3
MQSA Regulations, Inspections, and Enforcement

Mammography Quality Standards Act (MQSA) regulations have been in effect for more than 10 years, so a review at this time is appropriate to identify areas in need of enhancement. In addition to making suggestions for changes and possible additions to enhance the quality of mammography, the Committee examined the current regulations and Food and Drug Administration (FDA) data from inspection reports in an effort to identify components that could potentially be eliminated without a detrimental effect on quality. This was an important consideration because unnecessary regulations and tests add to the cost and workload of facilities, but do not benefit patients.

REGULATIONS OVERVIEW

Congress passed the Mammography Quality Standards Act of 1992 to provide a general framework for ensuring national quality standards in facilities performing screening mammography. The Secretary of Health and Human Services assigned FDA the authority to implement and regulate the Act’s provisions. FDA Final MQSA Regulations became effective in April 1999. A detailed outline of these regulations can be found in Box 3-1.

Briefly, FDA requires that each mammography facility be accredited and certified. Several accreditation and certification bodies exist today. Facilities must apply for accreditation once every 3 years, a process that requires review of both clinical and phantom images. Accrediting bodies are also responsible for reviewing equipment evaluations and quality control tests performed by each facility and reviewing the qualifications of mammography personnel.

All personnel at mammography facilities, including interpreting physicians, radiologic technologists, and medical physicists, must meet initial qualifications, demonstrate continued experience, and complete continuing education programs. To ensure the quality of patient care, FDA requirements also specify that facilities provide a summary of the mammographic assessment in lay terms to each patient in a timely manner.

The states and FDA perform annual inspections to verify personnel and quality control data and to examine compliance with quality standards such as radiation dosage and image processing. Inspectors also ensure that each facility has established a system to record medical outcomes audit data, such that positive mammographic results can be correlated with pathology outcomes. In order to measure and enforce compliance, FDA established a three-tiered violation system, with Level 1 being the most serious. Sanctions, such as directed plans of correction, civil money penalties, and certificate suspensions, can be imposed on delinquent facilities (Mammography Quality Standards Act Regulations, 21 C.F.R. § 900.12 [2003]).



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 82
Improving Breast Imaging Quality Standards 3 MQSA Regulations, Inspections, and Enforcement Mammography Quality Standards Act (MQSA) regulations have been in effect for more than 10 years, so a review at this time is appropriate to identify areas in need of enhancement. In addition to making suggestions for changes and possible additions to enhance the quality of mammography, the Committee examined the current regulations and Food and Drug Administration (FDA) data from inspection reports in an effort to identify components that could potentially be eliminated without a detrimental effect on quality. This was an important consideration because unnecessary regulations and tests add to the cost and workload of facilities, but do not benefit patients. REGULATIONS OVERVIEW Congress passed the Mammography Quality Standards Act of 1992 to provide a general framework for ensuring national quality standards in facilities performing screening mammography. The Secretary of Health and Human Services assigned FDA the authority to implement and regulate the Act’s provisions. FDA Final MQSA Regulations became effective in April 1999. A detailed outline of these regulations can be found in Box 3-1. Briefly, FDA requires that each mammography facility be accredited and certified. Several accreditation and certification bodies exist today. Facilities must apply for accreditation once every 3 years, a process that requires review of both clinical and phantom images. Accrediting bodies are also responsible for reviewing equipment evaluations and quality control tests performed by each facility and reviewing the qualifications of mammography personnel. All personnel at mammography facilities, including interpreting physicians, radiologic technologists, and medical physicists, must meet initial qualifications, demonstrate continued experience, and complete continuing education programs. To ensure the quality of patient care, FDA requirements also specify that facilities provide a summary of the mammographic assessment in lay terms to each patient in a timely manner. The states and FDA perform annual inspections to verify personnel and quality control data and to examine compliance with quality standards such as radiation dosage and image processing. Inspectors also ensure that each facility has established a system to record medical outcomes audit data, such that positive mammographic results can be correlated with pathology outcomes. In order to measure and enforce compliance, FDA established a three-tiered violation system, with Level 1 being the most serious. Sanctions, such as directed plans of correction, civil money penalties, and certificate suspensions, can be imposed on delinquent facilities (Mammography Quality Standards Act Regulations, 21 C.F.R. § 900.12 [2003]).

OCR for page 82
Improving Breast Imaging Quality Standards BOX 3–1 MQSA Regulations Overview Quality Standards Personnel. Interpreting physicians, radiologic technologists, and medical physicists must meet initial and continuing requirements. Documentation of these requirements must be available for inspection. Equipment. Only equipment designed specifically for mammography qualifies for certification. Medical Records and Mammography Reports. Summary data written in lay terms must be sent directly to all patients as soon as possible. Mammography films and reports must be retained for at least 5 years and up to 10 years, and labeled according to Food and Drug Administration (FDA) regulation. Quality Assurance. Quality control testing protocols must be used and maintained by each facility, including mammography equipment evaluations and an annual physics survey. Documentation of daily, weekly, quarterly, semiannual, and annual quality control tests must be retained for FDA inspections. Mammography Medical Outcomes Audit. An interpreting physician must annually review the medical outcomes audit data. Consumer Complaint Mechanism. Facilities must establish a written and documented system for collecting consumer complaints. Accreditation Current Accreditation Bodies. American College of Radiology (ACR), Iowa, Arkansas, and Texas. Responsibilities of Accreditation Bodies. Accreditation bodies must monitor facility compliance with quality standards, review clinical and phantom images from each facility at least once every 3 years, conduct annual onsite visits of at least 5 percent of the facilities it accredits, and maintain a consumer complaint system. Accreditation Body Audit. FDA will evaluate the performance of each accreditation body annually. Facility Accreditation. Facilities must submit verification that personnel, equipment, and practices conform to established quality standards to be eligible for accreditation. Certification Current Certification Bodies. FDA, Iowa, Illinois, and South Carolina. Responsibilities of Certification Bodies. Certification bodies must issue Mammography Quality Standards Act (MQSA) certificates allowing accredited facilities to operate lawfully, and must perform annual inspections of each certified facility. Facility Certification. Accredited facilities are eligible for certification. Certificates are valid for 3 years, and are renewable. Inspections General. Facilities must undergo annual inspections. Inspectors. Facilities may be inspected by FDA inspectors, state or local agency inspectors under FDA contract, or inspectors from states that are certifying agencies. Federal facilities can be inspected only by FDA inspectors.

