When Prakash Gupta* (name changed) had his 19-year-old son Rohit’s* blood tested in 2015, the results shocked the family. Rohit had been unwell for some time and the blood report indicated his platelet count was abnormally low (0.33 lakh/mm3).
Since a platelet count as low as Rohit’s usually denotes a life-threatening medical condition, for the Guptas of Mehrauli in Delhi, the report was life-shattering. However, there was something very odd about the numbers and the Guptas had only one way to find it out.
A second blood test was conducted the very next day and showed Rohit’s platelet count at 3.4 lakh/mm3 – in stark contrast to the previous test. Subsequent blood work confirmed the first report to be grossly incorrect. The family was, unsurprisingly, appalled.
But the Guptas aren’t the only ones who’ve suffered due erroneous reports – According to a Harvard study, India witnesses over 5.2 million cases of errors in medical reports annually.
The Rise of Pathetic Pathology Labs
Why are erroneous medical reports aplenty in India, especially when the country has witnessed double-digit growth in the health sector and had access to new machines which are designed to conduct blood tests accurately?
The answer lies in the rampant as well as unregulated growth of pathology labs in India, which often operate in the absence of regulatory mechanisms, as is the case in Delhi. Since the state hasn’t notified or implemented the Clinical Establishment Act, pathology labs in the city have little or no rules to follow.
A five minute walk from the All India Institute of Medical Sciences in New Delhi takes one to Yusuf Sarai, which has a few pathology laboratories. While most of these labs are branches of big chains, some are stand-alone, operating out of one-room collection centres.
A visit to one of the latter exposed how the blood-testing centre was using a pathologist’s digital signature, who “may or may not” have checked the blood report himself. When questioned whether the said pathologist would personally check all the 300 blood test reports the author had proposed to have done for homeless children, the representative at the laboratory didn’t give a clear answer.
Instead, he mentioned “the doctor had authorised the centre to use his signature in exchange for a fee and that’s how it works.” He further said the lab had tied-up with one pathologist whose signature was used on tests conducted under other branches of lab medicine like microbiology, biochemistry, haematology and so on.
300 Blood Reports in 4 Hours
While the lab outside AIIMS had its own share of malpractices, those operating from outside Delhi government’s Guru Teg Bahadur Hospital raise some serious questions over quality as well.
Right opposite gate number eight of GTB Hospital is a two-storied building which houses pathology labs and chemists, some of which have been shut after a recent raid by district officials. A flight of stairs leads up to the first floor, where at least two pathology laboratories are operational.
The owner of one of these pathology labs claimed that he would be able to present nearly 300 reports for 50 children in the span of 4-5 hours – a strange proposition given the representatives of the pathology lab would have to travel to Mayur Vihar, which would take about an hour, and set up a camp to collect samples.
Moreover, the owner claimed that all tests are conducted by the lab using machines in an adjacent room. The Quint could not get access to the lab.
A sample report obtained from the lab revealed that it too was using a doctor’s digital signature in reports prepared on its letterhead i.e. a single doctor’s signature would go on the 300 reports prepared in 4-5 hours.
When asked about certification, two labs said they would provide photocopies of their Delhi Pollution Control Committee certificates, which only deal with bio-waste disposal and cannot guarantee the quality of reports prepared by the lab.
Validity of Digitally Signed Reports
Registrar of the Delhi Medical Council Dr Girish Tyagi presented the reality check: lab reports are invalid unless physically signed by a registered doctor.
“The existence of digital signatures on reports mean that the doctor is not examining the reports himself and neither is it being prepared under his supervision. Every test, even those done by technicians must be conducted under the supervision of the doctor. A lab report is valid only when the doctor has signed it properly with his DMC number.”
Dr Tyagi recollected instances where a single doctor had signed blood reports in Gurguram, Noida and Delhi, all on the same day. The solution, he says, “is to legally introduce limits on the number of blood reports a doctor can sign in day. At the moment, there is no such regulation in place and doctors can sign on as many reports they want.”
However, since Delhi has not implemented the Clinical Establishments Act, pathology labs have gone unregulated by and large. This means that the national capital does not have any rules of quality control or procedure that pathology labs must follow, while preparing blood reports.
