of the present work, based on our laboratory experience, Sgoifo's methodology showed better results compared to DSI standard approach, but surgical procedure was not easy to perform and more invasive. The novel approach described in the present paper was characterised by simplicity, repeatability, high rate of survival and improved quality of ECG signals for all the implanted rats. Telemetry in small rodents became of particular interest in the early safety assessment of cardiovascular liability during the development of new chemical entities. Although several surgical procedures are well described in literature, none seem to offer high standard electrocardiography signals in order to reliably detect intervals or arrhythmias. In the Safety Pharmacology Laboratory at GlaxoSmithKline, Verona (Italy), a novel and alternative surgical placement of the electrocardiographic electrodes in Lead II configuration was developed, in the rat. The scope of the present paper is to illustrate that this alternative surgical procedure is easily reproducible, minimally invasive and gives high standard quality ECG signals. Copyright © 2010 Elsevier Inc. All rights reserved.

10 CFR 440.21 - Weatherization materials standards and energy audit procedures.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 75 percent; or, in the case of a solar system, it has a thermal efficiency rating of at least 15...) of this section describes the performance and quality standards for renewable energy systems... petition from a manufacturer requesting the Secretary to certify an item as a renewable energy system...

The influence of DNA degradation in formalin-fixed, paraffin-embedded (FFPE) tissue on locus-specific methylation assessment by MS-HRM.

PubMed

Daugaard, Iben; Kjeldsen, Tina E; Hager, Henrik; Hansen, Lise Lotte; Wojdacz, Tomasz K

2015-12-01

Readily accessible formalin-fixed paraffin embedded (FFPE) tissues are a highly valuable source of genetic material for molecular analyses in both research and in vitro diagnostics but frequently genetic material in those samples is highly degraded. With locus-specific methylation changes being widely investigated for use as biomarkers in various aspects of clinical disease management, we aimed to evaluate to what extent standard laboratory procedures can approximate the quality of the DNA extracted from FFPE samples prior to methylation analyses. DNA quality in 107 FFPE non-small cell lung cancer (NSCLC) samples was evaluated using spectrophotometry and gel electrophoresis. Subsequently, the quality assessment results were correlated with the results of locus specific methylation assessment with methylation sensitive high resolution melting (MS-HRM). The correlation of template quality with PCR amplification performance and HRM based methylation detection indicated a significant influence of DNA quality on PCR amplification but not on methylation assessment. In conclusion, standard laboratory procedures fairly well approximate DNA degradation of FFPE samples and DNA degradation does not seem to considerably affect locus-specific methylation assessment by MS-HRM. Copyright © 2015 Elsevier Inc. All rights reserved.

Standards for the Analysis and Processing of Surface-Water Data and Information Using Electronic Methods

USGS Publications Warehouse

Sauer, Vernon B.

2002-01-01

Surface-water computation methods and procedures are described in this report to provide standards from which a completely automated electronic processing system can be developed. To the greatest extent possible, the traditional U. S. Geological Survey (USGS) methodology and standards for streamflow data collection and analysis have been incorporated into these standards. Although USGS methodology and standards are the basis for this report, the report is applicable to other organizations doing similar work. The proposed electronic processing system allows field measurement data, including data stored on automatic field recording devices and data recorded by the field hydrographer (a person who collects streamflow and other surface-water data) in electronic field notebooks, to be input easily and automatically. A user of the electronic processing system easily can monitor the incoming data and verify and edit the data, if necessary. Input of the computational procedures, rating curves, shift requirements, and other special methods are interactive processes between the user and the electronic processing system, with much of this processing being automatic. Special computation procedures are provided for complex stations such as velocity-index, slope, control structures, and unsteady-flow models, such as the Branch-Network Dynamic Flow Model (BRANCH). Navigation paths are designed to lead the user through the computational steps for each type of gaging station (stage-only, stagedischarge, velocity-index, slope, rate-of-change in stage, reservoir, tide, structure, and hydraulic model stations). The proposed electronic processing system emphasizes the use of interactive graphics to provide good visual tools for unit values editing, rating curve and shift analysis, hydrograph comparisons, data-estimation procedures, data review, and other needs. Documentation, review, finalization, and publication of records are provided for with the electronic processing system, as well as archiving, quality assurance, and quality control.

Biobanking human endometrial tissue and blood specimens: standard operating procedure and importance to reproductive biology research and diagnostic development.

PubMed

Sheldon, Elizabeth; Vo, Kim Chi; McIntire, Ramsey A; Aghajanova, Lusine; Zelenko, Zara; Irwin, Juan C; Giudice, Linda C

2011-05-01

To develop a standard operating procedure (SOP) for collection, transport, storage of human endometrial tissue and blood samples, subject and specimen annotation, and establishing sample priorities. The SOP synthesizes sound scientific procedures, the literature on ischemia research, sample collection and gene expression profiling, good laboratory practices, and the authors' experience of workflow and sample quality. The National Institutes of Health, University of California, San Francisco, Human Endometrial Tissue and DNA Bank. Women undergoing endometrial biopsy or hysterectomy for nonmalignant indications. Collecting, processing, storing, distributing endometrial tissue and blood samples under approved institutional review board protocols and written informed consent from participating subjects. Standard operating procedure. The SOP addresses rigorous and consistent subject annotation, specimen processing and characterization, strict regulatory compliance, and a reference for researchers to track collection and storage times that may influence their research. The comprehensive and systematic approach to the procurement of human blood and endometrial tissue in this SOP ensures the high quality, reliability, and scientific usefulness of biospecimens made available to investigators by the National Institutes of Health, University of California, San Francisco, Human Endometrial Tissue and DNA Bank. The detail and perspective in this SOP also provides a blueprint for implementation of similar collection programs at other institutions. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Electroplating and stripping copper on molybdenum and niobium

NASA Technical Reports Server (NTRS)

Power, J. L.

1978-01-01

Molybdenum and niobium are often electroplated and subsequently stripped of copper. Since general standard plating techniques produce poor quality coatings, general procedures have been optimized and specified to give good results.

Introduction to ISO 15189: a blueprint for quality systems in veterinary laboratories.

PubMed

Freeman, Kathleen P; Bauer, Natali; Jensen, Asger L; Thoresen, Stein

2006-06-01

A trend in human and veterinary medical laboratory management is to achieve accreditation based on international standards. The International Organization for Standardization (ISO) 15189 standard is the first developed especially for accreditation of medical laboratories, and emphasizes the laboratory-client interface. European veterinary laboratories seeking to train candidates for the certification examination of the European College of Veterinary Clinical Pathology (ECVCP) require approval by the ECVCP Laboratory Standards Committee, which bases its evaluation in part on adherence to quality systems described in the ISO 15189 standards. The purpose of this article was to introduce the latest ISO quality standard and describe its application to veterinary laboratories in Europe, specifically as pertains to accreditation of laboratories involved in training veterinary clinical pathologists. Between 2003 and 2006, the Laboratory Standards Committee reviewed 12 applications from laboratories (3 commercial and 9 university) involved in training veterinary clinical pathologists. Applicants were asked to provide a description of the facilities for training and testing, current methodology and technology, health and safety policy, quality assurance policy (including internal quality control and participation in an external quality assurance program), written standard operating procedures (SOPs) and policies, a description of the laboratory information system, and personnel and training. Also during this time period multiple informal and formal discussions among ECVCP diplomates took place as to current practices and perceived areas of concern with regard to laboratory accreditation requirements. Areas in which improvement most often was needed in veterinary laboratories applying for ECVCP accreditation were the written quality plan, defined quality requirements for the tests performed, written SOPs and policies, training records, ongoing audits and competency assessments, and processes for identifying and addressing opportunities for improvement. Recommendations were developed for a stepwise approach towards achieving ISO 15189 standards, including 3 levels of quality components. The ISO 15189 standard provides a sound framework for veterinary laboratories aspiring to meet international quality standards.

Implementing self sustained quality control procedures in a clinical laboratory.

PubMed

Khatri, Roshan; K C, Sanjay; Shrestha, Prabodh; Sinha, J N

2013-01-01

Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be "too technical" whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance. The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month. The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients' samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided. In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports.

Modeling Major Adverse Outcomes of Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Catheterization: Observations From the NCDR IMPACT Registry (National Cardiovascular Data Registry Improving Pediatric and Adult Congenital Treatment).

PubMed

Jayaram, Natalie; Spertus, John A; Kennedy, Kevin F; Vincent, Robert; Martin, Gerard R; Curtis, Jeptha P; Nykanen, David; Moore, Phillip M; Bergersen, Lisa

2017-11-21

Risk standardization for adverse events after congenital cardiac catheterization is needed to equitably compare patient outcomes among different hospitals as a foundation for quality improvement. The goal of this project was to develop a risk-standardization methodology to adjust for patient characteristics when comparing major adverse outcomes in the NCDR's (National Cardiovascular Data Registry) IMPACT Registry (Improving Pediatric and Adult Congenital Treatment). Between January 2011 and March 2014, 39 725 consecutive patients within IMPACT undergoing cardiac catheterization were identified. Given the heterogeneity of interventional procedures for congenital heart disease, new procedure-type risk categories were derived with empirical data and expert opinion, as were markers of hemodynamic vulnerability. A multivariable hierarchical logistic regression model to identify patient and procedural characteristics predictive of a major adverse event or death after cardiac catheterization was derived in 70% of the cohort and validated in the remaining 30%. The rate of major adverse event or death was 7.1% and 7.2% in the derivation and validation cohorts, respectively. Six procedure-type risk categories and 6 independent indicators of hemodynamic vulnerability were identified. The final risk adjustment model included procedure-type risk category, number of hemodynamic vulnerability indicators, renal insufficiency, single-ventricle physiology, and coagulation disorder. The model had good discrimination, with a C-statistic of 0.76 and 0.75 in the derivation and validation cohorts, respectively. Model calibration in the validation cohort was excellent, with a slope of 0.97 (standard error, 0.04; P value [for difference from 1] =0.53) and an intercept of 0.007 (standard error, 0.12; P value [for difference from 0] =0.95). The creation of a validated risk-standardization model for adverse outcomes after congenital cardiac catheterization can support reporting of risk-adjusted outcomes in the IMPACT Registry as a foundation for quality improvement. © 2017 American Heart Association, Inc.

Methods for Monitoring Fish Communities of Buffalo National River and Ozark National Scenic Riverways in the Ozark Plateaus of Arkansas and Missouri: Version 1.0

USGS Publications Warehouse

Petersen, James C.; Justus, B.G.; Dodd, H.R.; Bowles, D.E.; Morrison, L.W.; Williams, M.H.; Rowell, G.A.

2008-01-01

Buffalo National River located in north-central Arkansas, and Ozark National Scenic Riverways, located in southeastern Missouri, are the two largest units of the National Park Service in the Ozark Plateaus physiographic province. The purpose of this report is to provide a protocol that will be used by the National Park Service to sample fish communities and collect related water-quality, habitat, and stream discharge data of Buffalo National River and Ozark National Scenic Riverways to meet inventory and long-term monitoring objectives. The protocol includes (1) a protocol narrative, (2) several standard operating procedures, and (3) supplemental information helpful for implementation of the protocol. The protocol narrative provides background information about the protocol such as the rationale of why a particular resource or resource issue was selected for monitoring, information concerning the resource or resource issue of interest, a description of how monitoring results will inform management decisions, and a discussion of the linkages between this and other monitoring projects. The standard operating procedures cover preparation, training, reach selection, water-quality sampling, fish community sampling, physical habitat collection, measuring stream discharge, equipment maintenance and storage, data management and analysis, reporting, and protocol revision procedures. Much of the information in the standard operating procedures was gathered from existing protocols of the U.S. Geological Survey National Water Quality Assessment program or other sources. Supplemental information that would be helpful for implementing the protocol is included. This information includes information on fish species known or suspected to occur in the parks, sample sites, sample design, fish species traits, index of biotic integrity metrics, sampling equipment, and field forms.

Automated standardization technique for an inductively-coupled plasma emission spectrometer

USGS Publications Warehouse

Garbarino, John R.; Taylor, Howard E.

1982-01-01

The manifold assembly subsystem described permits real-time computer-controlled standardization and quality control of a commercial inductively-coupled plasma atomic emission spectrometer. The manifold assembly consists of a branch-structured glass manifold, a series of microcomputer-controlled solenoid valves, and a reservoir for each standard. Automated standardization involves selective actuation of each solenoid valve that permits a specific mixed standard solution to be pumped to the nebulizer of the spectrometer. Quality control is based on the evaluation of results obtained for a mixed standard containing 17 analytes, that is measured periodically with unknown samples. An inaccurate standard evaluation triggers restandardization of the instrument according to a predetermined protocol. Interaction of the computer-controlled manifold assembly hardware with the spectrometer system is outlined. Evaluation of the automated standardization system with respect to reliability, simplicity, flexibility, and efficiency is compared to the manual procedure. ?? 1982.

A Method for Developing Standard Patient Education Program.

PubMed

Lura, Carolina Bryne; Hauch, Sophie Misser Pallesgaard; Gøeg, Kirstine Rosenbeck; Pape-Haugaard, Louise

2018-01-01

In Denmark, patients being treated on Haematology Outpatients Departments get instructed to self-manage their blood sample collection from Central Venous Catheter (CVC). However, this is a complex and risky procedure, which can jeopardize patient safety. The aim of the study was to suggest a method for developing standard digital patient education programs for patients in self-administration of blood samples drawn from CVC. The Design Science Research Paradigm was used to develop a digital patient education program, called PAVIOSY, to increase patient safety during execution of the blood sample collection procedure by using videos for teaching as well as procedural support. A step-by-step guide was developed and used as basis for making the videos. Quality assurance through evaluation with a nurse was conducted on both the step-by-step guide and the videos. The quality assurance evaluation of the videos showed; 1) Errors due to the order of the procedure can be determined by reviewing the videos despite that the guide was followed. 2) Videos can be used to identify errors - important for patient safety - in the procedure, which are not identifiable in a written script. To ensure correct clinical content of the educational patient system, health professionals must be engaged early in the development of content and design phase.

Reporting the accuracy of biochemical measurements for epidemiologic and nutrition studies.

PubMed

McShane, L M; Clark, L C; Combs, G F; Turnbull, B W

1991-06-01

Procedures for reporting and monitoring the accuracy of biochemical measurements are presented. They are proposed as standard reporting procedures for laboratory assays for epidemiologic and clinical-nutrition studies. The recommended procedures require identification and estimation of all major sources of variability and explanations of laboratory quality control procedures employed. Variance-components techniques are used to model the total variability and calculate a maximum percent error that provides an easily understandable measure of laboratory precision accounting for all sources of variability. This avoids ambiguities encountered when reporting an SD that may taken into account only a few of the potential sources of variability. Other proposed uses of the total-variability model include estimating precision of laboratory methods for various replication schemes and developing effective quality control-checking schemes. These procedures are demonstrated with an example of the analysis of alpha-tocopherol in human plasma by using high-performance liquid chromatography.

Baseline Assessment of 25-Hydroxyvitamin D Reference Material and Proficiency Testing/External Quality Assurance Material Commutability: A Vitamin D Standardization Program Study.

PubMed

Phinney, Karen W; Sempos, Christopher T; Tai, Susan S-C; Camara, Johanna E; Wise, Stephen A; Eckfeldt, John H; Hoofnagle, Andrew N; Carter, Graham D; Jones, Julia; Myers, Gary L; Durazo-Arvizu, Ramon; Miller, W Greg; Bachmann, Lorin M; Young, Ian S; Pettit, Juanita; Caldwell, Grahame; Liu, Andrew; Brooks, Stephen P J; Sarafin, Kurtis; Thamm, Michael; Mensink, Gert B M; Busch, Markus; Rabenberg, Martina; Cashman, Kevin D; Kiely, Mairead; Galvin, Karen; Zhang, Joy Y; Kinsella, Michael; Oh, Kyungwon; Lee, Sun-Wha; Jung, Chae L; Cox, Lorna; Goldberg, Gail; Guberg, Kate; Meadows, Sarah; Prentice, Ann; Tian, Lu; Brannon, Patsy M; Lucas, Robyn M; Crump, Peter M; Cavalier, Etienne; Merkel, Joyce; Betz, Joseph M

2017-09-01

The Vitamin D Standardization Program (VDSP) coordinated a study in 2012 to assess the commutability of reference materials and proficiency testing/external quality assurance materials for total 25-hydroxyvitamin D [25(OH)D] in human serum, the primary indicator of vitamin D status. A set of 50 single-donor serum samples as well as 17 reference and proficiency testing/external quality assessment materials were analyzed by participating laboratories that used either immunoassay or LC-MS methods for total 25(OH)D. The commutability test materials included National Institute of Standards and Technology Standard Reference Material 972a Vitamin D Metabolites in Human Serum as well as materials from the College of American Pathologists and the Vitamin D External Quality Assessment Scheme. Study protocols and data analysis procedures were in accordance with Clinical and Laboratory Standards Institute guidelines. The majority of the test materials were found to be commutable with the methods used in this commutability study. These results provide guidance for laboratories needing to choose appropriate reference materials and select proficiency or external quality assessment programs and will serve as a foundation for additional VDSP studies.

Standard operating procedures improve acute neurologic care in a sub-Saharan African setting

PubMed Central

Jaiteh, Lamin E.S.; Helwig, Stefan A.; Jagne, Abubacarr; Ragoschke-Schumm, Andreas; Sarr, Catherine; Walter, Silke; Lesmeister, Martin; Manitz, Matthias; Blaß, Sebastian; Weis, Sarah; Schlund, Verena; Bah, Neneh; Kauffmann, Jil; Fousse, Mathias; Kangankan, Sabina; Ramos Cabrera, Asmell; Kronfeld, Kai; Ruckes, Christian; Liu, Yang; Nyan, Ousman

2017-01-01

Objective: Quality of neurologic emergency management in an under-resourced country may be improved by standard operating procedures (SOPs). Methods: Neurologic SOPs were implemented in a large urban (Banjul) and a small rural (Brikama) hospital in the Gambia. As quality indicators of neurologic emergency management, performance of key procedures was assessed at baseline and in the first and second implementation years. Results: At Banjul, 100 patients of the first-year intervention group exhibited higher rates of general procedures of emergency management than 105 control patients, such as neurologic examination (99.0% vs 91.4%; p < 0.05) and assessments of respiratory rate (98.0% vs 81.9%, p < 0.001), temperature (60.0% vs 36.2%; p < 0.001), and glucose levels (73.0% vs 58.1%; p < 0.05), in addition to written directives by physicians (96.0% vs 88.6%, p < 0.05), whereas assessments of other vital signs remained unchanged. In stroke patients, rates of stroke-related procedures increased: early CT scanning (24.3% vs 9.9%; p < 0.05), blood count (73.0% vs 49.3%; p < 0.01), renal and liver function tests (50.0% vs 5.6%, p < 0.001), aspirin prophylaxis (47.3% vs 9.9%; p < 0.001), and physiotherapy (41.9% vs 4.2%; p < 0.001). Most effects persisted until the second-year evaluation. SOP implementation was similarly feasible and beneficial at the Brikama hospital. However, outcomes did not significantly differ in the hospitals. Conclusions: Implementing SOPs is a realistic, low-cost option for improving process quality of neurologic emergency management in under-resourced settings. Classification of evidence: This study provides Class IV evidence that, for patients with suspected neurologic emergencies in sub-Saharan Africa, neurologic SOPs increase the rate of performance of guideline-recommended procedures. PMID:28600460

Setting and Maintaining GCSE and GCE Grading Standards: The Case for Contextualised Cohort-Referencing

ERIC Educational Resources Information Center

Stringer, Neil Simon

2012-01-01

General Certificate of Secondary Education (GCSE) and General Certificate of Education (GCE) grading standards are determined by Awarding Bodies using procedures that adhere to the Code of Practice published by the regulator, Ofqual. Grade boundary marks (cut scores) are set using subject experts' (senior examiners) judgement of the quality of…

Medical three-dimensional printing opens up new opportunities in cardiology and cardiac surgery.

PubMed

Bartel, Thomas; Rivard, Andrew; Jimenez, Alejandro; Mestres, Carlos A; Müller, Silvana

2018-04-14

Advanced percutaneous and surgical procedures in structural and congenital heart disease require precise pre-procedural planning and continuous quality control. Although current imaging modalities and post-processing software assists with peri-procedural guidance, their capabilities for spatial conceptualization remain limited in two- and three-dimensional representations. In contrast, 3D printing offers not only improved visualization for procedural planning, but provides substantial information on the accuracy of surgical reconstruction and device implantations. Peri-procedural 3D printing has the potential to set standards of quality assurance and individualized healthcare in cardiovascular medicine and surgery. Nowadays, a variety of clinical applications are available showing how accurate 3D computer reformatting and physical 3D printouts of native anatomy, embedded pathology, and implants are and how they may assist in the development of innovative therapies. Accurate imaging of pathology including target region for intervention, its anatomic features and spatial relation to the surrounding structures is critical for selecting optimal approach and evaluation of procedural results. This review describes clinical applications of 3D printing, outlines current limitations, and highlights future implications for quality control, advanced medical education and training.

Consistency Across Standards or Standards in a New Business Model

NASA Technical Reports Server (NTRS)

Russo, Dane M.

2010-01-01

Presentation topics include: standards in a changing business model, the new National Space Policy is driving change, a new paradigm for human spaceflight, consistency across standards, the purpose of standards, danger of over-prescriptive standards, a balance is needed (between prescriptive and general standards), enabling versus inhibiting, characteristics of success-oriented standards, characteristics of success-oriented standards, and conclusions. Additional slides include NASA Procedural Requirements 8705.2B identifies human rating standards and requirements, draft health and medical standards for human rating, what's been done, government oversight models, examples of consistency from anthropometry, examples of inconsistency from air quality and appendices of government and non-governmental human factors standards.

Quality assurance plan for discharge measurements using broadband acoustic Doppler current profilers

USGS Publications Warehouse

Lipscomb, S.W.

1995-01-01

The recent introduction of the Acoustic Doppler Current Profiler (ADCP) as an instrument for measuring velocities and discharge in the riverine and estuarine environment promises to revolutionize the way these data are collected by the U.S. Geological Survey. The ADCP and associated software, however, compose a complex system and should be used only by qualifies personnel. Standard procedures should be rigorously followed to ensure that the quality of data collected is commensurate with the standards set by the Water Resources Division for all its varied activities in hydrologic investigations.

Innovative technology for colostomy irrigation: assessing the impact on patients.

PubMed

Pace, S; Manuini, F; Maculotti, D

2015-10-01

The main purpose of the trial was to evaluate the opinions expressed by a sample of subjects with permanent colostomy, as a result of the use of a new device designed for the execution of transtomal intestinal irrigation; their feedback was analyzed in relation to the concept of Quality of Life. The device was tested on a sample of 14 colostomized patients (10 men and 4 women, aged between 42 and 77 years) who were used to perform intestinal irrigation procedures independently and routinely, with standard technique. After testing the new device, the patients included in the study were asked to fill out a questionnaire built ad hoc for their situation. The analysis of the data collected led to the following conclusions: 93% of the patients described the new irrigation method as simpler than the standard procedure; the majority of the patients assessed bowel emptying as good; 64% of patients reported excellent comfort experienced during the procedure; the presence of a regulator to adjust the instillation speed of water into the intestinal lumen was considered useful to control the flow of the incoming fluid The use of the device guaranteed: psychological tranquility, minimum manual intervention, full achievement of the expected results and decrease in the issues normally encountered with the standard irrigation method. The practical features of the new device ensure easy and straightforward carrying out of the procedure; this ease of use affects the stomized patient's everyday life by reducing the time of procedure completion, thus positively influencing the perception of the patients' Quality of Life.

Gloss uniformity measurement update for ISO/IEC 19751

NASA Astrophysics Data System (ADS)

Ng, Yee S.; Cui, Chengwu; Kuo, Chunghui; Maggard, Eric; Mashtare, Dale; Morris, Peter

2005-01-01

To address the standardization issues of perceptually based image quality for printing systems, ISO/IEC JTC1/SC28, the standardization committee for office equipment chartered the W1.1 project with the responsibility of drafting a proposal for an international standard for the evaluation of printed image quality1. An ISO draft Standard2, ISO/WD 19751-1, Office Equipment - Appearance-based image quality standards for printers - Part 1: Overview, Procedure and Common Methods, 2004 describes the overview of this multi-part appearance-based image quality standard. One of the ISO 19751 multi-part Standard"s tasks is to address the appearance-based gloss and gloss uniformity issues (in ISO 19751-2). This paper summarizes the current status and technical progress since the last two updates3, 4. In particular, we will be discussion our attempt to include 75 degree gloss (G75) objective measurement5 in differential gloss and within-page gloss uniformity. The result for a round-robin experiment involving objective measurement of differential gloss using G60 and G75 gloss measurement geometry is described. The results for two perceptual-based round-robin experiments relating to haze effect on the perception of gloss, and gloss artifacts (gloss streaks/bands, gloss graininess/mottle) are discussed.

Gloss uniformity measurement update for ISO/IEC 19751

NASA Astrophysics Data System (ADS)

Ng, Yee S.; Cui, Chengwu; Kuo, Chunghui; Maggard, Eric; Mashtare, Dale; Morris, Peter

2004-10-01

To address the standardization issues of perceptually based image quality for printing systems, ISO/IEC JTC1/SC28, the standardization committee for office equipment chartered the W1.1 project with the responsibility of drafting a proposal for an international standard for the evaluation of printed image quality1. An ISO draft Standard2, ISO/WD 19751-1, Office Equipment - Appearance-based image quality standards for printers - Part 1: Overview, Procedure and Common Methods, 2004 describes the overview of this multi-part appearance-based image quality standard. One of the ISO 19751 multi-part Standard"s tasks is to address the appearance-based gloss and gloss uniformity issues (in ISO 19751-2). This paper summarizes the current status and technical progress since the last two updates3, 4. In particular, we will be discussion our attempt to include 75 degree gloss (G75) objective measurement5 in differential gloss and within-page gloss uniformity. The result for a round-robin experiment involving objective measurement of differential gloss using G60 and G75 gloss measurement geometry is described. The results for two perceptual-based round-robin experiments relating to haze effect on the perception of gloss, and gloss artifacts (gloss streaks/bands, gloss graininess/mottle) are discussed.

[Quality evaluation of the orthodontic practice for certification by ISO 9001. A procedure beneficial for medical, medico-dental or hospital service].

PubMed

Becker, G

2001-01-01

The accreditation of the ISO 9001 certification (ISO = International Standard Organization) is an external evaluation procedure carried out by independent experts, whose object is the analysis of the operational methods and practices of a medical care facility (e.g. hospital, private clinic, general practitioner's or dentist's practice) which decided to assume the concept, implementation and control of its own quality policy. The whole accreditation procedure represents the basic structure of a continuous dynamic progressiveness within a cabinet eager to offer outstanding quality. Moreover, it guarantees active and voluntary participation of every single member of the medical administration or technical team involved in the realization of this primary objective. In other words, we are talking about a very strong dynamic innovation leading to a change of views and the improvement of communication means, while simultaneously enhancing the security and quality aspects of medical care. The continuous guarantee of high quality medical care calls for precise planning and systematization of actions. First of all, these actions are defined, analyzed and listed in precise work procedures. As they are defined with the agreement of the whole team, they implicate respect and self control. This requires of course transparency of the treatment methods, whose different steps and procedures are described in detail in a logogramm set up in common.

Water quality bioassay using selected protozoa. I. [Paramecium candatum; Amoeba proteus; Euglena gracilis

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

Mills, W.L.

1976-01-01

The suitability of certain species of protozoa as indicators of water quality has been determined. Experiments were conducted under laboratory conditions to standardize a bioassay procedure for water quality using either Paramecium caudatum, Amoeba proteus, or Euglena gracilis as the indicator organism. The bioassay, which consists of exposing the organisms to a known concentration of pollutant under laboratory conditions, followed by microscopic observation to establish the time of death, affords a reliable, convenient and inexpensive way to monitor for water quality.

Solving the Problem: Genome Annotation Standards before the Data Deluge.

PubMed

Klimke, William; O'Donovan, Claire; White, Owen; Brister, J Rodney; Clark, Karen; Fedorov, Boris; Mizrachi, Ilene; Pruitt, Kim D; Tatusova, Tatiana

2011-10-15

The promise of genome sequencing was that the vast undiscovered country would be mapped out by comparison of the multitude of sequences available and would aid researchers in deciphering the role of each gene in every organism. Researchers recognize that there is a need for high quality data. However, different annotation procedures, numerous databases, and a diminishing percentage of experimentally determined gene functions have resulted in a spectrum of annotation quality. NCBI in collaboration with sequencing centers, archival databases, and researchers, has developed the first international annotation standards, a fundamental step in ensuring that high quality complete prokaryotic genomes are available as gold standard references. Highlights include the development of annotation assessment tools, community acceptance of protein naming standards, comparison of annotation resources to provide consistent annotation, and improved tracking of the evidence used to generate a particular annotation. The development of a set of minimal standards, including the requirement for annotated complete prokaryotic genomes to contain a full set of ribosomal RNAs, transfer RNAs, and proteins encoding core conserved functions, is an historic milestone. The use of these standards in existing genomes and future submissions will increase the quality of databases, enabling researchers to make accurate biological discoveries.

Solving the Problem: Genome Annotation Standards before the Data Deluge

PubMed Central

Klimke, William; O'Donovan, Claire; White, Owen; Brister, J. Rodney; Clark, Karen; Fedorov, Boris; Mizrachi, Ilene; Pruitt, Kim D.; Tatusova, Tatiana

2011-01-01

The promise of genome sequencing was that the vast undiscovered country would be mapped out by comparison of the multitude of sequences available and would aid researchers in deciphering the role of each gene in every organism. Researchers recognize that there is a need for high quality data. However, different annotation procedures, numerous databases, and a diminishing percentage of experimentally determined gene functions have resulted in a spectrum of annotation quality. NCBI in collaboration with sequencing centers, archival databases, and researchers, has developed the first international annotation standards, a fundamental step in ensuring that high quality complete prokaryotic genomes are available as gold standard references. Highlights include the development of annotation assessment tools, community acceptance of protein naming standards, comparison of annotation resources to provide consistent annotation, and improved tracking of the evidence used to generate a particular annotation. The development of a set of minimal standards, including the requirement for annotated complete prokaryotic genomes to contain a full set of ribosomal RNAs, transfer RNAs, and proteins encoding core conserved functions, is an historic milestone. The use of these standards in existing genomes and future submissions will increase the quality of databases, enabling researchers to make accurate biological discoveries. PMID:22180819

ISO9000 and the quality management system in the digital hospital.

PubMed

Liu, Yalan; Yao, Bin; Zhang, Zigang

2002-01-01

ISO9000 quality management system (ISO9000QMS) emphasize on the customer-oriented, managers' leadership and all staff's joining, adopt the process method and system management, spread the taking facts as a basis to make decision and improve consistently, and establish win-win relation with the suppliers. So, the digital hospital can adopt the ISO9000QMS. In order to establish the ISO9000QMS, the digital hospital should: (1) Design integrally, including analyzing the operation procedure, clarifying the job duties, setting up the spreading team and setting the quality policy and objectives: (2) Learning the ISO9000 quality standards; (3) Drawing up the documents, including the quality manual, program files and operation guiding files; (4) Training according the documents; (5) Executing the quality standard, including the service quality auditing, quality record auditing and quality system auditing; (6) Improving continually. With the establishment of ISO900QMS, the digital hospital can appraise more accurately, analyze quality matters statistically and avoid the interference of artificial factors.

Deriving Chesapeake Bay Water Quality Standards

USGS Publications Warehouse

Tango, Peter J.; Batiuk, Richard A.

2013-01-01

Achieving and maintaining the water quality conditions necessary to protect the aquatic living resources of the Chesapeake Bay and its tidal tributaries has required a foundation of quantifiable water quality criteria. Quantitative criteria serve as a critical basis for assessing the attainment of designated uses and measuring progress toward meeting water quality goals of the Chesapeake Bay Program partnership. In 1987, the Chesapeake Bay Program partnership committed to defining the water quality conditions necessary to protect aquatic living resources. Under section 303(c) of the Clean Water Act, States and authorized tribes have the primary responsibility for adopting water quality standards into law or regulation. The Chesapeake Bay Program partnership worked with U.S. Environmental Protection Agency to develop and publish a guidance framework of ambient water quality criteria with designated uses and assessment procedures for dissolved oxygen, water clarity, and chlorophyll a for Chesapeake Bay and its tidal tributaries in 2003. This article reviews the derivation of the water quality criteria, criteria assessment protocols, designated use boundaries, and their refinements published in six addendum documents since 2003 and successfully adopted into each jurisdiction's water quality standards used in developing the Chesapeake Bay Total Maximum Daily Load.

Headspace screening: A novel approach for fast quality assessment of the essential oil from culinary sage.

PubMed

Cvetkovikj, Ivana; Stefkov, Gjoshe; Acevska, Jelena; Karapandzova, Marija; Dimitrovska, Aneta; Kulevanova, Svetlana

2016-07-01

Quality assessment of essential oil (EO) from culinary sage (Salvia officinalis L., Lamiaceae) is limited by the long pharmacopoeial procedure. The aim of this study was to employ headspace (HS) sampling in the quality assessment of sage EO. Different populations (30) of culinary sage were assessed using GC/FID/MS analysis of the hydrodistilled EO (pharmacopoeial method) and HS sampling directly from leaves. Compound profiles from both procedures were evaluated according to ISO 9909 and GDC standards for sage EO quality, revealing compliance for only 10 populations. Factors to convert HS values, for the target ISO and GDC components, into theoretical EO values were calculated. Statistical analysis revealed a significant relationship between HS and EO values for seven target components. Consequently, HS sampling could be used as a complementary extraction technique for rapid screening in quality assessment of sage EOs. Copyright © 2016 Elsevier Ltd. All rights reserved.

Real Time Quality Control Methods for Cued EMI Data Collection

DTIC Science & Technology

2016-03-14

contents be construed as reflecting the official policy or position of the Department of Defense. Reference herein to any specific commercial product...This project evaluated the effectiveness of in-field quality control (QC) procedures during cued electromagnetic induction (EMI) data collection. The...electromagnetic induction ESTCP Environmental Security Technology Certification Program hr hour ISO Industry Standard Object IVS Instrument

Development and Exchange of Instructional Resources in Water Quality Control Programs, IV: Selecting Instructional Media and Instructional Systems.

ERIC Educational Resources Information Center

Durham, W. Harry; And Others

This document is one of a series of reports which reviews instructional materials and equipment for water and wastewater treatment plant personnel. A system is presented to assist in standardizing the production of lesson plans and instructional materials in the water quality control field. A procedure for selecting appropriate instructional media…

Standardizing lightweight deflectometer modulus measurements for compaction quality assurance : research summary.

DOT National Transportation Integrated Search

2017-09-01

The mechanistic-empirical pavement design method requires the elastic resilient modulus as the key input for characterization of geomaterials. Current density-based QA procedures do not measure resilient modulus. Additionally, the density-based metho...

Development of the Global Measles Laboratory Network.

