The National Accreditation Board for Testing and Calibration Laboratories (NABL) has instructed accredited medical testing laboratories to declare all collection centres, facilities or sources through which collections are made to NABL before December 12, 2020.
To download the letter of NABL, click here
The authority took the move realising that there are mismatches within the declarations made by labs to NABL and therefore the actual collection centres/ facilities/ sources of collection, stated on their websites or other documents like annual reports etc.
“Any sample collection not under the responsibility of the lab and not covered under its (quality) management system is noncompliant with the accreditation norms and susceptible to action by NABL. Therefore, all labs are advised to review such arrangements to make sure these are in line with norms for accreditation within the given deadline,” states the letter dated November 12.
Commenting on the letter, Dr A Velumani, director , Thyrocare said, “It may be a right time for NABL to insist that collection centres suits audits and accreditations. Accrediting labs alone might not suffice. it’s also a ground reality that some collection centres choose an area , regional and national brand supported the test that’s out sourced.”
Dr Jayaram Iyengar, director , Neuberg Anand Reference Laboratory, commented, “This requirement has been there with NABL for a few time now. While there’s little question about its purpose, which is to make sure that samples that reach an accredited lab for testing meet all required standards, keeping track of every and each source of sample is simply impossible in practice.
Laboratories receive samples from collection centres that they directly manage also as from other laboratories, hospitals and clinics. Most accredited labs have a process wherein the pre-analytical requirements for sample collection and transportation are made available to their collection centres either within the sort of printed documents or as soft copies.
While accredited laboratories maintain formal records of agreement with collection centres that send samples on a daily basis for testing, it becomes difficult with those centres that don’t do so on a daily basis. Nevertheless, accredited laboratories have a process for verifying integrity of samples supported the defined stability for specified tests.”
He continued, “With regards to declaration of every and each collection site and source on the web site , uploading details of centres under direct control also as details of labs that often refer samples for testing is possible . However, providing information about all sources of samples which may come to an accredited lab now then are going to be a challenge as this is often a dynamic and ever-changing list.”
Velumani further recommended that, “Transparency should be insisted by both the govt and public and there should even be various levels of accreditations for labs.”