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A retrospective study of quality management system at national reference laboratory in Mumbai - Highlighting quality in HIV testing

Swati Yardi, Mehul Rajpurkar, Aruna Shankarkumar.

Background: National reference laboratory (NRL) is a NABL certified center of HIV testing at National Institute of Immunohaematology. It has 2 union territories and 8 medical colleges as state reference laboratories (SRL’s) with integrated counseling and testing centers (ICTC’s) and blood banks (BB). It performs activities such as external quality assurance scheme, retesting of samples, and training programs.

Objective: A retrospective study was carried out from 2012 to 2016 highlighting NRL’s unceasing efforts in maintaining stringency in the quality management system.

Materials and Methods: Verification and calibration of pipettes, evaluation of hands-on expertise of technicians for Combaids assay and ELISA testing were assessed. Retesting of samples as part of the quality check was performed. Panel proficiency testing of all the centers was done twice annually.

Results: In 2013 and 2016 (81% and 36% pipettes) passed calibration, respectively. Evaluation of Combaids assay was done on the scale of excellent, medium, and poor. In ELISA testing, 53% followed standard operating procedure, 42% followed good laboratory practice, and 5% showed reproducibility in results. Evaluation of BB technicians was done using the borderline reactive sample in January 13, September 13, and January 14 showed correct results by 5%, 0%, and 11%, respectively, while 78% ICTC technicians gave correct results in Combaids assay. Proficiency testing showed few discordant results every year with need for calibration and technical assessment of personnel while total retesting samples tested from year 2012 to 2016 were 419.

Conclusion: NRL emphasizes on the preparation of borderline sample as in-house quality control sample, calibration of equipments, training regarding same for assuring reliability of test results.

Key words: Borderline Sample; Calibration; Good Laboratory Practices; Standard Operating Procedure; External Quality Assurance; State Reference Laboratorie; National Reference Laboratory

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