PubMed

Featherstone, David; Brown, David; Sanders, Ray

2003-05-15

The routine reporting of suspected measles cases and laboratory testing of samples from these cases is the backbone of measles surveillance. The Global Measles Laboratory Network (GMLN) has developed standards for laboratory confirmation of measles and provides training resources for staff of network laboratories, reference materials and expertise for the development and quality control of testing procedures, and accurate information for the Measles Mortality Reduction and Regional Elimination Initiative. The GMLN was developed along the lines of the successful Global Polio Laboratory Network, and much of the polio laboratory infrastructure was utilized for measles. The GMLN has developed as countries focus on measles control activities following successful eradication of polio. Currently more than 100 laboratories are part of the global network and follow standardized testing and reporting procedures. A comprehensive laboratory accreditation process will be introduced in 2002 with six quality assurance and performance indicators.

Performance characterization of structured light-based fingerprint scanner

NASA Astrophysics Data System (ADS)

Hassebrook, Laurence G.; Wang, Minghao; Daley, Raymond C.

2013-05-01

Our group believes that the evolution of fingerprint capture technology is in transition to include 3-D non-contact fingerprint capture. More specifically we believe that systems based on structured light illumination provide the highest level of depth measurement accuracy. However, for these new technologies to be fully accepted by the biometric community, they must be compliant with federal standards of performance. At present these standards do not exist for this new biometric technology. We propose and define a set of test procedures to be used to verify compliance with the Federal Bureau of Investigation's image quality specification for Personal Identity Verification single fingerprint capture devices. The proposed test procedures include: geometric accuracy, lateral resolution based on intensity or depth, gray level uniformity and flattened fingerprint image quality. Several 2-D contact analogies, performance tradeoffs and optimization dilemmas are evaluated and proposed solutions are presented.

Quality Control Practices for Chemistry and Immunochemistry in a Cohort of 21 Large Academic Medical Centers.

PubMed

Rosenbaum, Matthew W; Flood, James G; Melanson, Stacy E F; Baumann, Nikola A; Marzinke, Mark A; Rai, Alex J; Hayden, Joshua; Wu, Alan H B; Ladror, Megan; Lifshitz, Mark S; Scott, Mitchell G; Peck-Palmer, Octavia M; Bowen, Raffick; Babic, Nikolina; Sobhani, Kimia; Giacherio, Donald; Bocsi, Gregary T; Herman, Daniel S; Wang, Ping; Toffaletti, John; Handel, Elizabeth; Kelly, Kathleen A; Albeiroti, Sami; Wang, Sihe; Zimmer, Melissa; Driver, Brandon; Yi, Xin; Wilburn, Clayton; Lewandrowski, Kent B

2018-05-29

In the United States, minimum standards for quality control (QC) are specified in federal law under the Clinical Laboratory Improvement Amendment and its revisions. Beyond meeting this required standard, laboratories have flexibility to determine their overall QC program. We surveyed chemistry and immunochemistry QC procedures at 21 clinical laboratories within leading academic medical centers to assess if standardized QC practices exist for chemistry and immunochemistry testing. We observed significant variation and unexpected similarities in practice across laboratories, including QC frequency, cutoffs, number of levels analyzed, and other features. This variation in practice indicates an opportunity exists to establish an evidence-based approach to QC that can be generalized across institutions.

Reproducibility in light microscopy: Maintenance, standards and SOPs.

PubMed

Deagle, Rebecca C; Wee, Tse-Luen Erika; Brown, Claire M

2017-08-01

Light microscopy has grown to be a valuable asset in both the physical and life sciences. It is a highly quantitative method available in individual research laboratories and often centralized in core facilities. However, although quantitative microscopy is becoming a customary tool in research, it is rarely standardized. To achieve accurate quantitative microscopy data and reproducible results, three levels of standardization must be considered: (1) aspects of the microscope, (2) the sample, and (3) the detector. The accuracy of the data is only as reliable as the imaging system itself, thereby imposing the need for routine standard performance testing. Depending on the task some maintenance procedures should be performed once a month, some before each imaging session, while others conducted annually. This text should be implemented as a resource for researchers to integrate with their own standard operating procedures to ensure the highest quality quantitative microscopy data. Copyright © 2017. Published by Elsevier Ltd.

A Strategy to Establish a Quality Assurance/Quality Control Plan for the Application of Biosensors for the Detection of E. coli in Water.

PubMed

Hesari, Nikou; Kıratlı Yılmazçoban, Nursel; Elzein, Mohamad; Alum, Absar; Abbaszadegan, Morteza

2017-01-03

Rapid bacterial detection using biosensors is a novel approach for microbiological testing applications. Validation of such methods is an obstacle in the adoption of new bio-sensing technologies for water testing. Therefore, establishing a quality assurance and quality control (QA/QC) plan is essential to demonstrate accuracy and reliability of the biosensor method for the detection of E. coli in drinking water samples. In this study, different reagents and assay conditions including temperatures, holding time, E. coli strains and concentrations, dissolving agents, salinity and pH effects, quality of substrates of various suppliers of 4-methylumbelliferyl glucuronide (MUG), and environmental water samples were included in the QA/QC plan and used in the assay optimization and documentation. Furthermore, the procedural QA/QC for the monitoring of drinking water samples was established to validate the performance of the biosensor platform for the detection of E. coli using a culture-based standard technique. Implementing the developed QA/QC plan, the same level of precision and accuracy was achieved using both the standard and the biosensor methods. The established procedural QA/QC for the biosensor will provide a reliable tool for a near real-time monitoring of E. coli in drinking water samples to both industry and regulatory authorities.

A Strategy to Establish a Quality Assurance/Quality Control Plan for the Application of Biosensors for the Detection of E. coli in Water

PubMed Central

Hesari, Nikou; Kıratlı Yılmazçoban, Nursel; Elzein, Mohamad; Alum, Absar; Abbaszadegan, Morteza

2017-01-01

Rapid bacterial detection using biosensors is a novel approach for microbiological testing applications. Validation of such methods is an obstacle in the adoption of new bio-sensing technologies for water testing. Therefore, establishing a quality assurance and quality control (QA/QC) plan is essential to demonstrate accuracy and reliability of the biosensor method for the detection of E. coli in drinking water samples. In this study, different reagents and assay conditions including temperatures, holding time, E. coli strains and concentrations, dissolving agents, salinity and pH effects, quality of substrates of various suppliers of 4-methylumbelliferyl glucuronide (MUG), and environmental water samples were included in the QA/QC plan and used in the assay optimization and documentation. Furthermore, the procedural QA/QC for the monitoring of drinking water samples was established to validate the performance of the biosensor platform for the detection of E. coli using a culture-based standard technique. Implementing the developed QA/QC plan, the same level of precision and accuracy was achieved using both the standard and the biosensor methods. The established procedural QA/QC for the biosensor will provide a reliable tool for a near real-time monitoring of E. coli in drinking water samples to both industry and regulatory authorities. PMID:28054956

[Description of the ISO 9001/2000 certification process in the parenteral nutrition area].

PubMed

Miana Mena, M T; Fontanals Martínez, S; López Púa, Y; López Suñé, E; Codina Jané, C; Ribas Sala, J

2007-01-01

In order to guarantee quality and safety and to increase user satisfaction, healthcare organisations have integrated quality management systems into their structures. This study describes the process for introducing the UNE-EN-ISO-9001/2000 standard in the parenteral nutrition area. A multidisciplinary group established the scope of the standard, focusing on transcription, preparation, dispensation and microbiological control. A detailed procedure describing the sequences of circuits and associated activities, the responsible staff and the action guidelines to be followed was established. Quality and activity markers were also established. This process has enabled a standard system to be implemented, with its operation perfectly described and documented, allowing its stages to be traceable and supervised. As there is no record of the data obtained beforehand, no direct comparison can be made; its evolution must therefore be analysed in the future.

IMPORTANCE OF INTEGRATED MANAGEMENT SYSTEM APPLIED IN HEALTH ESTABLISHMENTS IN ORDER TO RAISE TREATMENT QUALITY.

PubMed

Dodić, Biljana; Miljković, Tatjana; Bjelobrk, Marija; Cemerlic Ađić, Nada; Ađić, Filip; Dodić, Slobodan

2016-01-01

The term "management" is best characterized as "managing" economic or social processes to achieve objectives through a rational use of material and immaterial resources by applying the principles, functions, and management methods. This study has been aimed at evaluating the value of an integrated quality management system implemented at the Institute of Cardiovascular Diseases of Vojvodina to improve the quality of treatment. In the period from 2008 to 2010 about 40 employees from the Institute of Cardiovascular Diseases of Vojvodina attended various courses given by the lecturers of the Faculty of Technical Sciences, where the function and significance of the "International Standards Organization" were explained, after which standards of interest were implemented at the Institute of Cardiovascular Diseases of Vojvodina. The Department of Cardiology has introduced 11 cardiac procedures with 5 special instructions, 14 general procedures, and 7 specific procedures with 2 instructions. The Department of Cardiac Surgery has introduced 7 procedures to be implemented. The "Vojvodina score" model was put into practice for the perioperative evaluation of cardiac surgery risk. During 2014, the Institute of Cardiovascular Diseases ofVojvodina obtained accreditation for the period of 7 years. The integrated quality management system must be applied in order to achieve a high level of health care in the shortest possible time and with the least possible consumption of material and human resources. The application of this system in practice gives a realistic insight into the working processes and facilitates their functioning. It demands and requires constant monitoring of the system efficiency along with continuous changes and improvements of all elements of the working processes and functional units.

[Method for the quality assessment of data collection processes in epidemiological studies].

PubMed

Schöne, G; Damerow, S; Hölling, H; Houben, R; Gabrys, L

2017-10-01

For a quantitative evaluation of primary data collection processes in epidemiological surveys based on accompaniments and observations (in the field), there is no description of test criteria and methodologies in relevant literature and thus no known application in practice. Therefore, methods need to be developed and existing procedures adapted. The aim was to identify quality-relevant developments within quality dimensions by means of inspection points (quality indicators) during the process of data collection. As a result we seek to implement and establish a methodology for the assessment of overall survey quality supplementary to standardized data analyses. Monitors detect deviations from standard primary data collection during site visits by applying standardized checklists. Quantitative results - overall and for each dimension - are obtained by numerical calculation of quality indicators. Score results are categorized and color coded. This visual prioritization indicates necessity for intervention. The results obtained give clues regarding the current quality of data collection. This allows for the identification of such sections where interventions for quality improvement are needed. In addition, process quality development can be shown over time on an intercomparable basis. This methodology for the evaluation of data collection quality can identify deviations from norms, focalize quality analyses and help trace causes for significant deviations.

Sampling protocol for post-landfall Deepwater Horizon oil release, Gulf of Mexico, 2010

USGS Publications Warehouse

Wilde, F.D.; Skrobialowski, S.C.; Hart, J.S.

2010-01-01

The protocols and procedures described in this report are designed to be used by U.S. Geological Survey (USGS) field teams for the collection of environmental data and samples in coastal areas affected by the 2010 Deepwater Horizon oil spill in the Gulf of Mexico. This sampling protocol focuses specifically on sampling for water, sediments, benthic invertebrates, and microorganisms (ambient bacterial populations) after shoreline arrival of petroleum-associated product on beach, barrier island, and wetland environments of the Gulf of Mexico coastal states. Deployment to sampling sites, site setup, and sample collection in these environments necessitates modifications to standard USGS sampling procedures in order to address the regulatory, logistical, and legal requirements associated with samples collected in oil-impacted coastal areas. This document, therefore, has been written as an addendum to the USGS National Field Manual for the Collection of Water-Quality Data (NFM) (http://pubs.water.usgs.gov/twri9A/), which provides the basis for training personnel in the use of standard USGS sampling protocols. The topics covered in this Gulf of Mexico oil-spill sampling protocol augment NFM protocols for field-deployment preparations, health and safety precautions, sampling and quality-assurance procedures, and decontamination requirements under potentially hazardous environmental conditions. Documentation procedures and maintenance of sample integrity by use of chain-of-custody procedures also are described in this protocol.

Minilaparoscopic versus standard laparoscopic hysterectomy for uteri ≥ 16 weeks of gestation: surgical outcomes, postoperative quality of life, and cosmesis.

PubMed

Uccella, Stefano; Cromi, Antonella; Casarin, Jvan; Bogani, Giorgio; Serati, Maurizio; Gisone, Baldo; Pinelli, Ciro; Fasola, Maddalena; Ghezzi, Fabio

2015-05-01

Hysterectomy for enlarged uteri is a surgical challenge. Our aim was to compare perioperative outcomes, cosmesis, and postoperative quality of life following laparoscopic hysterectomy for large uteri using minilaparoscopic 3-mm versus conventional laparoscopic 5-mm instruments. We prospectively enrolled women with a uterus between 16 and 20 weeks of gestation at the preoperative examination. These patients underwent laparoscopic procedures using either 3-mm (minilaparoscopy group) or 5-mm (standard laparoscopy group) instruments. Five months after surgery, patients were called back to fill out the validated Italian translation of the Short Form 12-item Health Survey. Data about the cosmetic outcome of the procedure were also collected, using a Numeric Rating Scale (NRS) from 0 to 10. Seventy-eight women were included (27 in the 3-mm and 51 in the 5-mm groups). Perioperative characteristics were comparable between groups. The median uterus weight was 575 (range, 440-1050) g and 550 (400-1000) g in the 3-mm and 5-mm groups, respectively. No minilaparoscopic procedure was converted to standard 5-mm or to an open approach. One (2%) conversion to open abdominal surgery was needed in the conventional laparoscopy group. A better subjective cosmetic outcome was found in the 3-mm (NRS, 9.7 ± 0.4) versus the 5-mm (NRS, 8.9 ± 1.2) group (P=.01). Postoperative quality of life was comparable between groups. Minilaparoscopic hysterectomy is feasible, even in the case of an enlarged-size uterus. Moreover, it is associated with a better cosmetic outcome, compared with conventional laparoscopy.

The Development of Quality Measures for the Performance and Interpretation of Esophageal Manometry

PubMed Central

Yadlapati, Rena; Gawron, Andrew J.; Keswani, Rajesh N.; Bilimoria, Karl; Castell, Donald O.; Dunbar, Kerry B.; Gyawali, Chandra P.; Jobe, Blair A.; Katz, Philip O.; Katzka, David A.; Lacy, Brian E.; Massey, Benson T.; Richter, Joel E.; Schnoll-Sussman, Felice; Spechler, Stuart J.; Tatum, Roger; Vela, Marcelo F.; Pandolfino, John E.

2016-01-01

Background and Aims Esophageal manometry (EM) is the gold standard for the diagnosis of esophageal motility disorders. Variations in the performance and interpretation of EM result in discrepant diagnoses and unnecessary repeated procedures, and may negatively impact patient outcomes. A method to benchmark the procedural quality of EM is needed. The primary aim of this study was to develop quality measures for performing and interpreting EM. Methods The RAND/University of California, Los Angeles Appropriateness Methodology (RAM) was utilized. Fifteen experts in esophageal manometry were invited to be a part of the panel. Potential quality measures were identified through a literature search and interviews with experts. The expert panel ranked the proposed quality measures for appropriateness via a two-round process on the basis of RAM. Results Fourteen experts participated in all processes. A total of 29 measures were considered; 17 of these measures were ranked as appropriate and related to competency (2), pre-procedure (2), procedure (3) and interpretation (10). The latter 10 were integrated into a single composite measure. Thus, 8 final measures were determined to be appropriate quality measures for EM. Five strong recommendations were also endorsed by the experts, however they were not ranked as appropriate quality measures. Conclusions Eight formally validated quality measures for the performance and interpretation of EM were developed on the basis of RAM. These measures represent key aspects of a high-quality EM study and should be uniformly adopted. Evaluation of these measures in clinical practice is needed to assess their impact on outcomes. PMID:26499925

Scientific Framework for Stormwater Monitoring by the Washington State Department of Transportation

USGS Publications Warehouse

Sheibley, R.W.; Kelly, V.J.; Wagner, R.J.

2009-01-01

The Washington State Department of Transportation municipal stormwater monitoring program, in operation for about 8 years, never has received an external, objective assessment. In addition, the Washington State Department of Transportation would like to identify the standard operating procedures and quality assurance protocols that must be adopted so that their monitoring program will meet the requirements of the new National Pollutant Discharge Elimination System municipal stormwater permit. As a result, in March 2009, the Washington State Department of Transportation asked the U.S. Geological Survey to assess their pre-2009 municipal stormwater monitoring program. This report presents guidelines developed for the Washington State Department of Transportation to meet new permit requirements and regional/national stormwater monitoring standards to ensure that adequate processes and procedures are identified to collect high-quality, scientifically defensible municipal stormwater monitoring data. These include: (1) development of coherent vision and cooperation among all elements of the program; (2) a comprehensive approach for site selection; (3) an effective quality assurance program for field, laboratory, and data management; and (4) an adequate database and data management system.

High-Penetration Photovoltaic Planning Methodologies

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

Gao, David Wenzhong; Muljadi, Eduard; Tian, Tian

The main objective of this report is to provide an overview of select U.S. utility methodologies for performing high-penetration photovoltaic (HPPV) system planning and impact studies. This report covers the Federal Energy Regulatory Commission's orders related to photovoltaic (PV) power system interconnection, particularly the interconnection processes for the Large Generation Interconnection Procedures and Small Generation Interconnection Procedures. In addition, it includes U.S. state interconnection standards and procedures. The procedures used by these regulatory bodies consider the impacts of HPPV power plants on the networks. Technical interconnection requirements for HPPV voltage regulation include aspects of power monitoring, grounding, synchronization, connection tomore » the overall distribution system, back-feeds, disconnecting means, abnormal operating conditions, and power quality. This report provides a summary of mitigation strategies to minimize the impact of HPPV. Recommendations and revisions to the standards may take place as the penetration level of renewables on the grid increases and new technologies develop in future years.« less

76 FR 43153 - Approval and Promulgation of Air Quality Implementation Plan; New Jersey and New York; Final...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

... the SIP. Accordingly, it affords no opportunity for EPA to fashion for small entities less burdensome... procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies...

76 FR 55842 - Partial Approval and Partial Disapproval of Air Quality Implementation Plans; California; San...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

... sometimes approves a rule only as a SIP strengthening action (e.g., to update definitions, add test methods... standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that...

7 CFR 58.437 - Salt.

Code of Federal Regulations, 2012 CFR

2012-01-01

... SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Quality Specifications for Raw Material § 58... requirements of the Food Chemical Codex. Operations and Operating Procedures ...

7 CFR 58.437 - Salt.

Code of Federal Regulations, 2013 CFR

2013-01-01

... SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Quality Specifications for Raw Material § 58... requirements of the Food Chemical Codex. Operations and Operating Procedures ...

7 CFR 58.437 - Salt.

Code of Federal Regulations, 2011 CFR

2011-01-01

... SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Quality Specifications for Raw Material § 58... requirements of the Food Chemical Codex. Operations and Operating Procedures ...

7 CFR 58.437 - Salt.

Code of Federal Regulations, 2014 CFR

2014-01-01

... SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Quality Specifications for Raw Material § 58... requirements of the Food Chemical Codex. Operations and Operating Procedures ...

Six sigma tools for a patient safety-oriented, quality-checklist driven radiation medicine department.

PubMed

Kapur, Ajay; Potters, Louis

2012-01-01

The purpose of this work was to develop and implement six sigma practices toward the enhancement of patient safety in an electronic, quality checklist-driven, multicenter, paperless radiation medicine department. A quality checklist process map (QPM), stratified into consultation through treatment-completion stages was incorporated into an oncology information systems platform. A cross-functional quality management team conducted quality-function-deployment and define-measure-analyze-improve-control (DMAIC) six sigma exercises with a focus on patient safety. QPM procedures were Pareto-sorted in order of decreasing patient safety risk with failure mode and effects analysis (FMEA). Quantitative metrics for a grouped set of highest risk procedures were established. These included procedural delays, associated standard deviations and six sigma Z scores. Baseline performance of the QPM was established over the previous year of usage. Data-driven analysis led to simplification, standardization, and refinement of the QPM with standard deviation, slip-day reduction, and Z-score enhancement goals. A no-fly policy (NFP) for patient safety was introduced at the improve-control DMAIC phase, with a process map interlock imposed on treatment initiation in the event of FMEA-identified high-risk tasks being delayed or not completed. The NFP was introduced in a pilot phase with specific stopping rules and the same metrics used for performance assessments. A custom root-cause analysis database was deployed to monitor patient safety events. Relative to the baseline period, average slip days and standard deviations for the risk-enhanced QPM procedures improved by over threefold factors in the NFP period. The Z scores improved by approximately 20%. A trend for proactive delays instead of reactive hard stops was observed with no adverse effects of the NFP. The number of computed potential no-fly delays per month dropped from 60 to 20 over a total of 520 cases. The fraction of computed potential no-fly cases that were delayed in NFP compliance rose from 28% to 45%. Proactive delays rose to 80% of all delayed cases. For potential no-fly cases, event reporting rose from 18% to 50%, while for actually delayed cases, event reporting rose from 65% to 100%. With complex technologies, resource-compromised staff, and pressures to hasten treatment initiation, the use of the six sigma driven process interlocks may mitigate potential patient safety risks as demonstrated in this study. Copyright © 2012 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Assessment in Education: A Case for Quality and Standards within the Context of Open and Distance Education--A Case Study of One Zimbabwean University

ERIC Educational Resources Information Center

Samkange, Wellington

2012-01-01

A study was carried out to assess the assessment procedures used at one Open and Distance Learning (ODL) institution in Zimbabwe. The study focused on the views and perceptions of current and former students of the university. The study also analyzed some documents on assessment procedures at the university. The study used the qualitative…

Issues concerning international comparison of free-field calibrations of acoustical standards

NASA Astrophysics Data System (ADS)

Nedzelnitsky, Victor

2002-11-01

Primary free-field calibrations of laboratory standard microphones by the reciprocity method establish these microphones as reference standard devices for calibrating working standard microphones, other measuring microphones, and practical instruments such as sound level meters and personal sound exposure meters (noise dosimeters). These primary, secondary, and other calibrations are indispensable to the support of regulatory requirements, standards, and product characterization and quality control procedures important for industry, commerce, health, and safety. International Electrotechnical Commission (IEC) Technical Committee 29 Electroacoustics produces international documentary standards, including standards for primary and secondary free-field calibration and measurement procedures and their critically important application to practical instruments. This paper addresses some issues concerning calibrations, standards activities, and the international key comparison of primary free-field calibrations of IEC-type LS2 laboratory standard microphones that is being planned by the Consultative Committee for Acoustics, Ultrasound, and Vibration (CCAUV) of the International Committee for Weights and Measures (CIPM). This comparison will include free-field calibrations by the reciprocity method at participating major national metrology laboratories throughout the world.

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

NASA Astrophysics Data System (ADS)

Willett, D. J.

1993-04-01

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

A Situative Metaphor for Teacher Learning: The Case of University Tutors Learning to Grade Student Coursework

ERIC Educational Resources Information Center

Boyd, Pete; Bloxham, Sue

2014-01-01

In the continuing concern about academic standards in the higher education sector a great deal of emphasis has been placed on quality assurance procedures rather than on considering how university tutors learn to grade the quality of work produced by students. As part of a larger research project focused on how tutors grade student coursework,…

Update on Standard Operating Procedures in Preclinical Research for DMD and SMA Report of TREAT-NMD Alliance Workshop, Schiphol Airport, 26 April 2015, The Netherlands.

PubMed

van Putten, Maaike; Aartsma-Rus, Annemieke; Grounds, Miranda D; Kornegay, Joe N; Mayhew, Anna; Gillingwater, Thomas H; Takeda, Shin'ichi; Rüegg, Markus A; De Luca, Annamaria; Nagaraju, Kanneboyina; Willmann, Raffaella

A workshop took place in 2015 to follow up TREAT-NMD activities dedicated to improving quality in the preclinical phase of drug development for neuromuscular diseases. In particular, this workshop adressed necessary future steps regarding common standard experimental protocols and the issue of improving the translatability of preclinical efficacy studies.

User's guide to FBASE: Relational database software for managing R1/R4 (Northern/Intermountain Regions) fish habitat inventory data

Treesearch

Sherry P. Wollrab

1999-01-01

FBASE is a microcomputer relational database package that handles data collected using the R1/R4 Fish and Fish Habitat Standard Inventory Procedures (Overton and others 1997). FBASE contains standard data entry screens, data validations for quality control, data maintenance features, and summary report options. This program also prepares data for importation into an...

Category 1 external quality assessment program for serum creatinine.

PubMed

González-Lao, Elisabet; Díaz-Garzón, Jorge; Corte, Zoraida; Ricós, Carmen; Perich, Carmen; Álvarez, Virtudes; Simón, Margarita; Minchinela, Joana; García-Lario, José Vicente; Boned, Beatriz; Biosca, Carmen; Cava, Fernando; Fernández-Fernández, Pilar; Fernández-Calle, Pilar

2017-03-01

The Commission of Analytical Quality and the Committee of External Quality Programs of Spanish Society of Laboratory Medicine (SEQC) in collaboration with the Dutch Foundation for the Quality organized the first national category 1 External Quality Assessment Programs (EQAP) pilot study. The aim is to evaluate the standardization of serum creatinine measurements in the Spanish laboratories through a category 1 external quality assurance program with commutable material and reference method assigned values. A total of 87 Spanish laboratories were involved in this program in 2015. Each day a sample control was measured by duplicate during 6 consecutive days. Percentage deviations and coefficients of variation obtained were compared with quality specifications derived from biological variation. A total of 1044 creatinine results were obtained. Laboratories were coded in 11 different method-traceability combinations. Only enzymatic methods get all results within the acceptability limits. To participate in a category 1 EQAP is a valuable tool to assess the standardization degree in our country; a big effort should be made to promote laboratories to change their procedures and to use enzymatic creatinine methods, in order to achieve a satisfactory standardization degree for this important analyte.

Quality assessment in head and neck oncologic surgery in a Brazilian cancer center compared with MD Anderson Cancer Center benchmarks.

PubMed

Lira, Renan Bezerra; de Carvalho, André Ywata; de Carvalho, Genival Barbosa; Lewis, Carol M; Weber, Randal S; Kowalski, Luiz Paulo

2016-07-01

Quality assessment is a major tool for evaluation of health care delivery. In head and neck surgery, the University of Texas MD Anderson Cancer Center (MD Anderson) has defined quality standards by publishing benchmarks. We conducted an analysis of 360 head and neck surgeries performed at the AC Camargo Cancer Center (AC Camargo). The procedures were stratified into low-acuity procedures (LAPs) or high-acuity procedures (HAPs) and outcome indicators where compared to MD Anderson benchmarks. In the 360 cases, there were 332 LAPs (92.2%) and 28 HAPs (7.8%). Patients with any comorbid condition had a higher incidence of negative outcome indicators (p = .005). In the LAPs, we achieved the MD Anderson benchmarks in all outcome indicators. In HAPs, the rate of surgical site infection and length of hospital stay were higher than what is established by the benchmarks. Quality assessment of head and neck surgery is possible and should be disseminated, improving effectiveness in health care delivery. © 2015 Wiley Periodicals, Inc. Head Neck 38: 1002-1007, 2016. © 2015 Wiley Periodicals, Inc.

The CRAC cohort model: A computerized low cost registry of interventional cardiology with daily update and long-term follow-up.

PubMed

Rangé, G; Chassaing, S; Marcollet, P; Saint-Étienne, C; Dequenne, P; Goralski, M; Bardiére, P; Beverilli, F; Godillon, L; Sabine, B; Laure, C; Gautier, S; Hakim, R; Albert, F; Angoulvant, D; Grammatico-Guillon, L

2018-05-01

To assess the reliability and low cost of a computerized interventional cardiology (IC) registry to prospectively and systematically collect high-quality data for all consecutive coronary patients referred for coronary angiogram or/and coronary angioplasty. Rigorous clinical practice assessment is a key factor to improve prognosis in IC. A prospective and permanent registry could achieve this goal but, presumably, at high cost and low level of data quality. One multicentric IC registry (CRAC registry), fully integrated to usual coronary activity report software, started in the centre Val-de-Loire (CVL) French region in 2014. Quality assessment of CRAC registry was conducted on five IC CathLab of the CVL region, from January 1st to December 31st 2014. Quality of collected data was evaluated by measuring procedure exhaustivity (comparing with data from hospital information system), data completeness (quality controls) and data consistency (by checking complete medical charts as gold standard). Cost per procedure (global registry operating cost/number of collected procedures) was also estimated. CRAC model provided a high-quality level with 98.2% procedure completeness, 99.6% data completeness and 89% data consistency. The operating cost per procedure was €14.70 ($16.51) for data collection and quality control, including ST-segment elevation myocardial infarction (STEMI) preadmission information and one-year follow-up after angioplasty. This integrated computerized IC registry led to the construction of an exhaustive, reliable and costless database, including all coronary patients entering in participating IC centers in the CVL region. This solution will be developed in other French regions, setting up a national IC database for coronary patients in 2020: France PCI. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Automating PACS quality control with the Vanderbilt image processing enterprise resource

NASA Astrophysics Data System (ADS)

Esparza, Michael L.; Welch, E. Brian; Landman, Bennett A.

2012-02-01

Precise image acquisition is an integral part of modern patient care and medical imaging research. Periodic quality control using standardized protocols and phantoms ensures that scanners are operating according to specifications, yet such procedures do not ensure that individual datasets are free from corruption; for example due to patient motion, transient interference, or physiological variability. If unacceptable artifacts are noticed during scanning, a technologist can repeat a procedure. Yet, substantial delays may be incurred if a problematic scan is not noticed until a radiologist reads the scans or an automated algorithm fails. Given scores of slices in typical three-dimensional scans and widevariety of potential use cases, a technologist cannot practically be expected inspect all images. In large-scale research, automated pipeline systems have had great success in achieving high throughput. However, clinical and institutional workflows are largely based on DICOM and PACS technologies; these systems are not readily compatible with research systems due to security and privacy restrictions. Hence, quantitative quality control has been relegated to individual investigators and too often neglected. Herein, we propose a scalable system, the Vanderbilt Image Processing Enterprise Resource (VIPER) to integrate modular quality control and image analysis routines with a standard PACS configuration. This server unifies image processing routines across an institutional level and provides a simple interface so that investigators can collaborate to deploy new analysis technologies. VIPER integrates with high performance computing environments has successfully analyzed all standard scans from our institutional research center over the course of the last 18 months.

7 CFR 58.633 - Color.

Code of Federal Regulations, 2011 CFR

2011-01-01

... SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Quality Specifications for Raw Material § 58... and Drug Administration as safe for human consumption. Operations and Operating Procedures ...

76 FR 48073 - Public Hearing for Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

... and all personal items must go through x-ray equipment, similar to airport security procedures. After..., views, or arguments concerning the proposed rule. The EPA may ask clarifying questions during the oral...

Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York - July 2001 Through June 2003

USGS Publications Warehouse

Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

2009-01-01

The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2001 through June 2003. Results for the quality-control samples for 19 analytical procedures were evaluated for bias and precision. Control charts indicate that data for six of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, chloride, magnesium, nitrate (ion chromatography), potassium, and sodium. The calcium procedure was biased throughout the analysis period for the high-concentration sample, but was within control limits. The total monomeric aluminum and fluoride procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The total aluminum, pH, specific conductance, and sulfate procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 16 of 18 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for the dissolved organic carbon or specific conductance procedures. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 18 of the 21 analytes. At least 90 percent of the samples met data-quality objectives for all procedures except total monomeric aluminum (83 percent of samples met objectives), total aluminum (76 percent of samples met objectives), ammonium (73 percent of samples met objectives), dissolved organic carbon (86 percent of samples met objectives), and nitrate (81 percent of samples met objectives). The data-quality objective was not met for the nitrite procedure. Results of the USGS interlaboratory Standard Reference Sample (SRS) Project indicated satisfactory or above data quality over the time period, with most performance ratings for each sample in the good-to-excellent range. The N-sample (nutrient constituents) analysis had one unsatisfactory rating for the ammonium procedure in one study. The T-sample (trace constituents) analysis had one unsatisfactory rating for the magnesium procedure and one marginal rating for the potassium procedure in one study and one unsatisfactory rating for the sodium procedure in another. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 90 percent of the samples met data-quality objectives for 10 of the 14 analytes; the exceptions were acid-neutralizing capacity, ammonium, dissolved organic carbon, and sodium. Data-quality objectives were not met in 37 percent of samples analyzed for acid-neutralizing capacity, 28 percent of samples analyzed for dissolved organic carbon, and 30 percent of samples analyzed for sodium. Results indicate a positive bias for the ammonium procedure in one study and a negative bias in another. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 90 percent of the samples analyzed for calcium, chloride, magnesium, pH, potassium, and sodium. Data-quality objectives were met by 78 percent of

[Laboratory accreditation and proficiency testing].

PubMed

Kuwa, Katsuhiko

2003-05-01

ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

[The design and development of a quality system for the diagnosis of exotic animal diseases at the National Centre for Animal and Plant Health in Cuba].

PubMed

de Oca, N Montes; Villoch, A; Pérez Ruano, M

2004-12-01

A quality system for the diagnosis of exotic animal diseases was developed at the national centre for animal and plant health (CENSA), responsible for coordinating the clinical, epizootiological and laboratory diagnosis of causal agents of exotic animal diseases in Cuba. A model was designed on the basis of standard ISO 9001:2000 of the International Organization for Standardization (ISO), standard ISO/IEC 17025:1999 of ISO and the International Electrotechnical Commission, recommendations of the World Organisation for Animal Health (OIE) and other regulatory documents from international and national organisations that deal specifically with the treatment of emerging diseases. Twenty-nine standardised operating procedures were developed, plus 13 registers and a checklist to facilitate the evaluation of the system. The effectiveness of the quality system was confirmed in the differential diagnosis of classical swine fever at an animal virology laboratory in Cuba.

[Quality of the Early Cervical Cancer Detection Program in the State of Nuevo León].

PubMed

Salinas-Martínez, A M; Villarreal-Ríos, E; Garza-Elizondo, M E; Fraire-Gloria, J M; López-Franco, J J; Barboza-Quintana, O

1997-01-01

To determine the quality of the Early Cervical Cancer Detection Program in the state of Nuevo León. A random selection of 4791 cytologic reports were analyzed, emitted by the State Ministry of Health, the University Hospital and the Mexican Institute for Social Security early cervical cancer detection modules. Pap tests of women with hysterectomy, current pregnancy, menopause or positive result were excluded. Quality was measured with previously defined standards. Analysis included, besides univariate statistics, tests of significance for proportions and means. The quality of the program was fairly satisfactory at the level of the State. The quality of the sampling procedure was low; 39.9% of the tests contained endocervical cells. Quality of coverage was low; 15.6% were women 25+years with first time Pap test. Quality of opportunity was high; 8.5 +/- 7 weekdays between the date of the pap smear and the interpretation date. Strategies are needed to increase the impact of the state program, such as improving the sampling procedure and the coverage quality levels.

ASCCP Colposcopy Standards: Colposcopy Quality Improvement Recommendations for the United States.

