The government needs a comprehensive regulatory framework and a strong intent to fight the mushrooming of fake path labs in the country which often endanger people’s lives with sub-standard services and bogus reports
Diagnosis, the first and the most important step of treatment for any patient, can, unfortunately, go wrong many a times, as it happened with 33-year-old Amit Sharma. It could have even cost him his life. His blood report that was misdiagnosed for chronic myelogenous leukaemia (CML) as acute lymphoid leukaemia, but fortunately doctors conducted a reanalysis and Sharma was given appropriate treatment and he recovered soon.
Misdiagnosis is not uncommon, and not everybody is as lucky as Sharma. Many end up becoming victims due to fake lab reports. Delhi Police busted a fake lab run by two brothers one of whom was a courier boy. They had managed to give out 30,000 fake lab reports which included tests of haematology, immunology, BCR-ABL quantitative, hepatitis profile, cytopathology, urine examination and thyroid hormone assay.
As per a Harvard study by Professor Ashish Jha, over 5.2 million medical error cases have been accounted for in India annually. The study also noted that most of these medical errors are triggered due to lack of skills and proper training. Since 70 per cent of the treatment outcome is dependent on the initial diagnosis, these fly-by-night operators are often the first point responsible for misdiagnosis and inappropriate treatment.
Industry experts inform that diagnostics services are the most significant part of the healthcare segment, which has been growing in India over the past couple of years at a rate of 15-20 per cent and is at nearly Rs 40,000 crore as of 2016. Among them, radiology accounted for 20 per cent and pathology accounted for nearly 80 per cent, but this market is dominated by unorganised players.
Need for strict regulation
Seven years ago, spending nearly six months interviewing clinicians and fellow diagnosticians to understand the pain points of the industry, Zoya Brar, Founder CEO, Core Diagnostics said, “Even then, it was clear to me that the chasm between those who were providing reliable results, and everyone else, was extremely wide. Today, not much has changed. Good news, though, is that we are talking about it more transparently. Unfortunately, the sheer number of diagnostic labs outnumber certified pathologists in the country. As a direct result of this skill gap, most laboratories are functioning illegally and their results are often suspicious. Another data point is that less than five per cent of the laboratories are authorised by the National Accreditation Board for Testing & Calibration Laboratories (NABL). Self-regulation works well in the domain of pricing, but when it comes to quality, lack of a mandatory and enforced system has brought us to the point we are at today.”
Mentioning that there are around 1000 NABL-accredited labs in India, which is a very small proportion of the total path labs in India, Nilaya Varma, Partner and Leader, Markets Enablement, KPMG India, said, “Even larger chains do not have all their labs accredited by NABL. Many rely on their internal processes and systems to monitor quality and ensure customers get reliable results. The real menace are the labs which have a poor quality control system and are in no position to give assurance on the reliability of test to their customers. Only having a pathologist associated with a lab will not necessarily provide reliable results.”
Shedding light on the challenge of shortage of pathologists in India, Varma said, “We need to review what would constitute ‘illegal path labs’ and what role should pathologists play for different category of tests that may require a different level of involvement from them. Accordingly, there could be a case to consider different types of licenses for path labs. For example, if a lab is doing only bio-chemistry tests using automated equipment and undertakes proper care to ensure the quality and reliability of tests, it may be issued a license only for these limited tests.”
Brig Dr Arvind Lal, CMD, Dr Lal Path Labs, touching upon this issue recently in an interview with Express Healthcare, informed that there are over 1,00,000 pathology labs in India but a majority of them are mere testing shops. Only 1,038 out of 1,00,000 labs are accredited by NABL, with hardly any government-sector lab being accredited. “I am happy to share with you that 32 of our labs are NABL accredited and another four are in the pipeline. You can see that there are very few quality labs in India. Ideally, like in developed countries, all labs should be accredited by the national body. In India, the first step should be to have strict regulation on the running of a lab as enshrined in the Clinical Establishment Act. This specifies clearly who can run a lab and the other basic requirements for running a lab. In most cases in India, labs are run by individuals who are not pathologists.
Voicing the consumer part and setting things into perspective, Professor Bejon Kumar Misra, Founder, Patient Safety and Access Initiative of India Foundation who had moved a Public Interest Litigation (PIL), sought directions to the government to formulate a ‘robust policy’ in the interest of patients for regulating the functioning and opening of pathological laboratories in the National Capital Territory (NCT) of Delhi and to constitute appropriate authority for regular checking of such laboratories. The PIL also called for strict implementation of the Clinical Establishment (Registration and Regulation) Act of 2010 in Delhi as many illegal pathological laboratories were killing people by providing incorrect test reports.
Clinical Establishment Act 2010 — Can’t be overlooked
Implementing a few measures in the right direction is the need of the hour. Varma informed that Clinical Establishment Act places more focus on minimum infrastructure and staffing that clinics and labs should have. While this would help in improving the standards of labs, additional efforts would be required to bring focus on the quality of test results. Further, he pointed out that the act has not been adopted by many states and the implementation needs to be strengthened further.
