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.