PubMed

Mayeaux, Edward J; Novetsky, Akiva P; Chelmow, David; Garcia, Francisco; Choma, Kim; Liu, Angela H; Papasozomenos, Theognosia; Einstein, Mark H; Massad, L Stewart; Wentzensen, Nicolas; Waxman, Alan G; Conageski, Christine; Khan, Michelle J; Huh, Warner K

2017-10-01

The American Society for Colposcopy and Cervical Pathology (ASCCP) Colposcopy Standards recommendations address the role of and approach to colposcopy and biopsy for cervical cancer prevention in the United States. The recommendations were developed by an expert working group appointed by ASCCP's Board of Directors. The ASCCP Quality Improvement Working Group developed evidence-based guidelines to promote best practices and reduce errors in colposcopy and recommended indicators to measure colposcopy quality. The working group performed a systematic review of existing major society and national guidelines and quality indicators. An initial list of potential quality indicators was developed and refined through successive iterative discussions, and draft quality indicators were proposed. The draft recommendations were then reviewed and commented on by the entire Colposcopy Standards Committee, posted online for public comment, and presented at the International Federation for Cervical Pathology and Colposcopy 2017 World Congress for further comment. All comments were considered, additional adjustments made, and the final recommendations approved by the entire Task Force. Eleven quality indicators were selected spanning documentation, biopsy protocols, and time intervals between index screening tests and completion of diagnostic evaluation. The proposed quality indicators are intended to serve as a starting point for quality improvement in colposcopy at a time when colposcopy volume is decreasing and individual procedures are becoming technically more difficult to perform.

Quality-Assurance Data for Routine Water Analyses by the U.S. Geological Survey Laboratory in Troy, New York--July 1999 through June 2001

USGS Publications Warehouse

Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

2006-01-01

The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's LabMaster data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality-control samples analyzed from July 1999 through June 2001. Results for the quality-control samples for 18 analytical procedures were evaluated for bias and precision. Control charts indicate that data for eight of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, total aluminum, calcium, chloride and nitrate (ion chromatography and colormetric method) and sulfate. The total aluminum and dissolved organic carbon procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits. The calcium and specific conductance procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The magnesium procedure was biased for the high-concentration and low concentration samples, but was within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 14 of 15 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic carbon. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 17 of the 18 analytes. At least 90 percent of the samples met data-quality objectives for all analytes except ammonium (81 percent of samples met objectives), chloride (75 percent of samples met objectives), and sodium (86 percent of samples met objectives). Results of the USGS interlaboratory Standard Reference Sample (SRS) Project indicated good data quality over the time period, with most ratings for each sample in the good to excellent range. The P-sample (low-ionic-strength constituents) analysis had one satisfactory rating for the specific conductance procedure in one study. The T-sample (trace constituents) analysis had one satisfactory rating for the aluminum procedure in one study and one unsatisfactory rating for the sodium procedure in another. The remainder of the samples had good or excellent ratings for each study. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 89 percent of the samples met data-quality objectives for 10 of the 14 analytes; the exceptions were ammonium, total aluminum, dissolved organic carbon, and sodium. Results indicate a positive bias for the ammonium procedure in all studies. Data-quality objectives were not met in 50 percent of samples analyzed for total aluminum, 38 percent of samples analyzed for dissolved organic carbon, and 27 percent of samples analyzed for sodium. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 91 percent of the samples analyzed for calcium, chloride, fluoride, magnesium, pH, potassium, and sulfate. Data-quality objectives were met by 75 percent of the samples analyzed for sodium and 58 percent of the samples analyzed for specific conductance.

Chapter A6. Field Measurements

USGS Publications Warehouse

Wilde, Franceska D.; Radtke, Dean B.

1998-01-01

The National Field Manual for the Collection of Water-Quality Data (National Field Manual) provides guidelines and standard procedures for U.S. Geological Survey (USGS) personnel who collect data used to assess the quality of the Nation's surface-water and ground-water resources. Chapter A6 presents procedures and guidelines for the collection of data on air and water temperature, and on dissolved-oxygen concentrations, specific electrical conductance, pH, reduction-oxidation potential, alkalinity, and turbidity in water. Each chapter of the National Field Manual is published separately and revised periodically. Newly published and revised chapters are posted on the World Wide Web on the USGS page 'National Field Manual for the Collection of Water-Quality Data.' The URL for this page is http://pubs.water.usgs.gov/twri9A (accessed August 6, 2005).

Discharge communication from inpatient care: an audit of written medical discharge summary procedure against the new National Health Service Standard for clinical handover.

PubMed

Reid, Daniel Brooks; Parsons, Shaun R; Gill, Stephen D; Hughes, Andrew J

2015-04-01

To audit written medical discharge summary procedure and practice against Standard Six (clinical handover) of the Australian National Safety and Quality Health Service Standards at a major regional Victorian health service. Department heads were invited to complete a questionnaire about departmental discharge summary practices. Twenty-seven (82%) department heads completed the questionnaire. Seven (26%) departments had a documented discharge summary procedure. Fourteen (52%) departments monitored discharge summary completion and 13 (48%) departments monitored the timeliness of completion. Seven (26%) departments informed the patient of the content of the discharge summary and six (22%) departments provided the patient with a copy. Seven (26%) departments provided training for staff members on how to complete discharge summaries. Completing discharge summaries was usually delegated to the medical intern. The introduction of the National Service Standards prompted an organisation-wide audit of discharge summary practices against the external criterion. There was substantial variation in the organisation's practices. The Standards and the current audit results highlight an opportunity for the organisation to enhance and standardise discharge summary practices and improve communication with general practice.

Canadian and U.S. Cooperation for the development of standards and specifications for emerging mapping technologies

USGS Publications Warehouse

Habib, A.; Jarvis, A.; Al-Durgham, M. M.; Lay, J.; Quackenbush, P.; Stensaas, G.; Moe, D.

2007-01-01

The mapping community is witnessing significant advances in available sensors, such as medium format digital cameras (MFDC) and Light Detection and Ranging (LiDAR) systems. In this regard, the Digital Photogrammetry Research Group (DPRG) of the Department of Geomatics Engineering at the University of Calgary has been actively involved in the development of standards and specifications for regulating the use of these sensors in mapping activities. More specifically, the DPRG has been working on developing new techniques for the calibration and stability analysis of medium format digital cameras. This research is essential since these sensors have not been developed with mapping applications in mind. Therefore, prior to their use in Geomatics activies, new standards should be developed to ensure the quality of the developed products. In another front, the persistent improvement in direct geo-referencing technology has led to an expansion in the use of LiDAR systems for the acquisition of dense and accurate surface information. However, the processing of the raw LiDAR data (e.g., ranges, mirror angles, and navigation data) remains a non-transparent process that is proprietary to the manufacturers of LiDAR systems. Therefore, the DPRG has been focusing on the development of quality control procedures to quantify the accuracy of LiDAR output in the absence of initial system measurements. This paper presents a summary of the research conducted by the DPRG together with the British Columbia Base Mapping and Geomatic Services (BMGS) and the United States Geological Survey (USGS) for the development of quality assurance and quality control procedures for emerging mapping technologies. The outcome of this research will allow for the possiblity of introducing North American Standards and Specifications to regulate the use of MFDC and LiDAR systems in the mapping industry.

Internal quality assurance in a clinical virology laboratory. II. Internal quality control.

PubMed Central

Gray, J J; Wreghitt, T G; McKee, T A; McIntyre, P; Roth, C E; Smith, D J; Sutehall, G; Higgins, G; Geraghty, R; Whetstone, R

1995-01-01

AIMS--In April 1991 additional quality control procedures were introduced into the virology section of the Clinical Microbiology and Public Health Laboratory, Cambridge. Internal quality control (IQC) samples were gradually included in the serological assays performed in the laboratory and supplemented kit controls and standard sera. METHODS--From April 1991 to December 1993, 2421 IQC procedures were carried out with reference sera. RESULTS--The IQC samples were evaluated according to the Westgard rules. Violations were recorded in 60 of 1808 (3.3%) controls and were highest in the IQC samples of complement fixation tests (25/312 (8%) of controls submitted for complement fixation tests). CONCLUSIONS--The inclusion of IQC samples in the serological assays performed in the laboratory has highlighted batch to batch variation in commercial assays. The setting of acceptable limits for the IQC samples has increased confidence in the validity of assay results. PMID:7730475

Effectiveness and legitimacy of forest carbon standards in the OTC voluntary carbon market.

PubMed

Merger, Eduard; Pistorius, Till

2011-08-17

In recent years, the voluntary over-the-counter (OTC) carbon market has reached a significant market volume. It is particularly interesting for forest mitigation projects which are either ineligible in compliance markets or confronted with a plethora of technical and financial hurdles and lacking market demand. As the OTC market is not regulated, voluntary standards have been created to secure the social and environmental integrity of the traded mitigation projects and thus to ensure the quality of the resulting carbon credits. Building on a theoretical efficiency-legitimacy framework, this study aims to identify and analyse the characteristics and indicators that determine the efficiency and organisational legitimacy of standards for afforestation/reforestation carbon projects. All interviewed market actors consider third-party certification and standards as a crucial component of market functionality, which provide quality assurance mechanisms that reduce information asymmetries and moral hazard between the actors regarding the quality of carbon credits, and thus reduce transaction costs. Despite this development, the recent evolution of many new and differing standards is seen as a major obstacle that renders it difficult for project developers and buyers to select an appropriate standard. According to the interviewed experts the most important legitimating factors of standards are assurance of a sufficient level of quality of carbon credits, scientifically substantiated methodological accounting and independent third-party verification, independence of standard bodies, transparency, wide market acceptance, back-up of the wider community including experts and NGOs, rigorous procedures, and the resemblance to the Afforestation/Reforestation (A/R) CDM due to its international policy endorsements. In addition, standards must provide evidence that projects contribute to a positive social and environmental development, do no harm as a minimum requirement and build a strong track record of successful projects. Project developers require clear, easily and practically applicable standards at lowest possible costs with a high potential in order to achieve good carbon prices, while buyers require that standards are legitimate, credible and that no public criticism arises when carbon credits are purchased from projects certified by a certain standard. Despite the fragmented and immature state of the OTC market, standards act as 'market-making' intermediaries and contribute to the quality and transparency of the OTC market. However, the variety of different standards imposes new hurdles for their efficiency and often creates confusion instead of confidence among potential buyers. Despite the lacking legitimacy of the standards, pressures from the institutional environment on standards ensure a minimum quality of carbon credits (including positive social and environmental impacts of carbon credits) that serves as an insurance mechanism for the integrity of standards. Its unregulated nature and the pressure from an increasingly competitive environment provides innovative space to deliver efficient certification procedures without imposing unreasonably high transaction costs on market actors. Furthermore, voluntary standards imply a more innovative certification approach, as one legal authority could do, because standards have to compete for adopters backed by civil society organisations. Thereby, the forest sector in OTC voluntary market bears great opportunities to provide the forest sector with crucial lessons for international climate policy and governmental institutions when designing regulation for forest regulation such as international and national REDDplus schemes.

Assuring the Quality of Next-Generation Sequencing in Clinical Microbiology and Public Health Laboratories.

PubMed

Gargis, Amy S; Kalman, Lisa; Lubin, Ira M

2016-12-01

Clinical microbiology and public health laboratories are beginning to utilize next-generation sequencing (NGS) for a range of applications. This technology has the potential to transform the field by providing approaches that will complement, or even replace, many conventional laboratory tests. While the benefits of NGS are significant, the complexities of these assays require an evolving set of standards to ensure testing quality. Regulatory and accreditation requirements, professional guidelines, and best practices that help ensure the quality of NGS-based tests are emerging. This review highlights currently available standards and guidelines for the implementation of NGS in the clinical and public health laboratory setting, and it includes considerations for NGS test validation, quality control procedures, proficiency testing, and reference materials. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

Harmonization in laboratory medicine: Requests, samples, measurements and reports.

PubMed

Plebani, Mario

2016-01-01

In laboratory medicine, the terms "standardization" and "harmonization" are frequently used interchangeably as the final goal is the same: the equivalence of measurement results among different routine measurement procedures over time and space according to defined analytical and clinical quality specifications. However, the terms define two distinct, albeit closely linked, concepts based on traceability principles. The word "standardization" is used when results for a measurement are equivalent and traceable to the International System of Units (SI) through a high-order primary reference material and/or a reference measurement procedure (RMP). "Harmonization" is generally used when results are equivalent, but neither a high-order primary reference material nor a reference measurement procedure is available. Harmonization is a fundamental aspect of quality in laboratory medicine as its ultimate goal is to improve patient outcomes through the provision of accurate and actionable laboratory information. Patients, clinicians and other healthcare professionals assume that clinical laboratory tests performed by different laboratories at different times on the same sample and specimen can be compared, and that results can be reliably and consistently interpreted. Unfortunately, this is not necessarily the case, because many laboratory test results are still highly variable and poorly standardized and harmonized. Although the initial focus was mainly on harmonizing and standardizing analytical processes and methods, the scope of harmonization now also includes all other aspects of the total testing process (TTP), such as terminology and units, report formats, reference intervals and decision limits as well as tests and test profiles, requests and criteria for interpretation. Several projects and initiatives aiming to improve standardization and harmonization in the testing process are now underway. Laboratory professionals should therefore step up their efforts to provide interchangeable and comparable laboratory information in order to ultimately assure better diagnosis and treatment in patient care.

The standardized fish bioassay procedure for detecting and culturing actively toxic Pfiesteria, used by two reference laboratories for atlantic and gulf coast states.

PubMed Central

Burkholder, J M; Marshall, H G; Glasgow, H B; Seaborn, D W; Deamer-Melia, N J

2001-01-01

In the absence of purified standards of toxins from Pfiesteria species, appropriately conducted fish bioassays are the "gold standard" that must be used to detect toxic strains of Pfiesteria spp. from natural estuarine water or sediment samples and to culture actively toxic Pfiesteria. In this article, we describe the standardized steps of our fish bioassay as an abbreviated term for a procedure that includes two sets of trials with fish, following the Henle-Koch postulates modified for toxic rather than infectious agents. This procedure was developed in 1991, and has been refined over more than 12 years of experience in research with toxic Pfiesteria. The steps involve isolating toxic strains of Pfiesteria (or other potentially, as-yet-undetected, toxic Pfiesteria or Pfiesteria-like species) from fish-killing bioassays with natural samples; growing the clones with axenic algal prey; and retesting the isolates in a second set of fish bioassays. The specific environmental conditions used (e.g., temperature, salinity, light, other factors) must remain flexible, given the wide range of conditions from which natural estuarine samples are derived. We present a comparison of information provided for fish culture conditions, reported in international science journals in which such research is routinely published, and we provide information from more than 2,000 fish bioassays with toxic Pfiesteria, along with recommendations for suitable ranges and frequency of monitoring of environmental variables. We present data demonstrating that algal assays, unlike these standardized fish bioassays, should not be used to detect toxic strains of Pfiesteria spp. Finally, we recommend how quality control/assurance can be most rapidly advanced among laboratories engaged in studies that require research-quality isolates of toxic Pfiesteria spp. PMID:11677184

Variation in hospital costs and reimbursement for endovascular aneurysm repair: A Vascular Quality Initiative pilot project.

PubMed

Lemmon, Gary W; Neal, Dan; DeMartino, Randall R; Schneider, Joseph R; Singh, Tej; Kraiss, Larry; Scali, Salvatore; Tassiopoulos, Apostolos; Hoel, Andrew; Cronenwett, Jack L

2017-10-01

Comparing costs between centers is difficult because of the heterogeneity of vascular procedures contained in broad diagnosis-related group (DRG) billing categories. The purpose of this pilot project was to develop a mechanism to merge Vascular Quality Initiative (VQI) clinical data with hospital billing data to allow more accurate cost and reimbursement comparison for endovascular aneurysm repair (EVAR) procedures across centers. Eighteen VQI centers volunteered to submit UB04 billing data for 782 primary, elective infrarenal EVAR procedures performed by 108 surgeons in 2014. Procedures were categorized as standard or complex (with femoral-femoral bypass or additional arterial treatment) and without or with complications (arterial injury or embolectomy; bowel or leg ischemia; wound infection; reoperation; or cardiac, pulmonary, or renal complications), yielding four clinical groups for comparison. MedAssets, Inc, using cost to charge ratios, calculated total hospital costs and cost categories. Cost variation analyzed across centers was compared with DRG 237 (with major complication or comorbidity) and 238 (without major complication or comorbidity) coding. A multivariable model to predict DRG 237 coding was developed using VQI clinical data. Of the 782 EVAR procedures, 56% were standard and 15% had complications, with wide variation between centers. Mean total costs ranged from $31,100 for standard EVAR without complications to $47,400 for complex EVAR with complications and varied twofold to threefold among centers. Implant costs for standard EVAR without complications varied from $8100 to $28,200 across centers. Average Medicare reimbursement was less than total cost except for standard EVAR without complications. Only 9% of all procedures with complications in the VQI were reported in the higher reimbursed DRG 237 category (center range, 0%-21%). There was significant variation in hospitals' coding of DRG 237 compared with their expected rates. VQI clinical data accurately predict current DRG coding (C statistic, 0.87). VQI data allow a more precise EVAR cost comparison by identifying comparable clinical groups compared with DRG-based calculations. Total costs exceeded Medicare reimbursement, especially for patients with complications, although this varied by center. Implant costs also varied more than expected between centers for comparable cases. Incorporation of VQI data elements documenting EVAR case complexity into billing data may allow centers to better align respective DRG reimbursement to total costs. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Machine-Specific Magnetic Resonance Imaging Quality Control Procedures for Stereotactic Radiosurgery Treatment Planning

PubMed Central

Taghizadeh, Somayeh; Yang, Claus Chunli; R. Kanakamedala, Madhava; Morris, Bart; Vijayakumar, Srinivasan

2017-01-01

Purpose Magnetic resonance (MR) images are necessary for accurate contouring of intracranial targets, determination of gross target volume and evaluation of organs at risk during stereotactic radiosurgery (SRS) treatment planning procedures. Many centers use magnetic resonance imaging (MRI) simulators or regular diagnostic MRI machines for SRS treatment planning; while both types of machine require two stages of quality control (QC), both machine- and patient-specific, before use for SRS, no accepted guidelines for such QC currently exist. This article describes appropriate machine-specific QC procedures for SRS applications. Methods and materials We describe the adaptation of American College of Radiology (ACR)-recommended QC tests using an ACR MRI phantom for SRS treatment planning. In addition, commercial Quasar MRID3D and Quasar GRID3D phantoms were used to evaluate the effects of static magnetic field (B0) inhomogeneity, gradient nonlinearity, and a Leksell G frame (SRS frame) and its accessories on geometrical distortion in MR images. Results QC procedures found in-plane distortions (Maximum = 3.5 mm, Mean = 0.91 mm, Standard deviation = 0.67 mm, >2.5 mm (%) = 2) in X-direction (Maximum = 2.51 mm, Mean = 0.52 mm, Standard deviation = 0.39 mm, > 2.5 mm (%) = 0) and in Y-direction (Maximum = 13. 1 mm , Mean = 2.38 mm, Standard deviation = 2.45 mm, > 2.5 mm (%) = 34) in Z-direction and < 1 mm distortion at a head-sized region of interest. MR images acquired using a Leksell G frame and localization devices showed a mean absolute deviation of 2.3 mm from isocenter. The results of modified ACR tests were all within recommended limits, and baseline measurements have been defined for regular weekly QC tests. Conclusions With appropriate QC procedures in place, it is possible to routinely obtain clinically useful MR images suitable for SRS treatment planning purposes. MRI examination for SRS planning can benefit from the improved localization and planning possible with the superior image quality and soft tissue contrast achieved under optimal conditions. PMID:29487771

Machine-Specific Magnetic Resonance Imaging Quality Control Procedures for Stereotactic Radiosurgery Treatment Planning.

PubMed

Fatemi, Ali; Taghizadeh, Somayeh; Yang, Claus Chunli; R Kanakamedala, Madhava; Morris, Bart; Vijayakumar, Srinivasan

2017-12-18

Purpose Magnetic resonance (MR) images are necessary for accurate contouring of intracranial targets, determination of gross target volume and evaluation of organs at risk during stereotactic radiosurgery (SRS) treatment planning procedures. Many centers use magnetic resonance imaging (MRI) simulators or regular diagnostic MRI machines for SRS treatment planning; while both types of machine require two stages of quality control (QC), both machine- and patient-specific, before use for SRS, no accepted guidelines for such QC currently exist. This article describes appropriate machine-specific QC procedures for SRS applications. Methods and materials We describe the adaptation of American College of Radiology (ACR)-recommended QC tests using an ACR MRI phantom for SRS treatment planning. In addition, commercial Quasar MRID 3D and Quasar GRID 3D phantoms were used to evaluate the effects of static magnetic field (B 0 ) inhomogeneity, gradient nonlinearity, and a Leksell G frame (SRS frame) and its accessories on geometrical distortion in MR images. Results QC procedures found in-plane distortions (Maximum = 3.5 mm, Mean = 0.91 mm, Standard deviation = 0.67 mm, >2.5 mm (%) = 2) in X-direction (Maximum = 2.51 mm, Mean = 0.52 mm, Standard deviation = 0.39 mm, > 2.5 mm (%) = 0) and in Y-direction (Maximum = 13. 1 mm , Mean = 2.38 mm, Standard deviation = 2.45 mm, > 2.5 mm (%) = 34) in Z-direction and < 1 mm distortion at a head-sized region of interest. MR images acquired using a Leksell G frame and localization devices showed a mean absolute deviation of 2.3 mm from isocenter. The results of modified ACR tests were all within recommended limits, and baseline measurements have been defined for regular weekly QC tests. Conclusions With appropriate QC procedures in place, it is possible to routinely obtain clinically useful MR images suitable for SRS treatment planning purposes. MRI examination for SRS planning can benefit from the improved localization and planning possible with the superior image quality and soft tissue contrast achieved under optimal conditions.

Assessment of nonpoint source chemical loading potential to watersheds containing uranium waste dumps associated with uranium exploration and mining, San Rafael Swell, Utah

USGS Publications Warehouse

Freeman, Michael L.; Naftz, David L.; Snyder, Terry; Johnson, Greg

2008-01-01

During July and August of 2006, 117 solid-phase samples were collected from abandoned uranium waste dumps, geologic background sites, and adjacent streambeds in the San Rafael Swell, in southeastern Utah. The objective of this sampling program was to assess the nonpoint source chemical loading potential to ephemeral and perennial watersheds from uranium waste dumps on Bureau of Land Management property. Uranium waste dump samples were collected using solid-phase sampling protocols. After collection, solid-phase samples were homogenized and extracted in the laboratory using a field leaching procedure. Filtered (0.45 micron) water samples were obtained from the field leaching procedure and were analyzed for Ag, As, Ba, Be, Cd, Cr, Cu, Fe, Mn, Mo, Ni, Pb, Sb, Se, U, V, and Zn at the Inductively Coupled Plasma-Mass Spectrometry Metals Analysis Laboratory at the University of Utah, Salt Lake City, Utah and for Hg at the U.S. Geological Survey National Water Quality Laboratory, Denver, Colorado. For the initial ranking of chemical loading potential of suspect uranium waste dumps, leachate analyses were compared with existing aquatic life and drinking-water-quality standards and the ratio of samples that exceeded standards to the total number of samples was determined for each element having a water-quality standard for aquatic life and drinking-water. Approximately 56 percent (48/85) of the leachate samples extracted from uranium waste dumps had one or more chemical constituents that exceeded aquatic life and drinking-water-quality standards. Most of the uranium waste dump sites with elevated trace-element concentrations in leachates were along Reds Canyon Road between Tomsich Butte and Family Butte. Twelve of the uranium waste dump sites with elevated trace-element concentrations in leachates contained three or more constituents that exceeded drinking-water-quality standards. Eighteen of the uranium waste dump sites had three or more constituents that exceeded trace-element concentrations for aquatic life water-quality standards. The proximity of the uranium waste dumps in the Tomsich Butte area near Muddy Creek, coupled with the elevated concentration of trace elements, increases the offsite impact potential to water resources. Future assessment and remediation priority of these areas may be done by using GIS-based risk-mapping techniques, such as Sensitive Catchment Integrated Mapping and Analysis Project.

[Scientific monitoring of the visitation procedure in inpatient rehabilitation centres of the German statutory pension insurance fund--the "Visit II" Project].

PubMed

Neuderth, S; Saupe-Heide, M; Brückner, U; Gross, B; Wenderoth, N; Vogel, H

2012-06-01

Visitation procedures are an established method of external quality assurance. They have been conducted for many years in the German statutory pension insurance's medical rehabilitation centres and have continuously been refined and standardized. The overall goal of the visitation procedure implemented by the German statutory pension fund is to ensure compliance with defined quality standards as well as information exchange and counselling of rehabilitation centres. In the context of advancing the visitation procedure in the German statutory pension funds' medical rehabilitation centres, the "Visit II" Project was initiated to evaluate the perspectives and expectations of the various professional groups involved in the visitations and to modify the materials used during visitations (documentation form and manual). Evaluation data from the rehabilitation centres visited in 2008 were gathered using both written surveys (utilization analysis) and telephone-based interviews with administration managers and chief physicians. The utilization analysis procedure was evaluated with regard to its methodological quality. In addition, the pension insurance physicians in charge of patient allocation during socio-medical assessment were surveyed with regard to potential needs for revision of the visitation procedure. Data collection was complemented by expert panels with auditors. Interviews with users as part of the formative evaluation of the visitation procedure showed positive results regarding acceptance and applicability of the visitations as well as of the utilization analysis procedures. Various suggestions were made with regard to modification and revision of the visitation materials, that could be implemented in many cases. Documentation forms were supplemented by current scientifically-based topics in rehabilitation (e. g., vocationally oriented measures), whereas items with minor relevance were skipped. The manual (for somatic indications) was thoroughly revised. The transparent presentation of visitation processes and visitation criteria has proven to be a useful basis for strengthening the cooperation between the statutory pension insurance funds and the rehabilitation centres. Moreover, it is a helpful tool for the systematic and continuous advancement of this complex method by including all parties involved. © Georg Thieme Verlag KG Stuttgart · New York.

Standard operating procedures improve acute neurologic care in a sub-Saharan African setting.

PubMed

Jaiteh, Lamin E S; Helwig, Stefan A; Jagne, Abubacarr; Ragoschke-Schumm, Andreas; Sarr, Catherine; Walter, Silke; Lesmeister, Martin; Manitz, Matthias; Blaß, Sebastian; Weis, Sarah; Schlund, Verena; Bah, Neneh; Kauffmann, Jil; Fousse, Mathias; Kangankan, Sabina; Ramos Cabrera, Asmell; Kronfeld, Kai; Ruckes, Christian; Liu, Yang; Nyan, Ousman; Fassbender, Klaus

2017-07-11

Quality of neurologic emergency management in an under-resourced country may be improved by standard operating procedures (SOPs). Neurologic SOPs were implemented in a large urban (Banjul) and a small rural (Brikama) hospital in the Gambia. As quality indicators of neurologic emergency management, performance of key procedures was assessed at baseline and in the first and second implementation years. At Banjul, 100 patients of the first-year intervention group exhibited higher rates of general procedures of emergency management than 105 control patients, such as neurologic examination (99.0% vs 91.4%; p < 0.05) and assessments of respiratory rate (98.0% vs 81.9%, p < 0.001), temperature (60.0% vs 36.2%; p < 0.001), and glucose levels (73.0% vs 58.1%; p < 0.05), in addition to written directives by physicians (96.0% vs 88.6%, p < 0.05), whereas assessments of other vital signs remained unchanged. In stroke patients, rates of stroke-related procedures increased: early CT scanning (24.3% vs 9.9%; p < 0.05), blood count (73.0% vs 49.3%; p < 0.01), renal and liver function tests (50.0% vs 5.6%, p < 0.001), aspirin prophylaxis (47.3% vs 9.9%; p < 0.001), and physiotherapy (41.9% vs 4.2%; p < 0.001). Most effects persisted until the second-year evaluation. SOP implementation was similarly feasible and beneficial at the Brikama hospital. However, outcomes did not significantly differ in the hospitals. Implementing SOPs is a realistic, low-cost option for improving process quality of neurologic emergency management in under-resourced settings. This study provides Class IV evidence that, for patients with suspected neurologic emergencies in sub-Saharan Africa, neurologic SOPs increase the rate of performance of guideline-recommended procedures. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Heller Myotomy for Achalasia: Quality of Life Comparison of Laparoscopic and Open Approaches

PubMed Central

Katilius, Marius

2001-01-01

Background: Achalasia is a relatively rare disorder with a variety of treatment options. Although laparoscopic Heller myotomy has become the surgical treatment of choice, little data exist on the overall quality of life of patients undergoing this technique versus standard open approaches. Methods: We prospectively evaluated all patients surgically treated for achalasia by a single surgeon. Laparoscopic Heller myotomy consisted of a long (≥ 6 cm) esophageal cardiomyotomy extending at least 2 cm onto the gastric cardia, with a concomitant Dor fundoplication. Patients were evaluated preoperatively and postoperatively for symptoms and quality of life using the SF-36, a standardized, generic quality of life instrument. Results: A total of 23 patients were surgically treated: 15 patients had a planned laparoscopic procedure, with 3 conversions; 8 had planned open procedures. Dysphagia resolved in 20 of 21 patients, with 1 patient in the laparoscopic group requiring reoperation due to an inadequate gastric myotomy. Compared with preoperative scores, a statistically significant improvement occurred in the general health domain of the SF-36 (70 to 82, P = 0.04). Compared with that in patients undergoing open surgery, the laparoscopic group had better scores in the domains of physical functioning and bodily pain. Conclusions: Laparoscopic Heller myotomy has comparable success to open Heller myotomy, and causes less early detriment to quality of life. This should be the primary treatment in all fit surgical patients with achalasia. PMID:11548827

Quality Assurance of RNA Expression Profiling in Clinical Laboratories

PubMed Central

Tang, Weihua; Hu, Zhiyuan; Muallem, Hind; Gulley, Margaret L.

2012-01-01

RNA expression profiles are increasingly used to diagnose and classify disease, based on expression patterns of as many as several thousand RNAs. To ensure quality of expression profiling services in clinical settings, a standard operating procedure incorporates multiple quality indicators and controls, beginning with preanalytic specimen preparation and proceeding thorough analysis, interpretation, and reporting. Before testing, histopathological examination of each cellular specimen, along with optional cell enrichment procedures, ensures adequacy of the input tissue. Other tactics include endogenous controls to evaluate adequacy of RNA and exogenous or spiked controls to evaluate run- and patient-specific performance of the test system, respectively. Unique aspects of quality assurance for array-based tests include controls for the pertinent outcome signatures that often supersede controls for each individual analyte, built-in redundancy for critical analytes or biochemical pathways, and software-supported scrutiny of abundant data by a laboratory physician who interprets the findings in a manner facilitating appropriate medical intervention. Access to high-quality reagents, instruments, and software from commercial sources promotes standardization and adoption in clinical settings, once an assay is vetted in validation studies as being analytically sound and clinically useful. Careful attention to the well-honed principles of laboratory medicine, along with guidance from government and professional groups on strategies to preserve RNA and manage large data sets, promotes clinical-grade assay performance. PMID:22020152

Tools, harmonization and standardization procedures of the impact and outcome evaluation indices obtained during a kindergarten-based, family-involved intervention to prevent obesity in early childhood: the ToyBox-study.

PubMed

Mouratidou, T; Miguel, M L; Androutsos, O; Manios, Y; De Bourdeaudhuij, I; Cardon, G; Kulaga, Z; Socha, P; Galcheva, S; Iotova, V; Payr, A; Koletzko, B; Moreno, L A

2014-08-01

The ToyBox-intervention is a kindergarten-based, family-involved intervention targeting multiple lifestyle behaviours in preschool children, their teachers and their families. This intervention was conducted in six European countries, namely Belgium, Bulgaria, Germany, Greece, Poland and Spain. The aim of this paper is to provide a descriptive overview of the harmonization and standardization procedures of the baseline and follow-up evaluation of the study (and substudies). Steps related to the study's operational, standardization and harmonization procedures as well as the impact and outcome evaluation assessment tools used are presented. Experiences from the project highlight the importance of safeguarding the measurement process to minimize data heterogeneity derived from potential measurement error and country-by-country differences. In addition, it was made clear that continuing quality control and support is an important component of such studies. For this reason, well-supported communication channels, such as regular email updates and teleconferences, and regular internal and external meetings to ensure smooth and accurate implementation were in place during the study. The ToyBox-intervention and its harmonized and standardized procedures can serve as a successful case study for future studies evaluating the efficacy of similar interventions. © 2014 World Obesity.

Water-Quality Data, Huron County, Michigan 2004

DTIC Science & Technology

2005-01-01

ecoregion VII, EPA 822-B-00-018: U.S. Environ - mental Protection Agency, 93 p. U.S. Environmental Protection Agency, Water Quality Crite- ria: U.S...U.S. Environmental Protection Agency, 2000a, and American Public Health Association, 1998, as well as the standard field procedures documented by the... environmental samples (Bird and others, 2001). Figure 1. Map showing surface-water and ground-water sampling locations in Huron County, Michigan KINDE ELKTON

Guide for Indoor Air Quality Surveys

DTIC Science & Technology

1992-05-01

investigations, but is most useful as a tool for the Heating, Ventilating, and Air-Conditioning ( HVAC ) experts. The standard describes two procedures for...providing acceptable air quality and includes design criteria for HVAC systems. Perhaps the most important contribution from ASHRAE 62-1989 is its...Selected Selected Cause Subcauses Subrates(%) Overall Rate(%) A. Inadequate Design or Maintenance of HVAC 70 (32/46) Al. Mold 47 (15/32) 33 (15/46) A2

The Manufacture, Shipping and Receiving and Quality Control of Rodent Bedding Materials

NASA Technical Reports Server (NTRS)

Kraft, Lisbeth M.

1980-01-01

The criteria for rodent bedding and nesting materials are discussed. The literature is reviewed regarding sources of bedding materials, manufacturing methods, quality control, procedures (microbiological, physical and chemical), storage, methods, shipment, methods of use and disposal, current knowledge concerning bedding effects on animals as related to research and testing and legal aspects. Future needs, especially with respect to the promulgation of standards, also are addressed.

Methods of analysis by the U.S. Geological Survey National Water Quality Laboratory; preparation procedure for aquatic biological material determined for trace metals

USGS Publications Warehouse

Hoffman, Gerald L.

1996-01-01

A method for the chemical preparation of tissue samples that are subsequently analyzed for 22 trace metals is described. The tissue-preparation procedure was tested with three National Institute of Standards and Technology biological standard reference materials and two National Water Quality Laboratory homogenized biological materials. A low-temperature (85 degrees Celsius) nitric acid digestion followed by the careful addition of hydrogen peroxide (30-percent solution) is used to decompose the biological material. The solutions are evaporated to incipient dryness, reconstituted with 5 percent nitric acid, and filtered. After filtration the solutions were diluted to a known volume and analyzed by inductively coupled plasma-mass spectrometry (ICP-MS), inductively coupled plasma-atomic emission spectrometry (ICP-AES), and cold vapor-atomic absorption spectrophotometry (CV-AAS). Many of the metals were determined by both ICP-MS and ICP-AES. This report does not provide a detailed description of the instrumental procedures and conditions used with the three types of instrumentation for the quantitation of trace metals determined in this study. Statistical data regarding recovery, accuracy, and precision for individual trace metals determined in the biological material tested are summarized.

Standard operating procedures for pre-analytical handling of blood and urine for metabolomic studies and biobanks.

