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Last updated: 06 Mar, 2019  

Tablet.9.Thmb.jpg Govt launches quality assurance scheme for small med labs

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SME Times News Bureau | 06 Mar, 2019

For sensitizing small laboratories to basic doable quality practices, NABL has launched another voluntary scheme called Quality Assurance Scheme (QAS) for Basic Composite (BC) Medical Laboratories (Entry Level) in February, 2019.

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

To encourage small pathology laboratories, the base criterion of the scheme is based on the requirements enlisted in Gazette notification dated 18th May, 2018 by Ministry of Health and Family Welfare (MOHFW) to amend Clinical Establishments (Central Government) Rules, 2012.

The scheme requires minimal documentation and a nominal fee has been prescribed for availing the scheme. 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 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.

Successful laboratories will be issued a certificate of compliance to QAS BC 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.

To familiarize and encourage more and more small labs, even in the remotest part of the country, to avail the scheme, NABL will organize awareness programs in various cities of India.

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.

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.

State Governments are being encouraged to adopt this entry level scheme for registering labs as establishments under Clinical Establishment Act. So far, the Act has been implemented in 11 states and all Union Territories. This will help organize the sector of diagnostics in these states.

 
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