Reiterating the same, Misra, said, “Encouraging existence of only accredited path labs in the country is important— irrespective of whether it is commercially viable or not. Health is a state subject; states have a responsibility towards protecting the health of the poorest of the poor. We cannot and should not allow mushrooming of path labs managed by unqualified professionals and non-calibrated testing equipment. The state governments need to engage them professionally and encourage them with business in the interest of the poor. It has to be part of the Public Health Delivery System (PHDS) supported by the Government and managed by qualified pathologists. Citizens’ health is paramount and we can never compromise on patient safety and quality.”
“We do not have a law as of the date on regulating the diagnostic centres and that is why we lack the data. We do not know how many labs are functioning in our country- they could run into millions. The Government of India enacted The Clinical Establishment Act in the year 2010 but none of the states have enforced it because of the strong opposition from the private sector healthcare providers, including medical practitioners. Even organisations like Indian Medical Association (IMA) are against the law because it will regulate the illegal activities and not allow unqualified and unaccredited labs to exist. We must immediately implement the Clinical Establishment Act of 2010. The government has failed to deliver in the interest of patients,” Misra added.
Stating that there is a need for the government to create policies to incentivise high quality, Brar said, “While there is a relevance of penalising those who don’t follow the law, there is a place for encouraging those who do. Both levers need to be deployed by the government in equal measure. Though the government has recently issued a public notice on minimum standards for diagnostics laboratories as well as implemented the Clinical Establishment Act, there is very little being done to create the former lever. And I believe this needs to be changed. The Clinical Establishments Act of 2010 seeks to regulate clinical establishments.
In order to bring uniformity in the healthcare delivery system, the much-needed move to unearth illegal path labs functioning without valid licensing will act as an entry barrier and help the shift from unorganised to organised side. Audits or checks under the act will hopefully ensure that these labs are maintaining standards, procedures and quality, thus maintaining a basic minimum level of quality in labs in India. As far as CORE is concerned, we view ourselves as not only building a company but reshaping an industry. Reshaping an industry is never a sprint— it is a marathon. And in the re-sculpted healthcare industry I envision that diagnostics will be at the centre-stage.”
She added that diagnostics makes up for only three per cent of the healthcare expense, it impacts 70 per cent of the cost downstream, and 100 per cent of the outcome. So, setting up a high-end testing facility not only bridges this important lacuna, but also places the apt responsibility and accountability on diagnostics as a segment.
“The improvement of clinical outcome and reduction of downstream cost is simply a corollary. It is bound to happen. Education will have to be an important component of not just our offering, but it must pervade our mindset because the end-goal is to re-build the ecosystem. We believe that the entire ecosystem of healthcare – from the patient to physician to payer to diagnosticians – needs to understand this,” Brar emphasised.
According to high-end diagnostics players, the government must help create a regulatory environment that ensures that organisations get incentivised to focus on providing the right quality. There should also be a severe penalty for those that are not following the principles laid down in the Clinical Establishments Act. Finally, those that are in a position to influence the ecosystem, should shoulder the responsibility of creating awareness and education on the need for high quality and the impact of allowing such illegal labs to survive.
Patients first
Reiterating that all pathological laboratories and diagnostic centres must get accredited by NABL, which is under Quality Council of India, all the states must immediately bring a law to assure quality and safety to the patients, Misra said, “As I am on the board of QCI, we are preparing on a war footing to train and qualify professionals to become assessors as we need them in thousands to get the labs accredited. I am also talking to the industry associations to encourage self-assessment and voluntary certification through a third-party assessment to allow patients to differentiate between the safe and quality-driven path labs/diagnostic centres and the fly-by-night operators. There is an urgent need for states to look into this issue as they are responsible to provide safety and quality to the patients.”
Asking the government to wake-up to the priorities, Misra said, “I had to take a legal approach as they were refusing to either listen or appreciate our expectations as patients. I had to start from Delhi as I live here and it became easier to manage the hearings and interventions. Delhi is also a reflection of our country. So, why go far, when my neighbourhood itself needs to get the accessibility to safe, quality and affordable healthcare. It is critical and life-threatening to curb all illegal path labs. Unfortunately, we do not have any data— as I said earlier, it might run into thousands in Delhi NCR. A strong law is required to mandate only accredited laboratories, diagnostic centres to exist, with an immediate ban on path labs managed by unqualified pathologists and even diagnostic centres. Till then we must encourage self-assessed labs/ diagnostic centres to be made public based on a self-declaration and open to third-party audits by registered patient organisations or accredited state government assessors. As I have been made to understand, the Delhi Government is taking steps to notify their own rules or law but does not agree to Clinical Establishment Act due to political conflict as health is a state subject. We are yet to hear from the government officially before the Members of the Delhi High Court as they have been directing to explain the reason for the delayed implementation of the law and action against illegal pathologists. As an eye-wash, Delhi government did conduct some raids and closed some of the illegal units but they seem to have come up again due to lack of effective and efficient law enforcement mechanism,” he said.
Going forward, Misra informed that a robust registry of all accredited pathological and diagnostic centres should be made public on a portal and accessible 24×7 via toll-free helpline. As patients or as a medical practitioner, one must know about the nearest diagnostic centre with the name, photograph and the degree of the qualified staff as per the requirement of the law for registration.
As voices like Misra’s are repeatedly calling for tougher government regulation of medical laboratories and while few high-end players are willing to walk the talk with the government, a joint effort is needed to save consumers like Sharma who are clogged between quality service and hyped prices.
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