Journal:Developing a customized approach for strengthening tuberculosis laboratory quality management systems toward accreditation

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Full article title Developing a customized approach for strengthening tuberculosis laboratory quality management systems toward accreditation
Journal African Journal of Laboratory Medicine
Author(s) Albert, Heidi; Trollip, Andre; Erni, Donatelle; Kao, Kekeletso
Author affiliation(s) Foundation for Innovative New Diagnostics
Primary contact Email: heidi dot albert at finddx dot org
Year published 2017
Volume and issue 6 (2)
Page(s) a576
DOI 10.4102/ajlm.v6i2.576
ISSN 2225-2010
Distribution license Creative Commons Attribution 2.0 Generic
Website http://www.ajlmonline.org/index.php/ajlm/article/view/576/826
Download http://www.ajlmonline.org/index.php/ajlm/article/viewFile/576/816 (PDF)

Abstract

Background: Quality-assured tuberculosis laboratory services are critical to achieve global and national goals for tuberculosis prevention and care. Implementation of a quality management system (QMS) in laboratories leads to improved quality of diagnostic tests and better patient care. The Strengthening Laboratory Management Toward Accreditation (SLMTA) program has led to measurable improvements in the QMS of clinical laboratories. However, progress in tuberculosis laboratories has been slower, which may be attributed to the need for a structured tuberculosis-specific approach to implementing QMS. We describe the development and early implementation of the Strengthening Tuberculosis Laboratory Management Toward Accreditation (TB SLMTA) program.

Development: The TB SLMTA curriculum was developed by customizing the SLMTA curriculum to include specific tools, job aids, and supplementary materials specific to the tuberculosis laboratory. The TB SLMTA Harmonized Checklist was developed from the World Health Organisation Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation checklist and incorporated tuberculosis-specific requirements from the Global Laboratory Initiative Stepwise Process Towards Tuberculosis Laboratory Accreditation online tool.

Implementation: Four regional training-of-trainers workshops have been conducted since 2013. The TB SLMTA program has been rolled out in 37 tuberculosis laboratories in 10 countries, using the workshop approach in 32 laboratories in five countries and the facility-based approach in five tuberculosis laboratories in five countries.

Conclusion: Lessons learned from early implementation of TB SLMTA suggest that a structured training and mentoring program can build a foundation towards further quality improvement in tuberculosis laboratories. Structured mentoring, and institutionalization of QMS into country programs, is needed to support tuberculosis laboratories to achieve accreditation.

Introduction

The World Health Organization’s (WHO) End TB Strategy calls for an end to the global tuberculosis epidemic. It aims to reduce deaths by 95 percent and new tuberculosis cases by 90 percent, and also ensure that no family is burdened with catastrophic expenses due to tuberculosis by 2025.[1] Despite the fall in global tuberculosis mortality by 47 percent since 1990, the disease still claimed more than 1.5 million lives in 2014.[2] A cascade of events — including poor screening, failure to link screened patients to diagnostic services, and failure to link diagnosed patients to treatment — means that many people die from tuberculosis due to delayed diagnosis and treatment initiation.[3]

Quality-assured laboratory services are critical for the provision of timely, accurate, and reliable results to support diagnosis, drug-resistance testing, treatment monitoring, and surveillance of disease. Weak laboratory systems result in high levels of laboratory error that impact patient care and undermine the confidence healthcare providers have in laboratory services.[4] In recent years, the focus on improving laboratory quality management systems (QMS), and assuring the quality of laboratory services by working toward national or international laboratory accreditation, has intensified.[5] Accreditation is the formal recognition of implementation of a QMS that adheres to international standards and has been shown to improve the quality of healthcare for patients through reduction in testing errors.[6]

The Strengthening Laboratory Management Toward Accreditation (SLMTA) program was developed by the United States Centers for Disease Control and Prevention in collaboration with the American Society for Clinical Pathology, the Clinton Health Access Initiative, and the WHO Regional Office for Africa to promote immediate and measurable quality improvement in laboratories in developing countries. SLMTA is a program that may be used to prepare laboratories for accreditation.[7] Since its launch in Kigali, Rwanda in 2009, SLMTA has been implemented in 47 countries (23 in Africa), with 617 laboratories already enrolled. Eighteen per cent of the enrolled laboratories are at the national level and most (98%) are providing HIV-related services.[8] Only four National Tuberculosis Reference Laboratories (NTRLs) in Africa have achieved international accreditation to date[9][10], and only six NTRLs have undergone a formal Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) audit by the African Society for Laboratory Medicine (T. Mekonen, personal communication). Accredited NTRLs are better equipped to support the national tuberculosis laboratory network and also provide reliable support to their national tuberculosis control and treatment programs.[11]

Since 2007, the Foundation for Innovative New Diagnostics (FIND) has worked with Ministries of Health to introduce new diagnostic technologies to improve the diagnosis of tuberculosis, detection of drug resistance[12] and upgrading of facilities.[13][14][15][16] Although technical capacity to conduct new tests can be developed within a relatively short time frame, persistent challenges to providing quality results in a consistent manner often remain, many of which are linked to laboratory quality system weaknesses. In 2011, through funding from the United States President’s Emergency Plan for AIDS Relief, FIND was involved in implementation of the SLMTA program in clinical laboratories in the Dominican Republic. Measurable improvement was observed in cohorts of laboratories participating in the program. However, tuberculosis laboratories were not included in this program. Concurrently, the Global Laboratory Initiative (GLI) was developing its Stepwise Process Towards Tuberculosis Laboratory Accreditation online tool.[17] This tool provided online resources and a framework consisting of four phases, but it did not have training materials or an implementation plan to enable adoption by tuberculosis laboratories. Tuberculosis laboratories, particularly at the central or regional-level, have separate facilities from other clinical laboratories. They have different requirements for biosafety and quality assurance, and they have often been excluded from accreditation efforts. Recognizing the unique needs of tuberculosis laboratories, FIND developed a comprehensive approach to tuberculosis laboratory strengthening based on the existing SLMTA approach and incorporating aspects of the GLI Stepwise Process Towards Tuberculosis Laboratory Accreditation online tool.

In this article, we describe the development of the Tuberculosis Strengthening Laboratory Management Toward Accreditation (TB SLMTA) program and the challenges experienced during early implementation in 10 countries. We also reflect on approaches that will ensure continued quality improvement to reach accreditation and institutionalization of the program.

TB SLMTA development

Customization of training materials

In 2012, FIND conducted a review of the SLMTA materials and customized the content for tuberculosis laboratories based on available tuberculosis resources (either developed internally by FIND or by other organizations). This customization included the development of specific tools, job aids, and supplementary materials for the implementation of a QMS in the tuberculosis laboratory (Table 1), but it kept the overall structure of the SLMTA curriculum. Customization included major changes to the content of the SLMTA Facilities and Safety and Quality Assurance modules (the focus was changed from the quantitative testing in SLMTA to the qualitative and semi-quantitative testing relevant to the tuberculosis laboratory). The SLMTA Laboratory Testing and Test Result Reporting modules were combined and an Auditing module was introduced. Tuberculosis laboratory-specific tools, examples and scenarios were introduced throughout all modules in the training. The TB SLMTA Harmonized Checklist was also introduced as part of the program.

The TB SLMTA curriculum was piloted in Cape Town in April 2013 in a shortened Training-of-Trainers (TOT) Workshop led by SLMTA Master Trainers and with experienced tuberculosis laboratory specialists as participants. Following the pilot workshop, some changes were made to the training materials (e.g., organization and cross-referencing of tools, adjustment of training notes for clarity, and editing errors) and the TB SLMTA Harmonised Checklist was revised.

Subsequent review and revision of the TB SLMTA curriculum has been conducted to keep the content current with an updated GLI tool (version 2.0, 2013) and WHO Regional Office for Africa SLIPTA (2015) tool. A review of the TB SLMTA curriculum was conducted in 2015 due to experience that improvement projects did not necessarily target the highest priority non-conformities. Based on feedback from previous training, minor changes were also made to the Cross-cutting, Facilities and Safety, and Quality Assurance modules.


Tab1 Albert AfricanJofLabMed2017 6-2.jpg

Table 1: Comparison of SLMTA and TB SLMTA program components

TB SLMTA Harmonized Checklist

The TB SLMTA Harmonized Checklist[18] is based on the WHO Regional Office for Africa SLIPTA checklist (2007)[19], and incorporates tuberculosis laboratory-specific requirements as provided in the GLI Stepwise Process Towards Tuberculosis Laboratory Accreditation tool, which were inserted as sub-clauses in the SLIPTA checklist. The TB SLMTA Harmonized Checklist is used to assess the QMS of the tuberculosis laboratory prior to enrollment in the program (baseline assessment) and after program completion (exit assessment). The differences between the scores obtained overall, and for each section, are a measure of the impact of the program. Assessors evaluate the laboratory operations as per checklist items, scoring the assessment and documenting their findings in detail.

The pilot version of the TB SLMTA Harmonized Checklist[20] had additional scores allocated to the tuberculosis-specific clauses. A revised checklist (TB SLMTA Harmonized Checklist v1.0), which maintained the original SLIPTA scoring system[21], was used in the TB SLMTA roll-out. Recognition is given using a five-star grading system, with the following scores corresponding to the indicated number of stars: zero stars (0–142 points; < 55%), one star (143–165 points; 55–64%), two stars (166–191 points; 65%–74%), three stars (192–217 points; 75%–84%), four stars (218–243 points; 85%–94%) and five stars (244–258 points; ≥ 95%).

The TB SLMTA Harmonized Checklist 1.0 was recently revised in keeping with SLIPTA v2:2015, and the additional clauses of International Organization for Standardization 15189:2012. The questions added pertain to risk assessment, laboratory information systems, contingency planning, and safety. The TB SLMTA Harmonized Checklist v1.0 is available in English and Spanish. The TB SLMTA Harmonized Checklist v2.1 is available in English and Russian.[16]

Implementation of TB SLMTA

Implementation of the TB SLMTA program starts with the initial engagement with the Ministry of Health on the program scope and expected outputs, as well as commitments required from the country (Figure 1). During this planning phase, the country selects the participating tuberculosis laboratories, the model of implementation, the trainees to attend the TOT, and the TB SLMTA participants who will attend the in-country training. Countries selects two or three participants per laboratory to attend the in-country TB SLMTA training. Typically, participants include the laboratory manager, quality officer, and one technician. After graduation from the TOT, the certified trainers implement the program in the country. Baseline and exit assessments are conducted with the TB SLMTA Harmonized Checklist v1.0 by trainers or SLIPTA-trained assessors with tuberculosis laboratory experience. In-country national or regional training is conducted over a period of 12–15 months. Between training sessions, participants work on improvement projects supervised by the TB SLMTA mentors. Post-TB SLMTA activities are conducted in the laboratories under supervision of the mentors before an external assessment determines the readiness for accreditation.


Fig1 Albert AfricanJofLabMed2017 6-2.jpg

Figure 1: Diagrammatic representation of the TB SLMTA program from initiation to accreditation

Training-of-trainers workshop

The TB SLMTA TOTs are conducted by SLMTA Master Trainers and are based on teach-back methodology.[22] This practice-based training approach requires trainees to play the roles of both trainer and participant as they teach the curriculum at the same time as they are learning the content. The TOTs provide trainees with an introduction to the TB SLMTA materials, practice in delivering the content and receiving feedback on their performance. The ratio of trainees to Master Trainers is a maximum of eight to one. To certify as trainers, trainees must demonstrate knowledge of TB SLMTA curriculum and proficiency in delivering training. Trainees that find teach-back challenging and do not show a good understanding of the materials graduate as one-one coaches. They can facilitate rollout in their laboratory but are not certified to train others.

Mentors are trainers who support the in-country training participants during the implementation phases between training sessions. During mentoring visits to the laboratory, they supervise the participants as they implement the improvement projects and provide resources (e.g., standard operating procedures) to implement what was taught in the training in the tuberculosis laboratory. The fundamentals of mentoring are modeled during the TOT. Trainees who are certified as trainers and who show an aptitude for mentoring are selected by the Master Trainers to perform mentoring in their countries. Mentoring in TB SLMTA builds on the relationship established between trainer and participant, and seeks to support program implementation in the laboratory. Master trainers support the certified trainers and mentors during their first national or regional training and where possible provide at least one interim visit to support mentoring. Trainers under supervision receive additional support from the Master Trainers during the workshop and, if assessed as proficient, can then graduate as trainers.

The TOTs are intensive and highly interactive, hence good language skills and a working knowledge of QMS concepts is required. Based on this observation and challenges experienced in conducting a TOT with participants with varying levels of English fluency, a mandatory online training was introduced prior to the TOT, based on the WHO's Laboratory Quality Management System: Handbook[23], to ensure that trainees have a basic understanding of QMS principles. In addition, trainees whose first language is not English are required to successfully complete an online language competency training before registration for the TOT.

References

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Notes

This presentation is faithful to the original, with only a few minor changes to grammar, spelling, and presentation, including the addition of PMCID and DOI when they were missing from the original reference. Reference 19 is a dead URL, and an archived version could not be located. Reference 21 can't be found at the author-supplied URL.