Improving Quality Management Systems of Laboratories in Developing Countries An Innovative Training Approach to Accelerate Laboratory Accreditation

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1 Kigali Conference / Improving Quality Management Systems Improving Quality Management Systems of Laboratories in Developing Countries An Innovative Training Approach to Accelerate Laboratory Accreditation Katy Yao, PhD, 1 Barbara McKinney, MD, MPH, 2 Anna Murphy, MT(ASCP), 2 Phil Rotz, 3 Winnie Wafula, MD, MSc, 4 Hakim Sendagire, PhD, 5 Scolastica Okui, MPH, 5 and John N. Nkengasong, PhD 1 Key Words: Accreditation; Management; Laboratory quality system; Laboratory ; Task-based training DOI: /AJCPNBBL53FWUIQJ Abstract The Strengthening Laboratory Management Toward Accreditation (SLMTA) program was developed to promote immediate, measurable improvement in laboratories of developing countries. The laboratory framework, a tool that prescribes managerial job tasks, forms the basis of the hands-on, activity-based curriculum. SLMTA is implemented through multiple workshops with intervening site visits to support improvement projects. To evaluate the effectiveness of SLMTA, the laboratory accreditation checklist was developed and subsequently adopted by the World Health Organization Regional Office for Africa (WHO AFRO). The SLMTA program and the implementation model were validated through a pilot in Uganda. SLMTA yielded observable, measurable results in the laboratories and improved patient flow and turnaround time in a laboratory simulation. The laboratory staff members were empowered to improve their own laboratories by using existing resources, communicate with clinicians and hospital administrators, and advocate for system strengthening. The SLMTA program supports laboratories by improving and building preparedness for accreditation. The fight against the HIV/AIDS epidemics in resourcelimited countries, particularly in sub-saharan Africa, has benefited from the recent global funding surge, primarily from the US President s Emergency Plan for AIDS Relief; the Global Fund for AIDS, Tuberculosis and Malaria; UNITAID; the World Bank; and other donors. The United States spends an estimated $10 billion per year on scaling up HIV/AIDS prevention, care, and treatment programs. 1,2 However, rapid program expansion has accentuated a problem that has long plagued the health system and undermined the program goals weak laboratory services, dilapidated laboratory infrastructures, and nonfunctioning laboratory networks. 3,4 Globally strengthening laboratory systems, infrastructure, and personnel is necessary to achieve universal access to care and treatment. 4-6 With the surge in program funding, investment in laboratory training has also increased. However, the funding for laboratory training appears limited. Furthermore, educating policy makers about the benefits of strong laboratory networks, thereby garnering support for laboratories, although crucial, is almost nonexistent. Laboratory staff tend to be promoted to supervisory and higher positions on the basis of seniority or technical expertise, not skills. Skills required to effectively manage a laboratory include using resources to efficiently meet service goals, supervising and motivating staff, initiating change, and managing relationships with patients and clinicians. 7 Management training is essential to enable laboratory managers to systematically improve their laboratories, provide quality services with limited resources, and achieve accreditation. Am J Clin Pathol 2010;134: DOI: /AJCPNBBL53FWUIQJ 401

2 Yao et al / Improving Quality Management Systems Although some effective training programs exist, 8,9 many times training alone does not lead to observable changes in laboratory practice. Ineffectiveness of workshops may relate to the curriculum content and a lack of follow-up. Often, the curriculum content is theorydense and based on generic topics such as leadership, motivation, team building, and problem solving. Trainees may have difficulty applying the theories in their daily work. The Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) Regional Office for Africa (AFRO), in partnership with the American Society for Clinical Pathology (ASCP) and the Clinton Foundation, developed Strengthening Laboratory Management Toward Accreditation (SLMTA) to provide an alternative approach to the training of laboratory and quality systems. In this article, we describe the development of a tool kit designed to guide laboratories toward the recently launched WHO AFRO Laboratory Accreditation through performance of daily tasks and routines. We also describe the results from pilot testing in Uganda. Methods Task-Based Laboratory Management Framework The framework defines in terms of laboratory-specific job tasks performed by managers. It operates under the assumption that effective training is prescriptive, not just descriptive. Instead of describing laboratory (for example, 5 traits of an effective leader ), training must be grounded in job tasks and job routines such as This is what you do to manage a laboratory effectively. 