Implementation of a quality systems approach for laboratory practice in resource-constrained countries

Abstract

Under the direction of the US Global AIDS Coordinator's Office, Department of Health and Human Services, the CDC Global AIDS programme helps resource-constrained countries to address the global HIV/AIDS pandemic. Activities include laboratory capacity and laboratory infrastructure development in 25 resource-constrained countries. Medical practitioners and public health programme leaders in industrialized countries rely on the use of quality laboratory data for evidence-based medical decision-making to determine policy for the implementation of disease control measures, to monitor disease to determine the impact of control programmes, and to support surveillance activities. In these countries, laboratory data to support decision-making processes have a level of quality attributable to laws, regulations and guidelines developed over many years. However, resource-constrained countries have not had similar experiences. Few countries have developed laws, regulations or guidelines, nor is there a data-use culture (e.g. evidence-based medicine) for those in the decision-making environment in resource-constrained countries. The strengthening of laboratory capability and capacity in resource-constrained countries is an important goal to improve accurate and reliable data for the diagnosis, treatment and monitoring of disease.A process for the implementation of a quality systems approach for a laboratory is presented: (i) acknowledgement of the need to improve the laboratory programme in the country at the Ministry of Health and at all decision-making levels within the provinces/states of the country; (ii) assessment of capabilities, capacities, infrastructure, and training needs; (iii) implementation of a national meeting of laboratorians; (iv) designation of a national Quality Assurance Office and leadership within that office; (v) the development and provision of technical training.

Assessing Proficiency of Interpretation of Rapid Human Immunodeficiency Virus Assays in Nonlaboratory Settings: Ensuring Quality of Testing

“…Consequently, it is important that the rapid HIV assays being used in nonlaboratory settings (e.g., voluntary counseling and testing centers within communities in developing countries) are equal in quality to that expected of laboratories. Inadequate quality assurance and minimal or inappropriate training present limitations to the usefulness and cost effectiveness of nonlaboratory-based rapid diagnostic testing programs (7,17,21).…”

“…The implementation of the essentials of quality management and monitoring outcomes through quality assurance programs will reduce variability and increase the accuracy of interpretation, therefore providing confidence in the testing process (6,7,10,17). Laboratory quality assurance monitors all aspects of the testing process (preanalytic, analytic, and postanalytic) and employs two major methods (5,7).…”

“…Thus, adequate initial and ongoing training needs may be identified through the use of carefully constructed EQA schemes (EQAS) and are an important measure to ensure both proficiency and accuracy (5). The quality assurance of rapid HIV assays (singleuse devices) might best include on-site performance monitoring and the retesting of samples as well as EQAS (17). The initial increased cost of EQAS means that testing programs in developing countries often are not deemed to have sufficient resources to allocate to quality assurance (17).…”

“…The quality assurance of rapid HIV assays (singleuse devices) might best include on-site performance monitoring and the retesting of samples as well as EQAS (17). The initial increased cost of EQAS means that testing programs in developing countries often are not deemed to have sufficient resources to allocate to quality assurance (17). Consequently, there is a need for alternative, less expensive methods that can be used in resource-constrained settings.…”

roles of laboratories and laboratory systems in effective tuberculosis control

“…In this respect, one critical difference in many developed countries is the presence of laboratory regulations or accreditation programmes. 37 Until countries develop, implement and monitor laboratory standards by regulation, a minimum step is to develop an accreditation process for NRLs.…”