2012 standards manual

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2012 Breast Center

Standards Manual

NAPBCNATIONAL ACCREDITATION PROGRAM

FOR BREAST CENTERS

A C C R E D I T A T I O N M A K E S A D I F F E R E N C


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2012 American College of Surgeons Chicago, IL All Rights Reserved

2012 Breast CenterStandards Manual


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N A P B C S T A N D A R D S M A N U A L / TA B L E O F C O N T E N T S

Table of Contents

FOREWORD ......................................................................................................... 3Benefts o Becoming a NAPBC-Accredited Center .......................................................... 3Member Organizations .......................................................................................................4

ACKNOWLEDGMENTS.........................................................................................5NAPBC-ACCREDITED CENTERS .........................................................................7

Breast Center Components ................................................................................................ 9The Survey Process ..........................................................................................................10The Survey Application Record (SAR) ............................................................................... 11Survey Fee ........................................................................................................................ 12Site Visit Agenda ...............................................................................................................13Documentation o Program Activity ................................................................................. 14Annual Data Submission Requirement ........................................................................... 15Medical Records Review Process ..................................................................................... 16Accreditation Program Standards Rating System ........................................................... 17Accreditation Award ......................................................................................................... 18Award Notifcation Process .............................................................................................. 19The Post-Survey Evaluation ............................................................................................. 20NAPBC Resources and Tools or Centers ........................................................................ 21

CHAPTER ONE CENTER LEADERSHIP ........................................................... 23Level o Responsibility and Accountability

Standard 1.1 ................................................................................................................... 24

Interdisciplinary Breast Cancer ConerenceStandard 1.2 ................................................................................................................... 25

Evaluation and Management Guidelines

Standard 1.3 ................................................................................................................... 27

CHAPTER TWO CLINICAL MANAGEMENT ..................................................... 29Interdisciplinary Patient Management

Standard 2.1 ................................................................................................................... 30

Patient NavigationStandard 2.2 ................................................................................................................... 31

Breast ConservationStandard 2.3 ................................................................................................................... 32

Sentinel Node BiopsyStandard 2.4 ................................................................................................................... 33

Breast Cancer SurveillanceStandard 2.5 ................................................................................................................... 34

Breast Cancer StagingStandard 2.6 ................................................................................................................... 35

Pathology ReportsStandard 2.7 ................................................................................................................... 36

Diagnostic ImagingStandard 2.8 ................................................................................................................... 37

Needle BiopsyStandard 2.9 ................................................................................................................... 38


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2 / T A B L E O F C O N T E N T S / N A P B C S T A N D A R D S M A N U A L

UltrasonographyStandard 2.10.................................................................................................................. 39

Stereotactic Core Needle Biopsy

Standard 2.11.................................................................................................................. 41Radiation Oncology

Standard 2.12.................................................................................................................. 43

Medical OncologyStandard 2.13.................................................................................................................. 45

NursingStandard 2.14.................................................................................................................. 46

Support and RehabilitationStandard 2.15.................................................................................................................. 47

Genetic Evaluation and ManagementStandard 2.16.................................................................................................................. 48

Educational ResourcesStandard 2.17.................................................................................................................. 50

Reconstructive SurgeryStandard 2.18.................................................................................................................. 51

Evaluation and Management o Benign Breast DiseaseStandard 2.19.................................................................................................................. 52

CHAPTER THREE RESEARCH ........................................................................ 53

Clinical Trial InormationStandard 3.1 ................................................................................................................... 54

Clinical Trial Accrual

Standard 3.2 ................................................................................................................... 55

CHAPTER FOUR COMMUNITY OUTREACH..................................................... 57Education, Prevention, and Early Detection Programs

Standard 4.1 ................................................................................................................... 58

CHAPTER FIVE PROFESSIONAL EDUCATION ................................................ 59Breast Center Sta Education

Standard 5.1 ................................................................................................................... 60

CHAPTER SIX QUALITY IMPROVEMENT......................................................... 61Quality and Outcomes

Standard 6.1 ................................................................................................................... 62

Quality ImprovementStandard 6.2 ................................................................................................................... 64

APPENDIX .......................................................................................................... 65


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N A P B C S T A N D A R D S M A N U A L / F O R E W O R D

Foreword

The evaluation and management of patients with diseases ofthe breast historically occurred in a fragmented, disorganizedsetting. Patients are best managed in this complex environmentthrough multidisciplinary coordination. This team approachresulted in the birth of the breast center concept in the UnitedStates in the 1970s. In the past three to four decades therehas been a proliferation of breast centers to accommodate thethousands of women diagnosed with breast cancer, as well asaddressing the equally compelling needs of the million or morewomen presenting annually with benign breast disease.

Evidence-based and consensus-developed standards havegained increasing importance and recognition.

The United States health care system is undergoing adramatic transformation centered on quality measurementand improvement and documentation of adherence to broadlyaccepted standards of care for all diseases including those

of the breast. No organization has established standards forthe evaluation and management of patients with diseases ofthe breast or a survey process to monitor compliance. The

NAPBC seeks to accredit established breast centers in order toimprove the quality of evaluation and management of patients.It recognizes that breast care is delivered in heterogeneoussettings in the United States. The program is designed to beinclusive and not exclusive. Accreditation will be awardedto large academic medical centers, teaching hospitals,nonteaching hospitals, free-standing centers, and small private

practices provided the NAPBC standards are met.

For purposes of this program and with respect to compliancewith the NAPBC standards, provided services are dened as

those elements of evaluation and management accountableto the local Breast Program Leadership (BPL). Accountableis dened as provided services that can be inuenced by theBPL. Such services may occur in a single geographic site or ina center without walls. Examples include: medical oncologyconsultation and treatment, radiation oncology consultation andtreatment, and breast imaging.