10,11 The framework was the product of a consensus by several organizations including the ASCP, Clinton Foundation, Association of Public Health Laboratories, American Society for Microbiology, Clinical and Laboratory Standards Institute, and Becton Dickinson. The components of the framework formed the backbone of the SLMTA curriculum and guided the development of the WHO AFRO Laboratory Accreditation Checklist. This framework Table 1 is organized into 4 levels of laboratories in a tiered health system. The 4 levels and the tasks performed by managers are as follows: (1) National level system strengthening tasks: Managers are responsible for the entire country s laboratory policy, infrastructure, and operations. They provide oversight to specialized reference laboratories. Their key responsibility is to create and execute a multiyear laboratory strategic plan for the country. On a daily basis, they monitor implementation of the plan and troubleshoot issues. (2) Regional/provincial level supervisory and mentoring tasks: Managers supervise specialized laboratories and departments and perform specialized testing. (3) District level laboratory operations tasks: The managers are generalists. They manage laboratories within their own institutions. (4) Community level basic laboratory operations tasks: A trained laboratory technician may manage the site under supervision from other medical staff. At each level of laboratory service described, the framework provides guidelines for managing laboratories at that level, including job tasks, routines, and job aids and tools. Job tasks answer the question, What does a manager do? These tasks are arranged into key areas of work. Desired outcomes associated with each area of work are also defined Table 2. Management routines specify when and how often each task is performed. Job aids and tools define how a task should be performed. The assessment checklist was designed to quantitatively define the situation in the laboratory in terms of observable, measurable results. It can be used for assessment during supervisory visits, planning and evaluating laboratory improvement projects, and assessing training effectiveness. The checklist, subsequently adopted as the checklist for the WHO AFRO Laboratory Accreditation scheme, now provides a roadmap for laboratories moving toward accreditation. Table 1 Task-Based Laboratory Management Framework National Regional District Community Job task list (what do you do?) Job task list (what do you do?) Job task list (what do you do?) Job task list (what do you do?) Management routines Management routines Management routines (when Management routines (when (when do you do it?) (when do you do it?) do you do it?) do you do it?) Job aids and tools Job aids and tools Job aids and tools Job aids and tools (how do you do it?) (how do you do it?) (how do you do it?) (how do you do it?) National laboratory assessment Laboratory assessment checklist Laboratory assessment checklist Laboratory assessment checklist checklist (observable results) (observable results) (observable results) (observable results) 402 Am J Clin Pathol 2010;134: DOI: /AJCPNBBL53FWUIQJ

3 Kigali Conference / Special Article The validity and applicability of the framework were field tested in Ethiopia and Uganda by interviewing 22 laboratory managers from all 4 levels. The field test resulted in only minor edits to the framework. However, as it is unrealistic to expect 1 framework to accurately reflect every country s laboratory system, it is presumed that the framework will require some country-specific customization. Nevertheless, this framework presents a comprehensive picture of what laboratory entails. SLMTA: A Task-Based Training and Mentoring Tool Kit The tool kit is a unique feature of SLMTA and includes the task-based framework, the interactive curriculum, and the checklist. The implementation model of multiple workshops with intervening site visits is an equally essential part of the training program. This tool kit may be used for on-site mentoring in addition to classroom training. Individual activities or tools may be selected based on identified gaps. The foundation of the tool kit is the laboratory operations (district-level) tasks of the framework. These tasks embody the fundamental requirements to manage a quality laboratory, irrespective of the level of the laboratory. The 10 modules in the SLMTA tool kit correspond to the 10 key areas of work in the framework Figure 1. The desired outcome of each area is the performance outcome of the module. The tasks become the learning objectives for the corresponding module. Each module contains activities designed to teach the job tasks. There are more than 40 activities in this tool kit, with a total delivery time greater than 50 hours. All of the activities are interactive and participatory, with less than 10% of total classroom time devoted to lecture. The curriculum also incorporates quality improvement tools such as process mapping, data monitoring, and Lean principles and methods (using less to do more by reducing waste in work processes) for laboratories. 