Attaining ISO 15189 accreditation through SLMTA: A journey by Kenya’s National HIV Reference Laboratory

Background The National HIV Reference Laboratory (NHRL) serves as Kenya’s referral HIV laboratory, offering specialised testing and external quality assessment, as well as operating the national HIV serology proficiency scheme. In 2010, the Kenya Ministry of Health established a goal for NHRL to achieve international accreditation. Objectives This study chronicles the journey that NHRL took in pursuit of accreditation, along with the challenges and lessons learned. Methods NHRL participated in the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme from 2010–2011. Improvement projects were undertaken to address gaps in the 12 quality system essentials through development of work plans, team formation, training and mentorship of personnel. Audits were conducted and the scores used to track progress along a five-star grading scale. Standard quality indicators (turn-around time, specimen rejection rates and service interruptions) were measured. Costs of improvement projects and accreditation were estimated based on expenditures. Results NHRL scored 45% (zero stars) at baseline in March 2010 and 95% (five stars) after programme completion in October 2011; in 2013 it became the first public health laboratory in Kenya to attain ISO 15189 accreditation. From 2010–2013, turn-around times decreased by 50% – 95%, specimen rejections decreased by 93% and service interruptions dropped from 15 to zero days. Laboratory expenditures associated with achieving accreditation were approximately US $36 500. Conclusion International accreditation is achievable through SLMTA, even for a laboratory with limited initial quality management systems. Key success factors were dedication to a shared goal, leadership commitment, team formation and effective mentorship. Countries wishing to achieve accreditation must ensure adequate funding and support.


Introduction
The burden of HIV in Kenya is high, with 1.6 million people living with the infection as of December 2011, including 621 813 patients who had been placed on antiretroviral therapy (ART) by 2010. In order to support diagnostic testing and laboratory monitoring of HIV patients, there is a high demand for quality laboratory services, as 5.7 million HIV tests were performed in 2012 alone. 1 have QMS in place and was not benchmarking itself against international standards. The quality of analytical testing and services was not validated, limiting its ability and authority to act as a centre of excellence.
In 2010, the NHRL adopted the Ministry of Health's goal to accredit all national and regional level public laboratories in Kenya to the International Organization for Standardization (ISO) 15189 standard, which is specifically designed to encourage medical laboratories to develop a highly disciplined approach to improving the quality of services. 7 ISO 15189 assesses the competence of the QMS within the laboratory, 8 provides a framework for increased analytical quality 9 and verifies that laboratories are not deviating from quality and competency standards. 10 The accreditation journey at the NHRL began in 2009 when laboratory management invited a consultant from A Global Healthcare Public Foundation (AGHPF) to review the current laboratory QMS and provide advice on needed improvements. The findings of this review stirred the management to seek assistance in the development and implementation of a more robust QMS.
In 2010, NHRL adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme and enrolled in Kenya's first cohort along with 12 other laboratories, with the goal of attaining ISO 15189 accreditation.
This paper chronicles the journey that the NHRL took in the pursuit of international accreditation, along with the challenges and lessons learnt. We show how management commitment, team formation, culture change and mentorship were instrumental in the successful completion of this journey.

Research method and design Study site
The NHRL is located in the capital city of Nairobi and consists of three main sections: serology, molecular, and ART monitoring. In addition, there are two cross-cutting sections: logistics, and monitoring and evaluation. Each section is managed by a team lead.
In its role as an HIV referral laboratory and centre of excellence, the NHRL is responsible for strengthening laboratory systems for HIV diagnosis, care, treatment and surveillance. It provides leadership and support to the national HIV laboratory programme by formulating policy and guidelines on HIV laboratory-related issues and coordinating activities and partners. The NHRL offers reference services in HIV testing and laboratory ART monitoring, including HIV viral load testing, early infant diagnosis, CD4 lymphocyte enumeration and the evaluation and monitoring of the quality of HIV testing reagents and equipment. It also provides and coordinates EQA services in HIV testing by running the national HIV Serology Quality Assurance Program for over 7000 laboratory and non-laboratory testing personnel. Additionally, the NHRL is responsible for EQA programmes in CD4 lymphocyte enumeration, haematology and chemistry. The NHRL also provides support and mentoring to HIV testing and ART monitoring personnel, as well as building in-country capacity to design, implement and evaluate HIV-related surveillance systems and surveys.

