Towards a biomedical engineering quality system: writing documentation to support clinical & laboratory accreditation at MRC unit in The Gambia

2012 ◽  
Author(s):  
A.W. Gomez ◽  
E. Nyassi ◽  
S. Mullally
Keyword(s):  
Biomedical Engineering ◽  
Clinical Laboratory ◽  
Laboratory Accreditation ◽  
Quality System ◽  
The Gambia

Clinical Laboratory Accreditation in India

2012 ◽  
Vol 32 (2) ◽  
pp. 281-292 ◽  
Author(s):  
Anil Handoo ◽  
Swaroop Krishan Sood
Keyword(s):  
Clinical Laboratory ◽  
Laboratory Accreditation

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.

Clinical Laboratory Accreditation in Poland

1994 ◽  
Vol 28 (4) ◽  
pp. 1197-1199
Author(s):  
Dagna Bobilewicz ◽  
Andrzej Brzezinski
Keyword(s):  
Clinical Laboratory ◽  
Laboratory Accreditation

A quality manual for the clinical laboratory including the elements of a quality system: Proposed guidelines

1993 ◽  
Vol 53 ◽  
pp. 60-77 ◽  
Author(s):  
R. Dybkaer ◽  
R. Jordal ◽  
P. J. Jørgensen ◽  
P. Hansson ◽  
M. Hjelm ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Quality System

Medical Laboratory Accreditation – A benchmark for performance

2012 ◽  
Vol 6 (1) ◽  
pp. 22-28
Author(s):  
Shaheda Anwar
Keyword(s):  
Public Health ◽  
Laboratory Accreditation ◽  
Quality System ◽  
Medical Laboratory ◽  
Reliability Of Results

Accreditation of health laboratories is the process by which an independent and authorized agency accredits the quality system and competence of a laboratory on the basis of certain pre-defined standards. Accreditation is done at regular intervals to ensure maintenance of standards and reliability of results generated to support clinical and public health activities by the laboratories.DOI: http://dx.doi.org/10.3329/bjmm.v6i1.19363 Bangladesh J Med Microbiol 2012; 06(01): 22-28

scholarly journals Verifying Performance Characteristics of Quantitative Analytical Systems: Calibration Verification, Linearity, and Analytical Measurement Range

2014 ◽  
Vol 138 (9) ◽  
pp. 1173-1181 ◽  
Author(s):  
Anthony A. Killeen ◽  
Tom Long ◽  
Rhona Souers ◽  
Patricia Styer ◽  
Christina B. Ventura ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Measurement Range ◽  
Test System ◽  
Laboratory Accreditation ◽  
Performance Characteristics ◽  
Performance Goals ◽  
Analytical Measurement ◽  
Quantitative Test ◽  
Test Systems ◽  
Accreditation Program

Context.—Both the regulations in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the checklists of the College of American Pathologists (CAP) Laboratory Accreditation Program require clinical laboratories to verify performance characteristics of quantitative test systems. Laboratories must verify performance claims when introducing an unmodified, US Food and Drug Administration–cleared or approved test system, and they must comply with requirements for periodic calibration and calibration verification for existing test systems. They must also periodically verify the analytical measurement range of many quantitative test systems. Objective.—To provide definitions for many of the terms used in these regulations, to describe a set of basic analyses that laboratories may adapt to demonstrate compliance with both CLIA and the CAP Laboratory Accreditation Program checklists for performing calibration verification and for verifying the analytical measurement range of test systems, to review some of the recommended procedures for establishing performance goals, and to provide data illustrating the performance goals used in some of the CAP's calibration verification and linearity surveys. Data Sources.—The CAP's calibration verification and linearity survey programs, the CLIA regulations, the Laboratory Accreditation Program requirements, and published literature were used to meet these objectives. Conclusions.—Calibration verification and linearity and analytical measurement range verification should be performed using suitable materials with assessment of results using well-defined evaluation protocols. We describe the CAP's calibration verification and linearity programs that may be used for these purposes.

Sign in / Sign up

Export Citation Format

Share Document