12,13 The same laboratory tasks that guided the design of the training activities also formed the basis of the WHO AFRO Laboratory Accreditation Checklist, which is consistent with ISO As a result, participants see a clear link between a task they are learning and the corresponding checklist items. Each activity references the framework tasks and checklist items that it is designed to fulfill Table 3. Multiworkshop Implementation Model The implementation process is crucial to the success of the program. The model uses a series of short training sessions delivered in a 6- to12-month period. Between sessions, active learning continues with laboratory improvement projects and supportive site visits. Because behavioral changes take time, implementing multiple workshops allows the changes to be planned, monitored, and sustained. This model also allows facilitators to assess the effectiveness of training and address any observed misconceptions or gaps in the next workshop or site visit. An emphasis on action sets this program apart from other workshops. Participants are assigned laboratory improvement projects, the benefits of which have been reported. 15,16 The improvement projects are assigned based on the content covered in training and the identified gaps from the baseline assessment. Intensive coaching on project planning increases the chances for success, as do timely follow-up visits to monitor project implementation. Site visits provide the link between the classroom curriculum and the participant s home laboratory. These visits affirm and reinforce continuous performance of good laboratory practices. Between the training sessions, facilitators or mentors visit participants laboratories to provide in-depth Key Areas of Work 1. Productivity 2. Work area 3. Inventory 4. Procurement 5. Preventive maintenance of equipment 6. Quality assurance 7. Specimen collection and processing 8. Laboratory testing 9. Test result reporting 10. Documents and records Training Module Module objectives Job tasks Module content Module outcome Checklist items Learning activities (how to perform the tasks and use the tools and job aids) Figure 1 How the Strengthening Laboratory Management Toward Accreditation program was developed. Am J Clin Pathol 2010;134: DOI: /AJCPNBBL53FWUIQJ 403

4 Yao et al / Improving Quality Management Systems Table 2 Job Task List for District Level Laboratories Key Areas of Work Desired Outcome Tasks (What do they do?) 1. Productivity Efficient work flow 1.1 Organize the laboratory and coordinate work space to allow for smooth, Evenly distributed workload efficient service operations Uninterrupted service 1.2 Design work flow for optimal productivity delivery 1.3 Prioritize and assign work according to personnel skill level, workloads, and completion timeframe 1.4 Assess personnel competency against standards, and determine corrective action and training needs 1.5 Conduct weekly staff meetings to coordinate activities, review lab operations, reward success, celebrate accomplishments, and resolve issues 1.6 Meet with staff individually to communicate expectations and provide feedback, coaching, or on-the-job training to ensure competency and productivity 1.7 Provide new-hire orientation and training to staff 1.8 Maintain and update personnel records (training, certification, competency assessment) 1.9 Create a work plan and budget based on personnel, test, facility, and equipment needs 1.10 Create, review, and/or forward reports on lab operations to upper 1.11 Implement measures to motivate staff to improve quality of work and productivity (eg, training, job rotation, employee of the month, thank-you letter) 1.12 Develop and implement lab improvement plans based on best practices and feedback from staff, patients, customers, quality indicators, and external assessment 1.13 Communicate to upper regarding personnel, facility, and operational needs 2. Work area Clean, adequate, safe, 2.1 Assess any reported incidents or abnormalities and functional equipment, 2.2 Authorize and follow-up on repairs work space, and storage 2.3 Monitor staff adherence to safety rules and practices area 2.4 Ensure appropriate physical work environment for testing 2.5 Ensure that safety equipment is accessible and readily available (eg, place safety equipment such as sharps box and personal protective equipment close to workstation to encourage use) 2.6 Ensure that safety