April 2009 Reprogramming:

$3,911,030 reprogramed (from unallocated mechanism id 11334.09) by M&O to reserve funds to be used

for emergency procurement stockout situations. Gap in funding is projected. Funds are to be

reprogrammed to fill gap.

New/Continuing Activity: New Activity

Continuing Activity:

Program Budget Code: 16 - HLAB Laboratory Infrastructure

Total Planned Funding for Program Budget Code: $7,125,000

Total Planned Funding for Program Budget Code: $0

Program Area Narrative:

PROGRAM AREA CONTEXT: LAB

The public health laboratory network in Tanzania consists of six referral hospital laboratories, 23 regional and 133 district

laboratories located in mainland Tanzania. Some large health centers have laboratories. Quick diagnostic procedures that do not

require laboratory personnel are performed at dispensaries The Ministries of Health and Social Welfare (MOHSW) Tanzania

mainland and Zanzibar, working in collaboration with the National AIDS Control Program (NACP) and the Zanzibar AIDS Control

Program (ZACP) respectively oversee laboratory services at referral and national levels while the ministries of Local Government

oversee laboratory services at regional, district and health center levels.The USG funds the MOHSW directly and provides

technical assistance through US-based laboratory and care and treatment implementing (ART) partners. USG partners include:

the American Society for Clinical Pathology (ASCP) which provides assistance with training, the Clinical Laboratory Standards

Institute (CLSI) provides assistance with the implementation of laboratory quality systems, the Association of Public Health

Laboratories (APHL) with management training and implementation of Laboratory Information Systems (LIS) and the American

International Health Alliance (AIHA) provides mentoring opportunities between US-based and Tanzanian institutions and

professionals. The USG also provides direct funding to the African Medical research Foundation (AMREF) to support the training

activities for the MOHSW and Columbia University which assists with implementation of the Early HIV Infant Diagnosis program.

USG activities complement those of other development partners such as the World Health Organization (WHO), AXIOS, The

Abbot Foundation, the Japanese International Cooperation Agency (JICA), Clinton Foundation, the Global Fund and the German

Development Cooperation (GTZ) who provide technical and financial assistance to MOHSW. Several of these development

partners contribute to the Sector Wide Approach (SWAP) Basket Fund. USG is guided by the National Laboratory Operational

Plan in Support of HIV/AIDS care and treatment, the National Laboratory Standard Guidelines and the National Laboratory Quality

Assurance Framework in providing laboratory infrastructure and capacity building support to MOHSW. USG liaises with all the

laboratory stakeholders through a regular laboratory development partners meeting chaired by the MOHSW. With USG support,

MOHSW developed a five year national laboratory strategic plan to guide the laboratory infrastructure and capacity building

activities through FY 2009. This was developed and completed in consultation with the National Tuberculosis and Leprosy

Program and the Malaria Control Program which works closely with the USG Presidential Malaria Initiative Program. The 5 year

strategic plan has incorporated laboratory activities for strengthening identification and quality assurance of opportunistic

infections, malaria and tuberculosis.The National Health Laboratory Quality Assurance and Training Center which houses the

national quality assurance programs and training for the implementation of quality systems was also completed in FY 2008 The

USG has prioritized implementation of the laboratory quality management systems and strengthening the public health laboratory

functions of the National Health Laboratory Quality Assurance and Training Center (NHLQATC). Improving the numbers and skill

levels of laboratory technicians as well as defining staff recognition, motivation and retention mechanisms based on quality

performance will be a key activity in FY 2009 to be achieved in collaboration with the Human Resources for Health program. USG

will strengthen the utilization of laboratory information systems to inform the prevention and care and treatment programs and

collaborate with the National Malaria and Tuberculosis and Leprosy programs in the provision of technical assistance in the

diagnosis and quality assurance for tuberculosis and malaria. Scale up of infant diagnosis, improvement of laboratory supplies

logistics management and equipment maintenance will also be addressed as a priorities in FY 2009. MOHSW in collaboration

with USG ART partners has embraced regionalization of care and treatment services. MOHSW plans to expand ART services to

700 sites from the current 200. To effectively implement this strategy, laboratory policy, guidelines and coordination will be

provided by MOHSW at central level while ART partners will translate these policies and guidelines into practice in the zonal

referral, regional and district laboratories working with facility based personnel and the Regional and District Health teams.

MOHSW has appointed and trained laboratory quality teams at zonal, regional and facility level to support the quality systems

implementation. The care and treatment partners have recruited laboratory staff who will work with the Council and Regional

Health Management teams (CHMTs and RHMTs) and facility based technical personnel. From FY 2006 to FY 2008, MOHSW

trained national trainers in rapid HIV testing, HIV rapid testing supervisors, early infant diagnosis, quality assurance, standard of

care tests, laboratory management, laboratory information systems and equipment management. The ART laboratory focal

personnel will work with the quality officers and the trainers to train and implement laboratory quality management systems at the

facilities in their regions. The ART partners' laboratory focal personnel are members of regional subcommittees on HIV and the

laboratory development partners meeting which meet regularly. At these meetings progress on activities is reported, challenges

identified and solutions agreed upon. These coordination mechanisms have had a great impact on the standardization of program

implementation and will continue to receive USG support through FY2009. In FY 2009 USG will support the National Health

Laboratory Quality Assurance and Training Centre (NHLQATC). The NHLQALTC will provide leadership and serve as a focal

point for HIV/AIDS-related laboratory training, quality systems implementation and will support and promote operational research

into various aspects of HIV including its, treatment, control and prevention and related opportunistic infections. The NHLQALTC

will serve as a referral laboratory for specimens that present unusual or unique testing problems and facilitate referral for

specialized testing not available in the country, such as genetic sub-typing, HIV drug resistance testing, HIV-1 incidence, and

other specialized microbiological assays. The NHLQALTC will build its own capacity and eventually undertake greater public

health laboratory functions such as the surveillance of new and emerging infections. In FY2008, 75 technologists were trained in

CD4, Chemistry and Hematology testing and 4 laboratory technologists in DNA PCR proficiency panel production and quality

assurance principles at the NHLQATC. CD4 external quality assessment (EQA) proficiency testing panels for 81 laboratories

enrolled in the CD4 EQA were distributed from the NHLQATC, the data collected and analyzed. Eighty of these laboratories

performed well. In collaboration with AMREF, MOHSW trained 40 HIV rapid HIV testing supervisors who perform on site

monitoring and administer the proficiency panels. NHLQATC supplied proficiency panels for rapid HIV testing using locally

produced EQA material for 417 facilities which constitute 20% of all rapid testing sites. Rapid HIV proficiency panels complement

the on site monitoring provided by quality assurance officers and rapid testing supervisors. In FY 2009, the NHLQATC will roll

out rapid HIV testing EQA to 60% of the facilities and provide EQA panels for HIV Enzyme Linked Immunosorbent Assay (ELISA)

serological testing. Bugando Medical Center's DNA PCR laboratory enrolled in CDC Atlanta's EQA program and the 7 National

Blood Transfusion service laboratories participating in the MPEP EQA program are doing well. Mbeya Referral Hospital, KCMC

and MNH laboratories all participate in different self motivated EQA programs. In FY09 the NHLQATC will implement a national

EQA scheme, procure and distribute EQA material thereby bringing all the EQA programs under one roof thereby reducing the

individual laboratories expenditure and provide comparability at a national level. Chemistry, hematology and opportunistic

infection EQA will be instituted in FY 2009. Through FY2009 USG will support the accreditation of the NHLQATC and its

transition to a semi autonomous agency which will provide it with greater autonomy and financial sustainability.

Inadequate numbers and skill level of laboratorians poses the largest barrier to provision of quality laboratory services. USG will

continue supporting the in - service training of staff at the NHLQATC and sponsor pre-service training at local and international

institutions of laboratory training, study tours and mentoring activities. As from FY 2009 USG will begin sponsoring 50 laboratory

assistants annually by enrolling them in an 18 month course at the local schools for laboratory training to upgrade them to diploma

level. Laboratory assistants form more than 50% of the technical laboratory works force in Tanzania. The USG will also sponsor

20 selected students for the three year diploma course and 20 technicians who are in service for the two year advanced diploma

course. Ten students will be sponsored for a four year Bachelor of Science degree in Medical Laboratory Sciences. This will lead

to an increase in the number of technicians and technologists available in the country with higher levels of education and skills

thereby also raising the number of laboratories managed by appropriately trained personnel from the current 43% to 60%

Tanzania has five institutions providing pre-service training in laboratory science. In FY2007-2008, USG assisted with

incorporation of HIV/AIDS in-service training modules into the pre-service training curriculum and provided the diploma laboratory

training schools with internet connectivity, reference manuals, textbooks, essential equipment and teaching aids. With FY 2009

funding the curriculum review will be extended to the certificate level training and to the university continuing education program.