N A P B C M I S S I O N S T A T E M E N T

The National Accreditation Program for Breast Centers (NAPBC) is a consortium ofnational, professional organizations focused on breast health and dedicated to the

improvement of quality care and outcomes of patients with diseases of the breast through

evidence-based standards and patient and professional education.

Referred services are dened as those components ofevaluation and management not under the accountability of tBreast Program Leadership and conducted in another settingExamples include: genetic counseling and a survivorship

program.

In effect, all patients with diseases of the breast will beafforded the most comprehensive evaluation and managemecurrently available.

Benefts o Becoming a NAPBC-Accredited CenterAccreditation by the NAPBC provides many notable benetthat will enhance a breast center and its quality of patient ca

NAPBC-accredited centers receive the following:

A model for organizing and managing a breast center toensure multidisciplinary, integrated, and comprehensive

breast care services.

Internal and external assessment of breast centerperformance based on recognized standards to demonstratcommitment to quality care.

Recognition as having met performance measures forhigh-quality breast care established by national health careorganizations.

National recognition and public promotion.

Participate in a National Breast Disease Database to reporpatterns of care and effect quality improvement.

Access to breast center comparison benchmark reportscontaining national aggregate data and individual center dto assess patterns of care and outcomes relative to nationanorms.


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4 / F O R E W O R D / N A P B C S T A N D A R D S M A N U A L

NAPBC Board Member Organizations

American Board of Surgery (ABS)

American Cancer Society (ACS) American College of Radiology Breast Imaging Commission

(ACRBIC)

American Cancer Radiology Imaging Network (ACRIN)

American College of Surgeons (ACoS)

American Institute for Radiologic Pathology (AIRP)

American Society for Radiation Oncology (ASTRO)

American Society of Breast Disease (ASBD)

American Society of Breast Surgeons (ASBS)

American Society of Clinical Oncology (ASCO)

American Society of Plastic Surgeons (ASPS)

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)


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N A P B C S T A N D A R D S M A N U A L / A C K N O W L E D G M E N T S

Acknowledgments

2 0 12 N A P B C B O A R D

Cary S. Kaufman, MD, FACS, Chair

James Connolly, MD, FCAP, Vice-Chair

Amy Alderman, MD

Douglas W. Arthur, MD

Jay A. Baker, MD

Paul Baron, MD, FACS

Anees Chagpar, MD, FACS

Judy Destouet, MD

Carl J. DOrsi, MD

Mahmoud El-Tamer, MD, FACS

Richard Fine, MD, FACS

Cheryl Herman, MD

Kevin S. Hughes, MD, FACS

Rosanne Iacono, RN.C, MSN, CRNP

Julio A. Ibarra, MD

Peter M. Jokich, MD

Paula Kim

M. Tish Knobf, RN, PhD, FAAN, AOCN

Scott H. Kurtzman, MD, FACS

Jessica Leung, MD

J. Leonard Lichtenfeld, MD, MACP

Shahla Masood, MD, FCAP

Michael F. McGuire, MD, FACS

Meena Moran, MD

Lisa A. Newman, MD, MPH, FACS

Ruth ORegan, MD

Helen Pass, MD, FACS

Barbara Rabinowitz, PhD, MSW, RN

Hester Hill-Schnipper, LICSW, BCD, OSW-C

Gordon F. Schwartz, MD, FACS

Rache M. Simmons, MD, FACS

Jean F. Simpson, MD, FCAP

Dana H. Smetherman, MD, FACRRandy Stevens, MD

Sandra Swain, MD, FACP

Scott M. Weissman, MS, LGC

Gary Whitman, MD, FACR

Shawna C. Willey, MD, FACS

Joann Zeller, MBA, CTR


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6 / A C K N O W L E D G M E N T S / N A P B C S T A N D A R D S M A N U A L

N A P B C S T A N D A R D S A N D A C C R E D I T A T I O N C O M M I T T E E

Scott H. Kurtzman, MD, FACS, Chair

James Connolly, MD, FCAP

Richard Fine, MD, FACS

Nora Hansen, MD, FACS

Cary S. Kaufman, MD, FACS

Claudia Z. Lee, MBA

Arthur Lerner, MD, FACS

Michael F. McGuire, MD, FACS

Barbara Rabinowitz, PhD, MSW, RN

Scott M. Weissman, MS, LGC

David P. Winchester, MD, FACS

N A P B C S T A F F

David P. Winchester, MD, FACS, Medical Director, Cancer Programs

Connie Bura, Administrative Director

Cindy Burgin, Manager

Tenisha Granville, Program Coordinator

Jennifer Fogarty, Education Administrator


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NAPBC-Accredited Centers


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8 / N A P B C - A C C R E D I T E D C E N T E R S / N A P B C S T A N D A R D S M A N U A L

NAPBC-Accredited Centers

The NAPBC encourages, hospitals, treatment centers, individual physician practices, and otheracilities committed to breast health care to improve the quality o care available at their center(s)through various breast-related programs. These programs are concerned with prevention, earlydetection, diagnosis, pre-treatment evaluation, staging, optimal treatment, rehabilitation, surveillanceor recurrent disease, support services, and end-o-lie care. The availability o a ull range o medical

services, along with a multidisciplinary team approach to patient care, ensures the provision ocontinuity o care or women with diseases o the breast.

NAPBC-accredited centers demonstrate theollowing services:

A multidisciplinary, team approach to coordinatethe best care and treatment options available.

Access to breast cancer-related information,education, and support.

