Experiences from the meeting with Director, NABL and NABL Accreditation Officers on Sunday May 27 at St. John’s Hospital Bangalore

I was fortunate to be present at the 2^nd Medical Assessors Conclave organized by NABL at St’ John’s Hospital Bangalore today. It was a conclave of NABL Lead Assessors as well as an opportunity for the laboratory representatives and consultants to have an interaction with NABL Director Dr. Anil Relia and other officers from NABL. Some of the highlights were:

Dr. Anil Relia, Director of NABL, gave a brief overview of NABL accreditation, the progress so far and the plans for future. According to him, about 400 laboratories in India have received NABL accreditation. Since NABL follows ISO 15189, the test results of an NABL accreditated laboratory are internally acceptable. He also gave an introduction to NABL 112 revised standards to the audience.

The talk by Dr. Anita Borges, Chairperson of Accreditation Committees, Clinical Labs, focused on the role of Accreditation Committee as part of NABL. 

According to her, some of the common problems that the accreditation committee has identified from the assessors’ report of lab audits are:

• Biosafety issues
• Biomedical Waste Management
• When & what corrective actions to be taken on poor IQC and EQA performance
• Harmonization of instruments
• Validation/verification of reagents
• Regulatory requirements for HIV testing

Other laboratory-related concerns of accreditation committee are:

• The impact of analyte stability on the quality of test results of samples transported over long distances
• The continuation of testing after withdrawal of a test from the scope especially when the withdrawal is due to an inability to meet quality requirements during an audit
• Complacency of accreditated labs leading in some cases to deterioration of quality performance

She also hinted that there is a possibility that NABL will make it mandatory that a lab will only get accreditation when it meets quality requirements for each and every test which is part of its scope because an accreditated lab gets to use NABL identifiers like logo to market itself, without letting the patients know that certain tests are not covered under the accreditation.

Dr. Prasad Sawant made an elaborate presentation on validation and verification requirement in medical testing. Dr. Jayaram from Anand Diagnostic Lab discussed the topic of Inter-Lab exchange of samples as an alternative to EQA when it is not feasible for a lab to undertake the EQA or Proficiency Test program.

The Chief Guest for the conclave, Sh. SV Ranganath, Chief Secretary, Govt. of Karnataka, spoke about the quality journey and his personal experience of working with the NABH leadership team for the accreditation of govt. hospitals and assured support to NABL for the accreditation of govt. labs. Of the challenges faced by him, he found resistance to change to be the biggest. Towards the end of his talk, he put forward 5 propositions, i.e.

1. Accreditation is a journey, not the destination.
2. Accreditation will improve the quality of Indian hospitals.
3. While accreditation is a wonderful tool to ensure quality, it does not guarantee outcomes.
4. Equal focus should be given to the accreditation of blood banks, taluk-level hospitals, diagnostic centres, dental facilities and ayurvedic clinics.
5. Focus should also be given to teaching hospitals as they produce doctors of tomorrow.

Dr. Thuppil Venkatesh, Professor Emeritus, St. John’s Medical College and Principal Advisor to Quality Council of India gave a talk on Ethics in laboratory medicine and proposed ten commandments for labs. 

He stressed on the fact that healthcare providers have responsibility towards the patients who put blind trust in them and spoke for the need for the audit of ethical system of the labs. Of course this is out of the scope of an accreditation body like NABL, but ethics and business virtues are equally important to ensure quality service.