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India amends Clinical Establishment Rules to prescribe minimum standards for medical laboratories

The Department of Health and Family Welfare under the Ministry of Health and Family Welfare, Government of India has amended the Clinical Establishment Amendment Rules of 2012 to prescribe minimum standards for laboratory facilities performing pathological, bacteriological, genetic, radiological, chemical or other biological investigations tests related to diagnosis or treatment of disease. 

The standards provide guidance on scope of services, infrastructure, safety measures, human resources, space requirement, legal, records and standard operating procedures for medical laboratories to operate and provide services. The amended rules will be called Clinical Establishments Amendment Rules, 2018 and were published in The Gazette of India on May 18, 2018. (The Gazette of India is a legal publication for all all Governement of India publications)

Source:  Ministry of Health and Family Welfare, Government of India