Procjena rizika od neautomatiziranog postupanja s hemolitičnim uzorcima za sigurnost pacijenata

master's thesis

• Title (english): Risk assessment for manual handling of hemolyzed samples on patient safety
• Author: Ana Helena Lukšić
• Mentor: Ana-Maria Šimundić (mentor)
• Committee member: Nada Vrkić (predsjednik povjerenstva)
• Committee member: Marija Grdić Rajković (član povjerenstva)
• Committee member: Sandra Šupraha Goreta (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of medical biochemistry and haematology); Zagreb
• Defense date and country: 2016-09-23, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Medical Biochemistry

Abstract

Neautomatizirano postupanje s hemolitičnim uzorcima nije standardizirano i dovodi do laboratorijskih pogrešaka koje mogu ugroziti sigurnost bolesnika. Cilj istraživanja bio je procijeniti rizik i ostale posljedice za bolesnika uzrokovane laboratorijskim pogreškama koje nastaju zbog neautomatiziranog postupanja s hemolitičnim uzorcima. Retrospektivnom analizom iz laboratorijskog informacijskog sustava prikupljeni su zadani testovi i izdani rezultati za sve uzorke prikupljene u periodu od tjedan dana. Za 25 hitnih pretraga utvrđen je ispravan način postupanja s rezultatima iz uzoraka kojima je vizualno procijenjen stupanj hemolize. Procjena rizika načinjena je prema standardu ISO 14971 s 5 kategorija rizika i učestalosti. U navedenom razdoblju u hitni laboratorij zaprimljeno je 495 (15,5%) hemolitičnih uzoraka. 102 (20,6%) nalaza dobivena iz hemolitičnih uzoraka je imalo napomenu o hemolizi. 31% (N=780) rezultata je pogrešno izdano, što je 4,8% od ukupno zatraženih pretraga u tom razdoblju. 67% rezultata je bilo izdano unatoč značajnom utjecaju hemolize na rezultat dok je 33% bilo nepotrebno odbijenih. Pretrage u kategoriji s najvećom kombinacijom učestalosti i rizika bile su troponin T, kalij i ukupni bilirubin. Neautomatizirano postupanje s hemolitičnim uzorcima dovodi do rizika od pogrešnog izdavanja rezultata za troponin T, kalij i ukupni bilirubin što može bitno utjecati na kliničku odluku i ishod liječenja. Osim toga, dovodi do nepotrebnog odbijanja rezultata na koje hemoliza ne utječe čime vodi ponovljenom vađenju krvi i nepotrebnom povećanju troškova.

Abstract (english)

Manual handling of hemolyzed samples is not standardized and is error prone. This could lead to significant impact on patient safety. We aimed to assess the risk and other consequences for patient safety caused by laboratory errors due to manual handling of hemolyzed samples. In this retrospective analysis data were obtained from laboratory information system for 25 emergency tests and results from samples in which hemolysis was assessed by comparison with a color chart. Correct way of handling the results was determined for each test. Risk assessment was done according to ISO 14971 standard with 5 risk categories and frequencies of occurrence. In the period of one week emergency laboratory 495 (15.5%) hemolyzed samples. 102 (20,6%) of final results recieved from hemolyzed samples had reference note about hemolysis. 31% were incorrectly reported accounting for 4.8% of the total test volume. 67% of erroneously reported results was made available to physicians in spite of being hemolysed, while 33% of samples were unnecessarily rejected. Tests in critical category with the highest combination of risk and occurrence rate were troponin T, potassium and total bilirubin. Manual handling with hemolyzed samples may lead to risk of errors in reporting results for troponin T, potassium and total bilirubin which may impact clinical decision and patient outcome. Furthermore, manual handling with hemolyzed samples may lead to unnecessary rejection of the results that are not affected by hemolysis leading to repeated blood draws and unnecessary expenses.

• Keywords: ISO 14971; hemoliza; interferencija; kalij; bilirubin; troponin T
• Keywords (english): ISO 14971; hemolysis; interference; potassium; bilirubin; troponin T
• Language: croatian
• URN:NBN: urn:nbn:hr:163:868810
• Study programme: Title: Medical biochemistry; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: magistar/magistra medicinske biokemije (magistar/magistra medicinske biokemije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Access restricted to students and staff of home institution
• Created on: 2016-12-09 11:56:30