INTEGRATED ACTIVITY FLAG: This activity is linked to Activity ID 12429.08.

This activity relates to partnerships with the United States Government (USG) partners in Laboratory

Infrastructure

SUMMARY: The activities included in this project relate to establish TB laboratory testing facility at the

National Public Health Laboratory (NPHL) for TB culture and drug resistance to Mycobacterium

Tuberculosis, hiring staff, training plus maintain its infrastructure.

Background: The NPHL was established in 2006. Laboratory space was allocated for its TB laboratory.

However, this laboratory is still empty and is only functioning as a TB slides QA/QC rereading operation.

Diagnosis of TB by sputum smear microscopy is useful as a screening test, but it has some limitation as it

can only detect 70% of TB cases. TB suspected cases with clinical symptoms but TB smear negative

should be further investigated and diagnosed by culture and/or radiology. There were numerous reports on

multiple drug resistance to Mycobacterium Tuberculosis globally including Dominican Republic, Haiti's

neighboring country that caused deaths. Co-infection of TB and HIV is common occurring. Multiple drug

resistance to TB is a public health threat. Currently, the Ministry of Health, (NPHL) does not have capacity

to conduct TB culture or performing MTB drug resistance and/or drug susceptibility testing. There is an

urgent need to set up such facility at the NPHL to provide TB laboratory services to TB/HIV patients.

In FY 2008, the USG will take steps to address this gap by allocating resources to the MOH to set up

culture and resistance testing at the National Laboratory.

Activity 1: The NPHL will strengthen its capacity by setting up a TB laboratory with culture facility to

establish reference methods for culture identification and drug sensitivity and/or resistance Mycobacterium

Tuberculosis at the NPHL. Supply Chain Management (PFSCM) will procure TB culture laboratory

equipment, specific equipment and lab supplies to establish TB culture and drug resistance testing for the

NPHL. The NPHL will subcontract local company to improve its TB laboratory infrastructure in order to

meet laboratory safety standard requirements, and to install lab equipment so that the TB culture laboratory

will be ready for operation. The NPHL will primarily work with French speaking TB lab consultants hired by

the American Society of Microbiology (ASM) in order to start up and implement the project. In COP 08, the

NPHL has a goal to conduct 1000 TB cultures and detection of MDRTB and XDRTB drug resistance for

clinical decision-making and drug resistance surveillance.

Activity 2: The NPHL will provide to 80 lab personnel at PEPFAR supported laboratories (ARV, and

palliative care labs) a refresher training course to conduct TB smear diagnosis. In addition, the NPHL will

train 40 lab personnel at TB clinics to conduct HIV rapid testing. This number of lab personnel is already

included and described in the NPHL narrative in the Lab Infrastructure program area.

Activity 3: The NPHL will continue to establish and expand an integrated quality assurance program of TB

smear diagnosis and HIV testing at 180 TB clinics nationwide. The QA/QC activities will include regular

supervisory visits, EQA TB smear diagnosis panel test development and proficiency testing, TB slides

rereading, and trouble shootings.

Activity 4: The NPHL will hire five TB laboratory in-country personnel and four supportive personnel to work

together with ASM consultants to establish the TB laboratory to implement the above described activities.

TARGETS:

- 1 TB culture lab established at the NPHL with facility to perform TB culture and TB drug resistance testing

- 80 lab personnel of USG-supported ARV and palliative care sites trained for TB smear diagnosis

- The national TB EQA TB smear diagnosis strengthened and continued

- 9 staff hired for the TB laboratory activities and the national TB smear diagnosis QA/QC program

Emphasis areas: healthcare worker

Quality control/quality assurance

TB/HIV diagnosis

Clinical services

Coverage - national

INTEGRATED ACTIVITY FLAG: This activity is linked to Activity ID 12374.08.

This activity relates to partnerships with the United States Government (USG) partners in Counseling and

Testing (CT), Prevention of Mother-to-Child Transmission (PMTCT), Tuberculosis (TB)/HIV, Palliative care,

and anti-retroviral (ARV) services.

SUMMARY: The activities in this project are related to building laboratory infrastructure in Haiti through

strengthening the capacity of the National Public Health Laboratory (NPHL) and its network. Funding will be

used to continue and expand the national laboratory quality assurance and quality control program (QA/QC)

in HIV and syphilis rapid testing as well as ARV and palliative care lab services. In addition, NPHL will

establish bacteriology and parasitology laboratory expertise for HIV/AIDS related opportunistic infections,

and establish a biomedical engineering service unit. PEPFAR funding also serves to help support NPHL

infrastructure, establish and maintain a repository for surveillance specimens, enable early infant diagnosis

of HIV by PCR and p24 antigen techniques, train laboratory staff; integrate the NPHL activities with the

department of epidemiology; and hire staff.

Background; Accurate test results are very critical for public health. With help from the USG team, Haiti has

established a functional regulatory body (NPHL) to evaluate laboratory performance in the country. COP 08

activities are consistent with NPHL and MSPP mission. All activities will be implemented by NPHL

employees, with technical assistance from Haitian Group for the Study of Kaposi's Sarcoma and

Opportunistic Infections (GHESKIO), USG and other PEPFAR-supported partners.

ACTIVITES AND EXPECTED RESULTS:

Activity 1: NPHL will expand its QA/QC program for HIV and syphilis rapid testing. A combination of QC

activities will be conducted: 1) use of a standardized logbook for recording information at VCT centers; 2)

regular supervisory sites visits to 133 VCT sites to track and monitor laboratory testing data on HIV and

syphilis; 3) Data quality assessments will use a standardized tool; 4) refresher courses on QA of rapid HIV

and syphilis testing; 5) for new VCT sites, 5% of samples will be retested by NPHL for the first three

months; and 6) participation of all VCT sites in External Quality Assurance (EQA) proficiency testing

implemented by NPHL. NPHL will assist the PEPFAR program to launch 20 new VCT sites by conducting

site assessment (in conjunction with APHL), training, coordination with SCMS, and supervisory visits.

