SUBSTANTIALLY CHANGED FROM LAST YEAR The purpose of this cooperative agreement is to

strengthen the national laboratory systems necessary to conduct quality assured surveillance for HIV

infection, sexually transmitted infections (STIs), and tuberculosis (TB), as well as to expand the access to

diagnostic and bio-clinical monitoring services.

To achieve these objectives the Namibia Institute of Pathology (NIP) will use funding through this IM to

accomplish the following activities:

1. Develop a plan for the continued quality improvement of systems for surveillance of HIV, STD and TB.

This will include improving the quality of testing at all levels of the NIP laboratory network. These

activities will emphasize the standardization of training and operating procedures, equipment and

supplies, laboratory information management systems, and a systematic staff proficiency testing scheme.

2. Improve and expand the use of dried blood spot technology for Early Infant Diagnosis in support of the

prevention of mother-to-child transmission (PMTCT) and pediatric ART programs.

3. Expand and improve HIV rapid test evaluation and monitoring systems to include quality assurance

schemes for testing, and staff proficiency evaluations.

4. Enhance and expand viral load and CD4 testing capacity, including use of point-of-care equipment.

5. Participate in a regional laboratory network to strengthen the quality of HIV and ART diagnostic and

bio-clinical monitoring services.

6. Increase the capacity of the NIP to perform routine laboratory tests to monitor patients on ART for

potential drug toxicity.

7. Develop the capacity of NIP to monitor HIV drug resistance, and to implement new serological

technologies to estimate HIV incidence.

8. Organize national workshops, working groups and meetings with laboratory representatives from

academia and the private sector to exchange information, develop consensus on mutual goals and

objectives, and facilitate quality control measures regarding HIV/AIDS, STDs and TB activities.

How the Implementing Mechanism is linked to the Partnership Framework goals and benchmarks over

the life of its agreement/award.

Through support for quality bio-clinical monitoring and training, this implementing mechanism is key to the

USG commitments related to the PF goal of "scaling up and enhancing antiretroviral treatment services

(including pre-ART) as well as reducing TB/HIV co-infection" The technical assistance delivered through

this IM will specifically aid the GRN and the USG to meet the following PF objectives:

1) Enhance the quality of ART care through quality assured bio-clinical monitoring.

2) Expand coverage of screening for TB/HIV co-infection.

The implementing Mechanism's geographic coverage and target population:

This mechanism is designed to provide national coverage through the NIP network of laboratories. APHL

will work with NIP and other partners to provide training to staff working in all of the NIP laboratories. The

gap analyses and mentoring assistance will be rolled out in a targeted manner, depending on identified

needs.

Key contributions to Health System Strengthening:

Strengthening an integrated laboratory network and providing quality and accessible laboratory services

to the country, will contribute to improvements in ART and TB drug adherence and patient monitoring.

These clinical improvements will, over time, contribute to a reduction in costs.

Implementing Mechanism's cross-cutting programs and key issues:

Strengthening laboratory capacity for the public healthcare system assures that services are accessible,

equitable, effective, affordable, and of high quality for all. Strategic planning has also been identified as a

priority for NIP and the Ministry of Health and Social Services (MOHSS) in the new National Strategic

Framework for HIV/AIDS (NSF). Direct TA to NIP staff will build local human resource capacity, another

key objective in the NSF.

The Implementing Mechanism's strategy to become more cost efficient over time:

The Namibia Institute of Pathology (NIP) is a public limited company established by Act of Parliament in

1999. NIP started operations in December 2000 and has assumed responsibility for 37 MOHSS

laboratories since then. This approach has avoided the creation of a parallel laboratory structure within

the HIV/AIDS response. NIP's budget is structured to recover a substantial portion of its costs through

reimbursements from public and private insurance plans. This innovative cost-recovery system is a

model that could be adapted by other GRN programs which could charge fees for services provided to the

private sector.

Monitoring and evaluation:

All CDC cooperative agreement grantees must submit a detailed work plan with their annual continuation

application. This work plan must be based on PEPFAR indicators and aligned with targets set for each

country. All IDP consortium members must also submit bi-annual status reports to the IDP program

manager in Atlanta. These reports are shared with CDC program managers in Namibia and used to

inform any year-on-year changes to the work plan.

NEW/REPLACEMENT NARRATIVE WITH SUBSTANTIAL CHANGES

This is a continuing activity from COP09. It includes one component: 1) salary support to the Namibia

Institute of Pathology (NIP) for a dedicated laboratory technologist to perform viral load tests.

1) Salary support for laboratory technician. With a growing number of patients on ART in Namibia, viral

load testing has become an increasingly critical part of bio-clinical monitoring. In 2006, the national ART

treatment guidelines were updated to include viral load testing for patients in whom treatment failure is

suspected. With USG support, NIP has equipped a state-of-the-art molecular biology lab with viral load

testing capacity. Anticipating increasing demand for viral load testing, a dedicated laboratory technician

will be supported in COP10 to ensure NIP may meet this demand. At least 12,000 viral load tests are

expected in COP10.

