New Delhi: 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, and 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. This scheme will also give a much needed support to Ayushmaan Bharat Yojana of Government of India. Under this Yojana, Government plans to set up 1,50,000 wellness centers which 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 majority of citizens especially those residing in villages and small towns by providing them access to quality diagnostics.
In addition to the existing accreditation scheme for Medical Laboratories as per ISO 15189 standard, 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 1300 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. The Accreditation program for Medical Laboratories is as per International standard ISO 15189. The program covers all disciplines of Medical Testing like Clinical Biochemistry, Clinical Pathology, Haematology & Immunohaematology, Microbiology & Serology, Histopathology, Cytopathology, Genetics and Nuclear Medicine (in-vitro testing only). Approximately 1100 Medical Laboratories have been granted accreditation under this program.
NABL is Mutual Recognition Arrangement (MRA) signatory to International bodies like 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). MRA are based on evaluation by peer Accreditation Bodies and facilitates acceptance of test/ calibration results between countries which MRA partners represent. Thus NABL accredited laboratory results are accepted across more than 80 economies around the world. National Accreditation Board for Testing and Calibration Laboratories (NABL) is a constituent board of Quality Council of India (QCI) under the Ministry of Commerce and Industry, Government of India.