Activity 2: NPHL will also provide QA/QC to ARV and palliative care laboratories using the same kinds of

activities, i.e. regular supervisory visits to the laboratory network, EQA proficiency testing for CD4, blood

chemistry and hematology, and retesting specimens. A pilot EQA for CD4 will be started at the end of FY

07. In FY08, NPHL will continue the EQA for CD4 and start an EQA program for blood chemistry and

hematology. After protocols for the EQA program are developed, EQA panels for CD4 enumeration, blood

chemistry, and hematology will be sent out to participating ARV and palliative care laboratories. Corrective

action will be conducted in case of error and/or discordance. NPHL will also hire 10 regional departmental

lab technicians who will provide regular QA/QC supervisory visits, train and troubleshoot. NPHL will assist

the USG to launch 5 new ARV and 10 palliative care sites by conducting site assessment, conducting

training, coordinate with SCMS for lab commodity delivery, and perform supervisory QA/QC visits.

Activity 3: NPHL will develop an inventory for laboratory equipment at ARV and palliative care sites under

the MSPP network and at the NPHL. A biomedical engineering service unit will be established which will be

responsible for 1) evaluating lab equipment, 2) installation of new ARV automated lab equipment, 3)

maintain, troubleshoot and repair equipment at all sites except the GHESKIO network where such staff are

already available, 5) maintain bio-safety cabinets at the NPHL, 6) train laboratory personnel how to routinely

maintain common lab equipment, and 7) procure equipment maintenance service contracts as appropriate

Activity 4: NPHL will maintain its infrastructure by ensuring a 24/7continuous electrical and water supply,

improving security, establishing a dependable communication system within the lab network. NPHL will

procure and install a 50 kilowatt generator equipped with ATS and Inverter backup to ensure constant

electrical supply to its refrigeration unit and cold chambers for maintaining optimal condition for preservation

of specimens and test kits.

Activity 5: NPHL will begin to act as a repository to store 54,000 blood specimens collected from future sero

-surveys. NPHL will take initial steps to obtain freezers, storage, temperature monitoring and alarming

system (-20C and -70C) through SCMS. NPHL will install those freezers, its storage system, and

temperature monitoring and alarm system. NPHL will use LIMS established by I-TECH to track the

specimens.

Activity 6: With technical assistance from the USG and GHESKIO, NPHL will begin to provide HIV pediatric

testing in order to confirm its role as a national reference laboratory using - DBS polymerase chain reaction

(PCR).

Activity 7: NPHL will take steps to set up bacteriology and parasitology laboratories to enhance diagnosis of

opportunistic infection associated with HIV/AIDS. One bacteriology lab will be at the NPHL while three will

be at departmental centers of excellence. Simple parasitology testing will be set up at the 10 departmental

laboratories and NPHL. NPHL will provide laboratory space and subcontract local company to furnish

laboratory furniture for these two laboratories at NPHL.

Activity 8: In collaboration with GHESKIO, INHSAC and other USG partners, NPHL will train 150 lab

personnel and health care workers to perform HIV and syphilis rapid tests, as well as the DPS QA/QC.

Additionally, NPHL will train 40 technicians for all relevant laboratory areas including CD4 counts,

hematology ,blood chemistry, parasitology and bacteriology. Forty people will also be trained in laboratory

equipment maintenance (see Activity 3). All training is a one week course. Training modules in lab-related

subjects will be developed by partners and NPHL. The modules will also include good laboratory practices

and methods for preventive maintenance of equipment.

Activity 9: NPHL will begin efforts to strengthen the integration of national lab and the department of

epidemiology by starting to develop a data management unit at NPHL. This unit will manage data from

LIMS, and also from future surveillances.

Activity Narrative: Activity 10: NPHL will continue to hire 21 staff recruited in 07 and hire additional staff including one

epidemiologist, four microbiologists (to work at HIV, bacteriology, parasitology and mycobacteriology

laboratories), two biomedical engineering staff, one laboratory manager, management and supportive staff.

In total, the NPHL will be hiring a total of 50 staff (30 clinical services and 20 for management and

supportive staff). The NPHL will provide work space and procure essential office equipment for the staff.

Activity 11: NPHL will partner with Management and Resources for Community Health (MARCH) to provide

laboratory improvement and personnel, including minor renovations at one MARCH site, assistance with

design of lab space and purchase of non-medical laboratory equipment as well as collection and transport

of Dried Blood Spot specimens to NPHL and GHESKIO for Early Infant Diagnostic testing.

TARGETS:

- VCT, ARV, PMTCT and Palliative care sites supported

- 5 new ARV and 10 palliative care sites perform HIV monitoring disease testing

- 4 bacteriology labs operated

- A biomedical engineering unit at the national lab operated

- Infrastructure of the NPHL maintained

- A repository unit established

- Early infant diagnosis of HIV infection and OI testing established

- 230 laboratory personnel trained

- Epidemiology department strengthened, and integrated with the NPHL

- 50 staff hired

EMPHASIS AREAS:

•Quality Assurance / Quality Improvement and Supportive Supervision

•Logistics

•Training

•Human resources

•Strategic Information

•Development of Network / Linkages / Referral Systems

•Commodity Procurement

TARGET POPULATIONS:

•Lab workers

•Program managers

•Non-governmental organizations

•Other health care workers