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Principles for the Certification of Mammography Medical Institutions

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  • Modify Date:Modify Date:2015/01/30
  • Publish Date:Publish Date:2015/01/30
1. Department of Health, Executive Yuan, Taiwan (hereinafter known as the department in the text) has drawn up the following principles for the certification of medical institutions of mammography.

2. The certification approval committee members will include invited experts and related business executives or associations that the department appoints or authorizes.

3. The approval procedures include two stages: a written application and on site inspection. Please see appendix 1 for the relevant regulations.

4. Medical institutions which pass the written application will be awarded the certificate of mammography medical institution.

5. An institution which passes the written application shall undergo an on-the-spot inspection within six months. Medical institutions that do not pass the test should undergo counseling and assistance within six months in order to pass it.

6. Duties that medical institutions of mammography should carry out include:
(1) Information relating to individual cases of mammography should be reported, according to the stipulated deadline and format.
(2) Any changes in staff or mammographic instruments should be reported to the department within two weeks of the changes occurring. If there are no qualified instruments or staff available due to the changes, the institution should terminate the screening mammography on the day the changes occur. Within two months, the department should receive information on staff having been recruited to fill in the job vacancy and/or sufficient instruments having been obtained. After the application for certificate of mammography medical institution has been approved, in accordance with the corresponding certifying principles, the medical institution can continue carrying out to perform screening mammography.
(3) Positive cases of mammographic screening should be followed up on their outcome and possible final diagnosis.
(4) Every one to two years, qualified medical institutions should undertake a follow-up inspection, and the related regulations are shown in appendix 2.

7. The certificate of medical institutions will be anulled if any of the following circumstances pertain:
(1) The second stage of certificate application, on-the-spot inspection, is not passed, and the situation has still not improved after counseling.
(2) In the follow-up inspection, it is found staffs are not qualified in accordance with the regulations.
(3) In the follow-up inspection, it is found that mean glandular radiation dose, half-value layer measurements, quality assurance of developing machines and calibration reports, phantom image analyses and clinical image evaluations do not meet the required standards. Furthermore, it is found that mammographic technologists have undertaken training, but do not pass the second inspection.
(4) The results of double reading of those screening positive mammograms by experts are higher than the standards. Furthermore, it is discovered that mammography interpretation physicians after attending mammography training seminars still do not pass the inspection in the subsequent year by random selection of mammography film interpretation.
(5) Medical institutions that do not report individual case information and changes in mammography staff and instruments, and follow up the suspected positive cases of mammographic screening on their confirmed diagnostic results.

8. Medical institutions, applying for a certificate of mammography medical institution, in accordance with these principles, that have not been approved or have been disqualified can re-apply for the certificate three months after the day of disapproval or disqualification.