manual with safety procedures for laboratory functions and possible emergencies is accessible to and reviewed by all staff 2.7 Ensure that reagents and chemicals are stored properly 2.8 Ensure that waste is properly disposed 3. Inventory No overstocking 3.1 Review inventory log of all equipment and parts No understocking 3.2 Review inventory log of all supplies and reagents No stock-out 3.3 Monitor consumption rate and inventory level to determine when and how much to order 3.4 Enforce good stock practices (eg, proper storage, stock cycling, inspection of incoming orders) 3.5 Inspect quality of existing inventory, and dispose of expired test kits, reagents, supplies, and equipment according to policy 4. Procurement Fresh supplies always 4.1 Accurately evaluate needs for equipment, supplies, and reagents taking into available for continuous consideration past patterns, present trends, and future plans service 4.2 Place orders as necessary in accordance with needs and budgetary constraints 4.3 Monitor procurement orders 4.4 Appropriately document and maintain accurate records of all purchase orders and requisitions 5. Routine/preventive Equipment functioning 5.1 Consolidate and post equipment service information (eg, contact, service frequency, maintenance of all the time to ensure and dates) at site equipment uninterrupted and quality 5.2 Ensure proper preventive maintenance (ie, cleaning, proper shutdown) on instruments service when used 5.3 Perform and record troubleshooting on malfunctioning equipment QC, quality control; SOPs, standard operating procedures. coaching for site-specific problems, evaluate the effectiveness of training, identify common gaps to shape the focus of the next training sessions, and assess the progress of improvement projects. In subsequent workshops, participants report results of their improvement projects and share lessons learned. These reporting sessions foster accountability, allow participants to learn from each other, and facilitate the formation of a peer-support learning network, a key tenant in improvement collaboratives. 16,17 The SLMTA tool kit provides a comprehensive foundation to effect immediate behavioral changes and laboratory improvement. However, additional training, mentoring, and ongoing support are necessary to achieve sustainable improvement leading to laboratory accreditation. Additional content or mentoring may be needed in the areas of quality control, biologic safety, quality systems, writing standard operating procedures, and method validation. Results Uganda Pilot Testing The goal of pilot testing was to assess the efficacy of the SLMTA program, specifically the task-based approach and 404 Am J Clin Pathol 2010;134: DOI: /AJCPNBBL53FWUIQJ

5 Kigali Conference / Special Article Key Areas of Work Desired Outcome Tasks (What do they do?) 5.4 Review and sign maintenance logs to ensure regular preventive maintenance and timely repairs 5.5 Take corrective actions or issue repair orders and record all issues 5.6 Follow-up on all corrective action; determine if equipment is properly functioning; observe for trends, or determine training needs 5.7 Communicate to upper equipment specifications and maintenance needs 6. Quality assurance Consistently accurate 6.1 Ensure that the quality manual with quality assurance policies and procedures and reliable test process is accessible to and reviewed by all staff (preanalytical, analytical, postanalytical) 6.2 Ensure that QC material is tested according to SOPs 6.3 Establish acceptable ranges for control material 6.4 Validate new equipment, reagents, and supplies 6.5 Track test performance (eg, Levy-Jennings chart) for trends 6.6 Review discordant rates, and determine appropriate action 6.7 Review records of environmental checks and QC trends to assess impact on testing, and take corrective action 6.8 Review occurrence log for patterns/trends, and take corrective action 6.9 Monitor reagent performance 6.10 Customize site-specific SOPs as needed 6.11 Ensure that SOPs are read and understood by staff 6.12 Enroll in external quality assessment program, monitor results, and take corrective actions 6.13 Periodically observe/assess accuracy of work of personnel, and take corrective action 7. Specimen Proper specimen collection, 7.1 Determine appropriate tests based on test request and assign test responsibility collection and labeling, packaging, 7.2 Review specimen log for completeness processing storage, tracking, and 7.3 Enforce good specimen handling and processing practices disposal 7.4 Ensure adherence to specimen referral requirements 7.5 Track specimen referral status, and review referral reports to ensure timely return of test results 8. Laboratory testing All laboratory tests performed 8.1 Monitor testing to ensure SOPs are followed and tests are performed and reported promptly and accurately; test results validated and recorded before release properly and promptly 8.2 Cross-check test reports against test request to ensure completion of all tests 8.3 Review test records and findings promptly to ensure accuracy and timely release of test results 8.4 Validate assigned tests and specific abnormal results 9. Test result Reporting of accurate test 9.1 Aggregate and report all test findings for each patient reporting results and findings within 9.2 Ensure test results reach referral sites or test requestors established turnaround 9.3 Consult with clients regarding specimen quality, test results, and findings in a time; satisfied clients professional manner, and ensure that each issue is resolved promptly and documented appropriately 9.4 Conduct customer satisfaction survey to identify areas for improvement 10. Documents Permanent, secure, and 10.1 Maintain a library of documents (eg, policies, guidelines, SOPs, references); review and records traceable records and and update annually approved, up-to-date, 10.2 Maintain integrity, organization, and confidentiality of records (eg, client test and easily accessible documents results, specimen transfer logs, maintenance logs, inventory logs) 10.3 Assure proper record retention, rotation to storage, and disposal according to protocol Table 3 Example of the Relationship Among Tasks, Training Activities, and Checklist Items * Task Associated Training Activities Corresponding Checklist Items Organize the laboratory and coordinate Process + Structure = Outcome 12.1 Is the layout of the laboratory, as a whole, organized work space to allow for smooth, Improving a problem floor plan so that workstations are positioned for efficient service operations Mapping out the floor plan of optimal workflow? your laboratory 12.2 Are the client area and the testing areas of the Redesigning the floor plan of your laboratory * Section 12 of the World Health Organization Regional Office for Africa checklist assesses facilities and safety. laboratory distinctly separate with microbiology and tuberculosis testing segregated from the general laboratory? 12.3 Is each individual workstation maintained free of clutter and set up for efficient operation? 12.4 Is the physical work environment appropriate for testing? Am J Clin Pathol 2010;134: DOI: /AJCPNBBL53FWUIQJ 405

6 Yao et al / Improving Quality Management Systems multiworkshop delivery model, capture lessons learned, refine the curriculum, and guide future program rollout. Pilot participants were 17 staff members from 15 laboratories in 7 districts, including 2 laboratory assistants, 6 laboratory technicians, 5 laboratory technologists, and 4 district laboratory focal persons. No attendees held the title of laboratory manager because the position does not exist in Uganda s health care system. Learners came from health center IV and district hospital laboratories. All 17 participants completed the pilot series. Pilot Structure The pilot included a series of 3 workshops conducted by CDC and ASCP facilitators Table 4. Each workshop spanned 3 days, separated by 3- or 4-month intervals. Participants implemented assigned improvement projects after each workshop. The Uganda National Laboratory training team was responsible for conducting the follow-up site visits. Some laboratories also received a second visit by the Ugandan team and the CDC-ASCP facilitators. A laboratory assessment tool was used to record the findings for each visit. Discussion Participants, who were actively engaged throughout the training, welcomed the practical, task-based approach. The improvement projects by jumpstarting change from the laboratories current stage led participants to believe that they could make a difference despite systemic challenges and limited resources. Outcomes of the pilot were measured in terms of laboratory improvements achieved Table 5, rather than written test scores. This pilot demonstrated that when improvement Table 5 Sample Improvement Project Results in Laboratories in Uganda Improvement Laboratory Problem Project Kawolo Hospital, Stock-outs, caused by Organizing Mukono outdated stock cards storeroom and disorganized storeroom Nkozi Hospital, Loss of data because results Improving data Mpigi were not recorded immedi- collection ately in log books or result slips were taken before they were recorded Sexually Uneven distribution of workload Implementing Transmitted among staff; staff members a duty roster Infections Clinic, Mulago started work anywhere they wanted; laboratory manager performed most of the work to cover work left unfinished by others projects were done properly, laboratories were able to achieve immediate and tangible laboratory improvement even without major policy intervention or resource reallocation. Through site visits, facilitators observed improvement in storerooms, workbenches, and the sample flow. A laboratory purchased a new waste bin to allow for