Quality Control and Quality Assurance
Upon receiving news that results of a chromosome analysis are abnormal (and even sometimes that they are normal), a patient will frequently ask: “How do I know that the lab didn’t make a mistake? How do I know that the sample they reported on was really mine? How can I be certain that this is all correct?” Most would be surprised to learn of the myriad of checks and balances that exist in clinical cytogenetics laboratories. Based on the consensus of professionals and on common sense, The American College of Medical Genetics (ACMG) Standards and Guidelines for Clinical Genetics Laboratories (ACMG 2009 Edition/Revised 01/2010; www.acmg.net/StaticContent/SGs/Section_E_2011.pdf) are the basis for oversight by regulatory agencies and are intended to prevent clinical and clerical errors. These comprise the area of laboratory medicine known as quality assurance and quality control (QA/QC). They are supplemented by both total quality management (TQM) and complete quality improvement (CQI) programs that seek to minimize errors when the laboratory interfaces with referring physicians and their patients.
KeywordsHematopoietic Cell Transplant Protected Health Information Material Safety Data Sheet Conventional Cytogenetic Label Error
The author extends special thanks to Michael S. Watson, Ph.D. of the American College of Medical Genetics and Genomics, first author of this chapter in previous editions, for providing the general scope and framework of the material. Additional thanks go to Fred Bauder, B.Sc., ART(CG), CG(ASCP)CM, Instructor and Program Head of Clinical Genetics Technology at the British Columbia Institute of Technology, for his assistance in preparing the section on Canadian personnel.
- 1.ACMG 2009 Edition/Revised 01/2010. www.acmg.net/StaticContent/SGs/Section_E_2011.pdf. Accessed 8 March 2012.
- 2.1992 modifications to the 1988 Clinical Laboratory Improvement Amendments (“CLIA’88”). http://www.cdc.gov/mmwr/preview/mmwrhtml/00016177.htm. Accessed 8 Mar 2012.
- 3.College of American Pathologists. CLIA accreditation program. http://www.cap.org/apps/cap.portal?_nfpb=true&_pageLabel=accreditation. Accessed 9 Mar 2012.
- 4.Wadsworth Center, New York State Department of Health, Clinical Laboratory Evaluation Program. http://www.wadsworth.org/labcert/clep/clep.html. Accessed 9 Mar 2012.
- 5.American Society for Clinical Pathology (ASCP) Board of Certification (BOC). http://www.ascp.org/pdf/ProceduresforExaminationCertification.aspx. Accessed 9 Mar 2012.
- 6.National Accrediting Agency for Clinical Laboratory Sciences (NAACLS). http://www.naacls.org/accreditation/cg/. Accessed 9 Mar 2012.
- 7.Canadian Society of Medical Laboratory Science (CSMLS). http://www.csmls.org/Certification/What-is-Certification.aspx.Accessed9Mar2012.
- 8.Canadian College of Medical Genetics (CCMG). http://www.ccmg-ccgm.org/training.php. Accessed 9 Mar 2012.