![]() In the last years, the technology and equipment at hospitals have been increase in a great way as the risks of their implementation. Murad, C Rubio, D Ponce, S Alvarez Abri, A Terron, A Vicencio, D Fascioli, E International Nuclear Information System (INIS) ![]() Presented results indicate major weak points of current practice in sweat test performance in Croatian MBL and stress the need for its standardization on a national level.Įlectromedical devices test laboratories accreditation Agreements to guidelines were found in approach to unsuitable patients (9/10) and sweat collection (8/9). Results reported by MBL indicated: lack of patient information policy (7/10), use of unacceptable electrodes (6/9), misuse of minimum of acceptable sweat weight (6/9), lack of internal quality assessment (5/9) and recommended reference ranges (5/9 and 4/9). All MBL included in this study replied to the questionnaire. An introduction of uniform sweat chloride measurement protocol resulted in CV of 15.5% and 14.7% reported in following two exercises in 2016. Reported results of EQA in 2015 exercises showed coefficients of variation (CV) from 28.9%, 29.0% to 35.3%, respectively. Survey results were compared to current guidelines for sweat test performance. ![]() A questionnaire regarding all phases of testing was mailed to involved MBL (N = 10). EQA for sweat chloride measurement was provided by Croatian Centre for Quality Assessment in Laboratory Medicine (CROQALM) in five consecutive exercises to medical biochemistry laboratories (MBL) that offered sweat testing. The aim of this study was an evaluation of external quality assessment (EQA) of sweat chloride measurement including sweat test performance in medical biochemistry laboratories in Croatia. All listed may be sources of inconsistencies in everyday practice. Its performance includes sweat stimulation, collection and analysis. Sweat test has a diagnostic role in evaluation of cystic fibrosis. The accreditation of medical laboratory will improve medical laboratory service and be useful for patients.Įvaluating performance in sweat testing in medical biochemistry laboratories in Croatia. Implementation of ISO 15189 will result in a significant improvement in medical laboratories management system and their technical competence. personnel, facility, instrument, and examination methods), moreover it requires that laboratories shall participate proficiency testing(s) and laboratories' examination results shall have traceability of measurements and implement uncertainty of measurement. The latter includes the requirements of laboratory competence (e.g. The former includes the requirements of all parts of ISO 9001, moreover it includes the requirement of conformity assessment body, for example, impartiality and independence from any other party. ISO 15189 requirements consist of two parts, one is management requirements and the other is technical requirements. The Japan Accreditation Board for Conformity Assessment (AB) and the Japanese Committee for Clinical Laboratory Standards (CCLS) are jointly developing the program of accreditation of medical laboratories. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities. While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines will also find it useful and appropriate. This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for competence and quality that are particular to medical laboratories. What are lab tests? Laboratory tests are medical devices that are intended for use on samples of blood, urine, or other tissues. Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal &.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |