Experts warn that health and safety measures in clinical laboratories should be of paramount importance, especially in view of the emergence of hepatitis and other communicable diseases.
With profiteering and overcharging of tests rampant in privately owned diagnostic laboratories across Kashmir, the number of illegal units has mushroomed, making it difficult for the government to keep a check and set a balance.
The investigation carried out by Kashmir Newsline revealed that the number of private diagnostic centres and nursing homes has exponentially gone up in all the district headquarters, especially in the central and northern parts of Kashmir.
In central Kashmir’s Magam, the then Chief Medical Officer, Budgam, Dr Tajamul Hussain , had issued a seizure order for a private diagnostic centre, which according to the authorities was caught operating from a dilapidated building, housing a chicken farm as well. The owner of the diagnostic lab had prevailed upon the authorities through a renowned cleric and political leader. However, the CMO refused to revoke the order. The diagnostic lab was closed down and guidelines were issued that no such units should be run in the district which would pose a threat to the lives of the masses.
“Imagine the samples being collected from a lab which was also housing chickens. You can imagine the health hazards it posed,” said Hussain.
“I received calls from several influential people warning me not to shut down the lab,” he recalled. “I didn’t agree. I think people’s health and life matter the most,” he said.
Meanwhile, officials at the Directorate of Health Services, Kashmir, (DHSK), revealed to Kashmir Newsline that there are around 4000 diagnostic labs operating across Srinagar alone.
“The number could be even higher,” a medic, choosing not to be named, posted at the Chief Medical Office, Srinagar, said.
“Unfortunately, we don’t have a solid mechanism to keep a check on this and the fact is that we are unable to restrict the numbers,” the official said.
Where are the Safety Measures?
Experts say that health and safety in clinical laboratories have turned out to be an increasingly important subject as a result of the emergence of highly infectious diseases such as hepatitis among other communicable diseases.
A senior Consultant at the Department of Health Services, Kashmir, (DHSK) Dr Masood Rashid, while talking to Kashmir Newsline said that the government needs to put in place foolproof mechanisms for bringing the diagnostic labs and nursing homes under the purview of safety measures. “The fact is that these diagnostic labs are unregulated and unchecked. There is no standard mechanism in place,” Dr Masood told this newspaper.
“The government can’t even regulate their numbers as more and more applicants are coming to set up new units. Limiting their mushrooming growth has become a herculean task as unemployment is taking its toll on the educated youth,” he said, adding “when you have so many professional degree holders coming forward, the monitoring becomes difficult.”
He suggested the government bring all the units under ICMR guidelines and not follow the closure policy. “The DHSK needs to have a separate head for the challan money and the department should be fully authorised to fine any unit holder,” he said, adding, “The fact is that currently there is no fear among unit holders and they keep on flouting the norms and bring disrepute to the medical profession and society also.”
Another medico, a haematologist at Government Medical College, Srinagar, Dr Javid Ahmad said that safety measures in the laboratories was a vital concern. Quoting national research conducted recently, the medico said that 60% of laboratories had person-in-charge of safety in the laboratory. 73% of the laboratories had safety education programs catering to various hazards. In 91% of the labs, the staff uses protective clothing while working. Hazardous material regulations are followed in 78% of the laboratories. Regular health check-ups are carried out among staff in 43.4% of the laboratories. He said that the safety manual is available in 56.5% of laboratories. 73.9% of laboratories are equipped with fire extinguishers. Fume cupboards are provided in 34.7% of the laboratories and they are regularly checked in 87.5% of them. In 78.26% of the laboratories, suitable measures are taken to minimize the formation of aerosols.
Accreditation a Golden Rule
The experts say that the accreditation of the laboratories would help in streamlining the overall services in these units.
“Waste material isn’t disposed of as per biomedical waste management handling rules. Laboratories and diagnostic labs should be accredited with the National Accreditation Board for Testing and Calibration Laboratories (NABL) and I am sure that the safety parameters will get fine-tuned,” Dr Ahmad said. “Installing safety-engineered devices apparently contributes to a significant decrease in injuries in laboratories; laboratory safety has to be a part of overall quality assurance programme in hospitals, private nursing homes and laboratories.”
Without any government rate list and comprehensive vigilant monitoring, scores of diagnostic labs continue to charge arbitrarily for various medical examinations. The prices patients pay for various diagnostic tests in Kashmir aren’t governed by any rule, for now, leaving huge scope for overcharging and profiteering. According to the insiders, the last rate list was framed in 2012 and was never implemented on the ground. The government had issued a rate list for diagnostic centres which was stayed as a result of a petition filed by the Private Diagnostic Center Association of Kashmir. Since then, the centres have been provided with a rate list by the association for various tests.
However, the rate list of the association has not been followed in letter and spirit, particularly in other districts of the valley. This flouting is largely due to the lack of monitoring from the Directorate of Health Services which mainly remains restricted to city centres.
One of the owners of an old diagnostic centre in Srinagar said there was no check from the government on centres on the outskirts of Srinagar.
“Those centres located in the heart of the city are monitored as it gets highlighted. But no one visits the ones in other parts of Kashmir,” the owner said.
