TY  - JOUR
A1  - Oeser, Reinhard
A1  - Buchta, C
A1  - Coucke, W
A1  - Mayr, Winfried
A1  - Müller, MM
A1  - Schweiger, CR
A1  - Körmöczi, GF
T1  - Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance - evaluation of immunohaematology external quality assessment results during 19 years in Austria
JF  - Clinical Chemistry and Laboratory Medicine (CCLM)
N2  - Background ISO 9001 and ISO 15189 have been established as continuative models for quality systems beyond national laws, mandatory standards and guidelines of expert associations regarding analytical and organisational performance of medical laboratories and transfusion services. Although widely used, their impact on laboratory performance has not been investigated. Methods We retrospectively analysed the results of 167 laboratories in 59 distributions of the Austrian red cell immunohaematology external quality assessment (EQA) scheme in the years 1999-2017. The performance for each parameter and trends of individual participants were compared with respect to certification or accreditation status of participants' quality systems and to laboratory type. Results Considering more than 52,000 EQA results, the absence or presence of a laboratory quality management system showed different error rates. Laboratories with ISO 9001 or ISO 15189 certification/accreditation had 0.7% incorrect results, while this rate was doubled without such quality systems (1.4%, p=0.0002). Statistically significant error reductions were seen upon ISO 9001/ISO 15189 implementation (1.3% before vs. 0.7% after; p=0.0468). Transfusion services had fewer errors (0.9%) compared to hospital and independent laboratories (both 1.2%). Conclusions Implementation and maintenance of quality systems according to ISO 9001 or ISO 15189 as well as laboratory specialisation result in better analytical performance as can be seen in immunohaematology EQA results. The conclusion is that these results apply to other laboratory tests and perhaps to other areas of health care.
KW  - ISO 15189
KW  - ISO 9001
KW  - External quality assessment
KW  - Immunohaematology
Y1  - 
VL  - 2018
IS  - 56 (12)
SP  - 2039
EP  - 2046
ER  - 
TY  - GEN
A1  - Mense, Alexander
A1  - Oeser, Reinhard
T1  - Elektronische Patienten Akte: Umsetzbarkeit des neuen Standards prEN 13606 in Österreich
KW  - Electronic Patient Record
Y1  - 2019
ER  - 
TY  - CHAP
A1  - Brunner, Sonja
A1  - Weber, T
A1  - Mora, A
A1  - Falkner-Radler, C
A1  - König, F
A1  - Oeser, Reinhard
A1  - Binder, S
T1  - Extracapsular cataract surgery and size changes of non-exsudative age-related macular degeneration (ecam)
T2  - Präsentation / 1st World Congress on Controversies in Ophthalmology (COPHy) Clarion Congress Hotel / 4-7 March 2010 / Prague (Czech Republic)
KW  - Surgery
KW  - Degeneration
KW  - Cataract
Y1  - 2019
ER  - 
TY  - GEN
A1  - Stancik, I
A1  - Bogoslavljevic, L
A1  - Oeser, Reinhard
A1  - Pflüger, H
T1  - Long-Term Follow-Up after Electomotive Drug Therapie for Peyronies Disease
KW  - Electromotive
KW  - Drug
KW  - Therapy
KW  - Peyronies
Y1  - 2019
ER  - 
TY  - CHAP
A1  - Mense, Alexander
A1  - Sauermann, Stefan
A1  - Wahl, Harald
A1  - Pucher, Robert
A1  - Oeser, Reinhard
T1  - Probing the Compatibility of CEN 13606 Part 4 and 5 with IHE
T2  - Proceedings of the 5th International Conference On Information Communication Technologies in Health (ICICTH) / Samos Island (Greece)
KW  - CEN
KW  - Compatibility
Y1  - 2019
SP  - 68
EP  - 73
ER  - 
TY  - CHAP
A1  - Oeser, Reinhard
A1  - Mense, Alexander
A1  - Sauermann, Stefan
A1  - Pucher, Robert
A1  - Wahl, Harald
T1  - Technologies for standards-conform message development: Testing the feasibility of recent CEN prEN 13606 standards developments in Austrian health care
T2  - Conference Proceedings 4th International Conference on Information Communication Technologies in Health (ICICTH), Samos Island (Greece)
KW  - Standards
KW  - Healthcare
Y1  - 2019
SP  - 215
EP  - 219
ER  -