The clinical laboratory system, part of the Ghana Health Service (GHS), is responsible for hospital laboratories in ten regional and 170 district hospitals. It is comprised of 406 private, quasi-government and government laboratories. The public health laboratory system in Ghana, also part of GHS, is comprised of one Natrional Public Health Reference Laboratory (NPHRL) and three zonal public health laboratories. A national health insurance bill has been passed into law by the parliament of Ghana which seeks to set up a National Health Insurance System (NHIS), which would enable residents in Ghana to obtain, at least, basic healthcare services without paying money at the point of delivery of the service. NHIS has recently launched a new scheme, making it mandatory for laboratories to obtain accreditation or risk losing the privileges provided by NHIS. Thus, the Ministry of Health (MOH) in Ghana has shown strong commitment towards laboratory accreditation.

The Global Fund is a key donor in the area of laboratory services for screening, treatment, and monitoring HIV/AIDS patients including drug resistance. Though these services exist, the provision of quality laboratory services and the conduct of reliable diagnostic testing are still challenges in Ghana. The quality management systems in the pre-analytical, analytical and post-analytical process for laboratories have not been addressed as a whole. In order to leverage and coordinate donor laboratory efforts, USG support will be targeted to reinforce the basic scale-up assistance coming from the Global Fund and from PMI. USG support will build national capacity for quality management systems, trainings and the monitoring of laboratory quality through accreditation using the tools of EQA and Proficiency Testing (PT).

USG Ghana's Partnership Framework (PF) will support cost-effective, quality laboratory practices to promote reliable and accurate results, thus contributing to effective patient care. This will in turn build a positive attitude by patients towards testing. USG Ghana will work closely with the GOG to support four zonal and 10 regional laboratories in preparation for the accreditation process. This will include evaluating, developing, improving, and maintaining the laboratories' quality management system (managerial and technical) in compliance with CAP and ISO 15189 requirements with the goal of accreditation. This will be a two to three year process.

CLSI will receive funds to support the implementation of quality management systems to ensure that the National Public Health Reference Laboratory (NPHRL) is accredited and will prepare three zonal and 10 regional hospital laboratories for accreditation.

As each laboratory is unique, CLSI will customize Quality System Essentials activities for each of the 14 laboratories. It will proceed methodically in the assessment and implementation of the Quality System Essentials as the primary focal area. Based on the initial gap assessment, laboratories will focus on three to four Quality System Essentials to start with. The work plan will be carried out in phases: (1) gap analysis of the baseline quality management systems; (2) action plan development to fill gaps to strengthen laboratory quality system and operation; (3) implementation of milestones through mentorship/twinning; (4) self-assessment of progress by the laboratory management; (5) quality improvement and on-going assistance based on needs.

CLSI will work closely with the GHS to constitute a task force to review and/or develop standard operating procedures, including safety procedures, and hold consensus workshops on revised standard operating procedures. Funds will also be used to print and disseminate revised standard operating procedures. CLSI will work with the two laboratory managers trained at the African Center for Integrated Laboratory Training as master trainers (per Capacity Building mechanism) to organize a series of training workshops for laboratory managers to improve the quality of laboratory management within the network and provide mentorship.

One of the key pieces of quality management systems is EQA, which includes on-site supervision and proficiency testing programs. CLSI will work closely with the NPHRL to reinforce existing quality assurance/quality control programs and to supervise the decentralization of EQA programs (proficiency testing, on-site supervisions) at the regional level and ensure national coverage.

CLSI will also support the NPHRL to enroll in the digital program for proficiency testing for rapid testing. It will implement a proficiency testing program for HIV at 200 HIV testing sites and organize training workshops on quality assurance for HIV testing for the Dried Tube Specimen technology for EQA in serology, and printing and dissemination of standardized logbooks for use at all HIV testing sites. In collaboration with NPHRL, CLSI will support the implementation of an EQA program for CD4, chemistry and hematology and enroll 20 testing facilities and laboratories in the program. It will support the distribution of proficiency testing panels, collection of results, and supervisory activities.

Lastly, CLSI will train a pool of 20 mentors to provide on-site mentoring for the 14 laboratories engaged in the accreditation process through 2011.