| Summary: | 碩士 === 長庚大學 === 醫務管理學研究所 === 92 === Medical technology is rapidly developing and the application of information technology has become commonplace. But medical information is lagging behind. As the standard of living rises, more importance is placed on safety and quality of medical treatment. As the competition in the medical treatment community increases, there should be an expectation of high safety, quality, and effectiveness from the providers of medical service. Are medical laboratories up to the task? Therefore, a fair and objective examination report is essential. Both certification of medical diagnosis and accreditation of medical laboratories need to improve the quality management and capabilities of medical laboratories in order to strengthen the government''s credibility to provide excellent medical service as expected by domestic responsible units. The accreditation of medical laboratories can also provide the added benefit of international reciprocal certification. Therefore, whether accreditation of medical laboratories may improve the quality of medical examinations poses an important issue.
The Department of Health has played the role of auditing quality management and technical capability of medical laboratories. These audits are commonly criticized as being influenced by medical professional insiders with a vested interest. If there is an independent third party that conducts such audits, it may satisfy the medical laboratories'' expectations of fairly accreditating quality management, technical capability and the safety for patients. Accreditation of medical laboratories has been common internationally for many years, so Taiwan must also follow step with modern practice. This study expects to explore how validation regulations defined by the authority overseeing domestic medical laboratories is consistent with laboratory directors’ attitudes toward the laboratories'' organizational structure, standard operating procedures, and promoting and maintaining quality.
The expert validity in regards to completeness and correctness of the questions in this questionnaire has been established. Furthermore, the correlation coefficient of each question has been validated by KMO statistical analysis and the Bartlett''s spherical methods. That is to say the results of this questionnaire are appropriate for a factor analysis. Utilizing principle component analysis, six (6) major factors can be extracted and named as follows：1) Promotional, 2) Regulatory, 3) Service, 4) Suitability, 5) Legality, 6) Fairness. These factors contain a high level of unique characteristics and explain over 50% of the total variation Cronbach''s α also verifies that the major factors provide a high level of reliability. The questions the organizational structure related questions 4.21 , standard operating procedures yields an average of 4.26, promotion and maintenance of quality yields an average of 4.10, which all reveal that establishing medical laboratories has an “ important ” influence.
The results of this investigation lead to the following recommendations. In regards to a validation system, a complete audit checklist should be developed to be utilized by fair-minded and objective evaluators. In regards to the oversight authority, the quality of medical laboratories that have passed the validation of medical laboratories can be assured. Therefore, hospital accreditation can be waived for these laboratories. In regards to those in charge of medical laboratories, when a laboratory is established, the same spirit behind validation regulations can also be used to assist in establishing quality.
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