Review and comparison of quality standards, guidelines and regulations for laboratories

Abstract

BackgroundThe variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system.ObjectivesThere is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories.MethodWe reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services.ResultsDifferences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents.ConclusionEach laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.

The Art of Writing and Implementing Standard Operating Procedures (SOPs) for Laboratories in Low-Resource Settings: Review of Guidelines and Best Practices

“…Categories are “clinical” (in context of patient care) and “nonclinical” (laboratory work not related to patient care, clinical research). Document types are categorized according to Datema et al [9]. S2 Appendix gives the scope and content of the documents and their organizations.…”

Comparison of Laboratories Directors' and Assessors’ Opinions on Challenges and Solutions of Standardization in Iran: A Qualitative Study

“…Adopting a stepwise approach to gradually overcome the challenges was also suggested in a study conducted in Africa (Guy-Michel et al, 2010) and such stepwise models have already been implemented successfully in Thailand, Argentina and Kenya ( Wattanasri, Manoroma, & Viriyayudhagorn, 2010 ; Fundación Bioquímica Argentina, 2010 ; Zeh et al, 2010 ). Furthermore, some studies suggested that local circumstances and different levels of quality improvement among the laboratories should be taken into account as they have been mainly caused by differences in laboratories’ resources ( Ahmad, Ahmad Khan, & Atif Ahmad, 2009 ; Wattanasri et al, 2010 ; Safadel et al, 2013 ; Datema et al, 2011 ).…”

“…Nowadays, many national and international quality standards exist for laboratory practices. These standards are lists of requirements that need to be met in order to ensure quality practice ( Datema, Oskam, & Klatser, 2011 ). Many countries have adopted internationally accepted standards such as ISO17025 and/or ISO15189 ( Nkengasong, 2010 ).…”

Laboratory Quality Audit in 25 Anti-Retroviral Therapy Facilities in North West of Nigeria

“…Resource constraints, limited technical knowhow and time factor in terms of available certified auditors for technical assistance, necessitated the design of a modified version of the WHO/AFRO quality assessment checklist to attain minimum acceptable local quality standards [6] [11]. A general qualitative appraisal of the laboratory situations served as guidance on where to place emphases in adapting the WHO-AFRO checklist.…”