Annually, nearly 39 million women undergo mammography in the United States (
U.S, 2011
), approximately 200,000 women are diagnosed with breast cancer, and 40,000 women die of the disease (U.S. Department of Health & Human Services. (2011). Food & Drug Administration, Radiation Emitting Products, MQSA National Statistics. Available: http://www.fda.gov. Accessed December 5, 2010.
Jemal et al., 2009
). As such, breast health remains a critical area focus not only for clinicians, but also for health care policy analysts, researchers, and payers. There has been a recent evolution to standardize the delivery of breast health care (BHC) across the nation, with defined guidelines, quality indicators (QI), and expectations for treating physicians. Why is the dissemination of this information important? As these initiatives in BHC gain acceptance and provide standards for practice and benchmarks for QI, the value of breast physician-specialists and breast programs meeting national standards and striving to deliver quality care will be realized, with the hope that participants in these initiatives will be identified (and distinguished) for their continued participation in these national “validation” processes, and ultimately, will improve upon the multidisciplinary care/outcomes for breast cancer.Mammography Quality Standards Act and National Quality Forum QI
The developments of national BHC initiatives using evidence-based medicine approaches, scientific-based QI, and multidisciplinary validation processes have been implemented on various levels to raise the bar for BHC over the last two decades. For example, the Mammography Quality Standards Act (MQSA), passed in 1992 by the U.S. Congress, was the first act to mandate that all mammography facilities meet uniform quality standards (
U.S, 2010
). The MQSA has exemplified how high-quality initiatives can improve the delivered of care. This goal was achieved by requiring 1) interval assessment of quality care measures; 2) documentation of adequate training for all physicians/technicians/physicists at each facility; 3) assessment of quality initiatives, equipment quality control, and self-audits to identify problems and actions to resolve each identified problem; and 4) annual inspection of each facility by either the state or the U.S. Food and Drug Administration. Over time, thousands of mammography facilities have raised the level of care to meet these standards, whereas others unable or unwilling have been forced to close their practices. With MQSA implementation, a positive impact has been demonstrated, in that of a cohort of sampled facilities before MQSA, 11% were unable to pass image quality testing. But in fewer than 5 years, Congress reported that the nationwide figure decreased to 2% (U.S. Department of Health & Human Services. (2010). Food & Drug Administration, Radiation Emitting Products, About the Mammography Program. Available: http://www.fda.gov. Accessed December 5, 2010.
United States General Accounting Office: Report to Congressional Committees, 1997, October
). Additionally, emerging data suggest that MSQA execution has been associated with improved patient outcomes; for example, a recent publication demonstrated that the higher the number of MQSA-certified mammography facilities in a given region, the lower the breast cancer mortality rates (Klein and Rawson, 2009
).Klein, K., & Rawson, J. (2009). Breast cancer mortality in Georgia: Is there a relationship with the number of MQSA certified facilities in a county? Health Services, Policy, & Practice. Proceedings from the RSNA Annual Meeting 2009, abstract SSK11-04. Available: http://rsna2009.rsna.org/. Accessed December 11, 2010.
More recently, national QI have been developed to assess specific treatment-related issues in breast cancer. What exactly are QI? They are a means of providing a simple and reliable way to measure achievement and benchmarks, to reflect changes after an intervention, or assess performance of a given variable (
MDF Tool, 2005
). Recently, several agencies independently generated sets of QI for breast cancer and subsequently combined efforts to put forth a single set of approved quality measures after realizing the similarity of their mission (MDF Tool. (2005). Indicators. Available: http://www.toolkitsportdevelopment.org. Accessed January 10, 2011.
