In doing inspections of mammography facilities, we are noticing an increasing pattern of noncompliance with certain State of Michigan mammography requirements. Before talking about the repeating areas of noncompliance, I want to point out that our requirements for all x-ray facilities are included in both Michigan law and in administrative rules. The underlying law, or statute, that defines radiation control in the state is Part 135 of the Public Health Code. The administrative rules that implement the statute are the Ionizing Radiation Rules. Both can be observed on our website here. Both the statute and the administrative rules have the effect of law.

Usually the Radiation Safety Section (RSS) will cite noncompliance with the rules, however, mammography legislation, Public Act 100 of 1994, was passed subsequent to the implementation of mammography rules (1993) and thus Public Act 100 of 1994 is not incorporated in the rules. For mammography inspections, RSS will cite both rules and sections of the statute.

Section 13523(2)(d)(iii) requires each mammography facility to designate a physician to function as medical director for the delivery of mammography services. This physician is required to conduct an ON-SITE VISIT to the mammography facility at least monthly for the purpose of providing professional feedback regarding image quality and quality assurance procedures, for review of quality control documentation, and for ensuring that safe operating procedures are used in the delivery of mammographic services. We are finding that even though there may be signed documentation of the monthly checks, we are discovering that often the medical director for the delivery of mammography services is NOT making an on-site visit to the facility at least monthly.

Rule 619 requires the mammography supervisor to evaluate the performance of each mammography technologist at least semiannually. This evaluation must be based on the DIRECT OBSERVATION OF THE TECHNOLOGIST during a standard procedure being performed by the technologist on at least 1 patient and on the review of clinical images. We are finding that even though there may be signed documentation of a performance review, in some cases the mammography supervisor is NOT observing the technologist with an actual patient during an actual procedure.

Both of these requirements are conditions for mammography authorization to be granted by the Department of Community Health. Rule 613 states that authorization may be withdrawn based on evidence of noncompliance with the rules and the statute. If mammography authorization is withdrawn, the x-ray machine cannot legally be used for mammography.

The purpose of this notice is to remind mammography facilities of their obligations under Michigan's mammography regulations. Our inspectors will thoroughly evaluate evidence of compliance for these 2 requirements during the next inspection cycle. In addition, we have updated our guidance documents BHS/HFS-890; Medical Director: Responsibilities and Duties and BHS/HFS-891; Mammography Supervisor: Responsibilities and Duties to more clearly specify what is being attested to when signing the forms contained in those documents to demonstrate compliance. If we continue to see these requirements violated, we will pursue withdrawal of mammography authorization.

Bruce Matkovich, Manager
Radiation Safety Section