MQSA Hot Topics (Continued)
Last Updated September 19, 2005 8

The continuing education requirement for specific mammography modality is addressed in MQSA as the following: 

21 CFR 900.12 (a)(2)(iii)(A) and (C): Continuing Education

• (A) Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were completed, the radiologic technologist shall have taught or completed at least 15 continuing education units in mammography during the 36 months immediately preceding the date of the facility’s annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility will choose one of these dates to determine the 36-month period.

• (C) At least six of the continuing education units required in paragraph (a)(2)(iii)(A) of this section shall be related to each mammographic modality used by the technologist.

All personnel will have to document training in each modality used even if the only modality is screen film. If a facility has screen film and digital imaging, they will have to document continuing education in both.

For interpreting physicians and technologist the number of hours for each modality are six. As for medical physicists there is not a specific number of hours requirement. If the documentation does not bread down the amount of credit issued by specific mammographic modality, the facilities can use the limited
attestation policy to document specific mammographic modality along with the course agenda. The inspector will begin citing facilities on April 28, 2006.

The medical audit general requirements is addressed in MQSA as the following:

21 CFR 900.12(f)(1): General requirements. Each facility shall establish a system to collect and review outcome data for all mammograms performed, including follow-up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physicians mammography
report. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility. In addition, any cases of breast cancer among patients imaged at the facility that subsequently become known to the facility shall prompt the facility to initiate follow-up on surgical and/or pathology results and review of the mammograms taken prior to the diagnosis of a malignancy.

The inspectors will be looking for a medical audit policy documenting how the medical audit will be performed. We will be specifically looking for the mechanism of tracking patients assessed with a “Suspicious”, “Highly Suggested of Malignance”, or recommended for biopsy report. The documentation should follow the patient from mammogram to biopsy, concluding with how the biopsy results will be documented. In the event that a patient does not have a biopsy or biopsy results are not obtainable, the facility should document what is done in those instances.

In Nevada, a person must obtain execption to NAC 459.554(3)(b) from the Radiological Health Section.

NAC 459.554(3). Persons must not be exposed to the useful beam except for the purposes of the healing arts where each exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:

(a) Exposure of a person for training, demonstration or other purposes unless there are also healing arts requirements and proper prescription has been provided.

(b) Exposure of a person for the purpose of healing arts screening without prior written approval of the Division. Screening means an exposure of a person without a prior examination by a licensed practitioner.

• Name of the disinfectant used

Documentation of in-between patient cleaning is not a requirement of MQSA, but the written procedure for performing this task is required.

It is advisable for ease during the inspection and for the facility employees, that these items be clearly stated and that a copy of the manufacturer’s recommendations be kept with the disinfection policy.