Cholesterol operational process specifications for assuring the quality required by CLIA proficiency testing
نویسندگان
چکیده
منابع مشابه
Cholesterol operational process specifications for assuring the quality required by CLIA proficiency testing.
Current U.S. governmental regulations and requirements for the quality of laboratory tests do not provide a consistent form, comparable numbers, or practical specifications for the routine operation of laboratory testing processes. For cholesterol, as an example, the Health Care Financing Administration provides an analytical performance criterion for proficiency testing to enforce the Clinical...
متن کاملEuropean specifications for imprecision and inaccuracy compared with operating specifications that assure the quality required by US CLIA proficiency-testing criteria.
Proposed and interim European quality specifications for imprecision and inaccuracy have been compared with the US CLIA total error criteria for proficiency testing (PT). To assess the relative demands of separate imprecision and inaccuracy specifications vs total error criteria, we derived the imprecision and inaccuracy that would be allowable if a testing process were to provide 90% assurance...
متن کاملLaboratory process specifications for assuring quality in the U.S. National Cholesterol Education Program.
We have assessed the laboratory specifications necessary for ensuring that cholesterol testing processes satisfy the quality required by the U.S. National Cholesterol Education Program (NCEP). A model for setting process specifications has been developed to relate the NCEP guidelines for medical interpretation of a cholesterol test to the pre-analytical and analytical variables that can affect ...
متن کاملLimitations of proficiency testing under CLIA '67.
Proficiency testing (PT), recognized as a quality-assurance (QA) and quality-improvement tool, also has become the cornerstone of the Health Care Financing Administration's (HCFA) regulatory strategy under the revised Clinical Laboratory Improvement Act of 1967 (CLIA '67) and the proposed Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). Use of PT as a regulatory tool corrupts it f...
متن کاملAssuring the model evolution of protocol software specifications by regression testing process improvement
Model-based testing helps test engineers automate their testing tasks so that they are more cost-effective. When the model is changed because of the evolution of the specification, it is important to maintain the test suites up to date for regression testing. A complete regeneration of the whole test suite from the new model, although inefficient, is still frequently used in the industry, inclu...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Clinical Chemistry
سال: 1991
ISSN: 0009-9147,1530-8561
DOI: 10.1093/clinchem/37.11.1938