Overview of the laboratory accreditation programme of the College of American Pathologists

Although Saudi medical laboratories have developed enormously over the past 25 years, the absence of a national body for medical laboratory accreditation has meant the number of accredited laboratories [seven] remains low. Of these, five are accredited by the College of American Pathologists’ Laboratory Accreditation Program [LAP] -the ‘gold standard’ of laboratory accreditation. It requires successful performance in the College of American Pathologists’ proficiency testing programme as well as passing on-site inspections carried out by practising laboratory technicians, after which the laboratory is accredited for a 2-year period. This article gives an insight into the current situation of laboratory accreditation in Saudi Arabia and an updated overview of the process involved in obtaining laboratory accreditation from the College of American Pathologists

Telaah Singkat Kebijakan Akreditasi Bagi Lembaga Uji Kesesuaian Pesawat Sinar-X

Brief Review of Accreditation Policy For X-Ray Compliance Testing Laboratory The Compli¬ance Test Program has been Implemented Since 2011 and The Updated Regulation was in 2018. According to the implementation progress, adjustments are needed to the dynamics of the problems that arise. In 2021, it is planned to prepare a draft amendment to BAPETEN Regulation Number 2 of 2018; therefore, an analysis of the implementation profile of the regulation is carried out to identify existing obstacles. One of the problems identified is the polemic of the urgency of accreditation obligations for the Compliance Testing Laboratory, which is the institution appointed by the Head of BAPETEN to carry out compliance tests and issue compliance certificates. Currently, 78% of laboratories are not accredited, most of which are importing companies. Therefore, it will have implications for reducing laboratory availability and constraining the compliance test process in health facilities. This paper aims to identify aspects that can hinder the application for laboratory accreditation, especially for importing companies, and the proposed solution that can recommend. This paper uses a regulatory impact analysis approach. The study results show that laboratory accreditation is essential to maintain the quality of services, competencies, and outputs of the laboratory so that four options that LUK can take are proposed in dealing with obstacles in applying for accreditation. This paper can provide contributions in preparing the draft amendments to BAPETEN Regulation Number 2 of 2018.

Communication: Implementation of biosafety in infection control: a 10-year review

Biosafety is an important issue globally, as a line of defence that protects health personnel, public and the environment from exposure to hazardous agents. Most developing nations have weak health systems and consequently weak biosafety. Engaging in an external quality program such as an accreditation process will help build capacity and competence in all areas. The Centre for Human Virology and Genomics (CHVG) laboratory of the Nigerian Institute of Medical Research, Lagos, Nigeria started its biosafety program in compliance to international standards stipulated by ISO 15189:2012, in its journey towards laboratory accreditation. Accreditation is widely used to attest for laboratory competence. In the quest for laboratory accreditation, several processes were implemented to ensure compliance, one of which was biosafety. Simple remedial actions and policies that have worked in other climes were applied over a 10-year period in the CHVG laboratory. A significant drop in nonconforming incidences and laboratory accidents was seen while biosafety audits showed improvement in safety practices. Keywords: Biosafety, Infection control, audit French Title: Mise en œuvre de la biosécurité dans la lutte contre les infections: un examen décennal La biosécurité est une question importante à l'échelle mondiale, en tant que ligne de défense qui protège le personnel de santé, le public et l'environnement de l'exposition à des agents dangereux. La plupart des pays en développement ont des systèmes de santé faibles et, par conséquent, une faible sécurité biologique. S'engager dans un programme de qualité externe tel qu'un processus d'accréditation aidera à renforcer les capacités et les compétences dans tous les domaines. Le laboratoire du Centre de virologie humaine et de génomique (CHVG) de l'Institut nigérian de recherche médicale de Lagos, au Nigéria, a commencé son programme de biosécurité conformément aux normes internationales stipulées par ISO 15189: 2012, dans son parcours vers l'accréditation des laboratoires. L'accréditation est largement utilisée pour attester la compétence du laboratoire. Dans la recherche de l'accréditation des laboratoires, plusieurs processus ont été mis en œuvre pour assurer la conformité, dont l'un était la biosécurité. Des mesures correctives simples et des politiques qui ont fonctionné sous d'autres climats ont été appliquées sur une période de 10 ans dans le laboratoire du CHVG. Une baisse significative des incidents non conformes et des accidents de laboratoire a été observée tandis que les audits de biosécurité ont montré une amélioration des pratiques de sécurité. Mots clés: Biosécurité, Contrôle des infections, audit

USGv6 Test Methods:

This document defines the scope of accreditation for the USGv6 Test Program, including test method validation procedures, laboratory accreditation process and roles of the accreditor.

Impact of ISO/IEC 17025 laboratory accreditation in sub-Saharan Africa: a case study

Background The number and severity of nonconformities generated during an audit of a medicine testing laboratory indicates its level of quality compliance. Quality standards are established and maintained to ensure the reliability of laboratory test reports. The National Medicines Regulatory Authority (NMRA) Quality Control laboratories assess the quality of medicines used by the populace as part of their regulatory function. Although countries desire to have reliable medicine testing facilities, accrediting a national laboratory to international standards poses financial and technical challenges for many low-income countries. Sharing the benefits of laboratory accreditation could help more countries within sub-Saharan Africa overcome existing challenges to achieve accreditation and robust quality systems. This study investigated the impact of ISO/IEC 17025 accreditation on the performance of an NMRA Quality Control laboratory to provide evidence of improved quality compliance within a low-resource setting. Methods Pre- and post- accreditation audits of nonconformities for management and technical requirements of the ISO/IEC17025:2005 standards were evaluated from a Quality Control laboratory in the National Agency for Food and Drug Administration and Control (NAFDAC), located in Nigeria, West Africa. The following research questions were addressed: “does accreditation impact the adherence to quality standards?” and “does accreditation decrease the severity of nonconformities in Quality Control laboratory audits?” Results Statistical analysis of the pre- to post- accreditation audits from the years 2013 through 2017 revealed a significant decrease in the total number of nonconformities (χ2 = 74, p-value = 9.99e-05, r = 0.67). Further examination of audits from the years 2013 through 2018 audits also revealed a reduction in the number of nonconformities (χ2 = 53, p-value = 9.99e-05, r = 0.62). A reduction in the number of major observations and a decrease in the severity of nonconformities was also observed. Conclusions A higher level of quality compliance was exhibited for the laboratory during the post-accreditation years. Overall, ISO/IEC 17025 accreditation of the NMRA Quality Control laboratory resulted in improved reliability of test reports and enhancement of the laboratory quality system.