Introduction of quality management in a National Reference Laboratory in Germany
Autoři:
Susanne Homolka aff001; Julia Zallet aff001; Heidi Albert aff003; Anne-Kathrin Witt aff001; Katharina Kranzer aff001
Působiště autorů:
National Reference Laboratory for Mycobacteria, Research Center Borstel, Borstel, Germany
aff001; Molecular and Experimental Mycobacteriology, Research Center Borstel, Borstel, Germany
aff002; Foundation for Innovative New Diagnostics (FIND) South Africa, Cape Town, South Africa
aff003; Clinical Research Department, London School of Hygiene and Tropical Medicine, London, England, United Kingdom
aff004
Vyšlo v časopise:
PLoS ONE 14(10)
Kategorie:
Research Article
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pone.0222925
Souhrn
Background
High quality diagnostic services are crucial for tuberculosis (TB) diagnosis, treatment and control. A strong laboratory quality management system (QMS) is critical to ensuring the quality of testing and results. Recent initiatives to improve TB laboratory quality have focused on low and middle-income countries, but similar issues also apply to high-income countries.
Methods and findings
Using a multipronged approach reviews of facilities, equipment, processes (purchasing, pre-analytic, analytic and post-analytic), staff, health and safety, documentation, information management and organization based on the ISO 15189 and the twelve quality system essentials were conducted between October 2015 and January 2016 at the National TB Reference Laboratory in Germany. Outcome assessment included proportion of smear positive slides, proportion of contaminated liquid cultures and DNA contamination rates before and after implementation of QMS. The odds ratio for these outcomes was calculated using a before/after comparison. Reviews highlighted deficiencies across all twelve quality system essentials and were addressed in order of priority and urgency. Actions aimed at improving analytical quality, health and safety and information management were prioritised for initial implementation in parallel with each other. The odds ratio for a sample to be tested as microscopically positive increased by 2.08 (95%CI 1.41–3.06) comparing the time before with the time after implementation of quality managed fluorescence microscopy. Liquid culture contamination rates decreased from 23.6- 7.6% in April-July 2016 to <10% in November 2017-March 2018. The proportion of negative controls showing evidence of DNA contamination decreased from 38.2% in 2013 to 8.1% in 2017, the corresponding odds ratio was 0.14 (95%CI 0.07–0.29).
Conclusion
This study showed marked improvement on quality indicators after implementation of a QMS in a National TB Reference Laboratory. The challenges and lessons learned in this study are valuable not just for high-income settings, but are equally generalizable to other laboratories.
Klíčová slova:
Equipment – Research laboratories – Biological laboratories – Clinical laboratory sciences – Government laboratories – Company laboratories – Safety equipment – Fire safety
Zdroje
1. Birx D, de Souza M, Nkengasong JN. Laboratory challenges in the scaling up of HIV, TB, and malaria programs: The interaction of health and laboratory systems, clinical research, and service delivery. Am J Clin Pathol 2009;131(6):849–51. doi: 10.1309/AJCPGH89QDSWFONS 19461092
2. Berner ES. Diagnostic Error in Medicine: Implications for Clinical Laboratory Scientists. Ann Clin Lab Sci 2017;47(6):649–56. 29263037
3. Plebani M. Diagnostic Errors and Laboratory Medicine–Causes and Strategies. EJIFCC 2015;26(1):7–14. 27683477
4. Allen LC. Role of a quality management system in improving patient safety—laboratory aspects. Clin Biochem 2013;46(13–14):1187–93. doi: 10.1016/j.clinbiochem.2013.04.028 Epub 13 May 3. 23648455
5. Witte DL, VanNess SA, Angstadt DS, et al. Errors, mistakes, blunders, outliers, or unacceptable results: how many? Clin Chem 1997;43(8 Pt 1):1352–6.
6. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem 2007;53(7):1338–42. doi: 10.1373/clinchem.2007.088344 Epub 2007 May 24. 17525103
7. Bundesärztekammer. Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen—Gemäß dem Beschluss des Vorstands der Bundesärztekammer vom 11.04.2014 und 20.06.2014, 2014. 111. http://www.bundesaerztekammer.de/fileadmin/user_upload/downloads/Rili-BAEK-Laboratoriumsmedizin.pdf last accessed 04.04.2018 [Regulations for quality management in laboratories—German Federal Medical Council]
8. 42 CFR 493—LABORATORY REQUIREMENTS: US Government, 2012. http://www.gpo.gov/fdsys/pkg/CFR-2011-title42-vol5/pdf/CFR-2011-title42-vol5-part493.pdf last accessed 04.04.2018
9. Musau S, McCarthy K, Okumu A, et al. Experience in implementing a quality management system in a tuberculosis laboratory, Kisumu, Kenya. Int J Tuberc Lung Dis 2015;19(6):693–5. doi: 10.5588/ijtld.14.0886 25946361
10. Kibet E, Moloo Z, Ojwang PJ, et al. Measurement of improvement achieved by participation in international laboratory accreditation in sub-Saharan Africa: the Aga Khan University Hospital Nairobi experience. Am J Clin Pathol 2014;141(2):188–95. doi: 10.1309/AJCPV8A9MRWHGXEF 24436265