Desch et al., 2008
). The three National Quality Forum (NQF) QIs are (percent of eligible patients who are) a) receiving adjuvant radiation within 1 year of diagnosis after breast-conserving surgery, b) hormone receptor positive receiving tamoxifen/third-generation aromatase inhibitors within 1 year of diagnosis, and c) initiation of chemotherapy within 4 months of diagnosis (Desch et al., 2008
). Practicing oncology specialists and comprehensive cancer center programs should all strive to ultimately reach 100% for these standards. These breast QI are the first to be developed within the realm of oncology (alongside colorectal) to provide an evidence-based mechanism to measure performance and have become widely recognized and utilized by breast centers and multiple national organizations.Multidisciplinary Management of BHC
Management of breast patients using a multidisciplinary approach has become standard of care over the last decade. For every breast patient, recommendations need to be based on published data and review of the patient’s case as interpreted by a diverse group of subspecialists. Thus, sequential referrals from one subspecialist to another (i.e., radiology to surgery to medical oncology to radiation) who independently render recommendations are no longer considered best practice. There is now a growing body of evidence that physicians who engage in multidisciplinary management have greater adherence to protocols and quality measures, which is associated with improvements in overall survival for breast cancer patients (
Chang et al., 2001
, Cheng et al., 2009
, Gort et al., 2007
). Moreover, the use of a multidisciplinary tumor board, where diagnostic tests and pathology are reviewed and treatment recommendations are rendered with supportive literature and national guidelines, leads to changes in initial recommendations in greater than 50% of cases (Newman et al., 2006
), and significantly improves appropriate use of diagnostic testing and therapeutic decisions (Pass et al., 2004
). Thus, the standard of care for breast diseases is a multidisciplinary approach to treatment/management.Validation of Individual Breast Practices Through Specialty Organizations
Subspecialty organizations have also developed programs
†
within breast oncology with standards, QIs and/or accreditation processes (i.e., radiology, surgery, radiation, or oncology) that are aimed at improving patient care within a given field (Subspecialty programs include (but are not limited to): American College of Radiology (Center of Excellence in Breast Imaging); American Society of Breast Surgeons (Mastery of Breast Surgery); American College of Clinical Oncology (Quality Oncology Practice Initiatives); American Society of Therapeutic Radiology and Oncology (Performance Assessment of the Advancement of Radiation Oncology Treatment Program; Radiation Facility Accreditation); National Consortium of Breast Centers (National Quality Measures for Breast Centers); U.S. Congress (Mammography Quality and Standards Act); Center for Medicaid and Medicare Services(Physicians Quality Reporting Initiative).
Lee, 1999
). Although participation in these programs is currently voluntary, it is likely that these subspecialty BHC programs will become mandatory in the setting of physicians’ eligibility for hospital accreditation, board recertification, and participation with insurers/payers, as health care policies undergo changes and pay-for-performance measures are adopted. Additionally, many subspecialty boards have changed board certification policies from previously awarded lifetime certificates to time-limited board certification with multiple levels of requirements for re-certification. Maintenance of Certification requires subspecialty physicians pass a board examination, accumulate annual CMEs, participate in self-assessment modules, and perform QI within their practice to renew board recertified every 10 years to ensure continued learning and quality improvement.Identification of Quality “Breast Centers/Programs”
There has been a nationwide surge of “Breast Centers/Breast Programs” established over the last two decades. Although one may envision a “breast center” as an academic institution or hospital-based comprehensive program providing all necessary services to the patient “within the walls” of one facility, such walls are not essential to quality breast care. The vast number of patients requiring breast evaluation and treatment in the United States are referred to single, private practice, subspecialty offices (i.e., surgical or radiology practices). Many of these practices, in reality, are “centers without walls” because they provide excellent care and comprehensive services through well-established referral patterns for additional resources outside of the scope of their practice (
Lee, 1999
).But how can patients, referring physicians, or payers identify quality breast programs? Especially in the setting of using a multidisciplinary approach when most existing programs offer only subspecialty accreditation, how is “quality” defined? The fundamental framework for quality-of-care delivery has 3 critical components: 1) Structure, 2) process, and 3) outcomes (
