Establishing India's first accredited EQA program in transplant immunology and Immunophenotyping: The CHIMERA® EQA...

Area of Science:

• Clinical Diagnostics
• Laboratory Medicine
• Transplant Immunology

Background:

• External Quality Assessment (EQA) is crucial for laboratory accuracy and international accreditation standards.
• India faces a shortage of accredited EQA providers in transplant immunology and immunophenotyping (IPT).
• A 2019 gap analysis revealed demand for a local, cost-effective EQA program in transplant immunology.

Purpose of the Study:

• To establish India's first accredited EQA program for transplant immunology and IPT.
• To address the critical gap in specialized EQA services for organ transplantation diagnostics.
• To demonstrate the feasibility of implementing an accredited EQA program with limited resources.

Main Methods:

• Established a Quality Management System (QMS) and technical protocols.
• Recruited qualified personnel and formed a specialized committee.
• Achieved ISO/IEC 17043 accreditation and conducted pilot surveys and audits.

Main Results:

• Successfully launched India's first ISO/IEC 17043 accredited EQA program for transplant immunology and IPT.
• The program covers 25 analytes and has conducted 82 proficiency testing (PT) surveys.
• Overcame challenges including sample acquisition, awareness, and digital infrastructure development.

Conclusions:

• An accredited EQA program in transplant immunology is feasible even with resource constraints.
• The program enhances diagnostic quality, regulatory compliance, and international recognition.
• This initiative supports India's growing organ transplant sector by improving laboratory testing reliability.