Abstract
Laboratory testing is of great value in the diagnosis and management of diseases. Good quality of results is essential if test results are to be meaningful. Uniformly high standards of laboratory practice are required to ensure that physicians may consistently rely on test results. Accreditation provides a way whereby a laboratory may meet international standards and provide assurance to a hospital’s administration, medical and laboratory staff and patients that the laboratory is providing high quality results. In the absence of a national accreditation program, laboratories should undertake the low-cost or no cost actions that are elements of all accreditation programs. National societies concerned with the field of laboratory medicine or clinical pathology should work together with the appropriate government agencies to establish a National Accrediting Body. Institution of an accrediting program will raise the visibility of clinical laboratory testing and ensure enhanced quality of testing for the entire population
Keywords: Clinical laboratory, Quality assurance, Accreditation
Summary
Laboratory testing is of great value in the diagnosis and management of diseases. Good quality of results is essential if test results are to be meaningful. Uniformly high standards of laboratory practice are required to ensure that physicians may consistently rely on test results. Accreditation provides a way whereby a laboratory may meet international standards and provide assurance to a hospital’s administration, medical and laboratory staff and patients that the laboratory is providing high quality results. In the absence of a national accreditation program, laboratories should undertake the low-cost or no cost actions that are elements of all accreditation programs. National societies concerned with the field of laboratory medicine or clinical pathology should work together with the appropriate government agencies to establish a National Accrediting Body. Institution of an accrediting program will raise the visibility of clinical laboratory testing and ensure enhanced quality of testing for the entire population
Correspondence: Dr. Donald S. Young, Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, PA, USA.
References
Resolution AFR/RC58R2, Strengthening public health laboratories in the WHO African region: a critical need for disease control. In: Fifty-eighth session of the WHO Regional Committee for Africa held in Yaounde, Republic of Cameroon, from 1 to 5 September 2008, Final Report. Yaoundé, World Health Organization, Regional Office for Africa, 2008 (AFR/RC58/6).
Nkengasong JN, Nsubuga P, Nwanyanwu O, et al Laboratory systems and services are critical in global health. Time to end the neglect? Am J Clin Pathol 2010;134: 368-373.
Cooper G. Preparations and considerations when seeking laboratory accreditation under ISO 15189. Bio-Rad Laboratories, Inc. 2009.
International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and World Association of Societies of Pathology and Laboratory Medicine (WASPaLM), Principles of Clinical Laboratory Accreditation, 1999 (http://www.waspalm.org-5-2-laboratory.htm).
Clinical Laboratory Improvement Act of 1988. U.S. Code of Federal Regulations. Title 42, Part 493, Laboratory Requirements. Revised October 1, 1996. U.S. Government Printing Office, Washington D.C. 1996
Westgard JO and Klee GG. Quality management. In Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Burtis CA, Ashwood ER, Bruns DE eds. 4th edition. St. Louis, MO. Elsevier Saunders. 2006.
Clinical Laboratory Standards Institute: Laboratory documents: development and control: Approved guideline – 5th edition: CLSI document GP02-A5, Wayne, PA, Clinical Laboratory Standards Institute, 2006.