December 12 deadline to submit details; triggered by mismatch in details declared to NABL and those on websites, annual reports etc.
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 have been made to NABL before December 12, 2020.
The authority took the move realising that there are mismatches in the declarations made by labs to NABL and 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 liable to action by NABL. Therefore, all labs are advised to review such arrangements to ensure 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, Managing Director, Thyrocare said, “It is a right time for NABL to insist that collection centres comply with audits and accreditations. Accrediting labs alone may not suffice. It is also a ground reality that some collection centres choose a local, regional and national brand based on the test that is out sourced.”
Dr Jayaram Iyengar, Managing Director, Neuberg Anand Reference Laboratory, commented, “This requirement has been there with NABL for some time now. While there is no doubt about its purpose, which is to ensure that samples that reach an accredited lab for testing meet all required standards, keeping track of each and every source of sample is just not possible in practice. Laboratories receive samples from collection centres that they directly manage as well 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 in the form of printed documents or as soft copies. While accredited laboratories maintain formal records of agreement with collection centres that send samples on a regular basis for testing, it becomes difficult with those centres that do not do so on a regular basis. Nevertheless, accredited laboratories have a process for verifying integrity of samples based on the defined stability for specified tests.”
He continued, “With regards to declaration of each and every collection site and source on the website, uploading details of centres under direct control as well as details of labs that regularly refer samples for testing is feasible. However, providing information about all sources of samples that might come to an accredited lab now and then will be a challenge as this is a dynamic and ever-changing list.”
Velumani further recommended that, “Transparency should be insisted by both the government and public and there should also be various levels of accreditations for labs.”
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