separation of waste; another purchased thermometers to monitor the temperatures in refrigerators and freezers. One participant met with upper regarding the removal of a nonfunctioning refrigerator, thereby freeing up space critically needed for testing. Increased communication, among laboratory staff and between laboratory staff and hospital administration, was also reported. In response to clinic administration s concerns about timely delivery of client results, the National STD (Sexually Table 4 Uganda Pilot Series Workshop No. and Time 1, August , November , March 2009 Workshop Laboratory framework Reporting of improvement projects Reporting of improvement projects content Discussion of baseline assessment results Cross-cutting Cross-cutting Cross-cutting Productivity Equipment maintenance Productivity Work area Quality assurance Improvement project planning Inventory Laboratory testing Procurement Test result reporting Specimen Improvement project planning Documents and records Improvement project planning Simulation Postworkshop Implement redesigned floor plan/ Measure turnaround time of 1 test Reorganize workstation to increase improvement specimen flow efficiency projects Create/implement a duty roster Perform safety audit, and improve Plan, develop, and assess customer 1 deficiency satisfaction An improvement project of your choice Organize storeroom or project of Arrange a meeting with clinicians your choice 406 Am J Clin Pathol 2010;134: DOI: /AJCPNBBL53FWUIQJ

7 Kigali Conference / Special Article Action Taken Achievement Challenges Held a staff meeting to share workshop Timely ordering now; disagreements, Some staff members were out for training for 2 wk, learning and discuss improvement accusations, and mistakes about leaving the task of updating stock cards for projects; organized the storeroom; misplaced items minimized 1 person updated the stock cards Held meeting with staff members to Data loss dropped from 2.5% (July) Regular monitoring of data to avoid relaxation of sensitize them about need to improve and 2.3% (August) to 0.4% (September); staff; being exemplary to the staff (personally data collection; scrutinized data collection data loss in October increased to1.5%; collecting data well) 2 mo before training and 2 mo after reasons for the increase investigated, training and corrective action performed Held a departmental meeting; studied Staff reporting to work on time knowing Resistance to the newly implemented check-in/ laboratory tasks, and created duty roster what to do; no complaint about check-put procedures; staff forgetting to with staff input; posted and implemented workload; proper workflow; supervisors follow the new procedures the duty roster; monitored and laboratory staff having confidence implementation in the manager as their leader Transmitted Disease) Clinic Laboratory in Kampala adopted turnaround time (TAT) for rapid HIV testing as its improvement project. The laboratory measured and recorded results on 1 day each week for 4 weeks. At the conclusion of the measurement period, the laboratory established that the TAT for rapid HIV testing was within 1 hour. The data confirmed that the laboratory was delivering timely services. This left clinic administration to assess other processes within the clinic to improve result reporting. In addition, the use of data to improve patient care was promoted throughout the clinic. The staff meeting activity incorporates the generic managerial concepts of communication and teamwork into a laboratory-specific, practical learning exercise. On returning to their respective laboratories, many of the participants instituted staff meetings to communicate the lessons learned and foster continuous improvement of laboratory services. One participant reported how malaria smear TAT was improved significantly as a result of meeting with, listening to, and coordinating efforts of the staff. Additional training outcomes were demonstrated in a final laboratory simulation exercise. In the phase I simulated laboratory scenario, chaos reigned. At the end of 34 minutes, the samples for 14 patients had been processed with an average TAT of 8.5 minutes. The participants were anxious to implement newly learned tools to improve the laboratory in phase II of the simulation. Working in teams, they redesigned the layout, streamlined the processes, organized inventory, specified tasks at each workstation, assigned personnel according to workload, and maintained equipment. Phase II showed noticeable improvement with an increased number of samples processed (from 14 to 34 samples), despite a shortened run time (21 vs 34 minutes). In addition, the average TAT decreased from 8.52 to 5.30 minutes. As several participants pointed out, they achieved these results without additional funding, staff, or laboratory space. Besides the observed behavioral changes and laboratory