Quality assurance external

External quality assessment schemes involve the distribution by the organizer, to participating laboratories, of aliquots from the same sample. Participants analyze the received specimen and send the results back to the organizer who prepares a report to summarize all data. 

The common feature of all EQAS is the use of RMs as the distributed specimens -for unless a stable, homogeneous, controlled material is used the objectives caimot be guaranteed. 

In 1978 the International Federation of Clinical Chemistry produced a comprehensive summary of the objectives of External Quality Assessment (IFCC 1978). The first six points of Table 4.1 summarize the IFCC objectives the seventh has developed since that time and is of considerable importance in many countries where strict control over laboratories undertaking particular types of work is required by legislation or by appropriate professional organizations. 

External quality assurance (EQA) is fundamental to the standardization of clinical laboratory methods because it provides a means to compare results generated in one laboratory with those of peer laboratories subscribing to the same EQA program. EQA programs are especially beneficial since internal QA and QC procedures are limited in their ability to detect bias in analytical methods. Internal QA/QC can only detect errors that result in a deviation from the original method validation inherent errors in the method may go unnoticed. Therefore, it is helpful to compare the results produced by a new method with those from other laboratories (Burtis and Ashwood, 2001). Monitoring the performance of laboratory procedures in a consistent manner keeps the laboratory accountable, and can reveal systematic errors that would otherwise be undetected. A prominent component of EQA is proficiency testing. 

FDA (2001). Guidance for Industry Bioanalytical Method Validation. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). http //www.fda.gov/cder/guidance/4252fnl.pdf. 

Fraser, C. G., Kallner, A., Kenny, D., Hyltoft Petersen, P. (1999). Introduction strategies to set global quality specifications in laboratory medicine. Scand J Clin Lab Invest, 59, 477 78. 

QUALITY ASSURANCE, QUALITY CONTROL AND METHOD VALIDATION 

Garfield, E. M., Klesta, E., Hirsch, J. (2000). Quality Assurance Principles for Analytical Laboratories, 3rd edn. Gaithersburg, MD AOAC International. 

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You should consider obtaining internal and external quality assurance reviews of the study (to ferret out errors in modeling, data, etc.). Independent peer reviews of the QRA results can be helpful by presenting alternate viewpoints, and you should include outside experts (either consultants or personnel from another plant) on the QRA review panel. You should also set up a mechanism wherein disputes between QRA team members (e.g., technical arguments about safety issues) can be voiced and reconciled. All of these factors play an essential role in producing a defendable, high-quality QRA. Once the QRA is complete, you must formally document your response to the project team s final report and any recommendations it contains. 

Support for sites is multi-tiered and includes participation by numerous federal, state, private, academic, and tribal organizations. Network operation includes rigorous field and laboratory quality assurance/quality control (QA/QC), including an external quality assurance program and periodic external on-site audits. 

STANDARD REFERENCE MATERIAL CELL LINE DEVELOPMENT AND USE OF REFERENCE CELL LINES AS STANDARDS FOR EXTERNAL QUALITY ASSURANCE OF HER2 IHC AND ISH TESTING... 

Bartlett JMS, Ibrahim M, Jasani B, et al. External quality assurance of HER2 FISH testing results of a UK NEQAS pilot scheme. J. Clin. Pathol. 2007 60 816-819. 

Sampling is just the beginning of the analytical process. On the way from sampling to the test report a lot of different requirements for high quality measurements have to be considered. There are external quality assurance requirements on the quality management system (e.g. accreditation, certification, GLP), internal quality assurance tools (e.g. method validation, the use of certified reference material, control charts) and external quality assurance measures (e.g. interlaboratoiy tests). 

When using medical laboratories, physicians frequently assume that the results provided are accurate and precise. Those working in the laboratory environment know that this is true only within the constraints of the methods, technology and processes available. In this chapter we will explore how internal quality control (IQC) and external quality assurance (EQA) procedures can inform both the analyst and the physician about the limitations of laboratory testing and permit a more intelligent use of laboratory data, while at the same time indicating areas where improvement is required. 

