CLINICAL LABORATORY CERTIFICATION PROGRAM
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Introduction
In 1985, the National Cholesterol Education Program (NCEP) began an unprecedented campaign to educate the medical community and the general public about risk factors for coronary artery disease. To identify persons at risk for coronary artery disease, NCEP recommended initial classification using the medical decision points of 200 milligrams/deciliter (mg/dL) and 240 mg/dL (5.17 millimole/liter [mmol/L] and 6.21 mmol/L) for total cholesterol (1). Proper classification of a patient's risk based on these medical decision points requires reliable and standardized cholesterol measurements. Therefore, NCEP also developed recommendations for accuracy and precision (2). The Centers for Disease Control and Prevention (CDC) established the CRMLN (see Manufacturer Certification Program) to aid manufacturers in calibration. In addition to the manufacturer certification program, the CRMLN developed a total cholesterol certification program for clinical laboratories.
Procedure
Since 1990, clinical laboratories have been able to evaluate their diagnostic system for measuring total cholesterol. This program was developed particularly for laboratories that use analytic systems that have not been certified by the manufacturer or those that consist of components from different manufacturers (e.g. an instrument from one manufacturer and reagents and calibrators from another manufacturer). However, any laboratory may participate in the certification program. The CRMLN provides physicians with a list of clinical laboratories that have been certified through this program.
Protocol
Date | Protocol | Format |
May 2004 | Certification Protocol for Clinical Laboratories | PDF 1.1MB |
Information Forms Only | PDF 159KB |
Reports
List of Analytical Systems | Format |
Analytical Systems Certified for Total Cholesterol | PDF ~45K |
Analytical Systems Certified for HDL Cholesterol | PDF ~45K |
Analytical Systems Certified for LDL Cholesterol | PDF ~45K |
As with the manufacturer certification program, the evaluation for clinical laboratories is based on analysis of fresh serum samples. Clinical laboratories analyze 6 fresh samples that are distributed over a specific concentration range. Certificates of Traceability are issued to clinical laboratories that have bias from the reference method ≤ 3% and a coefficient of variation (CV) ≤ 3%. These certificates are valid for six months.
References
Disclaimer
Use of trade names is for identification only and does not constitute endorsement by the CDC or the U.S. Department of Health and Human Services.