Breast cancer data collection on quality indicatorsfor all subspecialties involved in breast cancerdiagnosis and treatment.

Ongoing monitoring and improvement of care.

Information about clinical trials and new treatmentoptions.

Accreditation by the NAPBC is granted only to thosecenters that are voluntarily committed to providingthe best possible care to patients with diseaseso the breast. Each breast center must undergo arigorous evaluation and review o its perormanceand compliance with NAPBC standards. To maintainaccreditation, centers must monitor compliance withNAPBC standards to ensure quality care, and undergoan on-site review every three years.


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N A P B C S T A N D A R D S M A N U A L / N A P B C - A C C R E D I T E D C E N T E R S

Breast Center Components

1 If center has breast MRI, they must have image-guided

MRI biopsy capability.

A Breast Center Component Checklist is includedin the Appendix.

The ollowing outline provides a description o breast services recommended by the NationalAccreditation Program or Breast Centers. See specifc standards or survey purposes.

1. Imaginga. Screening mammography (digital or analog)

b. Diagnostic mammography (additional views beyondscreening mammography and workup of a clinicalabnormality)

c. Ultrasound

d. Breast MRI

2. Needle Biopsy

a. Needle biopsy palpation-guided

b. Image guided stereotactic

c. Image guided ultrasound

d. Image guided MRI1

3. Pathology

a. Report Completeness/CAP Protocols

b. Radiology-Pathology Correlation

c. Prognostic and predictive indicators

d. Gene studies (if available)

4. Interdisciplinary Conference

a. Historyandndings

b. Imaging studies

c. Pathology

d. Pre- and post-treatment interdisciplinary discussion

5. Patient Navigationa. Facilitates navigation through system for the patient

6. Genetic Evaluation and Management

a. Genetic risk assessment

b. Genetic counseling

c. Genetic testing

7. Surgical Care

a. Surgical correlation with imaging/concordance

b. Preoperative planning after biopsy for surgical care

c. Breast surgery: lumpectomy or mastectomy

d. Lymph node surgery: sentinel node/axillary dissection

e. Post initial surgical correlation/treatment planning

8. Plastic Surgery Consultation/Treatment

a. Tissue expander/Implants

b. TRAM/Latissimusaps

c. DIEPap/freeaps(ifavailable)

9. Nursing

a. Nurses with specialized knowledge and skills indiseases of the breast

10. Medical Oncology Consultation/Treatmenta. Hormone therapy

b. Chemotherapy

c. Biologics

d. Chemoprevention

11. Radiation Oncology Consultation/Treatment

a. Whole breast irradiation with or without boost

b. Regional nodal irradiation

c. Partial breast irradiation treatment or protocols

d. Palliative radiation for bone or systemic metastasis

e. Stereotactic radiation for isolated or limited brain

metastasis12. Data Management

a. Data collection and submission

13. Research

a. Cooperative trials

b. Institutional original research (not part of nationaltrials)

c. Industry sponsored trials

14. Education, Support, and Rehabilitation

a. Education along continuum of care (pre-treatment,during, post-treatment)

b. Psychosocial supporti. Individual support

ii. Family support

iii. Support groups

c. Symptom management

d. Physical therapy (for example, lymphedema riskreduction practices, and management, shoulder ROM

15. Outreach and Education

a. Community at-large education (including low-incommedically underserved)

b. Patient education

c. Physician education

16. Quality Improvement

a. Continuous quality improvement through annualstudies

17. Survivorship Program

a. Follow-up surveillance

b. Rehabilitation

c. Health promotion/risk reduction


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1 0 / N A P B C - A C C R E D I T E D C E N T E R S / N A P B C S T A N D A R D S M A N U A L

The Survey Process

NAPBC accreditation is granted only to those centers that have voluntarily committed to providethe best in breast cancer diagnosis and treatment and is able to comply with established NAPBCstandards. Each center must undergo a rigorous evaluation and review o its perormance andcompliance with the NAPBC standards. To maintain accreditation, centers must undergo an on-sitereview every three years.

To be considered for initial survey, the breast center leadershipdoes the following:

Ensures that the clinical services, interdisciplinary/multidisciplinary conference(s), and quality management

program are in place at the center.

Carefully reads the NAPBC Standards Manual, whichdeneseachstandard,andmeetstherequirementsoutlinedfor all standards. Please note: The following standardshavebeenidentiedasCritical Standards. Centers mustcomply with Standard 1.1 Level of Responsibility andAccountability, Standard 1.2 Interdisciplinary BreastCancer Conference, and Standard 2.1 Interdisciplinary

Patient Management. Failure to meet any or all of thesestandardswillresultinanalratingofAccreditationDeferred (see Accreditation Award) until which timeyouprovidetheNAPBCadministrativeofcewithdocumentation of compliance. Centers that do not resolvethis status within a 12-month period will be required toreapply for accreditation.

Completes the Pre-Application to Participate located onthe NAPBC website at www.accreditedbreastcenters.org, and reviews and applies an electronic signature to theParticipation Agreement and Business Associate Agreement,as required for compliance with the Health InsurancePortability and Accountability Act (HIPAA).

Following receipt of the completed Pre-Application and

executed agreements, the NAPBC will release the center forsurvey.

Ane-mailnoticationwillbesentthatwillincludethenameof the assigned surveyor, and a user name and password toaccess the online Survey Application Record (SAR). TheSAR must be completed online in its entirety no later thantwo weeks before the scheduled survey.

