American Journal of Law & Medicine

Who's monitoring the quality of mammograms? The Mammography Quality Standards Act of 1992 could finally provide the answer.


Breast cancer is the most compelling health threat to American women today. Of the 182,000 women who will be diagnosed with breast cancer in 1993, an estimated 46,000 will die from the disease.(1) The lack of information about its etiology(2) and its consistently high mortality rate since 1955 compound its power.(3) Today, one out of every nine American women who live to age eighty-five will develop breast cancer as compared to one out of eleven in 1980.(4) Although researchers have pinpointed a number of risk factors for breast cancer,(5) they have yet to establish a clear relationship between each factor and development of the disease.(6) However, coordinated research efforts are underway to gain a better understanding of these relationships and related issues.(7) The mysteries of breast cancer coupled with the magnitude of its impact prompt most authorities to agree that early detection and treatment represent the best preventive measures.(8) In fact, if cancer is detected early and treated promptly, the five-year survival rate is ninety-one percent, with most women free of cancer for the rest of their lives.(9)

Mammography, the procedure that produces an X-ray picture of the internal structure of the breast,(10) is the most capable weapon in this regard. Technological advancements over the past two decades have heightened its utility relative to other screening methods,(11) including ultrasound,(12) thermography,(13) and transillumination.(14) In fact, if all women underwent regularly scheduled screening mammograms, they could prevent thirty to forty percent of all breast cancer deaths.(15) Based on these statistics, which assume high quality and accuracy of mammograms, one cannot underestimate the importance of mammography in today's battle against breast cancer.(16)

At the same time, one must not overlook the vital importance of ensuring the comprehensive oversight of mammography in this country.(17) All too often, mammograms do not reflect their full potential as preventative tools because equipment, physicist, technologist, or radiologist "error(s)" compromise quality and accuracy.(18) Certainly, significant progress in the battle against breast cancer will not be possible without removing these risks of error, particularly as the demand for and access to mammography increase.(19) The problem may become more acute as low-cost, high-volume facilities proliferate,(20) and as physicians become more |territorial' about their patients by operating mammography equipment in their own offices and resisting outside referrals for mammography services.(21)

Failing to monitor the quality of mammography equipment and the qualifications of personnel operating that equipment represents the most crucial and most dangerous -- oversight in the "conflicting and overlapping patchwork of federal, state, and private, voluntary standards" developed to ensure high quality mammograms.(22) At the private level, the American College of Radiology (ACR)(23) has compiled the most stringent and comprehensive set of accreditation standards, but compliance is voluntary.(24) At the state level, only a handful of states have adopted legislation in the area of quality assurance specifically for mammography.(25) However, enforcement of these laws varies markedly.(26) At the federal level, as part of the Omnibus Budget Reconciliation Act of 1990,(27) Congress required the Secretary of Health and Human Services to establish quality standards for facilities providing screening mammograms to Medicare beneficiaries.(28) The Secretary issued an interim final rule on December 31, 1990, which allows facilities to self-certify, requires no annual inspections, and establishes no oversight or enforcement mechanisms to ensure compliance.(29) Since final quality assurance regulations have not been published, the program is operating under the interim rule.(30) The Mammography Quality Standards Act of 1992,(31) enacted on October 27, 1992,(32) may provide the necessary relief by unifying these approaches through national, uniform quality and safety standards for mammography facilities beginning in late 1994.

This Note illustrates the urgent need for uniform, mandatory quality and safety standards for mammography that the Mammography Quality Standards Act of 1992 seeks to address. Part II provides background on the incidence of breast cancer and the efficacy of mammography in early detection. Part III examines the response of the medical community, the states, and the federal government to the need for uniform standards for mammography equipment, personnel, and quality assurance. Taken together, these measures form no cohesive structure to guide women or the medical community in assuring the quality and accuracy of mammograms, thereby permitting potentially life-threatening variations among and within states.

Part IV presents the Mammography Quality Standards Act of 1992. Although this Note applauds the legislation, it calls for more aggressive steps to implement the program, and asserts that Congress should be more specific about the role of the Secretary of Health and Human Services in formulating standards, particularly the time within which such standards must be implemented. Furthermore, there is some concern about the proper role of the states in the regulation of mammography facilities. Although the legislation gives states the option to perform the necessary regulatory functions, there is little incentive for them to do so. Finally, because this Note seeks to empower women with information -- not disarm them with fear -- Part V presents future prospects in this area of law as well as inquiries women contemplating a mammogram should make, particularly of unaccredited providers.