In addition, there will be a mentoring and residence program to improve the quality and number of pre-service trainers and provide

professional advancement opportunities for the trainers. The availability of well trained trainers at the training institutions will

ensure a well trained and skilled workforce at graduation from training. There are three certificate and five diploma schools for

medical laboratory training with the average of 80 certificate and 160 diploma graduates annually. With the strengthening of the

schools of training there will be an input of 240 competent laboratorians into the laboratory system annually.In FY 2008 five

regional laboratories received mentorship. This will be increased to all 23 regional laboratories in FY 2009. This will be achieved

through development of 25 in-country mentors drawn from the existing technical work force thereby building sustainable

mentoring capacity in the country. The in country mentorship program will further strengthen the knowledge and skill base of the

existing workforce.With FY 2009 funding, the USG will support MOHSW in the roll out of the electronic Laboratory information

systems to an additional five regional and three zonal hospital laboratories. Additionally, the USG will train staff in basic

computer skills, assist MOHSW in data collection, transfer, analysis and utilization to inform the prevention, care and treatment

programs and the health care and laboratory information system. In FY 2007 there was only one laboratory providing dried blood

spot (DBS) based infant diagnosis on a public health basis. By the end of FY 2008 there were an additional three laboratories at

Kilimanjaro Medical Centre (KCMC), Mbeya Referral Hospital (MRH) and Muhimbili National Hospital (MNH).USG in collaboration

with the Clinton Foundation, AMREF and Columbia University assisted MOHSW train 11 laboratory technicians on DNA PCR

technology for infant diagnosis, procured lab equipment, reagents and consumables, developed national guidelines and standard

operating procedures, trained 308 health care workers in specimen collection, pediatric care and treatment, and pediatric patient

referral mechanisms at 59 health facilities. The training offered by MOHSW covers both laboratory and programmatic aspects.

Through this intervention, over 4500 HIV exposed infants were identified, more than 4000 tested using DNA PCR and over 758

HIV positive infants identified. By the end of FY 2008, 210 sites had been opened for specimen collection. In FY 2009 this

activity will be rolled out to an additional 240 new facilities to test 14,000 babies, thereby enabling the care and treatment program

move towards achieving its goal of having 20% of all cases presenting as pediatric patients. The EID program collaborates with all

other programs, inpatient, and outpatient facilities to identify HIV exposed children and refer them for testing. However there is a

programmatic challenge to identify the number of children successfully referred to care and treatment programs which will be

addressed in FY2009 by creating stronger referral linkages between the EID, PMTCT and care and treatment programs.The USG

in collaboration with APHL and the Supply Chain Management Systems (SCMS) will provide technical assistance and training for

MOHSW laboratory personnel in laboratory reagent forecasting, quantification and, laboratory logistics, taking advantage of the

harmonized HIV related tests and standardization of the equipment platforms at the different laboratory levels across the country

in order to mitigate the frequent reagent shortages. The MOHSW procures equipment and reagents through a centralized

government system and decentralized distribution procedures through branches of the Medical Stores Department. Care and

treatment partners provide additional support whenever reagent stock outs occur. In FY2009 USG assist MOHSW will train ten

equipment maintenance technicians and upgrade four equipment maintenance workshops thereby alleviating equipment

downtime due to inadequate skilled manpower and ill equipped maintenance workshops The USG laboratory team will develop

progress indicators and will undertake site visits in collaboration with MOHSW and partners to monitor program implementation.

Laboratory Support program supports all the prevention, care and treatment programs and will be monitored utilizing PEPFAR

indicators and program management tools. Reports on targets will also occur through systems strengthening, strategic

information and human capacity development program areas.

Table 3.3.16: