Implementing laboratory quality management in Africa and central Asia: a model for healthcare improvement.

BACKGROUND: Optimized laboratory services are recognized as an integral part of high-quality healthcare delivery. However, these services are often unavailable or substandard in resource-limited countries. The implementation of quality management systems (QMSs) in the laboratory can transform laboratory services and ultimately improve patient care in these settings. METHODS: The Clinical and Laboratory Standards Institute, through its Global Health Partnerships (GHP) program, has intervened in 32 laboratories to implement QMSs and improve performance. Standardized checklists were used before and after the structured intervention to quantify the impact of this program. RESULTS: QMS implementation resulted in a statistically significant improvement in overall mean checklist scores. All participating laboratories demonstrated improvement in their quality and performance, with 13 laboratories achieving national accreditation within the time frame of this study. CONCLUSION: A structured program that utilizes well-recognized, standardized checklists and has leadership and laboratory team support, professional training with onsite guidance (i.e. train the trainer) and access to professionals experienced with QMS implementation and maintenance can lead to significant improvements in quality in resource-limited countries.

The role of standards and training in preparing for accreditation.

Laboratory test results are the cornerstone for patient diagnosis and treatment, and the principles of high-quality laboratory testing are the same anywhere in the world. It is one area of health care that can and should be standardized. Resource-limited countries' laboratories lack equipment, proper funding, adequate training for laboratory workers, and systematic management of work, making it difficult to deliver accurate and reliable results. Quality management tools are being used to improve practices, with accreditation being a means to demonstrate that standards are being met. The World Health Organization (WHO), the US Centers for Disease Control and Prevention, and the Clinical and Laboratory Standards Institute have assumed responsibility for leading a harmonized approach to the provision of education and training in laboratories by publishing a training tool kit. The WHO Regional Office for Africa is leading a new stepwise approach to accreditation.

The World Health Organization African region laboratory accreditation process: improving the quality of laboratory systems in the African region.

Few developing countries have established laboratory quality standards that are affordable and easy to implement and monitor. To address this challenge, the World Health Organization Regional Office for Africa (WHO AFRO) established a stepwise approach, using a 0- to 5-star scale, to the recognition of evolving fulfillment of the ISO 15189 standard rather than pass-fail grading. Laboratories that fail to achieve an assessment score of at least 55% will not be awarded a star ranking. Laboratories that achieve 95% or more will receive a 5-star rating. This stepwise approach acknowledges to laboratories where they stand, supports them with a series of evaluations to use to demonstrate improvement, and recognizes and rewards their progress. WHO AFRO's accreditation process is not intended to replace established ISO 15189 accreditation schemes, but rather to provide an interim pathway to the realization of international laboratory standards. Laboratories that demonstrate outstanding performance in the WHO-AFRO process will be strongly encouraged to enroll in an established ISO 15189 accreditation scheme. We believe that the WHO-AFRO approach for laboratory accreditation is affordable, sustainable, effective, and scalable.