Ron Quicho, CLSI Projects Coordinator, and Sheila Woodcock, Principal Consultant, QSE Consulting Share Their Perspective of the Visit and Emphasize CLSI’s Commitment to Enhance Implementation of Global Quality Management Systems

Top row (from left to right):  Giselle Guevara, Manager, Laboratory Accreditation Division, Trinidad and Tobago Bureau of Standards; Epafra Anga, Program Officer, Laboratory Capacity Building, CDC Tanzania; Robert Moran, Assistant Professor of Chemistry and Physics, Wentworth Institute of Technology, and President, mvi Scientific; Sheila Woodcock, Principal Consultant, QSE Consulting; Ron Quicho, Projects Coordinator, CLSI;  Yash Chudasama, Head, Microbiology Department, St. Luke’s Hospital of Pennsylvania and Professor, Microbiology, Montgomery Community College, School of Nursing; Judy Arbique, Arbique-Rendell Onsite Training & Consulting; Karen McClure, Director, CLS Program, University of TX M.D. Anderson Cancer Center; and Dr. Simon Tatala, Head, Tanzania Food and Nutrition Center. 

Bottom row (from left to right):  Michael Mwasekaga, Coordinator, Laboratory Quality Systems, United Republic of Tanzania, Ministry of Health and Social Welfare (MOHSW); Dr. Michael Noble, Senior Technical Director and Senior Laboratory Advisor, University of British Columbia; Vincent Mgaya, Head, Diagnostic Services, MOHSW; Anne Rendell, Laboratory Technologist, Molecular Biology, Queen Elizabeth II Health Sciences Centre.

In September 2005, CLSI entered into a cooperative agreement with the Centers for Disease Control and Prevention (CDC) in support of the President's Emergency Plan for AIDS Relief (PEPFAR) initiatives to assist in the development and sustainability of clinical laboratory capacity in resource-constrained countries. This partnership will advance CLSI's vision of global growth and fulfill its mission to place its products where they will be of the most benefit to the most people, thereby improving health care worldwide.

Ron Quicho, Projects Coordinator at Clinical and Laboratory Standards Institute (CLSI), along with eight members of the CLSI cooperative agreement volunteer team, visited Arusha, Tanzania (East Africa) from 17 February – 1 March 2007 to conduct an introductory workshop focused on the development of standard operating procedures (SOPs) for implementation in Tanzanian laboratories, as well as tour zonal, regional, district, and private Tanzanian laboratories as part of CLSI’s latest efforts to enhance global implementation of quality management systems through the CDC Cooperative Agreement.

One of the members of the volunteer team and Chair of the CLSI Quality Systems and Laboratory Practices Area Committee, Sheila Woodcock, was full of positive comments about the visit. She declares, “It was an extremely successful visit from the perspective of the participants, the workshop speakers, and to advance CLSI’s global presence and visibility.”

Woodcock says, “For participants, it was a very practical workshop with very tangible outcomes. Not only did attendees receive draft SOPs, but they went away with the skills to take back to their workplace where they can teach others how to write procedures too. As a speaker, it was satisfying to work with the people in Tanzania who were so keen to learn and participate.” She adds, “It was equally satisfying to actually see CLSI documents used as a very practical tool. I am eager to see other CLSI documents used in a similar way as we move forward with the cooperative agreement to address other quality management issues.”
 
In an interview, Quicho also shares his impressions of his first visit to Tanzania, describes details of the CLSI workshop, and outlines the progress CLSI has made to train and develop SOPs and quality management system documents for Tanzanian laboratories.

What was the purpose of your visit to Tanzania?

The central focus of the trip was to facilitate a training session to assist local laboratory professionals in the development of laboratory documents (such as standard operating procedures and process flowcharts) to enable standardization of the process leading to consistent, reliable, and high-quality results. The workshop was facilitated by CLSI with support of the Tanzanian Ministry of Health and Social Welfare (MOHSW) and CDC Tanzania.

The workshop participants included 34 well-established laboratory professionals and leaders who were invited by the Tanzanian MOHSW. In addition, nine CLSI cooperative agreement writing group volunteers presented sessions and assisted with the workshop.

What was the highlight of your visit?

Personally, the highlight of my visit was meeting all the diverse, high-ranking healthcare officials in the country. Tanzanians are very warm and hospitable people. 

Ron, can you describe your impressions of the country?

My first impression of the country was that the atmosphere was laid back and refreshing. The country is definitely beautiful, with low pollution and a warm but comfortable climate. There is an eclectic mix of food available, including African, Indian, and American cuisine.

Did you visit district, regional, and local laboratories upon your arrival in Africa?

