LABORATORY ACCREDITATION - NEED OF THE HOUR Dr. Punam Bajaj Accreditation Officer-III NABL

IMPORTANCE OF MEDICAL LABORATORY Medical laboratories are critical part of healthcare system. A patient’s diagnosis and treatment are often based on test results and incorrect test results could lead to misdiagnosis which could have potentially fatal consequences. This is why accurate test results are critical - each and every time the tests are conducted.

INTERNATIONAL STANDARD ISO Ensures accurate, reliable and timely release of the test results

INTERNATIONAL STANDARD ISO Name of this standard is “Medical Laboratories- Requirements for quality and competence” Formal recognition by authoritative body is accreditation

NABL National Accreditation Board for Testing & Calibration Laboratories Autonomous Body under DST

HISTORY OF ACCREDITATION NCTCF Program started in 1981 in DST (175 labs accredited under the scheme). NABL was established with the objective to provide Government and Industry with a scheme for third- party assessment of testing, calibration & medical laboratories. Registered as an Autonomous Body under the Societies Act in 1998.

NABL is signatory to Asia Pacific Laboratory Accreditation Co- operation (APLAC) and International Laboratory Accreditation Co-operation (ILAC) MRA since First evaluated by APLAC in 2000 (for testing and calibration) Second evaluation by APLAC in 2004 (for testing & calibration) Third evaluation by APLAC in 2008 (for testing, calibration and medical), MRA valid for four years Fourth evaluation by APLAC in 2012 (for testing, calibration and medical)

ILAC EA IAAC SADCA APLAC ILAC International Laboratory Accreditation Cooperation APLAC Asia Pacific Laboratory Accreditation Cooperation EA European co-operation for Accreditation IAAC Inter-American Accreditation Cooperation SADCA Southern African Development Cooperation for Accreditation AFRAC African Accreditation Cooperation ARAC Arab Accreditation Council ARAC AFRAC

NABL NABL adopted this 2003 edition of ISO standard in year In year 2009, 2007 replaced and cancelled the earlier edition The current edition is 2012 Transition of all the Medical labs to 2012 edition completed by NABL in February, 2016

Medical Laboratories  Clinical Biochemistry  Clinical Pathology  Haematology and Immunohaematology  Microbiological & Serology  Histopathology  Cytopathology  Genetics  Nuclear Medicine (In-vitro Test Only) ACCREDITATION DISCIPLINES OF NABL

BENEFITS TO THE CUSTOMERS/USERS Increased confidence in reports Rights of patients are respected and protected Savings in terms of time and money as it reduces or eliminates the need of re-testing. International Recognition Benchmark with best laboratories It raises community confidence in the services provided by the laboratory. Finally, Accreditation provides an objective system of empanelment by insurance and other third parties. It encourages medical tourism.

SCENARIO OF DIAGNOSTIC LABORATORIES IN INDIA The exact number of laboratories, which exist in the country is not known as there is no mandatory procedure for registration. It is estimated there are a total of 50, pathology and diagnostic labs in India. Out of these 80% are supposedly small, 18% are medium and only 2% are large sized.

PRESENT STATUS: ACCREDITED LABS LESS THAN 1% OF TOTAL

CGHS EMPANELMENT In year 2009, mandatory NABL accreditation for CGHS empanelment gave a push which caused increased influx of application for accreditation & 225 applications were received

CGHS EMPANELMENT Of these 225 applications, 80% got closed as the laboratories could not meet the requirements. This can be due to lack of awareness among laboratories and users or here are major gaps in majority of laboratories

NATIONAL AIDS CONTROL ORGANIZATION(NACO) NACO initiated quality implementation in its HIV testing laboratories.

YEAR WISE STATUS OF NUMBER OF ACCREDITED LABS

SCENARIO IN DEVELOPED COUNTRIES Most of the developed world has a law making registration compulsory. Accreditation is mandatory.

WAY FORWARD Accreditation scheme in India is voluntary Unless appropriate wise steps are taken to encourage the laboratories for adopting quality practices, it will take centuries to fill the gaps

AWARENESS PROGRAMS To sensitize laboratories and physicians, NABL is holding awareness programs all over India NABL did programs jointly with FICCI, CMAI.

PREPAREDNESS OF NABL Training assessors-earlier 350 assessors 5 programs organized by NABL for Medical assessors in last one year, making the total number to 461 assessors Launched accreditation programs for PT Providers and RM Producers Presently, 3 medical PTP accredited, 1 application in pipeline

CLINICAL ESTABLISHMENT ACT The act has been implemented in many states of country. The exact total number of the diagnostic laboratories will be evident as registration is mandatory.

Long way to go…………………………

NABL ADDRESS Registered Office Department of Science & Technology Technology Bhavan New Mehrauli Road, New Delhi – NABL Secretariat (Contact Address) Plot No. 45, Sector 44, Gurgaon , Haryana Tel. no.: (30 lines) Fax: Website:

THANK YOU