Delhi bars labs ‘flouting’ rules, test capacity dips

The crisis came to a peak on Thursday when eight labs were banned from carrying out tests after the government pulled them up for not following protocols, and, according to the health minister, taking too long to report results.
The government also believes that the labs, by testing asymptomatic and low-risk individuals in violation of the testing guidelines, are effectively creating a bottleneck where people who desperately need to be tested have to wait.(Pratik Chorge/HT Photo)
The government also believes that the labs, by testing asymptomatic and low-risk individuals in violation of the testing guidelines, are effectively creating a bottleneck where people who desperately need to be tested have to wait.(Pratik Chorge/HT Photo)
Updated on Jun 05, 2020 01:27 AM IST
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Hindustan Times, New Delhi | ByAnonna Dutt and Ashish Mishra

A crisis of rules, procedures and performance of testing centres has put the government, labs and hospitals in Delhi on a collision course and led to a substantial setback to the national capital’s capacity to diagnose patients and check the spread of the coronavirus disease (Covid-19)

The crisis came to a peak on Thursday when eight labs were banned from carrying out tests after the government pulled them up for not following protocols, and, according to the health minister, taking too long to report results.

“Some labs were giving reports very late.If someone has taken a test for the coronavirus, the reports should be ready in 24 hours. At times, some have not given results for 5-6 days. This leads to a delay in hospitalisations because the special corona facilities say they will accept only patients who have a positive test. Other hospitals refuse to admit unless someone is confirmed to be corona-free,” health minister Satyender Jain told reporters.

The government also believes that the labs, by testing asymptomatic and low-risk individuals in violation of the testing guidelines, are effectively creating a bottleneck where people who desperately need to be tested have to wait. The counter argument is that testing of asymptomatic low-risk individuals was not resulting in any reduction in overall positivity rates (proportion of positives to tests) in the state, setting alarm bells ringing about the magnitude of the problem.

In all, eight laboratories are now under investigation for not adhering to the protocols defined by the Indian Council of Medical Research (ICMR) before allowing people to take Covid-19 tests. A show-cause notice sent to them said: “...data submitted by you in the ICMR portal and to the health and family welfare department in which it has been observed that a large number of asymptomatic patients were tested without following ICMR testing protocol.”

The eight labs together were able to carry out 4,000 tests a day, according to figures they shared with HT. The government initiated a similar enquiry over discrepancy in data against another laboratory, Dr Lal Path Labs, in early May. The largest chain of private laboratories in India, Lal Path Labs alone had the capacity to test 4,000 samples. According to officials who asked not to be named, the lab is yet to be allowed to resume tests.

The controversy around testing comes at a time when the national capital has been recording an increasing number of new cases. On Wednesday, the city crossed the 1,500 mark for single-day infections. On Thursday, this number was 1,359.

The Delhi government issued fresh orders to hospitals on Thursday to discharge any mild on asymptomatic Covid-19 patient they may have, and said that facilities that have been approved for treating Covid and well as non-Covid patients should turn away any patients.

“We already have our dedicated COVID-19 facilities. Three more private hospitals were added yesterday (Wednesday). And if those private hospitals with mixed use (20 per cent reserved beds) are facing logistics issues, then they will be fully converted into dedicated Covid-19 facilities,” deputy chief minister Manish Sisodia said, adding that “the focus is to save lives”.

Experts and doctors have said that widespread testing is the most crucial strategy for identification and containment of the outbreak.

“Anyone who can afford to get tested should be able to get tested by a private laboratory. For testing in a public health setting, they still need to follow some norms to rationally use their resources. Those tested positive and symptomatic should be isolated,” says Dr Giridhara Babu, head, lifecourse epidemiology, Indian Institute of Public Health, Public Health Foundation of India.

ICMR has approved 16 government and 22 private laboratories in Delhi for Covid-19 testing. Of the seven private laboratories, five have refused to comment on the matter.

Fortis hospital, which outsources all its tests to SRL diagnostics, said: “We have been following ICMR protocols or guidelines and we conduct tests only after receiving all the relevant documents from a patient. There have been some queries raised on sample assigned to “OTHERS” category as per the ICMR form. We are responding to these with further details on the same.”

“SRL is actively engaging with the MoHFW (Health and Family welfare department) and DGHS (Directorate General of Health Services) to understand the gaps. As an organisation that is at the forefront of fighting this pandemic with the government, SRL understands the sensitivity and seriousness of our business and is keen to fight the Covid battle along with the administration,” said Arindam Haldar, chief executive officer of SRL in a statement through Fortis representatives.

The other laboratories include: City X-Ray and Scan clinic, Prognosis Lab, Pathkind Diagnostics and Star Imaging.

Union health minister Harsh Vardhan, too, joined the issue on Thursday, saying there was a need to ramp up testing as well as surveillance, contact tracing and containment in Delhi. “Rising cases, high positivity rates and low testing levels in many districts are worrisome,” Harsh Vardhan was quoted as saying in a health ministry statement.

To be sure, Delhi tests the most people in the country per million population. On Wednesday night, this number stood at 11,615, at least 50% higher than Andhra Pradesh that comes second. The national average is 3,183 per million.

Experts say that while the idea of putting an end to frivolous testing is all well, Delhi is also excluding high-risk individuals. “Our (India’s) condition is probably worse than Italy, but we don’t know since we aren’t testing enough. We don’t acknowledge our real status in terms of disease spread because it seems our focus is largely on proving we are doing better than other countries in managing the disease. We have tested about 3.9 million people from a population of 1.3 billion, which is roughly about 0.3% of the population. How can you plan how to control a pandemic for the rest of the 99.7% of the population by merely looking at the results in 0.3% of the population?” said Dr T Jacob John, former virology head, Christian Medical College, Vellore John.

On Wednesday, the Delhi government tightened its testing criteria to exclude any asymptomatic person without known co-morbid conditions such as diabetes, hypertension and cancer.

ICMR guidelines allow for the testing of asymptomatic direct contacts such as those living in the same household on the fifth and 10th day.

After a meeting with representatives of the laboratories, an internal communication from the Delhi government on Thursday read, “Enquiry is on against these labs for taking samples against the protocols of ICMR. All the CDMOs are requested to suspend the registration of all the phlebotomists of all these labs… Also pl ensure that no samples are sent to this wef (with effect from) today.”

The Delhi government currently registers all the phlebotomists or laboratory technicians who collect the throat and nasal swabs with the district authorities, without which the samples cannot be collected.

In addition to Fortis, which used SRL, testing has also been stopped at Sir Ganga Ram Hospital as per the Delhi government directions. Both hospitals treat Covid-19 patients. On Wednesday, the government declared Sir Ganga Ram hospital as an entirely Covid-19 hospital.

When asked about the testing controversy, Dr Rajeev Garg, director general of health services, Government of India, said: “Today the health minister had a review meeting with the Delhi Govt in which the matter was discussed and resolved. There have been no wrongdoings from our side and it was clarified. There is no problem,”

After the change in testing protocol an official from one of Delhi’s government laboratory, on condition of anonymity had told HT, “The earlier category allowed for the testing of family members living in the same house or doctors and health care workers exposed to a Covid-19 patient even if they were asymptomatic. Most of the cases – around 70% -- were picked up in family members tested. Now, the government is allowing the testing of only those who have symptoms.”

(With inputs from Rhythma Kaul)

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