The workshop was held in Arusha, one of the major cities in Tanzania. All of the CLSI volunteers, including myself, had the chance to visit four different laboratories: one zonal, one regional, one district, and one privately owned.

Visits to the laboratories provided insight into the differences in zonal districts and divisions. They also provided a first-hand perspective of the specific equipment used in each laboratory. Seeing the laboratories in operation gave CLSI volunteers a better understanding of the scope and level of laboratory capacity in Tanzania.

In your view, was the need for standards and guidelines in the country evident?

The need for guidance to improve the country’s laboratory operations through structured SOP development and implementation within the context of quality management systems is necessary to better advance the delivery of health care. Tanzanians are extremely dedicated workers and they are eager to learn how to improve the services they offer their people. 

What was the agenda of the workshop?

The workshop provided an introduction to laboratory quality management; a description and outline of the benefits of SOPs; an introduction to the CLSI guideline, Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition (GP2-A5), as well as how to structure SOPs using GP2-A5; and an explanation of the steps for SOP development.

Dr. Michael A. Noble, MD, FRCPC, Senior Advisor, Laboratory Strengthening Program, CLSI, presented the introductory session about the development of quality management theory and the origins and modern cornerstone documents of laboratory quality management.

Karen McClure, PhD, MT(ASCP)SBB, The University of Texas M.D. Anderson Cancer Center, The School of Health Sciences, in a session titled “SOPs – Who, What, When, Where,” defined and explained the benefits of SOPs, as well as described how to successfully introduce SOPs in the laboratory.

In the session, “Introduction to Laboratory Documents: Development and Control (GP2-A5)”, presented by Sheila Woodcock, MBA, FCSMLS(D), President and Principal Consultant, QSE Consulting Inc., attendees learned different types of laboratory documents, how to determine what SOPs are needed, and the purpose of document control and management.

Judy Arbique, BHSc, ART(CSMLS), MLT, CLS(NCA), Arbique-Rendell Onsite (ARO) Training and Consulting discussed the importance of documenting laboratory processes prior to SOP development and the practical use of CLSI resources such as the GP2-A5 implementation guide and the CLSI procedure manual toolkit in the session, “Structuring SOPs Using Laboratory Documents: Development and Control (GP2-A5).”

In the session, “Developing SOPs in Developing Countries” Giselle Guevara, BSc, MPhil, Manager, Laboratory and Accreditation, outlined why SOPs are necessary and how to deal with challenges while developing quality management systems.

In your opinion, Ron, do you feel the workshop provided practical knowledge that Tanzanian laboratory professionals can use in their workplaces?

Absolutely.  Shortly after I returned to my office, one of the local leaders, Michael Mwasekaga, with whom I worked during the workshop, sent an email confirming the success of the training. Prior to CLSI’s visit, MOHSW in Tanzania formed a team to create SOPs applicable to zonal, district, and private laboratories in the country. This initial effort resulted in the creation of 39 SOPs. These SOPs developed by the Tanzanian team were sent to CLSI to be put into a standardized format (derived from GP2-A5) useful to all laboratories in the country. In the end, the 39 original SOPs became 62 covering a scope of pertinent topics—from operation and maintenance for specific analyzers to specimen handling and quality control. The SOPs are in final draft format pending approval and distribution by the MOHSW. Immediately after the workshop, Mwasekaga started distributing some of CLSI’s final draft SOPs to various zonal laboratories. This was just one of the many positive responses as a result of the workshop.

In what specific ways do you see CLSI’s role in implementing International Standards for credibility; establishing local control for sustainability; and ensuring clinical and laboratory improvements through enhanced quality management?

CLSI will continue to facilitate workshops on how to improve laboratory documents and procedures. As follow-up to the workshops, CLSI, in coordination with the MOHSW, will undertake initial laboratory assessments to uncover potential gaps in currently established processes. CLSI will work closely with in-country laboratory experts and professionals to establish local control and ensure successful implementation of laboratory quality improvements.

Ron, do you see yourself visiting other PEPFAR countries in support of the initiatives outlined in the cooperative agreement?

If given another chance, I would feel privileged for the opportunity to help and visit another PEPFAR country. 

What are CLSI’s future activities for the cooperative agreement in follow-up to this visit?

CLSI’s currently planned activities for the cooperative agreement include a follow-up visit in August 2007 to perform a gap analysis to identify deficiencies in the quality management practices, which will enable the system to become more effective and reliable. In addition, the CLSI cooperative agreement team will visit laboratory facilities to see how well the SOP documents have been implemented and to assess their effectiveness.

Watch for future eNews issues with updated information about the CDC Cooperative Agreement.