Tanzania Visit Illuminates Goals for CLSI Cooperative Agreement With CDC
CLSI Representatives Find Disparities, Strengths, Commitment to Change in Nation's Laboratories

The core team in Tanzania:  Dr. Noble; Michael Mwasakaga, Laboratory Quality Systems Coordinator, Tanzania Ministry of Health; Dr. Collins; Mr. Fine; and Epafra Anga, Program Officer, Laboratory Capacity Building, CDC Tanzania.

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) volunteer and quality systems expert Michael Noble, MD, FRCPC, and CLSI Executive Vice-President Glen Fine, MS, MBA, traveled to Tanzania in December 2005, as part of CLSI’s introductory work on the cooperative agreement with Centers for Disease Control and Prevention (CDC). 

Traveling with CDC’s Carlyn Collins, MD, MPH, FASCP, Dr. Noble and Mr. Fine made the visit with the purpose of acquainting themselves with the nation’s scope of laboratory testing settings and capabilities; meeting partner organizations; and moving towards an action plan for helping to implement quality systems in the region.

Dr. Noble and Mr. Fine visited ten different laboratories throughout Tanzania over the space of two weeks, including large urban hospital laboratories, a blood transfusion center, rural and community hospital laboratories, and a national research and medical training laboratory. 

Mr. Fine and Dr. Noble both say they were struck by the disparity of capabilities between visited laboratories.

“Laboratories in Tanzania today cross the full spectrum of size, complexity, equipment, resources, safety, and general environment,” says Mr. Fine, “but there is a palpable unevenness between the different laboratories.”

Mr. Fine describes the conditions within the different laboratory work areas:  some work areas large and spacious, others small and compact; supply and procurement capabilities both abundant and restricted; testing equipment both cutting-edge and rudimentary.  However, Fine says, at all of the laboratories he and Dr. Noble visited were motivated laboratorians whose skill and commitment to providing patient-testing services in their varied conditions revealed personnel to be “without a doubt, the most valuable resource of Tanzania’s laboratories.”

With motivated personnel, and a commitment to their role in the fight against HIV/AIDS already in place, Dr. Noble and Mr. Fine say that the implementation of baseline quality systems through the use of accepted international standards that are locally owned and implemented can serve as a “great equalizer” between the various laboratory environments within Tanzania. 

“In some respects, (the disparity) is a good-news story,” says Dr. Noble.  “The technologists that we saw were well-informed and committed people, so the insertion of standards, and the creation of the opportunity for standards, will take work but won’t take a huge amount of resources—and the impacts will be major.  Large, encouraging initial change can be made relatively easily and inexpensively; it’s when you get to the finer issues that things start to become increasingly expensive.”

The Tanzanian laboratory community is ready for change, Dr. Noble and Mr. Fine say, and even small procedural changes have the potential for major and even rapid impact on laboratories throughout the country.

“We saw that, increasingly, laboratories are also becoming aware of the notion of monitoring equipment at the beginning,” says Dr. Noble.  “As increasing the significance of quality control checks provides the opportunity for earlier improvements in sample outcome, these are small, but highly significant steps.”

Along with visits with hospital and laboratory leaders and personnel, Dr. Noble and Mr. Fine visited with leaders of the Tanzanian Ministry of Health, CDC Tanzania, and other organizations involved in the development of laboratory capacity, including the Clinton HIV/AIDS Foundation, the African Medical and Research Foundation (AMREF), and various faith-based groups.  Operating in conjunction with the National Laboratory System Operational Plan approved by the Tanzanian Ministry of Health, CLSI will work together with all parties concerned with HIV/AIDS in the region, in a role directly related to the organization’s core area of expertise—standards development and quality systems management for improved health care.

Through a presentation delivered during their stay, Dr. Noble and Mr. Fine presented CLSI’s proposed action plan, with major goals of helping Tanzania establish and implement baseline standards based on international guidelines for global credibility; aiding in the sustainable development of laboratory quality systems for local control by Tanzanian healthcare professionals; and assisting clinical and laboratory improvements through enhanced quality management. 

The major objectives of the proposed action plan are:

• Dissemination of relevant CLSI standards, guidelines, and best practice documents.
  CLSI will identify its documents and products that align with the Tanzanian Ministry of Health September 2005 Operational Plan for the National Laboratory System to Support National HIV/AIDS Care and Treatment plan goals.  The organization will also identify those documents that align with existing Tanzanian laboratory guidelines and activities.
• Through partnerships, integration of documents into collectively developed interpretive guides.
  While continuing to support the Tanzanian Ministry of Health-approved laboratory quality systems model, CLSI will work in partnerships to develop a series of interpretive and illustrative guidelines in a variety of formats and structures to assist understanding and implementation of the Quality System model.  CLSI will also scale or restructure the laboratory quality systems model to the range and complexity of the particular laboratory environment:  urban (referred to as “zonal” in Tanzania), suburban (regional), and rural (district) settings.
• Implementation of quality systems through an active gap analysis program.
  Sites will be selected to pilot a Quality Management gap analysis program.  The gap analysis will assess progress and help establish priorities for ongoing implementation.
• Proposal of assistance to the Tanzanian Ministry of Health and others to rebuild a full cycle External Quality Assessment (EQA) program.
  CLSI will offer technical assistance to the Ministry of Health and the Quality Assurance and Training Institute as they upgrade and revamp the existing Tanzanian external quality assessment program.
• Complimentary or deep discounted membership in CLSI, and opportunities to participate in standards development.

Providing the framework for CLSI’s quality improvement work in Tanzania will be CLSI quality systems documents HS1—A Quality Management System Model for Health Care and GP26—Application of a Quality Management System Model for Laboratory Services, and International Organization for Standardization (ISO) document 15189—Medical laboratories—Particular requirements for quality and competence.

While CLSI volunteers and staff will make further visits to Africa to ensure the ongoing progress of cooperative agreement efforts, Mr. Fine says that CDC Tanzania, as well as the Tanzanian Ministry of Health, will serve as an essential conduit for the development and implementation of CLSI’s quality systems standardization work for the nation by working directly with laboratories.

“The CDC and the Tanzanian Ministry of Health are CLSI’s two most vital partners in fulfilling our cooperative agreement,” Fine says.  “These efforts are more than simply educational; together, we’re assisting the Tanzanian people in enhancing their processes and technology.”

Dr. Noble agrees that the role of partnering Tanzanian organizations—and local people introducing quality procedures on an individual basis—will be key to the success of CLSI’s cooperative agreement efforts. 

“Resources in and of themselves are not always the issue,” says Dr. Noble.  “It’s awareness… that starts to improve laboratories.  One of the things that quality benefits from most is a committed champion.” 

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