An invoice for the survey fee will be generated at the timethe center is released for survey. The survey fee will includethebreastcenterandanyafliatedsatellitecentersidentiedduringtheapplicationprocess.Centerswithafliatedsatellite centers requiring combined survey will require anadditional 34 hour visit at each satellite, and may requirea 2-day visit. Discuss site visit details with the assignedsurveyor for planning purposes. Payment of the invoice isdue within 30 days of receipt. Failure to pay survey fee priorto scheduled visit will result in cancellation.

The assigned surveyor will contact the center within 30 daysfollowing date of release to schedule a mutually agreeabledate for survey. All surveys must be completed within six (6)

months from date of release for survey.

ProlesoftheNAPBCsurveyors,includingphotosandbriefbiographies, are available on the NAPBC website.

The center may decline the assigned surveyor within 14-daysfollowingnoticationofassignment,ifaconictofinterestexists.Aconictofinterestisdenedasfollows:

Afliationwiththecenterbeingsurveyed.

Has a vested interest in the center applying for NAPBCaccreditationorisafliatedwithanothercenterindirectcompetition with the center being surveyed.

The new surveyor assignment will be provided to the center

within30daysnoticationoftheconictofinterest.

Selection of a survey date is coordinated between the centerandtheassignedsurveyor.Conrmationofthesurveydateandtime is provided to the center leadership a minimum of 30 days

prior to the on-site visit.


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The Survey Application Record (SAR)

To acilitate a thorough and accurate evaluation o the breast center, the center completes or updatethe online Survey Application Record (SAR) 14 days prior to the scheduled on-site visit. The BreastProgram Leadership (BPL) is notifed when the SAR is available or completion. Completion o theSAR should be a team eort o members o BPL, with one individual chosen to coordinate the activitand complete the SAR.

The SAR is an online application that is password protected.A login and password will be provided once a center has beenreleased for survey. Once logged into the system, the centerwill navigate to a landing page unique to the center.It will contain a link and provide access to the completed

pre-application and the SAR. The SAR functionality includesdocument upload capability, drop down selections, tablecalculations, checkbox, and textbox completion.

Once successfully accredited, the landing page will provideaccess to the performance report, a press release, ad copy thatmay be utilized to advertise center accreditation locally, anda customizable template for centers to create a unique center

prolethatmaybedownloadedfromtheNAPBCwebsiteonceposted as an accredited center.

In addition to capturing information about breast centeractivity, the individual(s) responsible for completing portionof the SAR will perform a self-assessment and rate complianwith each standard using the rating system provided.

The NAPBC surveyor reviews the centers online SAR priorto the on-site visit to become familiar with the services andresources offered at the center and the breast centers activit


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Survey Fee

An invoice or the survey ee will be mailed to the Breast Program Leadership when the center isreleased or survey. Payment o the invoice is due within 30 days o receipt. Failure to pay survey eeprior to scheduled visit will result in cancellation.

Programs are discouraged from canceling or postponing thescheduled survey. If cancellation or postponement becomesnecessaryafterthesurveydateisconrmed,thecentermustcontactNAPBCstaffandsubmitawrittennotication.Thecenter may be assessed a cancellation fee of up to $1,000,which will cover all nonrefundable expenses incurred by the

NAPBC and the surveyor.

Cancellation requests received within two weeks of thescheduled survey will forfeit the previously collected surveyfee, and may be required to pay another survey fee prior torescheduling.


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Site Visit Agenda

The NAPBC surveyor will contact the center to establish a mutually agreeable date and time toconduct the on-site review. The surveyor will need a primary contact that can assist with providinginormation on local hotels, directions to the center, and a location and time where to meet.

Thesurveycanbecompletedwithinvetosixhours,anddepending on the timeframe, lunch should be provided. At thetime the survey is scheduled, the surveyor will also discussanagenda,whichshouldbeconrmed14dayspriortotheon-site visit. The surveyor will meet with key members of the

breast center to discuss the center and verify data in the SurveyApplication Record (SAR). The surveyors role is to assist inaccuratelydeningthestandardsandverifyingthatthecenterisincompliancewiththestandards.Partoftheverication

process will include a medical record chart review to assesscompliance with nine standards. The surveyor will also discussthe goals and responsibilities of the center. Following a reviewof documentation and discussion with the members of the

breast center team, a wrap-up session will be held with allavailable members of the team. The surveyor will delineatethe centers strengths and weaknesses and offer suggestions tocorrectanynoteddeciencies.Thesurveyorwillrespondtoquestions from the center leadership and staff regarding thestandards, SAR, and rating system. A sample agenda isas follows:

N A P B C S U R V E Y A G E N D A

A G E N D A I T E M T I M E R E Q U I R E

Time or the surveyor to speak/meet withthe breast center leadership and key staresponsible or various aspects o the programand to assess the centers compliance witheach standard through review o the surveyapplication.

12 hours

Time or chart review. 2 hours

Tour the center. 30 minutes

Attend a breast conerence (survey should beheld on a day when a conerence is scheduled).

1 hour

Surveyor private time to compilerecommendations.

30 minutes

Summation meeting with the breast centerteam.

30 minutes


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Documentation of Program Activity

Breast center activity is documented using the Survey Application Record (SAR), which must becompleted a minimum o 14 days prior to the on-site visit.

All required documentation must be submitted electronicallythrough the SAR, except for those documents outlined belowthat are to be provided to the surveyor on-site the day ofthe survey.

Provided Electronically The completed SAR.

A roster of the breast center steering committee or leadership(Standard 1.1).

A copy of the meeting minutes from the steering committeeor BPL meeting for the last complete year (Standard 1.1).

The breast conference schedule/calendar for the lastcomplete year (Standard 1.2).

