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2018, Cilt 16, Sayı 3, Sayfa(lar) 158-169
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Assessment of the results of a 3-Year Program for National Standardization and Quality Improvement of Medical Laboratories on Drug of Abuse Testing by the Ministry of Health in Turkey
Tuncay Küme1, Ferzane Mercan2, Hatice Topsakal2, Çiğdem Kararkükcü3, Mehmet Şeneş4, Aslı Pınar5, Mukaddes Gürler5, Hakan Kalafat6, Belgin Ünal7, Alain G. Verstraete8, Yeşim Hamurtekin9, Ahmet Aydınlı2, Yasemin Şenol2, Muhammed Ertuğrul Eğin2, Alper Cihan2, Elif Güler Kazancı2, Eyüp Gümüş2
1Dokuz Eylül Üniversitesi, Tıp Fakültesi Biyokimya AD, İzmir, Türkiye
2Türkiye Cumhuriyeti Sağlık Bakanlığı, Ankara, Türkiye
3Kayseri Eğitim ve Araştırma Hastanesi, Biyokimya Laboratuvarı, Kayseri, Türkiye
4Ankara Eğitim ve Araştırma Hastanesi, Biyokimya Laboratuvarı, Ankara, Türkiye
5Hacettepe Üniversitesi, Tıp Fakültesi Biyokimya AD, Ankara, Türkiye
6Ordu Devlet Hastanesi, Ordu Devlet Hastanesi, Ordu, Türkiye
7Dokuz Eylül Üniversitesi, Halk Sağlığı AD, İzmir, Türkiye
8Ghent Üniversitesi, Tıp Fakültesi Laboratuvar Tıbbı AD, Ghent, Belçika
9Doğu Akdeniz Üniversitesi, Eczacılık Fakültesi, Gazimagosa, Kuzey Kıbrıs TC
Keywords: drug abuse testing laboratory; government regulation; quality and safety requirements; total laboratory process; probation

Background: The aim of this study is to assess the results of inspections in the last three years on drug abuse testing in medical laboratories according to the last regulations in Turkey.

Materials and Methods: The on-site inspections of medical laboratories for drugs of abuse testing, performed in health institutions with Alcohol and Drug Addiction Treatment Centers in 2014-2016 are described, and laboratory processes and performance were evaluated. The performance of 35 laboratories in 2014, 62 laboratories in 2015, 94 laboratories in 2016 were scored according to overall answers of the inspection form. An inspected laboratory was considered to have an unconformity if the total score was less than 2/3. The total scores of inspections and the number of laboratories with deficiencies between years were compared using one-way analysis of variance and slope Chi-square for trend test, respectively.

Results: Total scores increased statistically significantly from 35.9 ± 16.2 in 2014, to 43.5 ± 16.3 in 2015 and 49.1 ± 1.3 in 2016 (p<0.001). The laboratories with unconformities decreased statistically significantly from 57% in 2014 to 37% in 2015 and 22% in 2016 (p<0.001).

Conclusion: The published legislation and the inspections contributed to national standardization and improved quality of service in medical laboratories for drug abuse testing.


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