Lok Sabha Question No. 5201 (UNSTARRED), answered on 2025-04-02
Subject: Standardization of Laboratory Procedures
Ministry: CONSUMER AFFAIRS, FOOD AND PUBLIC DISTRIBUTION
Asked by: Dr. Amar Singh

## Government of India

## Ministry of Consumer Affairs, Food and Public Distribution

## Department of Consumer Affairs

## LOK SABHA UNSTARRED QUESTION NO. 5201 TO BE ANSWERED ON 02.04.2025

## STANDARDIZATION OF LABORATORY PROCEDURES

5201.  DR. AMAR SINGH:

## Will the Minister of CONSUMER AFFAIRS, FOOD AND PUBLIC DISTRIBUTION be pleased to state:

- (a) whether  standardization  of  laboratory  procedures  and  maintenance  of  accurate  reference  ranges  is crucial to ensure consistent and comparable results across different laboratories;
- (b) if so, the details of the steps proposed to be taken by the Government keeping in mind that clinicians desperately need accurate results that are uniformly comparable between different laboratories; and
- (c) if not, the reasons therefor?

## ANSWER

## THE MINISTER OF STATE CONSUMER AFFAIRS, FOOD AND PUBLIC DISTRIBUTION (SHRI B.L.VERMA)

(a) to (c) : Standardization of laboratory procedures and maintenance of accurate reference ranges are crucial for  consistent  and  comparable  results  across  different  laboratories.  It  ensures  that  results  produced  by  a laboratory are consistent, reproducible, and comparable with other standardized laboratories with minimum or no  variability.  Reference  ranges  are  crucial  to  be  defined  with  their  basis  recorded  to  serve  the  users  and population  served  by  the  laboratories.  The  Government  emphasizes  consistency  in  test  results  for  accurate diagnosis and treatment, increasing confidence and satisfaction among stakeholders.

To ensure  consistent  results  that  can  help  clinicians  access  accurate  results  that  are  uniformly  comparable between  different  laboratories,  the  government  encourages  laboratories  to  obtain  accreditation  from  the National Accreditation Board for Testing and Calibration Laboratories, which is a constituent Board of the Quality Council of India (QCI) and is the national accreditation body of India w.r.t. conformity assessment bodies  offering  testing  (including  medical/diagnostic  testing),  calibration,  proficiency  testing  providers  and reference material producers. NABL has been providing accreditation services to laboratories in accordance with international standards (ISO/IEC 17011), accepted uniformly for laboratories across the world, such as:

- i. ISO/IEC 17025:2017 'General requirements for the competence of testing and calibration laboratories'
- ii. ISO 15189:2022 'Medical Laboratories- Requirements for quality and competence'
- iii. ISO/IEC 17043:2023 'Conformity assessment - General requirements for the competence of proficiency testing providers'
- iv. ISO 17034:2016 'General requirements for the competence of reference material producers'
- v. ISO 20387:2018 for 'Biotechnology-Biobanking-General requirements for Biobanking'

NABL accreditation ensures the following:

- i. that  all  the  components  of  laboratories-  facilities,  testing  environment  conditions,  resources  including personnel, equipment, Reagents and consumables, external services, examination methods, Internal quality checks,  external  quality  assurance  participation  and  management  system  requirements  fulfil  to  the requirements of standard. It ensures that reference ranges are defined with their basis recorded to serve the users and population served by the laboratories.
- ii. periodic assessments, surveillance and continuous monitoring to assess the fulfilment of the requirements of the standard in the laboratories.
- iii. third  party  assessment  wherein  competency,  impartiality  and  consistent  operation  of  the  laboratory  is assessed for specific test(s) performed
- iv. validity of test results by means of participation in  Proficiency Testing, Inter-laboratory comparison or Intra-laboratory comparisons
- v. quality  management  system  in  place  in  accordance  with  the  requirement  as  laid  down  in  relevant International standard i.e. ISO/IEC 17025 or ISO 15189

NABL accreditation  is  already  leveraged  as  a  requirement  for  empaneling  laboratories  for  regulatory  or various government health services as a benchmark of quality and competence.

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