improvements, participants also reported feeling more confident and empowered as laboratory managers. At the outset of the pilot, a sense of helplessness, owing to lack of resources and lack of decision-making power, was prevalent among participants. By the end of the pilot, that sentiment had changed. They now realized they could begin immediately to improve their laboratories without additional resources or outside help. The sense of empowerment extended to interaction with the other members of the health care team. Similarly, the benefits of the multiworkshop implementation model were well demonstrated in the pilot. For example, it took several iterations of the duty roster activity combined with the testimony from other laboratory staff to convince some participants of the benefits of assigning specific tasks and workstations to the staff. In addition, common deficiencies found during site visits often led the facilitators to revise planned training activities or create new ones. Noting several disorganized phlebotomy workstations prompted the creation of a new workstation set-up activity. Furthermore, photographs captured during site visits provided powerful teaching tools, allowing participants to critically review and assess their own and each other s laboratories. Challenges Despite promising pilot results, this program faces several challenges for implementation and spread. This approach to training has a higher cost per participant compared with other in-service courses owing to the multiworkshop format and required supervisory visits. Some of the improvement project results could not be verified during Am J Clin Pathol 2010;134: DOI: /AJCPNBBL53FWUIQJ 407

8 Yao et al / Improving Quality Management Systems supervisory visits, and other projects were not sustained. Behavioral change requires time, motivation, and consistent support. This highlights the importance of continuous senior involvement and the need to hold trainees accountable for demonstrating training results. Setting explicit requirements for successful course completion from the outset is beneficial. The WHO AFRO Accreditation Checklist, alpha version, was field-tested in 4 laboratories, while Uganda s standard national supervision checklist was used on all other visits. It would be ideal if the same checklist was used to enable before-and-after comparisons. The pilot provided a proof of concept. However, turning the pilot into a sustainable process requires investment in human resources so that current laboratory personnel are not overwhelmed with the additional workload. Conclusions and Recommendations The Uganda pilot demonstrated learning transfer and behavioral changes in the laboratory from the practical, taskbased training approach. The multiworkshop delivery model with improvement projects and site visits, although challenging, was implemented successfully with immediate and tangible outcomes. SLMTA embodies several unique features: The curriculum teaches specific tasks performed by laboratory managers on a daily basis rather than generic information Table 6. SLMTA is uniquely positioned to guide laboratories toward WHO AFRO accreditation. There is a clear link between the tasks learned and the corresponding item on the Laboratory Accreditation Checklist. In addition, the checklist serves as the ultimate tool to evaluate the effectiveness of the training. The implementation model with improvement projects and site visits is essential to the program s success. Although it has been demonstrated that a level of laboratory improvement is achievable without major interventions from outside, political support, national policy, intact laboratory networks, and adequate resources are essential to complement and sustain the improvement and achieve a higher level of quality patient care. Top-down and bottom-up strategies must be coordinated and linked to support sustained improvement and progress toward accreditation. Owing to the strong linkage between SLMTA and the WHO AFRO Laboratory Accreditation Checklist, this program is well positioned to support laboratories to accelerate the process toward accreditation by WHO AFRO. To achieve that goal, we recommend the following: 1. Setting prerequisites for entry into the program ensures laboratories are ready to embark on the accreditation process. Criteria may include availability of a country national laboratory strategic plan and policy, a laboratory director with decision-making power, a quality assurance manager, and participants committed to the same job responsibilities throughout the program time frame. 2. A baseline assessment of the selected facilities should be conducted using the WHO AFRO Laboratory Accreditation Checklist at the start of the program to determine gaps and guide development of an action plan. This plan will need to outline a strategy to close the gaps, including additional training, technical assistance, or mentoring programs to complement the SLMTA program. Areas for accreditation that are not addressed in depth by SLMTA include quality control principles and practices, writing standard operating procedures, biologic safety, and quality assurance manager training. 