HEALTH CARE

The accreditation process

RAVI SHARMA

THE government's accreditation programme for clinical laboratories launched in 1998 by the National Accreditation Board for Testing and Calibration Laboratories (NABL), a body under the aegis of the Union Ministry of Science and Technology, has not really scotched the questionable diagnostic practices. Less than 40 clinical laboratories in India are NABL accredited (with only a few of them having successfully accredited all their tests). Ironically, not a single government hospital's clinical laboratory is NABL accredited.

A team of NABL assessors will audit the laboratory, after its application is found satisfactory, twice (pre-assessment and assessment). During the audit, assessors may raise non-conformities (NCs), which the laboratory is expected to rectify. NCs are usually raised when the laboratory does not follow statutory government directions (such as pollution norms and waste disposal), standard NABL requirements/guidelines (14 in all, such as quality control programmes and staff pattern) or self-defined procedures pertaining to NABL requirements. Accreditation, which is based on the laboratory's "capability to perform tests and provide accurate and reliable results", is valid for three years subject to satisfying the annual surveillance.

The NABL is itself assessed by the Asia-Pacific Laboratory Accreditation Cooperation, which in turn draws its authority from the International Laboratory Accreditation Cooperation.

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