Implementation of the laboratory and quality management in a Turkish medical biochemistry laboratory

Yıl 2021, Cilt: 19 Sayı: 2, 1 - 25, 11.05.2022

Kadriye Akpınar , Baver Akcan

Öz

Objective: This study aims to show how a biochemistry laboratory in Turkey is managed by national regulations and practices, and thus give the laboratory directors a wider perspective on laboratory and quality management.
Materials and Methods: The pre-analytical, analytical, and post-analytical processes of our laboratory were evaluated according to the national regulations in Turkey by using the data of the patients who applied to our hospital, and the internal and external quality control results of the tests in 2020. Nucleus software was used as the laboratory and hospital information system (LIS/HIS) for data collection, and the Microsoft Excel program was used to analyze the data.
Results: In our biochemistry laboratory, the physical conditions and safety of the laboratory, the recording and storage of electronic data and, the execution of the total testing process (TTP) are by the Medical Laboratories Regulation (Date: 09.10.2013 Number: 28790) and the other national regulations. The evaluation results for 2020 were as follows: Pre-analytical, analytical, and post-analytical error rates were <1%. Total allowable errors (TEa) of 15 biochemical tests were under Turkey TEa limits. Critical values notification rates were >50% and quality indicator rates were <5% for every three months. Our average turnaround times of test groups were within our determined target times.
Conclusion: Our biochemistry laboratory successfully carried out the TTP in 2020. To give the most accurate and cost-effective test results to the patients timely, a lab director should manage the laboratory according to national and/or international regulations using medical and mathematical skills.

Anahtar Kelimeler

Total testing process, pre-analytical phase, quality indicators

Kaynakça

• Wikipedia. Medical laboratory. Website: https://en.wikipedia.org/wiki/Medical_laboratory [accessed 17 December 2020].
• World Health Organization. Quality management system handbook. 2011. Website: http://wwwwho.int/ihr/publications/lqms_en.pdf [accessed 17 December 2020].
• Plebani M, Astion ML, Barth JH, Chen W, Oliveira CA De, Escuer MI, et al. Harmonization of quality indicators in laboratory medicine. A preliminary consensus Clin Chem Lab Med. 2014;52(7):951–8.
• Official Gazette of the Republic of Turkey. Tıbbi laboratuvarlar yönetmeliği, 2013/28790. Website: https://www.resmigazete.gov.tr/eskiler/2013/10/20131009-11.htm [accessed 19 December 2020].
• Council of Ministers. Tıpta uzmanlık tüzüğü. 2002/24790. Website: https://www.mevzuat.gov.tr/MevzuatMetin/2.5.20024198.pdf [accessed 19 December 2020].
• Official Gazette of the Republic of Turkey. Sağlık meslek mensuplarının iş ve görev tanımlarına dair yönetmelik. 2014/29007. Website: https://www.resmigazete.gov.tr/eskiler/2014/05/20140522-14.htm [accessed 19 December 2020].
• Ministry of Health. Tıbbi laboratuvarlarda numune saklama süreleri, gözetimli hizmet laboratuvarları kapsamındaki testler hakkında genelge. 2014/95966346. Website: https://shgmlabdb.saglik.gov.tr/TR-4387/genelgeler.html [accessed 25 December 2020].
• Ministry of Health. Yasadışı ve kötüye kullanılan ilaç ve madde analizi yapan tıbbi laboratuvarlar ile madde bağımlılığı teşhis ve tedavi merkezlerindeki tıbbi laboratuvarlann çalışma usul ve esasları hakkında genelge. 2014/95966346. Website: https://shgmlabdb.saglik.gov.tr/TR-4387/genelgeler.html [accessed 25 December 2020].
• Ministry of Health. İdrar numunelerinde yasadışı ve kötüye kullanılan ilaç ve madde analizi yapan tıbbi laboratuvarlar ile madde bağımlılığı teşhis ve tedavi merkezlerindeki tıbbi laboratuvarların işleyiş esasları hakkında genelge. 2015/95966346. Website: https://shgmlabdb.saglik.gov.tr/TR-4387/genelgeler.html [accessed 25 December 2020].
• Ministry of Health. Tıbbi laboratuvarlarda kan numunelerinde etanol analizi işlemleri genelgesi, 2017/95966346. Website: https://shgmlabdb.saglik.gov.tr/TR-4387/genelgeler.html [accessed 25 December 2020].
• Ministry of Health. İzin verilen toplam hata sınırları. 2016/95966346. Website: https://shgmlabdb.saglik.gov.tr/TR-4387/genelgeler.html [accessed 25 December 2020].
• Official Gazette of the Republic of Turkey. Tıbbi laboratuvarlar yönetmeliği ekler, Ek-10, 2013/28790. https://www.resmigazete.gov.tr/eskiler/2013/10/20131009-11.htm [accessed 19 December 2020].
• Ministry of Health. Tıbbi laboratuvarların ruhsatlandırılmasında kullanılacak formlar ve kılavuzlar, 2014/95796091-010.07. Website: https://shgmlabdb.saglik.gov.tr/TR,4496/tibbi-laboratuvarlarin-ruhsatlandirilmasinda-kullanilacak-formlar-ve-kilavuzlar.html [accessed 19 December 2020].
• Ministry of Health. Tıbbi laboratuvar denetimleri. 2016/95966346. 2017;(7):5070.
• Ministry of Health. LOINC kullanımı, 2017/75730711. Website: https://shgmlabdb.saglik.gov.tr/Eklenti/9727/0/loinc-kullanimipdf.pdf [accessed 27 December 2020].
• Ministry of Health. Dış kalite değerlendirme. Website: https://dkd.saglik.gov.tr [accessed 27 December 2020].
• Ministry of Health. Hata sınıflandırma sistemleri. Website: https://kalite.saglik.gov.tr/TR-76486/hata-siniflandirma-sistemleri-hss.html [accessed 27 December 2020].
• Ministry of Health. Güvenlik raporlama sistemi. Website: https://grs.saglik.gov.tr/ [accessed 27 December 2020].
• Ministry of Health. Beyaz kod kullanıcı kılavuzu versiyon 2. Website: https://beyazkod.saglik.gov.tr/Giris.aspx [accessed 27 December 2020].
• Ministry of Health. Sağlıkta kalite standartları doküman yönetimi rehberi. 2020;1-29. Website: https://shgmkalitedb.saglik.gov.tr/TR-12638/sks-rehberleri.html [accessed 27 December 2020].
• Ministry of Health. Sağlıkta kalite standartları gösterge yönetimi rehberi. 2020;119-123. Website: https://shgmkalitedb.saglik.gov.tr/TR-12638/sks-rehberleri.html [accessed 27 December 2020].
• Turkish Accreditation Agency (TÜRKAK). TS EN ISO 15189’a göre tıbbi laboratuvarlar için başvuruda istenen belgeler, F701-064/rev.04/0520. Website: https://secure.turkak.org.tr/docs/eng/Forms/F701-008_11_0.pdf [accessed 29 December 2020].
• Ministry of Health. Laboratuvar güvenli̇ği̇ el ki̇tabı, 2019. Website: https://sbu.saglik.gov.tr/Ekutuphane/kitaplar/Labaratuvar_Guvenigi_El_Kitabi.pdf [accessed 29 December 2020].
• Official Gazette of the Republic of Turkey. Tıbbi atıkların kontrolü yönetmeliği. 2017/29959. Website: https://www.resmigazete.gov.tr/eskiler/2017/01/20170125-2.htm [accessed 19 December 2020].
• Ministry of Environment and Urbanization, Turkish Accreditation Agency (TÜBİTAK). Sağlık kuruluşları atık su/sıvı atık yönetimi el kitabı. 2017;1–24. Website: https://webdosya.csb.gov.tr/db/cygm/icerikler/saglik-kuruluslari-atiksusivi-atik-yonet-m--el-k-tabi-20180521152816.pdf [accessed 19 December 2020].
• Ministry of Health. Bi̇lgi̇ güvenli̇ği̇ poli̇ti̇kaları kılavuzu. 2019;224-228. Website: https://bilgiguvenligi.saglik.gov.tr/files/K%C4%B1lavuz%202.1%20Onay%20(16.07.2019).pdf [accessed 27 December 2020].
• World Health Organization (WHO). International Statistical Classification of Diseases and Related Health Problems 10th Revision. Website: https://www.who.int/classifications/icd/ICD10Volume2_en_2010.pdf [accessed 19 December 2020].
• Official Gazette of the Republic of Turkey. Sosyal güvenlik kurumu sağlık uygulama tebliğinde (SUT) değişiklik yapılmasına dair tebliği, Ek-2B Hizmet Başı İşlem Puan Listesi, 2020/31057. Website. https://www.resmigazete.gov.tr/eskiler/2020/03/20200303M1-1-1.pdf [accessed 19 December 2020].
• Ministry of Health. Akılcı laboratuvar kullanımı akılcı test istemi prosedürü. 2018/95966346. Website: https://dosyamerkez.saglik.gov.tr/Eklenti/15140,akilci-laboratuvar-kullanimi-aek42422915pdf.pdf [accessed 30 December 2020].
• Ministry of Health. Sağlıkta kalite standartları hastane. 2015;277-291. Website: https://kalite.saglik.gov.tr/Eklenti/3460/0/skshastanesetiv5r1pdf.pdf [accessed 29 December 2020].
• Turkish Biochemical Society. National preanalytical phase guideline for blood gases, pH and other related measurements. 2020;1-65. Website: https://www.eflm.eu/upload/docs/Turkey-2020-Blood_gas_testing.pdf [accessed 25 December 2020].
• Turkish Biochemical Society. National preanalytical phase guideline for coagulation tests. 2020;1-53. Website: https://www.eflm.eu/upload/docs/Turkey-2020-Coagulation.pdf [accessed 25 December 2020].
• Turkish Biochemical Society. Guideline for complete blood count in medical laboratories: effects of preanalytical parameters. 2020;1-48. Website: https://www.eflm.eu/upload/docs/Turkey-2021-Blood-Count.pdf [accessed 25 December 2020].
• Turkish Biochemical Society. Guidelines for venous blood collection (phlebotomy). 2018;1–27. Website: https://www.eflm.eu/upload/docs/Turkish-Venous_Blood_Collection2018.pdf [accessed 25 December 2020].
• Turkish Biochemical Society. Guidelines for centrifugate use in medical laboratories. 2017;1-40. Website: https://www.eflm.eu/upload/docs/Turkey%20-%202017%20Centrifugation%20guidelines.pdf [accessed 25 December 2020].
• Turkish Accreditation Agency (TÜRKAK). Deney/Analiz sonuçlarındaki ölçüm belirsizliği tahmini için TÜRKAK prensipleri. 2015;1–9. Website: https://secure.turkak.org.tr/docs/GuiedeLines/R20-02-01.pdf [accessed 27 December 2020].
• Ministry of Health. Akılcı laboratuvar kullanımı konsültasyon istemi prosedürü. 2018/95966346. Website: https://shgmlabdb.saglik.gov.tr/TR-53823/akilci-laboratuvar-kullanimi-konsultasyon-istemi-proseduru.html [accessed 30 December 2020].
• Ministry of Health. Akılcı laboratuvar kullanımı projesi çerçevesinde karar sınırı (eşik değer), kritik değer (panik değer) ve ölçüm birimlerinin harmonizasyonu prosedürü. 2018/95966346. Website: https://shgmlabdb.saglik.gov.tr/TR-53826/akilci-laboratuvar-kullanimi-projesi-cercevesinde-karar-siniri-esik-deger-kritik-deger-panik-deger-ve-olcum-birimlerinin-harmonizasyonu-proseduru.html [accessed 30 December 2020].
• Ministry of Health. Akılcı laboratuvar kullanımı projesi kapsamındaki sonuç raporlarının standardizasyonu çalışması. 2018. Website: https://shgmlabdb.saglik.gov.tr/TR-53822/akilci-laboratuvar-projesi-kapsamindaki-quotsonuc-raporlarinin-standardizasyonuquot-calismasi.html [accessed 30 December 2020].
• Ministry of Health. Akılcı Laboratuvar kullanımı projesi; onay destek sistemi. 2018/95966346. Website: https://shgmlabdb.saglik.gov.tr/Eklenti/15045/0/tibbi-laboratuvarda-onay-desteek41916132pdf.pdf [accessed 30 December 2020].
• Ministry of Health. Akılcı laboratuvar kullanımı refleks test ve reflektif test uygulamaları hakkında. 2018/95966346. Website: https://shgmlabdb.saglik.gov.tr/TR-53824/akilci-laboratuvar-kullanimi-refleks-test-ve-reflektif-test-uygulamalari-hakkinda.html [accessed 30 December 2020].
• Flegar-meštrić Z, Perkov S, Radeljak A, Marijana M, Paro K. Risk analysis of the preanalytical process based on quality indicators data. Clin Chem Lab Med. 2016;55(1):368–77.
• Piva E, Pelloso M, Penello L, Plebani M. Laboratory critical values: Automated notification supports effective clinical decision making. Clin Biochem. 2014;47:1163–8.
• International Organization for Standardisation. Medical laboratories-requirements for quality and competence. International standard ISO 15189. 3rd ed. ISO Copyright Office, Geneva. 2012.
• Aarsand AK, Sandberg S. How to achieve harmonisation of laboratory testing -The complete picture. Clin Chim Acta. 2014;432:8–14.
• Plebani M. Quality indicators to detect pre-analytical errors in laboratory testing. Clin Biochem Rev. 2012;33(3):85–8.
• Nwaokorie FO. Overview of the implementation of quality management system in Nigerian medical laboratories. Univ Lagos J Basic Med Sci. 2018;6(11):20-29.
• Ministry of Health. Bu test nerede yapılıyor? sistemi. Website: https://ckysweb.saglik.gov.tr/labtestlerapp/testlabara.aspx. [accessed 30 December 2020]