3. Implementation of the multiworkshop delivery model, with improvement projects and on-site monitoring Table 6 SLMTA Curriculum Compared With a Generalized Management Course SLMTA Generalized Management Course Structure Series of small training sessions over time, with participants All content delivered uninterrupted through a implementing laboratory improvement projects and mentors seminar or workshop providing support visits between training Course design Laboratory-specific, task-based; performance-driven Subject matter (general topics); knowledge-driven Teaching method During training: hands-on activities; only 10% lecture Lecture Between training sessions: on-site visits and mentoring Course evaluation Laboratory improvement projects implemented between Pretest/posttest; participant feedback form workshops; simulation; accreditation checklist; participant feedback form Immediate course Behavioral changes and measurable improvement (based on Increased knowledge outcomes checklist) at participants laboratories; improved score on the accreditation checklist from baseline to end-of-training assessment SLMTA, Strengthening Laboratory Management Toward Accreditation. 408 Am J Clin Pathol 2010;134: DOI: /AJCPNBBL53FWUIQJ

9 Kigali Conference / Special Article and support, requires strong and ongoing support from ministries of health and in-country partners. Resources must be allocated, and visits must be planned in advance, not as an afterthought. 4. At the end of the SLMTA training series, another assessment should be done using the checklist. The difference in scores between the baseline and the end-ofprogram assessment is a measure of the training impact. 5. Because of SLMTA s unique training approach and unconventional delivery model, trainers and implementers of the program should undergo a trainingof-trainers or training-of-mentors program to ensure that SLMTA reaches its full impact. SLMTA trainers in the full-time employ of a ministry of health or a nongovernment organization will need dedicated time to prepare and implement training and conduct site visits. From the 1 Centers for Disease Control and Prevention, Atlanta, GA; 2 American Society for Clinical Pathology, Chicago, IL; 3 Clinton Foundation, New York, NY; 4 Centers for Disease Control and Prevention, Uganda Office, and 5 Ministry of Health, Kampala, Uganda. Address reprint request to Dr. Yao: International Laboratory Branch, Global AIDS Program, MS G-45, Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA References 1. Roberts L, Jasny B. HIV/AIDS: money matters. Science. 2008;321: Cohen J. The great funding surge. Science. 2008;321: Vitoria M, Granich R, Gilks CF, et al. The global fight against HIV/AIDS, tuberculosis, and malaria. Am J Clin Pathol. 2009;131: Petti CA, Polage CR, Quinn T, et al. Laboratory medicine in Africa: a barrier to effective health care. Clin Infect Dis. 2006;42: Birx D, de Souza M, Nkengasong JN. Laboratory challenges in the scaling up of HIV, TB, and malaria programs. Am J Clin Pathol. 2009;131: Abimiku AG. Building laboratory infrastructure to support scale-up of HIV/AIDS treatment, care, and prevention. Am J Clin Pathol. 2009;131: Vetter LP. A laboratory primer. Lab Med. 2006;37: Umble KE, Brooks J, Lowman A, et al. Management training in Vietnam s national tuberculosis program: an impact evaluation. Int J Tuberc Lung Dis. 2009;13: Sogoric S, Dzakula A, Rukavina TV, et al. Evaluation of Croatian model of polycentric health planning and decision making. Health Policy. 2009;89: Northouse PG. Leadership: Theory and Practice. 4th ed. Thousand Oaks, CA: Sage Publications; Bratton J, Gold J. Human Resource Management: Theory and Practice. 3rd ed. Mahwah, NJ: Lawrence Erlbaum; Graban M, Padgett S. Lean laboratories: competing with methods from Toyota. Lab Med. 2008;39: Novis DA. Reducing errors in the clinical laboratory: a Lean production approach. Lab Med. 2008;39: International Organization for Standardization. Medical laboratories: particular requirements for quality and competence, 2nd ed. Geneva, Switzerland: International Organization for Standardization; ISO document 15189: Wilson T, Berwick DM, Cleary PD. What do collaborative improvement projects do? experience from seven countries. Jt Comm J Qual Saf. 2003;29: Schouten LM, Hulscher ME, van Everdingen JJ, et al. Evidence for the impact of quality improvement collaboratives: systematic review [published online ahead of print June 24, 2008]. BMJ. 2008;336: Burnham G. Quality assurance methods for developing countries Accessed October Am J Clin Pathol 2010;134: DOI: /AJCPNBBL53FWUIQJ 409