In this and few coming posts I have
decided to review few questions from last few years’ final exam papers. Today's
topic is lab accreditation in India.
Laboratories are integral part of a health care system, they
play crucial role in diagnosis, treatment, monitoring, prognosis of the disease
process, and clinical research. That is
why accurate test results are critical each and every time the tests are
conducted, and they should be accurate, reliable and reproducible. This can be only achieved if good laboratory
practices are observed. This is when accreditation comes in play.
Scenario in India: The exact number of laboratories, which exist in the country,
is not known. Rough estimates show
that there are some one lakh medical diagnostic laboratories in the country. NABL has accredited around 450 medical
laboratories (0.45%), with the rest (99.55%) having only registered themselves
with the respective state health departments.
Accreditation Definition: The concept of laboratory accreditation was developed to provide third-party certification that a laboratory is competent to perform the specific test or type of tests. It is the formal recognition, authorization and
registration of a laboratory that has demonstrated its capability, competence
and credibility to carry out the tasks it is claiming to be able to do. It
provides feedback to laboratories as to whether they are performing their work
in accordance with international criteria for technical competence.
NABL: NABL was established with the objective to provide
a scheme for third-party assessment of testing, & calibration labs later on
extended its services to the clinical laboratories in our country. The Program
started in 1981and is registered as an autonomous body under the Societies Act
in 1998 signatory to APLAC/ILAC. The international standard currently followed
by NABL specific for medical laboratories is ISO 15189 and NABL 112 specific
guidelines.
As per ISO 15189, 2007 international standard has five clauses
which include 1. Scope2. Normative references, 3.Terms and definations4. Management
requirements and technical requirements, it has three appendices and one of
which is ethics.
NABL 112 recommends
guidelines that are complied with and over above ISO 15189 and recommend to
define local Indian and state regulations ex. Notifiable disease, bio waste
management, classification of labs , retention times for specimens, and regulatory signatures.
NABL gives accreditation for certified scope only, reaccreditation
needs to be done in 2 years and unauthorized use can lead to suspension of the accreditation.
Benefits
of Lab accreditation:
1. Independent
certification of lab competence
2. Improves
lab performance
3. Increases
client confidence
4. Makes
the lab conscious of quality
5. Increase
laboratory competitiveness.
6. Build
staff morale
7. Improves
lab prospects.
Presently, NABL accreditation is voluntary. Ministry of
Health has mandated NABL accreditation for all medical laboratories empanelled
by CGHS and the laboratories under Centre and State Govt. hospitals. Clinical establishment act has been
implemented in many states of country that will make the exact total number of
the diagnostic laboratories evident as registration is mandatory and will lead
to shift of the labs from unorganized to organized sector.
References:
1.
Ramesh Adige, Indian health sector needs accreditation for medical
laboratories,
2.
Indian Journal of Clinical Biochemistry, 2005, 20 (2) 186-188, A.S
.Kanagasabapathy and Pragna Rao,laboratory accreditation - procedural
guidelines
Further Reading:
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