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Basics in Quality control |
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In clinical pathological laboratories, referred to as medical laboratories in our country Switzerland, the quality control issue is a concern since the introduction of laboratory medicine as a single field of competence. Standards, calibrators, reference controls and description of test procedures have been introduced since the 1950ies. Benchmark testing in addition to robin testing are in effect since several decennies. The statistical evaluation of test results using standard deviation calculations as well as variation coefficient appraisals are in use since that time. The current issues of legal aspects of health insurance ask for concepts and programs in quality control. Legal basis The federal list of laboratory analyses sets the stage for legal basis of quality control. Only those service providers which adhere to the legal requirements are entitled to bring their service to account. The partners in health insurance and providers, i.e. Federation of Analytical laboratories for Medical Health Care (FAMH), Federation of Medical Doctors in Switzerland (FMH), Swiss Pharmacy Association (SAV), santesuisse as well as MTK have agreed on 1st of july 1994 to enforce quality control on common grounds. The corresponding covenant agreement is implemented and describes the single measures to enforce quality control on a national level across the different health professional services. Agency The Swiss Agency for Quality Control in the Medical Laboratory (SCQCML – QUALAB) is entitled to enforce quality control in our country. The implementation of the regulatory issues are done by a committee of SCQCML. SCQCML reports periodically to the Federal Health Authority.
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