PubMed

Bernini, Patrizia; Bertini, Ivano; Luchinat, Claudio; Nincheri, Paola; Staderini, Samuele; Turano, Paola

2011-04-01

(1)H NMR metabolic profiling of urine, serum and plasma has been used to monitor the impact of the pre-analytical steps on the sample quality and stability in order to propose standard operating procedures (SOPs) for deposition in biobanks. We analyzed the quality of serum and plasma samples as a function of the elapsed time (t = 0-4 h) between blood collection and processing and of the time from processing to freezing (up to 24 h). The stability of the urine metabolic profile over time (up to 24 h) at various storage temperatures was monitored as a function of the different pre-analytical treatments like pre-storage centrifugation, filtration, and addition of the bacteriostatic preservative sodium azide. Appreciable changes in the profiles, reflecting changes in the concentration of a number of metabolites, were detected and discussed in terms of chemical and enzymatic reactions for both blood and urine samples. Appropriate procedures for blood derivatives collection and urine preservation/storage that allow maintaining as much as possible the original metabolic profile of the fresh samples emerge, and are proposed as SOPs for biobanking.

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.

Moving to patient reported collection of race and ethnicity data: implementation and impact in ten hospitals.

PubMed

Berry, Carolyn; Kaplan, Sue A; Mijanovich, Tod; Mayer, Andrea

2014-01-01

The purpose of this paper is to examine the feasibility of collecting standardized, patient reported race and ethnicity (RE) data in hospitals, and to assess the impact on data quality and utility. Part of a larger evaluation that included a comprehensive assessment. Sites documented RE data collection procedures before and after program implementation. Primary data collected through qualitative interviewing with key respondents in ten hospitals to assess implementation. Nine hospitals provided RE data on the same patients before and after implementation new data collection procedures were implemented to assess impact. Implementation went smoothly in nine of ten hospitals and had substantial effects on the hospital staff awareness on the potential for disparities within their hospitals. New procedures had minimal impact on characterization of readmitted patients. This study demonstrated that it is feasible for staff in a diverse group of hospitals to implement systematic, internally standardized methods to collect self-reported RE data from patients. Although this study found little impact patients' demographic characterizations, other benefits included greater awareness of and attention to disparities, uncovering small pockets of minorities, and dramatically increased RE data use in quality improvement efforts.

Systematic Review and Meta-Analysis of Objective and Subjective Quality of Life among Pediatric, Adolescent, and Young Adult Bone Tumor Survivors

PubMed Central

Stokke, Jamie; Sung, Lillian; Gupta, Abha; Lindberg, Antoinette; Rosenberg, Abby R.

2015-01-01

Background Pediatric, adolescent and young adult (AYA) survivors of bone sarcomas are at risk for poor quality of life (QOL). We conducted a systematic review and meta-analysis to summarize the literature describing QOL in this population and differences in QOL based on local control procedures. Procedure Included studies described ≥5 patients <25 years-old who had completed local control treatment for bone sarcoma, defined QOL as a main outcome, and measured it with a validated instrument. Data extraction and quality assessments were conducted with standardized tools. Meta-analyses compared QOL based on surgical procedure (limb-sparing versus amputation) and were stratified by assessment type (objective physical function, clinician-assessed disability, patient-reported disability and patient-reported QOL). Effect sizes were reported as the Standard Mean Difference when multiple instruments were used within a comparison and Weighted Mean Difference otherwise. All were weighted by inverse variance and modeled with random effects. Results Twenty-two of 452 unique manuscripts were included in qualitative syntheses, 8 of which were included in meta-analyses. Manuscripts were heterogeneous with respect to included patient populations (age, tumor type, time since treatment) and QOL instruments. Prospective studies suggested that QOL improves over time, and that female sex and older age at diagnosis are associated with poor QOL. Meta-analyses showed no differences in outcomes between patients who underwent limb-sparing versus amputation for local control. Conclusion QOL studies among children and AYAs with bone sarcoma are remarkably diverse, making it difficult to detect trends in patient outcomes. Future research should focus on standardized QOL instruments and interpretations. PMID:25820683

Quality-assurance plan for groundwater activities, U.S. Geological Survey, Washington Water Science Center

USGS Publications Warehouse

Kozar, Mark D.; Kahle, Sue C.

2013-01-01

This report documents the standard procedures, policies, and field methods used by the U.S. Geological Survey’s (USGS) Washington Water Science Center staff for activities related to the collection, processing, analysis, storage, and publication of groundwater data. This groundwater quality-assurance plan changes through time to accommodate new methods and requirements developed by the Washington Water Science Center and the USGS Office of Groundwater. The plan is based largely on requirements and guidelines provided by the USGS Office of Groundwater, or the USGS Water Mission Area. Regular updates to this plan represent an integral part of the quality-assurance process. Because numerous policy memoranda have been issued by the Office of Groundwater since the previous groundwater quality assurance plan was written, this report is a substantial revision of the previous report, supplants it, and contains significant additional policies not covered in the previous report. This updated plan includes information related to the organization and responsibilities of USGS Washington Water Science Center staff, training, safety, project proposal development, project review procedures, data collection activities, data processing activities, report review procedures, and archiving of field data and interpretative information pertaining to groundwater flow models, borehole aquifer tests, and aquifer tests. Important updates from the previous groundwater quality assurance plan include: (1) procedures for documenting and archiving of groundwater flow models; (2) revisions to procedures and policies for the creation of sites in the Groundwater Site Inventory database; (3) adoption of new water-level forms to be used within the USGS Washington Water Science Center; (4) procedures for future creation of borehole geophysics, surface geophysics, and aquifer-test archives; and (5) use of the USGS Multi Optional Network Key Entry System software for entry of routine water-level data collected as part of long-term water-level monitoring networks.

Are bowel purgatives and prokinetics useful for small-bowel capsule endoscopy? A prospective randomized controlled study.

PubMed

Postgate, Aymer; Tekkis, Paris; Patterson, Neil; Fitzpatrick, Aine; Bassett, Paul; Fraser, Chris

2009-05-01

Capsule endoscopy (CE) is limited by incomplete small-bowel transit and poor view quality in the distal bowel. Currently, there is no consensus regarding the use of bowel purgatives or prokinetics in CE. To evaluate the usefulness of bowel purgatives and prokinetics in small-bowel CE. Prospective single-blind randomized controlled study. Academic endoscopy unit. A total of 150 patients prospectively recruited. Patients were randomized to 1 of 4 preparations: "standard" (fluid restriction then nothing by mouth 12 hours before the procedure, water and simethicone at capsule ingestion [S]); "standard" + 10 mg oral metoclopramide before the procedure (M); Citramag + senna bowel-purgative regimen the evening before CE (CS); Citramag + senna + 10 mg metoclopramide before the procedure (CSM). Gastric transit time (GTT) and small-bowel transit time (SBTT), completion rates (CR), view quality, and patient acceptability. positive findings, diagnostic yield. No significant difference was noted among groups for GTT (median [minutes] M, CS, and CSM vs S: 17.3, 24.7, and 15.1 minutes vs 16.8 minutes, respectively; P = .62, .18, and .30, respectively), SBTT (median [minutes] M, CS, and CSM vs S: 260, 241, and 201 vs 278, respectively; P = .91, .81, and .32, respectively), or CRs (85%, 85%, and 88% vs 89% for M, CS, and CSM vs S, respectively; P = .74, .74, and 1.00, respectively). There was no significant difference in view quality among groups (of 44: 38, 37, and 40 vs 37 for M, CS, and CSM, vs S, respectively; P = .18, .62, and .12, respectively). Diagnostic yield was similar among the groups. CS and CSM regimens were significantly less convenient (P < .001), and CS was significantly less comfortable (P = .001) than standard preparation. Bowel purgatives and prokinetics do not improve CRs or view quality at CE, and bowel purgatives reduce patient acceptability.

Blood transfusion services in Delhi.

PubMed

Makroo, R N; Kumar, N D

1993-04-01

In 1991, approximately 40% of total blood requirement in Delhi was collected from commercial blood donors. The rest was supplied by voluntary and replacement donations in hospital-based blood banks and by voluntary blood recruiting agency (Indian Red Cross Society). This study analyses the standards of working and quality assurance in 26 blood transfusion centers in Delhi. The majority of these centers are ill-equipped and lack trained manpower. Most of these do not have adequate testing facilities and any standardized procedure for blood collection. Quality assurance scheme is not being followed and documentation and record maintenance is grossly inadequate. This reports also gives the recommendations for improvements of blood transfusion services in Delhi.

IMI's teaching design, feedback system and its localization

NASA Astrophysics Data System (ADS)

Wen, Tingting; Zhang, Xuexin

2017-08-01

In Britain, the Institute of the Motor Industry (IMI) sets the National Occupational Standards for all sectors of the automotive industry. The IMI certificate and associated training programs are well recognized for its high quality both in the United Kingdom (UK) and internationally. Using China's first groups studying IMI Level 3 certificate for teachers and Level 2 certificate for students as a sample, we analyzed the seven central aspects in IMI teaching, namely, assessment standard, environment, method, content, procedure, quality control and feedback. We then proposed strategies and guidelines for its localization in China, which would be particularly important for the establishment and expansion of IMI centers.

Systematic reviews of surgical procedures in children: quantity, coverage and quality.

PubMed

McGee, Richard G; Craig, Jonathan C; Rogerson, Thomas E; Webster, Angela C

2013-04-01

Systematic reviews have the potential to map those areas where children are under-represented in surgical research. We aimed to describe and evaluate the quantity, coverage and the quality of conduct and reporting of systematic reviews of surgical procedures in children. We searched four biomedical databases, a systematic review register, reference lists and conducted hand searching to identify relevant reviews. Two reviewers worked independently to critically appraise included studies and abstract data. We assessed reporting quality using the preferred reporting items for systematic reviews and meta-analysis statement and methodological quality using the Assessment of Multiple SysTemAtic Reviews tool. Fifteen systematic reviews were identified, representing 0.01% of all paediatric surgical citations in MEDLINE and Embase. Thirteen of the reviews were Cochrane reviews, and most reviews (12/15) addressed subspecialty interests such as otorhinolaryngology. The median number of included trials per systematic review was four (interquartile range 1 to 9.5), the median number of primary outcomes was 5.5 (interquartile range 3.5 to 7.5). In general, reporting and methodological quality was good although there were several omissions, particularly around completeness of reporting of statistical methods used, and utilisation of quality assessments in analyses. Outcomes were often not clearly defined and descriptions of procedures lacked sufficient detail to determine the similarities and differences among surgical procedures within the contributing trials. Systematic reviews of surgical procedures in children are rarely published. To improve the evidence base and guide research agendas, more systematic reviews should be conducted, using standard guidelines for conduct and reporting. © 2013 The Authors. Journal of Paediatrics and Child Health © 2013 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Quality control of colonoscopy procedures: a prospective validated method for the evaluation of professional practices applicable to all endoscopic units.

PubMed

Coriat, R; Pommaret, E; Chryssostalis, A; Viennot, S; Gaudric, M; Brezault, C; Lamarque, D; Roche, H; Verdier, D; Parlier, D; Prat, F; Chaussade, S

2009-02-01

To produce valid information, an evaluation of professional practices has to assess the quality of all practices before, during and after the procedure under study. Several auditing techniques have been proposed for colonoscopy. The purpose of this work is to describe a straightforward original validated method for the prospective evaluation of professional practices in the field of colonoscopy applicable in all endoscopy units without increasing the staff work load. Pertinent quality-control criteria (14 items) were identified by the endoscopists at the Cochin Hospital and were compatible with: findings in the available literature; guidelines proposed by the Superior Health Authority; and application in any endoscopy unit. Prospective routine data were collected and the methodology validated by evaluating 50 colonoscopies every quarter for one year. The relevance of the criteria was assessed using data collected during four separate periods. The standard checklist was complete for 57% of the colonoscopy procedures. The colonoscopy procedure was appropriate according to national guidelines in 94% of cases. These observations were particularly noteworthy: the quality of the colonic preparation was insufficient for 9% of the procedures; complete colonoscopy was achieved for 93% of patients; and 0.38 adenomas and 0.045 carcinomas were identified per colonoscopy. This simple and reproducible method can be used for valid quality-control audits in all endoscopy units. In France, unit-wide application of this method enables endoscopists to validate 100 of the 250 points required for continuous medical training. This is a quality-control tool that can be applied annually, using a random month to evaluate any changes in routine practices.

Quality-assurance data for routine water analyses by the U.S. Geological Survey laboratory in Troy, New York - July 2003 through June 2005

USGS Publications Warehouse

Lincoln, Tricia A.; Horan-Ross, Debra A.; McHale, Michael R.; Lawrence, Gregory B.

2009-01-01

The laboratory for analysis of low-ionic-strength water at the U.S. Geological Survey (USGS) Water Science Center in Troy, N.Y., analyzes samples collected by USGS projects throughout the Northeast. The laboratory's quality-assurance program is based on internal and interlaboratory quality-assurance samples and quality-control procedures that were developed to ensure proper sample collection, processing, and analysis. The quality-assurance and quality-control data were stored in the laboratory's Lab Master data-management system, which provides efficient review, compilation, and plotting of data. This report presents and discusses results of quality-assurance and quality control samples analyzed from July 2003 through June 2005. Results for the quality-control samples for 20 analytical procedures were evaluated for bias and precision. Control charts indicate that data for five of the analytical procedures were occasionally biased for either high-concentration or low-concentration samples but were within control limits; these procedures were: acid-neutralizing capacity, total monomeric aluminum, pH, silicon, and sodium. Seven of the analytical procedures were biased throughout the analysis period for the high-concentration sample, but were within control limits; these procedures were: dissolved organic carbon, chloride, nitrate (ion chromatograph), nitrite, silicon, sodium, and sulfate. The calcium and magnesium procedures were biased throughout the analysis period for the low-concentration sample, but were within control limits. The total aluminum and specific conductance procedures were biased for the high-concentration and low-concentration samples, but were within control limits. Results from the filter-blank and analytical-blank analyses indicate that the procedures for 17 of 18 analytes were within control limits, although the concentrations for blanks were occasionally outside the control limits. The data-quality objective was not met for dissolved organic carbon. Sampling and analysis precision are evaluated herein in terms of the coefficient of variation obtained for triplicate samples in the procedures for 18 of the 22 analytes. At least 85 percent of the samples met data-quality objectives for all analytes except total monomeric aluminum (82 percent of samples met objectives), total aluminum (77 percent of samples met objectives), chloride (80 percent of samples met objectives), fluoride (76 percent of samples met objectives), and nitrate (ion chromatograph) (79 percent of samples met objectives). The ammonium and total dissolved nitrogen did not meet the data-quality objectives. Results of the USGS interlaboratory Standard Reference Sample (SRS) Project indicated good data quality over the time period, with ratings for each sample in the satisfactory, good, and excellent ranges or less than 10 percent error. The P-sample (low-ionic-strength constituents) analysis had one marginal and two unsatisfactory ratings for the chloride procedure. The T-sample (trace constituents)analysis had two unsatisfactory ratings and one high range percent error for the aluminum procedure. The N-sample (nutrient constituents) analysis had one marginal rating for the nitrate procedure. Results of Environment Canada's National Water Research Institute (NWRI) program indicated that at least 84 percent of the samples met data-quality objectives for 11 of the 14 analytes; the exceptions were ammonium, total aluminum, and acid-neutralizing capacity. The ammonium procedure did not meet data quality objectives in all studies. Data-quality objectives were not met in 23 percent of samples analyzed for total aluminum and 45 percent of samples analyzed acid-neutralizing capacity. Results from blind reference-sample analyses indicated that data-quality objectives were met by at least 86 percent of the samples analyzed for calcium, chloride, fluoride, magnesium, pH, potassium, sodium, and sulfate. Data-quality objectives were not met by samples analyzed for fluoride. 

40 CFR Appendix A to Subpart Mmmm... - Alternative Capture Efficiency and Destruction Efficiency Measurement and Monitoring Procedures...

Code of Federal Regulations, 2013 CFR

2013-07-01

... change from job to job. The air balance in magnet wire ovens is critical to product quality. Magnet wire... Method D5291-02, “Standard Test Methods for Instrumental Determination of Carbon, Hydrogen, and Nitrogen...

40 CFR Appendix A to Subpart Mmmm... - Alternative Capture Efficiency and Destruction Efficiency Measurement and Monitoring Procedures...

Code of Federal Regulations, 2014 CFR

2014-07-01

... change from job to job. The air balance in magnet wire ovens is critical to product quality. Magnet wire... Method D5291-02, “Standard Test Methods for Instrumental Determination of Carbon, Hydrogen, and Nitrogen...

40 CFR Appendix A to Subpart Mmmm... - Alternative Capture Efficiency and Destruction Efficiency Measurement and Monitoring Procedures...

Code of Federal Regulations, 2012 CFR

2012-07-01

... change from job to job. The air balance in magnet wire ovens is critical to product quality. Magnet wire... Method D5291-02, “Standard Test Methods for Instrumental Determination of Carbon, Hydrogen, and Nitrogen...

40 CFR Appendix A to Subpart Mmmm... - Alternative Capture Efficiency and Destruction Efficiency Measurement and Monitoring Procedures...

Code of Federal Regulations, 2011 CFR

2011-07-01

... change from job to job. The air balance in magnet wire ovens is critical to product quality. Magnet wire... Method D5291-02, “Standard Test Methods for Instrumental Determination of Carbon, Hydrogen, and Nitrogen...

40 CFR Appendix A to Subpart Mmmm... - Alternative Capture Efficiency and Destruction Efficiency Measurement and Monitoring Procedures...

Code of Federal Regulations, 2010 CFR

2010-07-01

... change from job to job. The air balance in magnet wire ovens is critical to product quality. Magnet wire... Method D5291-02, “Standard Test Methods for Instrumental Determination of Carbon, Hydrogen, and Nitrogen...

32 CFR Appendix A to Part 290 - DCAA's Organization and Mission

Code of Federal Regulations, 2010 CFR

2010-07-01

... established audit quality control standards, policies, and procedures and other internal control requirements... Information Service, 5285 Port Royal Road, Springfield, VA 22161. (c) Objective. Assist in achieving the... provides accounting and financial advisory service regarding contracts to all DoD components responsible...

34 CFR 602.31 - Agency submissions to the Department.

Code of Federal Regulations, 2011 CFR

2011-07-01

... standards, policies, or procedures developed and applied by the agency and documentation of the application... capacity of the institutions or programs it accredits to accommodate significant growth in enrollment and to maintain educational quality; (2) The specific circumstances regarding the growth at the...

STANDARD OPERATING PROCEDURE FOR QUALITY ASSURANCE IN ANALYTICAL CHEMISTRY METHODS DEVELOPMENT

EPA Science Inventory

The Environmental Protection Agency's (EPA) Office of Research and Development (ORD) is engaged in the development, demonstration, and validation of new or newly adapted methods of analysis for environmentally related samples. Recognizing that a "one size fits all" approach to qu...

76 FR 4091 - Proposed Information Collection; Comment Request; Certification Requirements for NOAA's...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-24

... Collection; Comment Request; Certification Requirements for NOAA's Hydrographic Product Quality Assurance... hydrographic products are proposed for certification; by which standards and compliance tests are developed, adopted, and applied for those products; and by which certification is awarded or denied. These procedures...

How personal and standardized coordination impact implementation of integrated care.

PubMed

Benzer, Justin K; Cramer, Irene E; Burgess, James F; Mohr, David C; Sullivan, Jennifer L; Charns, Martin P

2015-10-02

Integrating health care across specialized work units has the potential to lower costs and increase quality and access to mental health care. However, a key challenge for healthcare managers is how to develop policies, procedures, and practices that coordinate care across specialized units. The purpose of this study was to identify how organizational factors impacted coordination, and how to facilitate implementation of integrated care. Semi-structured interviews were conducted in August 2009 with 30 clinic leaders and 35 frontline staff who were recruited from a convenience sample of 16 primary care and mental health clinics across eight medical centers. Data were drawn from a management evaluation of primary care-mental health integration in the US Department of Veterans Affairs. To protect informant confidentiality, the institutional review board did not allow quotations. Interviews identified antecedents of organizational coordination processes, and highlighted how these antecedents can impact the implementation of integrated care. Overall, implementing new workflow practices were reported to create conflicts with pre-existing standardized coordination processes. Personal coordination (i.e., interpersonal communication processes) between primary care leaders and staff was reported to be effective in overcoming these barriers both by working around standardized coordination barriers and modifying standardized procedures. This study identifies challenges to integrated care that might be solved with attention to personal and standardized coordination. A key finding was that personal coordination both between primary care and mental health leaders and between frontline staff is important for resolving barriers related to integrated care implementation. Integrated care interventions can involve both new standardized procedures and adjustments to existing procedures. Aligning and integrating procedures between primary care and specialty care requires personal coordination amongst leaders. Interpersonal relationships should be strengthened between staff when personal connections are important for coordinating patient care across clinical settings.

Laboratory diagnosis of creatine deficiency syndromes: a technical standard and guideline of the American College of Medical Genetics and Genomics.

PubMed

Sharer, J Daniel; Bodamer, Olaf; Longo, Nicola; Tortorelli, Silvia; Wamelink, Mirjam M C; Young, Sarah

2017-02-01

Disclaimer: These ACMG Standards and Guidelines are intended as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines is voluntary and does not necessarily assure a successful medical outcome. These Standards and Guidelines should not be considered inclusive of all proper procedures and tests or exclusive of others that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, clinical laboratory geneticists should apply their professional judgment to the specific circumstances presented by the patient or specimen. Clinical laboratory geneticists are encouraged to document in the patient's record the rationale for the use of a particular procedure or test, whether or not it is in conformance with these Standards and Guidelines. They also are advised to take notice of the date any particular guideline was adopted, and to consider other relevant medical and scientific information that becomes available after that date. It also would be prudent to consider whether intellectual property interests may restrict the performance of certain tests and other procedures.Cerebral creatine deficiency syndromes are neurometabolic conditions characterized by intellectual disability, seizures, speech delay, and behavioral abnormalities. Several laboratory methods are available for preliminary and confirmatory diagnosis of these conditions, including measurement of creatine and related metabolites in biofluids using liquid chromatography-tandem mass spectrometry or gas chromatography-mass spectrometry, enzyme activity assays in cultured cells, and DNA sequence analysis. These guidelines are intended to standardize these procedures to help optimize the diagnosis of creatine deficiency syndromes. While biochemical methods are emphasized, considerations for confirmatory molecular testing are also discussed, along with variables that influence test results and interpretation.Genet Med 19 2, 256-263.

Immediate tight sealing of skin incisions using an innovative temperature-controlled laser soldering device: in vivo study in porcine skin.

PubMed

Simhon, David; Halpern, Marisa; Brosh, Tamar; Vasilyev, Tamar; Ravid, Avi; Tennenbaum, Tamar; Nevo, Zvi; Katzir, Abraham

2007-02-01

A feedback temperature-controlled laser soldering system (TCLS) was used for bonding skin incisions on the backs of pigs. The study was aimed: 1) to characterize the optimal soldering parameters, and 2) to compare the immediate and long-term wound healing outcomes with other wound closure modalities. A TCLS was used to bond the approximated wound margins of skin incisions on porcine backs. The reparative outcomes were evaluated macroscopically, microscopically, and immunohistochemically. The optimal soldering temperature was found to be 65 degrees C and the operating time was significantly shorter than with suturing. The immediate tight sealing of the wound by the TCLS contributed to rapid, high quality wound healing in comparison to Dermabond or Histoacryl cyanoacrylate glues or standard suturing. TCLS of incisions in porcine skin has numerous advantages, including rapid procedure and high quality reparative outcomes, over the common standard wound closure procedures. Further studies with a variety of skin lesions are needed before advocating this technique for clinical use.

Prenatal nutrition services: a cost analysis.

PubMed

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

1987-02-01

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

Enumeration procedure for monitoring test microbe populations on inoculated carriers in AOAC use-dilution methods.

PubMed

Tomasino, Stephen F; Fiumara, Rebecca M; Cottrill, Michele P

2006-01-01

The AOAC Use-Dilution methods do not provide procedures to enumerate the test microbe on stainless steel carriers (penicylinders) or guidance on the expected target populations of the test microbe (i.e., a performance standard). This report describes the procedures used by the U.S. Environmental Protection Agency to enumerate the test microbe (carrier counts) associated with conducting the Use-Dilution method with Staphylococcus aureus (Method 955.15) and Pseudomonas aeruginosa (Method 964.02) and the examination of historical data. The carrier count procedure involves the random selection of carriers, shearing bacterial cells from the carrier surface through sonication, and plating of serially diluted inoculum on trypticase soy agar. For each Use-Dilution test conducted, the official AOAC method was strictly followed for carrier preparation, culture initiation, test culture preparation, and carrier inoculation steps. Carrier count data from 78 Use-Dilution tests conducted over a 6-year period were compiled and analyzed. A mean carrier count of 6.6 logs (approximately 4.0 x 10(6) colony-forming units/carrier) was calculated for both S. aureus and P. aeruginosa. Of the mean values, 95% fell within +/- 2 repeatability standard deviations. The enumeration procedure and target carrier counts are desirable for standardizing the Use-Dilution methods, increasing their reproducibility, and ensuring the quality of the data.

Bioaccumulation of toxic substances associated with dredging and dredged material disposal: a literature review

USGS Publications Warehouse

Seelye, James G.; Mac, Michael J.

1984-01-01

A literature review of sediment bioassessment was conducted as the first step in the development of a more standardized and ecologically sound test procedure for evaluating sediment quality. Based on the review, the authors concluded that 1) a standardized laboratory bioassessment test should consist of flowthrough exposure of at least 10 days duration using more than one aquatic organism including at least an infaunal benthic invertebrate and a fish species. 2) Before adoption of a laboratory sediment bioassessment procedure, the laboratory results should be evaluated by comparison with field conditions. 3) Most current sediment bioassessment regulatory tests measure acute toxicity or bioaccumulation. Development of tests to evaluate chronic, sublethal effects is needed.

Simulation improves procedural protocol adherence during central venous catheter placement: a randomized-controlled trial

PubMed Central

Peltan, Ithan D.; Shiga, Takashi; Gordon, James A.; Currier, Paul F.

2015-01-01

Background Simulation training may improve proficiency at and reduces complications from central venous catheter (CVC) placement, but the scope of simulation’s effect remains unclear. This randomized controlled trial evaluated the effects of a pragmatic CVC simulation program on procedural protocol adherence, technical skill, and patient outcomes. Methods Internal medicine interns were randomized to standard training for CVC insertion or standard training plus simulation-based mastery training. Standard training involved a lecture, a video-based online module, and instruction by the supervising physician during actual CVC insertions. Intervention-group subjects additionally underwent supervised training on a venous access simulator until they demonstrated procedural competence. Raters evaluated interns’ performance during internal jugular CVC placement on actual patients in the medical intensive care unit. Generalized estimating equations were used to account for outcome clustering within trainees. Results We observed 52 interns place 87 CVCs. Simulation-trained interns exhibited better adherence to prescribed procedural technique than interns who received only standard training (p=0.024). There were no significant differences detected in first-attempt or overall cannulation success rates, mean needle passes, global assessment scores or complication rates. Conclusions Simulation training added to standard training improved protocol adherence during CVC insertion by novice practitioners. This study may have been too small to detect meaningful differences in venous cannulation proficiency and other clinical outcomes, highlighting the difficulty of patient-centered simulation research in settings where poor outcomes are rare. For high-performing systems, where protocol deviations may provide an important proxy for rare procedural complications, simulation may improve CVC insertion quality and safety. PMID:26154250

[What is the methodological quality of articles on therapeutic procedures published in Cirugía Española?].

PubMed

Manterola, Carlos; Busquets, Juli; Pascual, Marta; Grande, Luis

2006-02-01

The aim of this study was to determine the methodological quality of articles on therapeutic procedures published in Cirugía Española and to study its association with the publication year, center, and subject-matter. A bibliometric study that included all articles on therapeutic procedures published in Cirugía Española between 2001 and 2004 was performed. All kinds of clinical designs were considered, excluding editorials, review articles, letters to editor, and experimental studies. The variables analyzed were: year of publication, center, design, and methodological quality. Methodological quality was determined by a valid and reliable scale. Descriptive statistics (calculation of means, standard deviation and medians) and analytical statistics (Pearson's chi2, nonparametric, ANOVA and Bonferroni tests) were used. A total of 244 articles were studied (197 case series [81%], 28 cohort studies [12%], 17 clinical trials [7%], 1 cross sectional study and 1 case-control study [0.8%]). The studies were performed mainly in Catalonia and Murcia (22% and 16%, respectively). The most frequent subject areas were soft tissue and hepatobiliopancreatic surgery (23% and 19%, respectively). The mean and median of the methodological quality score calculated for the entire series was 10.2 +/- 3.9 points and 9.5 points, respectively. Methodological quality significantly increased by publication year (p < 0.001). An association between methodological quality and subject area was observed but no association was detected with the center performing the study. The methodological quality of articles on therapeutic procedures published in Cirugía Española between 2001 and 2004 is low. However, a statistically significant trend toward improvement was observed.

Quality of radiotherapy reporting in randomized controlled trials of prostate cancer.

PubMed

Soon, Yu Yang; Chen, Desiree; Tan, Teng Hwee; Tey, Jeremy

2018-06-07

Good radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer. We searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting. We found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria. There is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.

Setting the standard, implementation and auditing within haemodialysis.

PubMed

Jones, J

1997-01-01

With an ever increasing awareness of the need to deliver a quality of care that is measurable in Nursing, the concept of Standards provides an ideal tool (1). Standards operate outside the boundaries of policies and procedures to provide an audit tool of authenticity and flexibility. Within our five Renal Units, while we felt confident that we were delivering an excellent standard of care to our patients and continually trying to improve upon it, what we really needed was a method of measuring this current level of care and highlighting key areas where we could offer improvement.

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

NONE

The study was conducted to determine the pollutants of concern in the Istanbul metropolitan area, monitoring equipment specifications and monitoring and data analysis procedures for an air quality and meteorological monitoring program. This volume consists of: (1) Introduction; (2) Selection of Pollutants of Concern; (3) Selection of Monitoring Locations; (4) Equipment Specifications; (5) Site Preparation and Security; (6) Standard Operating Procedures; (7) Data Reduction and Analysis; (8) Future Phases; (9) References. Also included are Attachments A through G and List of Tables and List of Figures.

Adjustment of regional regression models of urban-runoff quality using data for Chattanooga, Knoxville, and Nashville, Tennessee

USGS Publications Warehouse

Hoos, Anne B.; Patel, Anant R.

1996-01-01

Model-adjustment procedures were applied to the combined data bases of storm-runoff quality for Chattanooga, Knoxville, and Nashville, Tennessee, to improve predictive accuracy for storm-runoff quality for urban watersheds in these three cities and throughout Middle and East Tennessee. Data for 45 storms at 15 different sites (five sites in each city) constitute the data base. Comparison of observed values of storm-runoff load and event-mean concentration to the predicted values from the regional regression models for 10 constituents shows prediction errors, as large as 806,000 percent. Model-adjustment procedures, which combine the regional model predictions with local data, are applied to improve predictive accuracy. Standard error of estimate after model adjustment ranges from 67 to 322 percent. Calibration results may be biased due to sampling error in the Tennessee data base. The relatively large values of standard error of estimate for some of the constituent models, although representing significant reduction (at least 50 percent) in prediction error compared to estimation with unadjusted regional models, may be unacceptable for some applications. The user may wish to collect additional local data for these constituents and repeat the analysis, or calibrate an independent local regression model.

Quality evaluation of LC-MS/MS-based E. coli H antigen typing (MS-H) through label-free quantitative data analysis in a clinical sample setup.

PubMed

Cheng, Keding; Sloan, Angela; McCorrister, Stuart; Peterson, Lorea; Chui, Huixia; Drebot, Mike; Nadon, Celine; Knox, J David; Wang, Gehua

2014-12-01

The need for rapid and accurate H typing is evident during Escherichia coli outbreak situations. This study explores the transition of MS-H, a method originally developed for rapid H antigen typing of E. coli using LC-MS/MS of flagella digest of reference strains and some clinical strains, to E. coli isolates in clinical scenario through quantitative analysis and method validation. Motile and nonmotile strains were examined in batches to simulate clinical sample scenario. Various LC-MS/MS batch run procedures and MS-H typing rules were compared and summarized through quantitative analysis of MS-H data output for a standard method development. Label-free quantitative data analysis of MS-H typing was proven very useful for examining the quality of MS-H result and the effects of some sample carryovers from motile E. coli isolates. Based on this, a refined procedure and protein identification rule specific for clinical MS-H typing was established and validated. With LC-MS/MS batch run procedure and database search parameter unique for E. coli MS-H typing, the standard procedure maintained high accuracy and specificity in clinical situations, and its potential to be used in a clinical setting was clearly established. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Integrating standard operating procedures and industry notebook standards to evaluate students in laboratory courses.

PubMed

Wallert, Mark A; Provost, Joseph J

2014-01-01

To enhance the preparedness of graduates from the Biochemistry and Biotechnology (BCBT) Major at Minnesota State University Moorhead for employment in the bioscience industry we have developed a new Industry certificate program. The BCBT Industry Certificate was developed to address specific skill sets that local, regional, and national industry experts identified as lacking in new B.S. and B.A. biochemistry graduates. The industry certificate addresses concerns related to working in a regulated industry such as Good Laboratory Practices, Good Manufacturing Practices, and working in a Quality System. In this article we specifically describe how we developed a validation course that uses Standard Operating Procedures to describe grading policy and laboratory notebook requirements in an effort to better prepare students to transition into industry careers. © 2013 by The International Union of Biochemistry and Molecular Biology.

Improved telescope focus using only two focus images

NASA Astrophysics Data System (ADS)

Barrick, Gregory; Vermeulen, Tom; Thomas, James

2008-07-01

In an effort to reduce the amount of time spent focusing the telescope and to improve the quality of the focus, a new procedure has been investigated and implemented at the Canada-France-Hawaii Telescope (CFHT). The new procedure is based on a paper by Tokovinin and Heathcote and requires only two out-of-focus images to determine the best focus for the telescope. Using only two images provides a great time savings over the five or more images required for a standard through-focus sequence. In addition, it has been found that this method is significantly less sensitive to seeing variations than the traditional through-focus procedure, so the quality of the resulting focus is better. Finally, the new procedure relies on a second moment calculation and so is computationally easier and more robust than methods using a FWHM calculation. The new method has been implemented for WIRCam for the past 18 months, for MegaPrime for the past year, and has recently been implemented for ESPaDOnS.

Quality Assessment of Family Planning Sterilization Services at Health Care Facilities: Case Record Audit.

PubMed

Mathur, Medha; Goyal, Ram Chandra; Mathur, Navgeet

2017-05-01

Quality of sterilization services is a matter of concern in India because population control is a necessity. Family Planning Sterilization (FPS) services provided at public health care facilities need to be as per Standard Operating Procedures. To assess the quality of FPS services by audit of case records at selected health care facilities. This cross-sectional study was conducted for two and a half year duration at selected public health care facilities of central India by simple random sampling where FPS services were provided. As per the standards of Government of India, case records were audited and compliance was calculated to assess the quality of services. Results of record audit were satisfactory but important criteria like previous contraceptive history and postoperative counselling were found to be deviated from standards. At Primary Health Centres (PHCs) only 89.5% and at Community Health Centres (CHCs) 58.7% of records were having details of previous contraceptive history. Other criteria like mental illness (only 70% at CHCs) assessment were also inadequate. Although informed consent was found to be having 100% compliance in all records. Quality of care in FPS services is the matter of concern in present scenario for better quality of services. This study may enlighten the policy makers regarding improvements needed for providing quality care.

The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria

PubMed Central

Ho, Bella; Ho, Eric

2012-01-01

Introduction: ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO 15189 accreditation standard, encountered during the assessments of medical laboratories in Hong Kong, during 2004 to 2009. Materials and methods: Nonconformities reported in assessments based on ISO 15189 were analyzed in two periods – from 2004 to 2006 and in 2009. They are categorized according to the ISO 15189 clause numbers. The performance of 27 laboratories initially assessed between 2004 and 2006 was compared to their performance in the second reassessment in 2009. Results: For management requirements, nonconformities were most frequently reported against quality management system, quality and technical records and document control; whereas for technical requirements, they were reported against examination procedures, equipment, and assuring quality of examination procedures. There was no major difference in types of common nonconformities reported in the two study periods. The total number of nonconformities reported in the second reassessment of 27 laboratories in 2009 was almost halved compared to their initial assessments. The number of significant nonconformities per laboratory significantly decreased (P = 0.023). Conclusion: Similar nonconformities were reported in the two study periods though the frequency encountered decreased. The significant decrease in number of significant nonconformities encountered in the same group of laboratories in the two periods substantiated that ISO15189 contributed to quality improvement of accredited laboratories. PMID:22838190

The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria.

PubMed

Ho, Bella; Ho, Eric

2012-01-01

ISO 15189 was a new standard published in 2003 for accrediting medical laboratories. We believe that some requirements of the ISO 15189 standard are especially difficult to meet for majority of laboratories. The aim of this article was to present the frequency of nonconformities to requirements of the ISO 15189 accreditation standard, encountered during the assessments of medical laboratories in Hong Kong, during 2004 to 2009. Nonconformities reported in assessments based on ISO 15189 were analyzed in two periods - from 2004 to 2006 and in 2009. They are categorized according to the ISO 15189 clause numbers. The performance of 27 laboratories initially assessed between 2004 and 2006 was compared to their performance in the second reassessment in 2009. For management requirements, nonconformities were most frequently reported against quality management system, quality and technical records and document control; whereas for technical requirements, they were reported against examination procedures, equipment, and assuring quality of examination procedures. There was no major difference in types of common nonconformities reported in the two study periods. The total number of nonconformities reported in the second reassessment of 27 laboratories in 2009 was almost halved compared to their initial assessments. The number of significant nonconformities per laboratory significantly decreased (P = 0.023). Similar nonconformities were reported in the two study periods though the frequency encountered decreased. The significant decrease in number of significant nonconformities encountered in the same group of laboratories in the two periods substantiated that 15015189 contributed to quality improvement of accredited laboratories.

Development of standard operating procedures of Habbe Shifa: A polyherbal Unani formulation.

PubMed

Tarannum, Asira; Shamsi, Shariq; Zaman, Roohi

2013-07-01

Unani medicines are being used since antiquity. However, in spite of their efficacy, they have been widely criticized due to lack of standardization and poor quality presentation. For this reason, application of good manufacturing practices and development of standard operating procedures (SOPs) in the manufacture of herbal medicines became an essential tool to assure their quality. Therefore, the objective of the study was to develop the SOP of Habbe Shifa (HS) regarding the particle size (PS), binder, temperature of drying, and duration of drying. In this study, 24 batches of HS were prepared according to the instructions given in formulary to develop SOP. Three particle sizes (i.e., 80, 100, and 120 No. Mesh sieve), were taken for preparation of pills. Water and Samaghe Arabi (Gum Acacia mucilage [GAM]) were used as binder for preparing the lubdi (mass) in different batches. Different temperature and duration of drying were used to dry the pills in hot air oven to get satisfactory results. All the batches were assessed three times for hardness, friability, and disintegration time and mean regarded as standard parameter value. The batch with 150 μm PS (100 mesh sieve), 5% w/w GAM used as a binder, dried at 90°C for 120 min showed hardness 3.50 ± 0.00 kg/cm, friability 0.02 ± 0.003%, and disintegration time 25.00 ± 0.57 min, which showed most appropriate result among all batches and considered as final batch. Its SOP may be used for future reference which can help in setting up regulatory limit to assure the quality of Unani medicines.

New tools for non-invasive exploration of collagen network in cartilaginous tissue-engineered substitute.

PubMed

Henrionnet, Christel; Dumas, Dominique; Hupont, Sébastien; Stoltz, Jean François; Mainard, Didier; Gillet, Pierre; Pinzano, Astrid

2017-01-01

In tissue engineering approaches, the quality of substitutes is a key element to determine its ability to treat cartilage defects. However, in clinical practice, the evaluation of tissue-engineered cartilage substitute quality is not possible due to the invasiveness of the standard procedure, which is to date histology. The aim of this work was to validate a new innovative system performed from two-photon excitation laser adapted to an optical macroscope to evaluate at macroscopic scale the collagen network in cartilage tissue-engineered substitutes in confrontation with gold standard histologic techniques or immunohistochemistry to visualize type II collagen. This system permitted to differentiate the quality of collagen network between ITS and TGF-β1 treatments. Multiscale large field imaging combined to multimodality approaches (SHG-TCSPC) at macroscopical scale represent an innovative and non-invasive technique to monitor the quality of collagen network in cartilage tissue-engineered substitutes before in vivo implantation.

Gap Analysis for Chinese Drug Control Institutes to Achieve the Standards of World Health Organization Medicine Prequalification.

PubMed

Mao, Xin; Yang, Yue

2017-02-01

The study aims to explore the challenges and the gaps faced by Chinese Drug Control Institutes in achieving the standards of World Health Organization (WHO) Medicine Prequalification. The study was undertaken with 6 Provincial Drug Control Institutes in China from November 2012 to November 2013. The study assessed key elements required to comply with WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL). For GPPQCL, the study found gaps in quality management system, control of documentation, data-processing equipment, premises and equipment, contracts, reagents (water), reference substances and reference materials, calibration, verification of performance and qualification of equipment, instruments and other devices, analytical worksheet, evaluation of test results, personnel, and validation of analytical procedures. The study indicates that gaps are attributed to differences between the standards of Chinese Accreditation Standards and WHO-GPPQCL. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Health Care Cost Containment Education for Physicians in the Military Health Services System

DTIC Science & Technology

1980-09-01

active professional life IRoark 19783. The individual judgement used by the physicianj in ordering a particular procedu.re is difficult to examine...even more so* Quality assessment is unavoidably a value Judgement that involves the approximation of one or more normative standards [Twaddle and...methods of prospective reimbursement in an attempt to provide incentives to hold down costs, Professional Standards Review Organizations (PSRO’s) in an

The value proposition of structured reporting in interventional radiology.

PubMed

Durack, Jeremy C

2014-10-01

The purposes of this article are to provide a brief overview of structured radiology reporting and to emphasize the anticipated benefits from a new generation of standardized interventional radiology procedure reports. Radiology reporting standards and tools have evolved to enable automated data integration from multiple institutions using structured templates. In interventional radiology, data aggregated into clinical, research and quality registries from enriched structured reports could firmly establish the interventional radiology value proposition.

Primary calibrations of radionuclide solutions and sources for the EML quality assessment program

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

Fisenne, I.M.

1993-12-31

The quality assurance procedures established for the operation of the U.S. Department of Energy`s Environmental Measurements Laboratory (DOE-EML`s) Quality Assessment Program (QAP) are essentially the same as those that are in effect for any EML program involving radiometric measurements. All these programs have at their core the use of radionuclide standards for their instrument calibration. This paper focuses on EML`s approach to the acquisition, calibration and application of a wide range of radionuclide sources that are required to meet its programmatic needs.

40 CFR 204.57-3 - Test compressor preparation.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROGRAMS NOISE EMISSION STANDARDS FOR CONSTRUCTION EQUIPMENT Portable Air Compressors § 204.57-3 Test... measurement methodology. (c) In the event of compressor manfunction (i.e., failure to start, misfiring... in a normal manner. (d) No quality control, testing, assembly, or selection procedures shall be used...

The European general thoracic surgery database project.

PubMed

Falcoz, Pierre Emmanuel; Brunelli, Alessandro

2014-05-01

The European Society of Thoracic Surgeons (ESTS) Database is a free registry created by ESTS in 2001. The current online version was launched in 2007. It runs currently on a Dendrite platform with extensive data security and frequent backups. The main features are a specialty-specific, procedure-specific, prospectively maintained, periodically audited and web-based electronic database, designed for quality control and performance monitoring, which allows for the collection of all general thoracic procedures. Data collection is the "backbone" of the ESTS database. It includes many risk factors, processes of care and outcomes, which are specially designed for quality control and performance audit. The user can download and export their own data and use them for internal analyses and quality control audits. The ESTS database represents the gold standard of clinical data collection for European General Thoracic Surgery. Over the past years, the ESTS database has achieved many accomplishments. In particular, the database hit two major milestones: it now includes more than 235 participating centers and 70,000 surgical procedures. The ESTS database is a snapshot of surgical practice that aims at improving patient care. In other words, data capture should become integral to routine patient care, with the final objective of improving quality of care within Europe.

Assessment of the iodine concentration in table salt at the production stage in South Africa.

PubMed Central

Jooste, Pieter L.

2003-01-01

OBJECTIVE: To determine the iodine content of iodized salt at the production stage, to assess the perceptions and knowledge of salt producers about the prevention and control of iodine deficiency, and to examine the internal quality control procedures used during iodization in South Africa. METHOD: Salt samples were collected for iodine analysis by titration from the 12 producers iodizing salt in South Africa. Information on the producers' knowledge of iodine deficiency disorders and on internal quality control was obtained by means of questionnaires. FINDINGS: The legal requirement of 40-60 ppm iodine was met in 30.9% of salt samples; 57.9% contained more than 30 ppm iodine; 34.8% contained under 20 ppm iodine. There were shortcomings in perceptions and knowledge about iodine deficiency disorders and in the internal quality control procedures of a substantial proportion of the producers. CONCLUSION: In order to encourage and support salt producers to achieve optimal iodization there should be an information, education and communication strategy aimed at improving knowledge of iodine deficiency disorders and at raising the standard of internal quality control procedures. External monitoring should continue. PMID:12973644

Effectiveness and legitimacy of forest carbon standards in the OTC voluntary carbon market

PubMed Central

2011-01-01

Background In recent years, the voluntary over-the-counter (OTC) carbon market has reached a significant market volume. It is particularly interesting for forest mitigation projects which are either ineligible in compliance markets or confronted with a plethora of technical and financial hurdles and lacking market demand. As the OTC market is not regulated, voluntary standards have been created to secure the social and environmental integrity of the traded mitigation projects and thus to ensure the quality of the resulting carbon credits. Building on a theoretical efficiency-legitimacy framework, this study aims to identify and analyse the characteristics and indicators that determine the efficiency and organisational legitimacy of standards for afforestation/reforestation carbon projects. Results All interviewed market actors consider third-party certification and standards as a crucial component of market functionality, which provide quality assurance mechanisms that reduce information asymmetries and moral hazard between the actors regarding the quality of carbon credits, and thus reduce transaction costs. Despite this development, the recent evolution of many new and differing standards is seen as a major obstacle that renders it difficult for project developers and buyers to select an appropriate standard. According to the interviewed experts the most important legitimating factors of standards are assurance of a sufficient level of quality of carbon credits, scientifically substantiated methodological accounting and independent third-party verification, independence of standard bodies, transparency, wide market acceptance, back-up of the wider community including experts and NGOs, rigorous procedures, and the resemblance to the Afforestation/Reforestation (A/R) CDM due to its international policy endorsements. In addition, standards must provide evidence that projects contribute to a positive social and environmental development, do no harm as a minimum requirement and build a strong track record of successful projects. Project developers require clear, easily and practically applicable standards at lowest possible costs with a high potential in order to achieve good carbon prices, while buyers require that standards are legitimate, credible and that no public criticism arises when carbon credits are purchased from projects certified by a certain standard. Conclusions Despite the fragmented and immature state of the OTC market, standards act as 'market-making' intermediaries and contribute to the quality and transparency of the OTC market. However, the variety of different standards imposes new hurdles for their efficiency and often creates confusion instead of confidence among potential buyers. Despite the lacking legitimacy of the standards, pressures from the institutional environment on standards ensure a minimum quality of carbon credits (including positive social and environmental impacts of carbon credits) that serves as an insurance mechanism for the integrity of standards. Its unregulated nature and the pressure from an increasingly competitive environment provides innovative space to deliver efficient certification procedures without imposing unreasonably high transaction costs on market actors. Furthermore, voluntary standards imply a more innovative certification approach, as one legal authority could do, because standards have to compete for adopters backed by civil society organisations. Thereby, the forest sector in OTC voluntary market bears great opportunities to provide the forest sector with crucial lessons for international climate policy and governmental institutions when designing regulation for forest regulation such as international and national REDDplus schemes. PMID:21849036

Use of Joint Commission International Standards to Evaluate and Improve Pediatric Oncology Nursing Care in Guatemala

PubMed Central

Day, Sara W.; McKeon, Leslie M.; Garcia, Jose; Wilimas, Judith A.; Carty, Rita M.; de Alarcon, Pedro; Antillon, Federico; Howard, Scott C.

2017-01-01

Background Inadequate nursing care is a major impediment to development of effective programs for treatment of childhood cancer in low-income countries. When the International Outreach Program at St. Jude Children’s Research Hospital established partner sites in low-income countries, few nurses had pediatric oncology skills or experience. A comprehensive nursing program was developed to promote the provision of quality nursing care, and in this manuscript we describe the program’s impact on 20 selected Joint Commission International (JCI) quality standards at the National Pediatric Oncology Unit in Guatemala. We utilized JCI standards to focus the nursing evaluation and implementation of improvements. These standards were developed to assess public hospitals in low-income countries and are recognized as the gold standard of international quality evaluation. Methods We compared the number of JCI standards met before and after the nursing program was implemented using direct observation of nursing care; review of medical records, policies, procedures, and job descriptions; and interviews with staff. Results In 2006, only 1 of the 20 standards was met fully, 2 partially, and 17 not met. In 2009, 16 were met fully, 1 partially, and 3 not met. Several factors contributed to the improvement. The pre-program quality evaluation provided objective and credible findings and an organizational framework for implementing change. The medical, administrative, and nursing staff worked together to improve nursing standards. Conclusion A systematic approach and involvement of all hospital disciplines led to significant improvement in nursing care that was reflected by fully meeting 16 of 20 standards. PMID:23015363

Building a Quality Controlled Database of Meteorological Data from NASA Kennedy Space Center and the United States Air Force's Eastern Range

NASA Technical Reports Server (NTRS)

Brenton, James C.; Barbre. Robert E., Jr.; Decker, Ryan K.; Orcutt, John M.

2018-01-01

The National Aeronautics and Space Administration's (NASA) Marshall Space Flight Center (MSFC) Natural Environments Branch (EV44) has provided atmospheric databases and analysis in support of space vehicle design and day-of-launch operations for NASA and commercial launch vehicle programs launching from the NASA Kennedy Space Center (KSC), co-located on the United States Air Force's Eastern Range (ER) at the Cape Canaveral Air Force Station. The ER complex is one of the most heavily instrumented sites in the United States with over 31 towers measuring various atmospheric parameters on a continuous basis. An inherent challenge with large sets of data consists of ensuring erroneous data is removed from databases, and thus excluded from launch vehicle design analyses. EV44 has put forth great effort in developing quality control (QC) procedures for individual meteorological instruments, however no standard QC procedures for all databases currently exists resulting in QC databases that have inconsistencies in variables, methodologies, and periods of record. The goal of this activity is to use the previous efforts by EV44 to develop a standardized set of QC procedures from which to build meteorological databases from KSC and the ER, while maintaining open communication with end users from the launch community to develop ways to improve, adapt and grow the QC database. Details of the QC procedures will be described. As the rate of launches increases with additional launch vehicle programs, it is becoming more important that weather databases are continually updated and checked for data quality before use in launch vehicle design and certification analyses.

Assessment of three medical and research laboratories using WHO AFRO_SLIPTA Quality Standards in Southwestern Uganda: a long way to go.

PubMed

Taremwa, Ivan Mugisha; Ampaire, Lucas; Iramiot, Jacob; Muhwezi, Obed; Matte, Aloysius; Itabangi, Herbert; Mbabazi, Hope; Atwebembeire, Jeninah; Kamwine, Monicah; Katawera, Victoria; Mbalibulha, Yona; Orikiriza, Patrick; Boum, Yap

2017-01-01

While the laboratory represents more than 70% of clinical diagnosis and patient management, access to reliable and quality laboratory diagnostics in sub-Saharan Africa remains a challenge. To gain knowledge and suggest evidence based interventions towards laboratory improvement in Southwestern Uganda, we assessed the baseline laboratory quality standards in three medical and research laboratories in Southwestern Uganda. We conducted a cross sectional survey from October, 2013 to April, 2014. Selected laboratories, including one private research, one private for profit and one public laboratory, were assessed using the WHO AFRO_SLIPTA checklist and baseline scores were determined. The three laboratories assessed met basic facility requirements, had trained personnel, and safety measures in place. Sample reception was properly designed and executed with a well designated chain of custody. All laboratories had sufficient equipment for the nature of work they were involved in. However, we found that standard operating procedures were incomplete in all three laboratories, lack of quality audit schemes by two laboratories and only one laboratory enrolled into external quality assurance schemes. The SLIPTA scores were one star for the research laboratory and no star for both the public and private-for-profit laboratories. While most of the laboratory systems were in place, the low scores obtained by the assessed laboratories reflect the need for improvement to reach standards of quality assured diagnostics in the region. Therefore, routine mentorship and regional supportive supervision are necessary to increase the quality of laboratory services.

The grain-size lineup: A test of a novel eyewitness identification procedure.

PubMed

Horry, Ruth; Brewer, Neil; Weber, Nathan

2016-04-01

When making a memorial judgment, respondents can regulate their accuracy by adjusting the precision, or grain size, of their responses. In many circumstances, coarse-grained responses are less informative, but more likely to be accurate, than fine-grained responses. This study describes a novel eyewitness identification procedure, the grain-size lineup, in which participants eliminated any number of individuals from the lineup, creating a choice set of variable size. A decision was considered to be fine-grained if no more than 1 individual was left in the choice set or coarse-grained if more than 1 individual was left in the choice set. Participants (N = 384) watched 2 high-quality or low-quality videotaped mock crimes and then completed 4 standard simultaneous lineups or 4 grain-size lineups (2 target-present and 2 target-absent). There was some evidence of strategic regulation of grain size, as the most difficult lineup was associated with a greater proportion of coarse-grained responses than the other lineups. However, the grain-size lineup did not outperform the standard simultaneous lineup. Fine-grained suspect identifications were no more diagnostic than suspect identifications from standard lineups, whereas coarse-grained suspect identifications carried little probative value. Participants were generally reluctant to provide coarse-grained responses, which may have hampered the utility of the procedure. For a grain-size approach to be useful, participants may need to be trained or instructed to use the coarse-grained option effectively. (c) 2016 APA, all rights reserved).

[ISO 9001 certification of innovation and clinical research departments: Extending the scope of health assessment].

PubMed

Sambou, C; Guillemaut, S; Morelle, M; Achache, A; Le Corroller, A-G; Perol, D; Perrier, L

2017-04-01

The International organization for standardization (ISO) is the world leader in providing industrial and commercial standards and certifications. Beyond medical devices, four French clinical research and innovation departments have received an ISO 9001 certification (the standard for quality management). Simultaneously, medico-economic studies have become increasingly important in the public decision process. Using the clinical research and innovation department from the Léon-Bérard Cancer Center as an example, the purpose of this article is to show how the scope of the ISO 9001 certification has been extended to cover medico-economic studies. All of the processes, procedures, operating modes, documents, and indicators used by the clinical research and innovation department of the Léon-Bérard center were investigated. Literature searches were conducted using Medline keywords. The recommendations from the French national authority for health and other organizations, such as the International society for pharmacoeconomics and outcomes research (ISPOR), were also considered, as well as the recommendations of the General inspectorate of social affairs. In accordance with the national and international recommendations, two procedures were created and four procedures were revised at this center. Five indicators of quality and an evaluation chart were developed. By adopting the ISO 9001 certification into its medico-economic studies, the clinical research and innovation department of the Léon-Bérard center has used an innovative approach in the context of the growing importance of economic studies in decision-making. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

[Hybrid operating rooms: only for advanced endovascular procedures?].

PubMed

Verhoeven, E; Katsargyris, A; Töpel, I; Steinbauer, M

2013-10-01

The evolution of endovascular techniques has led to the concept of the "hybrid operating room" (hybrid OR). A hybrid OR combines the sterility of an OR in an operating theatre environment with a high-quality fixed imaging system. On the basis of these advantages it would be desirable that an angio-hybrid OR becomes a standard requirement for endovascular surgery. In Great Britain guidelines have already been published that require a hybrid OR even for normal endovascular management of the infrarenal aorta. However, in Germany there are no guidelines from professional societies or formal rules from the federal joint committee, thus in this article a classification of endovascular procedures according to their complexity and the necessary infrastructures are proposed in order to define particular procedures that should only be performed in an angio-hybrid OR. According to our experience, endovascular procedures can be classified into four categories based on their complexity and the requirements regarding fluoroscopy: level 1: standard EVAR, TEVAR, iliac and popliteal artery procedures; level 2: iliac branched (IBD) and standard (2 fenestrations for the renal arteries and a scallop for the superior mesenteric artery) fenestrated stent-grafting; level 3: more complex fenestrated procedures (three or four fenestrations); and level 4: branched stent-grafting for TAAA. At this moment it is still acceptable to perform level 1 and level 2 procedures outside of a hybrid OR. In our opinion, it is not recommended to perform level 3 and level 4 endovascular procedures without a hybrid OR. Georg Thieme Verlag KG Stuttgart · New York.

Practical semen analysis: from A to Z

PubMed Central

Brazil, Charlene

2010-01-01

Accurate semen analysis is critical for decisions about patient care, as well as for studies addressing overall changes in semen quality, contraceptive efficacy and effects of toxicant exposure. The standardization of semen analysis is very difficult for many reasons, including the use of subjective techniques with no standards for comparison, poor technician training, problems with proficiency testing and a reluctance to change techniques. The World Health Organization (WHO) Semen handbook (2010) offers a vastly improved set of standardized procedures, all at a level of detail that will preclude most misinterpretations. However, there is a limit to what can be learned from words and pictures alone. A WHO-produced DVD that offers complete demonstrations of each technique along with quality assurance standards for motility, morphology and concentration assessments would enhance the effectiveness of the manual. However, neither the manual nor a DVD will help unless there is general acknowledgement of the critical need to standardize techniques and rigorously pursue quality control to ensure that laboratories actually perform techniques 'according to WHO' instead of merely reporting that they have done so. Unless improvements are made, patient results will continue to be compromised and comparison between studies and laboratories will have limited merit. PMID:20111076

[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.

Tools for surveying and improving the quality of life: people with special needs in focus.

PubMed

Hoyningen-Süess, Ursula; Oberholzer, David; Stalder, René; Brügger, Urs

2012-01-01

This article seeks to describe online tools for surveying and improving quality of life for people with disabilities living in assisted living centers and special education service organizations. Ensuring a decent quality of life for disabled people is an important welfare state goal. Using well-accepted quality of life conceptions, online diagnostic and planning tools were developed during an Institute for Education, University of Zurich, research project. The diagnostic tools measure, evaluate and analyze disabled people's quality of life. The planning tools identify factors that can affect their quality of life and suggest improvements. Instrument validity and reliability are not tested according to the standard statistical procedures. This will be done at a more advanced stage of the project. Instead, the tool is developed, refined and adjusted in cooperation with practitioners who are constantly judging it according to best practice standards. The tools support staff in assisted living centers and special education service organizations. These tools offer comprehensive resources for surveying, quantifying, evaluating, describing and simulating quality of life elements.

Towards an integrated quality control procedure for eddy-covariance data

NASA Astrophysics Data System (ADS)

Vitale, Domenico; Papale, Dario

2017-04-01

The eddy-covariance technique is nowadays the most reliable and direct way, allowing to calculate the main fluxes of Sensible and Latent Heat and of Net Ecosystem Exchange, this last being the result of the difference between the CO2 assimilated by photosynthetic activities and those released to the atmosphere through the ecosystem respiration processes. Despite the improvements in accuracy of measurement instruments and software development, the eddy-covariance technique is not suitable under non-ideal conditions respect to the instruments characteristics and the physical assumption behind the technique mainly related to the well-developed and stationary turbulence conditions. Under these conditions the calculated fluxes are not reliable and need to be flagged and discarded. In order to discover these unavoidable "bad" fluxes and build dataset with the highest quality, several tests applied both on high-frequency (10-20 Hz) raw data and on half-hourly times series have been developed in the past years. Nevertheless, there is an increasing need to develop a standardized quality control procedure suitable not only for the analysis of long-term data, but also for the near-real time data processing. In this paper, we review established quality assessment procedures and present an innovative quality control strategy with the purpose of integrating the existing consolidated procedures with robust and advanced statistical tests more suitable for the analysis of time series data. The performance of the proposed quality control strategy is evaluated both on simulated and EC data distributed by the ICOS research infrastructure. It is concluded that the proposed strategy is able to flag and exclude unrealistic fluxes while being reproducible and retaining the largest possible amount of high quality data.

The six critical attributes of the next generation of quality management software systems.

PubMed

Clark, Kathleen

2011-07-01

Driven by both the need to meet regulatory requirements and a genuine desire to drive improved quality, quality management systems encompassing standard operating procedure, corrective and preventative actions and related processes have existed for many years, both in paper and electronic form. The impact of quality management systems on 'actual' quality, however, is often reported as far less than desired. A quality management software system that moves beyond formal forms-driven processes to include a true closed loop design, manage disparate processes across the enterprise, provide support for collaborative processes and deliver insight into the overall state of control has the potential to close the gap between simply accomplishing regulatory compliance and delivering measurable improvements in quality and efficiency.

Blood Sampling and Preparation Procedures for Proteomic Biomarker Studies of Psychiatric Disorders.

PubMed

Guest, Paul C; Rahmoune, Hassan

2017-01-01

A major challenge in proteomic biomarker discovery and validation for psychiatric diseases is the inherent biological complexity underlying these conditions. There are also many technical issues which hinder this process such as the lack of standardization in sampling, processing and storage of bio-samples in preclinical and clinical settings. This chapter describes a reproducible procedure for sampling blood serum and plasma that is specifically designed for maximizing data quality output in two-dimensional gel electrophoresis, multiplex immunoassay and mass spectrometry profiling studies.

Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products.

PubMed

Tulina, M A; Pyatigorskaya, N V

2018-03-01

The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.

KSC Center Director Bridges accepts an ISO 9001 certificate from DNV

NASA Technical Reports Server (NTRS)

1998-01-01

Center Director Roy Bridges displays the ISO 9001 certificate he was awarded by Det Norske Veritas (DNV), Inc., an international ISO certification organization, at a ceremony at KSC. Dalton Lyon of DNV made the presentation, which included a 2000th ISO Certificate Plaque. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already world-class team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification.

KSC-98pc907

NASA Image and Video Library

1998-08-11

Center Director Roy Bridges displays the ISO 9001 certificate he was awarded by Det Norske Veritas (DNV), Inc., an international ISO certification organization, at a ceremony at KSC. Dalton Lyon of DNV made the presentation, which included a 2000th ISO Certificate Plaque. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already world-class team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification

KSC-98pc908

NASA Image and Video Library

1998-08-11

Center Director Roy Bridges (right) displays the 2000th ISO Certificate Plaque he was given by Dalton Lyon (left) of Det Norske Veritas (DNV), Inc., an international ISO certification organization, at a ceremony at KSC. The plaque is a representation of the ISO 9001 certification awarded to KSC by DNV. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already worldclass team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification

49 CFR 192.245 - Repair or removal of defects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Welding of Steel in Pipelines § 192... be preheated if conditions exist which would adversely affect the quality of the weld repair. After... minimum mechanical properties specified for the welding procedure used to make the original weld are met...

49 CFR 192.245 - Repair or removal of defects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Welding of Steel in Pipelines § 192... be preheated if conditions exist which would adversely affect the quality of the weld repair. After... minimum mechanical properties specified for the welding procedure used to make the original weld are met...

49 CFR 192.245 - Repair or removal of defects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Welding of Steel in Pipelines § 192... be preheated if conditions exist which would adversely affect the quality of the weld repair. After... minimum mechanical properties specified for the welding procedure used to make the original weld are met...

49 CFR 192.245 - Repair or removal of defects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Welding of Steel in Pipelines § 192... be preheated if conditions exist which would adversely affect the quality of the weld repair. After... minimum mechanical properties specified for the welding procedure used to make the original weld are met...

49 CFR 192.245 - Repair or removal of defects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Welding of Steel in Pipelines § 192... be preheated if conditions exist which would adversely affect the quality of the weld repair. After... minimum mechanical properties specified for the welding procedure used to make the original weld are met...

A procedure for estimating the frequency distribution of CO levels in the micro-region of a highway.

DOT National Transportation Integrated Search

1979-01-01

This report demonstrates that the probability of violating a "not to be exceeded more than once per year", one-hour air quality standard can be bounded from above. This result represents a significant improvement over previous methods of ascertaining...

75 FR 32658 - Change of Contact Information; Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-09

... nonsubstantive content. List of Subjects 21 CFR Part 106 Food grades and standards, Infants and children, Nutrition, Reporting and recordkeeping requirements. 21 CFR Part 107 Food labeling, Infants and children..., 21 CFR Chapter I is amended as follows: PART 106--INFANT FORMULA QUALITY CONTROL PROCEDURES 0 1. The...

NCATE: Does it Matter? Research Series No. 92.

ERIC Educational Resources Information Center

Wheeler, Christopher W.

This study of the National Council for Accreditation of Teacher Education (NCATE) examines how NCATE applies its standards and the effect of its process on the quality of programs in professional education. The accreditation procedures are examined and criticism is leveled at the prevalence of an evaluation approach that frequently examines…

Bibliographic Control of Large Quantities of Research Material.

ERIC Educational Resources Information Center

Evans, Martha M.

1983-01-01

Guidelines for individual researcher describe bibliographic methods for achieving high standards of quality while maintaining maximum efficiency in each step of all necessary procedures involved in the construction of a bibliography ranging from several hundred to several thousand items. Ways to minimize waste motion and duplication of effort are…

Microbiological methods for the water recovery systems test, revision 1.1

NASA Technical Reports Server (NTRS)

Rhoads, Tim; Kilgore, M. V., Jr.; Mikell, A. T., Jr.

1990-01-01

Current microbiological parameters specified to verify microbiological quality of Space Station Freedom water quality include the enumeration of total bacteria, anaerobes, aerobes, yeasts and molds, enteric bacteria, gram positives, gram negatives, and E. coli. In addition, other parameters have been identified as necessary to support the Water Recovery Test activities to be conducted at the NASA/MSFC later this year. These other parameters include aerotolerant eutrophic mesophiles, legionellae, and an additional method for heterotrophic bacteria. If inter-laboratory data are to be compared to evaluate quality, analytical methods must be eliminated as a variable. Therefore, each participating laboratory must utilize the same analytical methods and procedures. Without this standardization, data can be neither compared nor validated between laboratories. Multiple laboratory participation represents a conservative approach to insure quality and completeness of data. Invariably, sample loss will occur in transport and analyses. Natural variance is a reality on any test of this magnitude and is further enhanced because biological entities, capable of growth and death, are specific parameters of interest. The large variation due to the participation of human test subjects has been noted with previous testing. The resultant data might be dismissed as 'out of control' unless intra-laboratory control is included as part of the method or if participating laboratories are not available for verification. The purpose of this document is to provide standardized laboratory procedures for the enumeration of certain microorganisms in water and wastewater specific to the water recovery systems test. The document consists of ten separate cultural methods and one direct count procedure. It is not intended nor is it implied to be a complete microbiological methods manual.

Practicing Surgeons Lead in Quality Care, Safety, and Cost Control

PubMed Central

Shively, Eugene H.; Heine, Michael J.; Schell, Robert H.; Sharpe, J Neal; Garrison, R Neal; Vallance, Steven R.; DeSimone, Kenneth J.S.; Polk, Hiram C.

2004-01-01

Objective: To report the experiences of 66 surgical specialists from 15 different hospitals who performed 43 CPT-based procedures more than 16,000 times. Summary Background Data: Surgeons are under increasing pressure to demonstrate patient safety data as quantitated by objective and subjective outcomes that meet or exceed the standards of benchmark institutions or databases. Methods: Data from 66 surgical specialists on 43 CPT-based procedures were accessioned over a 4-year period. The hospitals vary from a small 30-bed hospital to large teaching hospitals. All reported deaths and complications were verified from hospital and office records and compared with benchmarks. Results: Over a 4-year inclusive period (1999–2002), 16,028 elective operations were accessioned. There was a total 1.4% complication rate and 0.05% death rate. A system has been developed for tracking outcomes. A wide range of improvements have been identified. These include the following: 1) improved classification of indications for systemic prophylactic antibiotic use and reduction in the variety of drugs used, 2) shortened length of stay for standard procedures in different surgical specialties, 3) adherence to strict indicators for selected operative procedures, 4) less use of costly diagnostic procedures, 5) decreased use of expensive home health services, 6) decreased use of very expensive drugs, 7) identification of the unnecessary expense of disposable laparoscopic devices, 8) development of a method to compare a one-surgeon hospital with his peers, and 9) development of unique protocols for interaction of anesthesia and surgery. The system also provides a very good basis for confirmation of patient safety and improvement therein. Conclusions: Since 1998, Quality Surgical Solutions, PLLC, has developed simple physician-authored protocols for delivering high-quality and cost-effective surgery that measure up to benchmark institutions. We have discovered wide areas for improvements in surgery by adherence to simple protocols, minimizing death and complications and clarifying cost issues. PMID:15166954

Blood venous sample collection: Recommendations overview and a checklist to improve quality.

PubMed

Giavarina, Davide; Lippi, Giuseppe

2017-07-01

The extra-analytical phases of the total testing process have substantial impact on managed care, as well as an inherent high risk of vulnerability to errors which is often greater than that of the analytical phase. The collection of biological samples is a crucial preanalytical activity. Problems or errors occurring shortly before, or soon after, this preanalytical step may impair sample quality and characteristics, or else modify the final results of testing. The standardization of fasting requirements, rest, patient position and psychological state of the patient are therefore crucial for mitigating the impact of preanalytical variability. Moreover, the quality of materials used for collecting specimens, along with their compatibility, can guarantee sample quality and persistence of chemical and physical characteristics of the analytes over time, so safeguarding the reliability of testing. Appropriate techniques and sampling procedures are effective to prevent problems such as hemolysis, undue clotting in the blood tube, draw of insufficient sample volume and modification of analyte concentration. An accurate identification of both patient and blood samples is a key priority as for other healthcare activities. Good laboratory practice and appropriate training of operators, by specifically targeting collection of biological samples, blood in particular, may greatly improve this issue, thus lowering the risk of errors and their adverse clinical consequences. The implementation of a simple and rapid check-list, including verification of blood collection devices, patient preparation and sampling techniques, was found to be effective for enhancing sample quality and reducing some preanalytical errors associated with these procedures. The use of this tool, along with implementation of objective and standardized systems for detecting non-conformities related to unsuitable samples, can be helpful for standardizing preanalytical activities and improving the quality of laboratory diagnostics, ultimately helping to reaffirm a "preanalytical" culture founded on knowledge and real risk perception. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

A quality assessment tool for markup-based clinical guidelines.