Donabedian, 1966
). But who determines these? “A diverse group of stakeholders consisting of patients, physicians, methodologists, regulators, and payers should help develop the standards” (Mathews and Pronovost, 2008
). Recently, these important concepts on who and what defines quality care have these been applied to BHC.In response to patients’ and payers’ demand for identification of practices and centers whose outcomes meet or exceed national benchmarks (
Matula et al., 2009
), the National Accreditation Program for Breast Centers (NAPBC; available at: http://napbc-breast.org/) began in 2005 to gathered a diverse group of “stakeholders” to establish a multidisciplinary team to define standards and guidelines for the necessary components of BHC. The NAPBC is composed of a coalition of health care organizations/professional societies (Table 1) that includes patient advocacy representatives, surgeons, pathologists, oncologists, radiation oncologists, social workers, nurses, tumor registrars, geneticists, and others who have combined their expertise in BHC to established comprehensive standards for breast diseases across subspecialties (Moran et al., 2010
). This program allows for validation of the numerous breast program models ranging from single physician private practices (i.e., a radiology or a surgical practice) to comprehensive hospital-based centers, through a rigorous process to assess the required standards. The standards incorporate existing national subspecialty quality initiatives/programs such as MQSA, NQF breast QI, and participation in Maintenance of Certification/mandatory board certification, and a list of mandatory components for comprehensive delivery of BHC (Table 2).Table 1Organizations/Societies that Comprise the NAPBC Board
| Society/Organization | Acronym |
|---|---|
| American Board of Surgery | ABS |
| American Cancer Society | ACS |
| American College of Radiology, Commission on Breast Imaging | ACR |
| American College of Radiology Imaging Network | ACRIN |
| American College of Surgeons | ACoS |
| American Institute of Radiological Pathology | AIRP |
| American Society of Breast Disease | ASBD |
| American Society of Breast Surgeons | ASBS |
| American Society of Clinical Oncology | ASCO |
| American Society of Plastic Surgeons | ASPS |
| American Society for Radiation Oncology | ASTRO |
| Association of Cancer Executives | ACE |
| Association of Oncology Social Work | AOSW |
| College of American Pathologists | CAP |
| National Cancer Registrars Association | NCRA |
| National Consortium of Breast Centers | NCBC |
| National Society of Genetic Counselors | NSGC |
| Oncology Nursing Society | ONS |
| Society of Breast Imaging | SBI |
| Society of Surgical Oncology | SSO |
Each organization currently has one or more representative(s) that sit on the NAPBC Board. In addition, collaborating partners include: National Lymphedema Network, Research Advocacy Network, Susan G Komen for the Cure, Translating Research Across Communities, Y-Me National Breast Cancer Organization.
Table 2Synopsis of Components and Standards for Comprehensive Breast Health Care
| Necessary Components for NAPBC Breast Center accreditation |
| 1) Imaging |
| 2) Needle biopsy |
| 3) Pathology |
| 4) Interdisciplinary breast conference |
| 5) Patient navigation |
| 6) Genetic evaluation/management |
| 7) Surgical care |
| 8) Plastic surgery |
| 9) Nursing |
| 10) Medical oncology |
| 11) Consultation/treatment |
| 12) Radiation oncology |
| 13) Data management |
| 14) Research |
| 15) Education/support/rehabilitation |
| 16) Outreach and education |
| 17) Quality improvement |
| 18) Survivorship program |
| Synopsis of the 6 groups of standards required for comprehensive breast health care |
| 1) Center leadership |
| 1.1 Documentation of program leadership |
| 1.2 Interdisciplinary breast cancer conference: Frequency, attendance, prospective case presentation, AJCC staging, nationally accepted guidelines and total case presentation annually documented |
| 1.3 Leadership identifies/references evidence-based evaluation/management guidelines |
| 2) Clinical management |
| 2.1 Interdisciplinary patient management |
| 2.2 Patient navigation |
| 2.3 >50% of stage 0, I, or II treated with breast-conserving surgery |
| 2.4 Axillary sentinel lymph node biopsy is considered/performed in all clinical stage I and II |
| 2.5 Protocol for ensuring follow-up surveillance of patients |
| 2.6 Use of AJCC staging in treatment planning; process/results discussed and findings documented annually |
| 2.7 Pathology reports: CAP guidelines followed |
| 2.8 Diagnostic imaging: Must be MQSA certified |
| 2.9 Needle biopsy (rather than open biopsy) initial diagnostic approach |
| 2.10 Ultrasonography: ACR- or ASBS-certified use of diagnostic ultrasound/ultrasound-guided needle biopsy |
| 2.11 Stereotactic needle biopsy: ACR/ACoS/ASBS certified use |
| 2.12 Radiation oncology (provided or referred to) by board-certified physicians. Center has ACR/ASTRO accreditation or QA program in place, NQF for radiation utilized/reported |
| 2.13 Medical oncology (provided or referred to) by board certified physicians; NQF for medical oncology utilized/reported |
| 2.14 Nursing (provided or referred to) by nurses with specialized knowledge/skills in breast diseases; practices guided by evidence-based standards |
| 2.15 Support and rehabilitation (provided or referred to) by clinicians with specialized knowledge of breast diseases |
| 2.16 Genetic risk assessment/counseling/testing services (provided or referred to) are available |
| 2.17 Culturally appropriate patient educational resources and process to provide them; annual review/adjusted for patient population |
| 2.18 Reconstructive Surgery (provided or referred to) by board-certified physicians. All mastectomy patients offered a preoperative referral |
| 2.19 Evaluation/management of benign breast disease follows nationally recognized guidelines |
| 3) Research |
| 3.1 Information on clinical trial provided to patients via formal mechanism |
| 3.2 Annual accrual of >2% of center’s patients into (treatment-related) breast clinical trials/protocols |
| 4) Community outreach |
| 4.1 Annually, >2 on-site or community education, prevention, or early detection programs are provided with follow-up for patients with positive findings |
| 5) Professional education |
| 5.1 Staff education: Credentialed center members must participate in breast-specific educational programs annually |
| 6) Quality improvement |
| 6.1 Annually, >2 quality/outcomes studies must be conducted with dissemination of findings to center members |
Abbreviations: BPL, breast program leadership; ACoS, American College of Surgeons; ACR, American College of Radiology; ACJJ, American Joint Committee on Cancer; ASBS, American Society of Breast Surgeons; ASTRO, American Society for Radiation Oncology; CAP, College of American Pathologists; ER, estrogen receptor; PR, progesterone receptors; HER2, human epidermal growth receptor; MQSA, Mammography Quality Standards Act; NQF, National Quality Forum.
∗ As defined by the NAPBC.
The NAPBC program parallels the widely recognized accreditation programs for “Cancer Centers” (Commission on Cancer and National Cancer Institute) and the accreditation program for breast programs in Europe (European Society of Breast Cancer Specialists). Launching their program in 2008, there are now currently over 250 NAPBC-accredited breast centers across the United States. It is important to note that the vast majority these accredited programs are small individual subspecialty practices (i.e., a group of surgeons in private practice) or small, community-based programs with individual subspecialty private practices that come together to discuss cases in multidisciplinary tumor boards and continually strive to improve the quality care for their breast patients, and not large, academic, hospital-based programs as one might envision a “breast center.”
The accreditation process includes a comprehensive application and on-site survey (similar to MQSA certification) to verify availability of critical components of the program including, but not limited to, genetic counseling, patient navigation, multidisciplinary team, regular breast tumor boards, clinical trial availability, and supportive services such as lymphedema assessment, social services, and palliative care, either in house or as a referral in close proximity. Compliance with the evidence-based standards is verified during the on-site survey, patient records are audited to document multidisciplinary management and adherence to standards, and board certification of physicians. Annual documentation of ongoing compliance and a repeat on-site survey every 3 years is mandated to maintain accreditation. A national, interactive, centralized database is under development to enable data collection, assess quality measures, provide real-time feedback for physicians/programs, and allow each program the ability to benchmark its program with other similar programs across the nation (
Moran et al., 2010
). There are no minimal requirements for breast cases treated annually, and all models of a breast program are eligible for accreditation. The public, specifically patients, referring physicians and payers, have on-line access to information regarding the NAPBC accredited programs with details of available services and resources available at each center.Raising the Bar to Improve Clinical Outcomes
We are now amidst the evolution of defining “quality” in BHC, where multiple processes are now available for assessment/improvement of care that is delivered by subspecialist physicians. These programs allow for mechanisms of validation for physicians involved in management of breast diseases that practice in a variety of settings ranging from large, comprehensive hospital-based breast programs to smaller private practice settings.
Recognition of breast subspecialists and breast programs that participate in these programs will become increasingly important as it becomes evident that adherence to best practice guidelines (such as multidisciplinary management, physician access to performance data, external audits, patient navigation) and monitoring QI are associated with improvements in management decisions (
Newman et al., 2006
, Pass et al., 2004
), process of care (Boonyasai et al., 2007
), delivery/continuity of care (- Boonyasai R.T.
- Windish D.M.
- Chakraborti C.
- Feldman L.S.
- Rubin H.R.
- Bass E.B.
Effectiveness of teaching quality improvement to clinicians: A systematic review.
JAMA: The Journal of the American Medical Association. 2007; 298 ([Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov’t Review]): 1023-1037
Chen et al., 2010
, Freeman, 2006
, Vargas et al., 2008
) and ultimately, patient outcomes (Chang et al., 2001
, Cheng et al., 2009
, Gort et al., 2007
, Pass et al., 2004
). With the emergence of standardized QI, guidelines and structured programs, the bar has been raised to promote a consistently higher level of quality BHC across the nation.In summary, adoption of best practice standards and participation in accreditation programs facilitates the use of evidence-based practices and improves overall practice performance and patient outcomes (
Jacobson et al., 2008
, - Jacobson J.O.
- Neuss M.N.
- McNiff K.K.
- Kadlubek P.
- Thacker 2nd, L.R.
- Song F.
- et al.
Improvement in oncology practice performance through voluntary participation in the Quality Oncology Practice Initiative [Evaluation Studies].
Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology. 2008; 26: 1893-1898
U.S, 2010
). Although participation in accreditation programs does not guarantee high-quality care, it fosters team commitment to monitor processes and outcomes, and ensures that the necessary structural components for the delivery of quality care for breast diseases are available for the patient. These quality initiatives will ultimately empower the patient by identifying individual specialty physicians and nationally validated programs committed to delivering quality care. Moreover, we are hopeful that policy makers, health care researchers, and payers will acknowledge the importance of these initiatives, recognize physicians and breast programs participating in these programs, and endorse participation in the various “validation” processes, which will hopefully ultimately improve the overall quality of BHC across the nation.U.S. Department of Health & Human Services. (2010). Food & Drug Administration, Radiation Emitting Products, About the Mammography Program. Available: http://www.fda.gov. Accessed December 5, 2010.
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Biography
Meena S. Moran, MD, is an Associate Professor in Therapeutic Radiology at Yale University School of Medicine. She is a board-certified radiation oncologist who specializes in breast cancer and represents American Society for Therapeutic Radiation Oncology (ASTRO) on the board of the National Accreditation Program for Breast Centers (NAPBC). She also serves the role of medical director at a community hospital-based breast program in Norwich, CT.
Biography
M. Tish Knobf, PhD, RN, FAAN, AOCN, Dr. Knobf is a Professor at the Yale School of Nursing who specializes in breast cancer. She represents Oncology Nursing Society (ONS) on the board of the National Accreditation Program for Breast Centers (NAPBC).
Article info
Publication history
Published online: October 31, 2011
Accepted:
August 23,
2011
Received in revised form:
August 23,
2011
Received:
August 16,
2011
Identification
Copyright
© 2012 Jacobs Institute of Women's Health. Published by Elsevier Inc. All rights reserved.
