Quality control of lipid measurements in epidemiological studies: the U.S. Air Force HEART program.

1985 ◽  
Vol 31 (2) ◽  
pp. 261-263 ◽  
Author(s):  
A Hainline ◽  
P Hill ◽  
L Garbaczewski ◽  
C Winn
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Air Force ◽  
Reference Materials ◽  
Internal Control ◽  
Density Lipoprotein ◽  
Quality Assurance Program ◽  
Internal Quality ◽  
Surveillance Program ◽  
The U.S

Abstract A special standardization and quality assurance program, similar to that created for the Lipid Research Clinics Program (LRC), was developed for the American Health Foundation Laboratory by the Centers for Disease Control (CDC) to assure the quality of lipid measurements in the U.S. Air Force Health Evaluation and Risk Tabulation (HEART) Program. This study was designed to test the feasibility of reducing the incidence of heart disease in active-duty U.S. Air Force personnel through life-study intervention. During the 18-month study, CDC provided serum calibrators and reference materials for internal control and an external surveillance program for measurements of total cholesterol (TC) and high-density-lipoprotein cholesterol (HDLC). The Laboratory, using an automated enzymic method to measure cholesterol, achieved an overall goal for accuracy of less than 2% error (av systematic error, -30.6 mg/L) for TC, as measured on nine reference pools for which values were assigned by CDC. The average bias of measurements of HDLC with heparin-manganese to separate the lipoproteins in five CDC reference pools was -4.6 mg/L. Bias was estimated relative to the values assigned to the reference materials by the CDC reference methods for TC and HDLC. The average CV for TC was 0.89%, for HDLC 2.66%. Accuracy of cholesterol measurements can be assured over time with a standardization and quality-assurance program that incorporates accurately labeled reference materials for calibration, internal quality control, and external surveillance.

scholarly journals Sigma metrics in quality control- An innovative tool

2022 ◽  
Vol 8 (4) ◽  
pp. 253-259
Author(s):  
Juby Sara Koshy ◽  
Afsheen Raza
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Assessment Tool ◽  
Clinical Laboratory ◽  
Density Lipoprotein ◽  
Internal Quality ◽  
Control Procedure ◽  
Gamma Glutamyl Transferase ◽  
Level 1 ◽  
Glutamyl Transferase

The clinical laboratory in today’s world is a rapidly evolving field which faces a constant pressure to produce quick and reliable results. Sigma metric is a new tool which helps to reduce process variability, quantitate the approximate number of analytical errors, and evaluate and guide for better quality control (QC) practices.To analyze sigma metrics of 16 biochemistry analytes using ERBA XL 200 Biochemistry analyzer, interpret parameter performance, compare analyzer performance with other Middle East studies and modify existing QC practices.This study was undertaken at a clinical laboratory for a period of 12 months from January to December 2020 for the following analytes: albumin (ALB), alanine amino transferase (SGPT), aspartate amino transferase (SGOT), alkaline phosphatase (ALKP), bilirubin total (BIL T), bilirubin direct (BIL D), calcium (CAL), cholesterol (CHOL), creatinine (CREAT), gamma glutamyl transferase (GGT), glucose (GLUC), high density lipoprotein (HDL), triglyceride (TG), total protein (PROT), uric acid (UA) and urea. The Coefficient of variance (CV%) and Bias % were calculated from internal quality control (IQC) and external quality assurance scheme (EQAS) records respectively. Total allowable error (TEa) was obtained using guidelines Clinical Laboratories Improvement Act guidelines (CLIA). Sigma metrics was calculated using CV%, Bias% and TEa for the above parameters. It was found that 5 analytes in level 1 and 8 analytes in level 2 had greater than 6 sigma performance indicating world class quality. Cholesterol, glucose (level 1 and 2) and creatinine level 1 showed >4 sigma performance i.e acceptable performance. Urea (both levels) and GGT (level 1) showed <3 sigma and were therefore identified as the problem analytes. Sigma metrics helps to assess analytic methodologies and can serve as an important self assessment tool for quality assurance in the clinical laboratory. Sigma metric evaluation in this study helped to evaluate the quality of several analytes and also categorize them from high performing to problematic analytes, indicating the utility of this tool. In conclusion, parameters showing lesser than 3 sigma need strict monitoring and modification of quality control procedure with change in method if necessary.

scholarly journals Production and Use of BCR Reference Materials for Quality Assurance in Environmental Analysis: An Update

2001 ◽  
Vol 84 (6) ◽  
pp. 1786-1792 ◽  
Author(s):  
Philippe Quevauviller
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Reference Materials ◽  
Environmental Analysis ◽  
Control Charts ◽  
Certified Reference Materials ◽  
Background Information ◽  
Analytical Quality Control ◽  
Analytical Quality ◽  
Invaluable Tool

Abstract Reference materials represent an invaluable tool for analytical quality control. Certified Reference Materials (CRMs) are used for the validation of methods, whereas various types of (uncertified) Reference Materials (RMs) are used for routine quality control (establishment of control charts) and interlaboratory testing (e.g., proficiency testing). This paper provides background information on the production and use of environmental RMs and describes recent CRMs produced by the BCR (European Commission) for quality assurance in environmental analysis.