Table 1.2.1 Examples of quantitative external quality assurance (EQA) schemes available in Europe in biochemical genetics...

Ruijter GJG, Boer M, Weykamp CW, de Vries R, van den Berg I, Janssens-Puister J, Niezen-Koning K, Wevers RA, Poorthuis BJHM, van Diggelen OP (2005) External quality assurance programme for enzymatic analysis of lysosomal storage diseases a pilot study. J Inherit Metab Dis 28 979-990... 

Participation in cooperative tests is an important means of external quality assurance. 

Preparation of the patient, sampling of specimens Pre-analytical handling of specimens Accurate and precise analytical performance Selection of appropriate, sensitive and specific methods Calibration of analytical systems Internal and external quality assurance Post-analytical handling of test results Clinical interpretation of test results Reporting process... 

A total of about 30,000 ring test measurements are performed every year by approximately 4,000 medical laboratories. For several of the measurands for which external quality assurance is required by the B K guidelines, accredited calibration laboratories do not yet exist. 

Examples of quality assurance protocols that are considered standard practice in any data collection scheme include the use of both internal control samples (e.g. use of field blanks and spikes6) and external quality assurance samples (e.g. duplicate samples of known concentrations sent to different laboratories) to determine the extent of intra- and interlaboratory variation. Ensuring that the data have not been compromised or corrupted may also require setting up accessible data archives of original paper or electronic records so that the accuracy of summaries of the data published in documents and articles can be verified. 

Internal quality assurance provides confidence to the management whereas external quality assurance provides confidence to the client. They are planned activities designed to ensure that the quality control activities are being properly implemented. 

A Proficiency Test (PT) is defined as the study of laboratory performance by means of ongoing interlaboratory test comparisons . It is also known as an external quality assessment scheme, external laboratory performance check or external quality assurance (EQA). There are many such schemes run by independent external bodies for different analytes in a variety of matrices. Evidence in published papers shows that the performance of analytical laboratories improves as a result of participating in Proficiency Testing schemes and the betw een-laboratory precision can improve, sometimes dramatically. This is especially true in the early years of participation. 

S248 Wilson, J.F., Tsanaclis, L.M., Williams, J., Tedstone, J.E. and Richens, A. (1989) Evaluation of assay techniques for the measurement of antiepileptic drugs in serum A study based on external quality assurance measurements. Ther. Drug Monit. 11, 185-195. 

Oil inputs are to be measured within PLC-4 for the first time. To support external quality assurance measures and to obtain information on the proficiency of the nominated laboratories, an interlaboratory comparison on the determination of hydrocarbons in water was conducted before the start of routine monitoring. 

Summarising the results of this study, mineral oils can be determined in water samples by solvent extraction and gas chromatography. This test item will be mandatory within the framework of PLC-4. Nevertheless, further interlaboratory comparisons should be performed in the course of PLC-4 as an external quality-assurance measure within this monitoring programme. 

An example of data from an external quality assurance scheme for POCT is shown in Figure 12-12. Such schemes are run on a national and mternational basis, and some Web site schemes are listed in references. ... 

Regulators or organizers of external quality assurance schemes... 

A pilot National External Quality Assurance Scheme was set up in the United Kingdom in 1996. In the light of poor overall performance highlighted by the scheme, recommendations have been made for a laxative screening service. ... 

Seth J, Hanning I, Al-Sadie R, Bacon RRA, Hunter WM. The UK external quality assurance scheme (EQAS) for FSH, LH and prolactin— the past decade. Clin Chem 1990 36 1003. 

Quality of cervical cytology is poor. No formal training or retraining for cytologists. Inadequate internal and no external quality assurance. 

Potential partnerships The National Cytology Institute can assist in establishing external quality assurance scheme and accreditation system for participating clinics. 

The Committee was informed that the external quality assurance assessment scheme had been ongoing over the last five to six years. An... 

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