Quality accreditation for Covid-19 labs may have faltered, reports suggest

The accreditation body, NABL seems to have strayed from its rules during the pandemic to rope-in private labs to do Covid-19 testing,which my have led to a considerable gap in the quality control, suggests a report done by The Wire Science.

National Accreditation Board for Testing and Calibration Laboratories(NABL), a self-financed body that provides accreditation to industry associations, is a stickler for rules and details when it comes to conducting audits and granting seals. However, the long complex process was shrunk to five hours when the pandemic hit.

Typically, accreditation involves submission of several documents and manuals, pre-assessment and final assessment done through a two-day on-site audit. Due to Covid-19, private labs were asked to conduct an RT-PCR test and upon successful completion, accreditation was granted. Some audits were conducted through video calls.

Instruments in possession to perform RT-PCR tests, the number of sample collection centres across the country, and other accreditations already acquired by the labs were also taken into consideration.

An anonymous NABL assessor told The Wire Science that it is the first time the organisation has been so lenient in the accreditation process and it is strange to have allowed such a large deviation.

There are many variables that can cause a false negative test result. Most audit tests were conducted with a blood sample. While detecting the RNA virus in the blood is easy, it is a much more difficult task when the sample from a nose swab.

Between October 2019 and May 2021, the number of labs engaged in the required testing has increased greatly. The RT-PCR test (reverse-transcription polymerase chain reaction) falls under the category of molecular testing. "As of the 2019 edition of list of NABL's labs with active accreditation, only 12 labs in the country were performing molecular testing. Since the pandemic began, 1,200 labs were given accreditation," reported The Wire Science.

Typically, the NABL is strict with the details of individuals who perform the tests. However, large diagnostics chains seem to have the same personnel signing off on reports at multiple test locations.

The Ministry of Health and Family Welfare (MoHFW) decided to involve the private sector of India to perform Covid-19 tests to keep up with the increase in requirement and put the Indian Council of Medical Research (ICMR) in charge of approving private laboratories fit for the job.

However, ICMR has no experience in the assigned task. It is designed for coordinating and promoting biomedical research in the country. ICMR reached for the expertise of NABL to conduct the audit.