OCR for page 82
Improving Breast Imaging Quality Standards Inspector Audit. Annual assessment of state performance is carried out by FDA auditors. Fees. The facility undergoing inspection is responsible for all inspection fees. As of October 1, 2003, a fee of $1,749 is charged for the first mammography unit inspected, and $204 for every unit thereafter. Follow-up inspection fees are $991. Compliance and Enforcement Levels of Noncompliance Level 1: Failure to meet a key MQSA requirement that may seriously compromise mammography quality. The facility is given 15 days to respond with corrective actions. Level 2: All critical MQSA requirements met, yet a significant mammography quality item overlooked. The facility is given 30 days to respond, Level 3: A minor deviation from MQSA standards. The facility is given until next annual inspection to address the problem, although it is advised to correct it as soon as possible, Enforcement/Sanctions/Other FDA may impose one or more of the following sanctions: Directed Plan of Correction, allowing facility to correct violations in a timely manner, while being monitored by FDA. Patient and Physician Notification, requiring facilities to inform those that may be at risk due to unacceptable image quality or other conditions that could cause significant negative impact on patient health. Follow-up Inspection. Certificate Revocation or Suspension. Civil Money Penalties of up to $10,000 per examination or per violation per day may be applied to facilities performing mammography services without proper certification or for other significant violations. Advisory Committee Title. The establishment of a National Mammography Quality Assurance Advisory Committee (NMQAAC) was mandated by MQSA. Members. FDA appoints members from the community of physicians, health professionals, consumer organizations, and industry representatives. Responsibilities. The NMQAAC advises FDA on appropriate quality standards, assists in the development of sanctions, designs a method to investigate consumer complaints, reports on new developments in breast imaging, determines whether a shortage of health professionals exists, and measures the costs and benefits of MQSA compliance. SOURCE: Mammography Quality Standards Act, 42 U.S.C. § 263b (2003). 21 C.F.R. § 900.1 (2003).

OCR for page 82
Improving Breast Imaging Quality Standards SUGGESTED CHANGES TO FDA REGULATIONS The Institute of Medicine Committee on Improving Mammography Quality Standards was charged with making recommendations for changes to existing regulatory requirements in order to further improve quality and to reduce unnecessary burdens on mammography facilities. FDA citation data were one source of information used to identify inspection criteria that may be unnecessary to ensure quality mammography (FDA, 2004a). FDA should take responsibility for reviewing the current regulations to delete obsolete language, reduce redundancy, and improve overall clarity. Furthermore, review of regulations should be an ongoing process undertaken by FDA. The following is a summary of the Committee’s views on the current FDA regulations; a complete summary of suggested regulation changes is presented in Table 3–1. Accreditation Sections 900.3 and 900.4 of FDA regulations discuss application for approval as an accreditation body and standards for accreditation bodies, respectively. The Committee agreed on several changes to simplify the accreditation process. First, facilities should submit only the results of the medical physicist’s equipment evaluation to the accreditation body, not the full evaluation, during initial application of a new unit for accreditation. (This is the current FDA-approved practice for accrediting bodies; the regulation change would clarify the practice.) Second, facilities should no longer be required to submit surveys and equipment evaluations to their accreditation body annually; instead, they should be submitted every 3 years as consistent with the renewal process. This information is already being reviewed during the annual MQSA inspection, and additional submission to accreditation bodies is unnecessarily redundant. New Mammography Units Qualifications for MQSA certification in Subpart B should be expanded to require facilities to undergo accreditation of all new mammography units, including digital equipment. Inspection data collected since 2001 have revealed numerous citations for nonaccredited units (FDA, 2004a). FDA should employ a more strict enforcement policy for facilities lacking accreditation for all units. Additionally, the accreditation process for any newly purchased units should begin prior to use. Luminance and Illumination Viewing conditions are critical for accurate interpretation of subtle contrast differences on mammography films (Haus et al., 1993; Wang and Gray, 1998; Waynant et al., 1998, 1999). The 1999 American College of Radiology (ACR) mammography quality control manual suggests standards for viewbox luminance and illumination levels; however, compliance with these recommended standards varies. An estimate from facilities in North Carolina in 2002 suggests approximately 15 percent (40 out of 248 total) of facilities did not meet the recommended ACR viewing standards.1 FDA should require that viewboxes used for interpreting mammograms should produce a 1   Personal communication, G.Britt, North Carolina Department of Health and Human Services, Division of Public Health, Cancer Prevention and Control Branch, February 10, 2004.

OCR for page 82
Improving Breast Imaging Quality Standards TABLE 3–1 Suggested Changes to MQSA Regulations Regulation Additions/Deletions Proposed Regulation Rationale 900.2(aa) Definitions Mammography means radiography of the breast, but, for the purposes of this part, does not include: (1) Radiography of the breast performed during invasive interventions for localization or biopsy procedures; or (2) Radiography of the breast performed with an investigational mammography device as part of a scientific study conducted in accordance with FDA’s investigational device exemption regulations in part 812 of this chapter. Mammography means radiography of the breast, but, for the purposes of this part, does not include: (1) Radiography of the breast performed during invasive interventions for localization procedures; or (2) Radiography of the breast performed with an investigational mammography device as part of a scientific study conducted in accordance with FDA’s investigational device exemption regulations in part 812 of this chapter. (1) Stereotactic breast biopsy procedures utilize X-ray imaging. In the preamble to the final rules, the FDA stated the following: “Since the publication of the proposed regulations on April 3, 1996, significant progress has occurred in the professional community and FDA now believes that there is enough information to begin the development of interventional mammographic regulations. However, that development requires a comprehensive and careful approach that addresses all the factors involved in such procedures. The agency has already begun the development process by bringing this issue before NMQAAC during its October 1996 meeting and is continuing to gather information and data. Although the agency has concluded that the final regulations should exclude coverage of interventional mammography, FDA expects to propose regulations covering all aspects of interventional mammography in the near future.” Because the profession has considerably more experience with stereotactic breast biopsy since 1996, the FDA should remove this exemption. (2) FDA should not require accreditation specifically for non-stereotactic biopsy interventional procedures (e.g., wire needle localization), since accreditation programs do not exist for these procedures. Instead, FDA should only require that all mammography machines used for non-biopsy interventional procedures be accredited under the basic MQSA requirements.

OCR for page 82
Improving Breast Imaging Quality Standards Regulation Additions/Deletions Proposed Regulation Rationale 900.4(c)(5)(i) Review physicians Have at least 50% of each year’s practice in breast imaging, be currently actively practicing in the modality reviewed at an MQSA-certified mammography facility, meet the interpreting physician requirements specified in Sec. 900.12(a)(1) and meet such additional requirements as have been established by the accreditation body and approved by FDA. Have at least 50% of each year’s practice in breast imaging, be currently actively practicing in the modality reviewed at an MQSA-certified mammography facility, meet the interpreting physician requirements specified in Sec. 900.12(a)(1) and meet such additional requirements as have been established by the accreditation body and approved by FDA. It is essential that accreditation body reviewers passing judgment on the performance quality of mammography facilities have considerably more experience than the minimum established by the regulations for physicians interpreting mammograms. Likewise, reviewers evaluating images of a specific modality (e.g., digital) should have current experience with that modality. 900.4(e)(1)(i) With its initial accreditation application, the results of a mammography equipment evaluation that was performed by a medical physicist no earlier than 6 months before the date of application for accreditation by the facility. Such evaluation shall demonstrate compliance of the facility’s equipment with the requirements in Sec. 900.12(e). With its initial accreditation application, the results of a mammography equipment evaluation that was performed by a medical physicist no earlier than 6 months before the date of application for accreditation by the facility. Such evaluation shall demonstrate compliance of the facility’s equipment with the requirements in Sec. 900.12(e). The ACR currently requests only the equipment evaluation results with the initial accreditation application. The FDA has approved this process. 900.4(e)(1)(ii) Reports of mammo equipment evaluations, surveys, and QC Prior to accreditation, an annual survey that was performed no earlier than 614 months before the date of application for accreditation or accreditation renewal by the facility. Such survey shall assess the facility’s compliance with the facility standards referenced in paragraph (b) of this section. Prior to accreditation, an annual survey that was performed no earlier than 14 months before the date of application for accreditation or accreditation renewal by the facility. Such survey shall assess the facility’s compliance with the facility standards referenced in paragraph (b) of this section. “Annual” and “or accreditation renewal” should be included to be consistent with other regulations in this part and minimize confusion about what is required. “Six months” should be changed to “14 months” to make this requirement consistent with the current MQSA inspection process as well as the process currently used by ABs. The way it is currently written may force a facility to unnecessarily have more than one annual survey in the same year.

OCR for page 82
Improving Breast Imaging Quality Standards Regulation Additions/Deletions Proposed Regulation Rationale 900.4(e)(2)(iii) Reports of mammo equipment evaluations, surveys, and QC Facilities submit the results of such surveys and any other information that the body may require to the body at least annually. (NONE) Inspectors currently review annual surveys and equipment evaluations during the facility’s annual MQSA inspection. The current requirement that facilities also submit annual survey results to the AB each year is a redundant process and an unnecessary burden for mammography facilities. Eliminating this redundancy would allow the AB to focus on obtaining important identification and contact information. 900.4(h)(1) Collect and submit to FDA the information required by 42 U.S.C. 263b(d) for each facility when the facility is initially accredited, when notified by the facility and every three years during renewal, in a manner and at a time specified by FDA. Collect and submit to FDA the information required by 42 U.S.C. 263b(d) for each facility when the facility is initially accredited, when notified by the facility and every three years during renewal, in a manner and at a time specified by FDA. Consistent with the suggested change to 900.4(e)(2)(iii). 900.11(b)(1)(i) Certificates In order to qualify for a certificate, a facility must apply to an FDA-approved accreditation body, or to another entity designated by the FDA for accreditation of all mammography units. The facility shall submit to such body or entity the information required in 42 U.S.C. 263b(d)(1). In order to qualify for a certificate, a facility must apply to an FDA-approved accreditation body, or to another entity designated by the FDA for accreditation of all mammography units. The facility shall submit to such body or entity the information required in 42 U.S.C. 263b(d)(1). Add “for all units” to ensure all new mammography units, including digital, are accredited. 900.11(b)(1)(iii) Certificates Facilities must notify their accrediting body of new units and begin accreditation before use. Facilities must notify their accrediting body of new units and begin accreditation before use. Ensures all new equipment is reported to the accrediting body.

OCR for page 82
Improving Breast Imaging Quality Standards Regulation Additions/Deletions Proposed Regulation Rationale 900.11(c) Reinstatement policy A previously certified facility that has allowed its certificate to expire, that has been refused a renewal of its certificate by FDA, or that has had its certificate suspended or revoked by FDA, may apply to have the certificate reinstated so that the facility may be considered to be a new facility and therebybe eligible for a provisional certificate. A previously certified facility that has allowed its certificate to expire, that has been refused a renewal of its certificate by FDA, or that has had its certificate suspended or revoked by FDA, may apply to have the certificate reinstated so that the facility may be eligible for a provisional certificate. The current wording confuses facilities. In practice, a reinstating facility is not “considered to be a new facility” because they retain their MAP ID number, their MQSA certificate number, and, most importantly, their accreditation history. 900.12(a)(1)(ii)(A) Continuing experience and education for interpreting physicians Following the second anniversary date of the end of the calendar quarterin which the requirements of paragraph (a)(1)(i) of this section were completed, the interpreting physician shall have interpreted or multi-read at least 960 mammographic examinations during the 24 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 24 month period previous two calendar years. Continuing experience obtained outside of the U.S. is also acceptable. Following the second anniversary date in which the requirements of paragraph (a)(1)(i) of this section were completed, the interpreting physician shall have interpreted or multiread at least 960 mammographic examinations during the previous two calendar years. Continuing experience obtained outside of the U.S. is also acceptable. (1) The current timeframe for counting this experience has been extremely confusing for personnel and even inspectors. Basing these numbers on calendar years will simplify compliance with no loss of quality. (2) There are a number of instances where physicians who initially qualified in the U.S. under MQSA practice temporarily outside the U.S. and then return. While at a foreign facility they continue to interpret mammograms using the skills they obtained while qualified in the U.S. They should not be prevented from using the examinations interpreted at a foreign site (as long as it is adequately documented) toward meeting the continuing experience requirements in the U.S. upon their return. Currently, FDA guidance prohibits the use of this foreign experience toward meeting MQSA requirements.

