Türkiye’de Ulusal Antimikrobiyal Direnç Sürveyans Sistemi UAMDSS için duyarlılık testlerinin laboratuvar değerlendirmesi

Yıl 2018, Cilt: 75 Sayı: 1, 1 - 12, 01.03.2018

Efsun Akbaş Nilay Çöplü Hüsniye Şimşek Berrin Esen Berna Sezgin

Öz

Amaç: Antimikrobiyal direnç dünya çapında büyüyen bir problemdir ve bu problem ile savaşmak için bazı önlemler alınmalıdır. Mevcut durum analizi bunlardan biridir ve Ulusal Antimikrobiyal Direnç Surveyans Sistemi UAMDSS bu amaçla kurulmuştur. Verilerin kalitesi katılımcı laboratuvarların performansına bağlıdır, o nedenle sistemdeki laboratuvarların değerlendirilmesine ihtiyaç olmuştur. Bu çalışma, katılımcı laboratuvarların antimikrobiyal duyarlılık testi ihtiyaçları için durumlarını analiz etmeyi amaçlamaktadır. Yöntem: UAMDSS için ülke çapında seçilmiş 77 katılımcı laboratuvar bulunmaktadır. Kapasite analizi çalışmasına bunlardan 25 adedi dahil edilmiştir. Laboratuvarların değerlendirilmesi için ‘kontrol listesi’ özellikleri olan bir Laboratuvar Değerlendirme Aracı LAT yüz yüze görüşmelerle kullanılmıştır. LAT, Dünya Sağlık Örgütü DSÖ tarafından geliştirilmiş, 10 modülde 677 soru içeren bir programdır. Antimikrobiyal duyarlılık testleri ADT için sorular eklenerek kullanılmıştır. Laboratuvar ziyaretleri öncesinde, bir çalıştayda eğitim alan toplam 33 gönüllü uzmandan ekipler oluşturuldu ve her ekipte en az iki kişi bulunmaktaydı. LAT’ı uygulamak için bu ekipler laboratuvarları ziyaret etmiştir. Veriler bir veritabanına aktarılmıştır ve hem genel koşullar, hem de ADT kapasitesi için analiz edilmiştir. Bulgular: Laboratuvarların kurumsal dağılımı üniversite hastanesi n = 17 , eğitim ve araştırma hastanesi n = 4 , devlet hastanesi n = 2 ve askeri hastane n = 2 şeklindeydi. UAMDSS laboratuvarları, biri hariç tanımlama ve ADT otomatize sistemlerin yanısıra disk difuzyon ve minimum inhibitör konsantrasyon MIK testleri ile yapmaktadır. Ayrıca, laboratuvarlar modüllerden üçü için genellikle “iyi durumda” yaklaşık >%85 olup diğer modüller, farklı derecelerde “bazı gelişmelere ihtiyaç duyan” sorunlar olduğunu öne sürmektedir. İç kalite kontrol uygulamaları dışındaki ADT’ye odaklandığında, ADT kültür ortamı ve reaktifleri için kullanılabilirlik, tanımlama ve ADT kapasitesinin %84-95 arasında olduğu gözlenmiştir. Toplam kalite gerekliliklerinin sağlanması %67 olarak bulunmuştur. Sonuç: UAMDSS laboratuvarlarının hem sürveyans sistemi, hem de hastaların etkin tedavisinde kanıta dayalı kararlar için gerekli olan ADT’de güvenilir sonuçlar sağlayabildikleri görülmektedir. Öte yandan, bazı diğer konularda iyileştirme gerekmektedir.

Anahtar Kelimeler

antimikrobiyal direnç, bakteriyel, sürveyans, kalite kontrol

Laboratory Evaluation of susceptibility tests for National Antimicrobial Resistance Surveillance System NAMRSS in Turkey

Öz

Objective: Antimicrobial resistance is a growing problem worldwide, and to combat with this problem some measures should be taken. One of them is analysis of current situation and National Antimicrobial Resistance Surveillance System NAMRSS was established for this purpose. The quality of the data depends on the participating laboratories performance, so there was need for an assessment of the laboratories in the system. This study was aimed to analyse the status of the participating laboratories for antimicrobial susceptibility testing requirements. Methods: There were 77 participating laboratories selected for NAMRSS throughout the country. Twentyfive of them were included in for capacity analysis study. A Laboratory Assessment Tool LAT was used for the evaluation of laboratories with ‘checklist’ features, and face-to-face interviews were used. LAT was a programme containing 677 questions in 10 modules that were developed by World Health Organization WHO . A set of questions were added to use for antimicrobial susceptibility tests AST . Teams were formed from a total of 33 volunteer experts who received training prior to laboratory visits in a workshop, and there were at least two people in each team. They have visited the laboratories for implementing the LAT. Data were transferred to a database and analysed for both general conditions, and AST capacity. Results: Laboratories were distributed institutionally as university hospital n=17 , training and research hospital n = 4 , state hospital n = 2 and military hospital n = 2 . NAMRSS laboratories performed identification and AST by automated systems as well as disc diffusion and minimum inhibitory concentration MIC tests except for one laboratory. Also, the laboratories were generally in ‘good standing’ approx. > 85% for three of the modules, where the other modules suggest that there are issues that ‘need some improvements’ at different degrees. When focused on AST, outside of internal quality control applications, it was observed that availability for AST culture media and reagents, identification and AST capacity are between 84-95%. It was found that total quality was 67%. Conclusion: NAMRSS laboratories seem to be able to provide reliable results in AST, which is essential for both surveillance system and evidence based decisions in effective treatment of patients. On the other hand, improvement in some other issues is necessary.

