How diagnostic labs are failing patients in India in terms of poor standards

Of the nearly 1.1 lakh medical laboratories in the country, whose test reports determine over 70 per cent of medical decisions, just about 1,039 are accredited.
Image for representational purpose only. ( File | EPS)
Image for representational purpose only. ( File | EPS)

NEW DELHI: Between 2012 and 2019, there was a nearly 200 per cent jump in the number of diagnostic laboratories that have accreditation, a gold standard which offers an assurance to patients of quality services and reliable reports.

While the figure gives hope, especially as it concerns a sector which has little to do with rules and regulation, the state of affairs on the ground remains grim.

Of the nearly 1.1 lakh medical laboratories in the country, whose test reports determine over 70 per cent of medical decisions, just about 1,039 are accredited.

The issue over diagnostic labs of questionable quality, which have mushroomed in every nook and cranny of our urban landscape, is so grave that even NATHEALTH-Healthcare Federation of India, an industry body, highlighted it recently through a report titled, ‘An Assessment of India's Laboratory Diagnostic Industry’.

“Undefined standards lead to varying levels of quality and clinical standards compliance. Defining the minimum norm will help patients avail quality diagnostic services,” noted the report released some weeks ago.

It’s not that the government is not aware of a complete lack of standards, a qualification required for people employed at these labs and a necessary provision for a regular audit of these centres where clinical biochemistry and clinical pathology; haematology; microbiology and infectious disease serology; histopathology, cytopathology and several imaging services are offered.

In 2010, the Union government, through its Clinical Establishment (Registration and Regulation) Act, had sought to regulate the pathology and imaging laboratories and there was also a provision for asking these centres to get accredited with recognised bodies such as the National Accreditation Board for Testing and Calibration Laboratories.

However, 10 years on none of the states, including Uttar Pradesh, which implemented the Act, have made it mandatory for laboratories to get accreditation. On a visit to UP, this correspondent met patients narrating horrific accounts of misdiagnosis by laboratories.

“The medical laboratory industry in the country is a jungle without any rules where every Tom, Dick and Harry can open a shop and play with the trust and lives of vulnerable patients. This is essentially due to a complete lack of enforcement anywhere,” said Dr Navin Dang, who runs a leading laboratory chain in the national capital region.

“Things won’t change unless accreditation is made mandatory rather than voluntary,” he added. His concerns are not unfounded as they are reflected in testimonies by helpless patients who bore the brunt of wrong reports by the laboratories.

Soni Kumari, a 32-year old woman in Ghaziabad’s Chhapraula is one of them. Three years ago, Soni, while working as a nanny in a daycare centre, developed a lump in her right breast.

On the advice of a local physician, Dr Suresh Mittal, who suspected cancer, she got a blood marker test and a mammogram done at a diagnostic centre in the city. The test showed malignancy.

The physician, who is also a consultant at a Delhi hospital, advised her to start a chemotherapy course at the earliest. 

No ray of hope for patients  from diagnostic laboratories

“However, after two rounds of chemotherapy, which made me feel sick in indescribable ways for nearly a month and cost me huge amount of money, another mammogram was performed. As it turned out, I had no cancer at all,” said Soni, who now works as a domestic help at a housing society in Ghaziabad.

Soni, whose family income is barely Rs 16,000 per month, could not do much other than confronting the technician at the first laboratory. But that was that.

“I had no means or energy to fight them,” she said. Dr Dang recalls how four laboratories, where the blood samples of a 22-year-old girl, running a persistent fever for nearly two months, were collected had failed to detect Leukaemia.

“It was beyond bizarre, as a simple complete blood count test ought to indicate something that is so clearly wrong. However, in her case, none of the labs could detect the obvious abnormality in her samples,” he said, hinting that it was possible that her samples were probably never examined at all.

Those in the healthcare industry are aware what a sink testing is. It is a form of medical laboratory diagnostics healthcare fraud where clinical specimens are discarded, via a sink drain, and fabricated results are reported, without the clinical specimen actually having been tested.

It’s a phenomenon long known but rarely ever addressed. Dr VK Paul, member (health) Niti Aayog and the chairperson of the Medical Council of India’s Board of Governors, admitted that lack of specified standards in infrastructure, qualification and transparency in case of laboratories is has been a “huge concern” for the government.

However, if the government is worried, it does not really reflect in its actions. Only recently, nearly three years after the Supreme Court passed an order that all laboratories and diagnostic reports can only be signed by qualified pathologists, the Union health ministry, on the advice of MCI-BOG, passed an order to allow even non-doctors, with relevant degrees, to issue reports but without offering any medical opinion or interpretation.

This, said officials, was being done as the number of quality pathologists and radiologists in the country was only a small fraction of the total labs in operation. Those pitching for reform in the sector, however, are agitated.

“It will further encourage and promote fraud in a sector where unqualified professionals, proxy signatories, sub-standard equipment and reagents are the norm,” said a senior executive in one of the most well known corporate laboratory chains in India, requesting anonymity.

In UP, where Soni and millions like her are suffering due to poor quality of diagnostic services, the state concedes it’s a long way before it can divert its focus to the issue.

“We are aware that it is important to ensure the highest standard at every step. It is important to eliminate any human or machine-made error as it’s a question of someone’s health and wellbeing,” state health minister Jai Pratap Singh said.“However, the fact is that over 90 per cent of diagnostic services is in the private sector and at the moment, we are not in a position to govern them properly,” he added.

(The author has received support in the form of a grant from Thakur Foundation, USA to report a series related to the Clinical Establishment (Registration and Regulation) Act, 2010.)

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