PubMed

Shalom, Erez; Shahar, Yuval; Taieb-Maimon, Meirav; Lunenfeld, Eitan

2008-11-06

We introduce a tool for quality assessment of procedural and declarative knowledge. We developed this tool for evaluating the specification of mark-up-based clinical GLs. Using this graphical tool, the expert physician and knowledge engineer collaborate to perform scoring, using pre-defined scoring scale, each of the knowledge roles of the mark-ups, comparing it to a gold standard. The tool enables scoring the mark-ups simultaneously at different sites by different users at different locations.

Valid internal standard technique for arson detection based on gas chromatography-mass spectrometry.

PubMed

Salgueiro, Pedro A S; Borges, Carlos M F; Bettencourt da Silva, Ricardo J N

2012-09-28

The most popular procedures for the detection of residues of accelerants in fire debris are the ones published by the American Society for Testing and Materials (ASTM E1412-07 and E1618-10). The most critical stages of these tests are the conservation of fire debris from the sampling to the laboratory, the extraction of residues of accelerants from the debris to the activated charcoal strips (ACS) and from those to the final solvent, as well as the analysis of sample extract by gas chromatography-mass spectrometry (GC-MS) and the interpretation of the instrumental signal. This work proposes a strategy for checking the quality of the sample conservation, the accelerant residues transference to final solvent and GC-MS analysis, using internal standard additions. It is used internal standards ranging from a highly volatile compound for checking debris conservation to low volatile compound for checking GC-MS repeatability. The developed quality control (QC) parameters are not affected by GC-MS sensitivity variation and, specifically, the GC-MS performance control is not affected by ACS adsorption saturation that may mask test performance deviations. The proposed QC procedure proved to be adequate to check GC-MS repeatability, ACS extraction and sample conservation since: (1) standard additions are affected by negligible uncertainty and (2) observed dispersion of QC parameters are fit for its intended use. Copyright © 2012 Elsevier B.V. All rights reserved.

The Typhoid Fever Surveillance in Africa Program (TSAP): Clinical, Diagnostic, and Epidemiological Methodologies

PubMed Central

von Kalckreuth, Vera; Konings, Frank; Aaby, Peter; Adu-Sarkodie, Yaw; Ali, Mohammad; Aseffa, Abraham; Baker, Stephen; Breiman, Robert F.; Bjerregaard-Andersen, Morten; Clemens, John D.; Crump, John A.; Cruz Espinoza, Ligia Maria; Deerin, Jessica Fung; Gasmelseed, Nagla; Sow, Amy Gassama; Im, Justin; Keddy, Karen H.; Cosmas, Leonard; May, Jürgen; Meyer, Christian G.; Mintz, Eric D.; Montgomery, Joel M.; Olack, Beatrice; Pak, Gi Deok; Panzner, Ursula; Park, Se Eun; Rakotozandrindrainy, Raphaël; Schütt-Gerowitt, Heidi; Soura, Abdramane Bassiahi; Warren, Michelle R.; Wierzba, Thomas F.; Marks, Florian

2016-01-01

Background. New immunization programs are dependent on data from surveillance networks and disease burden estimates to prioritize target areas and risk groups. Data regarding invasive Salmonella disease in sub-Saharan Africa are currently limited, thus hindering the implementation of preventive measures. The Typhoid Fever Surveillance in Africa Program (TSAP) was established by the International Vaccine Institute to obtain comparable incidence data on typhoid fever and invasive nontyphoidal Salmonella (iNTS) disease in sub-Saharan Africa through standardized surveillance in multiple countries. Methods. Standardized procedures were developed and deployed across sites for study site selection, patient enrolment, laboratory procedures, quality control and quality assurance, assessment of healthcare utilization and incidence calculations. Results. Passive surveillance for bloodstream infections among febrile patients was initiated at thirteen sentinel sites in ten countries (Burkina Faso, Ethiopia, Ghana, Guinea-Bissau, Kenya, Madagascar, Senegal, South Africa, Sudan, and Tanzania). Each TSAP site conducted case detection using these standardized methods to isolate and identify aerobic bacteria from the bloodstream of febrile patients. Healthcare utilization surveys were conducted to adjust population denominators in incidence calculations for differing healthcare utilization patterns and improve comparability of incidence rates across sites. Conclusions. By providing standardized data on the incidence of typhoid fever and iNTS disease in sub-Saharan Africa, TSAP will provide vital input for targeted typhoid fever prevention programs. PMID:26933028

Software Development Standard Processes (SDSP)

NASA Technical Reports Server (NTRS)

Lavin, Milton L.; Wang, James J.; Morillo, Ronald; Mayer, John T.; Jamshidian, Barzia; Shimizu, Kenneth J.; Wilkinson, Belinda M.; Hihn, Jairus M.; Borgen, Rosana B.; Meyer, Kenneth N.;

Critical Issues That Need to Be Addressed to Improve Outcomes for Patients With Carotid Stenosis.

PubMed

Abbott, Anne

2016-05-01

Significant improvement in outcomes for patients with carotid stenosis requires liberation from the historic fixation with randomization and a procedurally based, late-stage, reactive approach to medical care. We require a multipronged and multidisciplinary approach that includes all of the following: (i) removal of overreliance on, and biased use of, randomized trial data; (ii) using accurate ways to rank evidence quality and relevance; (iii) improved research reporting standards; (iv) building quality assurance and other research capability into routine practice; (v) producing evidence-true rather than evidence-based guidelines; (vi) bringing current optimal medical treatment to the community and measuring its effectiveness; (vii) funding only interventions known to help patients when and where they are treated and use the savings to fund vital research, including quality assurance in routine practice; and (viii) recognize that making the indication for carotid procedures obsolete is a good thing. © The Author(s) 2016.

Chapter A7. Biological Indicators

USGS Publications Warehouse

Myers, Donna N.; Wilde, Franceska D.

2003-01-01

The National Field Manual for the Collection of Water-Quality Data (National Field Manual) provides guidelines and standard procedures for U.S. Geological Survey (USGS) personnel who collect data used to assess the quality of the Nation's surface-water and ground-water resources. This chapter of the manual includes procedures for the (1) determination of biochemical oxygen demand using a 5-day bioassay test; (2) collection, identification, and enumeration of fecal indicator bacteria; (3) collection of samples and information on two laboratory methods for fecal indicator viruses (coliphages); and (4) collection of samples for protozoan pathogens. Each chapter of the National Field Manual is published separately and revised periodically. Newly published and revised chapters are posted on the World Wide Web on the USGS page 'National Field Manual for the Collection of Water-Quality Data.' The URL for this page is http://pubs.water.usgs.gov/twri9A/ (accessed November 25, 2003).

[The dangers and drifts of health McDonaldization].

PubMed

Cembrani, Fabio

2016-01-01

The author reflects on the healthcare crisis, starting from globalization and liquid-modern society, with its systemic contradictions. The health care system is influenced by McDonald's success and its philosophy: efficiency, productivity, cost reduction, procedural standardization and control. This article underlines the deficiencies and manipulations in the health care system. The profit-oriented economic model is successful due to lack of attention to product quality from the globalised and hyper-consumerist society. Italian legislation has regulated the standardization in healthcare procedure, aiming at cost reduction of defensive medicine. It has been underlined that it defines actions, nevertheless human activity is mainly realized through language, gesture and creation. A new anthropological model is proposed, based on commitment and distributive justice.

The pancreatic surgery registry (StuDoQ|Pancreas) of the German Society for General and Visceral Surgery (DGAV) - presentation and systematic quality evaluation.

PubMed

Wellner, Ulrich F; Klinger, Carsten; Lehmann, Kai; Buhr, Heinz; Neugebauer, Edmund; Keck, Tobias

2017-04-05

Pancreatic resections are among the most complex procedures in visceral surgery. While mortality has decreased substantially over the past decades, morbidity remains high. The volume-outcome correlation in pancreatic surgery is among the strongest in the field of surgery. The German Society for General and Visceral Surgery (DGAV) established a national registry for quality control, risk assessment and outcomes research in pancreatic surgery in Germany (DGAV SuDoQ|Pancreas). Here, we present the aims and scope of the DGAV StuDoQ|Pancreas Registry. A systematic assessment of registry quality is performed based on the recommendations of the German network for outcomes research (DNVF). The registry quality was assessed by consensus criteria of the DNVF in regard to the domains Systematics and Appropriateness, Standardization, Validity of the sampling procedure, Validity of data collection, Validity of statistical analysis and reports, and General demands for registry quality. In summary, DGAV StuDoQ|Pancreas meets most of the criteria of a high-quality clinical registry. The DGAV StuDoQ|Pancreas provides a valuable platform for quality assessment, outcomes research as well as randomized registry trials in pancreatic surgery.

Elaborating European Pharmacopoeia monographs for biotherapeutic proteins using substances from a single source.

PubMed

Buda, M; Wicks, S; Charton, E

2016-01-01

For more than twenty years, the European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutic proteins have been elaborated using the multisource approach (Procedure 1), which has led to robust quality standards for many of the first-generation biotherapeutics. In 2008, the Ph. Eur. opened up the way towards an alternative mechanism for the elaboration of monographs (Procedure 4-BIO pilot phase), which is applied to substances still under patent protection, based on a close collaboration with the Innovator company, to ensure a harmonised global standard and strengthen the quality of the upcoming products. This article describes the lessons learned during the P4-BIO pilot phase and addresses the current thinking on monograph elaboration in the field of biotherapeutics. Case studies are described to illustrate the standardisation challenges associated with the complexity of biotherapeutics and of analytical procedures, as well as the approaches that help ensure expectations are met when setting monograph specifications and allow for compatibility with the development of biosimilars. Emphasis is put on monograph flexibility, notably by including tests that measure process-dependent microheterogeneity (e.g. glycosylation) in the Production section of the monograph. The European Pharmacopoeia successfully concluded the pilot phase of the P4-BIO during its 156 th session on 22-23 November 2016.

A tiered quality assurance review process for clinical data management standard operating procedures in an academic health center.

PubMed

Ittenbach, Richard F; Baker, Cynthia L; Corsmo, Jeremy J

2014-05-01

Standard operating procedures (SOPs) were once considered the province of the pharmaceutical industry but are now viewed as a key component of quality assurance programs. To address variability and increase the rigor of clinical data management (CDM) operations, the Cincinnati Children's Hospital Medical Center (CCHMC) decided to create CDM SOPs. In response to this challenge, and as part of a broader institutional initiative, the CCHMC leadership established an executive steering committee to oversee the development and implementation of CDM SOPs. This resulted in the creation of a quality assurance review process with three review panels: an SOP development team (16 clinical data managers and technical staff members), a faculty review panel (8 senior faculty and administrators), and an expert advisory panel (3 national CDM experts). This innovative, tiered review process helped ensure that the new SOPs would be created and implemented in accord with good CDM practices and standards. Twelve fully vetted, institutionally endorsed SOPs and one CDM template resulted from the intensive, iterative 10-month process (December 2011 to early October 2012). Phased implementation, which incoporated the CDM SOPs into the existing audit process for certain types of clinical research studies, was on schedule at the time of this writing. Once CCHMC researchers have had the opportunity to use the SOPs over time and across a broad range of research settings and conditions, the SOPs will be revisited and revalidated.

Development of the private practice management standards for psychology.

PubMed

Mathews, Rebecca; Stokes, David; Littlefield, Lyn; Collins, Leah

2011-01-01

This paper describes the process of developing a set of private practice management standards to support Australian psychologists and promote high quality services to the public. A review of the literature was conducted to identify management standards relevant to psychology, which were further developed in consultation with a panel of experts in psychology or in the development of standards. Forty-three psychologists in independent private practice took part in either a survey (n=22) to provide feedback on the relevance of, and their compliance with, the identified standards, or a 6-month pilot study (n=21) in which a web-based self-assessment instrument evaluating the final set of standards and performance indicators was implemented in their practice to investigate self-reported change in management procedures. The pilot study demonstrated good outcomes for practitioners when evaluation of compliance to the standards was operationalized in a self-assessment format. Study results are based on a small sample size. Nevertheless, relevance and utility of the standards was found providing an initial version of management standards that have relevance to the practice of psychology in Australia, along with a system for evaluating psychological service provision to ensure best practice in service delivery. © 2010 National Association for Healthcare Quality.

Development of a framework of quality assurance practices for a radon passive dosemeter service.

PubMed

D'Alessandro, M; Leonardi, F; Tonnarini, S; Trevisi, R; Veschetti, M

2010-06-01

Etched track detectors are widely used for the detection of radon and its decay products. The reliability of radon measurement performed with such devices requires that laboratories producing analytical data are able to provide results of the required quality. The need for uniform results from laboratories at an international level therefore requires the implementation of a quality assurance programme, the harmonization of criteria, sampling procedures, calculations and the reporting of results, agreed on the basis of fundamental principles and international standards. The quality assurance programme described here is the first step on the way to ISO/IEC 17025 certification for the RI-RN (ISPESL) laboratory.

Total mesorectal excision training in soft cadaver: feasibility and clinical application.

PubMed

Tantiphlachiva, Kasaya; Suansawan, Channarong

2006-09-01

The major problem in the treatment of rectal cancer is local recurrence. After the introduction of total mesorectal excision (TME), the recurrent rate decreased from 100% to around 10%. The purpose of the present study was to evaluate the quality of organ and tissue plane preservation in soft cadaver and to assess the feasibility to perform the procedure (mobilization of colon and rectum, total mesorectal excision and stapler anastomosis) in soft cadaver. Colorectal Division, Department of Surgery and Surgical Training Center Department of Anatomy, Faculty of Medicine, Chulalongkorn University. Prospective descriptive study. Seven soft cadavers were used for total mesorectal excision (TME) training. These procedures were performed by 21 participants (1 soft cadaver for 3 participants). The procedures were done under the supervision of experienced colorectal surgeons. The successfulness, satisfaction in performing the procedure and the quality of organ preservation were evaluated using standardized questionnaires. Participants were satisfied about TME training in soft cadaver (mean 8.24-8.71) and rated that soft cadavers were good in terms of internal organs and tissue plane preservation (mean 7.19-8.19) (0 = extremely unsatisfied, 10 = extremely satisfied). Training of TME in soft cadaver is feasible. The similarity in tissue quality (texture, consistency, color) of the preserved organs to that of the living and the good feel of performing the procedure make the trainee better understand the techniques and improve their skills.

US EPA Nonattainment Areas and Designations-PM10 (1987 NAAQS)

EPA Pesticide Factsheets

This web service contains the following layer: PM10 Nonattainment Areas (1987 NAAQS). Full FGDC metadata records for each layer may be found by clicking the layer name at the web service endpoint (https://gispub.epa.gov/arcgis/rest/services/OAR_OAQPS/NAA1987PM10/MapServer) and viewing the layer description. These layers identify areas in the U.S. where air pollution levels have not met the National Ambient Air Quality Standards (NAAQS) for criteria air pollutants and have been designated nonattainment?? areas (NAA). The data are updated weekly from an OAQPS internal database. However, that does not necessarily mean the data have changed. The EPA Office of Air Quality Planning and Standards (OAQPS) has set National Ambient Air Quality Standards for six principal pollutants, which are called criteria pollutants. Under provisions of the Clean Air Act, which is intended to improve the quality of the air we breathe, EPA is required to set National Ambient Air Quality Standards for six common air pollutants. These commonly found air pollutants (also known as criteria pollutants) are found all over the United States. They are particle pollution (often referred to as particulate matter), ground-level ozone, carbon monoxide, sulfur oxides, nitrogen oxides, and lead. For each criteria pollutant, there are specific procedures used for measuring ambient concentrations and for calculating long-term (quarterly or annual) and/or short-term (24-hour) exposure levels. The metho

US EPA Nonattainment Areas and Designations-Lead (2008 NAAQS)

EPA Pesticide Factsheets

This web service contains the following layers: Lead NAA 2008 NAAQS and Lead NAA Centroids 2008 NAAQS. Full FGDC metadata records for each layer may be found by clicking the layer name at the web service endpoint (https://gispub.epa.gov/arcgis/rest/services/OAR_OAQPS/NAA2008Lead/MapServer) and viewing the layer description. These layers identify areas in the U.S. where air pollution levels have not met the National Ambient Air Quality Standards (NAAQS) for criteria air pollutants and have been designated nonattainment?? areas (NAA). The data are updated weekly from an OAQPS internal database. However, that does not necessarily mean the data have changed. The EPA Office of Air Quality Planning and Standards (OAQPS) has set National Ambient Air Quality Standards for six principal pollutants, which are called criteria pollutants. Under provisions of the Clean Air Act, which is intended to improve the quality of the air we breathe, EPA is required to set National Ambient Air Quality Standards for six common air pollutants. These commonly found air pollutants (also known as criteria pollutants) are found all over the United States. They are particle pollution (often referred to as particulate matter), ground-level ozone, carbon monoxide, sulfur oxides, nitrogen oxides, and lead. For each criteria pollutant, there are specific procedures used for measuring ambient concentrations and for calculating long-term (quarterly or annual) and/or short-term (24-hour) exposure l

US EPA Nonattainment Areas and Designations-8 Hour Ozone (2008 NAAQS)

EPA Pesticide Factsheets

This web service contains the following layers: Ozone 2008 NAAQS NAA State Level and Ozone 2008 NAAQS NAA National Level. Full FGDC metadata records for each layer may be found by clicking the layer name at the web service endpoint (https://gispub.epa.gov/arcgis/rest/services/OAR_OAQPS/NAA2008Ozone8hour/MapServer) and viewing the layer description. These layers identify areas in the U.S. where air pollution levels have not met the National Ambient Air Quality Standards (NAAQS) for criteria air pollutants and have been designated nonattainment?? areas (NAA). The data are updated weekly from an OAQPS internal database. However, that does not necessarily mean the data have changed. The EPA Office of Air Quality Planning and Standards (OAQPS) has set National Ambient Air Quality Standards for six principal pollutants, which are called criteria pollutants. Under provisions of the Clean Air Act, which is intended to improve the quality of the air we breathe, EPA is required to set National Ambient Air Quality Standards for six common air pollutants. These commonly found air pollutants (also known as criteria pollutants) are found all over the United States. They are particle pollution (often referred to as particulate matter), ground-level ozone, carbon monoxide, sulfur oxides, nitrogen oxides, and lead. For each criteria pollutant, there are specific procedures used for measuring ambient concentrations and for calculating long-term (quarterly or annual) and/or short-

US EPA Nonattainment Areas and Designations-8 Hour Ozone (1997 NAAQS)

EPA Pesticide Factsheets

This web service contains the following layers: Ozone 1997 NAAQS NAA State Level and Ozone 1997 NAAQS NAA National Level. Full FGDC metadata records for each layer may be found by clicking the layer name at the web service endpoint (https://gispub.epa.gov/arcgis/rest/services/OAR_OAQPS/NAA1997Ozone8hour/MapServer) and viewing the layer description. These layers identify areas in the U.S. where air pollution levels have not met the National Ambient Air Quality Standards (NAAQS) for criteria air pollutants and have been designated nonattainment?? areas (NAA). The data are updated weekly from an OAQPS internal database. However, that does not necessarily mean the data have changed. The EPA Office of Air Quality Planning and Standards (OAQPS) has set National Ambient Air Quality Standards for six principal pollutants, which are called criteria pollutants. Under provisions of the Clean Air Act, which is intended to improve the quality of the air we breathe, EPA is required to set National Ambient Air Quality Standards for six common air pollutants. These commonly found air pollutants (also known as criteria pollutants) are found all over the United States. They are particle pollution (often referred to as particulate matter), ground-level ozone, carbon monoxide, sulfur oxides, nitrogen oxides, and lead. For each criteria pollutant, there are specific procedures used for measuring ambient concentrations and for calculating long-term (quarterly or annual) and/or short

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

PubMed

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

2014-07-01

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

[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.

Ground-water-quality assessment of the Carson River basin, Nevada and California; analysis of available water-quality data through 1987

USGS Publications Warehouse

Welch, A.H.; Plume, R.W.; Frick, E.A.; Hughes, J.L.

1989-01-01

Data on groundwater quality, hydrogeology, and land and water use for the Carson River basin, Nevada and California were analyzed as part of the U. S. Geological Survey National Water-Quality Assessment program. The basin consists of six hydrographic areas--a mountainous headwaters area and five downstream areas interconnected by the Carson River. Each valley contains one or more basin-fill aquifers. The data on groundwater quality came from several agencies and were screened to verify site location and to avoid analyses of treated water. The screened data are stored in the U. S. Geological Survey National Water Information System data base. Differences in sample-collection and preservation procedures among some of the data-collection agencies restrict use of the data to a descriptive analysis. Drinking water standards were employed as the basis for evaluating reported concentrations. Frequencies with which primary or secondary standards are exceeded increase from upstream parts of the basin to downstream parts. Primary standards commonly exceeded are fluoride in upstream areas and arsenic and fluoride in downstream areas. Secondary standards commonly exceeded are iron and manganese in upstream areas and chloride, dissolved solids, iron, manganese, and sulfate in downstream areas. The poorer-quality groundwater generally is a result of natural geochemical reactions, rather than the introduction of chemicals by man. Limited data indicate, however , that manmade organic compounds are present, mostly at or near urban land. (USGS)

Data management in clinical research: An overview

PubMed Central

Krishnankutty, Binny; Bellary, Shantala; Kumar, Naveen B.R.; Moodahadu, Latha S.

2012-01-01

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. In the present scenario, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. With the implementation of regulatory compliant data management tools, CDM team can meet these demands. Additionally, it is becoming mandatory for companies to submit the data electronically. CDM professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. This article highlights the processes involved and provides the reader an overview of the tools and standards adopted as well as the roles and responsibilities in CDM. PMID:22529469

A risk analysis for production processes with disposable bioreactors.

PubMed

Merseburger, Tobias; Pahl, Ina; Müller, Daniel; Tanner, Markus

2014-01-01

: Quality management systems are, as a rule, tightly defined systems that conserve existing processes and therefore guarantee compliance with quality standards. But maintaining quality also includes introducing new enhanced production methods and making use of the latest findings of bioscience. The advances in biotechnology and single-use manufacturing methods for producing new drugs especially impose new challenges on quality management, as quality standards have not yet been set. New methods to ensure patient safety have to be established, as it is insufficient to rely only on current rules. A concept of qualification, validation, and manufacturing procedures based on risk management needs to be established and realized in pharmaceutical production. The chapter starts with an introduction to the regulatory background of the manufacture of medicinal products. It then continues with key methods of risk management. Hazards associated with the production of medicinal products with single-use equipment are described with a focus on bioreactors, storage containers, and connecting devices. The hazards are subsequently evaluated and criteria for risk evaluation are presented. This chapter concludes with aspects of industrial application of quality risk management.

DNA origami-based standards for quantitative fluorescence microscopy.

PubMed

Schmied, Jürgen J; Raab, Mario; Forthmann, Carsten; Pibiri, Enrico; Wünsch, Bettina; Dammeyer, Thorben; Tinnefeld, Philip

2014-01-01

Validating and testing a fluorescence microscope or a microscopy method requires defined samples that can be used as standards. DNA origami is a new tool that provides a framework to place defined numbers of small molecules such as fluorescent dyes or proteins in a programmed geometry with nanometer precision. The flexibility and versatility in the design of DNA origami microscopy standards makes them ideally suited for the broad variety of emerging super-resolution microscopy methods. As DNA origami structures are durable and portable, they can become a universally available specimen to check the everyday functionality of a microscope. The standards are immobilized on a glass slide, and they can be imaged without further preparation and can be stored for up to 6 months. We describe a detailed protocol for the design, production and use of DNA origami microscopy standards, and we introduce a DNA origami rectangle, bundles and a nanopillar as fluorescent nanoscopic rulers. The protocol provides procedures for the design and realization of fluorescent marks on DNA origami structures, their production and purification, quality control, handling, immobilization, measurement and data analysis. The procedure can be completed in 1-2 d.

Reporting Qualitative Research: Standards, Challenges, and Implications for Health Design.

PubMed

Peditto, Kathryn

2018-04-01

This Methods column describes the existing reporting standards for qualitative research, their application to health design research, and the challenges to implementation. Intended for both researchers and practitioners, this article provides multiple perspectives on both reporting and evaluating high-quality qualitative research. Two popular reporting standards exist for reporting qualitative research-the Consolidated Criteria for Reporting Qualitative Research (COREQ) and the Standards for Reporting Qualitative Research (SRQR). Though compiled using similar procedures, they differ in their criteria and the methods to which they apply. Creating and applying reporting criteria is inherently difficult due to the undefined and fluctuating nature of qualitative research when compared to quantitative studies. Qualitative research is expansive and occasionally controversial, spanning many different methods of inquiry and epistemological approaches. A "one-size-fits-all" standard for reporting qualitative research can be restrictive, but COREQ and SRQR both serve as valuable tools for developing responsible qualitative research proposals, effectively communicating research decisions, and evaluating submissions. Ultimately, tailoring a set of standards specific to health design research and its frequently used methods would ensure quality research and aid reviewers in their evaluations.

Standard Free Droplet Digital Polymerase Chain Reaction as a New Tool for the Quality Control of High-Capacity Adenoviral Vectors in Small-Scale Preparations

PubMed Central

Boehme, Philip; Stellberger, Thorsten; Solanki, Manish; Zhang, Wenli; Schulz, Eric; Bergmann, Thorsten; Liu, Jing; Doerner, Johannes; Baiker, Armin E.

2015-01-01

Abstract High-capacity adenoviral vectors (HCAdVs) are promising tools for gene therapy as well as for genetic engineering. However, one limitation of the HCAdV vector system is the complex, time-consuming, and labor-intensive production process and the following quality control procedure. Since HCAdVs are deleted for all viral coding sequences, a helper virus (HV) is needed in the production process to provide the sequences for all viral proteins in trans. For the purification procedure of HCAdV, cesium chloride density gradient centrifugation is usually performed followed by buffer exchange using dialysis or comparable methods. However, performing these steps is technically difficult, potentially error-prone, and not scalable. Here, we establish a new protocol for small-scale production of HCAdV based on commercially available adenovirus purification systems and a standard method for the quality control of final HCAdV preparations. For titration of final vector preparations, we established a droplet digital polymerase chain reaction (ddPCR) that uses a standard free-end-point PCR in small droplets of defined volume. By using different probes, this method is capable of detecting and quantifying HCAdV and HV in one reaction independent of reference material, rendering this method attractive for accurately comparing viral titers between different laboratories. In summary, we demonstrate that it is possible to produce HCAdV in a small scale of sufficient quality and quantity to perform experiments in cell culture, and we established a reliable protocol for vector titration based on ddPCR. Our method significantly reduces time and required equipment to perform HCAdV production. In the future the ddPCR technology could be advantageous for titration of other viral vectors commonly used in gene therapy. PMID:25640117

[The quality of medication orders--can it be improved?].

PubMed

Vaknin, Ofra; Wingart-Emerel, Efrat; Stern, Zvi

2003-07-01

Medication errors are a common cause of morbidity and mortality among patients. Medication administration in hospitals is a complicated procedure with the possibility of error at each step. Errors are most commonly found at the prescription and transcription stages, although it is known that most errors can easily be avoided through strict adherence to standardized procedure guidelines. In examination of medication errors reported in the hospital in the year 2000, we found that 38% reported to have resulted from transcription errors. In the year 2001, the hospital initiated a program designed to identify faulty process of orders in an effort to improve the quality and effectiveness of the medication administration process. As part of this program, it was decided to check and evaluate the quality of the written doctor's orders and the transcription of those orders to the nursing cadre, in various hospital units. The study was conducted using a questionnaire which checked compliance to hospital standards with regard to the medication administration process, as applied to 6 units over the course of 8 weeks. Results of the survey showed poor compliance to guidelines on the part of doctors and nurses. Only 18% of doctors' orders in the study and 37% of the nurses' transcriptions were written according to standards. The Emergency Department showed an even lower compliance with only 3% of doctors' orders and 25% of nurses' transcriptions complying to standards. As a result of this study, it was decided to initiate an intensive in-service teaching course to refresh the staff's knowledge of medication administration guidelines. In the future it is recommended that hand-written orders be replaced by computerized orders in an effort to limit the chance of error.

Possibilities of psychoacoustics to determine sound quality

NASA Astrophysics Data System (ADS)

Genuit, Klaus

For some years, acoustic engineers have increasingly become aware of the importance of analyzing and minimizing noise problems not only with regard to the A-weighted sound pressure level, but to design sound quality. It is relatively easy to determine the A-weighted SPL according to international standards. However, the objective evaluation to describe subjectively perceived sound quality - taking into account psychoacoustic parameters such as loudness, roughness, fluctuation strength, sharpness and so forth - is more difficult. On the one hand, the psychoacoustic measurement procedures which are known so far have yet not been standardized. On the other hand, they have only been tested in laboratories by means of listening tests in the free-field and one sound source and simple signals. Therefore, the results achieved cannot be transferred to complex sound situations with several spatially distributed sound sources without difficulty. Due to the directional hearing and selectivity of human hearing, individual sound events can be selected among many. Already in the late seventies a new binaural Artificial Head Measurement System was developed which met the requirements of the automobile industry in terms of measurement technology. The first industrial application of the Artificial Head Measurement System was in 1981. Since that time the system was further developed, particularly by the cooperation between HEAD acoustics and Mercedes-Benz. In addition to a calibratable Artificial Head Measurement System which is compatible with standard measurement technologies and has transfer characteristics comparable to human hearing, a Binaural Analysis System is now also available. This system permits the analysis of binaural signals regarding physical and psychoacoustic procedures. Moreover, the signals to be analyzed can be simultaneously monitored through headphones and manipulated in the time and frequency domain so that those signal components being responsible for noise annoyance can be found. Especially in complex sound situations with several spatially distributed sound sources, standard, one-channel measurements methods cannot adequately determine sound quality, the acoustic comfort, or annoyance of sound events.

External quality assurance programs as a tool for verifying standardization of measurement procedures: Pilot collaboration in Europe.

PubMed

Perich, C; Ricós, C; Alvarez, V; Biosca, C; Boned, B; Cava, F; Doménech, M V; Fernández-Calle, P; Fernández-Fernández, P; García-Lario, J V; Minchinela, J; Simón, M; Jansen, R

2014-05-15

Current external quality assurance schemes have been classified into six categories, according to their ability to verify the degree of standardization of the participating measurement procedures. SKML (Netherlands) is a Category 1 EQA scheme (commutable EQA materials with values assigned by reference methods), whereas SEQC (Spain) is a Category 5 scheme (replicate analyses of non-commutable materials with no values assigned by reference methods). The results obtained by a group of Spanish laboratories participating in a pilot study organized by SKML are examined, with the aim of pointing out the improvements over our current scheme that a Category 1 program could provide. Imprecision and bias are calculated for each analyte and laboratory, and compared with quality specifications derived from biological variation. Of the 26 analytes studied, 9 had results comparable with those from reference methods, and 10 analytes did not have comparable results. The remaining 7 analytes measured did not have available reference method values, and in these cases, comparison with the peer group showed comparable results. The reasons for disagreement in the second group can be summarized as: use of non-standard methods (IFCC without exogenous pyridoxal phosphate for AST and ALT, Jaffé kinetic at low-normal creatinine concentrations and with eGFR); non-commutability of the reference material used to assign values to the routine calibrator (calcium, magnesium and sodium); use of reference materials without established commutability instead of reference methods for AST and GGT, and lack of a systematic effort by manufacturers to harmonize results. Results obtained in this work demonstrate the important role of external quality assurance programs using commutable materials with values assigned by reference methods to correctly monitor the standardization of laboratory tests with consequent minimization of risk to patients. Copyright © 2013 Elsevier B.V. All rights reserved.

High-throughput biomonitoring of dioxins and polychlorinated biphenyls at the sub-picogram level in human serum.

PubMed

Focant, Jean-François; Eppe, Gauthier; Massart, Anne-Cécile; Scholl, Georges; Pirard, Catherine; De Pauw, Edwin

2006-10-13

We report on the use of a state-of-the-art method for the measurement of selected polychlorinated dibenzo-p-dioxins, polychlorinated dibenzofurans and polychlorinated biphenyls in human serum specimens. The sample preparation procedure is based on manual small size solid-phase extraction (SPE) followed by automated clean-up and fractionation using multi-sorbent liquid chromatography columns. SPE cartridges and all clean-up columns are disposable. Samples are processed in batches of 20 units, including one blank control (BC) sample and one quality control (QC) sample. The analytical measurement is performed using gas chromatography coupled to isotope dilution high-resolution mass spectrometry. The sample throughput corresponds to one series of 20 samples per day, from sample reception to data quality cross-check and reporting, once the procedure has been started and series of samples keep being produced. Four analysts are required to ensure proper performances of the procedure. The entire procedure has been validated under International Organization for Standardization (ISO) 17025 criteria and further tested over more than 1500 unknown samples during various epidemiological studies. The method is further discussed in terms of reproducibility, efficiency and long-term stability regarding the 35 target analytes. Data related to quality control and limit of quantification (LOQ) calculations are also presented and discussed.

Towards European urinalysis guidelines. Introduction of a project under European Confederation of Laboratory Medicine.

PubMed

Kouri, T T; Gant, V A; Fogazzi, G B; Hofmann, W; Hallander, H O; Guder, W G

2000-07-01

Improved standardized performance is needed because urinalysis continues to be one of the most frequently requested laboratory tests. Since 1997, the European Confederation of Laboratory Medicine (ECLM) has been supporting an interdisciplinary project aiming to produce European urinalysis guidelines. More than seventy clinical chemists, microbiologists and ward-based clinicians, as well as representatives of manufacturers are taking part. These guidelines aim to improve the quality and consistency of chemical urinalysis, particle counting and bacterial culture by suggesting optimal investigative processes that could be applied in Europe. The approach is based on medical needs for urinalysis. The importance of the pre-analytical stage for total quality is stressed by detailed illustrative advice for specimen collection. Attention is also given to emerging automated technology. For cost containment reasons, both optimum (ideal) procedures and minimum analytical approaches are suggested. Since urinalysis mostly lacks genuine reference methods (primary reference measurement procedures; Level 4), a novel classification of the methods is proposed: comparison measurement procedures (Level 3), quantitative routine procedures (Level 2), and ordinal scale examinations (Level 1). Stepwise strategies are suggested to save costs, applying different rules for general and specific patient populations. New analytical quality specifications have been created. After a consultation period, the final written text will be published in full as a separate document.

Consensus Statement of Standards for Interventional Cardiovascular Nursing Practice.

