The core of biotechnological industry is biomedical products which are related to health and life and need clinical trial. Laboratory data are collected during different stages of clinical trial. Laboratory data are provided by laboratories which are accreditated internationally. Most of medical laboratories in Taiwan are not accreditated.
This exploratory research is to understand the change of healthcare envirovement and the stratege of accreditation to be taken when we develop the biotechnological industry which needs to be accreditated. We used questionare as a tool and mailed 616 and received 152. The statistical methods are descriptive and nonparametrical statistics.
The results show as following: 94.7% of the responders agreed to have Taiwanese own medical laboratory accreditation system which should be approved by the Department of Health.
The surveyors of hospital accreditation are appraised. Most of the responders (89.5%) did not agree the replacement of professional peer review by physicians without clinical laboratory training. The quality and quantity of CNLA surveyors need to be improved.
Continous quality improvement gets concensus of the responders. The certification of accreditation shall connect to the payment system of national health insurance but does not equal to good clinical laboratory.
Most of the responders (88.8%) recognized that implementing medical laboratory accreditation system is a part of organization learning. ISO 15189 medical laboratory accreditation is the first choice of the responders (50.7%) and CAP-LAP is the second (28.3%).
The reasons for implementing and not implementing medical laboratory accreditation system are improving quality and the change of hospital accreditation, and just applying hospital accreditation and not required by law.
Key words¡Ghospital accreditation, ISO 15189:2003, CAP-LAP, program for improving biotechnology industries, contract research organization, business strategy, organization learning.
| Identifer | oai:union.ndltd.org:NSYSU/oai:NSYSU:etd-0731105-112242 |
| Date | 31 July 2005 |
| Creators | Lee, Jang-Hwa |
| Contributors | Chen-I Kuo, Jen-Her Wu, Jen-Her Wu, Iuan-yuan Lu |
| Publisher | NSYSU |
| Source Sets | NSYSU Electronic Thesis and Dissertation Archive |
| Language | Cholon |
| Detected Language | English |
| Type | text |
| Format | application/pdf |
| Source | http://etd.lib.nsysu.edu.tw/ETD-db/ETD-search/view_etd?URN=etd-0731105-112242 |
| Rights | unrestricted, Copyright information available at source archive |
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