Ade-identiedaccession(case)listofbreastcancercases diagnosed and treated during the last complete year(calendar year or most current 12 month period) to includeaccession or medical record number, patient age, histology,dateofdiagnosis,anddenitivesurgicalresectionforallstage 0, I, II, and III patients only. This list should notincludepatientidentiers(Standards 2.3, 2.4, 2.7, 2.9, 2.12,2.13, 2.19).

Charts, graphs, or reports demonstrating participation in anational quality improvement initiative related to breast care(see options in Standard 6.1).

Each year performance rates are documented in the QualityImprovement page of the SAR (Standards 2.3, 2.4, 2.9,2.12(2), 2.13(2)).

Provided On-Site Twenty(20)medicalrecordsthathavebeenidentiedbythesurveyorfromthede-identiedpatientlistuploadedintheSAR will be reviewed on-site. In addition, the surveyor willreview ten (10) records of patients diagnosed with benignbreastdiseaseofthecenterschoosing,veofwhichshouldrepresent patients diagnosed with atypical ductal hyperplasia(ADH) or atypical lobular hyperplasia (ALH). The remainingrecords may include young women diagnosed withbroadenoma,bloodynippledischarge,recurrentbreastcystsrequiring aspiration, and/or patients deemed to be high-riskfor the development of breast cancer (see Medical Records

Review Process). Samples of educational resources provided to patients(Standard 2.17).

Samples of clinical trial materials provided to patients(Standard 3.1).

Examples of prevention, education, and/or early detectionprograms held in the last year (Standard 4.1).

A demonstration of the system used by the center toparticipate in a national quality improvement initiativerelated to breast care (see options in Standard 6.1).


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Annual Data Submission Requirement

Standard 6.2 Quality Improvement will be required or compliance by centers applying or initialaccreditation and centers undergoing re-accreditation beginning in 2013. A phase-in component othis new standard will require all centers to submit aggregate data demonstrating center compliancwith six quality measures outlined as part o Standard 6.2.

M E A S U R E

1. Breast conservation surgery rate for women with AJCC Stage 0, I,or II breast cancer.

2. Needle/core biopsy is performed prior to surgical treatment ofbreast cancer.

3. Radiation therapy is administered within one year (365 days) ofdiagnosis for women under age 70 receiving breast conserving

surgery for breast cancer.

4. Radiation therapy is considered or administered within one year(365 days) of diagnosis for women undergoing mastectomy forbreast cancer with four or more positive regional lymph nodes.

5. Combination chemotherapy is considered or administered withinfour months (120 days) of diagnosis for women under the ageof 70 with AJCC T1c, Stage II, or III hormone-receptor-negative

breast cancer.6. Tamoxifen or third generation aromatase inhibitor is considered or

administered within one year (365 days) of diagnosis for women withAJCC T1c, Stage II, or III hormone receptor positive breast cancer.

A Performance Measures section has been added to theSurvey Application Record (SAR). Beginning July 1 througSeptember 30, 2012, the NAPBC will issue a Call for Data tall accredited centers and those scheduled for initial surveyrequiring aggregate data entry for the six quality measures f

patients treated in 2011.

The Performance Measures section will require completionof a Measures Eligibility Worksheet prior to calculating

performance for each of the six measures. The data willestablish a compliance rate for the center for each measure twillbedisplayedintheSAR.ForthosecentersafliatedwiCommission on Cancer-accredited cancer program, these da

will be retrievable from the cancer registry.Centers due for survey between July 1 and December 31, 20will be required to do some duplicate data entry in the SAR include the quality measures section AND Standard 2.3 BreaConservation and Standard 2.9 Needle Biopsy. This issue wi

be corrected in the 2013 SAR.

Following the Call for Data, the NAPBC will begin compilithe data and develop reporting tools that will allow accreditecenters to compare their performance with other accreditedcenters.


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Medical Records Review Process

Please be advised that the medical records review will includepatients diagnosed and treated at your facility (class of case1014).

The surveyor will develop the survey agenda in collaborationwith the breast center. A minimum of two hours is generallyrequired to review 30 medical records (20 breast cancerrecords and 10 benign breast disease records). The breastcancer records will be assessed for compliance with seven(7) standards: 2.3 Breast Conservation, 2.4 Sentinel NodeBiopsy, 2.7 Pathology Reports, 2.9 Needle Biopsy, 2.12Radiation Oncology, 2.13 Medical Oncology, and 2.18Reconstructive Surgery. The benign medical records will be

assessed for compliance with Standard 2.19 Evaluation andManagement of Benign Breast Disease. See the NAPBCStandards Manual for additional detail regarding compliancecriteria for these standards, and direction on items requiringcompletion in the Survey Application Record (SAR).

Breast centers scheduled for an NAPBC survey are requiredto upload a copy of the accession list into the SAR inadvance of survey:

Provideade-identiedaccession(case)listofbreastcancer cases diagnosed and treated during the lastcomplete year (calendar year or most current 12 month

period) to include accession or medical record number,patientage,histology,dateofdiagnosis,anddenitivesurgical resection for all malignant breast diagnoses. This

listshouldnotincludepatientidentiers.(Thislistwillbereferenced in several other standards.)

Prior to the on-site survey, the surveyor will contact thecenter identifying the 20 medical records that need to

be pulled for chart review on the day of the survey. Ifthe medical record is electronic, the center will need tocommunicate with the surveyor to determine if the surveyorwants to review the record online or have paper copiesavailable. The following items should be made available and/oraggedineachmedicalrecordtofacilitateeaseofreview:

Surgical pathology report(s)

Operative report

Staging form, if applicable

Medical oncology consult/report(s)

Radiation oncology consult/report(s)Case abstract form (if Commission on Cancer accredited).

