NABL launches quality assurance scheme for small medical labs

The second such initiative by NABL, the new scheme aims at sensitising small medical laboratories to basic doable quality practices. 

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 will be eligible to apply under this scheme. 

The ministry of health and family welfare (MOHFW) had through a Gazette notification on 18 May 2018, amended the Clinical Establishments (Central Government) Rules, 2012 with a view to encourage small pathology laboratories to follow quality norms.

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 roots 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 familiarise and encourage more and more small labs, even in the remotest part of the country, to avail the scheme, NABL will organise awareness programmes in various cities of India. The scheme is expected to bring transformational change in more than 5,000 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.

This scheme will also give a much needed support to Ayushmaan Bharat Yojana of Government of India. Under this Yojana, the government plans to set up 1,50,000 wellness centers which will cover over 100 million 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 majority of citizens especially those residing in villages and small towns by providing them access to quality diagnostics.

Small laboratories who wish to achieve quality through QAS BC scheme may apply to NABL in application document NABL 155 available on NABL Website www.nabl-india.org, the ministry release added.

NABL has also launched the ‘Recognition of Sample Collection Centers of Medical Testing Laboratories’ last year. The objective is to assess all declared Sample Collection Centers and Facilities (SFCs) of Medical Testing laboratories. This will ensure end-to-end sample integrity leading to reliable test results and help laboratories to gain patient’s trust and satisfaction. The scheme has proved to be a success and about 1,300 SCFs have been recognized by NABL since the launch of this scheme.

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