Posted March 1, 2012
Gaurav Sharma, MD, FCAP
CAP Standards Committee
Every day, millions of laboratory tests are performed in medical laboratories across the world. With a myriad of treatment decisions dependent on test results, it is vital that they are accurate and reproducible. The College of American Pathologists (CAP) has led the effort to produce and implement standards for the medical laboratory. Its national proficiency testing or Surveys program was launched in 1949.1 Through the late 1940s and 1950s, CAP leaders and members explored the creation of a national laboratory performance evaluation program, which led to the creation of the CAP's Laboratory Accreditation Program (LAP) in 1961.
Laboratory standards documents specifically define criteria—for personnel, equipment, and operations—that must be met to satisfy the standard of care in medical laboratory practice. Thus, they serve as the foundation of all clinical laboratory testing practice guidelines. Independent organizations, such as the Clinical Laboratory Standards Institute (CLSI) and International Organization for Standardization (ISO), prepare, release, and update guidelines and standards. Accreditation refers to the compliance of a laboratory to a specific standard.
The beginning of standards in the United States can in part be traced to the CAP’s 1950s publication Basic Requirements of a Department in Clinical Pathology in a Modern Hospital.2 In 1977, the American National Standards Organization (ANSI),1 which oversees the creation, promulgation, and use of thousands of norms and guidelines that directly impact businesses in nearly every sector, accredited the National Committee for Clinical Laboratory Standards (NCCLS) as a standards writing body.3 In 1998, the NCCLS began collaborating with the World Health Organization. The organization changed its name to Clinical and Laboratory Standards Institute (CLSI) in January 2005 to better reflect its broader, international health care objectives.2 CLSI standards, written as guidelines, currently cover every aspect of medical laboratory testing.
The CAP’s accreditation program uses the CLSI standards to develop its checklist requirements that are used during periodic, unannounced inspections.4 External, CAP-trained pathologists and other laboratory professionals conduct the inspections. The Centers for Medicare and Medicaid Services (CMS) grants authority to organizations to perform inspections as outlined in the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) regulations.5 The CAP is one of the organizations with CMS authorization. Today, more than 7,000 laboratories, nationally and internationally, are CAP accredited.4
In an era of globalization and expansion of health care delivery beyond national borders, along with sourcing of material from different countries, the regulations that affect the practice of pathology and the reagents, supplies, and materials used in the laboratory must be coordinated on an international level. ISO, a federation of national societies authorized by and representing more than 160 countries, identifies, writes, and delivers standards for business, government, and society that may become the basis for international trade.6 In 2003, ISO first published its 15189 standard: Medical laboratories—Particular requirements for quality and competence for clinical laboratory testing and in vitro diagnostic test systems, for use in medical laboratories worldwide to develop their quality management systems and assess competence.7 The CAP now offers a laboratory accreditation program using the ISO 15189 standard.4 With 16 laboratories currently accredited under the CAP’s 15189 program and several more laboratories in process, positive results have been seen in areas such as document management, employee engagement, and quality management systems. The CAP 15189 program builds upon the strength of the CAP’s Laboratory Accreditation Program to ensure competent and quality laboratory testing by adding a quality systems structure to manage this operation and be even more responsive to patients’ needs.
In the past 60 years, laboratory standards have evolved from a local consensus among laboratories to nationally and internationally ratified documents defining uniform expectations and standards of laboratory practice. This has enabled development of different accreditation systems that are now synergizing the experience gained from quality practices with the most recent management concepts, enabling laboratories to be both reliable and competitive in a global health care industry.
- College of American Pathologists. CAP History Timeline Website. Updated October 20, 2009. Accessed December 29, 2011.
- Basic requirements of a department of clinical pathology of a modern hospital. Pa Med J. 1946:49:985–989.
- Clinical and Laboratory Standards Institute. About CLSI: Our History Website. http://clsi.org/Content/NavigationMenu/AboutCLSI/OurHistory/Our_History.htm. Accessed December 29, 2011.
- College of American Pathologists. About the CAP Accreditation Program Website. Updated November 16, 2011. Accessed December 29, 2011.
- Centers for Medicare & Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA): Overview Website. Updated November 23, 2011. Accessed December 29, 2011.
- International Organization for Standardization. About ISO Website. Accessed December 29, 2011.
- International Organization for Standardization. ISO 15189:2007 Website. Accessed December 29, 2011.
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NewsPath® Editor: Kyle L. Eskue, MD
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