Ten (10) medical records of patients that have benign breastdisease that have been evaluated by the managing breastsurgeon;veofwhichshouldbeADH/ALHcasesandtheotherveselectedatyourdiscretion,arerequiredtobechosen by the center and made available for surveyor reviewthedayofthesurvey.Thefollowingitemsshouldbeaggedin each record to facilitate ease of review:

Physician note

Radiology reports, if indicated

Operative report, if indicated

Surgical pathology report, if indicated


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Accreditation Program Standards Rating System

The following rating system is used to assign a compliancerating to each standard:

1. Compliant2. Non-compliant

Basedontheratingcriteriaspeciedforeachstandard,acompliance rating is assigned by the center and the surveyor asfollows:

R A T I N G C O M M E N T S

Center

Surveyor

AdeciencyisdenedasanystandardwitharatingofNon-compliant.

Adeciencyinoneormorestandard(s)willaffecttheaccreditation award.


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Accreditation Award

A C C R E D I T AT I O N A W A R D M A T R I X B A S E D O N C O M P L I A N C E W I T H 2 8 S T A N D A R D S

T H R EE -Y E AR / F UL L AC CR ED I T A T I O N T HR EE -Y E AR C ON T I NG EN C YA C C R E D I T A T I O N

A C C R E D I T AT I O N D E F E R R E D

Ninety percent or more [26 or more] othe eligible standards are met at the timeo survey. Three-year/Full accreditationis awarded and resolution o all defcientstandards is documented within 12-monthsrom the date o survey.

Less than 90 percent and greater than 75percent [between 21 and 25] o the eligiblestandards are met at the time o survey. Fullaccreditation withheld until resolution o alldefcient standards is documented within a12-months rom the date o survey.

Less than 75 percent [less than 21] o theeligible standards are met. Full accreditationdeerred until correction o defcient standardsand resurvey in 12 months.

Accreditation awards are based on consensus ratings by the surveyor and NAPBC sta, and whenrequired, the Standards and Accreditation Committee or a subgroup thereo. Please note: Standard 1.1 Level o Responsibility and Accountability, Standard 1.2 Interdisciplinary Breast Cancer Conerence,and Standard 2.1 Interdisciplinary Patient Management are considered critical standards and thecenter must be in compliance with them at the time o survey in order to receive NAPBC Accreditation.

Three-Year/Full Accreditationis granted to centers that

comply with 90 percent or more [26 or more] of the standardswithresolutionofalldecientstandardsdocumentedwithina12-month period from the date of survey. A performance reportandcerticateofaccreditationareissued,andthesecentersaresurveyed at a three-year interval from the date of the survey.Centersthatdonotresolvealldeciencieswithina12-monthperiod from the date of survey will be at risk of losing theirNAPBC accreditation status and will be required to reapplyfor accreditation.

Three-Year Contingency Accreditationis granted to centersthat meet less than 90 percent but more than 75 percent[between 21 and 26] of the standards at the time of survey.The contingency status is resolved by the submission of

documentation of compliance within 12-months from thedate of survey. The documentation required to resolve adeciencyisavailableontheNAPBCwebsite.Three-Year/Full Accreditation is granted following submission, review,and approval of documentation to establish compliance with allstandards.Aperformancereportandcerticateofaccreditationareissuedafterresolutionofalldeciencies,andthesecentersare surveyed at a three-year interval from the date of thesurvey.Adeciencywouldbedenedasanystandardwitha rating of 2 Non-compliant. Accreditation Deferred statuswill be granted to those centers unable to resolve outstandingdeciencieswithinthe12-monthperiod.Centersthatdonotresolve this status at the end of a 12-month period from thedate of survey will be required to reapplyfor accreditation.

Accreditation Deferredis granted to centers that meet less

than 75 percent [less than 21] of the standards at the time ofsurvey. The deferred status is resolved by the submission ofdocumentation for compliance and resurvey within 12 months.ThedocumentationrequiredtoresolveadeciencyisavailableontheNAPBCwebsite.Three-Year/FullAccreditationis granted following submission, review, and approval ofdocumentation to establish compliance and the results of theresurveyin12months.Basedontheresolutionofdecienciesandsurveyresults,aperformancereportandcerticateofaccreditation are issued, and these centers are surveyed at athree-year interval from the date of the resurvey. Centers thatdo not resolve this status at the end of a 12-month period fromthe date of survey will be required to reapply for accreditation.


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AwardNoticationProcess

Basedontheprocessdenedforreviewinganddeterminingaccreditationawards,centernoticationnormallytakesplacewithin eight weeks of the survey visit. The performance reportis an electronic document that will be posted to your password

protected landing page. The center will receive an e-mail whenthe report is available for online viewing. The performancereport includes the following:

Comprehensive summary of centers compliance rating witheach standard.

Anarrativedescriptionofdecienciesthatrequirecorrection, and the due date for submission of compliancedocumentation, if applicable.

Cover letter on how to interpret the report. Certicateofaccreditation(deliveredbyU.S.mail).

Press release (made available on SAR landing pagefollowingaccreditationnotication).

NAPBC ad template

NAPBClogole

Posting on the NAPBC website, which includes acustomized,downloadablecenterprole

Accredited Centers Patient Brochure (available for purchase)

Thecentermayappealadeciencyndingforanystandaor the accreditation award within 60 days of receipt of theaccreditation/performance report. The appeals process isoutlined in the cover letter that accompanies the report, asfollows:

Appeal documentation may be uploaded into the SARthroughthedeciencyresolutiontabdemonstratingthatth

breast center was meeting the standard criteria at the time survey.

Appeals are processed monthly by the Standards andAccreditation Committee or a subgroup thereof. An updated

performance report will be provided to the breast center

indicating the appeal outcome.

