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REGULATING PATH LABS

P A Francis
Wednesday, June 14, 2017, 08:00 Hrs  [IST]

With sharp rise in life style diseases and reemergence of some of the infectious diseases during last 20 years, there has been a corresponding surge in the diagnostic tests to be carried out by the patients across the country. For any effective treatment of medical conditions, physicians and surgeons need to have accurate diagnostic test reports of patients prepared and certified by the competent pathologists. Certification of medical reports by unqualified persons can lead to erroneous assessment of the medical conditions and wrong treatment putting patients at serious risk. And there has been numerous instances of such medical treatments based on unreliable medical reports generated by pathology laboratories and other diagnostic centres in recent years. Currently, India is reported to have over one lakh diagnostic and pathology labs offering these services. And a large number of them are run by technicians with Diploma in Medical Laboratory Technology (DMLT) or equivalent qualifications. These technicians collect samples, conduct tests and certify reports. As per the norms laid by Medical Council of India, a registered medical practitioner having a post-graduate degree in pathology can only certify test reports.

But this is not happening in most of the states as existing rules and norms are not enforced by the state health authorities. Absence of a specific set of Central rules to regulate and monitor this sector is also responsible for the current state of affairs. Maharashtra Association of Practitioners in Pathology and Microbiology (MAPPM) recently urged state directorate of health services to conduct inspection of path labs in the state as it detected several illegal pathology laboratories are operating in the state. According to an estimate, there are around 8,000 path labs operating in Maharashtra alone and out of that, around 4,000 labs are stated to be run by technicians with DMLT or similar qualifications. The situation cannot be different in most of the other states considering the fact that health administration is generally weak in most parts of the country. It is high time for the state governments took action against such illegal operators jeopardizing public health. The Central government had issued a notification pertaining to minimum standards for path labs to regulate quality of tests some time back. As per the notification, the path labs have been classified into three categories viz. basic, medium, and advanced. The classification has been made on the basis of number of employees, number of samples, infrastructure and medical equipments. The classification is indeed a right initiative but what is more important is the regular inspection of path labs by empowering health inspectors in states. Simultaneously there is a need to adopt the Clinical Establishment Act by all the states so that none of the path labs remain unregistered. Many state governments are yet to adopt this important legislation which is notified by the Central government years ago.

 

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