The recent statistics associated with breast cancer are truly staggering. In 1991, for example, an American woman was diagnosed as having breast cancer every three and one-half minutes; one died from the disease every twelve minutes.(33) The main factors associated with the initiation or spread of breast cancer include age, family history of breast cancer, and personal history of breast cancer.(34) Additional considerations are hormonal risk factors, such as age at menstrual cycle (i.e., less risk if it first occurred at an early age), first pregnancy (i.e., less risk if it occurred at an early age), and menopause (i.e., less risk if it occurred at a later age).(35) Also included are external risk factors, such as radiation exposure (particularly at an early age),(36) hormone replacement therapy,(37) and diet (particularly fat and alcohol intake, as well as obesity).(38)

Though risk factors supply some guidance, they hold little predictive value, for up to seventy-five percent of all women who develop breast cancer have no risk factors at all.(39) Therefore, "selecting women for screening on the basis of risk factors is not likely to reduce mortality in the overall population of women."(40) Further complicating this area of research is the fact that breast cancer, unlike heart disease and lung cancer, has no known cause.(41) Although nearly 800 articles regarding breast cancer were published in scientific periodicals by 1991,(42) "understanding of the etiology is still insufficient to reduce the incidence significantly."(43) As a result, early detection and prompt treatment represent the best methods for reducing the number of breast cancer deaths.(44) In that regard, early detection is possible through various screening methods, including monthly breast self-examinations, periodic clinical examinations, and mammography.(45)


Breast self-examination (BSE) involves the techniques of inspection and palpation that a woman uses to examine her breasts' shape, size, nipple area, contour, and tissue softness.(46) A doctor also uses these techniques when performing the examination in a clinical setting.(47) Ideally, beginning at the age of twenty, a woman should perform her BSE monthly, two to three days after her period ends (i.e., when her breasts are least likely to be tender and swollen).(48) Although BSE is important to women insofar as it actively involves them in monitoring their health,(49) it cannot substitute for routine mammograms or a doctor's regular breast examinations.(50) Furthermore, since breast examinations by a health professional, though important, may entail the drawbacks associated with BSE,(51) "mammography is our most effective tool for detecting breast cancer in its early, highly treatable stages. Other methods are being tested . . . but none yet equals mammography's effectiveness or safety."(52)


A mammogram is an x-ray picture of the internal structure of the breast.(53) As one woman described the procedure,

The X-ray machine . . . is roughly the size and shape of a two door

refrigerator with a couple of appendages: One is the camera, positioned

above the breasts, the other is a set of two plates, each about

the size of [a] magazine. [After I stripped to the waist and donned an

open-front hospital gown], a female technician positioned my right

breast on the lower plate, which holds the film, with my right arm

raised and resting on the edge of the camera. She then lowered the

upper plate, a clear piece of Plexiglas, squeezing the breast as flat as

possible . . . . The technician told me to hold my breath, dipped

behind a screen and less than five seconds later returned to repeat

the process on the other breast. She then swiveled the plates ninety

degrees and took side-to-side views of each breast.(54)

A complete mammographic study usually involves two views of each breast, one from the side and one from the top.(55) Because mammograms can detect lesions as small as one-half centimeter (lesions may be at least one centimeter before felt),(56) they can detect lumps two years before BSE.(57) Dr. Jerome Levy compared thermography,(58) computer tomography (CT) imaging,(59) transillumination,(60) ultrasound,(61) and magnetic resonance imaging (MRI)(62) to mammography and concluded, "[s]o far, none of them can do what mammography does; its image quality remains unsurpassed."(63) Furthermore, well-designed studies continually demonstrate the benefits of mammography in detecting nonpalpable, cancerous lesions and lowering mortality in women, particularly among those women over the age of fifty.(64) For example, Dr. Susan Love reviewed two investigations that showed a one-third reduction in mortality among screened women over fifty years of age as compared to those in control groups.(65)

Since breast tissue becomes less dense as women age,(66) the efficacy of mammography for women over fifty years of age increases.(67) As a result, members of the medical community have feuded over the appropriate frequency of mammograms for women between forty and fifty years of age, and the benefits women under the age of fifty may receive from mammograms.(68) Before 1989, there was no consensus within the medical community concerning the age at which asymptomatic(69) Women should begin regular mammography screening. In late 1989, however, the American Medical Association (AMA) issued screening guidelines.(70) The AMA recommends that asymptomatic women begin the screening process by age forty, and undergo annual clinical examinations and annual or biannual screening mammograms,

according to their physician's recommendation.(71) In addition, asymptomatic women fifty years of age and older should havean annual clinical examination and mammogram.(72)

At least twelve major medical organizations have endorsed the AMA guidelines.(73) Despite this support, the medical community remains divided, particularly since the release of a controversial Canadian study of nearly 90,000 women that revealed no benefits from screening mammography for women under the age of fifty.(74) A former supporter of these guidelines, the National Cancer Institute (NCI), recently announced plans to scale back its guidelines, citing a lack of evidence that screening mammography reduces deaths from breast cancer among asymptomatic women under fifty years of age.(75) In this revision, NCI would no longer recommend that asymptomatic women between the ages of forty and forty-nine receive an annual or biannual screening mammogram; instead, "they should |discuss' the appropriateness of a screening mammogram individually with their physicians, taking into account individual risk factors'" and undergo annual clinical examinations.(76) Most major medical groups, including the American Cancer Society, the American College of Radiology, and the American College of Obstetrics and Gynecology, oppose these revisions, contending that there are no new scientifically significant data that would justify these or other changes.(77) The debate continues unabated.(78)

Although cost and access issues still pervade medical literature and political discussion about mammography,(79) concerns about safety and quality remained obscure until only recently. Since high-quality mammography is essential for detecting early breast cancers, informed, productive discussions about cost and access are impossible without reference to the quality of mammography equipment, the clarity of mammograms, and the qualifications of those who perform the procedures.


Unless mammography is done with quality, there is no use doing

it.... It isn't enough to get a woman to get a mammogram. It has to

be a good mammogram. And it has to be interpreted by someone

who is experienced and trained in it.(80) Until the Mammography Quality Standards Act of 1992 becomes effective, women have no such guarantee. The current system does not assure that mammograms or the persons producing them meet uniform quality and safety standards. Instead, the onus falls on women to ask questions regarding facility accreditation, personnel qualifications, and technical aspects of the procedure. Given the serious health risk that poor quality mammography poses to women, this onus is extreme and unfair. The Mammography Quality Standards Act of 1992 could alleviate that burden and allow women to trust the results of this sensitive(81) -- and potentially life-saving -- procedure.


During the early to mid-1980s, many radiologists believed that the use of modern, dedicated mammographic units(82) was enough to ensure optimal image quality and low radiation dose.(83) However, several studies and an increasing number of women reporting "false negative" mammograms quickly dispelled this notion.(84) Although data on false negative rates are limited, the Physician Insurers Association of America (PIAA) found that thirty-five percent of all claimants with breast cancer had a negative mammogram and another fourteen percent had equivocal mammograms.(85) In another study, experts indicated that conventional mammography detects about eighty percent of detectable breast cancers, while the remaining twenty percent remain undetected because of inadequate quality images, difficulties or errors in interpretation, and problems with imaging the structure and tissue/fat composition of the breast.(86) One study reported large variations in image quality and radiation dose from dedicated mammographic equipment at sites across the nation, while another showed variations from site to site and from day to day at the same sites.(87)

Today, few doubt that, in addition to dedicated equipment, "earlier detection of breast cancers requires careful positioning, adequate compression, optimal technical factors, careful processing, and accurate interpretation."(88) The impact of this precious balance is most dramatic when women who receive false negative mammograms also receive a false sense of security, suffer unnecessarily, and, in some cases, lose their lives to breast cancer.(89)


In 1986, as part of the American Cancer Society's Breast Cancer Awareness Screening Campaign, the American Cancer Society (ACS) and the ACR formed the Committee on Mammographic Screening.(90) The Committee focused on safety and quality control, aiming for guidelines that would ensure high-quality mammograms, low radiation dose, and accurate interpretation. …

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