Haryana Govt Set To Stipulate Minimum Standards For Diagnostic Labs Soon

Mumbai, 9 Jan 2019: The Haryana government is all set to notify implementation of Clinical Establishments (Central Government) Amendment Rules, 2018 in the state soon stipulating minimal standards for pathology laboratories.

The government action comes in the wake of the Punjab and Haryana High Court order in which the court on November 28, 2018 had directed the state government to ensure implementation of Supreme Court order stating that laboratory report can be counter signed only by registered medical practitioners with a post graduate qualification in pathology.

The apex court passed the judgment on December 12, 2017 in the matter of North Gujarat unit of Association of Self Employed Owners (Paramedical) of Private Pathology Laboratories of Gujarat vs North Gujarat Pathologists Association, Maharashtra Association of Practising Pathologists and Microbiologists (MAPPM) and others.

Saurabh Mohunta, deputy advocate general appearing for Haryana government submitted that instruction issued by state government shall be looked into by the concerned department and a decision shall be taken within one month.

Sources said if the Haryana government implements the Supreme Court order, this will make the situation worse in the state having a significant number of path labs lacking pathologists.

It is learnt that around 10,000 path labs are being run by non-pathologists in the state. 

Hence, the state government in a damage control exercise is set to come out with a circular notifying implementation of Clinical Establishments (Central Government) Amendment Rules, 2018 within a week in line with governments of Rajasthan, Gujarat, Bihar, Delhi and Jharkhand. 

As per Rules, lab technicians with Diploma in Medical Technology (DMLT) or Bachelor of Science Medical Laboratory Technology (B.Sc MLT) or Master of Science Bio-chemistry or Microbiology can run basic composite (small) pathology labs independently and sign medical test reports. It has made presence of MBBS doctor in small labs desirable.

The small labs can perform routine biochemistry tests like blood sugar, renal function tests, liver function tests, amylase, lipase, lipid profile, Cerebro-Spinal Fluid (CSF) and other biological fluids (glucose and protein), oral glucose tolerance test, electrolytes, calcium or phosphate, HbA1c, any bio-chemistry based rapid test as well as haematology tests like haemogram, bleeding time, clotting time, prothrombin time, activated partial thromboplastin time, blood grouping and matching. 

So far Rajasthan government on August 12 last year had implemented the central act followed by Gujarat on August 23 last year, Bihar on September 9 last year, Delhi on December 12 last year and Jharkhand on January 4, 2019. Pharmabiz