OCR for page 82
Improving Breast Imaging Quality Standards Regulation Additions/Deletions Proposed Regulation Rationale 900.12(a)(1)(ii)(B) Continuing experience and education for interpreting physicians Following the third anniversary date of the end of the calendar quarterin which the requirements of paragraph (a)(1)(i) of this section were completed, the interpreting physician shall have taught or completed at least 15 category I continuing medical education units in mammography during the previous three calendar years. 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. This training shall include at least six category I continuing medical education credits in each mammographic modality used by the interpreting physician in his or her practice. Following the third anniversary date in which the requirements of paragraph (a)(1)(i) of this section were completed, the interpreting physician shall have taught or completed at least 15 category I continuing medical education units in mammography during the previous three calendar years. (1) The current timeframe for counting this education has been extremely confusing for personnel and even inspectors. Basing these numbers on calendar years will simplify compliance with no loss of quality. (2) Delete “six category I continuing medical education credits in each mammographic modality used by the interpreting physician in his or her practice.” The interpreting physician has already obtained the required initial 8 hours of training to begin interpreting from a new modality. It is more important to allow the physician to select CMEs for continuing experience to help improve breast disease interpretation skills. These do not change with the modality used. 900.12(a)(2)(iii)(A) Continuing education for radiologic technologists Following the third anniversary date of the end of the calendar quarterin 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 those dates to determine the 36 month periodprevious three calendar years. Following the third anniversary date 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 previous three calendar years. The current timeframe for counting this education has been extremely confusing for personnel and even inspectors. Basing these numbers on calendar years will simplify compliance with no loss of quality.

OCR for page 82
Improving Breast Imaging Quality Standards Regulation Additions/Deletions Proposed Regulation Rationale 900.12(a)(2)(iii)(C) Continuing education for radiologic technologists 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. This continuing education shall include training appropriate to each mammographic modality used by the technologist. This continuing education shall include training appropriate to each mammographic modality used by the technologist. The current requirement that technologists (and, in effect, continuing education-granting organizations) designate credits with the modality (i.e., screen-film or FFDM) is not reasonable. Most current existing credits are either on general breast disease or specific to screen-film mammography, thus, awarding 6 credits is excessive. They should just be required to include some (as with the original requirements for medical physicists). 900.12(a)(2)(iv)(A) Continuing experience for radiologic technologists Following the second anniversary date of the end of the calendar quarterin which the requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were completed or of April 28, 1999, whichever is later, the radiologic technologist shall have performed a minimum of 200 mammography examinations during the 24 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 24 month period previous two calendar years. Following the second anniversary date in which the requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were completed or of April 28, 1999, whichever is later, the radiologic technologist shall have performed a minimum of 200 mammography examinations during the previous two calendar years. The current timeframe for counting this experience has been extremely confusing for personnel and even inspectors. Basing these numbers on calendar years will simplify compliance with no loss of quality.

OCR for page 82
Improving Breast Imaging Quality Standards Regulation Additions/Deletions Proposed Regulation Rationale 900.12(a)(3)(iii)(A) Continuing education for medical physicists Following the third anniversary date of the end of the calendar quarterin which the requirements of paragraph (a)(3)(i) or (a)(3)(ii) of this section were completed, the medical physicist 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 inspection or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility shall choose one of these dates to determine the 36 month periodprevious three calendar years. This continuing education shall include hours of training appropriate to each mammographic modality evaluated by the medical physicist during his or her surveys or oversight of quality assurance programs. Units earned through teaching a specific course can be counted only once toward the required 15 units in a 36 month period three calendar years, even if the course is taught multiple times during the 36 monthsthis time period. Following the third anniversary date in which the requirements of paragraph (a)(3)(i) or (a)(3)(ii) of this section were completed, the medical physicist shall have taught or completed at least 15 continuing education units in mammography during the previous three calendar years. This continuing education shall include hours of training appropriate to each mammographic modality evaluated by the medical physicist during his or her surveys or oversight of quality assurance programs. Units earned through teaching a specific course can be counted only once toward the required 15 units in three calendar years, even if the course is taught multiple times during this time period. The current timeframe for counting this education has been extremely confusing for personnel and even inspectors. Basing these numbers on calendar years will simplify compliance with no loss of quality.

OCR for page 82
Improving Breast Imaging Quality Standards FIGURE 3–1 Full Field Digital Mammography (FFDM) growth. Data collected by the American College of Radiology and reported by Destouet et al. (in press) demonstrate an increase in both the number of FFDM units and the number of facilities with FFDM units since October 2003. The percentage of FFDM units and facilities with FFDM units is also represented graphically. SOURCE: Destouet et al. (In press). Reprinted from the Journal of the American College of Radiology, In press, Destouet JM, Bassett LW, Yaffe MJ, Butler PF, Wilcox PA. The American College of Radiology Mammography Accreditation Program—10 years of experience since MQSA, with permission from The American College of Radiology. QC tests and test criteria across all digital systems. Uniform standards should not preclude performance of additional tests on some digital systems, as recommended by the equipment manufacturer. MQSA inspectors should be trained to perform onsite inspections of all digital equipment. Computer-aided detection (CAD) is yet another emerging technology utilized in mammography to facilitate interpretation. However, CAD is software that physicians typically apply to FFDM or digitized film images after the images have been acquired, and may therefore be outside the purview of MQSA. FDA has considered this issue in the past in conjunction with issues surrounding double reading, and came to the conclusion that CAD was not a technology that could be readily dealt with through regulation.5 The Committee concurs with this determination. 5   Personal communication, C.Finder, M.D., Associate Director, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs (formerly the Office of Health and Industry Programs), CDRH, FDA, November 2004.

OCR for page 82
Improving Breast Imaging Quality Standards Facility Closures The ACR has reported that between April 2001 and October 2004, approximately 19 percent (1,563 out of 8,325 fully accredited facilities) of their accredited mammography facilities have closed (Destouet et al., in press). Approximately one-third reportedly closed for financial reasons; movement to a sister site, equipment problems, and staffing shortages were also cited as reasons leading to closure. FDA has received a number of complaints from patients who were not informed when their mammography facility closed, and as a result were unable to or unsure of how to access their mammography records (FDA, 2003). Currently FDA guidelines suggest the “facility should make reasonable attempts to inform its former patients of how they can obtain their mammography records [original mammography films and reports],” but no official patient notification is necessary (FDA, 2003). This reflects a serious lapse in patient care. Mammography facilities that close should be required to notify all patients and their doctors of the closure, and should be required to provide information regarding future access to mammography films and reports. However, in cases where facilities are unable to notify patients (e.g., facility bankruptcy), FDA should notify patients and referring physicians on that facility’s behalf. Enforcement of MQSA Inspection Testing Review of FDA inspection data from 2001 to 2003 revealed several inspection areas that could be streamlined, based on the low number of citations issued and the redundancy of the measurements by other entities. Radiation dose is currently measured by the accrediting body and annually by the medical physicist, and measurements rarely fail to meet MQSA regulation. Consequently, FDA should no longer measure radiation dose during inspection; analysis of dose measurements collected by the medical physicist will suffice. Additionally, inspectors should review and score phantom images taken previously by the facility; generation of new phantom images during the inspection is unnecessary. The exposure reproducibility coefficient of variation evaluation should be made only for three-phase units, as the medical physicist evaluates this annually. Half-value layer should no longer be evaluated for the same reason. Inspectors should continue the darkroom fog, collimator, and compression paddle tests due to the relatively larger number of FDA citations during annual inspections. Likewise, the inspectors should continue the processor tests primarily because these are not conducted by the medical physicists (FDA, 2004a). Reducing the frequency of inspections for facilities with good performance records was considered as another way to reduce the burden of MQSA on mammography facilities. As part of the Mammography Quality Standards Reauthorization Act of 1997, Congress gave FDA the authority to organize an inspection demonstration program (IDP) to determine whether MQSA inspections could be conducted less frequently than annually (Mammography Quality Standards Reauthorization Act. Pub. L. No. 105–248 [1998]). Eligible facilities had undergone at least two annual inspections under the final regulations and had received no regulatory (i.e., compliance) actions. After 2 years,

OCR for page 82
Improving Breast Imaging Quality Standards FIGURE 3–2 Percentage of facilities by highest violation level. Data collected from the FDA Inspection Demonstration Program suggest there are a higher percentage of Level 1, 2, and 3 violations at facilities undergoing biennial inspections as compared with facilities undergoing the currently mandated annual inspections. SOURCE: Adapted from FDA (2005). compliance data from the control (annual inspection) and study (biennial inspection) groups revealed more Level 1, 2, and 3 violations at facilities undergoing biennial inspections than at the facilities undergoing annual inspections. By percentage, there were more violations at each level for study facilities than there were at all facilities inspected nation-wide (Figure 3–2) (FDA, 2005a). Thus, current evidence suggests that reducing the frequency of inspections, even at historically compliant facilities, would negatively impact mammography quality. Accreditation Failure The inability of FDA to require facilities to cease performing mammography after two consecutive unsuccessful attempts at accreditation is another area of concern. The ACR has always strongly recommended that these facilities cease mammography, and has terminated accreditation until these facilities take corrective action and reinstate. Until 2003, FDA required facilities to cease in these cases. In 2003, FDA informed accrediting bodies that they can no longer require facilities to cease mammography if their MQSA certificate is still valid. However, FDA does tell these facilities they “should” cease mammography (FDA, 2004a). In the past year, the ACR has documented two cases in which a facility denied accreditation during the renewal process continued to practice mammography, one for 29 days and the other for 32 days, under a valid MQSA certificate.6 Regardless of MQSA certificate status, facilities failing to reaccredit after two at- 6   Personal communication, P.Butler, Senior Director, Breast Imaging Accreditation Programs, American College of Radiology, November 15, 2004.

OCR for page 82
Improving Breast Imaging Quality Standards tempts should be required to cease performing mammography until reinstated; FDA should have the authority to enforce this requirement. Suspensions or Revocations of MQSA Certificates Regulation 900.13 outlines the role of FDA following the revocation of a facility’s accreditation. Currently, FDA can either declare a certificate “no longer in effect” under Section 900.13, or can fully revoke a certificate under Section 900.14, when a facility’s accreditation is revoked or when the facility is deemed a serious risk to human health. Both regulations prevent the facility in question from performing mammography; as a result, FDA typically invokes 900.13 for timing and efficiency purposes.7 Between 2001 and 2003, FDA declared a facility’s certificate “no longer in effect” once for reasons of accreditation revocation (FDA, 2004b). Although FDA usually requires these facilities to notify their patients and referring physicians of such action (i.e., Patient/Physician Notification), there is currently no public notification system warning consumers in general about such facilities. FDA should require facilities to notify patients and their physicians if the MQSA certificate either is revoked or deemed no longer in effect. NATIONAL QUALITY STANDARDS Prior to the enactment of MQSA, the quality of mammography varied tremendously across the United States (U.S. Government Accountability Office, 1990; Galkin et al., 1988). Much of that variation stemmed from differences in the degree that states enacted legislation or regulations to ensure the quality of mammography within their borders. State legislation details requirements in four main areas: equipment specifications, equipment performance testing, facility quality assurance procedures, and personnel qualifications. More than 40 states enacted laws governing mammography quality in one or more areas, although how extensive these laws are varies from state to state. Required enforcement procedures were also variable from state to state (Fintor et al., 1995). MQSA was designed to foster uniform, high-quality mammography throughout the country by providing national standards that would eliminate the need for the patchwork of state regulations governing mammography standards. In recent years, this patchwork has begun to reemerge; vague regulations regarding requirements for accreditation bodies and the role of states has resulted in significant inconsistencies in the regulation of mammography in different states. Inconsistencies Across Accreditation Bodies MQSA provides a degree of decentralized oversight of mammography through the accreditation process. As discussed previously, a mammography facility must apply for reaccreditation through a qualified accreditation body every 3 years, once initial accreditation is granted. Currently, the American College of Radiology and the states of Texas, Iowa, and Arkansas have been approved by FDA to act as accreditation bodies. (California was also approved to accredit facilities, but the state’s accreditation program 7   Personal communication, C.Finder, M.D., Associate Director, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs (formerly the Office of Health and Industry Programs), CDRH, FDA, October 2004.

