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8/12/2019 Cricormf Bca

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CRICO/RMF Breast Care

Management AlgorithmImproving Breast Patient Safety

Created: 1995

Revised: 2000, 2003

Current: 2010


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CRICO/RMF Breast Care Management Algorithm

2 2010 CRICO/RM

Failure to diagnose breast cancer affects -insured providers across a spectrum of

specialties. To reduce the likelihood of such events, a task force of breast care specialists,

coordinated by /, identified the key factors contributing to allegations of

mismanaged breast care and subsequently developed the / Breast CareManagement Algorithm.

e /Algorithmcombines peer-reviewed evidence and proven risk

management strategies to aid providers at various decision points across three

domains of breast health care:

patients without known breast cancer risks,

individuals seeking an assessment of their risks for developing breast cancer, and

patients who present with specific breast complaints.

e /Algorithmis designed to help providers of primary breast care

appropriately use available diagnostic tools. e provider is expected to gatherinformation such as family history, atypia on previous biopsy, thoracic radiation before

age , and reproductive risk factors to determine if changes to normal screening, or a

referral to high-risk counseling, is indicated.

Even after a referral, providers of primary breast care have an ongoing responsibility

for tracking and coordinating their patients routine breast care. In addition to being a

tenet of good care, comprehensive provider follow-up is a significant safeguard against

allegations of failure to diagnose breast cancer.

e / Breast Care Management Algorithmis a suggested guideline and should

not be construed as a standard of care. Physicians may choose to follow alternate

recommendations (especially for mammographic screening) as their standard practice.

Risk Management for Breast Care

Self-detected mass:e majority of s failure to diagnose breast cancer cases

involve a patient-detected mass, lump, or thickening. Whether or not you can confirm a

mass, the patient presenting with a self-detected lump must be followed to conclusion.

Risk factors:Assessmentand periodic updatingof a patients personal and family

history ensures timely age- and risk-stratified breast cancer screening, including

appropriate referrals to high risk counseling.

Test results:Primary care providers are responsible for confirming receipt of, reviewing,

and transmitting to the patient, all diagnostic tests they order.Follow up:Document follow-up testing recommendations and communicate the

follow-up plan to the patient and all responsible providers.

Referrals:For a patient referred to a specialist, make sure to coordinate the care among

providers and clarify for the patient the specific roles and responsibilities.

Improving Breast Patient Safety

Breakdowns in the Process of Carein Breast Cancer Cases

Step # casestotal

incurred

1. Patient seeks care 0 $0

2. History/physical/evaluation 3 $2,850,000

3. Order of diagnostic/lab tests

8 $7,350,000

4. Performance of tests 2 $1,470,000

5. Interpretation of tests 15 $15,011,000

6. Receipt/transmittalof test results

0 $0

7. Physician follow upwith patient

3 $2,620,000

8. Referral management 1 $1,090,000

9. Patient compliance withfollow-up plan

1 $890,000

N=18 cases asserted 20052009 with a diagnosis-related majorallegation and a final diagnosis of breast cancer.

prostatelungcolorectalbreast

20002004cases asserted

20052009

14 18 26 16 19 20 6 21

Top Cancer Types in CRICO Cases

N=140 CRICO cases asserted 20002009 with a diagnosis-related major allegation; $103 million total incurred losses.

Total incurred is the aggregate of expenses, reserves, andpayments on open and closed cases.

oncology surgery

general surgery

pathology

ob/gyn

general medicine

24 radiology

6

2

2

2

1

Physician Defendants Named inBreast Cancer Diagnosis-related Cases

N=37 CRICO physicians named in 18 cases asserted20052009 with a diagnosis-related major allegationand a final diagnosis of breast cancer.


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3 2010 CRICO/RMF

Patients with a genetic predisposition to breast cancer Recommendations

Known carrier of a BRCA1or BRCA2mutation, or close relative

with known mutation

Known carrier or close relative with another hereditary breast cancer syndrome gene a

Beginning at age 25, clinical breast exam (CBE) at least once per year.

Consider twice yearly.

Annual mammogram and MRIbeginning at age 25or individualized based on earliest

age onset in family. Preliminary data suggest that alternating MRIand mammographyevery six months may be helpful.

Patients without a known genetic predisposit ion to breast cancer Recommendations

Personal or family history of breast cancer

Personal history of breast cancer diagnosed age 40, or ovarian cancer at any age.

Family history of breast cancer age 40or ovarian cancer (any age) in 1stdegree relative,

or in paternal 2nddegree relative

Family history of breast cancer in two 1stdegree relatives, at least one diagnosed age 50b

Family history of ovarian cancer and breast cancer in one 1stor 2nd degree relative,

or in close relatives in the same lineage

One or more male relatives with breast cancer

Any 1

st

or 2

nd

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.

Annual CBEbeginning at age 25.

Annual mammogram beginning at age 40, or 510years younger than earliest

affected relative (but not before age 25), or after personal history of breast cancer

< age 40.

Consider annual MRIin addition to annual mammogram.

Consider referral to high-risk counseling, then recategorize as appropriate.

Therapeutic thoracic radiation (e.g. Hodgkins) < age 30c CBEat least once per year beginning at age 25.

Annual mammogram beginning 810years after radiation or at age 25.

Consider annual MRIin addition to annual mammogram.

Histology

Lobular carcinoma in situ (LCIS)

History of ductal carcinoma in situ (DCIS)

History of invasive breast cancer

Atypical ductal or lobular hyperplasia (ADHor ALH)

(consider using the Gail Model for risk assessment)

CBEat least once per year.

Annual mammogram after diagnosis.

Consider referral to high-risk counseling, chemoprevention, or risk reducing

medication.

Reproductive and other risk factors

Age at menarche 30

Prior breast biopsy

>5years of combined estrogen/ progesterone hormone replacement therapy

For patients age 35with a constellation of these risk factors, consider assessment

via the Gail Model to determine their levels of risk for breast cancer.

For patients with a Gail Model value


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4 2010 CRICO/RM

Screening Mammogram(not appropriate for women with breast complaints)

BIRADSCategory 1 & 2



Follow up by PCP,continue routine

screening

Follow radiologyadvice for

follow-up imaging

Image-guidedcore needle biopsy

If not availableaor amenable, refer

to surgeon forexcisional biopsy

Biopsy resultsreviewed by

radiologist andcommunicated

to PCP

Spontaneous Nipple Dischargewith no palpable mass (non-lactating)

Single duct Multiple ducts

Refer to surgeonPhysical exam. Forwomen age 30,

bilateral diagnosticmammogram

Any evidenceof blood,

positive guaiac

Non-bloody,negative guaiac

Refer to surgeon

Medical evaluation,

consider galactor-rhea workup


screening

Screening by Age

Screening recommendations for patients at usual risk vary among experts. The

following recommendations are based on the 2009 NCCNGuidelines.

Women 4069 years old should be screened annually.

Women more than 70 years old should be screened at least biennially, with

consideration for overall quality of life.

Screening Technology

Overall, digital mammography is of equivalent sensitivity to film/screen

mammography.

Digital mammography has slightly better sensitivity than film/screen

mammography for women less than age 50, with dense breasts,

and/or pre-menopausal.

Data do not support the use of MRI or whole breast ultrasound as screening

tools for women at usual risk.

a. Patients should be informed about their options for image-guided core needle biopsy.

b. Consider referral to surgeon for excision of mass > 2cm.

c. Ductal carcinoma in situ or invasive cancer.

American College of Radiology Breast Imaging Reporting

and Data System (BIRADS)

0 Assessment is incomplete; additional imaging needed

1 Negative

2 Benign finding

3 Probably benign findingshort interval follow-up suggested.

Probable risk of breast cancer 2%.

4 Suspicious abnormalitybiopsy should be considered.

Probable risk of breast cancer:

a) low suspicion (


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5 2010 CRICO/RMF

Palpable Mass Detected or Confirmed by Cliniciana

Patient < age 30

a. If the physician does not concur with the patient regarding the presence of a mass, confirmthat routine screening is up to date, and advise the patient to return if concern persists.

b. Patients should be informed about their options for image-guided core needle biopsy.

c. Consider referral to surgeon for excision of mass > 2cm.

Diagnosticmammogram

and ultrasound

Patient age 30

No specific findings

Pre-menopause

Re-examine aftertwo cycles

Diagnostic ultrasound. If abnormal,add diagnostic mammogram at

discretion of radiologist

Mass persists

Refer to surgeon

Post-menopause

Refer to surgeon

Mass resolves


screening

Specific imagingfindings

Solid mass orcomplex/solid

cystic mass

Simple cystComplicated cyst

Aspirateif uncomfortable forthe patient or thepatient requests

Image-guidedaspirationbased on

radiologistrecommendation

No fluid,therefore solid


screening

Non-bloody fluidBloody fluid

Image-guided coreneedle biopsy

Not completely

decompressedby ultrasoundeRefer to surgeon

Radiology/pathology

discordance

Completely

decompressedby ultrasound

Refer to surgeonfor excisional

biopsy


screening

Benignc

Refer to surgeon

Malignantd

Refer to surgeon

Continued from Breast Painguideline, positive imaging result.

d. Ductal carcinoma in situ or invasive cancer.

e. Image-guided core needle biopsy or ultrasound after two cycles at discretion of radiologist.

f. Lesions that may fit this category include LCIS, atypical lobular hyperplasia, atypical ductalhyperplasia, radial scar (benign s clerosing lesion), some papillary lesions, mucin-producing lesionsand potential phyllodes tumor.

Biopsy resultsreviewed by

radiologist andcommunicated

to PCP

Atypical lesions,papillomas,radial scarsf

All other findings


screening

If not availablebor amenable, refer

to surgeon forexcisional biopsy


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6 2010 CRICO/RM

Breast Pain

History & physicala

If mass, referto Palpable Mass

guideline

a. Differential diagnosis includes: chest wall pain, costochondritis, cervical radiculopathy, MI,lung disease, hiatal hernia, cholelithiasis, thoracic aortic dissection, aortic aneurysm, postpartum mastitis.

No mass

Cyclical

Non-cyclical

Wait two cyclesb

No resolution

If resolves, followup by PCP, continue

routine screening

Bilateral Unilateral

Global Focalpatient < age 30

Ultrasound

Negative Positive

Diagnosticmammogram

at discretion ofradiologist

Follow specificimaging findingson Palpable Mass

guideline

Patient < age 30 Patient age 30

Bilateral diagnosticmammogram

Symptomaticmanagement

Positive Negative

FollowMammogram

guidelinesfor BIRADS3, 4, or 5


Follow up by PCP,

continue routinescreening

Focalpatient age 30

Ultrasound andbilateral diagnostic

mammogram

Negative Positive

Follow specificimaging findingson Palpable Mass

guideline



screening

b. Cycles if premenopausal; months if postmenopausal.


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7 2010 CRICO/RMF

e / Breast Care Management Algorithmis a suggested guideline for the

evaluation of breast health and the care of a patient with a breast complaint. It is

intended for use by clinicians providing primary breast care. It should not be construed

as a standard of care.

Reference Articles

National Comprehensive Cancer Network Practice Guidelines in Oncology.

Breast cancer screening and diagnosis guidelines. Version . . Available at

www.nccn.org/professionals/physician_gls//breast-screening.pdf.

National Comprehensive Cancer Network Practice Guidelines in Oncology.

Genetic/familial high-risk assessment: breast and ovarian. Version . . Available at

www.nccn.org/professionals/physician_gls//genetics_screening.pdf.

Screening for Breast Cancer, Topic Page. November . U.S. Preventive Services Task

Force. Agency for Healthcare Research and Quality. Rockville, . http://www.ahrq.gov/clinic/uspstf/uspsbrca.htm

CRICO/RMF Breast Care Management

Algorithm Task Force

Robyn Birdwell, MDSection Head of Breast ImagingBrigham and Womens Hospital

Judy E. Garber, MD, MPHDirector, Cancer Risk and PreventionDepartment of Adult Oncology

Dana Farber Cancer InstituteGila Kriegel, MDAssistant Professor in MedicineBeth Israel Deaconess Medical Center

Michelle Specht, MDAssistant Professor in SurgeryMassachusetts General Hospital

Susan Troyan, MD, FACSSurgical Director, Breast Care CenterBeth Israel Deaconess Medical Center

CRICO/RMF Breast Care Management

Algorithm Review Committee

Robert Barbieri, MDChief of Obstetrics/GynecologyBrigham and Womens Hospital

Elizabeth Buechler, MD

Obstetrics/GynecologyHarvard Vanguard Medical Associates

Chris Coley, MDAssistant Chief of Medicine for Quality AssuranceMassachusetts General Hospital

Mehra Golshan, MDDirector, Breast Surgical ServicesBrigham &Womens Hospital

Sherry Haydock, MDDirector, Internal Medical AssociatesMassachusetts General Hospital

Elsie Levin, MDFaulkner HospitalDirector, Sagoff Breast Imaging and Diagnostic Centre

Jennifer Potter, MDDirector, Womens Health CenterBeth Israel Deaconess Medical Center

Betty Rafferty, MDDirector of Breast ImagingMassachusetts General Hospital

Isaac Schiff, MDChief of Obstetrics/GynecologyMassachusetts General Hospital

Nadine Tung, MDDirector, Cancer Risk Evaluation ProgramBeth Israel Deaconess Medical Center

Project Support: CRICO/RMF

Alison AndersonJock HoffmanAnn Louise Puopolo, BSN, RN

The entire CRICO/RMFBreast Care ManagementAlgorithm,along with related information and links,is available at www.rmf.harvard.edu/bca.

For more information contact the CRICO/RMFLossPrevention/Patient Safety Department at617.679.1552.

Photo images 2010iStockphoto.


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Important Physician-patient Discussion PointsRelated to Breast Patient Safety

Patient-detected lump/mass

A self-discovered lump should be followed to resolution evenif there is provider-patient discordance on the presence of thelump. Follow every mass to conclusion.

Patient unsatisfied with a negative finding

Engage the patient in a discussion about her breast caremanagement subsequent to negative test/imaging results.Develop a clear and effective plan, and ensure the patientsunderstanding and agreement of that plan.

Document all interactions as they occur to support futurecare and to clarify any disputes that may arise later. isincludes:

in the history and physicals section of the record, includethe findings of the breast examination (notein quotes

what the patient said, as well as your own findings);

for a confirmed lump or lesion, use a diagram to recordthe exact location; and

for an unconfirmed mass, recordin the patientswordsthe location and nature of the complaint.

Significance of early detection of breast cancer

Without reliable evidence that early detection of breastcancer can significantly reduce the risk of mortality, healthcare providers cannot guarantee a cure based on the timingof the diagnosis. Patients may need to be educated as to therigors and subtleties of research data, and discrepancies infindings among various studies.

Risk of breast cancer for women younger than age 30

Although the level of risk for women under is muchlower than for older women, it is not non-existent (anapproximately in , chance of being diagnosed withbreast cancer at an early age). Women with multiple riskfactorsespecially those that indicate a high level of risk andpossible / gene mutationshould be concernedabout the possibility of early breast cancer.

Communication

Communicate all abnormal findings to the patient anddocument that act.

Avoid sending the wrong message to a patient by justtelling her that a palpable lump is probably benign.Stress that additional studies may be needed to rule outmalignancy.

Share any uncertainty on your part in a way that helpsyour patient appreciate the importance of compliance withfollow-up.

Confirm and document with other providers which of youwill be the clinician of record and responsible for orderingtests and following up with the patient.

Test results

Explain to the patient how test results will becommunicated to her and (if appropriate) other clinicians.

Document any telephone conversations with patients

regarding the reported results. To ensure notification of test results, employ a

system to track ordered tests through the receipt andcommunication to the patient.

Follow up

Make follow-up or test appointments before the patientleaves your office.

Physicians and patients share responsibility for follow up;explain to your patients your tracking and compliancesystem (contacting patients a day or two before theirfollow-up appointments can reduce noncompliance).

Track all surgical referrals to ensure that you are receivinga timely report from the surgeon.

Ask the radiology department, breast care center, orspecialist to notify your office of patients who do not keepscheduled appointments. Document all patient no-showsor cancellations.

If a patient refuses follow up, explain the risks of nothaving a recommended diagnostic test or procedure. Notethe patients refusal for follow up in the record; considerusing an informed refusal form signed by the patient.

Documentation

Document a thorough breast examination in the historyand physical examination; enter, in quotes, the patientsbreast complaints and what she says.

Use a diagram to record the exact location of allconfirmed lumps or lesions.

For an unconfirmed mass, recordin the patientswordsthe location and nature of the complaint.

In the event that a patients breast care is being managedby another clinician, document the date of the patientslast exam to ensure that subsequent exams are performed

when appropriate.

During each visit, update the patients risk factor

assessment and your recommendations for screeningbased on that patients current risk for developing breastcancer.

Consider using a problem list to highlight patients with apositive family history of breast cancer.

Reference1 Feuer EJ, Wun LM. DEVCAN: Probability of Developing or Dying of Cancer. Version 4.0.

Bethesda MD: National Cancer Institute. 1999.

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