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Laboratory testing involves multistep processes that are susceptible to multiple sources of error. These errors can lead to significant result variability and decreased accuracy, which in turn can potentially lead to incorrect diagnosis and inappropriate treatment. Production of quality data on which clinical decisions are based lies at the very heart of ethical practice enshrined in the ICH guidelines and other international conventions. High quality laboratory results are also required to protect the health and safety of clinical trial participants and to provide reliable clinical data that can be used for evidence-based decision making to improve standard care.
Laboratory accreditation is a widely accepted process of evaluation of a laboratory’s quality, performance, reliability and efficiency. It is a means to promote and enforce better quality in laboratory testing and to ultimately reduce testing errors. Accreditation also increases the credibility of the results and services delivered by a laboratory through providing recognition that it is compliant with quality and competence standards considered necessary for accurate, reliable and safe testing. The value of accreditation lies in promoting the delivery of reliable results for patient management or generation of reliable data for critical public health interventions.
It is common to hear of an accreditation process rather than full accreditation due to the audits and re-audits required to achieve it. The accreditation process has to do with the laboratory's sustained capability to perform quality testing, and calibration/measurement activities. The laboratory assessment process include domains of quality performance such as personnel and organisation, quality management system, equipment and reagents, supplies and sample management, records and systems management, etc. The standards used as the guiding framework for the accreditation process are internationally accepted and harmonised. They include good clinical laboratory practice (GCLP) in the case of clinical research laboratories and ISO15189 for medical testing, among others.
Accreditation bodies are organisations authorized to assess laboratories and certify their performance against the quality standards. The list of international accreditation bodies include the College of American Pathologists (CAP), the International Standardisation Organisation (ISO), the South African National Accreditation Scheme (SANAS), the Joint Commission International (JCI), the United Kingdom Accreditation Services (UKAS), the Clinical Pathology Accreditation (CPA) and the National Association of Testing Authorities (NATA). Regional initiatives also exist, such as the East African Public Health Laboratory Networking Project and other initiatives widely promoted by the Centres for Disease Control and Prevention in collaboration with the recently created African Society for Laboratory Medicine.
The accreditation process is beneficial for individual laboratories since it allows them to identify areas that require attention and focus their improvement efforts. It also provides incentives to constantly achieve the performance levels required to maintain their accredited status and a means to justify the resources they need to maintain quality.
However, the accreditation process is expensive and it might not be affordable for small and medium research and clinical laboratories in resource-limited settings. Moreover, it is not necessary for a laboratory to be accredited to achieve a high level of consistency, accuracy and reliability in the reported test results, i.e. laboratory quality. To accomplish this, it is essential that all processes and procedures in the laboratory are performed properly through implementing a comprehensive quality management system. A laboratory quality management system addresses all aspects of the laboratory operation and establishes a set of coordinated policies, processes and procedures to direct and control a laboratory to assure quality and compliance with internationally recognised standards and guidelines (GCLP, ISO15189, etc.).
GCLP specifies best practices in the clinical diagnostic and research laboratories in terms of organization, personnel, equipment, reagents, process control, data management, records, assessments, safety, etc. Some of the critical elements addressed in these guidelines are a clear line of communication in the laboratory, responsibility, logic of pre-analytic, analytic and post-analytic processes, training and re-training, good documentation practices (SOPs), equipment logs and preventive maintenance, staff delegation, record keeping and inventory control, internal quality control, proficiency testing, etc. The WHO provides GCLP guidelines that can be accessed online at http://www.who.int/tdr/publications/documents/gclp-web.pdf.
The WHO/AFRO also promotes an approach to quality improvement towards accreditation called Step-wise Laboratory Improvement Towards Accreditation (SLIPTA) in the African Region, which can be helpful for laboratories with limited resources worldwide. This method proposes that each Clinical Laboratory should improve their systems at a pace which they are comfortable with, using the locally available resources. The lack of accreditation should not stop any laboratory that strictly follows the principles of GCLP to perform a clinical trial and should also not be used as an excuse by any sponsor or pharmaceutical firms for not providing funding.
It is important to bear in mind that accreditation is just an instrument to determine the effectiveness of a laboratory’s quality management system, not a goal in itself. Laboratories need to keep up with quality standards to maintain the level of credibility of their quality management systems and overall dependability.
If you want to learn more about specific aspects of the accreditation process and the essential activities required to implement a laboratory quality management system, have a look at the WHO Laboratory Quality Management System handbook (http://www.who.int/ihr/publications/lqms/en/) and the WHO/AFRO Guide for the Stepwise Laboratory Improvement Process Towards Accreditation (http://www.afro.who.int/en/clusters-a-programmes/hss/blood-safety-laboratories-a-health-technology/blt-highlights/3859-who-guide-for-the-stepwise-laboratory-improvement-process-towards-accreditation-in-the-african-region-with-checklist.html). Alternatively you can download these and other laboratory related WHO guidelines, as well as the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Essentials of Clinical Laboratory Management in Developing Regions in the Global Health Laboratories’ Downloadable Documents area (https://globalhealthlaboratories.tghn.org/categorised_resources/downloadable-documents/).
To get more insight about the accreditation process in resource-limited countries, here is an interesting article about how The Biotechnology Centre at Yaoundé, Cameroon was established as a high quality clinical research laboratory and became recognised by the WHO/TDR for full implementation of good clinical laboratory practices, a vital step towards professional accreditation (https://globalhealthtrials.tghn.org/articles/clinical-research-laboratories-trials-global-health-central-africa/).
This resource was originally posted in Global Health Laboratories.
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Another interesting article that talks about the challenges faced by laboratories conducting clinical research in resource-limited setting is the one published by the Therapeutics Research Program, Division of AIDS (DAIDS) on the Journal of Acquired Immune Deficiency Syndromes (JAIDS).