PubMed

White, Kevin; Macfarlane, Heather; Hoffmann, Bernadette; Sirvas-Brown, Helene; Hines, Kathryn; Rolley, John Xavier; Graham, Sandi

2018-05-01

Interventional cardiovascular nursing is a critical care nursing specialty providing complex nursing interventions to patients prone to clinical deterioration, through the combined risks of the pathophysiology of their illness and undergoing technically complex interventional cardiovascular procedures. No guidelines were identified worldwide to assist health care providers and educational institutions in workforce development and education guidelines to minimise patients' risk of adverse events. The Interventional Nurses Council (INC) developed a definition and scope of practice for interventional cardiac nursing (ICN's) in 2013. The INC executive committee established a working party of seven representatives from Australia and New Zealand. Selection was based on expertise in interventional cardiovascular nursing and experience providing education and mentoring in the clinical and postgraduate environment. A literature search of the electronic databases Science Direct, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline and Health Source was performed, using the search terms: clinical deterioration, ST elevation myocardial infarction, vital signs, primary percutaneous coronary intervention, PCI, AMI, STEMI, acute coronary syndrome, peri-procedural care, unstable angina, PCI complications, structural heart disease, TAVI, TAVR, cardiac rhythm management, pacing, electrophysiology studies, vascular access, procedural sedation. Articles were limited to the cardiac catheterisation laboratory and relevance to nursing based outcomes. Reference lists were examined to identify relevant articles missed in the initial search. The literature was compared with national competency standards, quality and safety documents and the INC definition and scope of practice. Consensus of common themes, a taxonomy of education and seven competency domains were achieved via frequent teleconferences and two face-to-face meetings. The working party finalised the standards on 14 July 2017, following endorsement from the CSANZ, INC, Heart Rhythm Council, CSANZ Quality Standards Committee and the Australian College of Critical Care Nurses (ACCCN). The resulting document provides clinical practice and education standards for interventional cardiac nursing practice. Copyright © 2017. Published by Elsevier B.V.

[IMPLEMENTATION OF A QUALITY MANAGEMENT SYSTEM IN A NUTRITION UNIT ACCORDING TO ISO 9001:2008].

PubMed

Velasco Gimeno, Cristina; Cuerda Compés, Cristina; Alonso Puerta, Alba; Frías Soriano, Laura; Camblor Álvarez, Miguel; Bretón Lesmes, Irene; Plá Mestre, Rosa; Izquierdo Membrilla, Isabel; García-Peris, Pilar

2015-09-01

the implementation of quality management systems (QMS) in the health sector has made great progress in recent years, remains a key tool for the management and improvement of services provides to patients. to describe the process of implementing a quality management system (QMS) according to the standard ISO 9001:2008 in a Nutrition Unit. the implementation began in October 2012. Nutrition Unit was supported by Hospital Preventive Medicine and Quality Management Service (PMQM). Initially training sessions on QMS and ISO standards for staff were held. Quality Committee (QC) was established with representation of the medical and nursing staff. Every week, meeting took place among members of the QC and PMQM to define processes, procedures and quality indicators. We carry on a 2 months follow-up of these documents after their validation. a total of 4 processes were identified and documented (Nutritional status assessment, Nutritional treatment, Monitoring of nutritional treatment and Planning and control of oral feeding) and 13 operating procedures in which all the activity of the Unit were described. The interactions among them were defined in the processes map. Each process has associated specific quality indicators for measuring the state of the QMS, and identifying opportunities for improvement. All the documents associated with requirements of ISO 9001:2008 were developed: quality policy, quality objectives, quality manual, documents and records control, internal audit, nonconformities and corrective and preventive actions. The unit was certified by AENOR in April 2013. the implementation of a QMS causes a reorganization of the activities of the Unit in order to meet customer's expectations. Documenting these activities ensures a better understanding of the organization, defines the responsibilities of all staff and brings a better management of time and resources. QMS also improves the internal communication and is a motivational element. Explore the satisfaction and expectations of patients can include their view in the design of care processes. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

A Comparison of Image Quality and Radiation Exposure Between the Mini C-Arm and the Standard C-Arm.

PubMed

van Rappard, Juliaan R M; Hummel, Willy A; de Jong, Tijmen; Mouës, Chantal M

2018-04-01

The use of intraoperative fluoroscopy has become mandatory in osseous hand surgery. Due to its overall practicality, the mini C-arm has gained popularity among hand surgeons over the standard C-arm. This study compares image quality and radiation exposure for patient and staff between the mini C-arm and the standard C-arm, both with flat panel technology. An observer-based subjective image quality study was performed using a contrast detail (CD) phantom. Five independent observers were asked to determine the smallest circles discernable to them. The results were plotted in a graph, forming a CD curve. From each curve, an image quality figure (IQF) was derived. A lower IQF equates to a better image quality. The patients' entrance skin dose was measured, and to obtain more information about the staff exposure dose, a perspex hand phantom was used. The scatter radiation was measured at various distances and angles relative to a central point on the detector. The IQF was significantly lower for the mini C-arm resulting in a better image quality. The patients' entrance dose was 10 times higher for the mini C-arm as compared with the standard C-arm, and the scatter radiation threefold. Due to its improved image quality and overall practicality, the mini C-arm is recommended for hand surgical procedures. To ensure that the surgeons' radiation exposure is not exceeding the safety limits, monitoring radiation exposure using mini C-arms with flat panel technology during surgery should be done in a future clinical study.

77 FR 40550 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Revision for the Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-10

... filtered spray booth and enclosed spray gun cleaner. Maryland's 1997 SIP-approved regulation COMAR 26.11.19... equipment and materials storage such as spray booths, spray guns, and sealed containers for cleaning rags... standards include procedures for cleaning the spray gun equipment for applying automotive coatings. Affected...

40 CFR 131.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-07-01

... the Clean Water Act. Additional specific procedures for developing, reviewing, revising, and approving water quality standards for Great Lakes States or Great Lakes Tribes (as defined in 40 CFR 132.2) to conform to section 118 of the Clean Water Act and 40 CFR part 132, are provided in 40 CFR part 132. [60 FR...

40 CFR 131.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-07-01

... the Clean Water Act. Additional specific procedures for developing, reviewing, revising, and approving water quality standards for Great Lakes States or Great Lakes Tribes (as defined in 40 CFR 132.2) to conform to section 118 of the Clean Water Act and 40 CFR part 132, are provided in 40 CFR part 132. [60 FR...

40 CFR 131.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-07-01

... the Clean Water Act. Additional specific procedures for developing, reviewing, revising, and approving water quality standards for Great Lakes States or Great Lakes Tribes (as defined in 40 CFR 132.2) to conform to section 118 of the Clean Water Act and 40 CFR part 132, are provided in 40 CFR part 132. [60 FR...

40 CFR 131.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-07-01

... the Clean Water Act. Additional specific procedures for developing, reviewing, revising, and approving water quality standards for Great Lakes States or Great Lakes Tribes (as defined in 40 CFR 132.2) to conform to section 118 of the Clean Water Act and 40 CFR part 132, are provided in 40 CFR part 132. [60 FR...

AN EVALUATION OF SAMPLE DISPERSION MEDIAS USED WITH ACCELERATED SOLVENT EXTRACTION FOR THE EXTRACTION AND RECOVERY OF ARSENICALS FROM LFB AND DORM-2

EPA Science Inventory

An accelerated solvent extraction (ASE) device was evaluated as a semi-automated means for extracting arsenicals from quality control (QC) samples and DORM-2 [standard reference material (SRM)]. Unlike conventional extraction procedures, the ASE requires that the sample be dispe...

Modeling of dough mixing profile under thermal and non thermal constraint for evalution of breadmaking quality of Hard Spring Wheat flour

USDA-ARS?s Scientific Manuscript database

This research was initiated to investigate the association between flour breadmaking traits and mixing characteristics and empirical dough rheological property under thermal stress. Flour samples from 30 hard spring wheat were analyzed by a mixolab standard procedure at optimum water absorptions. Mi...

The Judgement Processes Involved in the Moderation of Teacher-Assessed Projects

ERIC Educational Resources Information Center

Crisp, Victoria

2017-01-01

Classroom-based assessments have the potential to enhance validity by facilitating the assessment of important skills that are difficult to assess in written examinations. Such assessments tend to be marked by teachers. To ensure consistent marking standards, quality assurance procedures are needed. In the context of continued debate over the…

Guidelines for the Production of Audio Materials for Print Handicapped Readers.

ERIC Educational Resources Information Center

National Library of Australia, Canberra.

Procedural guidelines developed by the Audio Standards Committee of the National Library of Australia to help improve the overall quality of production of audio materials for visually handicapped readers are presented. This report covers the following areas: selection of narrators and the narration itself; copyright; recording of books, magazines,…

A COMPREHENSIVE NONPOINT SOURCE FIELD STUDY FOR SEDIMENT, NUTRIENTS, AND PATHOGENS IN THE SOUTH FORK BROAD RIVER WATERSHED IN NORTHEAST GEORGIA

EPA Science Inventory

This technical report provides a description of the field project design, quality control, the sampling protocols and analysis methodology used, and standard operating procedures for the South Fork Broad River Watershed (SFBR) Total Maximum Daily Load (TMDL) project. This watersh...

In-transit temperature extremes could have negative effects on ladybird (Coleomegilla maculata) hatch rate

USDA-ARS?s Scientific Manuscript database

The shipment of mass-produced natural enemies for augmentative release is a standard procedure used by the biological control industry. Yet there has been insufficient research on the effects of temperature change, experienced during shipment, on the quality of predators as they arrive at release si...

CEMENT. "A Concrete Experience." A Curriculum Developed for the Cement Industry.

ERIC Educational Resources Information Center

Taylor, Mary Lou

This instructor's guide contains 11 lesson plans for inplant classes on workplace skills for employees in a cement plant. The 11 units cover the following topics: goals; interpreting memoranda; applying a standard set of work procedures; qualities of a safe worker; accident prevention; insurance forms; vocabulary development; inventory control…

77 FR 64480 - Notice of Final Determination of Sales at Less Than Fair Value: Circular Welded Carbon-Quality...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... INFORMATION CONTACT: John Drury or Ericka Ukrow, AD/CVD Operations, Office 7, Import Administration... conducted sales and cost verifications between June 18 and 28, 2012 of the questionnaire responses submitted by Al Jazeera. We used standard verification procedures, including examination of relevant accounting...

The importance of standard operating procedures in clinical trials.

PubMed

Sajdak, Rebecca; Trembath, Lisaann; Thomas, Kathy S

2013-09-01

This special contribution provides insight into the role that standard operating procedures (SOPs) play in an imaging department and their value in building a high-quality research site. If you have ever participated in a clinical trial, many of the principles described in this article should be familiar. However, this article goes a step further by presenting information from a pharmaceutical or device sponsor's point of view-what the sponsor expects from a site during the course of a research study. This article is intended not to provide a complete set of instructions on how to create a great SOP but, instead, to present guidelines to ensure that the key elements are included. After reading the article, you will be able to define SOPs as they pertain to the clinical trial environment, describe key components of an SOP, list the clinical research SOPs that exist in your institution and imaging department, identify which additional SOPs might improve site performance, and describe how the sponsor relies on SOPs to ensure that the highest quality of research is attained.

Immediate Tight Sealing of Skin Incisions Using an Innovative Temperature-controlled Laser Soldering Device

PubMed Central

Simhon, David; Halpern, Marisa; Brosh, Tamar; Vasilyev, Tamar; Ravid, Avi; Tennenbaum, Tamar; Nevo, Zvi; Katzir, Abraham

2007-01-01

Background: A feedback temperature-controlled laser soldering system (TCLS) was used for bonding skin incisions on the backs of pigs. The study was aimed: 1) to characterize the optimal soldering parameters, and 2) to compare the immediate and long-term wound healing outcomes with other wound closure modalities. Materials and Methods: A TCLS was used to bond the approximated wound margins of skin incisions on porcine backs. The reparative outcomes were evaluated macroscopically, microscopically, and immunohistochemically. Results: The optimal soldering temperature was found to be 65°C and the operating time was significantly shorter than with suturing. The immediate tight sealing of the wound by the TCLS contributed to rapid, high quality wound healing in comparison to Dermabond or Histoacryl cyanoacrylate glues or standard suturing. Conclusions: TCLS of incisions in porcine skin has numerous advantages, including rapid procedure and high quality reparative outcomes, over the common standard wound closure procedures. Further studies with a variety of skin lesions are needed before advocating this technique for clinical use. PMID:17245173

Requirements for Printed Wiring Boards

NASA Technical Reports Server (NTRS)

1984-01-01

In order to maintain the high standards of the NASA printed wiring programs, this publication: prescribes NASA's requirements for assuring reliable rigid printed wiring boards; describes and incorporates basic considerations necessary to assure reliable rigid printed wiring boards; establishes the supplier's responsibility to train and certify personnel; provides for supplier documentation of the fabrication and inspection procedures to be used for NASA work, including supplier innovations and changes in technology; and provides visual workmanship standards to aid those responsible for determining quality conformance to the established requirements.

[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.

A comparison between antenatal care quality in public and private sector in rural Hebei, China.

PubMed

Chen, Li; Dai, Yaohua; Zhang, Yanfeng; Wu, Qiong; Rudan, Diana; Saftić, Vanja; van Velthoven, Michelle H M M T; Su, Jianqiang; Tan, Zangwen; Scherpbier, Robert W

2013-04-01

To evaluate the quality of antenatal care (ANC) in Hebei Province and compare it between the public and private sector and within the public sector. We conducted a Maternal, Newborn and Child Health Household Survey in 2010 using a two-stage sampling procedure and included 1079 mothers. The quality of ANC was assessed on the basis of the number of ANC visits, the time of the first ANC visit, 16 different ANC procedures, owning a maternal health care booklet, and the type of service provider. Almost all women (98%) received ANC services at least once, 80% at least four times, and 54% at least five times. About half of the women (46%) visited ANC facility within their first trimester. Neither public nor private sector provided all 16 standardized services, but significantly more women in public sector received ANC procedures. Most women received ANC in county or higher-level hospitals (75%) and very few in township hospitals (8%). Significantly fewer women were weighed and tested for HIV/AIDS in township than in county or higher-level hospitals. The quality of ANC in Hebei was poorer than required by China's national and World Health Organization norms. Although the public sector performed better than the private sector, the utilization and quality of care of ANC services in this sector varied and women generally visited county or higher-level health facilities.

Orthopaedic surgery in natural disaster and conflict settings: how can quality care be ensured?

PubMed

Alvarado, Oscar; Trelles, Miguel; Tayler-Smith, Katie; Joseph, Holdine; Gesline, Rodné; Wilna, Thélusma Eli; Mohammad Omar, Mohammad Karim; Faiz Mohammad, Niaz Mohammad; Muhima Mastaki, John; Chingumwa Buhu, Richard; Caluwaerts, An; Dominguez, Lynette

2015-10-01

Médecins sans Frontières (MSF) is one of the main providers of orthopaedic surgery in natural disaster and conflict settings and strictly imposes a minimum set of context-specific standards before any surgery can be performed. Based on MSF's experience of performing orthopaedic surgery in a number of such settings, we describe: (a) whether it was possible to implement the minimum standards for one of the more rigorous orthopaedic procedures--internal fixation--and when possible, the time frame, (b) the volume and type of interventions performed and (c) the intra-operative mortality rates and postoperative infection rates. We conducted a retrospective review of routine programme data collected between 2007 and 2014 from three MSF emergency surgical interventions in Haiti (following the 2010 earthquake) and three ongoing MSF projects in Kunduz (Afghanistan), Masisi (Democratic Republic of the Congo) and Tabarre (Haiti). The minimum standards for internal fixation were achieved in one emergency intervention site in Haiti, and in Kunduz and Tabarre, taking up to 18 months to implement in Kunduz. All sites achieved the minimum standards to perform amputations, reductions and external fixations, with a total of 9,409 orthopaedic procedures performed during the study period. Intraoperative mortality rates ranged from 0.6 to 1.9 % and postoperative infection rates from 2.4 to 3.5 %. In settings affected by natural disaster or conflict, a high volume and wide repertoire of orthopaedic surgical procedures can be performed with good outcomes when minimum standards are in place. More demanding procedures like internal fixation may not always be feasible.

Deep Needle Procedures: Improving Safety With Ultrasound Visualization

PubMed Central

Peabody, Christopher R.; Mandavia, Diku

2017-01-01

Abstract Promoting patient safety and increasing health care quality have dominated the health care landscape during the last 15 years. Health care regulators and payers are now tying patient safety outcomes and best practices to hospital reimbursement. Many health care leaders are searching for new technologies that not only make health care for patients safer but also reduce overall health care costs. New advances in ultrasonography have made this technology available to health care providers at the patient’s bedside. Point-of-care ultrasound assistance now aids providers with real-time diagnosis and with visualization for procedural guidance. This is especially true for common deep needle procedures such as central venous catheter insertion, thoracentesis, and paracentesis. There is now mounting evidence that clinician-performed point-of-care ultrasound improves patient safety, enhances health care quality, and reduces health care cost for deep needle procedures. Furthermore, the miniaturization, ease of use, and the evolving affordability of ultrasound have now made this technology widely available. The adoption of point-of-care ultrasonography has reached a tipping point and should be seriously considered the safety standard for all hospital-based deep needle procedures. PMID:24786918

Morphology, geology and water quality assessment of former tin mining catchment.

PubMed

Ashraf, Muhammad Aqeel; Maah, Mohd Jamil; Yusoff, Ismail

2012-01-01

Bestari Jaya, former tin mining catchment covers an area of 2656.31 hectares comprised of four hundred and forty-two different-size lakes and ponds. The present study area comprise of 92 hectares of the catchment that include four large size lakes. Arc GIS version 9.2 used to develop bathymetric map, Global Positioning System (GPS) for hydrographical survey and flow meter was utilized for water discharge analysis (flow routing) of the catchment. The water quality parameters (pH, temperature, electric conductivity, dissolved oxygen DO, total dissolved solids TDS, chlorides, ammonium, nitrates) were analyzed by using Hydrolab. Quality assurance (QA) and quality control (QC) procedures were strictly followed throughout the field work and data analysis. Different procedures were employed to evaluate the analytical data and to check for possible transcription or dilution errors, changes during analysis, or unusual or unlikely values. The results obtained are compared with interim national water quality standards for Malaysia indicates that water quality of area is highly degraded. It is concluded that Bestri Jaya ex-mining catchment has a high pollution potential due to mining activities and River Ayer Hitam, recipient of catchment water, is a highly polluted river.

Morphology, Geology and Water Quality Assessment of Former Tin Mining Catchment

PubMed Central

Ashraf, Muhammad Aqeel; Maah, Mohd. Jamil; Yusoff, Ismail

2012-01-01

Bestari Jaya, former tin mining catchment covers an area of 2656.31 hectares comprised of four hundred and forty-two different-size lakes and ponds. The present study area comprise of 92 hectares of the catchment that include four large size lakes. Arc GIS version 9.2 used to develop bathymetric map, Global Positioning System (GPS) for hydrographical survey and flow meter was utilized for water discharge analysis (flow routing) of the catchment. The water quality parameters (pH, temperature, electric conductivity, dissolved oxygen DO, total dissolved solids TDS, chlorides, ammonium, nitrates) were analyzed by using Hydrolab. Quality assurance (QA) and quality control (QC) procedures were strictly followed throughout the field work and data analysis. Different procedures were employed to evaluate the analytical data and to check for possible transcription or dilution errors, changes during analysis, or unusual or unlikely values. The results obtained are compared with interim national water quality standards for Malaysia indicates that water quality of area is highly degraded. It is concluded that Bestri Jaya ex-mining catchment has a high pollution potential due to mining activities and River Ayer Hitam, recipient of catchment water, is a highly polluted river. PMID:22761549

Capillary blood sampling: national recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine

PubMed Central

Krleza, Jasna Lenicek; Dorotic, Adrijana; Grzunov, Ana; Maradin, Miljenka

2015-01-01

Capillary blood sampling is a medical procedure aimed at assisting in patient diagnosis, management and treatment, and is increasingly used worldwide, in part because of the increasing availability of point-of-care testing. It is also frequently used to obtain small blood volumes for laboratory testing because it minimizes pain. The capillary blood sampling procedure can influence the quality of the sample as well as the accuracy of test results, highlighting the need for immediate, widespread standardization. A recent nationwide survey of policies and practices related to capillary blood sampling in medical laboratories in Croatia has shown that capillary sampling procedures are not standardized and that only a small proportion of Croatian laboratories comply with guidelines from the Clinical Laboratory Standards Institute (CLSI) or the World Health Organization (WHO). The aim of this document is to provide recommendations for capillary blood sampling. This document has been produced by the Working Group for Capillary Blood Sampling within the Croatian Society of Medical Biochemistry and Laboratory Medicine. Our recommendations are based on existing available standards and recommendations (WHO Best Practices in Phlebotomy, CLSI GP42-A6 and CLSI C46-A2), which have been modified based on local logistical, cultural, legal and regulatory requirements. We hope that these recommendations will be a useful contribution to the standardization of capillary blood sampling in Croatia. PMID:26524965

Capillary blood sampling: national recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

PubMed

Krleza, Jasna Lenicek; Dorotic, Adrijana; Grzunov, Ana; Maradin, Miljenka

2015-01-01

Capillary blood sampling is a medical procedure aimed at assisting in patient diagnosis, management and treatment, and is increasingly used worldwide, in part because of the increasing availability of point-of-care testing. It is also frequently used to obtain small blood volumes for laboratory testing because it minimizes pain. The capillary blood sampling procedure can influence the quality of the sample as well as the accuracy of test results, highlighting the need for immediate, widespread standardization. A recent nationwide survey of policies and practices related to capillary blood sampling in medical laboratories in Croatia has shown that capillary sampling procedures are not standardized and that only a small proportion of Croatian laboratories comply with guidelines from the Clinical Laboratory Standards Institute (CLSI) or the World Health Organization (WHO). The aim of this document is to provide recommendations for capillary blood sampling. This document has been produced by the Working Group for Capillary Blood Sampling within the Croatian Society of Medical Biochemistry and Laboratory Medicine. Our recommendations are based on existing available standards and recommendations (WHO Best Practices in Phlebotomy, CLSI GP42-A6 and CLSI C46-A2), which have been modified based on local logistical, cultural, legal and regulatory requirements. We hope that these recommendations will be a useful contribution to the standardization of capillary blood sampling in Croatia.

Assay optimisation and technology transfer for multi-site immuno-monitoring in vaccine trials

PubMed Central

Harris, Stephanie A.; Satti, Iman; Bryan, Donna; Walker, K. Barry; Dockrell, Hazel M.; McShane, Helen; Ho, Mei Mei

2017-01-01

Cellular immunological assays are important tools for the monitoring of responses to T-cell-inducing vaccine candidates. As these bioassays are often technically complex and require considerable experience, careful technology transfer between laboratories is critical if high quality, reproducible data that allows comparison between sites, is to be generated. The aim of this study, funded by the European Union Framework Program 7-funded TRANSVAC project, was to optimise Standard Operating Procedures and the technology transfer process to maximise the reproducibility of three bioassays for interferon-gamma responses: enzyme-linked immunosorbent assay (ELISA), ex-vivo enzyme-linked immunospot and intracellular cytokine staining. We found that the initial variability in results generated across three different laboratories reduced following a combination of Standard Operating Procedure harmonisation and the undertaking of side-by-side training sessions in which assay operators performed each assay in the presence of an assay ‘lead’ operator. Mean inter-site coefficients of variance reduced following this training session when compared with the pre-training values, most notably for the ELISA assay. There was a trend for increased inter-site variability at lower response magnitudes for the ELISA and intracellular cytokine staining assays. In conclusion, we recommend that on-site operator training is an essential component of the assay technology transfer process and combined with harmonised Standard Operating Procedures will improve the quality, reproducibility and comparability of data produced across different laboratories. These data may be helpful in ongoing discussions of the potential risk/benefit of centralised immunological assay strategies for large clinical trials versus decentralised units. PMID:29020010

[Advantages and disadvantages of different methods for the implementation and the support of standard operating procedures: From PDF files to an app- and webbased SOP management system].

PubMed

Bauer, M; Riech, S; Brandes, I; Waeschle, R M

2015-11-01

The quality assurance of care and patient safety, with increasing cost pressure and performance levels is of major importance in the high-risk and high cost area of the operating room (OR). Standard operating procedures (SOP) are an established tool for structuring and standardization of the clinical treatment pathways and show multiple benefits for quality assurance and process optimization. An internal project was initiated in the department of anesthesiology and a continuous improvement process was carried out to build up a comprehensive SOP library. In the first step the spectrum of procedures in anesthesiology was transferred to PDF-based SOPs. The further development to an app-based SOP library (Aesculapp) was due to the high resource expenditure for the administration and maintenance of the large PDF-based SOP collection and to deficits in the mobile availability. The next developmental stage, the SOP healthcare information assistant (SOPHIA) included a simplified and advanced update feature, an archive feature previously missing and notably the possibility to share the SOP library with other departments including the option to adapt each SOP to the individual situation. A survey of the personnel showed that the app-based allocation of SOPs (Aesculapp, SOPHIA) had a higher acceptance than the PDF-based developmental stage SOP form. The SOP management system SOPHIA combines the benefits of the forerunner version Aesculapp with improved options for intradepartmental maintenance and administration of the SOPs and the possibility of an export and editing function for interinstitutional exchange of SOPs.

Standardizing the classification of abortion incidents: the Procedural Abortion Incident Reporting and Surveillance (PAIRS) Framework.

PubMed

Taylor, Diana; Upadhyay, Ushma D; Fjerstad, Mary; Battistelli, Molly F; Weitz, Tracy A; Paul, Maureen E

2017-07-01

To develop and validate standardized criteria for assessing abortion-related incidents (adverse events, morbidities, near misses) for first-trimester aspiration abortion procedures and to demonstrate the utility of a standardized framework [the Procedural Abortion Incident Reporting & Surveillance (PAIRS) Framework] for estimating serious abortion-related adverse events. As part of a California-based study of early aspiration abortion provision conducted between 2007 and 2013, we developed and validated a standardized framework for defining and monitoring first-trimester (≤14weeks) aspiration abortion morbidity and adverse events using multiple methods: a literature review, framework criteria testing with empirical data, repeated expert reviews and data-based revisions to the framework. The final framework distinguishes incidents resulting from procedural abortion care (adverse events) from morbidity related to pregnancy, the abortion process and other nonabortion related conditions. It further classifies incidents by diagnosis (confirmatory data, etiology, risk factors), management (treatment type and location), timing (immediate or delayed), seriousness (minor or major) and outcome. Empirical validation of the framework using data from 19,673 women receiving aspiration abortions revealed almost an equal proportion of total adverse events (n=205, 1.04%) and total abortion- or pregnancy-related morbidity (n=194, 0.99%). The majority of adverse events were due to retained products of conception (0.37%), failed attempted abortion (0.15%) and postabortion infection (0.17%). Serious or major adverse events were rare (n=11, 0.06%). Distinguishing morbidity diagnoses from adverse events using a standardized, empirically tested framework confirms the very low frequency of serious adverse events related to clinic-based abortion care. The PAIRS Framework provides a useful set of tools to systematically classify and monitor abortion-related incidents for first-trimester aspiration abortion procedures. Standardization will assist healthcare providers, researchers and policymakers to anticipate morbidity and prevent abortion adverse events, improve care metrics and enhance abortion quality. Copyright © 2017 Elsevier Inc. All rights reserved.

SU-C-202-07: Protocol and Hardware for Improved Flood Field Calibration of TrueBeam FFF Cine Imaging

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

Adamson, J; Faught, A; Yin, F

2016-06-15

Purpose: Flattening filter free photon energies are commonly used for high dose treatments such as SBRT, where localization accuracy is essential. Often, MV cine imaging may be employed to verify correct localization. TrueBeam Electronic Portal Imaging Devices (EPIDs) equipped with the 40×30cm{sup 2} Image Detection Unit (IDU) are prone to image saturation at the image center especially for higher dose rates. While saturation often does not occur for cine imaging during treatment because the beam is attenuated by the patient, the flood field calibration is affected when the standard calibration procedure is followed. Here we describe the hardware and protocolmore » to achieve improved image quality for this model of TrueBeam EPID. Methods: A stainless steel filter of uniform thickness was designed to have sufficient attenuation to avoid panel saturation for both 6XFFF and 10XFFF at the maximum dose rates (1400 MU/min & 2400 MU/min, respectively). The cine imaging flood field calibration was then acquired with the filter in place for the FFF energies under the standard calibration geometry (SDD=150cm). Image quality during MV cine was assessed with & without the modified flood field calibration using a low contrast resolution phantom and an anthropomorphic phantom. Results: When the flood field is acquired using the standard procedure (no filter in place), a pixel gain artifact is clearly present in the image center (r=3cm for 10XFFF at 2400 MU/min) which appears similar to and may be mis-attributed to panel saturation in the subject image. The artifact obscured all low contrast inserts at the image center and was also visible on the anthropomorphic phantom. Using the filter for flood field calibration eliminated the artifact. Conclusion: Use of a modified flood field calibration procedure improves image quality for cine MV imaging with TrueBeams equipped with the 40×30cm{sup 2} IDU.« less

The quest to standardize hemodialysis care.

PubMed

Hegbrant, Jörgen; Gentile, Giorgio; Strippoli, Giovanni F M

2011-01-01

A large global dialysis provider's core activities include providing dialysis care with excellent quality, ensuring a low variability across the clinic network and ensuring strong focus on patient safety. In this article, we summarize the pertinent components of the quality assurance and safety program of the Diaverum Renal Services Group. Concerning medical performance, the key components of a successful quality program are setting treatment targets; implementing evidence-based guidelines and clinical protocols; consistently, regularly, prospectively and accurately collecting data from all clinics in the network; processing collected data to provide feedback to clinics in a timely manner, incorporating information on interclinic and intercountry variations; and revising targets, guidelines and clinical protocols based on sound scientific data. The key activities for ensuring patient safety include a standardized approach to education, i.e. a uniform education program including control of theoretical knowledge and clinical competencies; implementation of clinical policies and procedures in the organization in order to reduce variability and potential defects in clinic practice; and auditing of clinical practice on a regular basis. By applying a standardized and systematic continuous quality improvement approach throughout the entire organization, it has been possible for Diaverum to progressively improve medical performance and ensure patient safety. Copyright © 2011 S. Karger AG, Basel.

[Investigation on pattern of quality control for Chinese materia medica based on famous-region drug and bioassay--the work reference].

PubMed

Yan, Dan; Xiao, Xiaohe

2011-05-01

Selection and standardization of the work reference are the technical issues to be faced with in the bioassay of Chinese materia medica. Taking the bioassay of Coptis chinensis. as an example, the manufacture process of the famous-region drugs extraction was explained from the aspects of original identification, routine examination, component analysis and bioassay. The common technologies were extracted, and the selection and standardization procedures of the work reference for the bioassay of Chinese materia medica were drawn up, so as to provide technical support for constructing a new mode and method of the quality control of Chinese materia medica based on the famous-region drugs and bioassay.

Anthropometric standardisation and quality control protocols for the construction of new, international, fetal and newborn growth standards: the INTERGROWTH-21st Project.

PubMed

Cheikh Ismail, L; Knight, H E; Ohuma, E O; Hoch, L; Chumlea, W C

2013-09-01

The primary aim of the INTERGROWTH-21(st) Project is to construct new, prescriptive standards describing optimal fetal and preterm postnatal growth. The anthropometric measurements include the head circumference, recumbent length and weight of the infants, and the stature and weight of the parents. In such a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes in detail the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. The initial standardisation session was in Nairobi, Kenya, using newborns, which was followed by similar sessions in the eight participating study sites in Brazil, China, India, Italy, Kenya, Oman, UK and USA. The intraobserver and inter-observer technical error of measurement values for head circumference range from 0.3 to 0.4 cm, and for recumbent length from 0.3 to 0.5 cm. These standardisation protocols implemented at each study site worldwide ensure that the anthropometric data collected are of the highest quality to construct international growth standards. © 2013 Royal College of Obstetricians and Gynaecologists.

IEC 61511 and the capital project process--a protective management system approach.

PubMed

Summers, Angela E

2006-03-17

This year, the process industry has reached an important milestone in process safety-the acceptance of an internationally recognized standard for safety instrumented systems (SIS). This standard, IEC 61511, documents good engineering practice for the assessment, design, operation, maintenance, and management of SISs. The foundation of the standard is established by several requirements in Part 1, Clauses 5-7, which cover the development of a management system aimed at ensuring that functional safety is achieved. The management system includes a quality assurance process for the entire SIS lifecycle, requiring the development of procedures, identification of resources and acquisition of tools. For maximum benefit, the deliverables and quality control checks required by the standard should be integrated into the capital project process, addressing safety, environmental, plant productivity, and asset protection. Industry has become inundated with a multitude of programs focusing on safety, quality, and cost performance. This paper introduces a protective management system, which builds upon the work process identified in IEC 61511. Typical capital project phases are integrated with the management system to yield one comprehensive program to efficiently manage process risk. Finally, the paper highlights areas where internal practices or guidelines should be developed to improve program performance and cost effectiveness.

Establishment of a Quality Management System Based on ISO 9001 Standard in a Public Service Fungal Culture Collection.

PubMed

Simões, Marta F; Dias, Nicolina; Santos, Cledir; Lima, Nelson

2016-06-22

Collaborations between different Microbiological Resource Centres (mBRCs) and ethical sourcing practices are mandatory to guarantee biodiversity conservation, successful and sustainable preservation and fair share of benefits that arise from the use of genetic resources. Since microbial Culture Collections (CCs) are now engaged in meeting high quality operational standards, they are facing the challenge of establishing quality control criteria to certify their biological materials. The authentication/certification of strains is nowadays a demand from the bioeconomy sector for the global operation of mBRCs. The achievement of consistent quality assurance and trust within the mBRCs and microbial CCs context is a dynamic and never-ending process. A good option to facilitate that process is to implement a Quality Management System (QMS) based on the ISO 9001 standard. Here, we report a detailed description of all the steps taken for the QMS implementation at the Portuguese CC of filamentous fungi: Micoteca da Universidade do Minho (MUM). Our aim is to provide guidelines for the certification of other CCs, so that they can also enhance the search and choice of the most consistent, reliable, and effective operating methods, with assured procedures and validation of preservation; and guarantee trustworthy relations with all stakeholders.

Establishment of a Quality Management System Based on ISO 9001 Standard in a Public Service Fungal Culture Collection

PubMed Central

Simões, Marta F.; Dias, Nicolina; Santos, Cledir; Lima, Nelson

2016-01-01

Collaborations between different Microbiological Resource Centres (mBRCs) and ethical sourcing practices are mandatory to guarantee biodiversity conservation, successful and sustainable preservation and fair share of benefits that arise from the use of genetic resources. Since microbial Culture Collections (CCs) are now engaged in meeting high quality operational standards, they are facing the challenge of establishing quality control criteria to certify their biological materials. The authentication/certification of strains is nowadays a demand from the bioeconomy sector for the global operation of mBRCs. The achievement of consistent quality assurance and trust within the mBRCs and microbial CCs context is a dynamic and never-ending process. A good option to facilitate that process is to implement a Quality Management System (QMS) based on the ISO 9001 standard. Here, we report a detailed description of all the steps taken for the QMS implementation at the Portuguese CC of filamentous fungi: Micoteca da Universidade do Minho (MUM). Our aim is to provide guidelines for the certification of other CCs, so that they can also enhance the search and choice of the most consistent, reliable, and effective operating methods, with assured procedures and validation of preservation; and guarantee trustworthy relations with all stakeholders. PMID:27681915

Opening the black box of ethics policy work: evaluating a covert practice.