Anahtar Kelimeler

antimicrobial resistance, bacterial, surveillance, quality control

Kaynakça

• 1. Antimicrobial resistance: global report on surveillance. World Health Organization. 2014. http://www.who.int/drugresistance/documents/ surveillancereport/en/ Accessed December 12, 2015.
• 2. National Antimicrobial Resistance Surveillance System, NAMRSS: Annual Report 2011. http:// uamdss.thsk.gov.tr/index.php?option=com_phoc adownload&view=category&id=6:raporlar&Item id=13 Turkish, Accessed December 12, 2015.
• 3. Heuer O. EARS-Net Results-2011. Surveillance Section. European Centre for Disease Prevention and Control (ECDC). http://ecdc.europa.eu/ en/activities/diseaseprogrammemes/arhai/ presentations2011warsaw/arhai-networksmeeting_plenary-session-two-2-oler-heuer.pdf Accessed December 12, 2015
• 4. Gözalan A, Çöplü N, Aktaş D, Şimşek H, Erdem GB, Mumcuoğlu İ. Performance evaluation of the microbiology laboratories in Turkey for culture and antibiotic susceptibility tests and the selection of laboratories to provide data for National Antimicrobial Resistance Surveillance System: Questionnary application. Turk Hij Den Biyol Derg. 2015; 72(3): 175 - 182.
• 5. National Antimicrobial Resistance Surveillance System Laboratory tests, Quality control and quality assurance standard opreating procedure and WHONET software porgramme. 2011, February. ISBN: 978-975-590-347-7.
• 6. Çöplü N, Gülay Z, Temel F, Şimşek H, Göl N, Aktaş D et al. National Antimicrobial Resistance Surveillance System External Quality Assurance Proficiency Assesment Study P129. XXXV. Turkish Microbiology Congress. 3-7 November 2012, Kuşadası, Aydın, Turkey.
• 7. Laboratory Assessment Tool, World Health Organization. http://www.who.int/ihr/ publications/laboratory_tool/en/.
• 8. International Health Regulations (2005). Second ed. WHO, http://www.who.int/ihr/ publications/9789241596664/en/ Accessed December 12, 2015.
• 9. EARSS Annual Report 2008: On-going surveillance of S. pneumoniae, S. aureus, E. coli, E. faecium, E. faecalis, K. pneumoniae, P. aeruginosa. http:// ecdc.europa.eu/en/activities/surveillance/EARSNet/Documents/2008_EARSS_Annual_Report.pdf Accessed October 27, 2015.
• 10. By-law on the Surveillance and Control Principles of Communicable Diseases (amendment). Official Journal 02/04/2011 – 27893. http://www. resmigazete.gov.tr/main.aspx?home=http://www. resmigazete.gov.tr/eskiler/2011/04/20110402. htm&main=http://www.resmigazete.gov.tr/ eskiler/2011/04/20110402.htm Turkish, Accessed December 12, 2015.
• 11. Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community. http://eur-lex.europa.eu/ resource.html?uri=cellar:b97ab1a4-21f5-49de9964-bc25617d3485.0008.02/DOC_1&format=PDF Accessed December 12, 2015.
• 12. Commission Decision (No 2000/96/EC) of 22 December 1999 on the communicable diseases to be progressively covered by the Community network under Decision No 2119/98/EC of the European Parliament and of the Council. http:// eur-lex.europa.eu/legal-content/EN/TXT/PD F/?uri=CELEX:32000D0096&from=EN Accessed December 12, 2015.
• 13. ECDC TECHNICAL REPORT. EU Laboratory Capability Monitoring System (EULabCap) Report on 2013 survey of EU/EEA country capabilities and capacities. Stockholm, February. 2016. doi 10.2900/63194.4
• 14. Central Asian and Eastern European Surveillance of Antimicrobial Resistance, Annual Report 2014. 2015. World Health Organization, Regional Office for Europe. http://www.euro.who.int/_data/assets/ pdf_file/0006/285405/CEASER-SurveillanceAntimicrobial-Resistance2014.pdf?ua=1.
• 15. SURVEILLANCE REPORT. Antimicrobial Resistance Surveillance in Europe, 2014. Antimicrobial resistance surveillance in Europe Annual report of the European Antimicrobial Resistance Surveillance Network (EARS-Net) 2014. Stockholm, November 2015. doi 10.2900/23549.
• 16. Joint WHO – CDC Conference on Health Laboratory Quality Systems. WHO/HSE/IHR/LYO/2008.3 Lyon, France, 9 - 11 April 2008. http://www.who.int/ ihr/lyon/report20080409.pdf Accessed December 12, 2015.
• 17. Laboratory Quality Management System: Handbook. World Health Organization. ISBN: 978 92 4 154827 4. 2011. http://whqlibdoc.who. int/publications/2011/9789241548274_eng.pdf Accessed December 12, 2015.