Quality assurance scheme for basic composite medical laboratories
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This document discusses NABL's new Quality Assurance Scheme (QAS) for basic composite medical laboratories at the entry level. The scheme aims to recognize quality practices in small laboratories that perform basic testing, as getting full ISO 15189 accreditation is not feasible for most small labs due to costs, infrastructure requirements, and stringent protocols. The QAS criteria are based on requirements in the Clinical Establishments Rules of 2012. Laboratories that comply with the QAS can switch to ISO 15189 accreditation later if desired. Benefits of the QAS include a certificate of compliance and recognition of quality efforts for small laboratories.
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An introduction on Evidence-Based Clinical Practice Guidelines in Health Care Organizations
Brief on Alexandria Center for EBCPGs in Alexandria University Hospitals, Egypt
By Dr. Yasser Sami Abdel Dayem Amer, MBBCh, MS 2013
Special Thanks to
Prof Dr Mahmoud Elzalabany
Prof Dr Tarek Omar
Prof Dr Nabil Dowidar
Prof Dr Afaf GaberLeanlondon mar12 presentation
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Mtr corporate
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Laboratory quality management notes
What is quality?
Importance of a quality management system in the laboratory
Quality system essential elements
The history of development of quality principles
Discuss relationship of this quality model to ISO and CLSI standards
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Quality assurance scheme for basic composite medical laboratories
- 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