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Teleconference

The following information is provided in response to inquiries related to the February 18, 1999 FDA MQSA satellite teleconference.

Subject: "FACILITY INSPECTIONS UNDER THE MAMMOGRAPHY QUALITY STANDARDS ACT (MQSA) FINAL REGULATIONS." Date: Thursday, February 18, 1999

Target Audience: Mammography facility personnel, inspectors, and other interested parties.

This live teleconference provided information about what mammography facility personnel and inspectors need to prepare for MQSA inspections conducted under the Final MQSA Regulations that become effective on April 28, 1999. Presentations focused on new requirements related to: 1) personnel; 2) equipment; 3) reporting of exam results to patients; and 4) the consumer complaint mechanism, and changes in the approach to quality assurance. The material presented is useful to facilities in understanding MQSA and valuable towards improving mammography quality.

Policy Regarding CME/CEU Credit for the Teleconference:

Background. The main benefit thought to be derived from viewing the teleconference was always planned to be the information provided. However, in the early planning stages, the agency did look into the possibility of obtaining approval from one or more professional bodies to award CME/CEU as a "bonus" for viewing it. Upon discussion, we concluded that we lacked the resources necessary for providing this service.

Policy for Viewing "Live" Telecast. While we cannot issue any CME/CEU credit per se for the teleconference aired on February 18, 1999, we will allow facility personnel to classify the teleconference as a formal in-house training course and, therefore, count it toward the CME/CEU continuing education requirement.

Important: Facility staffers seeking credits were responsible for arranging to have a responsible person present during the live teleconference to document their attendance -- it was not the responsibility of someone at the downlink site. Although some downlink sites volunteered to provide this documentation, they were not obliged to do so.

Policy for Viewing Via Televised Re-runs and Videotape for:

Radiologic Technologists. Normally, we would accept credits for educational videos approved by the American Society for Radiologic Technologists (ASRT), but the ASRT is not issuing any credits for this program. To not lose the opportunity to allow facility personnel to gain from this program, FDA is applying ASRT-like rules to allow 3 credit hours of in-house training to count as 3 CME/CEU credits. The individual must:

• View the tape in a formal in-house training setting.
• Participate in a discussion or question and answer period at the conclusion of the tape.
• Acquire appropriate documentation (such as a letter) from the facility or viewing site, stating that the personnel viewed the tape in a formal setting and was present for the entire viewing and the follow-up discussion or question and answer period.

Interpreting Physicians. The above conditions apply to interpreting physicians seeking CME credits. Keep in mind that the viewing must have taken place before the April 28, 1999 effective date of the MQSA final regulations. Under the final regulations now in effect, only category I CME is acceptable for meeting the interpreting physician continuing education requirement.

If you have any further questions about CME/CEU credit that are not addressed above, please fax them to:
Pam Chissler @ 301-594-3306.

Copies of Teleconference Videotapes. Videotaped copies of the teleconference can be ordered (for a fee) through the National Technical Information Service (NTIS). For NTIS ordering information, phone (703)-605-6186.

Updated June 3, 1999