Kashmir Private Diagnostic Centres Association JK urged Lieutenant Governor Manoj Sinha-led government to frame a new rate list for carrying out different tests as the present price list was framed a decade ago. The huge disparity in rates of biochemical, radiological, microbiological, pathological and other tests is rampant in Kashmir. Stakeholders have for a long time demanded a regulatory mechanism in the market to help patients who have no idea about rates.
“There is no one to check the rates for tests,” a senior doctor said. He said that any test, from the most basic to the advanced, must have a cap price, above which no lab should be permitted to charge. However, nothing of that sort exists.
President Kashmir Private Diagnostic Centers Association J K, Rouf Rangraze said, “Governments over the years have slept on it.” He said that there was a desperate need for such a rate list for all medical investigations. “This will help in streamlining the functioning of diagnostic centres and help the consumers.” He said that the rate list, when framed, must be mandated to be displayed in the labs. “That way every consumer gets a uniform rate for the tests. This also adds to the trust bond between the consumer and the labs.”
Monitoring is the Key
As hundreds of diagnostic labs in Kashmir have also faced closure, experts say that it was mandatory to have a doctor on board for signing reports with the Private Diagnostic Lab Association calling it “unfair.”
“Monitoring is very important,” said a doctor. “You can’t just play with the lives of thousands of people.”
He said that all medical establishments should be brought under the strict surveillance of the government watchdogs. “That will improve the quality delivery of the healthcare system.”
Meanwhile, owners of hundreds of diagnostic labs in Kashmir fear they may have to wrap up their enterprises with a fresh rule being implemented in the UT that requires every laboratory, even those doing the most basic of tests, to have an MBBS doctor on board.
The debate that has been going on in India for the past couple of years has reached Kashmir. With the Clinical Establishments Rule Amendment 2020, and its applicability in J&K, every diagnostic laboratory is required to have at least an MBBS doctor on board to sign the reports.
This applies to all laboratories with no distinction based on the scope of tests being carried out. This was not the case earlier and people with diploma or degree in Lab Technology were able to sign a report in J&K. Many diagnostic laboratories that run on small scale across villages, towns, and cities of J&K, may have to close down if they fail to have an in-house doctor. For th lab technologists, the move is sure to render them jobless and escalate the prices of diagnostic tests. The Health and Medical Education Department, a delegation of these lab owners said, has not been renewing their registrations as they do not come up to the fresh norms.
“We have run these labs for decades, after spending time and money for our degrees and diplomas, and now suddenly, the entire scenario has changed for us,” said a laboratory owner. “The tests we run are basic and we are qualified enough to carry out tests that require interpretation. Now even for simple readings such as blood glucose, hemoglobin, PH value of urine and the level of electrolytes, we need to have a doctor,” he said.
The Kashmir Private Diagnostic Centres Association (KPDCA) said the rule does not apply in all states of India. “Look at Gujarat, Himachal Pradesh, Rajasthan. These states haven’t made it mandatory to have an MBBS doctor sign the reports of basic tests,” President, KPDCA, said.
He said that in many states, small scale labs are exempted from having an MBBS doctor for basic tests. He said that the laboratories have been divided into categories and those, categorized as basic composite and the reports containing only numerical value are exempted. “We request the same norms be applied here,” he said.
He further said that many countries have standardized and regularized medical laboratory profession and professionals, thus enhancing performance of laboratories, medical professionals and laboratory technicians.
The professionals and the association have appealed the Health and Medical Education Department to re-establish the right of registration of their establishments under the J&K Nursing Homes and Clinical Establishments Act. 1963. “Restore our right to authenticate the medical lab reports as is the trend globally,” the KPDCA said.
According to government officials at the civil secretariat, as per the Nursing Homes/Clinical establishments under the J&K Nursing Homes & Clinical Establishments Act 1963 (Amendment 2006), an application form is to be issued to the applicant who wants to establish a diagnostic centre / nursing home against a proper prescribed fee in the shape of G.R. and after that when they submit the application form along with all requisite formalities in all respects as envisaged in the norms accompanied with the documentary support, the case files are to be submitted to the inspection committees. Thereafter, the case files of those nursing homes, diagnostic centers, clinical establishments, who fulfill all the requisite norms and guidelines are recommended by the designated committee in accordance with the government order in pursuance of directions of the High Court in OWP No. 191/2006 titled G M Khan Vs State and others the resignation of the Nursing homes, diagnostic establishments shall be undertaken after inspections by the committee. The committee would include a specialist of health, medical colleges in respect of specialists involved in the registration of a particular centre to be nominated by the Director of Health Services/Principal Govt. Medical college. For centres where specialists are not available in the district, the same shall be included from Govt. Medical College, Director Health Services.
The inspection committee shall certify and furnish a report to this effect to this Directorate for grant of Certificate of Registration, Renewal of registration as per the relevant guideline Act as the case may be. So, to curb the illegal running of clinical establishments, it is mandatory for all the controlling officers of the districts from time to time to adhere to the norms and regulations applicable to the registration of nursing homes, private hospitals and other diagnostic centers running in the valley.
Secretary, Health and Medical Education, Jammu and Kashmir government, Bhupinder Kumar, said that the controlling officers have been advised to ensure that no such establishment is found running without registration. Besides, the district level officers have been instructed to take appropriate action under the rules in case any such establishment is found running or violating the rules and regulations without registration in their areas of jurisdiction and any establishment which is not registered (registration expired) or is deviating norms shall be sealed immediately as per the provisions in the relevant Act.