Democracy in Quality Recognition

1. Democracy in Quality Recognition
Dr. Jayesh Warade MBBS MD FACB
NABL NABH Assessor
Consultant Biochemistry & Molecular Biology
Sr. Manager Quality
Meenakshi Mission Hospital and Research Center, Madurai

2. NABL Initiative
• Quality Assurance
Scheme for Basic
Composite Medical
Laboratories
• (Entry Level)

3. What is it??
• Similar Entry Level (NABH)
• Recognition of qualty practices by NABL for
small laboratories performing basic lab
testing

4. Introduction
• Estimated Daignoctic
Laboratory = 1,00,000
• 80% Small, 18% Medium,
2 % Large
• Out of this 1,00,000
Labs only 1000 are NABL
accredited i.e. Just 1%

5. Barriers For ISO15189 Accreditations
• Getting ISO 15189
accredidation is not
feasible for small
laboratories
– High Cost
– Manpower
– Infrastructure
– Stringent Protocol

6. Road to Recognition of Quality
• How to bring Quality in
Laboratory at Gross Root Level?
• The simplest way - gradual
sensitization the majority
category
• Performing Basic Quality
Practies
• Encouraged to achieve next set
of quality approaches.
• Finally, majority of them would
aspire to meet requirements of
ISO 15189 in totality.

7. NABL Initiative
• Introducing to the world of quality recognition
certification
• NABL has initiated a voluntary scheme named as
“Quality Assurance Scheme (QAS) for Basic
Composite (BC) Medical Laboratories (Entry Level)”
For Laboratories performing basic testing

8. Clinical Establishments Rules, 2012
• The criterion is based on the requirements enlisted in
“Gazette notification dated 18th May, 2018 by
MOHFW to amend Clinical Establishments (Central
Government) Rules, 2012”.

9. Future Prospectus
• The laboratories can switch to accreditation as
per ISO 15189 at any point of time.

10. Finances
• Application fee of: Rs.
1000/-
• Assessment Charges: Rs.
10000/-
• Annual Memebership Fee:
Rs. 1000/-

11. What You Will Get?
• Certificate of Compliance will be issued to the
laboratories upon approval by NABL

12. How to Claim?
QAS-BC-Entry Level-XX