Title:Implementation of Class II biological safety cabinet good maintenance practice: protective countermeasures against SARS CoV 2 for ISO 15189:2012 accredited medical laboratories

Author:Dennis Mok, Sharfuddin Chowdhury, Rana Nabulsi, Naria Eloyan, Martina Jürs and María del Rocío González Guerrero

Abstract:Objectives: The aim of this study was to develop a good maintenance practice for the Class II biological safety cabinet that can be implemented by the medical laboratory when accreditation for SARS‑CoV‑2 testing is specified.
Methods: The good maintenance practice was developed by adapting appropriate criteria and requirements from International, national, and regional guidance documents: International Standard ISO 15189:2012, Australian Standard AS 2252.2—2009, China National Standard YY 0569—2011, Japanese Industrial Standard JIS K 3800:2009, American National Standard NSF/ANSI 49‑2018 and European Standard EN 12469:2000 as well as accreditation related documents (n = 76) of the 83/101 (82 %) accreditation bodies in 80/249 (32 %) countries.
Results: A total of 64/1515 (4 %) conformance requirements relating to equipment maintenance were identified in ISO 15189:2012. Clauses 4 and 5 of ISO 15189:2012 contained 8/64 (12.5 %) conformance requirements and 56/64 (87.5 %) conformance requirements, respectively. Comparative analysis of national and regional guidance documents determined that AS 2252.2—2009 contained 8 requirements, YY 0569—2011 contained 8 requirements, JIS K 3800:2009 contained 3 requirements,
NSF/ANSI 49‑2018 contained 10 requirements, and EN 12469:2000 contained 5 requirements. Accreditation related documents from 7/83 (8.4 %) national accreditation bodies in 7/80 (8.8 %) countries were found to contain supplementary criteria with the following results: Australia (AUS) had 2 requirements, Hong Kong (HKG) had 5 requirements, New Zealand (NZL) had 2 requirements, Singapore (SGP) had 3 requirements, Sri Lanka (LKA) had 2 requirements, the United Arab Emirates (ARE) had 2 requirements and Viet Nam (VNM) had 7 requirements. Overall, conformance requirements (n = 64) from ISO 15189:2012 and further testing requirements (n = 15) were found to be suited to good maintenance practice for Class II biological safety cabinets.
Conclusions: The current study strengthens the medical laboratory’s good practice associated with protective countermeasures against SARS‑CoV‑2 during the entire examination process. The findings have provided reasonably practical heightened control measures for the medical laboratory to implement to help ensure a safe laboratory environment.
Key words: compliance, conformity, ISO 15189:2012, laboratory safety, quality management, SARS‑CoV‑2
«Back         Download this article as PDF
✖