What Clinical Establishments Act Says
- Name, qualification & registration of persons in-charge and their timings on signage
- Preservation of the specimens and slides
- Temperature control for specialized equipment.
- Minimum qualification of Technical Head of Laboratory or Specialist or Authorized Signatories
- List of minimum medical diagnostics laboratory equipment with quantity
- Policy of annual maintenance contract or comprehensive maintenance contract and records for equipment
- Reports of all patients date wise and specialty wise for example: Histopathology, Cytology, Haematology and Laboratory Medicine.
- Record keeping of technicians working in laboratory indicating their details of qualification training and others
- Process of calibration of equipment and reagents Quality Control in the form of external quality assurance scheme or inter-laboratory comparison, as the case may be
- Policy of proficiency testing of tests performed
A Public Battle
Troubled by the growing menace of unethical pathology labs, consumer activist Bejon Misra had, in September 2018, filed a petition in the Delhi High Court asking for the formulation of a robust policy and the constitution of an authority to monitor labs in the city.
Despite repeated reminders, the Delhi government has failed to provide details of steps taken to monitor and regulate unethical pathology labs within its jurisdiction. However, Delhi is not the only state to not notify the act. According to Misra, “A majority of the states haven’t notified the act and those who have, aren’t implementing it in its true spirit,” says Misra.
Delhi Government Releases Draft Bill
Meanwhile, the Delhi Government’s Health Department, on Saturday, 21 September, released the Draft Health Bill, 2019, which carries provisions for the regulation and classification of clinical establishments in the union territory and has been modelled after the Centre’s Clinical Establishment Amendment Act.
The Bill proposes setting up State Council for Clinical Establishments and the State Registration Authority, which will have powers to grant, renew, and cancel the registration of clinical establishments.
Although the Bill proposes the inspection of clinical establishments by assessors, and requires them to display names of doctors, their fees and others charges prominently, it allows the same establishments to operate with a provisional certificate, which may not require a prior inspection.
This means that under the draft Bill establishments will only have to submit a form along with a fee, following which they may receive a provisional certificate, without undergoing an inquiry. It must be noted that the Centre’s Act too, allows establishments to operate with a provisional certificates for up to two years.
Why Accreditation Is Important
One of the key requirements of the 2018 amendment is quality control in the form of external quality assurance scheme. This means that pathology labs – in states that have notified the amendment – must obtain a document from a recognised organisation or audit agency, that can certify that the lab is conforming to certain basic standards.
However, the National Accreditation Board for Testing and Calibration Laboratories (NABL) is a recognised body that provides pathological labs with accreditation in accordance to international standards. Dr Vandana Jain, the director of NABL, says that the body conforms to the highest accreditation standards and has certified about 1,200 labs in the country.
“A lab has to first apply for accreditation, following which we vet the application. If the application is in the right format and meets our requirements, we send a team of experts who verify each and every aspect, including calibration of machines, qualification of staff, records and so on and so forth.”Dr Vandana Jain, Director, NABL Director
The team files a report on compliance to standards, which is further reviewed by NABL, following which the accreditation is granted. The process, as an AIIMS doctor familiar with the process points out, is “long one, that requires months of preparations.” The doctor mentions that not only is it important to maintain records, but also to constantly check and calibrate machines to ensure that they are testing what they are supposed to test.
“Even the centrifugal machine must be checked to ensure that a vial is being rotated a said number of times per second. This is how detailed the entire process of accreditation is,” the doctor adds.
Accreditation Not Compulsory
Crucial as NABL accreditation might be to accurate lab results, the reality remains that out of lakhs of pathology laboratories in India, only about 1,200 have NABL accreditation. Dr LalPath Labs, the country’s biggest pathology lab in terms of number of samples tested, has received NABL accreditation for 32 of its 204 labs all across the country.
Dr Arvind Lal, chairman and MD of Dr Lal PathLabs, says that although several of their “accreditation requests remain in the pipeline, the diagnostic chain maintains the same quality control across all its testing laboratories.”
The solution to unethical pathology laboratories, he feels, lies in proper implementation of the Clinical Establishments Amendment Act. At first, labs without qualified technicians and improper equipment must be shut down. Once the law is effectively implemented, NABL accreditation can come in to ensure that labs maintain the same consistency in quality.