In a pathbreaking move to prescribe minimum standards for Medical Diagnostic Laboratories (or Pathological Laboratories), the Ministry of Health and Welfare has notified the Clinical Establishments (Central Government) Amendment Rules, 2018 (“Amendment Rules”) effective 18th May, 2018.
The Amendment Rules requires ‘every clinical establishment relating to diagnosis or treatment of diseases, where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services, are usually carried on with the aid of laboratory or other medical equipment’, to comply with the minimum standards of facilities and services as specified in the Schedule.
In effect, a new Schedule has been inserted, which prescribes the minimum standards that must be followed by Medical Diagnostic Laboratories or Pathological Laboratories.
Source : Ministry of Health and Welfare