OCR for page 82
Improving Breast Imaging Quality Standards was closed in late 2003.) However, MQSA sets standards only for the data that accreditation bodies must collect; specific requirements for accreditation vary across accreditation bodies. One particular area of issue is discussed below. Qualifications for Review Physicians Qualifications for physicians serving as image reviewers for accreditation bodies should be more comprehensive than the minimum required to interpret mammograms under MQSA. Accreditation body reviewers reviewing the performance quality of mammography facilities should have considerably more experience than the minimum established for physicians interpreting mammograms. The ACR currently requires review physicians to have 5 years of post residency experience in diagnostic radiology, with at least 50 percent of each year’s practice in breast imaging, and be actively practicing in the modality reviewed. Increasing FDA standards to this level is not expected to cause a shortage of qualified review physicians for the state accreditation bodies of Iowa, Texas, or Arkansas. Texas already contracts with ACR-qualified reviewers, and the state of Iowa unofficially applies similar criteria to its own review physicians.8,9,10 Thus, all accreditation bodies should require review physicians to match current ACR review physician criteria. Inconsistencies Across States Many states continue to impose regulations beyond those currently required by FDA, which can lead to confusion regarding state requirements for accreditation or certification that conflict with, or are in addition to, federal MQSA requirements. State requirements can also add to the cost of mammography because states that act as certifying bodies can require facilities to undergo additional inspections and can impose additional inspection fees and fines. For example, Missouri charges an additional per-unit fee at every facility in the state (Mo. Rev. Stat. § 192.764 [1992]; Mammography Authorization 19 C.S.R. 30–11.010 [1992]). Evidence is lacking to evaluate the effects of additional state requirements on facility practices, but these measures do not necessarily improve quality, and might detract from the time and resources devoted to breast imaging. The potential for conflict of interest is also a concern because reviewers for state programs generally reside in the same state they are inspecting. Because an increasing number of states are pursuing status as certification bodies, the Committee agreed that this trend warrants close observation. MQSA regulations cannot supersede those of states; part (m) of the Act specifically states that “Nothing in this section shall be construed to limit the authority of any State to enact and enforce laws relating to the matters covered by this section that are at least as stringent as this section or the regulations issued under this section.” However, because MQSA regulations are so extensive, there may be a compelling reason to 8   Personal communication, K.Kemp, Iowa Department of Public Health, November 2004. 9   Personal communication, K.Goss-Terry, Mammography Accreditation Program Manager, Texas Department of State Health Services, October 2004. 10   Personal communication, J.Bibb, Mammography Program Administrator, Arkansas Department of Health, November 2004.

OCR for page 82
Improving Breast Imaging Quality Standards BOX 3–2 Examples of Preemptive National Standards Federal laws and regulations generally preempt state laws of the same scope if that is the expressly stated intent of the federal law or regulation. An example of such preemption is found in Section 521 [360k] of the Federal Food, Drug, and Cosmetic Act (FFDCA). This section specifies for devices intended for human use, that no states may establish, or continue to enforce, any requirement related to safety or effectiveness that is different from, or in addition to, those the federal act requires. Because the preemption clause in regard to the agency’s regulation of devices was expressly stated, a case brought against the maker of a heart pump was denied. The claim stated that the device caused a death because it was defectively designed and manufactured, as well as inadequately labeled. The Food and Drug Administration considered the design, manufacturing process, and label of the heart pump before it approved the device for marketing; thus its regulation preempted state law tort claims, the court ruled. When national laws or regulations do not specify a preemption clause, they can still preempt state laws if there is implied preemption. Such preemption presides when state law conflicts with federal law. For example, California passed a law called Proposition 65, which requires companies to include in the labeling of their products any chemicals that might cause cancer or reproductive toxicity. Armed with this law, a plaintiff sued the maker of nicotine gum and patches for failing to warn that its products were allegedly known to cause reproductive harm. The California Supreme Court ruled that the state law was preempted because it conflicted with the labeling requirements of the FFDCA. Implied preemption also occurs when federal law is so extensive and pervasive that it can be assumed that Congress did not intend states to supplement it. But it can be waived if state rulings are more comprehensive and traditionally relied on, as was seen in a case regarding the labeling of wines in California. That case hinged on a California law that prohibits the use of the name “Napa” on the label of any wine not made with at least 75 percent of Napa County-grown grapes. This state law was not preempted by federal law because the protection of consumers from potentially misleading brand names and labels of wine is a subject that traditionally has been regulated by the states, the California Supreme Court stated in its ruling. Deference to state rules on wine labels is especially appropriate, the ruling added, considering the importance of the industry to California. Both implied and expressly stated preemption will prevail only if courts find the state law in question governs the same area as the federal law presumed to preempt it. SOURCES: High court (2004); Pitney Hardin LLP (2004); California court (2004); Drug and medical device cases (2002); California Office of Environmental Health Hazard Assessment (2003). explicitly include a preemptive clause (Box 3-2) in the legislation.11 Replacing part (m) with a reemption clause could help ensure that MQSA regulations are uniformly followed by facilities in all states, largely because these regulations would provide both minimum and maximum requirements for mammography facilities and personnel. An expressly stated preemption clause would also relieve mammography facilities and per- 11   Personal communication, J.A.Levitt. Esq., Hogan & Hartson LLP, Washington, DC. October 2004.

