Detailed Mechanism Funding and Narrative

Years of mechanism: 2007 2008 2009

Details for Mechanism ID: 5273
Country/Region: Nigeria
Year: 2007
Main Partner: Clinical and Laboratory Standards Institute
Main Partner Program: NA
Organizational Type: NGO
Funding Agency: HHS/CDC
Total Funding: $200,000

Funding for Laboratory Infrastructure (HLAB): $200,000

ACTIVITY DESCRIPTION: The Clinical and Laboratory Standards Institute (CLSI) is a global, nonprofit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. We are recognized worldwide for the application of our unique consensus process. CLSI is based on the principle that consensus is an efficient and cost-effective way to improve patient testing and services. Currently, CLSI is involved in building laboratory capacity in Tanzania, and will become engaged in similar efforts in Namibia and Vietnam in 2007.

The objectives of the PEPFAR program are to: enhance the quality of HIV rapid testing, and other related laboratory testing; establish quality management systems practices; provide capacity building assistance by developing mechanisms to ensure strengthening of national laboratory systems, create new supportive relationships, and establish a system for ongoing scientific and educational updates through sponsored active participation in CLSI. CLSI will collaborate with USG-Nigeria to actively support PEPFAR program activities for strenghtening laboratory infrastructure through completion of process maps, harmonization of standard operating procedures, guides, and job aides to provide a framework that will ensure consistency in testing performance, increase efficiency and cost effectiveness, provide training opportunities as appropriate, and assure a quality foundation in testing and organizational practices to reduce testing-related errors.

CLSI will participate in an initial site visit to gather critical information (e.g., laboratory infrastructure, locally developed standard operating procedures). CLSI will work with the Government of Nigeria, IP's and USG technical experts to harmonize/standardized SOPs for use throughout Nigeria as part of an overall plan for implementing a national quality management system for the laboratory. Activities will be conducted in a coordinated fashion through the USG-Nigeria sponsored Laboratory Working Group to ensure harmonization with other IP and the Nigerian government.

CLSI will also work in close coordination with its coalition partner, ASCP, to prepare designated laboratories (2) for accreditation. Preparation will be facilitated through use of CLSI best practices and other internationally-accepted standards. These labs will serve as models for other clinical laboratories.

There will be indirect benenfits (targets) through CLSI's actitives in Nigeria. The 2 accedited labs will serve as a model for 4 other labs in Nigeria which will adopt appropriate practices which could lead to accreditation in the future.

CONTRIBUTIONS TO OVERALL PROGRAM AREA The successful implementation of PEPFAR goals requires a significant strengthening and expansion of laboratory services. CLSI, working together with the USG team, will enhance laboratory systems in Nigeria by harmonizing laboratory SOP's. CLSI will develop a national approach to quality systems by implementing comprehensive laboratory quality services with the ultimate goal of accrediting 2 laboratories in Nigeria and providing continuing education on the value of accreditation.

LINKS TO OTHER ACTIVITIES Improved quality of HIV diagnostic testing has implications for VCT (HVCT-3.3.09). Strong clinical labs support monitoring and treatment of HIV infected individuals and improves palliative care (HBHC-3.3.06 and HVTB-3.3.07).

POPULATIONS BEING TARGETED CLSI will train laboratorians at two sites in the laboratory accreditaction process. CLSI will collaborate with the Government of Nigeria, IP's and USG technical experts.It will also work with laboratorians based in clinical health labs in the correct use of standerdized laboratory SOP's.

KEY LEGISLATIVE ISSUES ADDRESSED: N/A

EMPHASIS AREAS: The major emphasis of this activity is quality assurance and quality improvement of laboratory testing. There is minor emphasis on infrastructure improvement in preparing demonstration lab for accreditation.