Questions about an appeal or the appeals process should bedirected to the NAPBC at [email protected].


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The Post-Survey Evaluation

The post-survey evaluation is a required part o the breast center evaluation and is completed onlinethrough the SAR immediately ollowing the on-site visit. The purpose o the post-survey evaluation isto capture eedback rom the center, which enables the NAPBC to evaluate and improve all aspects othe survey process, including surveyor perormance and administrative support. This inormation willhelp guide the development o uture educational materials and training programs or the surveyors

and participating centers.

Allresponsesarecondentialandwill notinuencetheaccreditation award. Responses on the evaluation form shouldrepresent a consensus opinion of the breast center team. Thepost-survey evaluation will appear in the SAR as a separate tabthe day following your survey and should be completed withinone week (7 days) following the survey date.


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Survey-related resources and tools are available on theCenters Resource tab in the SAR and on the NAPBC website.Resources available include, but are not limited to, thefollowing:

Breast Conference Grid (Example)

Medical Records Review Process

Lymphedema Screening and Treatment Guidelines (NationalLymphedema Network)

Radiation Therapy Quality Assurance Program Guide

DeciencyResolutionDocumentation

Accreditation Performance Report (Sample)

NAPBC Resources and Tools for Centers


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Center Leadership

Purpose: The standard establishes the medical director and/orcodirectors, or interdisciplinary steering committee as the Breast Program

Leadership (BPL) responsible and accountable for breast center activities.

C H A P T E R 1


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2 4 / C E N T E R L E A D E R S H I P / N A P B C S T A N D A R D S M A N U A L

Level of Responsibility and Accountability

Standard 1.1 The organizational structure o the breast center gives the BPL responsibility andaccountability or provided breast center services.

Defnition and RequirementsLeadership is the key element in an effective breast center andits success depends on effective breast program leadership.The breast program leadership is responsible for goal setting,as well as planning, initiating, implementing, evaluating, andimproving all breast-related activities in the center. A process isin place to evaluate these activities annually.

The BPL is responsible for conrming that all professionallycredentialed members of the breast center have specialtycertication. All physician team members are required to beboard certied or in the process of obtaining board certicationwithin ve (5) years of completion of training, or havespecialty qualications that are acceptable to the NAPBCStandards and Accreditation Committee.

The center or medical staff formally establishes theresponsibility, accountability, and multidisciplinarymembership required for the breast program leadership tofulll its role. The center documents the breast programleaders responsibility and accountability using a methodappropriate to the centers organizational structure. Examplesinclude, but are not limited to, the following:

The center bylaws designate the breast program leader(s)as a subcommittee of the cancer committee within a largerinstitution with authority dened.

The medical staff bylaws designate the breast programleader(s) to be a standing committee with authority dened.

Policies and procedures for the center dene authority of thebreast program leader(s).

Policies and procedures for the medical staff dene theauthority of the breast program leader(s).

Other leadership organization and operation are acceptable.

The BPL is responsible for an annual audit of the following:

Interdisciplinary Breast Cancer Conference Activity(Standard 1.2).

Breast Conservation Rate (Standard 2.3).

Sentinel Lymph Node Biopsy Rate (Standard 2.4).

Breast Cancer Staging (Standard 2.6).

Needle Biopsy Rate (Standard 2.9).

Reconstructive Surgery Referral Rate (Standard 2.18).

Clinical Trial Accrual (Standard 3.2).

Quality and Outcomes (Standard 6.1).

Quality Improvement (Standard 6.2).

DocumentationThe center completes the online Survey Application Record(SAR) and provides the following in the text box and drop-down choices provided:

Briey describe the organizational structure of the breastcenter, and leadership roles and responsibilities.

Attach the following documents, as available:

A roster of the breast center steering committee orleadership.

A copy of the meeting minutes from the steering committee

or BPL meetings for the last complete year.

A copy of the center bylaws or policy and procedures,or other center-approved methods used to document thelevel of responsibility and accountability designated to the

breast program leader. For example, private practice ofcesmay not have policy and procedures documented, and arerequested to dene the structure.

The surveyor will discuss the organizational structure of thecenter, and conrm specialty certication for all professionallycredentialed team members, and board certication for all

physician team members of the breast center, at the time ofsurvey.

Rating1. Compliant The organizational structure of the breast

center gives the BPL responsibility and accountability forprovided breast center services.

2. Non-compliant The organizational structure of thebreast center does not give the BPL responsibility andaccountability for provided breast center services.


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N A P B C S T A N D A R D S M A N U A L / C E N T E R L E A D E R S H I P

Interdisciplinary Breast Cancer Conference

Standard 1.2 The BPL establishes, monitors, and evaluates the interdisciplinary breast cancerconerence requency, multidisciplinary and individual attendance, prospective case presentation,and total case presentation annually, including AJCC staging and discussion o nationallyaccepted guidelines.

Defnition and RequirementsConferences that include case presentations are madeavailable to the entire medical staff and are the preferredformat. Consultative services are optimal when physicianrepresentatives from diagnostic radiology, pathology (includingAJCC staging), surgery, medical oncology and radiationoncology participate in the breast conference. Prospective case

presentation ensures that patients newly diagnosed or undertreatment and requiring review have access to multidisciplinaryevaluation, including staging, treatment management, andfollow-up evaluation.

Setting the interdisciplinary breast conference frequency andformat allow for prospective review of breast cancer cases andencourages multidisciplinary involvement in the care processand should occur no less frequently than every other weekor twice monthly. Breast cancer conferences are integral toimproving the care of breast cancer patients by contributing tothe patient management process and outcomes and providingeducation to physicians and other staff in attendance. CMEcredit is recommended.