OCR for page 82
Improving Breast Imaging Quality Standards TABLE 3–2 Self-Reported Estimate of the Cost of MQSA Compliance MQSA Compliance Category Cost per Procedure (in hospital, $) Cost per Procedure (in office, $) Continuing education/experience 0.90 1.93 Recordkeeping 0.10 0.19 Patient notification 4.84 4.15 Medical audit 7.54 5.78 Quality control tests 0.65 0.57 Annual physicist survey 1.00 0.35 Accreditation 0.31 0.39 MQSA inspection 0.45 0.65 Total 15.79 14.01 NOTES: Compliance with MQSA regulations presents a significant financial burden on mammography facilities. Recently, the American College of Radiology (ACR) conducted a cost survey of mammography practices. The ACR data, obtained from 15 hospital outpatient clinics and 22 office or freestanding practices, calculate the clinical staff, supplies, equipment, and indirect costs of performing screening mammography. To estimate the direct cost of MQSA compliance, the ACR survey data were sorted into eight categories devised by Farria and Feig (2000). Equipment costs, including upgrades to meet MQSA standards, are unknown and omitted from the cost total presented above. SOURCES: Farria and Feig (2000); Personal communication, P.Kassing, Senior Director, Economics and Health Policy, American College of Radiology, January 5, 2005. sonnel from the burden and confusion of trying to meet both MQSA and state certification and accreditation requirements. The Committee believes that federal preemption of state standards is necessary. However, this national standard must be flexible in order to facilitate adoption of standards that may advance the quality of breast imaging. Similarly, if a preemption clause is enacted, provisions should be developed to foster the efforts of states that traditionally have been on the forefront of quality improvement initiatives, and to add such approaches to the national standard in a timely fashion. THE COSTS AND BENEFITS OF MQSA In 1997, FDA commissioned a study to assess the economic impact of compliance with MQSA Final Rules (Eastern Research Group and FDA, 1997). The Eastern Research Group (ERG) estimated that the average annualized total compliance cost at the time was $38.2 million by “identifying the most typical, least-cost methods of complying with each requirement,” although the report likely underestimated the true cost of compliance. For example, ERG estimated no compliance costs for the medical audit and outcome analysis because project consultants indicated that outcomes analysis was already standard practice at most facilities. However, a recent cost survey conducted by the ACR

OCR for page 82
Improving Breast Imaging Quality Standards indicated that substantial costs are associated with medical audits.12 The ACR collected self-reported cost data from 37 facilities and estimated that the cost of MQSA compliance was $14–$15.70 per mammogram, as shown in Table 3–2. At the time of their study, the FDA estimated that approximately 22.5 million mammograms were performed per year, which translates to $1.70 per mammogram ($2.00 in 2004 dollars). The true cost of MQSA compliance likely falls somewhere between the two estimates from FDA and the ACR. FDA also used a model to estimate health outcomes at various levels of mammography quality (measured by sensitivity and specificity). The report concluded that a 5 percent improvement in quality would have associated annual benefits of between $182 million and $263 million, with 75 fewer annual breast cancer deaths. It is difficult to estimate the cost of the Committee’s recommendations aimed at improving interpretive quality because costs will vary considerably depending on the current set up of a given facility. For example, facilities that already use software that separates screening and diagnostic exams may be able calculate the required measure with little change. Facilities that do all of their tracking and auditing on paper may find it more expensive to meet the new requirements. Similarly, some facilities already track patients with a BI-RADS 0 assessment, but most do not and thus will experience an additional compliance cost. The added cost of tracking women with 0 assessments will depend in part on the population being served and the recall rate for a particular facility. Facilities that participate in the voluntary advanced medical audit procedures will likely incur additional costs for data entry, but they will save the time and costs that would be needed to organize and analyze the data (since that will be done by the statistical coordinating center). Also, some facilities may already have established methods of communication with pathologists, whereas others may need to devote considerable effort to establish and maintain adequate communication in order to meet the requirements of the advanced audit. The statistical coordinating center will require funds for staff and infrastructure, perhaps similar to the core costs of the Breast Cancer Surveillance Consortium, but ultimately the cost per mammogram will depend in part on how many providers participate in the advanced medical audit program. It might be useful for FDA to survey all facilities regarding their intentions to participate in the voluntary advanced audits or to seek designation as a Center of Excellence prior to implementation. FDA could also commission another study on the economic impact of compliance with the new medical audit procedures, as they did in 1997. SUMMARY AND CONCLUSIONS The final FDA Mammography Quality Standards Act regulations, promulgated in 1999, understandably require revision given the development of mammography practice in recent years. Advancements in technology, particularly digital mammography, require expansion of the current regulations to ensure quality in each mammographic modality. The Committee specifically recommends removing the regulatory exemption on interventional mammographic procedures. The experience of facilities, personnel, and accreditation bodies with MQSA has revealed several areas of overlap that should be addressed; for example, inspection data have demonstrated that several quality control tests are un- 12   Personal communication, P.Kassing, Senior Director, Economics and Health Policy, American College of Radiology, January 5, 2005.

OCR for page 82
Improving Breast Imaging Quality Standards necessary due to redundancy and exceptionally low rates of citation, and therefore could be removed. Regarding enforcement of MQSA regulations, FDA must have the authority to stop facilities from performing mammography following two unsuccessful attempts at reaccreditation, regardless of the validity of that facility’s MQSA certificate. The Committee also recommends that patients and their referring physicians should be notified when a mammography facility either decides to close or has had its MQSA certificate revoked. Finally, the Committee believes that federal preemption of state standards is necessary to preserve the nature of MQSA as a single, unified set of mammography quality standards. The Committee recognizes that the recommended revisions will require a substantial amount of work by FDA. The regulation revision process is staff-intensive; formal revisions would require solicitation of input from outside scientific and medical experts as well as mammography facilities and practitioners, followed by public hearings and a public comment period. Current guidance documents would also require revision. In addition to the staff costs associated with regulation revision, additional costs would be incurred by FDA following promulgation of the updated regulations. FDA would be responsible for educating facilities, providers, and inspectors about the revisions, and would also be responsible for strengthening enforcement. Therefore, sufficient funding should be made available to FDA for the additional resources and costs associated with revision of the current MQSA regulations. In short, revision of the current FDA regulations is necessary to ensure that adequate enforcement of quality standards continues, to streamline the inspection process, and ultimately to reduce the burden of inspections on facilities without reducing mammography quality. Screening is only one stage in the process of breast care. Although the purview of MQSA is limited to breast imaging, other chapters in this report more fully discuss how the process of breast care can be improved. REFERENCES ACR (American College of Radiology). 2004. Stereotactic Breast Biopsy Accreditation Program. [Online]. Available: http://www.acr.org/s_acr/sec.asp?CID=593&DID=14257 [accessed September 14, 2004]. ACR. Unpublished. ACR Mammography Accreditation Program Scheduled On-Site Surveys: Recommendations for Corrective Action [as of December 2004]. American Cancer Society. 2003. Reauthorization of the Mammography Quality Standards Act. Statement at the April 8, 2003, hearing of the Subcommittee on Aging, Committee on Health, Education, Labor, and Pensions, U.S. Senate. American College of Surgeons and American College of Radiology. 1998. Physician qualifications for stereotactic breast biopsy: A revised statement. Bulletin of the American College of Surgeons 83(5):30–33. Bloomquist AK, Yaffe MJ, Pisano E, Hendrick RE, Mawdsley GE, Bright S, Shen SZ, Mahesh M, Nickoloff E, Fleischman R, Williams M, Maidment A, Biedeck D, Och J, Seibert AB. Submitted. Quality control for digital mammography in the ACRIN DMIST trial. Medical Physics. California court ruling could set legal precedent. 2004 (April 26). Washington Drug Letter. 36(17).

OCR for page 82
Improving Breast Imaging Quality Standards California Office of Environmental Health Hazard Assessment. 2003. Proposition 65. [Online]. Available: http://www.oehha.org/prop65/background/p65plain.html [accessed December 8, 2004]. Dean PB, Pamilo M. 1999. Screening mammography in Finland—1.5 million examinations with 97 percent specificity. Mammography Working Group, Radiological Society of Finland. Acta Oncologica 38(Suppl 13):47–54. Dershaw DD. Professor of Radiology, Cornell University Medical College; President, Society for Breast Imaging. 2003. Mammography Quality Standards Act Reauthorization. Statement at the April 8, 2003, hearing of the Subcommittee on Aging, Committee on Health, Education, Labor, and Pensions, U.S. Senate. Destouet JM, Bassett LW, Yaffe MJ, Butler PF, Wilcox PA. In press. The American College of Radiology Mammography Accreditation Program—10 years of experience since MQSA. Journal of the American College of Radiology. Drug and medical-device cases raise questions of preemption. 2002 (September 6). Los Angeles Daily Journal . [Online]. Available: http://www.reedsmith.com/library/publicationView.cfm?itemid=20939 [accessed December 7, 2004]. Eastern Research Group and FDA. 1997. Economic impact analysis of regulations under the Mammography Quality Standards Act of 1992. Contract ID 223–94–8031. Lexington, MA: Eastern Research Group, Inc. Elmore JG, Nakano CY, Koepsell TD, Desnick LM, D’Orsi CJ, Ransohoff DF. 2003. International variation in screening mammography interpretations in community-based programs. Journal of the National Cancer Institute 95(18):1384–1393. Farria D, Feig SA. 2000. An introduction to economic issues in breast imaging. Radiologic Clinics of North America 38(4):825–842. FDA (U.S. Food and Drug Administration). 2004a. 2001–2003 Citations—NMQAAC, April 19, 2004. [Online]. Available: http://www.fda.gov/ohrms/dockets/ac/04/briefing/4030b1-02-2001-2003-Citations.pdf [accessed November 15, 2004]. FDA. 2004b. Mammography Facility Adverse Event and Action Report—2003. [Online]. Available: http://www.fda.gov/CDRH/MAMMOGRAPHY/MFAER-03.html [accessed November 9, 2004]. FDA. 2005a. The Effect of Reducing Inspection Frequency: A Study Authorized by the Mammography Quality Standards Reauthorization Act of 1998. [Online]. Available: http://www.fda.gov/cdrh/mammography/report-reducingfrequency.html [accessed February 24, 2005]. FDA. 2005b. Policy Guidance Help System: Communication of Results to Patients. [Online]. Available: http://www.fda.gov/cdrh/mammography/robohelp/start.htm [accessed February 24, 2005]. FDA, Center for Devices and Radiological Health, Division of Mammography Quality and Radiation Programs. 2003. The Mammography Quality Standards Act Final Regulations, Modifications and Additions to Policy Guidance Help System #7; Guidance for Industry and FDA. Rockville, MD: CDRH. Fintor L, Alciati MH, Fischer R. 1995. Legislative and regulatory mandates for mammography quality assurance. Journal of Public Health Policy 16(1):81–107. Galkin BM, Feig SA, Muir HD. 1988. The technical quality of mammography in centers participating in a regional breast cancer awareness program. Radiographics 8(1):133–145. Haus AG, Gray JE, Daly TR. 1993. Evaluation of mammographic viewbox luminance, illuminance, and color. Medical Physics 20(3):819–821.

OCR for page 82
Improving Breast Imaging Quality Standards Hendrick RE, Berns EA. 2000. Optimizing techniques in screen-film mammography. Radiologic Clinics of North America 38(4):viii, 701–718. Hendrick RE, Klabunde C, Grivegnee A, Pou G, Ballard-Barbash R. 2002. Technical quality control practices in mammography screening programs in 22 countries. International Journal for Quality in Health Care 14(3):219–226. High court rejects preemption claims, upholds law limiting use of “Napa” in wine labeling. 2004 (August 6.) Metropolitan News Enterprise. P. 1. National Mammography Quality Assurance Advisory Committee, U.S. Food and Drug Administration. 2004. NMQAAC Meeting: Monday, April 19, 2004 [Transcript]. [Online]. Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=507 [accessed December 8, 2004]. Pitney Hardin LLP. 2004. Supreme Court upholds ERISA preemption. New Jersey Employment Law Letter 12(11):853. Rowden D, Affiliate Service Member, Susan G. Komen Breast Cancer Foundation. 2003. The Mammography Quality Standards Act. Statement at the April 8, 2003, hearing of the Subcommittee on Aging, Committee on Health, Education, Labor, and Pensions, U.S. Senate. U.S. Government Accountability Office. 1990. Screening Mammography: Low-Cost Services Do Not Compromise Quality. Washington, DC: U.S. Government Accountability Office. Wang J, Gray JE. 1998. Detection of small low-contrast objects in mammography: Effect of viewbox masking and luminance. American Journal of Roentgenology 170(1):105–108. Waynant RW, Chakrabarti K, Kaczmarek RA, Dagenais I. 1999. Testing optimum viewing conditions for mammographic image displays. Journal of Digital Imaging 12(2 Suppl 1):209–210. Waynant RW, Chakrabarti K, Kaczmerak R, Suleiman O, Rowberg A. 1998. Improved sensitivity and specificity of mammograms by producing uniform luminance from viewboxes. Journal of Digital Imaging 11(3 Suppl 1):189–191.