SLMTA process and evaluation
The SLMTA programme uses the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist in order to identify strengths and weaknesses and to measure progress. The SLIPTA checklist provides an evaluation score based on laboratory quality in the 12 quality system essentials (QSEs). Laboratories are assigned a 'star' level based on their scores: zero stars (0% -54%), one star (55% -64%), two stars (65% -74%), three stars (75% -84%), four stars (85% -94%), and five stars (≥ 95%). Laboratories that score five stars are encouraged to pursue ISO 15189 accreditation. 11 A baseline audit was conducted in March 2010 by SLMTA in-country trainers using the SLIPTA checklist. This was followed by the first SLMTA workshop in April 2010, then the second workshop in September of the same year and the third workshop in January 2011. An exit audit was conducted by auditors from the Kenya Accreditation Service (KENAS) in October 2011.
In February 2012, a consultant from the South Africa National Accreditation Service (SANAS) performed a preaccreditation assessment utilising the SANAS 15189 checklist in order to determine readiness for accreditation.
Several quality indicators were monitored weekly, monthly or annually so as to assess the impact of the SLMTA programme on laboratory service quality and patient care. Specimen turnaround times for viral load, enzyme-linked immunosorbent assay (ELISA) and CD4 tests were calculated using data from the laboratory information management system (LIS). Information on service interruptions because of equipment downtime and stockouts was obtained from the LIS monthly and averaged over a calendar year. Customer satisfaction was estimated from patient feedback forms that were availed either in laboratory reception areas or by mailing to customers. Specimen rejections were tallied from the LIS. Corrective actions and occurrence management were evaluated based on completed corrective action forms and quarterly reports. These were divided into three phases: pre-analytic, analytic and post-analytic. Routine results from EQA panel tests for all analytes were collated and performance evaluated using Microsoft ® Excel 2007, by aggregating the score achieved in every EQA challenge and obtaining a percentage score. A score of 100% was desirable, whilst any score below this would call for corrective action.

Team formation
To implement the QMS, a strategic, tiered, accreditation team structure with a clear reporting mechanism was formed. The structure included a Management Team, a Quality Assurance (QA) Team and Section Teams.
The Management Team was composed of the laboratory manager, deputy laboratory manager/QA manager, Section Team leads, the safety officer and the logistician. This core group guided the accreditation process and held regular review meetings in order to track progress and monitor the quality indicators adopted by the laboratory. They also reviewed gaps identified in both internal and external audits and formulated plans for continuous quality improvement.
The QA Team, reporting to the Management Team, was chaired by the QA manager/deputy laboratory manager and two QA officers (one also serving as the safety officer). This team was responsible for monitoring the accreditation process, offering leadership and coordinating the implementation of various improvement projects. Each member of this team was assigned to a section and mentored by the QA manager.
Section Team leads were given authority to make decisions and were ultimately responsible for improvement projects within their section. The Section Teams held weekly meetings to discuss problems and possible solutions and to track the progress of improvement projects within their section. Section Team leads reported to the QA team on all critical issues pertaining to QMS implementation.
Annual staff retreats were held at the beginning of each year, during which work plans were developed with clear timelines and action points that incorporated all 12 QSEs and were based on ISO 15189 requirements. Team building also took place during the annual staff retreats. These plans were posted on bulletin boards where they were visible to all staff. Regular monthly staff meetings were held in order to review work plans and monitor progress of the quality improvement initiative. After every internal and external audit, work plans were modified so as to reflect progress made and to redirect efforts where needed.
Individual staff members set annual accreditation goals and targets against which they were appraised for their annual staff performance contracts. An employee recognition scheme was put in place and incentives were provided. Laboratory management led the way by prioritising accreditation and making sure that all personnel were keenly aware of the accreditation goal; accreditation was the main agenda item in all meetings and took priority in budget considerations, ensuring that resources required for the process were secured.

Improvement projects
Improvement projects were undertaken for all 12 QSEs in order to address the gaps identified in the audits. Each member of the NHRL staff was responsible for at least one project with clear timelines. The findings of routine audits were used to make continual improvements within the QMS. The laboratory undertook more improvement projects (Table 1) than required by Kenya's SLMTA team, including changes to the design of the laboratory and development of workflow diagrams. The plan-do-check-act cycle was adopted in implementation of the quality improvement projects. 12 Most importantly, method validation was performed in order to assess the methods and equipment utilised in the laboratory. 13 All staff members were actively involved in the quality improvement projects. Work plans were developed at the beginning of each year and after every audit. The work plans involved establishing a strategic goal and objective, with responsibility and project timeline assigned. Work plans were reviewed regularly in staff meetings and were located centrally in the laboratory for easy reference. The work plans served as valuable tools for setting realistic targets, measuring progress and enforcing individual responsibility, leading to a focused implementation of improvement projects. Flow diagrams were developed to assist in identifying weak areas and making necessary improvements.

