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For the first time in over 20 years, the FDA has proposed amendments to the Mammography Quality Standards Act (MQSA) in an effort to expand the information provided to patients and physicians, modernize standards for mammograms, and enable better enforcement of safety and quality regulations. In this interview with i3 Health, Theresa W. Gillespie, PhD, MA, RN, Professor at Emory University School of Medicine and at Emory's Winship Cancer Institute, discusses the significance of these changes and the impact that they will have on nurses and patients.
What are your thoughts on the FDA's proposed changes to the MQSA?
Theresa W. Gillespie, PhD, MA, RN: The MQSA was put into place in 1992. Much has changed regarding breast imaging technology since then, so it seems appropriate to have the FDA propose federal changes to the MQSA in order to ensure that modern standards and best practices are in place in every state in the US and that quality does not vary from state to state.Two of the most important changes proposed are likely to impact both patients and nurses: 1) refinement and addition of mammogram finding categories (eg, "negative," "benign," and a new category, "known biopsy proven malignancy"); and 2) patient notification regarding breast density (four categories that can be grouped into "low" or "high" density breasts), along with an explanation of breast density and its role in potentially affecting the sensitivity of mammography.
To what extent will these amendments alter current practice?
Dr. Gillespie: Some of the changes will primarily affect imaging facilities and radiologists who read and interpret mammograms; the amendments will alter current practice related to how images are sent to physicians who read mammograms in order to ensure that the most accurate images are available. Others will affect referring physicians or staff, such as the proposed timeframe for communicating with the referring provider and patient if a report is "suspicious" or "highly suggestive of malignancy."
What impact do you think that the changes will have on oncology nurses?
Dr. Gillespie: Oncology nurses and other health care providers will likely be asked by patients for help in interpreting these revised mammogram reports, particularly those with assessment of breast density. Although breast density has been talked about for years, its precise role both in mammographic detection of existing breast cancers and in the debate about breast density as a risk factor for the development of breast cancer de novo are liable to become topics for discussion and patient education in greater detail when mammogram reports begin including this information. Nurses and other health care providers will need to educate themselves about the evidence and guidelines, and they will need to integrate the data into their practice.
About Dr. Gillespie
Theresa W. Gillespie, PhD, MA, RN, is a Professor in the Department of Surgery and in the Department of Hematology & Medical Oncology at Emory University School of Medicine and Emory's Winship Cancer Institute. Dr. Gillespie has over 30 years of experience in clinical oncology, including direct patient care. Her research interests have focused on breast, prostate, lung, and gastrointestinal malignancies. She serves as Principal Investigator for multiple studies examining decision-making regarding screening and treatment options for cancers among underserved populations, including studies focused on informed decision-making regarding cancer clinical trials. In addition, Dr. Gillespie holds memberships in a multitude of professional organizations, including the American Society for Clinical Oncology, the Oncology Nursing Society, and the Georgia Cancer Coalition, among others.
For More Information
The proposed amendments are available online for public comment until June 26, 2019: Mammography Quality Standards Act
Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily represent the views of i3 Health.