Title: Laboratory Quality Management Systems (QMS) Implementation in support of HIV/AIDS prevention

care and treatment

NEED and COMPARATIVE ADVANTAGE: The diagnosis of HIV and other major infectious diseases all

start with an accurate lab test. There are significant needs in order to implement, coordinate, and sustain

essential quality systems in Tanzania medical laboratories in order to enhance the effectiveness of each

laboratory and strengthen the overall diagnostic HIV/AIDS prevention and treatment plan. To do so, Clinical

and laboratory standards institute (CLSI) plans to initiate a resident mentorship program that will prepare

five major Zonal medical laboratories in Tanzania to achieve accreditation to internationally recognized

standards. CLSI's expertise in quality management and laboratory standards practice will provide solid

foundation in the implementation of quality systems in each laboratory facilities ultimately achieving

standards practice that will be an integral aspect of laboratory accreditation. This set of activities will build

upon the solid foundations, training and relationships built in FY 2007 activities. The focus will be on

achieving the 12 Laboratory Quality System essentials necessary to assure accurate and timely clinical lab

test performance.

Operationalization of the National HIV Laboratory and Quality Assurance Training Center (NHLQATC) will

need experts that can provide assistance in building a strong foundation for the training program. CLSI

plans to provide this technical expertise and focus on sustainability of the center's specific activities.

ACCOMPLISHMENTS: 1.) Quality management and document workshop and related activities successfully

completed in February 2007 for the TZ national lab team. Thirty nine national standards operating

procedure (SOP) documents were presented to the CLSI team for technical review and further

standardization. To increase effectiveness of each document, Sixty two standardized SOPs were created.

2.) A Gap analysis assessment trip was conducted in August 2007. CLSI team visited six zonal laboratories

in seven days using internationally-accepted requirements, particularly ISO 15189 as basis for assessment.

ACTIVITIES: Two primary scopes of work are planned to continue the QMS implementation; including

resident mentorship program in Five Zonal Laboratory in Tanzania and providing Technical assistance to

support the National HIV Laboratory and Quality Assurance Training Center.

An implementation plan based on gap analysis and national laboratory plan and QA roadmap for five zonal

laboratories. The CLSI team performed an assessment utilizing checklists "crosswalking" internationally-

accepted requirements for quality and competence in the medical laboratory. Following gap analysis,

strengths, and deficiencies of the laboratories will be reported, and strategies to move laboratory capacity

forward will be established.

CLSI will set up extended resident mentorship program where five CLSI Volunteers will be placed in five

zonal hospital laboratories. Resident mentors will stay in Tanzania for a period of approximately three

months to help zonal laboratories implement the "gaps" identified by the gap analysis team in August 2007.

The NHQLATC will be a training center for laboratory HIV/AIDS and Quality Assurance related areas for the

whole of Tanzania. Will develop national laboratory operating standards for laboratory services; Provision of

External Quality Assurance and Proficiency testing technical assistance and coordination for all of

Tanzania. Become Tanzania's central resource for new technology assessment, dissemination, and

consultation for the medical laboratory

CLSI will provide technical assistance to the National HIV Laboratory and Quality Assurance Training

Center. CLSI will work in partnership to develop a series of interpretive and illustrative guidelines in a

variety of formats and structures to assist understanding and implementation of Quality System model. In

coordination with CDC partners, Tanzania MOHSW, CLSI will assist in the scaling or restructuring or

laboratory quality systems to the range and complexity of the particular lab environment (e.g., Zonal,

Referral, Regional, District settings).

CLSI offers technical assistance to MOHSW and others to rebuild a full cycle External Quality Assessment

(EQA) program as they revamp the existing Tanzanian external quality system. CLSI will eventually work

with MOHSW, and other Coalition partners in selection of assessors with broad knowledge and expertise

with international laboratory standards. The focus of the continuous assessment is to follow the

development of quality management system in each laboratory to ensure that a strong foundation of

external quality management program.

CLSI provides partnership with MOH and CDC Tanzania by providing CLSI organization membership giving

both immediate access to all CLSI document standards, guidelines, job aides and tool kits, and other

products that can contribute to ensuring a quality managed laboratory. These CLSI documents can cover all

aspects of laboratory including Chemistry, Hematology, Microbiology, Point of Care, and laboratory method

evaluation.

LINKAGES: CLSI will coordinate laboratory management training with coalition partners (i.e., ASCP, APHL

and APHL) in close cooperation with the MOHSW, CDC-Tanzania and other appropriate implementing

partners. CLSI continue to work under the directives of MOHSW and continue to support the MOHSW

approved laboratory systems model.

CHECK BOXES: This activity addresses laboratory infrastructure for the diagnosis, monitoring and

treatment of HIV/AIDS and related laboratory requirements for pre- and post-analytical phases of testing.

Both in-service and pre-service training on quality management is performed through SOP development

workshop, gap analysis workshop and assessment, and mentorship program that will facilitate regular

monitoring and training session to various aspects of maintaining and running a quality system in a

laboratory.

M&E: Data gathering tool for monitoring the success of the extended mentorship program will be developed.

Resident mentors will stay in Tanzania for a period of approximately 3 months to help zonal laboratories

implement "gaps" as identified by the gap analysis in August 2007. During the mentorship program,

residents will monitor and review the currently existing quality system in the laboratory including specimen

processing that ranges from pre-analytic, analytic, and post-analytic procedures that affect patient specimen

testing.

Proper use of standardized SOPs and guidelines will be assessed by ensuring that each laboratory staff are

well trained to use each SOP document, and follow necessary steps in updating an effective standardized

guideline.

SUSTAINAIBLITY: The extended resident mentorship program will be conducted by CLSI with the zonal

laboratories in conjunction with MOHSW Tanzania, and support from CDC Tanzania. The activities of the

Activity Narrative: National HIV Laboratory Training and Quality Assurance center will be coordinated by MOHSW Tanzania,

with continued support from CLSI.

Sustainability will be achieved through the post service training of existing laboratory staff (Medical,

Technical and Support) in all key areas of quality laboratory services provision.