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NABL Accreditation Need of the hour
Dr. Vandana Jain Director NABL QCI [email protected]
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