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NABL launches quality assurance scheme for basic composite medical laboratories

NABL has launched a new quality assurance scheme for sensitising small laboratories to basic doable quality practices. The scheme will help to bring quality at the grass root level of India’s health system where laboratories follow the imperatives of quality in all their processes.

Mar 7, 2019 18:40 IST
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The National Accreditation Board for Testing and Calibration Laboratories launched a voluntary scheme called Quality Assurance Scheme (QAS) for basic composite medical laboratories in February 2019 for sensitising small laboratories to basic doable quality practices.

The scheme is expected to bring transformational change in more than 5000 laboratories over the next 5 years and to transform them into labs providing quality service. To familiarise and encourage more and more small labs, even in the remotest part of the country, to avail the scheme, NABL would be organising awareness programs in various cities of India.

Eligibility Criteria

The laboratories performing only basic routine tests like blood glucose, blood counts, rapid tests for common infections, liver and kidney function tests and routine tests of urine are eligible to apply under the scheme.

Key Highlights

The scheme requires minimal documentation and a nominal fee has been prescribed for availing the scheme. The components of competence assessment have been added for assuring quality and validity of test results.

The scheme will help to bring quality at the grass root level of India’s health system where laboratories follow the imperatives of quality in all their processes.

This will, in turn, inculcate the habit of quality and facilitate the laboratories to achieve benchmark accreditation of ISO 15189 over a period of time.

The laboratories may upgrade to accreditation as per ISO 15189 at any point of time. The successful laboratories will be issued a certificate of compliance to the scheme by NABL and they will be allowed to use a distinct symbol on the test reports as a mark of endorsement to the basic standard for a defined time frame before which they will have to transition to full accreditation as per ISO 15189.

Significance

Through this scheme, patients availing services of small labs in primary health centers, community health centers, doctor’s clinic, standalone small labs, labs in small nursing homes will also have access to quality lab results.

This scheme will also give a much-needed support to Ayushmaan Bharat Yojana of the union government.

Under the Yojana, the government plans to set up 1, 50,000 wellness centers that will cover over 10 crore poor and vulnerable families.

This entry level scheme of NABL will enhance the intent of Ayushmaan Bharat Yojana of universal access to quality healthcare for the majority of citizens especially those residing in villages and small towns by providing them access to quality diagnostics.

Background

The Union Government is encouraging the state governments to adopt this entry-level scheme for registering labs as establishments under the Clinical Establishment Act.

So far, the Act has been implemented in 11 states and all Union Territories. This will help organise the sector of diagnostics in these states.

Accurate, reliable pathology laboratory results are critical aids which enable doctors to provide evidence-based patient care and treatment.

About NABL

  • The National Accreditation Board for Testing and Calibration Laboratories is a constituent board of Quality Council of India under the Union Ministry of Commerce and Industry.
  • The NABL is mutual recognition arrangement signatory to International bodies such as International Laboratory Accreditation Co-operation (ILAC) and Asia Pacific Accreditation Co-operation (APAC) for accreditation of testing including medical and calibration laboratories.
  • NABL is also having APAC Mutual Recognition Arrangement (MRA) for Proficiency Testing Provider (PTP) & Reference Materials Producers (RMP).
  • The MRA are based on evaluation by peer accreditation bodies and facilitates acceptance of test and calibration results between countries which MRA partners represent.
  • Thus NABL accredited laboratory results are accepted across more than 80 economies around the world.

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