N Venkateswaran, CEO, National Accreditation Board for Testing and Calibration Laboratories (NABL) speaks to Prathiba Raju, Elets News Network on the multiple benefits of lab accreditation and how accreditation is playing an important role in supporting regulations.
Q What is the trend in the accreditation of labs before and after the pandemic? What are the regulatory changes made during the pandemic?
NABL always ensures a robust mechanism for accreditation of laboratories and continuous improvement in the accreditation process.
Many private medical laboratories invested in enhancing the testing capacity of the nation to test RNA viruses (E.g., SARS-CoV-2). The gold standard for detection of these viruses is the RT PCR technique, which is a specialized technique and requires relevant expertise to ensure the proper conduct of the test and reliability in the results.
However, during the lockdown, NABL made use of digitization to its advantage and all NABL staff, together with NABL assessors, accreditation committee members could adopt to these digital technologies, continue with the predefined process and were able to grant accreditation to laboratories.
ICMR mandated NABL accreditation as the criteria for recognition of private medical laboratories testing viruses. Also, a widespread understanding was observed in ensuring the testing requirement for supporting products (E.g., PPE, Masks) which were also mandated from NABL accredited testing laboratories.
Also read: India’s Diagnostics Journey – and the Future
The recent examples underline how accreditation is playing an important role in supporting regulations.
Q Why is lab accreditation important and how accreditation boosts confidence in the testing laboratories?
Accreditation is the third-party attestation related to a conformity assessment body conveying the formal demonstration of its competence to carry out specific conformity assessment task. Conformity Assessment Body (CAB) is a body which includes testing including medical Laboratory, Calibration Laboratory, Proficiency Testing Provider, Certified Reference Material Producer.
Laboratory accreditation is a procedure by which an authoritative body gives formal recognition of technical competence for specific tests/ measurements, based on third party assessment and following international standards.
Formal recognition of the competence of a laboratory by an Accreditation body in accordance with international criteria has many advantages:
• Increased confidence in Testing/ Calibration Reports issued by the laboratory
• Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent
• Potential increase in business due to enhanced customer confidence and satisfaction
• Customers can search and identify the laboratories accredited by NABL for their specific requirements from the NABL Web-site or Directory of Accredited Laboratories
• Users of accredited laboratories enjoy greater access for their products, in both domestic and international markets
• Savings in terms of time and money due to reduction or elimination of the need for retesting of products.
Q Can you detail how NABL has simplified the accreditation process for labs?
NABL adopted digitization of accreditation procedure bringing easy access and a venue for quick submission/transfer of information with a single point of interface for laboratories for all accreditation activities. This simplifies the availability of information and quick update on all accreditation related activities.
NABL ensures the availability of relevant information to laboratories through the NABL website (www. nabl-india.org). All publicly available documents are available for download free of cost on the NABL website.
NABL also conducts regular awareness programs to ensure that simple requirements for accreditation are clearly explained and available. Demo videos for CABs are available on the portal along with a help manual with screenshots which would help the laboratory to fill the application on the portal.
Q Can you tell us how many private laboratories have initiated TrueNat/CBNAATbased tests for COVID-19 and applied to NABL to ensure quality testing?
Initially NABL had around 60 laboratories accredited for testing RNA viruses as per RT PCR technique. Some of these laboratories were testing using the TrueNat/ CBNAAT for RNA viruses of H1N1, malaria, etc.
Later with the need for ramping up the testing capability of the country, due to the pandemic situation, we could process the request for accreditation of laboratories for testing both open (RT – PCR) and closed (TrueNat/CBNAAT) systems to around 1000 laboratories in 7-8 months. As of date, there are more than 1150 labs accredited for testing RNA viruses using RT PCR.
Q Despite we have labs that are approved to offer tests for the novel coronavirus, the unauthorized market is thriving locally. What steps should be taken to keep them in control?
NABL has always encouraged laboratories to adopt quality practices and rise up to the level of international standard ISO 15189. This increases the acceptance of our laboratories internationally.
We understand that there are many labs in the market that are not accredited. We could understand the needs of many such laboratories and introduced the NABL M(EL) T Labs Program – NABL Medical (Entry-level) testing labs program which is aimed at encouraging very small entry-level laboratories to understand the simple requirements of accreditation. This will enable them to distinguish themselves as laboratories providing reliable test results. Also, two new categories of Micro, Mini were introduced to encourage small laboratories to meet the ISO 15189 requirements and proudly claim NABL accreditation.
I am sure people will get well informed and in due course start demanding quality services especially in the medical sector. We all have learned a lot and general perception had changed since 2020. All the local/ small laboratories are bound to get motivated to distinguish themselves through accreditation in order to cater in the future.
Q As an industry expert, how has the Covid-19 pandemic impacted the diagnostics sector and how do you foresee India’s diagnostics space during the post-vaccination period?
The pandemic has taught us valuable lessons on the important role that quality plays in medical testing and how accreditation ensures that laboratories actively ensure the quality of their test results.
Health is a sector that is constantly seeing innovations and the same can be said about the diagnostic space also. We have come to a level, where the nation could adequately ramp up its testing capability in the face of the pandemic. Also, our vaccine production capability is also noteworthy. Tests for the prevention of serious ailments will gain importance in the time to come.