This is a continuing activity from FY07.

By March 2009, in collaboration with Vietnam's Ministry of Health (MOH), the U.S. Laboratory Consortium

will provide technical assistance in the development of a 5 year national strategic plan specifically for

laboratories in Vietnam. The Consortium will support MOH to identify and prioritize the need for clinical

laboratories; develop and conduct training in standard operating procedures and Quality Assurance (QA) for

bio-safety and universal precautions; provide guidance on the execution of the national laboratory strategy;

provide eligibility criteria for a National Reference Laboratory (NRL); and assess laboratories to guide

designation of an appropriate laboratory that can meet the requirements of a clinical NRL. They will also co-

ordinate technical assistance and training for rapid test rollout in surveillance sites, training-of-trainers for

diagnosis of AFB smears at the provincial and district levels, and strengthening of QA in laboratories

specializing in sexually transmitted infections.

Specifically funds will support the following activities:

1) Needs assessment:

The U.S. Laboratory Consortium will work with key partners including NIHE, VAAC, CHAI, the Global Fund,

and ESTHER, to perform a needs assessment/gap analysis for the clinical laboratory network focusing on

capacity building, sustainability, data management, and laboratory management. The deliverable is a report

of current and future needs of laboratories in terms of physical infrastructure, equipment, staffing, types and

number of tests performed, and educational background of staff. This report will provide recommendations

for overall strengthening of the clinical laboratory network in Vietnam.

2) National Laboratory Strategy:

On 17th March 2004, the Prime Minister of Vietnam approved the National Strategy on HIV/AIDS

Prevention and Control in Vietnam. Laboratory activities are a part of seven of the nine action points. The

strategy states that Vietnam will establish laboratories of national and international standards. However,

these standards will be hard to realize until the government has a vision, a strategic plan, and an approved

and continued source of funding. The U.S. Laboratory Consortium will provide technical assistance and

expert guidance on the development of the first five-year national laboratory strategy.

3) Standard Operating Procedures (SOP):

In FY07, PEPFAR funded the U.S. Laboratory Consortium to develop SOPs for both clinical and diagnostic

laboratory systems. The activity in FY08 is geared towards facilitating training to implement these SOPs at

the national, regional, and provincial levels, and to ensure the quality of training. PEPFAR will collaborate

with the Global Fund and the World Bank to organize trainings of laboratory staff in northern, central, and

southern Vietnam to write SOP and strengthen QA activities.

4) National Reference Laboratory (NRL):

One of the main reasons for the lack of standardized QA procedures and SOP is the lack of a designated

NRL for clinical laboratories with responsibility for policy and decision making. This leads to issues with

developing and implementing QA practices and external quality assessments. MOH's Department of

Therapy (DoT) oversees the clinical laboratory network with laboratories located in the provincial general

hospital of each of the 64 provinces as well as in each of the three regional hospitals in the northern,

central, and southern regions of Vietnam. Roles of supervision and referral of patients and specimens are

undefined within the network. In FY08, the U.S. Laboratory Consortium will work directly with MOH and DoT

to conduct a needs assessment to establish a NRL for the clinical laboratory network. PEPFAR will fund

DoT through an MOU with VAAC.

5) Training:

In FY08, PEPFAR will provide funds to the U.S. Laboratory Consortium to provide technical assistance for

training at surveillance sites using the rapid test rollout packet developed by HHS/CDC; provide training-of-

trainers for diagnosis of AFB smears at provincial and district level laboratories using the AFB smear

training package developed by HHS/CDC; and institute QA in laboratories specializing in sexually

transmitted infections using the guidelines and STI Atlas developed by Family Health International.