11. Peter TF, Rotz PD, Blair DH, et al. Impact of laboratory accreditation on patient care and the health system. Am J Clin Pathol 2010;134(4):550–5. doi: 10.1309/AJCPH1SKQ1HNWGHF 20855635
12. RKI-Bericht zur Epidemiologie der Tuberkulose in Deutschland für 2016: Robert Koch Institute, Berlin 2017. [Tuberculosis Epidemiology in Germany 2016—Robert Koch Institute]
13. Laboratory Biosafety Manual—Third Edition. Geneva: World Health Organisation, 2004. https://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf?ua=1 last accessed 10.05.2019
14. Handbook: Laboratory Quality Management System. Geneva: World Health Organization, 2011. https://apps.who.int/iris/bitstream/handle/10665/44665/9789241548274_eng.pdf?sequence=1 last accessed 15.05.2019
15. TRBA 100 „Schutzmaßnahmen für Tätigkeiten mit biologischen Arbeitsstoffen in Laboratorien“: Ausschuss für Biologische Arbeitsstoffe, 2013. http://www.baua.de/DE/Angebote/Rechtstexte-und-Technische-Regeln/Regelwerk/TRBA/pdf/TRBA-100.pdf?__blob=publicationFile&v=4 last accessed 20.01.2018[Health and Savety Regulations when Working with Biological Hazards]
16. Normenausschuss Medizin im DIN. Medizinische Mikrobiologie-Tuberkulosediagnostik Teil 3: Kulturelle Methoden zum Nachweis von Mykobakterien DIN 58943–3. Germany: Beuth Verlag, 2011. [Standards in Medicine. Microbiology—Tuberculosis Diagnostics: Culture Methods for Diagnosis of Mycobacteria]
17. Aubert E. Cold stain for acid-fast bacteria. Can J Public Health 1950;41(1):31. 15403681
18. Fluorescent light-emitting diode (LED) microscopy for diagnosis of tuberculosis. Geneva: World Health Organization, 2011. https://apps.who.int/iris/bitstream/handle/10665/44602/9789241501613_eng.pdf?sequence=1 last accessed 15.5.2019
19. Steingart KR, Henry M, Ng V, et al. Fluorescence versus conventional sputum smear microscopy for tuberculosis: a systematic review. Lancet Infect Dis 2006;6(9):570–81. doi: 10.1016/S1473-3099(06)70578-3 16931408
20. Zallet J, Olaru ID, Witt AK, et al. Evaluation of OMNIgene((R)) SPUTUM reagent for mycobacterial culture. Int J Tuberc Lung Dis 2018;22(8):945–49. doi: 10.5588/ijtld.17.0020 29991406
21. Verstraete A, van Boeckel E, Thys M, et al. Attitude of laboratory personnel towards accreditation. Int J Health Care Qual Assur Inc Leadersh Health Serv 1998;11(1):27–30. 10177368
22. Gough LA, Reynolds TM. Is clinical pathology accreditation worth it? A survey of CPA-accredited laboratories. Clin Perform Qual Health Care 2000;8(4):195–201. 11189081
23. Shin BM, Chae SL, Min WK, et al. The implementation and effects of a clinical laboratory accreditation program in Korea from 1999 to 2006. Korean J Lab Med 2009;29(2):163–70. doi: 10.3343/kjlm.2009.29.2.163 19411785
24. Jang MA, Yoon YA, Song J, et al. Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories. Ann Lab Med 2017;37(3):213–22. doi: 10.3343/alm.2017.37.3.213 28224767
25. Tan KB, Chang SA, Soh VC, et al. Quality indices in a cervicovaginal cytology service: before and after laboratory accreditation. Arch Pathol Lab Med 2004;128(3):303–7. doi: 10.1043/1543-2165(2004)128<303:QIIACC>2.0.CO;2 14987158
26. Gachuki T, Sewe R, Mwangi J, et al. Attaining ISO 15189 accreditation through SLMTA: A journey by Kenya's National HIV Reference Laboratory. Afr J Lab Med 2014;3(2):216. doi: 10.4102/ajlm.v3i2.216 Epub 2014 Nov 3. 26753130
27. Olaru ID, Albert H, Zallet J, et al. Impact of quality improvement in tuberculosis laboratories in low- and lower-middle-income countries: a systematic review. Int J Tuberc Lung Dis 2018;22(3):309–20. doi: 10.5588/ijtld.17.0629 29471910
28. The Maputo Declaration on strengthening of laboratory systems. Geneva: World Health Organization, 2008. http://www.who.int/diagnostics_laboratory/Maputo-Declaration_2008.pdf last accessed 10.03.2018
29. Barbe B, Yansouni CP, Affolabi D, et al. Implementation of quality management for clinical bacteriology in low-resource settings. Clin Microbiol Infect 2017;23(7):426–33. doi: 10.1016/j.cmi.2017.05.007 Epub 17 May 12. 28506781
30. Ombelet S, Ronat JB, Walsh T, et al. Clinical bacteriology in low-resource settings: today's solutions. The Lancet Infectious diseases 2018;5(18):30093–8.
31. Alemnji GA, Zeh C, Yao K, et al. Strengthening national health laboratories in sub-Saharan Africa: a decade of remarkable progress. Trop Med Int Health 2014;19(4):450–8. doi: 10.1111/tmi.12269 Epub 2014 Feb 10. 24506521
32. Andiric LR, Chavez LA, Johnson M, et al. Strengthening Laboratory Management Toward Accreditation, A Model Program for Pathology Laboratory Improvement. Clin Lab Med 2018;38(1):131–40. doi: 10.1016/j.cll.2017.10.010 Epub 17 Dec 19. 29412877
33. Luman ET, Yao K, Nkengasong JN. A comprehensive review of the SLMTA literature part 1: Content analysis and future priorities. Afr J Lab Med 2014;3(2):265. doi: 10.4102/ajlm.v3i2.265 eCollection 2014. 29043200
34. Luman ET, Yao K, Nkengasong JN. A comprehensive review of the SLMTA literature part 2: Measuring success. Afr J Lab Med 2014;3(2):276. doi: 10.4102/ajlm.v3i2.276 eCollection 2014. 29043201
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