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Transparency with strict enforcement of regulations is a definite need

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Dr Ravi Gaur, COO, Oncquest Laboratories, talks to Prathiba Raju about how the lack of strict regulations has led to many illegal path labs cropping up all over the country and how these labs pose a major challenge to the organised pathology sector

How is the increasing illegal pathlabs and widening shortage of pathologists in the country a major pain point for diagnostics industry? What steps should be taken to mitigate it?
Pathology diagnostics plays a major role in health management. There are more of medical laboratories in India than there are certified pathologists to supervise and direct them. This is becoming a source of conflict. On one side are patients who want quality-driven laboratory testing services which they can trust and government regulators who want to enforce the law. On the other side are tens of thousands of illegal pathlabs that continue to operate without certified pathologists and other trained lab scientists who lack knowledge, skill and adequate qualifications. Such illegal pathlabs are a threat for the diagnostic ecosystem in our country and pose a major challenge to the organised pathology sector. However, these labs, despite being run by under-qualified people, contribute significantly to the growing healthcare sector in India.

The lack of strict regulations has led to many illegal pathlabs cropping up all over the country. The government should work more aggressively to enforce regulations/court orders that dictate who may or may not operate medical laboratories, diagnose test results or issue reports. The lack of enforcement puts patients at and increased morbidity and mortality, misdiagnosis, malpractice and casts suspicion on the entire field of clinical pathology.

How such labs are being a constraint to major diagnostic centres/chains? Are there any statistics on this?
These illegal pathlabs run by under-qualified technical staff are prepared to go to any lengths to secure their ‘business’. It is degrading for qualified pathologists to compete with technicians, but many consultants accept these reports from these labs. However, when it comes to the consultants’ own relatives or friends, they always go to a qualified pathologist even for the simplest of tests. What’s good enough for other patients is not so for the doctors’ kith and kin. There are no such official numbers but a mere fact that there are about 3,000 pathologists registered in Maharashtra, but the state has over 12,000 pathology labs. The numbers speak of the problems itself. There are nearly 1.4 lakh pathlabs, of which 60 per cent are run by under-qualified technicians.

What are the immediate measures that should be taken to curb this practice? As an industry player, what measures have you taken or would you like to take in this regard?
New stricter laws, strong enforcement of current regulations, penalties, mandatory registration, accreditation, quality compliance, etc. is the need of the hour. Nearly 70 per cent of clinical decisions are based on pathological findings. It is highly unfortunate that this section of the healthcare industry is so undermined, simply due to lack of awareness of the role of pathology. It is necessary for the government to intervene and take immediate measures to ensure patient safety and quality-driven pathology lab reports. At Oncquest, we ensure that almost all clinically relevant reports are explained by qualified pathologist to patients and if need be, to our clinicians too. This creates awareness among consumers about the importance of having qualified technical force behind your report, which is essential for one’s good health. We do conduct drives and public awareness campaigns besides explaining importance of accreditation and quality control programmes to our consumers and public at large.

What kind of regulatory mechanisms need to be in place before and after opening of a pathological or diagnostic lab in Delhi ?
Registration of pathology labs, along with qualified signatory, should be made mandatory. All labs should participate in external quality assurance scheme which should be available online and displayed prominently. I am sure the establishment of the Clinical Establishments (Registration and Regulation) Act of 2010, though it needs to be revisited on many clauses, will definitely help in cracking down such illegal pathlabs.

Do you think capping of prices on the essential diagnostic tests will have any impact on the unorganised path labs?
I don’t think it would be much of a deterrent to such illegal labs. Quality-driven reports cost a bit more. The government should make it a point to have differential pricing for registered pathology labs. This would not only help the already strained organised sector, but also create awareness in public about such illegal labs.

Can digitisation or technology help to curb these unorganised labs ?
Definitely! It would be of big help. Digitalisation should occur across all aspects of sample processing. This should include pre-analytical, analytical and post-analytical processes. Not only the sample-related information, but also the lab registration details should be available online. Transparency with strict enforcement of the regulations is a definite need.

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