Applicability of various quality-control sera to assay of high-density lipoprotein cholesterol.

1980 ◽  
Vol 26 (7) ◽  
pp. 903-907
Author(s):  
D G Bullock ◽  
T J Carter ◽  
S V Hughes
Keyword(s):  
Quality Control ◽  
High Density Lipoprotein ◽  
Quality Assessment ◽  
High Density Lipoprotein Cholesterol ◽  
External Quality Assessment ◽  
Density Lipoprotein ◽  
High Density ◽  
Lipoprotein Cholesterol ◽  
Internal Quality ◽  
External Quality

Abstract Effective internal quality control and external quality assessment of high-density lipoprotein cholesterol assay is made difficult by analyte instability, and the suitability of quality-control sera for this purpose has not been studied. We have therefore investigated the properties of 25 different control sera from 15 suppliers by estimating within-batch precision for the two precipitation procedures used most widely (phosphotungstate/Mg2+ and heparin/Mn2+ with enzymic measurement of cholesterol. Some sera had properties similar to those of fresh human serum, but others demonstrated poor precision for one or both procedures or contained apparent high-density lipoprotein cholesterol in unphysiological concentrations. A study of six sera indicated that between-batch precision was consistent with the within-batch findings. We found that eight of the 25 batches of quality-control serum we investigated may be used for internal quality control and external quality assessment of high-density lipoprotein cholesterol assay.

scholarly journals Development of the Analytical Methods and Reference Materials Program for Dietary Supplements at The National Institutes of Health

2004 ◽  
Vol 87 (1) ◽  
pp. 162-165 ◽  
Author(s):  
Leila G Saldanha ◽  
Joseph M Betz ◽  
Paul M Coates
Keyword(s):  
Quality Control ◽  
Dietary Supplements ◽  
Reference Materials ◽  
Analytical Methods ◽  
Research Agenda ◽  
Control Unit ◽  
Lessons Learned ◽  
National Institutes Of Health ◽  
Good Manufacturing Practices ◽  
The U.S

Abstract The need for validated analytical methods and reference materials to identify and measure constituents in dietary supplements is essential. Such methods allow for the documentation that products meet manufacturer's specifications and contain what their labels declare. In March 2003, the U.S. Food and Drug Administration issued a proposed rule that would establish specific current good manufacturing practices for dietary supplements. This proposed rule requires that companies create a quality control unit to set specifications and ensure compliance with these specifications using scientifically valid procedures. This report provides insights and lessons learned from 3 meetings the Office of Dietary Supplements (ODS) at the National Institutes of Health helped organize. These meetings were structured to (1) educate individuals about the importance and need for validated analytical methods and reference materials to identify and quantify constituents of dietary supplements; (2) identify resources required to fulfill this need; and (3) serve as a platform to obtain input from interested parties to help frame the research agenda for the Dietary Supplements Methods and Reference Materials Program within ODS. Stakeholder's opinions and views expressed at these 3 meetings are outlined in this report.

ASCO research program quality assessment tool: Basics for a quality community-based research site.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 97-97
Author(s):  
Patricia A. Hurley ◽  
Renee Yvonne Smith ◽  
Nicholas J. Robert
Keyword(s):  
Quality Assurance ◽  
Quality Assessment ◽  
Research Program ◽  
Quality Assurance Program ◽  
Internal Quality ◽  
Community Based ◽  
Community Based Research ◽  
Minimum Standards ◽  
Research Programs ◽  
Internal Quality Assurance

97 Background: In 2008, ASCO published a statement to identify minimum standards and exemplary attributes of clinical trial sites. Recommendations were made to assist with the development and implementation of high-quality research programs. Based on feedback from an ASCO needs assessment survey, ASCO’s Community Research Forum (CRF) sought to develop a tool to help community-based research sites exceed the minimum standards of conducting clinical research, and to identify important components for an internal quality assurance program. Methods: A tool was developed to incorporate elements of ASCO publications on minimal standards and exemplary attributes of research sites. The tool was designed to assist community-based research sites with the development and implementation of an internal quality assurance program. A checklist was also developed to help sites easily conduct an assessment of their program. Community-based researchers provided feedback on the tool’s content and utilization. Feedback was incorporated and the tool was released for widespread use in March 2014. Results: The tool was very well received by reviewers. All reviewers indicated that the level of detail of the tool was sufficient; 94% indicated that it presented realistic expectations, in terms of resources required to implement; and 81% indicated that it would be valuable for conducting a quality assessment of their research program. As of July 2014, the tool was downloaded by over 150 practices from 8 different countries and early feedback continued to be favorable, particularly from small and/or new research programs. Conclusions: Many community-based research programs do not have the resources to support an effective quality assurance program and rely heavily on external audits. The ASCO Research Program Quality Assessment Tool provides self-directed continual process improvement to help community-based research sites create an internal quality assurance program and exceed minimum standards of conducting clinical research. The CRF will learn more from users of the tool about the quality of research programs and processes, and key quality metrics. The tool is available for download at www.asco.org/communityresearchforum.

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