Mentorship
Two mentors from CDC's International Laboratory Branch, Division of Global HIV/AIDS in Atlanta spent a total of eight weeks in the NHRL during the SLMTA process. An initial three-week visit was made in January 2011 following the second SLMTA workshop. To make effective use of the mentors' time on site, a brief report was prepared by the NHRL in advance of the first visit and shared with the mentors, including information on test methods and equipment used in the NHRL. At the beginning of the visit an internal audit was performed and a work plan developed based on the findings, in collaboration with the QA team and individual members of the various laboratory sections. At the end of the visit another audit was performed and the entire team participated in development of another work plan for outstanding issues.
Long-distance support then followed via email for a sixmonth period. An additional two-week visit was made by one of the mentors, who is also a member, inspector and team lead for the College of American Pathologists. A final three-week visit was made by both mentors in January 2012, three months after the exit audit, in order to prepare the laboratory for the ISO accreditation pre-assessment.

Audit scores and accreditation
At the baseline audit in March 2010 before SLMTA implementation, NHRL scored 45%, corresponding to zero stars. At the October 2011 exit audit, the laboratory more than doubled their score to 95%, earning five stars. In March 2013, three years after initiation of SLMTA, the NHRL achieved accreditation to ISO 15189.

Improvement projects
Gaps were identified in all 12 QSEs after the baseline audit. Improvement projects were undertaken to address these problems (Table 1). Some projects were one-time activities, such as development of policies and procurement; for example a policy on environmental control was developed and room thermometers were procured. Other projects implemented more comprehensive on-going changes to laboratory procedures, such as quarterly analysis of occurrence management and keeping minutes at staff meetings. All the improvement projects that were undertaken were completed by the time the laboratory attained accreditation.

Quality indicators and costs
Average turn-around time for viral load testing decreased from 20 days in 2010 to six days in 2013 (70%). Similarly, ELISA turn-around time decreased from 191 days to 10 days (95%). CD4 turn-around time decreased from 24 hours to 12 hours (50%). The number of rejected specimens decreased from 133 in 2010 to nine in 2013 (93%) and the number of service interruption days decreased from 15 to zero (100%) ( Table 2).
The cost to the laboratory to conduct SLMTA improvement projects and to continue through to ISO 15189 accreditation was US$36 500 (Table 3).

Discussion
The NHRL was successful in achieving accreditation to ISO 15189 in March 2013, three years after beginning the quality improvement process. High-quality laboratory testing is critical for patient care, disease prevention and disease surveillance. 5 Although the majority of laboratory testing is done by public laboratories, no laboratory in the public sector had been accredited previously in Kenya, as all eight accredited laboratories were private or research laboratories. In fact, in all of sub-Saharan Africa except South Africa, only two public laboratories had been accredited previously to international standards: one in Namibia and one in Botswana. 14 The success of NHRL was a result of several factors. Firstly, the team was built with a shared vision, all striving to   meet ISO 15189 requirements. Collective involvement has been shown elsewhere to be important in implementing change. 15,16 The SLMTA trainees shared their projects with all staff, who then took up responsibility; this helped to prevent the mentality that quality improvement was 'someone else's job' and ensured shared ownership of the process. In the weekly section meetings, brainstorming led to development of local solutions and sharing of best practices, ensuring there was no slackening of momentum. These meetings also enhanced the cohesiveness of the entire NHRL staff team.
Secondly, the old adage is true: what gets measured, gets done. SLIPTA scores and star levels provided a framework for identifying strengths and weaknesses and quantifying progress. The baseline audit offered an objective analysis of processes in the laboratory, revealed critical gaps in the system and guided the team in initiating a gradual process of preparedness for accreditation. The exit audit documented how far the laboratory had come, giving leadership and staff the motivation to continue improving and the confidence to seek international accreditation.
Thirdly, the SLMTA programme provided NHRL staff the training needed to make QMS improvements quickly and to prepare for accreditation. The laboratory used SLMTA improvement projects as a springboard to implement additional projects with a wider scope in order to cover all aspects of the QMS. Changes to the design of the laboratory and workflow diagrams allowed efficient and logical flow of work processes. Improvement in testing turn-around time was achieved by preventing service disruptions, ensuring uninterrupted reagent supply, establishing equipment service contracts and creating a back-up programme.
Fourthly, mentorship was key in helping the laboratory customise solutions. Effective mentorship has been shown to be a success factor in the implementation of SLMTA in various settings. 16,17 The two CDC mentors not only spent periods of time in the facility but also offered guidance and assistance remotely. The intense preparation conducted by laboratory staff before the visits enhanced focus and sustainability when the mentors left. The mentors did not perform tasks, but instead guided laboratory staff to do them, fostering ownership and building capacity. Contact was maintained with mentors after they left, ensuring continuity. The mentees identified high-priority areas in which they required assistance, saving time onsite. A positive staff attitude facilitated the productive relationships with mentors; no time was wasted in finding common ground because all shared the same goal of NHRL accreditation.
Finally, continued focus on accreditation after SLMTA allowed the laboratory to reach even higher levels. The preaccreditation assessment conducted by the SANAS assessor offered an objective in-depth analysis using a different checklist and gave laboratory staff an idea of what to expect in the accreditation visit. Findings from this assessment were used to address remaining gaps prior to the official inspection.
NHRL faced many critical challenges in implementing QMS, as summarised in Table 4. One serious problem that remains unsolved is staff attrition. Because the government handles staff deployment, trained staff members are often transferred to other laboratories. NHRL is working with the Ministry of Health to prioritise continuity of staff and training for new staff members in order to sustain quality levels.
The NHRL spent approximately US$36 500 in pursuit of ISO 15189 accreditation, in addition to that spent by the Ministry of Health on SLMTA training and by partners for mentorship and additional training. One of the largest expenses was the placement of equipment on service contracts. To reduce costs, the laboratory adopted the equipment placement model, whereby an equipment manufacturer places equipment in a laboratory at no cost, recovering their expenses by selling reagents to the laboratory. Other substantial expenses included the renovation of a storage room to overcome space shortages and installation of a

Challenge identified Solution
Staff thought that the accreditation mandate belonged to the QA manager alone Change in staff culture and attitude resulted from a three pronged approach: mentorship in accredited laboratories, training on ISO 15189, and training on Good Clinical Laboratory Practice. As a result, staff were now knowledgeable on what was required, best practises, and the benefit of accreditation. All staff were involved in selecting and managing improvement projects. This made it easier for everyone to embrace the quality management system.

Lack of knowledge on ISO 15189 standard requirements
All laboratory staff received training on ISO 15189 and Good Clinical Laboratory Practice. Everyone was also given a personal copy of the ISO standard, and were challenged to refer to it often to identify issues that they could help resolve.
Staff concerns about filling out corrective action forms and occurrence management reports because they thought of them as punitive The training on ISO helped staff understand the importance of occurrence management. This was reinforced by involving them in revising the existing corrective action form followed by training by the Quality Assurance Team. Staff were reassured that the forms and reports would be used for improvement only, and would not be used against them.
Procurement process was slow, delaying implementation of projects Staff learned to plan ahead and place orders with long lead times.

Development of method validation protocols for each test method is complicated
Method validation training was provided to all staff, including training on accuracy, precision, and reportable ranges.

Various experts and mentors had contradicting styles and opinions
Early in the process, the laboratory selected two mentors that they used exclusively for the duration of the process. Proper engagement structures were set in place for stakeholders and support partners.
Major safety deficiencies and shortage of space Due to shortage of space, the laboratory was borrowing storage space over which it did not have control. It was therefore difficult to set up emergency exits and dedicated areas for freezers and fridges. Permanent space was eventually acquired in nearby facilities.
Lack of accredited public laboratories to use as back-up (private accredited laboratories would require payment) A checklist for evaluation of nearby public laboratories was developed to help identify and prepare other laboratories to perform back-up services.
QA, Quality Assurance; ISO, International Organization for Standardization. temperature-monitoring system in order to improve the archiving of specimens. The largest single expense was the purchase of a back-up generator; this purchase also benefited other users within the National Public Health Laboratories complex. Many key components of the programme were paid for by various partners and were thus not included in the cost estimate. For example, ISO training was sponsored by Management Sciences for Health and included staff from other laboratories. Personnel were immunised by the Division of Vaccination in the Ministry of Health. Finally, the AGHPF consultant and CDC mentors, critical for readying the laboratory for accreditation, were sponsored by their respective organisations.
Cost considerations must be weighed against the benefits of quality improvement. Some improvements will result in large cost savings over time. Human resource management has been made easier as staff competencies are assessed annually; personnel are now more efficiently assigned to specific responsibilities based on their core competencies. The process of HIV results confirmation, which used to take more than one month, now takes less than 10 days, ensuring rapid resolution nationwide for clients with discrepant HIV results. HIV viral load results are now received in less than 10 days; this information is critical with regard to alerting clinicians to the need to change treatment regimens for patients with treatment failure, thus reducing their likelihood of developing drug resistance. Services are no longer interrupted because of reagent shortages or equipment downtime and adherence to sample handling guidelines has greatly reduced rejected samples, decreasing both costs and wastage. 18 Accreditation also provides immeasurable benefits in enabling the NHRL to fulfil its mission as the country's reference laboratory for HIV testing. It has accorded the NHRL international recognition and elevated customer confidence with respect to the reliability of services as they fulfil their mandate. Pursuit of accreditation has led to significant improvement in the quality of both analytical test results and customer service. Because of the central role the laboratory plays in Kenya, these benefits have a direct impact on the quality of HIV testing and monitoring throughout the country.

Conclusion
The experience of Kenya's NHRL shows that it is feasible to attain international accreditation through the implementation of the SLMTA programme, even in settings with poor resources and laboratories without initial systems.