Biorepository Proficiency Testing for the Quality Control of Biospecimens for the Global Biobanking Community

2011 ◽  
Vol 9 (4) ◽  
pp. 415-417 ◽  
Keyword(s):  
Quality Control ◽  
Proficiency Testing

Achieving Quality Reproducible Results and Maintaining Compliance in Molecular Diagnostic Testing of Human Papillomavirus

2003 ◽  
Vol 127 (8) ◽  
pp. 978-983 ◽  
Author(s):  
Jacqueline M. Seabrook ◽  
Roger A. Hubbard
Keyword(s):  
Quality Control ◽  
Human Papillomavirus ◽  
Method Validation ◽  
Proficiency Testing ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Laboratory Accreditation ◽  
Medical Laboratory ◽  
Molecular Diagnostic ◽  
High Complexity

Abstract Laboratories contemplating either the addition of new molecular tests or modifying methods approved by the Food and Drug Administration for human papillomavirus testing should be aware of a variety of procedural, performance, and regulatory issues surrounding such activity. Diagnostic medical laboratory testing in the United States is regulated by the Centers for Medicare and Medicaid Services, an agency formerly known as the Health Care Finance Administration. The regulatory vehicle of the Centers for Medicare and Medicaid Services is manifested in the Clinical Laboratory Improvement Amendments (CLIA). The CLIA program has put into place specific regulations for laboratory quality control, which includes specific recommendations for method validation. Regulations that must be followed regarding personnel, quality control, quality assurance, method validation, and proficiency testing depend on the complexity category of the individual test. All molecular diagnostic tests, including those for human papillomavirus, are considered high complexity. The Centers for Medicare and Medicaid Services retains the authority to allow private, national accreditation organizations to “deem” that a laboratory is compliant with CLIA '88 requirements. Accreditation organizations, such as the Joint Commission for Accreditation of Hospitals, the Commission on Office Laboratory Accreditation, and the College of American Pathologists (CAP), as well as several state medical laboratory–accrediting agencies, possess the authority to deem laboratories as “CLIA-approved.” The CAP, through its Laboratory Accreditation Program, has promoted standards for laboratory performance and method validation. In general, guidelines set forth in the CAP Laboratory Accreditation Program checklists specify that all clinical laboratory testing must essentially meet those requirements defined for high-complexity testing under CLIA '88, including test validation standards, reportable/reference ranges, performance criteria, and proficiency testing.

scholarly journals Leukopak PBMC sample processing for preparing quality control material to support proficiency testing programs

2014 ◽  
Vol 409 ◽  
pp. 99-106 ◽  
Author(s):  
Ambrosia Garcia ◽  
Sarah Keinonen ◽  
Ana M. Sanchez ◽  
Guido Ferrari ◽  
Thomas N. Denny ◽  
...  
Keyword(s):  
Quality Control ◽  
Proficiency Testing ◽  
Quality Control Material ◽  
Sample Processing ◽  
Control Material ◽  
Pbmc Sample

Experience with Certified Reference Material Proficiency Testing for Quality Control of Wheat

1998 ◽  
Vol 6 (A) ◽  
pp. A53-A61
Author(s):  
Judit Budai ◽  
Judit Fükó
Keyword(s):  
Quality Control ◽  
Reference Material ◽  
Proficiency Testing ◽  
Reference Materials ◽  
Certified Reference Material ◽  
Certified Reference Materials ◽  
Long Term Stability ◽  
Determining Factors ◽  
Chemical Section

The Chemical Section of OMH1,2 embarked on the preparation of a series of wheat samples as Certified Reference Materials (CRMs) in 1992. The certification processes were carried out according to the recommendations of ISO. Since then we have developed a series of flour samples as well. The investigations of the long-term stability and the application of wheat and flour CRMs are continuous. Wheat is one of the most widely grown crops in Hungary and it is one of the major determining factors of the economy. Its uniform and objective qualification is of great importance. There are well-equipped laboratories available with sufficient experience but, as the proficiency testing regularly showed, certified samples need to be used to achieve exact and uniform measuring results.

Charts of operational process specifications ("OPSpecs charts") for assessing the precision, accuracy, and quality control needed to satisfy proficiency testing performance criteria

1992 ◽  
Vol 38 (7) ◽  
pp. 1226-1233 ◽  
Author(s):  
J O Westgard
Keyword(s):  
Quality Control ◽  
Proficiency Testing ◽  
Measurement Procedure ◽  
Performance Criteria ◽  
Operating Point ◽  
Operational Process ◽  
Testing Performance ◽  
Analytical Errors ◽  
Current Operating ◽  
Selection Of

Abstract “Operational process specifications” have been derived from an analytical quality-planning model to assess the precision, accuracy, and quality control (QC) needed to satisfy Proficiency Testing (PT) criteria. These routine operating specifications are presented in the form of an “OPSpecs chart,” which describes the operational limits for imprecision and inaccuracy when a desired level of quality assurance is provided by a specific QC procedure. OPSpecs charts can be used to compare the operational limits for different QC procedures and to select a QC procedure that is appropriate for the precision and accuracy of a specific measurement procedure. To select a QC procedure, one plots the inaccuracy and imprecision observed for a measurement procedure on the OPSpecs chart to define the current operating point, which is then compared with the operational limits of candidate QC procedures. Any QC procedure whose operational limits are greater than the measurement procedure's operating point will provide a known assurance, with the percent chance specified by the OPSpecs chart, that critical analytical errors will be detected. OPSpecs charts for a 10% PT criterion are presented to illustrate the selection of QC procedures for measurement procedures with different amounts of imprecision and inaccuracy. Normalized OPSpecs charts are presented to permit a more general assessment of the analytical performance required with commonly used QC procedures.

Proficiency testing for blood-gas quality control.

1976 ◽  
Vol 22 (10) ◽  
pp. 1675-1684 ◽  
Author(s):  
C J Delaney ◽  
E T Leary ◽  
V A Raisys ◽  
M A Kenny
Keyword(s):  
Quality Control ◽  
Proficiency Testing ◽  
Human Blood ◽  
Internal Control ◽  
Blood Gas Analysis ◽  
Gas Analysis ◽  
Blood Gas ◽  
Testing Program ◽  
Control Programs ◽  
Voluntary Community

Abstract We have conducted a voluntary, community blood-gas proficiency testing program, with use of tonometered human blood, for 32 analyzers located in 16 laboratories. Instruments initially showed inaccuracies as large as -30.8 to +17.3% for po(2), and -14.0 to +42.9% for pco(2), but inaccuracy and imprecision decreased in most laboratories during the program. For a typical 15-week period, mean group precision (CV) was 4.3 To 5.1% for po(2) from 6.92 to 33.3 Pa (52 to 250 mmHg), and 4.0 to 6.9% for pco(2) from 2.0 to 6.8 Pa (15 to 51 mmHg). This program can detect increasing imprecision or inaccuracy caused by analyzer deterioration, and can identify interlaboratory or interinstrument bias and problems not detected by participant quality-control programs. Participants have used the proficiency information in discussing data quality with clinicians, promoting internal control and maintenance programs, and justifying instrument purchases. We believe that proficiency-testing documentation of variability in blood-gas analysis may help to establish realistic patient-care protocols.

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