Supportive Supervision: The NIP laboratory technician will receive supportive supervision and mentoring

from the CDC laboratory technical advisor, and by technical experts funded through the International

Laboratory Branch Consortium (see APHL, ASM, ASCP and/or CLSI narratives).

Sustainability: NIP is a public limited company established by Act of Parliament in 1999. NIP started

operations in December 2000 and has assumed responsibility for 37 MOHSS laboratories since then.

NIP's budget is structured to recover a substantial portion of its costs through reimbursements from

public and private insurance plans. PEPFAR will work with NIP to ensure that this and other USG-

subsidized positions are gradually absorbed by the NIP or GRN budgets.

NEW/REPLACEMENT NARRATIVE WITH SUBSTANTIAL CHANGES This is a continuing activity from COP09. It includes two components: 1) Ongoing quality assurance (QA) support for rapid testing, and; (2) salary support for six staff. 1) Ongoing QA for Rapid Testing. These activities support the expansion of provider-initiated testing and counseling (PITC), as well as existing HCT. To date, a total of 1,043 health workers and community counselors have been successfully trained in rapid HIV testing. Among these, 887 have been certified and 156 are in the process of certification. From July 2008 to September 2008, 3,234 retests were performed for the certification of testing personnel. An additional 1,566 retests were performed as part of the quality assurance program. The MOHSS has lowered the retesting requirement from 10% of tests to 5%. During the same period, 148 sets of External Quality Assurance proficiency panels and 370 Quality Control sets were sent out to the RT sites. NIP will continue to support these activities in COP10. 2) Salary Support for Staff. In COP10, PEPFAR will support fewer NIP staff due to a transition of the responsibility for HCT QA to the MOHSS. (See MOHSS HVCT narrative for details.) The six NIP staff to be supported in COP10 will include: - one senior QA manager - four QA medical technologists - one administrative assistant The QA staff will be responsible for the validation of any new RT technologies introduced in Namibia, and for making recommendations to the MOHSS on the RT algorithm and selection of test kits. These QA experts will also support training and post-training certification of all MOHSS personnel who administer rapid tests; preparation, distribution, and analysis of quality controls and proficiency panels; retesting of 5% of all rapid tests done at sites by ELISA; proficiency follow-up with rapid test sites and personnel;, and; submission of reports on rapid test QA to the MOHSS HCT unit. Supportive Supervision: NIP laboratory technicians will receive supportive supervision and mentoring from MOHSS QA officers based in the HCT program. The QA staff will provide follow-up supervision and mentoring to MOHSS personnel who perform rapid tests at the facility-level. Additional mentoring and

supervision will be provided by the CDC laboratory technical advisor, and by technical experts funded through the International Laboratory Branch Consortium (see APHL, ASM, ASCP and/or CLSI narratives). Sustainability: As noted above, changes in the MOHSS quality assurance policy for rapid testing has reduced the proportion of tests subject to QA re-testing each year. This reduction has reduced costs associated with the NIP QA program. Additional costs savings are anticipated as supportive supervision is expanded and the skills of rapid test users improve. As a public limited company, NIP's budget is structured to recover a substantial portion of its costs through reimbursements from public and private insurance plans. PEPFAR will work with NIP to ensure that these and other USG-subsidized positions are gradually absorbed by the NIP or GRN budgets.

NEW/REPLACEMENT NARRATIVE WITH SUBSTANTIAL CHANGES

This is a continuation activity from COP09. It includes one component: 1) salary support for a dedicated

technologist at the Namibia Institute of Pathology (NIP) in support of early infant HIV diagnosis (EID) by

PCR.

1. Dedicated technology to support EID. NIP is responsible for provision of all HIV-related testing

technologies for the public sector. During COP05, the diagnostic algorithm for using dried blood spots

(DBS) and PCR for pediatric diagnosis was developed and field-tested in Namibia. During COP06, the

Ministry of Health and Social Services (MOHSS) PMTCT program and NIP began testing symptomatic

infants and screening HIV-exposed infants at six weeks of age.

Laboratory staff has been trained in PCR, new equipment has been procured, specimens are being

processed, and health workers have been trained in the collection of DBS specimens. Approximately

20,000 EID PCR tests will be performed in COP 10. The technologist funded by PEPFAR will be

dedicated to ensuring all of these tests are performed in a quality assured and timely manner.

Supportive supervision: The NIP technician will receive supportive supervision and mentoring from the

CDC laboratory technical advisor. Additional mentoring and supervision may be provided throughout the

year by technical experts funded through the International Laboratory Branch Consortium (see APHL,

ASM, ASCP and/or CLSI narratives).

Sustainability: NIP is a public limited company established by Act of Parliament in 1999. NIP started

operations in December 2000 and has assumed responsibility for 37 MOHSS laboratories since then.

NIP's budget is structured to recover a substantial portion of its costs through reimbursements from

public and private insurance plans. PEPFAR will work with NIP to ensure that this and other USG-

subsidized positions are gradually absorbed by the NIP or GRN budgets.

