Laboratory Accreditation - Need of The Hour: Dr. Punam Bajaj Accreditation Officer-III Nabl

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 15189
Ensures accurate, reliable and timely release of

the test results
INTERNATIONAL STANDARD ISO 15189
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 2000.
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
APLAC
EA
ARAC
AFRAC IAAC
SADCA
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
NABL
NABL adopted this 2003 edition of ISO 15189

standard in year 2006.
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
ACCREDITATION DISCIPLINES OF NABL
Medical Laboratories
 Clinical Biochemistry
 Clinical Pathology
 Haematology and Immunohaematology
 Microbiological & Serology
 Histopathology
 Cytopathology
 Genetics
 Nuclear Medicine (In-vitro Test Only)

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 50,000-100000

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
 Mostof 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 – 110 016
NABL Secretariat (Contact Address)

Plot No. 45, Sector 44, Gurgaon -
122002,
Haryana Tel. no.: 91-124-4679700 (30
lines) Fax: 91-124-4679799
Website: www.nabl-india.org
THANK YOU

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LABORATORY

Dr. Punam Bajaj

A patient’s diagnosis and treatment are often

This is why accurate test results are critical -

Ensures accurate, reliable and timely release of

Name of this standard is “Medical Laboratories-

Formal recognition by authoritative body is

National Accreditation Board for Testing &

Autonomous Body under DST

NABL was established with the objective to provide

Registered as an Autonomous Body under the

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

Fourth evaluation by APLAC in 2012 (for testing, calibration and

ILAC International Laboratory Accreditation Cooperation

NABL adopted this 2003 edition of ISO 15189

In year 2009, 2007 replaced and cancelled the

The current edition is 2012

Transition of all the Medical labs to 2012 edition

 Haematology and Immunohaematology

 Microbiological & Serology

 Nuclear Medicine (In-vitro Test Only)

 Savings in terms of time and money as it

 Benchmark with best laboratories

 It raises community confidence in the services

The exact number of laboratories, which exist in

It is estimated there are a total of 50,000-100000

This can be due to lack of awareness among

NACO initiated quality implementation in its

 Unless appropriate wise steps are taken to

 NABL did programs jointly with FICCI, CMAI.

 Launched accreditation programs for PT

 Presently,3 medical PTP accredited, 1

 The exact total number of the diagnostic

NABL Secretariat (Contact Address)

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