In Poland, there are no legal regulations covering point-of-care testing (POCT). It is unclear who is qualified to perform POCT or who should supervise the POCT program. The aim of this study was to evaluate the role of hospital laboratories in Malopolska province, Poland, in supervising POCT procedures and the voluntary use of the ISO 22870 standard. The study was conducted in hospitals in Malopolska province in Poland using a survey of the heads of the hospital clinical laboratories. Complete responses were obtained from 81% of the initial hospitals. The evaluation included, among other items, what POCT equipment was being used, the types of tests performed, and staff training and supervision by the laboratory, including quality control. Hospital wards most often use POCT glucose meters (94% of facilities), and 28% use blood-gas analyzers or analyzers for troponin or D-dimer testing. In most of the units (81%), there was no supervision over the tests, and no relationship between the POCT and the laboratory. The lack of quality control and competent supervision over POCT testing may result in low quality and affect the validity of the testing. It will be necessary to establish government regulations that will broaden the responsibility of hospital laboratories to oversee POC testing in hospitals.
Personal blood glucose meters (BGM) are used for the determination of glucose mainly by diabetic patients, but glucose meters for self-monitoring are also frequently in use in hospital wards as point-of-care test (POCT) devices. 1 The use of BGM, similarly to other diagnostic in vitro devices, requires permanent quality control (QC). The objective of the study was to analyze the recommendations of the QC performance of the BGM manufacturers and the evaluation of the compatibility of clinical practice with the recommendations.The manuals of the 27 BGMs, available on the Polish market (Arkray, Bayer, BSI, Bionime, Beurer medical, CSL, Diagnosis, Genexo, I-sense, Johnson & Johnson, MedTrust, Pharmbos, PTS, Roche), were studied in the terms of the QC. The heads of 29 hospital medical laboratories in the Malopolska province (Poland) were obliged to analyze the performance of the QC of BGM used in the hospital's wards and respond to the detailed questions presented in the questionnaire.Most of the manufacturers of analyzed BGM recommend to perform the QC upon the first use of the device, and in the case of suspected malfunction of the device or when the test strips do not function properly. Twenty-three (85%) BGM manufacturers recommend performing the QC if the test result is not consistent with the clinical symptoms. A recommended once-aweek QC performance was found only in 5 devices user manuals (19%). Sixteen (59%) companies suggest performing the QC test when a new box/vial of test strips is opened.Twenty-eight completed questionnaires, representing 96% of the distributed questionnaires, were returned. The internal QC performed, according to the manufacturers' recommendations, was carried out in 10 (42%) hospitals. Only in 1 hospital (4%) was the QC performed daily. Eleven (46%) of surveyed hospitals do not carried out QC of POCT BGM at all (Figure 1).It seems obvious that to receive reliable results of laboratory tests, the proper QC is required. The current standards for QC of BG measurement in laboratory require to perform it on 2 or 3 levels of glucose concentrations, 2 or 3 times every day. In the case of the QC for BGM according to the manufacturers suggestions are low-maintenance, and it is acceptable to perform QC once a week or less. Unfortunately, these nonrestrictive recommendations are not often respected in hospital wards where BGM are used as POCT devices. In many hospitals there is a lack of policy regarding QC for BGM. The potential risk of severe health consequences, when BGM are not properly controlled in the hospital, cannot be ignored. 2,3 It is essential to ensure proper hospital policy regarding QC for BGM use in the POCT. Over the past 30 years, experience in clinical chemistry has shown that regular and properly performed control of BG has a beneficial effect on morbidity, mortality of patients, and costs of treatment. 4 Therefore both diabetes associations and manufactures should clearly define unified recommendations for QC for glucose meters in self-monitoring as well as in POCT.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.