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CRICO/RMF Breast Care

Management Algorithm
Improving Breast Patient Safety

Created: 1995
Revised: 2000, 2003
Current: 2010

© 2010 CRICO/RMF 2 .850.000 Risk factors: Assessment—and periodic updating—of a patient’s personal and family history ensures timely age.and risk-stratified breast cancer screening. Performance of tests 2 $1. coordinated by CRICO/RMF.350. Referrals: For a patient referred to a specialist. Receipt/transmittal of test results 0 $0 7. History/physical/evaluation 3 $2. thoracic radiation before age 30. all diagnostic tests they order. Test results: Primary care providers are responsible for confirming receipt of. Risk Management for Breast Care Self-detected mass: The majority of CRICO’s failure to diagnose breast cancer cases involve a patient-detected mass.470. Physicians may choose to follow alternate recommendations (especially for mammographic screening) as their standard practice.000 9.000 8. ■■ 24 radiology ob/gyn 2 pathology 2 general surgery The CRICO/RMF Breast Care Management Algorithm is a suggested guideline and should not be construed as a standard of care. and payments on open and closed cases. ■■ Total incurred is the aggregate of expenses. Breakdowns in the Process of Care in Breast Cancer Cases Step patients who present with specific breast complaints. Physician Defendants Named in Breast Cancer Diagnosis-related Cases 6 patients without known breast cancer risks. The CRICO/RMF Algorithm combines peer-reviewed evidence and proven risk management strategies to aid providers at various decision points across three domains of breast health care: 14 18 breast 26 16 colorectal 19 20 lung 6 21 prostate ■■ N=140 CRICO cases asserted 2000–2009 with a diagnosisrelated major allegation. $103 million total incurred losses. or thickening. and transmitting to the patient.000 6. # cases total incurred 1. 1 oncology surgery N=37 CRICO physicians named in 18 cases asserted 2005–2009 with a diagnosis-related major allegation and a final diagnosis of breast cancer. Patient seeks care 0 $0 2.000 4.CRICO/RMF Breast Care Management Algorithm Improving Breast Patient Safety Top Cancer Types in CRICO Cases cases asserted 2000–2004 2005–2009 Failure to diagnose breast cancer affects CRICO-insured providers across a spectrum of specialties. Referral management 1 $1. identified the key factors contributing to allegations of mismanaged breast care and subsequently developed the CRICO/RMF Breast Care Management Algorithm. In addition to being a tenet of good care.011. Whether or not you can confirm a mass. make sure to coordinate the care among providers and clarify for the patient the specific roles and responsibilities. or a referral to high-risk counseling.090. and reproductive risk factors to determine if changes to normal screening. and The CRICO/RMF Algorithm is designed to help providers of primary breast care appropriately use available diagnostic tools. Physician follow up with patient 3 $2. Interpretation of tests 15 $15. atypia on previous biopsy. To reduce the likelihood of such events.000 5. Patient compliance with follow-up plan 1 $890. lump. Order of diagnostic/ lab tests 8 $7. including appropriate referrals to high risk counseling. comprehensive provider follow-up is a significant safeguard against allegations of failure to diagnose breast cancer. providers of primary breast care have an ongoing responsibility for tracking and coordinating their patients’ routine breast care. The provider is expected to gather information such as family history. general medicine 2 individuals seeking an assessment of their risks for developing breast cancer. N=18 cases asserted 2005–2009 with a diagnosis-related major allegation and a final diagnosis of breast cancer. the patient presenting with a self-detected lump must be followed to conclusion. is indicated.000 3. reserves.620. Follow up: Document follow-up testing recommendations and communicate the follow-up plan to the patient and all responsible providers. reviewing. a task force of breast care specialists. Even after a referral.

e Gail Model (for women ≥ age 35) The Gail Model calculates actuarial estimates of future breast cancer risk based on race. consider assessment via the Gail Model to determine their levels of risk for breast cancer. chemoprevention. then recategorize as appropriate. The index patient is counted as one of the relatives. Screening recommendations for patients at usual risk vary among experts. Histology ■■ Lobular carcinoma in situ (LCIS) CBE at least once per year. or after personal history of breast cancer < age 40. Hodgkins) < age 30c CBE at least once per year beginning at age 25. ■■ History of invasive breast cancer Consider referral to high-risk counseling. d. fluoroscopy for TB. age. The Gail Model calculates the risk of developing cancer over the next five years. b. or ovarian cancer at any age.gov/ bcrisktool. reproductive risk factors. For patients with a Gail Model value <1. clinical breast exam (CBE) at least once per year. Patient may also be eligible for risk reducing clinical trials. ■■ >5 years of combined estrogen/ progesterone hormone replacement therapy For patients with Gail Model value ≥1.67 CBE every 1–3 years until age 40. and an annual mammogram beginning at age 40.CRICO/RMF Breast Care Management Algorithm Risk Assessment and Recommendations (based on NCCN Guidelines) Patients with a genetic predisposition to breast cancer Recommendations ■■ Known carrier of a BRCA1 or BRCA2 mutation. e. The CRICO/RMF Breast Care Management Algorithm recommendations are based on the 2009 NCCN Guidelines. ■■ Family history of breast cancer in two 1st degree relatives. and previous biopsy status. annual mammogram. Peutz-Jeghers syndrome. Annual CBE beginning at age 25. or multiple X-rays for scoliosis is not well quantified. Therapeutic thoracic radiation (e. Notes a. or 5–10 years younger than earliest affected relative (but not before age 25). Risk from therapeutic radiation is much greater than risk from diagnostic radiation. beginning at age 40. at least one diagnosed ≤ age 50b Annual mammogram beginning at age 40. Annual mammogram beginning 8–10 years after radiation or at age 25.cancer.d Patients at usual risk Recommendations Patients without any of the above risk factors or a Gail Model value <1. with known mutation ■■ Known carrier or close relative with another hereditary breast cancer syndrome genea Annual mammogram and MRI beginning at age 25 or individualized based on earliest age onset in family.67: annual CBE. Cowden’s disease.g. or in paternal 2nd degree relative or in close relatives in the same lineage Consider referral to high-risk counseling. ■■ Atypical ductal or lobular hyperplasia (ADH or ALH) (consider using the Gail Model for risk assessment) Reproductive and other risk factors ■■ Age at menarche <12 ■■ Nulliparity ■■ Age at first birth >30 ■■ Prior breast biopsy For patients age ≥35 with a constellation of these risk factors.67: CBE at least once per year. The risk from infant thymus radiation. or close relative Beginning at age 25. ■■ One or more male relatives with breast cancer ■■ Any 1st or 2nd degree relative with breast cancer < age 50 ■■ Two or more relatives in the same lineage with early onset breast cancer ■■ Women of Ashkenazi Jewish ancestry may be included despite fewer affected relatives or later age onset. other. consider high-risk counseling or risk reducing medication. The computerized version of the Gail Model is available at: www. maternal family history. Li-Fraumeni syndrome. Consider twice yearly. hereditary diffuse gastric cancer. then annually. © 2010 CRICO/RMF 3 . ■■ Family history of ovarian cancer and breast cancer in one 1st or 2nd degree relative. The Gail Model may underestimate the risk for patients with a strong family history of breast or ovarian cancer. or risk reducing medication. ■■ Family history of breast cancer ≤ age 40 or ovarian cancer (any age) in 1st degree relative. Annual mammogram. ■■ History of ductal carcinoma in situ (DCIS) Annual mammogram after diagnosis. Preliminary data suggest that alternating MRI and mammography every six months may be helpful. Patients without a known genetic predisposition to breast cancer Recommendations Personal or family history of breast cancer ■■ Personal history of breast cancer diagnosed ≤ age 40. c. beginning at age 40. Consider annual MRI in addition to annual mammogram. Consider annual MRI in addition to annual mammogram.

atypical ductal hyperplasia. and potential phyllodes tumor. Data do not support the use of MRI or whole breast ultrasound as screening tools for women at usual risk. with consideration for overall quality of life. b. consider galactorrhea workup Refer to surgeon Follow up by PCP. © 2010 CRICO/RMF 4 . radial scarsd All other findings Refer to surgeon Follow up by PCP. mucin-producing lesions. continue routine screening Screening by Age Screening recommendations for patients at usual risk vary among experts. d. and/or pre-menopausal. additional imaging needed Negative Benign finding Probably benign finding—short interval follow-up suggested. 4 Suspicious abnormality—biopsy should be considered. radial scar (benign sclerosing lesion).CRICO/RMF Breast Care Management Algorithm Screening Mammogram Spontaneous Nipple Discharge (not appropriate for women with breast complaints) with no palpable mass (non-lactating) BIRADS Category 1 & 2 BIRADS Category 0 & 3 BIRADS Category 4 & 5 Single duct Follow up by PCP. negative guaiac Refer to surgeon Malignantc Medical evaluation. Screening Technology ■■ ■■ ■■ Overall. atypical lobular hyperplasia. Patients should be informed about their options for image-guided core needle biopsy. c. refer to surgeon for excisional biopsy Any evidence of blood. Ductal carcinoma in situ or invasive cancer. bilateral diagnostic mammogram American College of Radiology Breast Imaging Reporting and Data System (BIRADS) 0 1 2 3 Assessment is incomplete. digital mammography is of equivalent sensitivity to film/screen mammography. continue routine screening Follow radiology advice for follow-up imaging Image-guided core needle biopsy Refer to surgeon Biopsy results reviewed by radiologist and communicated to PCP If not availablea or amenable. Digital mammography has slightly better sensitivity than film/screen mammography for women less than age 50. positive guaiac Non-bloody. continue routine screening Benignb Radiology/ pathology discordance Refer to surgeon for excisional biopsy Atypical lesions. papillomas. Women more than 70 years old should be screened at least biennially. Consider referral to surgeon for excision of mass > 2cm. with dense breasts. ■■ ■■ Women 40–69 years old should be screened annually. The following recommendations are based on the 2009 NCCN Guidelines. some papillary lesions. a. Probable risk of breast cancer: a) low suspicion (<15%) b) intermediate suspicion (15–60%) c) high suspicion (60–95%) 5 Highly suspicious of malignancy—do biopsy. For women ≥ age 30. Probable risk of breast cancer is greater than 95%. Lesions that may fit this category include LCIS. Probable risk of breast cancer 2%. 6 Known biopsy-proven malignancy—appropriate action should be taken. Multiple ducts Physical exam.

therefore solid Not completely decompressed by ultrasounde Follow up by PCP. b. continue routine screening d. and advise the patient to return if concern persists. © 2010 CRICO/RMF 5 . c. radial scarsf All other findings Refer to surgeon Follow up by PCP. If not availableb or amenable. f. e. atypical lobular hyperplasia. Lesions that may fit this category include LCIS. radial scar (benign sclerosing lesion). and potential phyllodes tumor. Image-guided core needle biopsy or ultrasound after two cycles at discretion of radiologist. papillomas. some papillary lesions. Patients should be informed about their options for image-guided core needle biopsy. continue routine screening Continued from Breast Pain guideline. refer to surgeon for excisional biopsy Biopsy results reviewed by radiologist and communicated to PCP Follow up by PCP. If the physician does not concur with the patient regarding the presence of a mass. continue routine screening a. atypical ductal hyperplasia. confirm that routine screening is up to date. Consider referral to surgeon for excision of mass > 2cm.CRICO/RMF Breast Care Management Algorithm Palpable Mass Detected or Confirmed by Cliniciana Patient < age 30 Patient ≥ age 30 Diagnostic ultrasound. Specific imaging findings No specific findings Solid mass or complex/solid cystic mass Complicated cyst Simple cyst Image-guided aspiration based on radiologist recommendation Aspirate if uncomfortable for the patient or the patient requests Refer to surgeon Non-bloody fluid Completely decompressed by ultrasound No fluid. Ductal carcinoma in situ or invasive cancer. continue routine screening Benignc Bloody fluid Image-guided core needle biopsy Radiology/ pathology discordance Malignantd Refer to surgeon for excisional biopsy Refer to surgeon Atypical lesions. positive imaging result. mucin-producing lesions. If abnormal. add diagnostic mammogram at discretion of radiologist Diagnostic mammogram and ultrasound Pre-menopause Post-menopause Re-examine after two cycles Refer to surgeon Mass persists Mass resolves Refer to surgeon Follow up by PCP.

thoracic aortic dissection. follow up by PCP. months if postmenopausal. Differential diagnosis includes: chest wall pain. or 5 Symptomatic management Negative Positive Negative Positive Diagnostic mammogram at discretion of radiologist Symptomatic management Follow specific imaging findings on Palpable Mass guideline Follow specific imaging findings on Palpable Mass guideline Follow up by PCP. aortic aneurysm. post partum mastitis. hiatal hernia. refer to Palpable Mass guideline History & physicala Wait two cyclesb Cyclical If resolves. Cycles if premenopausal. continue routine screening a. 4.CRICO/RMF Breast Care Management Algorithm Breast Pain If mass. cholelithiasis. MI. © 2010 CRICO/RMF 6 . b. lung disease. cervical radiculopathy. costochondritis. continue routine screening No mass Non-cyclical Bilateral No resolution Unilateral Global Focal patient < age 30 Focal patient ≥ age 30 Patient < age 30 Patient ≥ age 30 Ultrasound Ultrasound and bilateral diagnostic mammogram Symptomatic management Bilateral diagnostic mammogram Positive Negative Follow Mammogram guidelines for BIRADS 3. continue routine screening Follow up by PCP.

Available at www. MD Assistant Professor in Surgery Massachusetts General Hospital Susan Troyan.htm Robyn Birdwell. For more information contact the CRICO/RMF Loss Prevention/Patient Safety Department at 617. MD Obstetrics/Gynecology Harvard Vanguard Medical Associates Chris Coley.org/professionals/physician_gls/PDF/genetics_screening. Agency for Healthcare Research and Quality. MD Director of Breast Imaging Massachusetts General Hospital Isaac Schiff.CRICO/RMF Breast Care Management Algorithm CRICO/RMF Breast Care Management Algorithm Task Force The CRICO/RMF Breast Care Management Algorithm is a suggested guideline for the evaluation of breast health and the care of a patient with a breast complaint. Cancer Risk Evaluation Program Beth Israel Deaconess Medical Center Project Support: CRICO/RMF Alison Anderson Jock Hoffman Ann Louise Puopolo. MD. MD Section Head of Breast Imaging Brigham and Women’s Hospital Judy E.nccn. It is intended for use by clinicians providing primary breast care.S.edu/bca. 2009. MD Assistant Chief of Medicine for Quality Assurance Massachusetts General Hospital Mehra Golshan. MD. Screening for Breast Cancer.pdf.nccn. MD Chief of Obstetrics/Gynecology Brigham and Women’s Hospital Elizabeth Buechler. Photo images ©2010 iStockphoto.org/professionals/physician_gls/PDF/breast-screening. is available at www. MD Faulkner Hospital Director. MD Director. Available at www. Rockville. Breast Surgical Services Brigham & Women’s Hospital Sherry Haydock. Topic Page. Cancer Risk and Prevention Department of Adult Oncology Dana Farber Cancer Institute Gila Kriegel. MD Director. Genetic/familial high-risk assessment: breast and ovarian.rmf. November 2009. Version 2. MD Director.harvard. U. MD. MD Director. FACS Surgical Director. MD Chief of Obstetrics/Gynecology Massachusetts General Hospital Nadine Tung.pdf. Preventive Services Task Force. It should not be construed as a standard of care. http://www. gov/clinic/uspstf/uspsbrca. MD Assistant Professor in Medicine Beth Israel Deaconess Medical Center Michelle Specht. Internal Medical Associates Massachusetts General Hospital Elsie Levin. 2009. BSN.1552. © 2010 CRICO/RMF 7 . Garber. MPH Director. RN The entire CRICO/RMF Breast Care Management Algorithm.ahrq. Women’s Health Center Beth Israel Deaconess Medical Center Betty Rafferty. along with related information and links. National Comprehensive Cancer Network Practice Guidelines in Oncology.679. Version 1. Breast Care Center Beth Israel Deaconess Medical Center CRICO/RMF Breast Care Management Algorithm Review Committee Robert Barbieri. Reference Articles National Comprehensive Cancer Network Practice Guidelines in Oncology. Sagoff Breast Imaging and Diagnostic Centre Jennifer Potter. Breast cancer screening and diagnosis guidelines.

Physicians and patients share responsibility for follow up. 1999. breast care center. Follow every mass to conclusion. Patient unsatisfied with a negative finding Engage the patient in a discussion about her breast care management subsequent to negative test/imaging results. Develop a clear and effective plan. include the findings of the breast examination (note—in quotes— what the patient said. it is not non-existent (an approximately 1 in 2.0. Ask the radiology department. use a diagram to record the exact location. Document all patient no-shows or cancellations. update the patient’s risk factor assessment and your recommendations for screening based on that patient’s current risk for developing breast cancer. as well as your own findings). and discrepancies in findings among various studies.Important Physician-patient Discussion Points Related to Breast Patient Safety Patient-detected lump/mass A self-discovered lump should be followed to resolution even if there is provider-patient discordance on the presence of the lump. Consider using a problem list to highlight patients with a positive family history of breast cancer. Wun LM. During each visit. employ a system to track ordered tests through the receipt and communication to the patient. Document any telephone conversations with patients regarding the reported results. Explain to the patient how test results will be communicated to her and (if appropriate) other clinicians. Share any uncertainty on your part in a way that helps your patient appreciate the importance of compliance with follow-up. To ensure notification of test results. DEVCAN: Probability of Developing or Dying of Cancer. . and for an unconfirmed mass. Bethesda MD: National Cancer Institute. For an unconfirmed mass. Note the patient’s refusal for follow up in the record. in quotes. health care providers cannot guarantee a cure based on the timing of the diagnosis. Stress that additional studies may be needed to rule out malignancy. or specialist to notify your office of patients who do not keep scheduled appointments. the patient’s breast complaints and what she says. consider using an informed refusal form signed by the patient. In the event that a patient’s breast care is being managed by another clinician. Document all interactions as they occur to support future care and to clarify any disputes that may arise later. Use a diagram to record the exact location of all confirmed lumps or lesions. Documentation Risk of breast cancer for women younger than age 30 Although the level of risk for women under 30 is much lower than for older women. for a confirmed lump or lesion. document the date of the patient’s last exam to ensure that subsequent exams are performed when appropriate. and ensure the patient’s understanding and agreement of that plan. explain to your patients your tracking and compliance system (contacting patients a day or two before their follow-up appointments can reduce noncompliance). Confirm and document with other providers which of you will be the clinician of record and responsible for ordering tests and following up with the patient. This includes: ■■ ■■ ■■ in the history and physicals section of the record. Test results ■■ ■■ ■■ Follow up ■■ ■■ ■■ ■■ Significance of early detection of breast cancer Without reliable evidence that early detection of breast cancer can significantly reduce the risk of mortality.000 chance of being diagnosed with breast cancer at an early age). record—in the patient’s words—the location and nature of the complaint. Version 4. Make follow-up or test appointments before the patient leaves your office. record—in the patient’s words—the location and nature of the complaint. enter.1 Women with multiple risk factors—especially those that indicate a high level of risk and possible BRCA1/BRCA2 gene mutation—should be concerned about the possibility of early breast cancer. Avoid sending the wrong message to a patient by just telling her that a palpable lump is probably benign. If a patient refuses follow up. ■■ ■■ ■■ ■■ ■■ Communication ■■ ■■ ■■ ■■ Communicate all abnormal findings to the patient and document that act. explain the risks of not having a recommended diagnostic test or procedure. Reference 1 Feuer EJ. Track all surgical referrals to ensure that you are receiving a timely report from the surgeon. Patients may need to be educated as to the rigors and subtleties of research data. ■■ ■■ Document a thorough breast examination in the history and physical examination.