TABLE 2.
Area | Status | Remarks | Est. Score |
---|---|---|---|
Top level Leadership engagement | Clear buy-in by all management and leadership levels about the role of POC testing in healthcare | There is a need to provide updates about POC testing; need for sensitisation on regional and international standards and ministerial declarations on POC testing and to seek additional resources. | 80% |
Coordination at national level | Quality assurance office staffed by a national quality assurance officer at CPHL and supported by quality assurance TWG as a sub-committee of LTC | The quality assurance office requires additional staff; Accreditation (1), Basic LQMS (1), EQA (1). | 60% |
Definition of roles and responsibilities | Regional quality committees are in place. Their role is coordination of quality efforts in the districts (7–10) within their catchment areas; there are quality focal points in facilities | The regional quality assurance networks require further strengthening. There is still doubt in many labs as to where responsibility for quality falls. | 60% |
Policy and Strategic plan | A National Health Laboratory Policy, NHL Strategic Plan, NHL M&E plan and Quality master plan exist | There is no specific policy statement on POC testing. There is a need to update the policies and plans to provide specific reference to POC testing. | 40% |
National Laboratory Standards | Minimum standards for laboratories have been set. | The country has not yet set minimum standards that focus on POC testing. There is a need to review manufacturers’ performance and specifications versus performance in the field for each POC test and then set goals and standards. | 30% |
CPHL, Central Public Health Laboratory; EQA, external quality assurance; LTC, National Health Laboratories Technical Committee; LQMS, Laboratory Quality Management System; M&E, monitoring and evaluation; NHL, National Health Laboratory; POC, point-of-care; TWG, technical working group.