A breast cancer survivor calls for mandatory accreditation for stereotactic breast biopsy.

Suspicious microcalcifications were found on my yearly screening mammogram 18 months ago. A surgeon attempted to perform a stereotactic breast biopsy, but was unable to localize my lesion. I then went to an accredited breast center where a dedicated breast-imaging radiologist did find my lesion and I was diagnosed with low-grade ductal carcinoma in situ. My outcome was favorable and it is these events that have encouraged me to fight for women to obtain breast biopsies in the least invasive manner, without compromising accuracy, and delivered by a dedicated, accredited physician.

I began gathering facts to establish my knowledge of the standards for physicians who perform either stereotactic or ultrasound-guided core needle breast biopsies. I realized that the standards are different for surgeons and radiologists who perform the exact same procedure. These standards were established by a Joint Task Force of the American College of Radiology and the American College of Surgeons, and the major differences are that the radiologist who performs stereotactic breast biopsy must be fully accredited under the Mammography Quality Standards Act (MQSA) and must read 480 mammograms per year. The surgeon does not have to be qualified under the MQSA and must “evaluate” only 240 mammograms per year in consultation with the physician who is qualified to interpret under the MQSA. At this time they can perform the procedure without accreditation, because it is not mandated that they meet even these established standards. At present, this image-driven procedure may be performed by a physician without imaging expertise.

I have brought this issue to the hospital where my first biopsy was attempted, and this has led to a major uproar. I have written to my senators, congressman, Secretary of Health and Human Services Tommy Thompson, Senator Barbara Mikulski, who introduced the MQSA in 1992, and various leading physicians in breast care to establish why accreditation of image-guided core needle breast biopsies is not mandated and is still only voluntary. I have attempted to gain knowledge as to why, even now, when core needle breast biopsy is the standard of care for diagnosing most palpable and nonpalpable breast lesions, there still is a very large percentage of open breast biopsies being performed for diagnosis throughout the United States.

I have been approached by many women who have had similar experiences. One woman, in particular, had four lesions in her breast, one palpable lesion, one microcalcification, and two cysts, and was told by her surgeon that he would surgically remove all four lesions to establish a diagnosis. She wanted another opinion and was sent to an accredited breast center where she had four image-guided, nonsurgical procedures. All of these lesions were benign. She was thus spared the greater cost and disfiguring incisions that could make later mammography interpretation more difficult.

As the various stories unfold, I realize that women are not always given choices. At a time when they, like myself, just want an answer, does quality play the key role in this process? Does every physician who sees the patient with a suspicious lesion give the woman all of her choices for methods of diagnosis? Are they all dedicated to this high standard? Do turf battles play a role?

The Mammography Quality Standards Reauthorization Act of 2004, for the first time in the act’s history, will reauthorize MQSA for 2 years instead of 5 years. In this ensuing time frame, the Institute of Medicine and the General Accounting Office will be conducting studies to identify additional ways of improving mammography quality and review the existing regulations for negative impact. Allowing stereotactic guided core needle breast biopsy accreditation to remain voluntary impacts the quality of the diagnostic procedure and may lead to more open biopsies, if the physician lacks imaging skills to complete the procedure and resorts to the next biopsy approach. Quality mammography plays a critical role in early diagnosis of breast care, but the next step to diagnosis requires the same high standards we have placed on mammography.

We have a 2-year window to make changes in mammography. The government has instructed the Institute of Medicine to gather the information to substantiate the ways to improve breast care from detection to diagnosis and treatment. As a women’s advocate for quality breast care, I ask that you contact your government representatives, especially Senator Mikulski and Secretary Thompson, regarding the need to set high standards for core needle breast biopsy and mandate accreditation for all physicians who perform this procedure.

Judy Wagner, RN, is a nurse who has worked for 20 years in intensive care and 10 years in home intravenous therapy. She is a member of the National Consortium of Breast Centers and is married to a radiologist who practices in the Milwaukee Metropolitan Area.