行政院衛生署疾病管制局九十三年度科技研究計畫

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月饭闫
7 years ago
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1 DOH 93-DC

2 1. ( 3 ) 2. ( 6 ) 3. ( 9 ) 3.1 ( 9 ) 3.2 ( 13) 3.3 ( 19) 3.4 ( 23) 3.5 ( 27) 3.6 ( 29) 3.7 ( 31) 4. ( 57) ( 224)

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4 2. ISO ( 24 ) 10 ( 59 ) 2 ( 11 ) 1 ( 6 ) 2. ISO 15189( ) 6 ( 35 ) / ISO ( 6 ) ISO 15189

5 10 ( 59 ) ISO 15189

6 3.Abstract Key Word Medical laboratories Particular requirements for quality and competence, the regulations on Employment and Management of Foreign Workers, Laboratory Accreditation Objects It is an important defense to the epidemic prevention in Taiwan from the health examination of the foreign laborers working in Taiwan. However, the quality of the health examination is not only depended on the ability of examination and process in the hospital but also on whether the hospital can really meet the regulations which will influence the outcome of infection disease control. The new thought of laboratory accreditation system was adopted in the draft regulation on Employment and Management of Foreign Workers from CDC last year and they wish it can improve the testing ability of health care in foreign laborers of assigned hospital. CDC also expects to make the health care in foreign laborers of assigned hospital meet the international criteria by leading into the thirty party accreditation systems. Besides the management of accreditation system, we believe that the management system will be more accuracy for the testing result, good quality process and clear responsibility future by arrange with the surveillance, investigation and assistance from regulator. The object of this quality investigation project is to understand whether the operation process, examination ability and quality assurance in health care in foreign laborers of assigned hospital will meet the draft regulation and accreditation requirement from onsite witness. It also wants to help the hospital

7 understand the contents of the draft regulation and medical accreditation criteria, which is based on ISO 15189; 2003 (Medical laboratories Particular requirements for quality and competence). Method: This program will be aim at 15~20 assigned hospitals for foreign laborers health care which are chosen by random from 34 hospitals with high business in health care for foreign laborers. The checklist will include examination process, patient identification, preventing specimen from exchanging, quality assurance and testing record. The quality expert, parasitologists, thoracic doctor and the officers from Department of Health will compose the assessor team. Result: After the wholeness evaluation, there are 4 hospitals, 24% in all investigation hospitals will meet the regulation after correcting the non-conformance future. There are also 10 hospitals, 59% in all investigation hospitals will meet the regulation after correcting the non-conformance and enhance the on personal job training future but there are 24hospitals, 11% in all investigation hospitals will be more difference to meet the regulation future. In additional, there is one hospital, 6% in all investigation hospitals will not easily evaluate under on site witness because of no examination requesters at that day. Actually, there is a nice management system of the hospital according to the instruction from the hospital accompanist but we suggest the hospital shall concern more improvement in the testing process and accommodation. Furthermore, there are 6 hospitals, 35% in all investigation hospitals will meet the ISO 1589 after improving the on personal job training and monitor, authority of management, quality assurance, calibration and maintain equipment, management of good housekeeping, corrective action of the non-conformance from the testing item future but there are one hospital, 6% in all investigation

8 hospitals will be more difference to meet the ISO future. In additional, there is 10 hospitals, 59% in all investigation hospitals are setting up or will plan to establish their laboratory quality system to meet the ISO Conclusion and Suggestion Although there are few problems of the cost and personal operation activities in some hospitals to meet the regulation, we can understand almost hospitals will improve their management system to meeting the regulation from CDC after getting new draft from the quality investigation project. Further, more expectable training courses in parasite examination, leprosy training and laboratory accreditation training will be provided by CDC.

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10 X (EQA) (The International Organizati on for standardization; ISO) (TC 212) (ISO/DIS Quality Management in the Medical Laboratory) Medical Laboratories - Particular Requirements for Quality and Competence( -- ) CNLA ISO

11 ISO ISO 15189

12 ISO (Chinese accreditation body; CNLA) (APLAC) (ILAC) (APLAC) (EA) (ILAC 2000 MRA) tested once, accepted everywhere

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14 E. ISO F. ISO G.

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26 (International Laboratory Accreditation Cooperation ; ILAC)

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29 1. Elbatawi MA. Migrant workers. In: Occupational Health in Developing Countries. Jeyaratnam J ed. New York; Oxford 1992: Bonvin L & Zellweger J. Mass miniature X-ray screening for tuberculosis among immigrants entering Switzerland. Tubercle & Lung Disease, 73(6): 322-5, Dec Ciesielski SD et al. The epidemiology of tuberculosis among North Carolina migrant farm workers. JAMA, 265(13): , Apr Akao N et al. A survey of intestinal parasites of the foreign laborers (Indonesians and Filipinos) in Ishikawa Prefecture. Journal of the Japanese Association for Infectious Diseases, 66(9): , Sep Jochelson K. et al. Human immunodeficiency virus and migrant labor in South Africa. International Journal of Health Services, 21(1): , Jones JL et al. HIV-related characteristics of migrant workers in rural South Carolina. Southern Medical Journal, 84(9): , Sep KuniiO. & Nomiyama K. Present status of medical care for foreigners in Tochigi Prefecture, Japan (1): Survey at all clinics 7 and hospitals. Japanese Journal of Hygiene, 48(3): , Aug KuniiO. & Nomiyama K. Present status of medical care for foreigners in Tochigi Prefecture, Japan (2): Illness behavior of foreign workers. Japanese Journal of Hygiene, 48(3): , Aug Bourdillon F et al. The health of foreign populations in France. Social Science & Medicine, 32(11): , Goh KT et al. Epidemiology of sudden unexpected death syndrome among Thai migrant workers in Singapore. International Journal of Epidemiology, 22(1):88-95, Feb

30 11. McDermott S & Lee CV. Injury among male migrant farm workers in South Carolina. Journal of Community Health, 15(5): , Oct Choi BK. Definition, sources, magnitude, effect modifiers and stratigies of reduction of the healthy worker effect. JOM, 34: , ISO/DIS CNLA prEN ISO/DIS 15189:2002 Medical Laboratories - Particular Requirements for Quality and Competence 17. ISO/IEC General requirements for the competence of testing and calibration laboratories

31 % 0 0 % 4 24 % % 2 11 % 1 6 % ( / )

32 ISO 15189( % 0 0 % 6 35 % 1 6 % % ( / ) / ISO 15189

33 ( / ) % % % % % % % % % % % % % % % % % % % % % % HBsAg 2 12 % HBsAg 1 6 % HBsAg 3 18 % % 75

34 17 75 SOP

41 ) ( ) a. MIF 4 MIF mL MIF MIF b. 5mL MIF 2.2 MIF

42 MIF Stool Urine Blood Stool 5C.C. 5% Stool Urine Blood

43 3.1 X a. X b. X PACS 3.2 X X X X 4.3 X X

44 5.1 X 3 7 X X (Ocular micrometer) ( Nikon eclipse E (ocular microm 7.2 Ocular Micrometer / a. b. c. Stage Micrometer d. MCV (80-96 fl) Ocular Micrometer 20 RBC 1 20 RBC Mean 7.1 m CV 3.19% 2 20 RBC Mean 7.47 m CV 4.98%

45 CV 5% Ocular Micrometer Stage Micrometer HIV HIV parafilm RPR TPHA 10.2 TPHA TPHA TPHA SOP SOP SOP

46 10.4 RPR test SOP FTA-ABS para-film HBsAg 13.1 B SOP B

47 HBsAg 14.1 HBsAg Cutoff TFS ELISTA-HBsAg JMB ISO 430 (0.298) ISO 637 (0.423) cutoff AxSYM ISO S/N Negative ISO S/N Negative HBsAg 15.1 HBsAg para-film UCG

48 16.3 B-hcG (low titer) BCG ( ) X 17.3 ( -1 CG) (MIU/mL) 2 MIU/mL 2 MIU/mL "Negative (<2)".2 25 MIU/mL 48hrs 25 MIU/mL 25 MIU/mL "Positive" 17.4

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50 21.1

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Microsoft Word - 28-QM03.doc

Microsoft Word - 28-QM03.doc MAY 19, pp466-476 二十一世紀的新醫學健康保證 vs 疾病醫療廖素娥張英明蔡三元陳舒宏董光世仁濟醫院檢驗室主任張淑貞張志發葉秀貞仁濟醫院院長 suher.liaw@tjci.org.tw 黃德政蕭惠文蔡佩玲仁濟醫院健康管理中心摘要二十