NEW/REPLACEMENT NARRATIVE WITH SUBSTANTIAL CHANGES

This is a continuing activity from COP09. It includes three components: (1) the maintenance of

laboratory testing equipment and revisions to the MEDITECH Laboratory Information System (LIS); (2)

support to expand access to MEDITECH at ARV clinics, and; (3) salary support for two laboratory

trainers, a training administrative assistant and a program officer based at the Namibia Institute of

Pathology (NIP).

1.Equipment maintenance. Namibia's antiretroviral treatment program is rapidly expanding in remote

areas. By its mandate, NIP is required to support the treatment program wherever it is launched. NIP will

continue to strengthen its peripheral laboratories in providing diagnostics and basic bio-clinical monitoring

services in these facilities. Increased access to facility-based laboratory services will minimize costs,

delays and risk of loss associated with transporting samples to central testing facilities. In COP10, funds

will be used to maintain laboratory equipment purchased for these sites in previous years. A portion of

the funds in this budget line will be used to support revisions in the MEDITECH health information

system.

2. Linking data systems. The MEDITECH revisions described above will be aimed at integrating data

captured by the NIP laboratory information system (LIS) and the broader health information system used

by the Ministry of Health and Social Services (MEDITECH). Linking the LIS to ARV clinics will allow

clinicians to access lab results as soon as they are available. This will reduce waiting time for patients

and contribute to a reduction in the number of patients lost to follow-up. In collaboration with MOHSS,

this work will include the development of a standardized unique identification system to improve tracking

of patient records and laboratory records.

3. Salary support. COP10 funds will support the following NIP salaries:

- Two laboratory trainers

- One administrative assistant assigned to the training unit

- One program officer assigned to the training unit.

Prior year support for training and renovation is not described in COP10. NIP will use carry-over funds

from COP09 to support on-going training activities, as well as renovations.

Supportive Supervision: NIP staff will receive supportive supervision and mentoring from the CDC

laboratory technical advisor, the CDC SI advisor; information technology consultants hired by the

MOHSS, and, where relevant, by technical experts funded through the International Laboratory Branch

Consortium (see APHL, ASM, ASCP and/or CLSI narratives).

Sustainability: NIP is a public limited company established by Act of Parliament in 1999. NIP started

operations in December 2000 and has assumed responsibility for 37 MOHSS laboratories since then.

NIP's budget is structured to recover a substantial portion of its costs through reimbursements from

public and private insurance plans. PEPFAR will work with NIP to ensure that this and other USG-

subsidized positions and activities are gradually absorbed by the NIP or GRN budgets. Support for

routine maintenance will be emphasized throughout the NIP program. Technical assistance will

encourage the inclusion of routine maintenance and the amortization of replacement costs in future NIP

budgets.

NEW/REPLACEMENT NARRATIVE

This is a continuing activity from COP09. It includes one component: 1) salary support for TB laboratory staff based in the Namibia Institute of Pathology (NIP).

(Note: USG support for TA and other costs for TB drug resistance surveillance in COP10 is described in the MOHSS Strategic Information narrative.)

1) Salary Support for NIP TB staff. The following NIP positions will be subsidized by PEPFAR in COP10. - One TB Central Lab Supervisor. The TB Lab supervisor is responsible for the day-to-day management of the TB Reference Laboratory, providing leadership to the team, overseeing implementation of all activities including the evaluation of new technology, assessing the competency of technologists, training, updating SOPs and compiling reports. - One medical technologist for Quality Assurance. The TB QA technologist is responsible for monitoring the implementation of quality indicators at the facility level, managing proficiency testing results, doing blind slides rechecking, and site supervisions. - Six laboratory assistants. The Laboratory assistants are deployed as microscopist and lab aids at district lower level laboratories. These are good examples of task shifting in the context of lack of qualified lab technologists.

Supportive supervision: The Central Laboratory Supervisor will provide direct supportive supervision to the medical technologist and laboratory assistants assigned to TB screening work. The medical technologist will provide step-down supervision to facility-based staff related to quality assurance testing. All NIP laboratory staff will receive supportive supervision and mentoring from the CDC laboratory technical advisor. Additional mentoring and supervision may be provided throughout the year by technical experts funded through the International Laboratory Branch Consortium (see APHL, ASM, ASCP and/or

CLSI narratives).

Sustainability: NIP is a public limited company established by Act of Parliament in 1999. NIP started operations in December 2000 and has assumed responsibility for 37 MOHSS laboratories since then. NIP's budget is structured to recover a substantial portion of its costs through reimbursements from public and private insurance plans. PEPFAR will work with NIP to ensure that this and other USG- subsidized positions are gradually absorbed by the NIP or GRN budgets. The laboratory assistant positions are an example of task-shifting within the laboratory sector. The laboratory assistant position was created though a task-shifting initiative at NIP. As such, these entry-level positions represent a locally-owned response to staffing shortages at the facility level. These positions are also a first rung on the laboratory service career ladder, and may provide young or inexperienced workers an opportunity to advance over time.