A medical laboratory or clinical laboratory is a laboratory where clinical pathology tests are carried out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease.
Accreditation
Credibility of medical laboratories is paramount to the health and safety of the patients relying on the testing services provided by these labs. Credentialing agencies vary by country. The international standard in use today for the accreditation of medical laboratories is ISO 15189 - Medical laboratories - Requirements for quality and competence.
In the United States, accreditation is performed by the Joint Commission, College of American Pathologists, AAB (American Association of Bioanalysts), and other state and federal agencies. Legislative guidelines are provided under CLIA 88 (Clinical Laboratory Improvement Amendments) which regulates Medical Laboratory testing and personnel.
The accrediting body in Australia is NATA, where all laboratories must be NATA accredited to receive payment from Medicare. In France the accrediting body is COFRAC (COFRAC). In 2010, modification of legislation established ISO 15189 accreditation as an obligation for all clinical laboratories.
In the United Arab Emirates, the Dubai Accreditation Department (DAC) is the accreditation body that is internationally recognised by the International Laboratory Accreditation Cooperation (ILAC) for many facilties and groups, including Medical Laboratories, Testing and Calibration Laboratories, and Inspection Bodies.
In Hong Kong, the accrediting body is Hong Kong Accreditation Service (HKAS). On 16 February 2004, HKAS launched it's medical testing accreditation programme.
In Canada, laboratory accreditation is not mandatory, but is becoming more and more popular. Accreditation Canada (AC) is the national reference. Different provincial oversight bodies mandate laboratories in EQA participations like LSPQ (Quebec), IQMH (Ontario) for example.
In India the accreditation is voluntary. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.
A medical laboratory or clinical laboratory is a laboratory where clinical pathology tests are carried out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease.