Pregled regulative preiskovanja bioloških vzorcev za COVID - 19 v obdobju 2019 - 2021 v Republiki Sloveniji

Jerebic, Karmen (author), Božič, Borut (mentor)

Epidemija covida-19 je med letom 2019 in 2022 povzročila veliko javnozdravstveno krizo pri nas in po svetu. Ključni del preprečevanja širjenja okužbe je odkrivanje okuženih pacientov, nudenje ustrezne zdravstvene pomoči in izolacija okuženih, za kar je bilo potrebno vzpostaviti učinkovito mrežo izvajalcev mikrobioloških preiskav na SARS-CoV-2 in sezname ustreznih in vitro diagnostičnih medicinskih pripomočkov za različne namene uporabe. Namen magistrske naloge je bila analiza spreminjanja regulative v Republiki Sloveniji na področju laboratorijske medicine v času epidemije. Sistematični pregled sprejete regulative v Republiki Sloveniji smo izvedli s pomočjo besednih nizov, vezanih na pravne akte (zakon, pravilnik, uredba in direktiva) in testiranje (in vitro diagnostični medicinski pripomoček, covid in SARS-CoV-2), s pomočjo spletnih brskalnikov ali strani z vgrajenimi iskalniki: Google, Pravno informacijski sistem, Uradni list RS, Ministrstvo za zdravje, Javna agencija za zdravila in medicinske pripomočke, Nacionalni inštitut za javno zdravje. Zbrane rezultate smo ovrednotili številčno po posamezni spletni strani, vsebinsko in časovno. Skupno je bilo sprejetih 27 pravnih aktov, ki so vplivali na pogoje testiranja na SARS-CoV-2, na vseh zakonodajnih ravneh. V obdobju 2019 – 2021 se je izteklo tudi prehodno obdobje za prehod od Evropske Direktive o medicinskih pripomočkih v Evropsko Uredbo o in vitro diagnostičnih medicinskih pripomočkih. Sprejeti so bili 4 interventni zakoni na področju zdravstva, spremenjena oziroma dopolnjena pa sta bila Zakon o zdravstveni dejavnosti in Zakon o nalezljivih boleznih, ki sta bila podlaga za sprejemanje številnih podzakonskih pravnih aktov. Pravni akti so se sprejemali pod časovnim pritiskom in po skrajšanih postopkih zaradi povečanih potreb po izvajanju diagnostičnih testiranj, kar se odraža tudi v delni neskladnostih veljavnih aktov v tem obdobju. S sprejetimi pravnimi akti se namreč ni zadostilo pogojem kakovosti, ki jih je na področju laboratorijske medicine uvedel Pravilnik o pogojih, ki jih morajo izpolnjevati laboratoriji za izvajanje preiskav na področju laboratorijske medicine, na osnovi zahtev standarda ISO 15189:2012 Medicinski laboratoriji – zahteve za kakovost in kompetentnost. Z zbranimi izkušnjami iz epidemije se lahko ustrezno in načrtovano pripravimo na izredna stanja, ki nas morebiti lahko doletijo v prihodnosti. V nobenem primeru pa ne smemo dopustiti, da bi padla zanesljivost izvidov ali da varnost pacientov in zdravstvenih delavcev ne bi bila na prvem mestu.

• Language: Slovenian
• Keywords: covid-19, regulativa, in vitro diagnostični medicinski pripomočki, biološki vzorci, diagnostika.
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2022
• PID: 20.500.12556/RUL-142928
• Publication date in RUL: 03.12.2022

Secondary language

• Language: English
• Title: Review of the regulatory framework on biological samples testing for COVID - 19 during 2019 – 2021 in the Republic of Slovenia

Abstract

Covid-19 epidemic has caused a major public health crisis in years between 2019 and 2022 all around the world. A key part of preventing the spread of infection is detecting and isolating infected patients and providing medical care, which requires an effective network of SARS-CoV-2 microbiological testing providers and lists of appropriate in vitro diagnostic medical devices for different uses. The aim of the Master's thesis was to analyse the changing regulation in the field of laboratory medicine in the Republic of Slovenia during the epidemic. The systematic review of the adopted regulation in Slovenia was carried out using the keywords related to legal acts (law, rule book, decree and directive) and testing (in vitro diagnostic medical device, covid and SARS-CoV-2) with the help of web browsers or sites with built-in search engines: Google, Pravno informacijski sistem, Uradni list Republike Slovenije, Ministrstvo za zdravje, Javna agencija za zdravila in medicinske pripomočke, Nacionalni inštitut za javno zdravje. The collected results were evaluated numerically per website, in terms of content and time. In total, 27 pieces of legislation have been adopted at all legislative levels that have had an impact on the conditions for SARS-CoV-2 testing. In years between 2019 and 2021, the transition period from the European Medical Devices Directive to the European Regulation on In Vitro Diagnostic Medical Devices has also come to an end. Four intervention health laws were adopted. Health Care Act and the Infectious Diseases Act were amended or supplemented, providing the basis for a number of sub-legislative acts. Legal acts were passed under time pressure and in abbreviated procedures, due to the increased need for diagnostic testing, which is also reflected in the partial inconsistencies of the acts in force during this period. The legal acts that were passed did not meet the quality requirements introduced in the field of laboratory medicine by the Regulation on the conditions to be met by laboratories for carrying out tests in the field of laboratory medicine, based on the requirements of ISO 15189:2012 Medical laboratories - Requirements for quality and competence. With the lessons learned from the epidemic, we can prepare adequately and in a planned way for emergencies that may befall us in the future. In any case, we must not allow the reliability of the results or the safety of patients and health professionals to be compromised.

• Keywords: covid-19, regulation, in vitro diagnostic medical devices, biological samples, diagnostics.