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Clinical Laboratory Measurements Traceable to the National Reference System for Cholesterol

Accurate laboratory measurements of blood lipids and lipoproteins (including total cholesterol {TC}, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides) are important for diagnosing and managing coronary heart disease. The medical decision points established by the National Cholesterol Education Program (NCEP) were determined from an epidemiologic database standardized by the CDC reference method (RM) (1). The NCEP recommends that TC measurements made by all clinical laboratories in the United States be traceable (i.e., have a documented relation) to this accuracy base. The NCEP established specific national performance goals for the precision and accuracy of TC measurements. The goal for intralaboratory precision is less than or equal to 3% coefficient of variation, and the goal for bias is less than or equal to 3% from the true value. Laboratories can achieve the precision guidelines by establishing an active internal quality-control program. They can achieve the accuracy guidelines by improving the calibration of analytical systems and by verifying traceability to the National Reference System for Cholesterol (NRS/CHOL), of which the CDC RM is an integral part.

To facilitate access to the NRS/CHOL and to provide an appropriate means for verifying traceability, in 1989, CDC established the Cholesterol Reference Method Laboratory Network (CRMLN). Clinical laboratories can evaluate their performance on fresh samples by completing a comparison with the reference method in a CRMLN laboratory. Participation is voluntary. The CRMLN documents successful comparisons with a "Certificate of Traceability," which is valid for 6 months.

A national health objective for the year 2000 is to increase to at least 90% the proportion of clinical laboratories that meet the recommended accuracy standard for TC measurement (objective 15.17) (2). To verify the accuracy of their TC measurements, laboratories should contact a CRMLN laboratory (Table_1). Information about how clinical laboratories can participate in the program and the list of laboratories that have received Certificates of Traceability will be available beginning March 18, 1994, through the CDC Voice Information System, telephone (404) 332-2592.

Reported by: Special Activities Br, Div of Environmental Health Laboratory Sciences, National Center for Environmental Health, CDC.

References

  1. National Heart, Lung, and Blood Institute. Recommendations for improving cholesterol measurement: a report from the Laboratory Standardization Panel of the National Cholesterol Education Program. Bethesda, Maryland: US Department of Health and Human Services, Public Health Service, National Institutes of Health, 1990; publication no. (NIH)90-2964:3-4.

  2. Public Health Service. Healthy people 2000: national health promotion and disease prevention objectives -- full report, with commentary. Washington, DC: US Department of Health and Human Services, Public Health Service, 1991; DHHS publication no. (PHS)91-50212:112-4.




Table_1
Note: To print large tables and graphs users may have to change their printer settings to landscape and use a small font size.

TABLE 1. Laboratories participating in the Cholesterol Reference Method Laboratory
Network -- United States and international

UNITED STATES
                                                   Pacific Biometrics Research Foundation
State Laboratory of Hygiene                        1100 Eastlake Avenue
University of Wisconsin                            Seattle, WA 98109
Center for Health Sciences                         G. Russell Warnick, M.S.
465 Henry Mall                                     (206) 233-9151 Phone
Madison, WI 53706                                  (206) 233-0198 Fax
David Hassemer, M.S.
(608) 833-1770 (ext. 102) Phone                    INTERNATIONAL
(608) 833-2803 Fax                                 Rotterdam University Hospital
                                                   Department of Clinical Chemistry
Pennsylvania State Department of Health            Lipid Reference Laboratory
Bureau of Laboratories                             3015 GD Rotterdam, THE NETHERLANDS
Division of Chemistry and Toxicology               Christa M. Boersma-Cobbaert, Ph.D.
RO. Box 500                                        31-10-4633493 Phone
Exton, PA 19341-0500                               31-10-4367894 Fax
Irene Daza
(215) 363-8500 Phone                               Center for Adult Diseases, Osaka
(215) 436-3346 Fax                                 Department of Epidemiology
                                                   and Mass Examination for CVD
University of Minnesota                            3 Nakamichi 1-chome
Department of Laboratory Medicine and Pathology    Higashinari-ku
Box 198 UMHC                                       Osaka 537, JAPAN
420 Delaware Street                                Masakazu Nakamura, Ph.D.
Minneapolis, MN 55455-0392                         81-6-972-1181 (ext. 2211) Phone
John H. Eckfeldt, M.D.                             81-6-972-7749 Fax
(612) 626-3176 Phone
(612) 625-6994 Fax                                 Institute of Biochemistry
                                                   Department of Pathological Biochemistry
Northwest Lipid Research Laboratories              Glasgow Royal Infirmary
Core Laboratory                                    4th Floor Alexandra Parade
2121 N. 35th Street                                Glasgow G31 2ER, GREAT BRITAIN
Seattle, WA 98103                                  Chris J. Packard, Ph.D.
Santica Marcovina, Ph.D.                           44-41-552-3535 Phone
(206) 685-3331 Phone                               44-41-553-2558 Fax
(206) 685-3279 Fax
                                                   Canadian Reference Foundation
The Cleveland Clinic Foundation                    307-2083 Alma Street
Department of Biochemistry, L-11                   Vancouver, British Columbia V6R 4N6, CANADA
9500 Euclid Avenue                                 David W. Seccombe, M.D.
Cleveland, OH 44195                                (604) 222-1879 Phone
Joan A. Waletzky                                   (604) 222-0134 Fax
(216) 444-8301 Phone
(216) 444-4414 Fax
                                                   UNDERGOING STANDARDIZATION
Wadsworth Center for Laboratories and Research
New York State Department of Health                H.S. Raffaele
Empire State Plaza                                 Laboratorio Analisi Cliniche
Albany, NY 12201                                   Via Olgettina 60
Robert Rej, Ph.D.                                  30132 Milano, ITALY
(518) 473-0117 Phone                               Ferruccio Ceriotti, Ph.D.
(518) 474-7992 Fax                                 CERTIOTF%IMIHSRA.BITNET@VM.CNUCE.CNR.IT
                                                   011-39-2-2643-2315 (or 2313) Phone
Washington University School of Medicine           011-39-2-2643-2640 Fax
Lipid Research Center
4566 Scott Avenue                                  Centre de Medicine Preventive
St. Louis, MO 63110                                Laboratorie de Biologie Clinique
Thomas G. Cole, Ph.D.                              2, avenue du Doyen J. Parisot
(314) 362-3522 Phone                               54500 Vandowuvre-les-Nancy, FRANCE
(314) 362-7657 Fax                                 Prof. Gerard Siest
                                                   Josiane Steinmetz, Ph.D.
USDA Human Nutrition Research Center on Aging      011-33-83-444415 Phone
Tufts University                                   011-33-83-440361 Fax
711 Washington Street, Room 501
Boston, MA 02111
Judith R. McNamara
(617) 556-3104 Phone
(617) 556-3103 Fax



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