Detailed Mechanism Funding and Narrative

Years of mechanism: 2011 2012 2013 2014 2015 2016 2017

Details for Mechanism ID: 13335
Country/Region: Caribbean Region
Year: 2012
Main Partner: African Field Epidemiology Network
Main Partner Program: NA
Organizational Type: NGO
Funding Agency: HHS/CDC
Total Funding: $730,000

The purpose of this mechanism is to assist countries within the region in the implementation of the ISO 15189 Quality Management System (QMS) and accreditation of their laboratories. Previous Caribbean-led regional laboratory strategies have trained over 1,000 laboratory personnel within the region on the ISO 15189 QMS but due to extensive requirements and the involved process for obtaining laboratory accreditation, the training alone did not lead to accreditation of laboratories in the region. Recognizing the challenges of past accreditation efforts, the CDC Caribbean Regional Office, in collaboration with the African Field Epidemiology Network (AFENET), will provide financial and technical support to laboratories to achieve accreditation using the user friendly PAHO-CDC Stepwise process for Quality Management Systems Implementation and Laboratory Accreditation. This activity will target the National Reference Laboratories of all the 12 countries within the PEPFAR Caribbean Partnership Framework. This mechanism is in direct support of the USG Caribbean Partnership Framework Laboratory Systems Goal 3, Objective 3.2: Improve laboratory systems and services, Sub-Objective 3.2.2: Accreditation. Through this mechanism, national and regional capacity for quality management systems and monitoring of laboratory quality through accreditation will be improved. Such an inbuilt system with a participatory approach will ensure both short and long-term ownership and sustainability of laboratory quality management systems within the entire Caribbean region. The CDC Caribbean Regional Office will work in close collaboration with the government of these countries to ensure compliance and monitoring during the entire accreditation process, including quarterly reports outlining progress

Funding for Laboratory Infrastructure (HLAB): $730,000

AFENET in collaboration with the CDC Caribbean Regional Office will use the step wise scheme proposed by PAHO and CDC to work with the National Reference Laboratories of the twelve countries to outline opportunities to enhance current practices, identify gaps and barriers to the achievement of Good Clinical Laboratory Practices (GCLP) and provide mentorship towards accreditation of these laboratories. AFENET will organize work sessions with in-country government officials, laboratory personnel, and management and quality officers to introduce the stepwise scheme. AFENET will carry out the following activities: conduct gap analysis, collect and document all relevant information within the laboratory QMS, identify and document non-conformances, and classify laboratories according to the stepwise checklist. Furthermore, AFENET will participate in the resolution of non-conformances, assist in establishing laboratory documents including laboratory policy manuals, SOPs, and procedures, fully implement the ISO 15189:2003 QMS, and define steps and actions to move laboratories to WHO-AFRO accreditation scheme step five. This activity will continue for a period of three years. AFENET will work with National Reference Laboratories of the twelve countries under the current USG Partnership Framework to register and participate in EQA proficiency testing (PT) for HIV serology, CD4, hematology, chemical pathology, and TB diagnosis. In addition, the Barbados Reference Laboratory and laboratories in Jamaica, Bahamas, Trinidad and Tobago and Suriname with molecular testing capacity will be registered to participate in PT for viral load and DNA PCR. AFENET will work with the all the laboratories to implement the Dried Tube Specimen PT activity for HIV rapid testing. Specifically, AFENET will organize training workshops on quality assurance for HIV testing for the Dried Tube Specimen (DTS) technology for EQA in serology, printing and dissemination of standardized logbooks for use at all HIV testing sites. In summary, the AFENET will support the distribution of PT panels, collection of results, and supervisory activities.