Diagnostics sector plays a crucial role in the health and wellbeing of the nation. The results produced by these medical testing laboratories provide valuable information for diagnosis in health issues and further indicate the steps to be taken to improve health, writes N Venkateswaran, CEO, National Accreditation Board for Testing and Calibration Laboratories (NABL).

NABL accreditation is increasingly being used by regulators and the government to ascertain the quality of products. Accredited Conformity Assessment Bodies (CABs) can objectively state conformance of product or service to specified requirements.

NABL provides accreditation services to Testing and Calibration Laboratories (based on ISO/ IEC 17025:2017), Medical Testing Laboratories (based on ISO 15189), Proficiency Testing Providers–PTP (based on ISO/ IEC 17043), and Reference Material Producers–RMP (based on ISO 17034). NABL complies to ISO/ IEC 17011 “Conformity Assessment – Requirements for Accreditation Bodies (AB) accrediting Conformity Assessment Bodies”. NABL is a full member and a signatory (since 2000) to International Laboratory Accreditation Cooperation (ILAC) as well as Asia Pacific Accreditation Cooperation (APAC) Mutual Recognition Arrangements (MRA), which is based on peer evaluation.

The International Standard ‘ISO 15189: Medical Laboratories – Requirements for quality and competence’ ensures that the laboratories accredited are competent and produce quality results comparable to any other International laboratory.

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Currently, more than 1800 laboratories are accredited by NABL in accordance with ISO 15189. These laboratories are capable of testing in the disciplines such as Clinical Biochemistry, Clinical Pathology, Haematology, Microbiology, and Infectious disease serology, Histopathology, Cytopathology, Flow Cytometry, Cytogenetics, and Molecular Testing.

The COVID-19 pandemic emphasised the important role of medical testing on human health and safety. Further, it has underlined the importance of laboratory accreditation to enable trust in the test results generated.

NABL accredited medical testing laboratories were identified which were capable of detecting the RNA viruses using the RT PCR technique. Further, to increase the testing capability of the nation, ICMR mandated NABL accreditation as the preliminary criteria for laboratories to be listed for detecting the SARS-CoV-2 virus. Many medical laboratories had pooled in their resources and improved their capability to provide medical testing services during this crisis.

NABL took measures to ensure that the requests from all medical laboratories for accreditation could be handled quickly despite the lockdown. Currently, NABL has accredited around 1125 laboratories (1109 Private & 16 government) laboratories that are capable of testing RNA Viruses using RT PCR techniques. Accreditation of these laboratories ensured the availability of competent medical testing laboratories providing quality results in all parts of the nation.

In order to benefit small laboratories and encourage them to come forward for accreditation, NABL has introduced two new categories of micro and mini laboratories in addition to the existing categories of small, medium, and large. These measures are intended to benefit laboratories eager to prove their competence which increases their brand value.

Further, to simplify the concept of accreditation and help laboratories understand the basic requirements of NABL accreditation, the NABL Medical (Entry Level) Labs Testing program was launched {NABL M(EL) T Labs} in line with the National Health Mission (NHM). The program is based on successful participation in proficiency testing and NABL requirements. This is a part of our constant endeavour to bring the benefits of accreditation to all the citizens and achieving the goals of universal access to equitable, affordable, and quality healthcare services that are accountable and responsible to people’s needs.

NABL accredited testing laboratories have also come forward in supporting the medical sector through testing products such as masks, sanitizers, PPE in ensuring that these products meet the laid down requirements. Further, NABL accredited calibration laboratories help in providing the necessary metrological traceability to the measurements of medical devices and equipment such as ECG, ventilators, etc. NABL accredited proficiency testing providers ensure the important aspect of quality assurance through PT schemes to both accredited laboratories and laboratories aspiring for accreditation.

As the awareness of quality and accreditation improves, the diagnostic sector is poised to reach new heights benefitting the common man through the best of services and assured quality in test results through accreditation. The pandemic although alarming had changed the priority of the diagnostic sector from quantity to quality service, which is poised to create greener pastures benefitting the nation as a whole.

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