NABL Accreditation Need of the hour

Dr. Vandana Jain Director NABL QCI vandana@nabl.qci.org

CAHOCON 2017, New Delhi

Medical Laboratories

• Playing prominent role in diagnosis, management, prevention & treatment of disease.

• 70% of clinical decision making depends on diagnostics.

• Any incorrect test results can lead to misdiagnosis, wrong treatment, fatal consequences or poor patient care.

• Accurate test results have huge impact on outcome of patient & health of people.

Need of Clinicians, Patients, Regulator

Accurate , timely and technically valid results

How to assure that ?

NABL Accreditation

as per ISO 15189:2012

A tool to demonstrate the competence of medical laboratories and ensure the delivery of timely, accurate and reliable results.

A Recognition of Competence

OVERVIEW OF

ACCREDITATION PROCESS

QM

Adequacy

Pre-

assessment Final

assessment

Annual

Surveillance Reassessment

Application for accreditation by the laboratory

Acknowledgement & scrutiny by NABL Secretariat

Unique ID no. MC-

XXXX

Adequacy quality Manual

30 days

30 days

Pre-assessment of the laboratory by Lead assessor

Final assessment of the laboratory by the assessment team

Scrutiny of assessment report by NABL secretariat

Recommendation for accreditation by accreditation committee

Approval for accreditation by Chairman, NABL

Issue of NABL certificate by NABL

60 days

60 days

Certificate no. MC-

XXXX

Accreditation Process

NABL Certificate

Mark of International recognition

Certificate Number MC-0000

Signing authority

Benefits of accreditation

• Global Acceptance of Reports

• Better control of laboratory operations

• Improves staff confidence and enhances business

• Enhanced customer confidence and satisfaction

• Reliability of data for R&D

• Insurance companies can rely on test results

• Ensures better support in the event of legal cases

• Provides traceability in measurements to national standard

• Saving of time & money due to re-testing

• Recognized by regulators

International Recognition

Present scenario

• Estimated 100,000 labs

• About 760 district hospitals each with a lab

• About 460 medical colleges

• Number of private labs ??

87 88

145

194

221

340

425

461

581

679

816

0

100

200

300

400

500

600

700

800

900

March ,2007 March ,2008 March ,2009 March ,2010 March ,2011 March ,2012 March ,2013 March ,2014 March ,2015 March ,2016 March , 2017

Growth of Accredited Medical Laboratories

New Initiatives

• Accreditation of PT providers

• Scheme for accreditation sample collection facilities

• Scheme to accredit public heath laboratories

QUESTIONS

Thank You