1. ACTIVITY DESCRIPTION AND EMPHASIS AREAS

Since 2000 when the Government of Kenya declared HIV/AIDS a national emergency, Kenya has scaled up

counseling and testing (CT) services through a mix of service delivery models using provider-initiated

testing and counseling (PITC), community based CT and promotional campaigns. Currently there are more

than 1200 HTC sites in Kenya, approximately 80% of which are integrated into existing health facilities. In

addition to HTCs, there are more than 3,000 sites for the prevention of mother-to-child transmission

(PMTCT), and hospitals and health centers have begun incorporating provider-initiated HIV testing and

counseling as a routine standard of care. Through the combination of all these sites, the country proposes

to conduct about 11,000,000 tests in FY 09.

Owing to the shortage of trained and qualified laboratory technicians and technologists, Kenya strategically

task shifted both counseling and testing to auxiliary health workers and cadres including nurses, clinical

officers, doctors, and professional or lay counselors, after adequate training on performing the tests.

However, as efforts to achieve universal access, particularly using lay counselors-continue, poor quality and

consistency of results have been highlighted, pointing to the need to establish and implement a time-

sensitive external quality assurance (EQAS) program according to established guidelines. Among the

HTCs, PMTCT settings continue to record less than satisfactory performance in regard to quality and

consistency of testing. Possible explanations for this include: inadequate training and on-site supervision

given to the PMTCT facilities by the laboratory team, and the fact that laboratory testing in a non-core duty

of the nurses working in PMTCT settings.

Development and roll out of an EQAS system continues to be a challenge, with most of the provincial and

district laboratories burdened with routine hospital work. This leaves a huge burden on the National HIV

Reference Laboratory. Presently, the national HIV reference laboratory (NHRL) provides retesting of 1/10

samples for the rapid HIV testing sites. This plan, however, has not worked well as it has been impossible to

retest all samples in one laboratory. Since FY08, this activity has been decentralized to the provincial level.

In FY09 PEPFAR will support the development of an integrated QA plan inclusive of a national set of

standards and integrated quality monitoring systems. Part of this new plan is to do proficiency testing in

larger /existing sites. As part of the on-going efforts at improving quality of laboratories services, in FY 09

PEPFAR will also support the process of laboratory accreditation within the NPHLS, starting from the

central level. As the planned activities require a considerable effort partnering with the QA dedicated staff at

the NHRL and regional laboratories, the TBD will coordinate QA training on a national scale to develop and

maintain Quality Assurance (QA) programs for HIV rapid testing in counseling sites and at laboratories

offering monitoring for patients on ARVs to support provision of accurate, reproducible, and traceable

Laboratory results for diagnosis of HIV and for Monitoring of HIV/AIDS patients on ART. The TBD will work

with the USG, partners and country representatives to implement the national strategic plans for laboratory

quality systems and ensure that laboratory testing is available, accurate, reliable and timely. Following

nation wide training, the TBD will focus on two provincial hospitals, one district hospital and 10 VCT sites to

develop comprehensive laboratory Quality management systems. Additionally, the TBD will strengthen the

Ministry of Health Microbiology Reference Laboratory in QA for the diagnosis of opportunistic infection in

HIV/AIDS patients. The TBD will support the national QA plan including national needs for quality testing

and training. The TBD is expected to leverage its expertise to development and use of standard operating

procedures for specimen tracking, testing procedures, results reporting, equipment maintenance and

inventory.

This activity includes major emphasis in the area of local organization capacity development and minor

emphasis in the area of development of laboratory policies and guidelines.

2. CONTRIBUTIONS TO OVERALL PROGRAM AREA

These functions are essential for the implementation and sustenance of all HIV /AIDS prevention strategies

such as Counseling and Testing (HVCT), Prevention of Mother to Child Transmission (MTCT) and ARV

treatment programs.

3. LINKS TO OTHER ACTIVITIES

This activity relates to activities in Counseling and Testing and TB/HIV, PMTCT, HLAB. This activity is

linked to the agreement with the Kenya Medical Research Institute Laboratory Infrastructure , which

supports the development of National Quality Assurance Programs within the National Public Health

Laboratories (NPHLS) for Blood Safety and HIV testing in Surveillance, HVCT, MTCT and monitoring of anti

-retroviral treatment regimens, and all MTCT, Counseling and Testing, and HIV treatment programs.

4. POPULATIONS BEING TARGETED

This activity primarily targets laboratory workers.

5. SECONDARY CROSS-CUTTING BUDGET ATTRIBUTIONS

This activity supports key cross-cutting budget attributions relating to human capacity development through

performance assessment and on-site supervision and training on essential elements of a quality laboratory

system.

New/Continuing Activity: New Activity

Continuing Activity:

Emphasis Areas

Health-related Wraparound Programs

* Malaria (PMI)

* Safe Motherhood

* TB

Human Capacity Development

Estimated amount of funding that is planned for Human Capacity Development

Public Health Evaluation

Food and Nutrition: Policy, Tools, and Service Delivery

Food and Nutrition: Commodities

Economic Strengthening

Education

Water

Table 3.3.16: