Difference between revisions of "Journal:Developing a customized approach for strengthening tuberculosis laboratory quality management systems toward accreditation"

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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.<ref name="YaoImproving10">{{cite journal |title=Improving quality management systems of laboratories in developing countries: An innovative training approach to accelerate laboratory accreditation |journal=American Journal of Clinical Pathology |author=Yao, K.; McKinney, B.; Murphy, A. et al. |volume=134 |issue=3 |pages=401–9 |year=2010 |doi=10.1309/AJCPNBBL53FWUIQJ |pmid=20716796}}</ref> 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.<ref name="YaoEvidence14">{{cite journal |title=Evidence from 617 laboratories in 47 countries for SLMTA-driven improvement in quality management systems |journal=African Journal of Laboratory Medicine |author=Yao, K.; Luman, E.T.; SLMTA Collaborating Authors |volume=3 |issue=3 |pages=262 |year=2014 |doi=10.4102/ajlm.v3i2.262 |pmid=26753132 |pmc=PMC4706175}}</ref> Only four National Tuberculosis Reference Laboratories (NTRLs) in Africa have achieved international accreditation to date<ref name="SANASDirectory15">{{cite web |url=http://home.sanas.co.za/?page_id=38 |title=Directory of Accredited Facilities |publisher=South African National Accreditation System |date=2015 |accessdate=22 August 2016}}</ref><ref name="IPACDirectorio">{{cite web |url=http://www.ipac.pt/pesquisa/acredita.asp |title=Directório de Entidades Acreditradas |publisher=Instituto Português de Acreditação |accessdate=19 January 2016}}</ref>, 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.<ref name="RidderhofRoles07">{{cite journal |title=Roles of laboratories and laboratory systems in effective tuberculosis programmes |journal=Bulletin of the World Health Organization |author=Ridderhof, J.C.; van Deun, A.; Kam, K.M. et al. |volume=85 |issue=5 |pages=354-9 |year=2007 |pmid=17639219 |pmc=PMC2636656}}</ref>
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.<ref name="YaoImproving10">{{cite journal |title=Improving quality management systems of laboratories in developing countries: An innovative training approach to accelerate laboratory accreditation |journal=American Journal of Clinical Pathology |author=Yao, K.; McKinney, B.; Murphy, A. et al. |volume=134 |issue=3 |pages=401–9 |year=2010 |doi=10.1309/AJCPNBBL53FWUIQJ |pmid=20716796}}</ref> 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.<ref name="YaoEvidence14">{{cite journal |title=Evidence from 617 laboratories in 47 countries for SLMTA-driven improvement in quality management systems |journal=African Journal of Laboratory Medicine |author=Yao, K.; Luman, E.T.; SLMTA Collaborating Authors |volume=3 |issue=3 |pages=262 |year=2014 |doi=10.4102/ajlm.v3i2.262 |pmid=26753132 |pmc=PMC4706175}}</ref> Only four National Tuberculosis Reference Laboratories (NTRLs) in Africa have achieved international accreditation to date<ref name="SANASDirectory15">{{cite web |url=http://home.sanas.co.za/?page_id=38 |title=Directory of Accredited Facilities |publisher=South African National Accreditation System |date=2015 |accessdate=22 August 2016}}</ref><ref name="IPACDirectorio">{{cite web |url=http://www.ipac.pt/pesquisa/acredita.asp |title=Directório de Entidades Acreditradas |publisher=Instituto Português de Acreditação |accessdate=19 January 2016}}</ref>, 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.<ref name="RidderhofRoles07">{{cite journal |title=Roles of laboratories and laboratory systems in effective tuberculosis programmes |journal=Bulletin of the World Health Organization |author=Ridderhof, J.C.; van Deun, A.; Kam, K.M. et al. |volume=85 |issue=5 |pages=354-9 |year=2007 |pmid=17639219 |pmc=PMC2636656}}</ref>
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<ref name="RaizadaAMulti14">{{cite journal |title=A multi-site validation in India of the line probe assay for the rapid diagnosis of multi-drug resistant tuberculosis directly from sputum specimens |journal=PLoS One |author=Raizada, N.; Sachdeva, K.S.; Chauhan, D.S. et al. |volume=9 |issue=2 |pages=e88626 |year=2014 |doi=10.1371/journal.pone.0088626 |pmid=24586360 |pmc=PMC3929364}}</ref> and upgrading of facilities.<ref name="RaizadaFeasib14">{{cite journal |title=Feasibility of decentralised deployment of Xpert MTB/RIF test at lower level of health system in India |journal=PLoS One |author=Raizada, N.; Sachdeva, K.S.; Sreenivas, A. et al. |volume=9 |issue=2 |pages=e89301 |year=2014 |doi=10.1371/journal.pone.0089301 |pmid=24586675 |pmc=PMC3935858}}</ref><ref name="AlbertRapid10">{{cite journal |title=Rapid screening of MDR-TB using molecular Line Probe Assay is feasible in Uganda |journal=BMC Infectious Diseases |author=Albert, H.; Bwanga, F.; Mukkada, S. et al. |volume=10 |pages=41 |year=2010 |doi=10.1186/1471-2334-10-41 |pmid=20187922 |pmc=PMC2841659}}</ref><ref name="AlbertPerform10">{{cite journal |title=Performance of three LED-based fluorescence microscopy systems for detection of tuberculosis in Uganda |journal=PLoS One |author=Albert, H.; Manabe, Y.; Lukyamuzi, G. et al. |volume=5 |issue=12 |pages=e15206 |year=2010 |doi=10.1371/journal.pone.0015206 |pmid=21203398 |pmc=PMC3011008}}</ref><ref name="ParamasivanExperience10">{{cite journal |title=Experience establishing tuberculosis laboratory capacity in a developing country setting |journal=International Journal of Tuberculosis and Lung Disease |author=Paramasivan, C.N.; Lee, E.; Kao, K. et al. |volume=13 |issue=1 |pages=59-64 |year=2010 |pmid=20003696}}</ref> 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.<ref name="GLIStepwise">{{cite web |url=http://www.gliquality.org/ |title=GLI Stepwise Process towards TB Laboratory Accreditation |publisher=Global Laboratory Initiative |accessdate=22 August 2016}}</ref> 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.


==References==
==References==

Revision as of 21:59, 15 January 2018

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.

References

  1. World Health Organization (2015). "WHO End TB Strategy: Global strategy and targets for tuberculosis prevention, care and control after 2015". http://who.int/tb/post2015_strategy/en/. Retrieved 22 August 2016. 
  2. World Health Organization (2015). "Global Tuberculosis Report 2015" (PDF). ISBN 9789241565059. http://apps.who.int/iris/bitstream/10665/191102/1/9789241565059_eng.pdf. Retrieved 22 August 2016. 
  3. Kuznetsov, V.N.; Grjibovski, A.M.; Mariandyshev, A.O. et al. (2014). "Two vicious circles contributing to a diagnostic delay for tuberculosis patients in Arkhangelsk". Emerging Health Threats Journal 7: 24909. doi:10.3402/ehtj.v7.24909. PMC PMC4147085. PMID 25163673. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4147085. 
  4. Alemnji, G.A.; Zeh, C.; Yao, K.; Fonjungo, P.N. (2014). "Strengthening national health laboratories in sub-Saharan Africa: a decade of remarkable progress". Tropical Medicine & International Health 19 (4): 450-8. doi:10.1111/tmi.12269. PMC PMC4826025. PMID 24506521. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4826025. 
  5. Gershy-Damet, G.M.; Rotz, P.; Cross, D. et al. (2010). "The World Health Organization African region laboratory accreditation process: Improving the quality of laboratory systems in the African region". American Journal of Clinical Pathology 134 (3): 393-400. doi:10.1309/AJCPTUUC2V1WJQBM. PMID 20716795. 
  6. Peter, T.F.; Rotz, P.D.; Blair, D.H. et al. (2010). "Impact of laboratory accreditation on patient care and the health system". American Journal of Clinical Pathology 134 (4): 550-5. doi:10.1309/AJCPH1SKQ1HNWGHF. PMID 20855635. 
  7. Yao, K.; McKinney, B.; Murphy, A. et al. (2010). "Improving quality management systems of laboratories in developing countries: An innovative training approach to accelerate laboratory accreditation". American Journal of Clinical Pathology 134 (3): 401–9. doi:10.1309/AJCPNBBL53FWUIQJ. PMID 20716796. 
  8. Yao, K.; Luman, E.T.; SLMTA Collaborating Authors (2014). "Evidence from 617 laboratories in 47 countries for SLMTA-driven improvement in quality management systems". African Journal of Laboratory Medicine 3 (3): 262. doi:10.4102/ajlm.v3i2.262. PMC PMC4706175. PMID 26753132. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4706175. 
  9. "Directory of Accredited Facilities". South African National Accreditation System. 2015. http://home.sanas.co.za/?page_id=38. Retrieved 22 August 2016. 
  10. "Directório de Entidades Acreditradas". Instituto Português de Acreditação. http://www.ipac.pt/pesquisa/acredita.asp. Retrieved 19 January 2016. 
  11. Ridderhof, J.C.; van Deun, A.; Kam, K.M. et al. (2007). "Roles of laboratories and laboratory systems in effective tuberculosis programmes". Bulletin of the World Health Organization 85 (5): 354-9. PMC PMC2636656. PMID 17639219. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2636656. 
  12. Raizada, N.; Sachdeva, K.S.; Chauhan, D.S. et al. (2014). "A multi-site validation in India of the line probe assay for the rapid diagnosis of multi-drug resistant tuberculosis directly from sputum specimens". PLoS One 9 (2): e88626. doi:10.1371/journal.pone.0088626. PMC PMC3929364. PMID 24586360. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3929364. 
  13. Raizada, N.; Sachdeva, K.S.; Sreenivas, A. et al. (2014). "Feasibility of decentralised deployment of Xpert MTB/RIF test at lower level of health system in India". PLoS One 9 (2): e89301. doi:10.1371/journal.pone.0089301. PMC PMC3935858. PMID 24586675. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3935858. 
  14. Albert, H.; Bwanga, F.; Mukkada, S. et al. (2010). "Rapid screening of MDR-TB using molecular Line Probe Assay is feasible in Uganda". BMC Infectious Diseases 10: 41. doi:10.1186/1471-2334-10-41. PMC PMC2841659. PMID 20187922. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2841659. 
  15. Albert, H.; Manabe, Y.; Lukyamuzi, G. et al. (2010). "Performance of three LED-based fluorescence microscopy systems for detection of tuberculosis in Uganda". PLoS One 5 (12): e15206. doi:10.1371/journal.pone.0015206. PMC PMC3011008. PMID 21203398. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3011008. 
  16. Paramasivan, C.N.; Lee, E.; Kao, K. et al. (2010). "Experience establishing tuberculosis laboratory capacity in a developing country setting". International Journal of Tuberculosis and Lung Disease 13 (1): 59-64. PMID 20003696. 
  17. "GLI Stepwise Process towards TB Laboratory Accreditation". Global Laboratory Initiative. http://www.gliquality.org/. Retrieved 22 August 2016. 

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.