PubMed

Frolic, Andrea; Drolet, Katherine; Bryanton, Kim; Caron, Carole; Cupido, Cynthia; Flaherty, Barb; Fung, Sylvia; McCall, Lori

2012-01-01

Hospital ethics committees (HECs) and ethicists generally describe themselves as engaged in four domains of practice: case consultation, research, education, and policy work. Despite the increasing attention to quality indicators, practice standards, and evaluation methods for the other domains, comparatively little is known or published about the policy work of HECs or ethicists. This article attempts to open the "black box" of this health care ethics practice by providing two detailed case examples of ethics policy reviews. We also describe the development and application of an evaluation strategy to assess the quality of ethics policy review work, and to enable continuous improvement of ethics policy review processes. Given the potential for policy work to impact entire patient populations and organizational systems, it is imperative that HECs and ethicists develop clearer roles, responsibilities, procedural standards, and evaluation methods to ensure the delivery of consistent, relevant, and high-quality ethics policy reviews.

Effect of production variables on microbiological removal in locally-produced ceramic filters for household water treatment.

PubMed

Lantagne, Daniele; Klarman, Molly; Mayer, Ally; Preston, Kelsey; Napotnik, Julie; Jellison, Kristen

2010-06-01

Diarrhoeal diseases cause an estimated 1.87 million child deaths per year. Point-of-use filtration using locally made ceramic filters improves microbiological quality of stored drinking water and prevents diarrhoeal disease. Scaling-up ceramic filtration is inhibited by lack of universal quality control standards. We investigated filter production variables to determine their affect on microbiological removal during 5-6 weeks of simulated normal use. Decreases in the clay:sawdust ratio and changes in the burnable decreased effectiveness of the filter. Method of silver application and shape of filter did not impact filter effectiveness. A maximum flow rate of 1.7 l(-hr) was established as a potential quality control measure for one particular filter to ensure 99% (2- log(10)) removal of total coliforms. Further research is indicated to determine additional production variables associated with filter effectiveness and develop standardized filter production procedures prior to scaling-up.

Benefits of a Pharmacology Antimalarial Reference Standard and Proficiency Testing Program Provided by the Worldwide Antimalarial Resistance Network (WWARN)

PubMed Central

Lourens, Chris; Lindegardh, Niklas; Barnes, Karen I.; Guerin, Philippe J.; Sibley, Carol H.; White, Nicholas J.

2014-01-01

Comprehensive assessment of antimalarial drug resistance should include measurements of antimalarial blood or plasma concentrations in clinical trials and in individual assessments of treatment failure so that true resistance can be differentiated from inadequate drug exposure. Pharmacometric modeling is necessary to assess pharmacokinetic-pharmacodynamic relationships in different populations to optimize dosing. To accomplish both effectively and to allow comparison of data from different laboratories, it is essential that drug concentration measurement is accurate. Proficiency testing (PT) of laboratory procedures is necessary for verification of assay results. Within the Worldwide Antimalarial Resistance Network (WWARN), the goal of the quality assurance/quality control (QA/QC) program is to facilitate and sustain high-quality antimalarial assays. The QA/QC program consists of an international PT program for pharmacology laboratories and a reference material (RM) program for the provision of antimalarial drug standards, metabolites, and internal standards for laboratory use. The RM program currently distributes accurately weighed quantities of antimalarial drug standards, metabolites, and internal standards to 44 pharmacology, in vitro, and drug quality testing laboratories. The pharmacology PT program has sent samples to eight laboratories in four rounds of testing. WWARN technical experts have provided advice for correcting identified problems to improve performance of subsequent analysis and ultimately improved the quality of data. Many participants have demonstrated substantial improvements over subsequent rounds of PT. The WWARN QA/QC program has improved the quality and value of antimalarial drug measurement in laboratories globally. It is a model that has potential to be applied to strengthening laboratories more widely and improving the therapeutics of other infectious diseases. PMID:24777099

Developing tools to measure quality in congenital catheterization and interventions: the congenital cardiac catheterization project on outcomes (C3PO).

PubMed

Chaudhry-Waterman, Nadia; Coombs, Sandra; Porras, Diego; Holzer, Ralf; Bergersen, Lisa

2014-01-01

The broad range of relatively rare procedures performed in pediatric cardiac catheterization laboratories has made the standardization of care and risk assessment in the field statistically quite problematic. However, with the growing number of patients who undergo cardiac catheterization, it has become imperative that the cardiology community overcomes these challenges to study patient outcomes. The Congenital Cardiac Catheterization Project on Outcomes was able to develop benchmarks, tools for measurement, and risk adjustment methods while exploring procedural efficacy. Based on the success of these efforts, the collaborative is pursuing a follow-up project, the Congenital Cardiac Catheterization Project on Outcomes-Quality Improvement, aimed at improving the outcomes for all patients undergoing catheterization for congenital heart disease by reducing radiation exposure.

Chronic pancreatitis: A surgical disease? Role of the Frey procedure

PubMed Central

Roch, Alexandra; Teyssedou, Jérome; Mutter, Didier; Marescaux, Jacques; Pessaux, Patrick

2014-01-01

Although medical treatment and endoscopic interventions are primarily offered to patients with chronic pancreatitis, approximately 40% to 75% will ultimately require surgery during the course of their disease. Although pancreaticoduodenectomy has been considered the standard surgical procedure because of its favorable results on pain control, its high postoperative complication and pancreatic exocrine or/and endocrine dysfunction rates have led to a growing enthusiasm for duodenal preserving pancreatic head resection. The aim of this review is to better understand the rationale underlying of the Frey procedure in chronic pancreatitis and to analyze its outcome. Because of its hybrid nature, combining both resection and drainage, the Frey procedure has been conceptualized based on the pathophysiology of chronic pancreatitis. The short and long-term outcome, especially pain relief and quality of life, are better after the Frey procedure than after any other surgical procedure performed for chronic pancreatitis. PMID:25068010

Echogenic Catheters and Embryo Transfer Standardization.

PubMed

Urbina, Maria Teresa; Benjamin, Isaac; Medina, Randolfo; Lerner, Jorge

2015-05-01

1.To describe the standardization process and protocols of the ET method at our center. 2.To compare the performance of non-echogenic catheters with echogenic catheters during ultrasound-guided ET. Retrospective analysis of 2630 ET performed at UNIFERTES during 1997-2014, to describe standardization process and to compare the percentage of difficult ET between echogenic and non-echogenic catheters. We tested 17 non-echogenic and three echogenic catheters. Many variables were associated with the ease of ET: informed patients, waiting time for the procedure, speculum use, clinical touch, uterine contractions, cervical mucus removal, presence of blood before or after the procedure, full bladder, ultrasound guidance, uterocervical angle, mock transfer, catheter type (soft or hard, echogenic or non-echogenic, with stylet or not), catheter loading technique, duration of embryo loading (time interval since the embryos were removed from the incubator for loading until the catheter is passed to the physician), transfer procedure (time interval from the catheter was handed to the physician until the embryos were discharged in the uterus), catheter tip placement, retained embryos, bed rest after ET, operator´s proficiency. The diversity of catheters used and the percentage of difficult transfers decrease as the use of echogenic catheters increases. This process is necessary to minimize variation, ensure high quality, safe and evidence-based practice, and improve outcomes. To standardize the ET method allowed a quicker and easier transfer. The use of echogenic catheters simplified ET procedures guided by abdominal ultrasound.

End-of-fabrication CMOS process monitor

NASA Technical Reports Server (NTRS)

Buehler, M. G.; Allen, R. A.; Blaes, B. R.; Hannaman, D. J.; Lieneweg, U.; Lin, Y.-S.; Sayah, H. R.

1990-01-01

A set of test 'modules' for verifying the quality of a complementary metal oxide semiconductor (CMOS) process at the end of the wafer fabrication is documented. By electrical testing of specific structures, over thirty parameters are collected characterizing interconnects, dielectrics, contacts, transistors, and inverters. Each test module contains a specification of its purpose, the layout of the test structure, the test procedures, the data reduction algorithms, and exemplary results obtained from 3-, 2-, or 1.6-micrometer CMOS/bulk processes. The document is intended to establish standard process qualification procedures for Application Specific Integrated Circuits (ASIC's).

Doctors or technicians: assessing quality of medical education

PubMed Central

Hasan, Tayyab

2010-01-01

Medical education institutions usually adapt industrial quality management models that measure the quality of the process of a program but not the quality of the product. The purpose of this paper is to analyze the impact of industrial quality management models on medical education and students, and to highlight the importance of introducing a proper educational quality management model. Industrial quality management models can measure the training component in terms of competencies, but they lack the educational component measurement. These models use performance indicators to assess their process improvement efforts. Researchers suggest that the performance indicators used in educational institutions may only measure their fiscal efficiency without measuring the quality of the educational experience of the students. In most of the institutions, where industrial models are used for quality assurance, students are considered as customers and are provided with the maximum services and facilities possible. Institutions are required to fulfill a list of recommendations from the quality control agencies in order to enhance student satisfaction and to guarantee standard services. Quality of medical education should be assessed by measuring the impact of the educational program and quality improvement procedures in terms of knowledge base development, behavioral change, and patient care. Industrial quality models may focus on academic support services and processes, but educational quality models should be introduced in parallel to focus on educational standards and products. PMID:23745059

Doctors or technicians: assessing quality of medical education.

PubMed

Hasan, Tayyab

2010-01-01

Medical education institutions usually adapt industrial quality management models that measure the quality of the process of a program but not the quality of the product. The purpose of this paper is to analyze the impact of industrial quality management models on medical education and students, and to highlight the importance of introducing a proper educational quality management model. Industrial quality management models can measure the training component in terms of competencies, but they lack the educational component measurement. These models use performance indicators to assess their process improvement efforts. Researchers suggest that the performance indicators used in educational institutions may only measure their fiscal efficiency without measuring the quality of the educational experience of the students. In most of the institutions, where industrial models are used for quality assurance, students are considered as customers and are provided with the maximum services and facilities possible. Institutions are required to fulfill a list of recommendations from the quality control agencies in order to enhance student satisfaction and to guarantee standard services. Quality of medical education should be assessed by measuring the impact of the educational program and quality improvement procedures in terms of knowledge base development, behavioral change, and patient care. Industrial quality models may focus on academic support services and processes, but educational quality models should be introduced in parallel to focus on educational standards and products.

Implementation Considerations for Multisite Clinical Trials with Cognitive Neuroscience Tasks

PubMed Central

Keefe, Richard S. E.; Harvey, Philip D.

2008-01-01

Multisite clinical trials aimed at cognitive enhancement across various neuropsychiatric conditions have employed standard neuropsychological tests as outcome measures. While these tests have enjoyed wide clinical use and have proven reliable and predictive of functional disability, a number of implementation challenges have arisen when these tests are used in clinical trials. These issues are likely to be magnified in future studies when cognitive neuroscience (CN) procedures are explored in these trials, because in their current forms CN procedures are less standardized and more difficult to teach and monitor. For multisite trials, we anticipate that the most challenging issues will include assuring tester competence, monitoring tester performance, specific challenges with complex assessment methods, and having resources available for adequate monitoring of data quality. Suggestions for overcoming these implementation challenges are offered. PMID:18495645

[Introduction of a quality management system compliant with DIN EN 9001:2000 in a university department of nuclear medicine].

PubMed

Jansen-Schmidt, V; Paschen, U; Kröger, S; Bohuslavizki, K H; Clausen, M

2001-12-01

In 1995, the management of the University Clinic Hamburg-Eppendorf proposed to establish a total quality assurance (QA) system. A revised QA-system has been introduced stepwise in the department of nuclear medicine since 1997, and certification was achieved in accordance with DIN EN ISO 9001:2000 on February 14, 2001. The QA-handbook is divided into two parts. The first part contains operational (diagnostic and therapeutic) procedures in so-called standard operating procedures (SOP). They describe the indication of procedures as well as the competences and time necessary in a standardized manner. Up to now, more than 70 SOPs have been written as a collaborative approach between technicians and physicians during daily clinical routine after analysing and discussing the procedures. Thus, the results were more clearly defined processes and more satisfied employees. The second part consists of general rules and directions concerning the security of work and equipment as well as radiation protection tasks, hygiene etc. as it is required by the law. This part was written predominantly by the management of the department of nuclear-medicine and the QA-coordinator. Detailed information for the patients, documentation of the work-flows as well as the medical report was adopted to the QM-system. Although in the introduction phase of a QA-system a vast amount of time is necessary, some months later a surplus for the clinical workday will become available. The well defined relations of competences and procedures will result in a gain of time, a reduction of costs and a help to ensure the legal demands. Last but not least, the QA-system simply helps to build up confidence and acceptance both by the patients and the referring physicians.

Video on Diet Before Outpatient Colonoscopy Does Not Improve Quality of Bowel Preparation: A Prospective, Randomized, Controlled Trial.

PubMed

Rice, Sean C; Higginbotham, Tina; Dean, Melanie J; Slaughter, James C; Yachimski, Patrick S; Obstein, Keith L

2016-11-01

Successful outpatient colonoscopy (CLS) depends on many factors including the quality of a patient's bowel preparation. Although education on consumption of the pre-CLS purgative can improve bowel preparation quality, no study has evaluated dietary education alone. We have created an educational video on pre-CLS dietary instructions to determine whether dietary education would improve outpatient bowel preparation quality. A prospective randomized, blinded, controlled study of patients undergoing outpatient CLS was performed. All patients received a 4 l polyethylene glycol-based split-dose bowel preparation and standard institutional pre-procedure instructions. Patients were then randomly assigned to an intervention arm or to a no intervention arm. A 4-min educational video detailing clear liquid diet restriction was made available to patients in the intervention arm, whereas those randomized to no intervention did not have access to the video. Patients randomized to the video were provided with the YouTube video link 48-72 h before CLS. An attending endoscopist blinded to randomization performed the CLS. Bowel preparation quality was scored using the Boston Bowel Preparation Scale (BBPS). Adequate preparation was defined as a BBPS total score of ≥6 with all segment scores ≥2. Wilcoxon rank-sum and Pearson's χ 2 -tests were performed to assess differences between groups. Ninety-two patients were randomized (video: n=42; control: n=50) with 47 total video views being tallied. There were no demographic differences between groups. There was no statistically significant difference in adequate preparation between groups (video=74%; control=68%; P=0.54). The availability of a supplementary patient educational video on clear liquid diet alone was insufficient to improve bowel preparation quality when compared with standard pre-procedure instruction at our institution.

Functions of standard CPR training on performance qualities of medical volunteers for Mt. Taishan International Mounting Festival.

PubMed

Fanshan, Meng; Lin, Zhao; Wenqing, Liu; Chunlei, Lu; Yongqiang, Liu; Naiyi, Li

2013-01-01

Cardiopulmonary resuscitation (CPR) is a sudden emergency procedure that requires a rapid and efficient response, and personnel training in lifesaving procedures. Regular practice and training are necessary to improve resuscitation skills and reduce anxiety among the staff. As one of the most important skills mastered by medical volunteers serving for Mt. Taishan International Mounting Festival, we randomly selected some of them to evaluate the quality of CPR operation and compared the result with that of the untrained doctors and nurses. In order to evaluate the functions of repeating standard CPR training on performance qualities of medical volunteers for Mt. Taishan International Mounting Festival, their performance qualities of CPR were compared with those of the untrained medical workers working in emergency departments of hospitals in Taian. The CPR performance qualities of 52 medical volunteers (Standard Training Group), who had continually taken part in standard CPR technical training for six months, were tested at random and were compared with those of 68 medical workers (Compared Group) working in emergency departments of hospitals in Taian who hadn't attended CPR training within a year. The QCPR 3535 monitor (provided by Philips Company) was used to measure the standard degree of single simulated CPR performance, including the chest compression depth, frequency, released pressure between compressions and performance time of compression and ventilation, the results of which were recorded in the table and the number of practical compression per minute was calculated. The data were analyzed by x2 Test and t Test. The factors which would influence CPR performance, including gender, age, placement, hand skill, posture of compression and frequency of training, were classified and given parameters, and were put to Logistic repression analysis. The CPR performance qualities of volunteers were much higher than those of the compared group. The overall pass rates were respectively 86.4% and 31.9%; the pass rates of medical volunteers in terms of the chest compression depth, frequency, released pressure between compressions were higher than those of the compared group, which were 89.6%, 94.2%, 95.8% vs 50.3%, 53.0%, 83.1%, P<0.01; there were few differences in overall performance time, which were (118.4 ± 13.5s) vs (116.0 ± 10.4s), P>0.05; the duration time of ventilation in each performance section was much shorter than that in the compared group, which were (6.38 ± 1.2) vs (7.47 ± 1.7), P<0.01; there were few differences in the number of practical compression per minute, which were (78.2 ± 3.5) vs (78.8 ± 12.2), P>0.05); the time proportion of compression and ventilation was 2.6:1 vs 2.1:1. The Logistic repression analysis showed that CPR performance qualities were clearly related to hand skill, posture of compression and repeating standard training, which were respectively OR 13.12 and 95%CI (2.35~73.2); OR 30.89, 95%CI (3.62~263.5); OR 4.07,95%CI (1.16~14.2). The CPR performance qualities of volunteers who had had repeating standard training were much higher than those of untrained medical workers, which proved that standard training helped improve CPR performance qualities.

The Typhoid Fever Surveillance in Africa Program (TSAP): Clinical, Diagnostic, and Epidemiological Methodologies.

PubMed

von Kalckreuth, Vera; Konings, Frank; Aaby, Peter; Adu-Sarkodie, Yaw; Ali, Mohammad; Aseffa, Abraham; Baker, Stephen; Breiman, Robert F; Bjerregaard-Andersen, Morten; Clemens, John D; Crump, John A; Cruz Espinoza, Ligia Maria; Deerin, Jessica Fung; Gasmelseed, Nagla; Sow, Amy Gassama; Im, Justin; Keddy, Karen H; Cosmas, Leonard; May, Jürgen; Meyer, Christian G; Mintz, Eric D; Montgomery, Joel M; Olack, Beatrice; Pak, Gi Deok; Panzner, Ursula; Park, Se Eun; Rakotozandrindrainy, Raphaël; Schütt-Gerowitt, Heidi; Soura, Abdramane Bassiahi; Warren, Michelle R; Wierzba, Thomas F; Marks, Florian

2016-03-15

New immunization programs are dependent on data from surveillance networks and disease burden estimates to prioritize target areas and risk groups. Data regarding invasive Salmonella disease in sub-Saharan Africa are currently limited, thus hindering the implementation of preventive measures. The Typhoid Fever Surveillance in Africa Program (TSAP) was established by the International Vaccine Institute to obtain comparable incidence data on typhoid fever and invasive nontyphoidal Salmonella (iNTS) disease in sub-Saharan Africa through standardized surveillance in multiple countries. Standardized procedures were developed and deployed across sites for study site selection, patient enrolment, laboratory procedures, quality control and quality assurance, assessment of healthcare utilization and incidence calculations. Passive surveillance for bloodstream infections among febrile patients was initiated at thirteen sentinel sites in ten countries (Burkina Faso, Ethiopia, Ghana, Guinea-Bissau, Kenya, Madagascar, Senegal, South Africa, Sudan, and Tanzania). Each TSAP site conducted case detection using these standardized methods to isolate and identify aerobic bacteria from the bloodstream of febrile patients. Healthcare utilization surveys were conducted to adjust population denominators in incidence calculations for differing healthcare utilization patterns and improve comparability of incidence rates across sites. By providing standardized data on the incidence of typhoid fever and iNTS disease in sub-Saharan Africa, TSAP will provide vital input for targeted typhoid fever prevention programs. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

A reference standard-based quality assurance program for radiology.

PubMed

Liu, Patrick T; Johnson, C Daniel; Miranda, Rafael; Patel, Maitray D; Phillips, Carrie J

2010-01-01

The authors have developed a comprehensive radiology quality assurance (QA) program that evaluates radiology interpretations and procedures by comparing them with reference standards. Performance metrics are calculated and then compared with benchmarks or goals on the basis of published multicenter data and meta-analyses. Additional workload for physicians is kept to a minimum by having trained allied health staff members perform the comparisons of radiology reports with the reference standards. The performance metrics tracked by the QA program include the accuracy of CT colonography for detecting polyps, the false-negative rate for mammographic detection of breast cancer, the accuracy of CT angiography detection of coronary artery stenosis, the accuracy of meniscal tear detection on MRI, the accuracy of carotid artery stenosis detection on MR angiography, the accuracy of parathyroid adenoma detection by parathyroid scintigraphy, the success rate for obtaining cortical tissue on ultrasound-guided core biopsies of pelvic renal transplants, and the technical success rate for peripheral arterial angioplasty procedures. In contrast with peer-review programs, this reference standard-based QA program minimizes the possibilities of reviewer bias and erroneous second reviewer interpretations. The more objective assessment of performance afforded by the QA program will provide data that can easily be used for education and management conferences, research projects, and multicenter evaluations. Additionally, such performance data could be used by radiology departments to demonstrate their value over nonradiology competitors to referring clinicians, hospitals, patients, and third-party payers. Copyright 2010 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Prevalidation in pharmaceutical analysis. Part I. Fundamentals and critical discussion.

PubMed

Grdinić, Vladimir; Vuković, Jadranka

2004-05-28

A complete prevalidation, as a basic prevalidation strategy for quality control and standardization of analytical procedure was inaugurated. Fast and simple, the prevalidation methodology based on mathematical/statistical evaluation of a reduced number of experiments (N < or = 24) was elaborated and guidelines as well as algorithms were given in detail. This strategy has been produced for the pharmaceutical applications and dedicated to the preliminary evaluation of analytical methods where linear calibration model, which is very often occurred in practice, could be the most appropriate to fit experimental data. The requirements presented in this paper should therefore help the analyst to design and perform the minimum number of prevalidation experiments needed to obtain all the required information to evaluate and demonstrate the reliability of its analytical procedure. In complete prevalidation process, characterization of analytical groups, checking of two limiting groups, testing of data homogeneity, establishment of analytical functions, recognition of outliers, evaluation of limiting values and extraction of prevalidation parameters were included. Moreover, system of diagnosis for particular prevalidation step was suggested. As an illustrative example for demonstration of feasibility of prevalidation methodology, among great number of analytical procedures, Vis-spectrophotometric procedure for determination of tannins with Folin-Ciocalteu's phenol reagent was selected. Favourable metrological characteristics of this analytical procedure, as prevalidation figures of merit, recognized the metrological procedure as a valuable concept in preliminary evaluation of quality of analytical procedures.

Virtual reality-based simulators for spine surgery: a systematic review.

PubMed

Pfandler, Michael; Lazarovici, Marc; Stefan, Philipp; Wucherer, Patrick; Weigl, Matthias

2017-09-01

Virtual reality (VR)-based simulators offer numerous benefits and are very useful in assessing and training surgical skills. Virtual reality-based simulators are standard in some surgical subspecialties, but their actual use in spinal surgery remains unclear. Currently, only technical reviews of VR-based simulators are available for spinal surgery. Thus, we performed a systematic review that examined the existing research on VR-based simulators in spinal procedures. We also assessed the quality of current studies evaluating VR-based training in spinal surgery. Moreover, we wanted to provide a guide for future studies evaluating VR-based simulators in this field. This is a systematic review of the current scientific literature regarding VR-based simulation in spinal surgery. Five data sources were systematically searched to identify relevant peer-reviewed articles regarding virtual, mixed, or augmented reality-based simulators in spinal surgery. A qualitative data synthesis was performed with particular attention to evaluation approaches and outcomes. Additionally, all included studies were appraised for their quality using the Medical Education Research Study Quality Instrument (MERSQI) tool. The initial review identified 476 abstracts and 63 full texts were then assessed by two reviewers. Finally, 19 studies that examined simulators for the following procedures were selected: pedicle screw placement, vertebroplasty, posterior cervical laminectomy and foraminotomy, lumbar puncture, facet joint injection, and spinal needle insertion and placement. These studies had a low-to-medium methodological quality with a MERSQI mean score of 11.47 out of 18 (standard deviation=1.81). This review described the current state and applications of VR-based simulator training and assessment approaches in spinal procedures. Limitations, strengths, and future advancements of VR-based simulators for training and assessment in spinal surgery were explored. Higher-quality studies with patient-related outcome measures are needed. To establish further adaptation of VR-based simulators in spinal surgery, future evaluations need to improve the study quality, apply long-term study designs, and examine non-technical skills, as well as multidisciplinary team training. Copyright © 2017 Elsevier Inc. All rights reserved.

Protocol for monitoring metals in Ozark National Scenic Riverways, Missouri: Version 1.0

USGS Publications Warehouse

Schmitt, Christopher J.; Brumbaugh, William G.; Besser, John M.; Hinck, Jo Ellen; Bowles, David E.; Morrison, Lloyd W.; Williams, Michael H.

2008-01-01

The National Park Service is developing a monitoring plan for the Ozark National Scenic Riverways in southeastern Missouri. Because of concerns about the release of lead, zinc, and other metals from lead-zinc mining to streams, the monitoring plan will include mining-related metals. After considering a variety of alternatives, the plan will consist of measuring the concentrations of cadmium, cobalt, lead, nickel, and zinc in composite samples of crayfish (Orconectes luteus or alternate species) and Asian clam (Corbicula fluminea) collected periodically from selected sites. This document, which comprises a protocol narrative and supporting standard operating procedures, describes the methods to be employed prior to, during, and after collection of the organisms, along with procedures for their chemical analysis and quality assurance; statistical analysis, interpretation, and reporting of the data; and for modifying the protocol narrative and supporting standard operating procedures. A list of supplies and equipment, data forms, and sample labels are also included. An example based on data from a pilot study is presented.

KSC Center Director Bridges accepts an ISO 9001 certification plaque from DNV

NASA Technical Reports Server (NTRS)

1998-01-01

Center Director Roy Bridges (right) displays the 2000th ISO Certificate Plaque he was given by Dalton Lyon (left) of Det Norske Veritas (DNV), Inc., an international ISO certification organization, at a ceremony at KSC. The plaque is a representation of the ISO 9001 certification awarded to KSC by DNV. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already world- class team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification.

Optimization of a protocol for myocardial perfusion scintigraphy by using an anthropomorphic phantom.

PubMed

Ramos, Susie Medeiros Oliveira; Glavam, Adriana Pereira; Kubo, Tadeu Takao Almodovar; de Sá, Lidia Vasconcellos

2014-01-01

To develop a study aiming at optimizing myocardial perfusion imaging. Imaging of an anthropomorphic thorax phantom with a GE SPECT Ventri gamma camera, with varied activities and acquisition times, in order to evaluate the influence of these parameters on the quality of the reconstructed medical images. The (99m)Tc-sestamibi radiotracer was utilized, and then the images were clinically evaluated on the basis of data such as summed stress score, and on the technical image quality and perfusion. The software ImageJ was utilized in the data quantification. The results demonstrated that for the standard acquisition time utilized in the procedure (15 seconds per angle), the injected activity could be reduced by 33.34%. Additionally, even if the standard scan time is reduced by 53.34% (7 seconds per angle), the standard injected activity could still be reduced by 16.67%, without impairing the image quality and the diagnostic reliability. The described method and respective results provide a basis for the development of a clinical trial of patients in an optimized protocol.

Technology transfer through a network of standard methods and recommended practices - The case of petrochemicals

NASA Astrophysics Data System (ADS)

Batzias, Dimitris F.; Karvounis, Sotirios

2012-12-01

Technology transfer may take place in parallel with cooperative action between companies participating in the same organizational scheme or using one another as subcontractor (outsourcing). In this case, cooperation should be realized by means of Standard Methods and Recommended Practices (SRPs) to achieve (i) quality of intermediate/final products according to specifications and (ii) industrial process control as required to guarantee such quality with minimum deviation (corresponding to maximum reliability) from preset mean values of representative quality parameters. This work deals with the design of the network of SRPs needed in each case for successful cooperation, implying also the corresponding technology transfer, effectuated through a methodological framework developed in the form of an algorithmic procedure with 20 activity stages and 8 decision nodes. The functionality of this methodology is proved by presenting the path leading from (and relating) a standard test method for toluene, as petrochemical feedstock in the toluene diisocyanate production, to the (6 generations distance upstream) performance evaluation of industrial process control systems (ie., from ASTM D5606 to BS EN 61003-1:2004 in the SRPs network).

KSC-98pc909

NASA Image and Video Library

1998-08-11

Center Director Roy Bridges speaks to KSC employees at the ISO certification ceremony held at the Training Auditorium. Bridges was presented an ISO 9001 certificate and plaque awarded to KSC by Det Norske Veritas (DNV), Inc., an international ISO certification organization. ISO 9001 comprises the most detailed, comprehensive set of standard requirements for quality programs established by the International Standards Organization. The presentation followed a successful independent audit by DNV of the KSC Management System in May of this year. The third-party auditors examined about 20 elements of KSC's system, including management responsibility, design control, documentation, test and inspection, and corrective action procedures. DNV found that KSC met or exceeded the stringent quality standards in all areas. KSC will use this certification as a tool to improve an already worldclass team. All NASA centers are required by NASA Administrator Daniel S. Goldin to be ISO 9001 registered by September 1999. NASA is the first federal agency to seek the quality certification. Next to Bridges is Heidi Hollingsworth, with the Center for Independent Living, who uses American Sign Language for any hearing-impaired employees in the audience

Optimization of a protocol for myocardial perfusion scintigraphy by using an anthropomorphic phantom*

PubMed Central

Ramos, Susie Medeiros Oliveira; Glavam, Adriana Pereira; Kubo, Tadeu Takao Almodovar; de Sá, Lidia Vasconcellos

2014-01-01

Objective To develop a study aiming at optimizing myocardial perfusion imaging. Materials and Methods Imaging of an anthropomorphic thorax phantom with a GE SPECT Ventri gamma camera, with varied activities and acquisition times, in order to evaluate the influence of these parameters on the quality of the reconstructed medical images. The 99mTc-sestamibi radiotracer was utilized, and then the images were clinically evaluated on the basis of data such as summed stress score, and on the technical image quality and perfusion. The software ImageJ was utilized in the data quantification. Results The results demonstrated that for the standard acquisition time utilized in the procedure (15 seconds per angle), the injected activity could be reduced by 33.34%. Additionally, even if the standard scan time is reduced by 53.34% (7 seconds per angle), the standard injected activity could still be reduced by 16.67%, without impairing the image quality and the diagnostic reliability. Conclusion The described method and respective results provide a basis for the development of a clinical trial of patients in an optimized protocol. PMID:25741088

Water Quality Standards for Coral Reef Protection | Science ...

EPA Pesticide Factsheets

The U.S. Clean Water Act provides a legal framework to protect coastal biological resources such as coral reefs, mangrove forests, and seagrass meadows from the damaging effects of human activities. Even though many resources are protected under this authority, water quality standards have not been effectively applied to coral reefs. The Environmental Protection Agency is promoting biocriteria and other water quality standards through collaborative development of bioassessment procedures, indicators and monitoring strategies. To support regulatory action, bioassessment indicators must be biologically meaningful, relevant to management, responsive to human disturbance, and relatively immune to natural variability. A rapid bioassessment protocol for reef-building stony corals was developed and tested for regulatory applicability. Preliminary testing in the Florida Keys found indicators had sufficient precision and provided information relevant to coral reef management. Sensitivity to human disturbance was demonstrated in the U.S. Virgin Islands for five of eight indicators tested. Once established, monitoring programs using these indicators can provide valuable, long-term records of coral condition and regulatory compliance. Development of a rapid bioassement protocol for reef-building stony corals was tested for regulatory applicability.

Assessment methods for rehabilitation.

PubMed

Biefang, S; Potthoff, P

1995-09-01

Diagnostics and evaluation in medical rehabilitation should be based on methods that are as objective as possible. In this context quantitative methods are an important precondition. We conducted for the German Pensions Insurance Institutions (which are in charge of the medical and vocational rehabilitation of workers and employees) a survey on assessment methods for rehabilitation which included an evaluation of American literature, with the aim to indicate procedures that can be considered for adaptation in Germany and to define further research requirements. The survey identified: (1) standardized procedures and instrumented tests for the assessment of musculoskeletal, cardiopulmonary and neurophysiological function; (2) personality, intelligence, achievement, neuropsychological and alcoholism screening tests for the assessment of mental or cognitive function; (3) rating scales and self-administered questionnaires for the assessment of Activities of Daily Living and Instrumental Activities of Daily Living (ADL/IADL Scales); (4) generic profiles and indexes as well as disease-specific measures for the assessment of health-related quality of life and health status; and (5) rating scales for vocational assessment. German equivalents or German versions exist only for a part of the procedures identified. Translation and testing of Anglo-Saxon procedures should have priority over the development of new German methods. The following procedures will be taken into account: (a) instrumented tests for physical function, (b) IADL Scales, (c) generic indexes of health-related quality of life, (d) specific quality of life and health status measures for disorders of the circulatory system, metabolic system, digestive organs, respiratory tract and for cancer, and (e) vocational rating scales.

US EPA Nonattainment Areas and Designations-SO2 (2010 NAAQS)

EPA Pesticide Factsheets

This web service contains the following layer: SO2 2010 NAAQS State Level. Full FGDC metadata records for each layer may be found by clicking the layer name at the web service endpoint (https://gispub.epa.gov/arcgis/rest/services/OAR_OAQPS/NAA2010SO21hour/MapServer) and viewing the layer description. These layers identify areas in the U.S. where air pollution levels have not met the National Ambient Air Quality Standards (NAAQS) for criteria air pollutants and have been designated nonattainment?? areas (NAA). The data are updated weekly from an OAQPS internal database. However, that does not necessarily mean the data have changed. The EPA Office of Air Quality Planning and Standards (OAQPS) has set National Ambient Air Quality Standards for six principal pollutants, which are called criteria pollutants. Under provisions of the Clean Air Act, which is intended to improve the quality of the air we breathe, EPA is required to set National Ambient Air Quality Standards for six common air pollutants. These commonly found air pollutants (also known as criteria pollutants) are found all over the United States. They are particle pollution (often referred to as particulate matter), ground-level ozone, carbon monoxide, sulfur oxides, nitrogen oxides, and lead. For each criteria pollutant, there are specific procedures used for measuring ambient concentrations and for calculating long-term (quarterly or annual) and/or short-term (24-hour) exposure levels. The methods and a

US EPA Nonattainment Areas and Designations-24 Hour PM2.5 (2006 NAAQS)

EPA Pesticide Factsheets

This web service contains the following layers: PM2.5 24hr 2006 NAAQS State Level and PM2.5 24hr 2006 NAAQS National. Full FGDC metadata records for each layer may be found by clicking the layer name at the web service endpoint (https://gispub.epa.gov/arcgis/rest/services/OAR_OAQPS/NAA2006PM2524hour/MapServer) and viewing the layer description. These layers identify areas in the U.S. where air pollution levels have not met the National Ambient Air Quality Standards (NAAQS) for criteria air pollutants and have been designated nonattainment?? areas (NAA). The data are updated weekly from an OAQPS internal database. However, that does not necessarily mean the data have changed. The EPA Office of Air Quality Planning and Standards (OAQPS) has set National Ambient Air Quality Standards for six principal pollutants, which are called criteria pollutants. Under provisions of the Clean Air Act, which is intended to improve the quality of the air we breathe, EPA is required to set National Ambient Air Quality Standards for six common air pollutants. These commonly found air pollutants (also known as criteria pollutants) are found all over the United States. They are particle pollution (often referred to as particulate matter), ground-level ozone, carbon monoxide, sulfur oxides, nitrogen oxides, and lead. For each criteria pollutant, there are specific procedures used for measuring ambient concentrations and for calculating long-term (quarterly or annual) and/or short-ter