The interdisciplinary breast conference is focused on treatmentplanning for newly diagnosed and recurrent breast cancerpatients, andincludes discussion of tumor stage and relevant,nationally accepted breast cancer patient care guidelinesdeveloped by national organizations. This conference is

designed for surgeons, medical, and radiation oncologiststo provide a comprehensive update on new data and recentadvances in surgery and systemic/local therapy that arecritical to the optimal management of breast cancer patients.Radiologists and pathologists provide essential expertisein diagnosis. Nurses, fellows, cancer registrars, geneticcounselors, social workers, and pharmacists in the oncologyeld are also invited to attend. Attendance is monitored by theBPL to assure multidisciplinary representation and individualattendance.

Conference frequency is dependent upon annual caseload,and case presentation thresholds are determined by the BPL.The interdisciplinary breast cancer conference should meet

at regularly scheduled intervals. Depending upon the analyticcase volume, the conference frequency should be at least everytwo weeks or twice monthly to ensure timely prospective

patient case review. Input should be encouraged from allmembers.

Centers with less than 100 analytic breast cancer cases peryear have the option of including these cases as part of thegeneral cancer conference. The breast cancer case presentationsshould be scheduled at a designated time during the conferenceto allow for maximum multidisciplinary attendance, and 85percent of these cases must be presented prospectively.

Centers with 100250 analytic breast cancer cases per year arequired to meet no less frequently than every two weeks ortwice monthly, or more frequently at the discretion of the BP

Centers with more than 250 analytic breast cancer cases peryear are required to meet weekly.

A N A L Y T I C C A S E L O A DR E Q U I R E D C O N F E R E N C

F R E Q U E N C Y

100 cases or less Every other week or twicemonthly or included in aweekly cancer conference ata designated time to allow formaximum attendance, andpresent 85 percent of thesecases prospectively.

100250 cases Every other week or twicemonthly or more frequently athe discretion of the BPL.

250+ cases Weekly

Prospective case reviews include, but are not limited to,the following:

Comprehensive clinical summary provided by attendingphysician or designee.

Imaging and pathology reviews.

Newly diagnosed breast cancer and treatment not yet

initiated. Newly diagnosed breast cancer and treatment initiated, bu

discussion and additional treatment is needed.

Previously diagnosed, initial treatment completed, butdiscussion of adjuvant treatment or treatment recurrence o

progression is needed.

Consideration for clinical trials.

Previously diagnosed, and discussion of supportive orpalliative care is needed.

Monitoring of breast cancer conference activity by the BPL,including multidisciplinary representation and individualattendance, ensures that conferences provide consultative

services for patients, as well as offer education to physiciansand allied health professionals. The condentiality of allinformation disclosed at these conferences is to be maintaine

by all participants.

(continued on next pa


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2 6 / C E N T E R L E A D E R S H I P / N A P B C S T A N D A R D S M A N U A L

DocumentationThe breast program leadership determines the method fordocumenting breast conference activity based on facilityrequirements and the needs of the program. A breast cancerconference grid, calendar, or tracking tool that shows theannual conference schedule and attendance may be used.

The center completes the online SAR and provides thefollowing in the text box and drop-down choices provided:

Briey describe the breast cancer conference program toinclude frequency, and case presentation.

Attach a copy of the breast cancer conference attendance

record conrming individual and multidisciplinaryattendance from the last complete year.

Attach a copy of the breast cancer conference schedule/calendar from the last complete year.

The surveyor attends a breast cancer conference to observe themultidisciplinary involvement in case presentations at the timeof survey.

Rating1. Compliant The BPL establishes, monitors, and evaluates

the interdisciplinary breast cancer conference frequency,multidisciplinary and individual attendance, prospectivecase presentation, and total case presentation annually,including AJCC staging and discussion of nationallyaccepted guidelines.

2. Non-compliant The BPL does not establish, monitor,and/or evaluate the interdisciplinary breast cancerconference frequency, multidisciplinary and individualattendance, prospective case presentation, and totalcase presentation annually, including AJCC staging and

discussion of nationally accepted guidelines.

Interdisciplinary Breast Cancer Conference (continued)


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N A P B C S T A N D A R D S M A N U A L / C E N T E R L E A D E R S H I P

Evaluation and Management Guidelines

Standard 1.3 The BPL identifes and reerences evidence-based breast care evaluationand management guidelines.

Defnition and RequirementsPatient management and treatment guidelines promote anorganized approach to providing care. The BPL will reviewand adopt breast care evaluation and management guidelinesdeveloped by national organizations appropriate to the patientsthat are diagnosed and treated by the center. Examples ofreferencing these guidelines could include:

PowerPoint presentations or handouts at a cancerconferences or BPL meetings of relevant, nationally accepted

breast care guidelines.

National organizations that have developed breast care

guidelines include, but are not limited to, the following:O R G A N I Z A T I O N

S U G G E S T E D C O N F E R E N C E

F R E Q U E N C Y

L I N K

Adjuvant Online www.adjuvantonline.com/index.jsp

American Society of Clinical Oncology(ASCO)

www.asco.org/ASCOv2/Practice+%26+Guidelines/Guidelines

American Society for RadiationOncology (ASTRO)

www.astro.org/Clinical-Practice/Guidelines/Index.aspx

National Comprehensive CancerNetwork(NCCN)

www.nccn.org/professionals/physician_gls/PDF/breast.pdf

Guidelines adopted by the BPL for use by the center aredocumented. This is in addition to patient management andtreatment guidelines required by the NAPBC. The BPLestablishes the concordance rate for adherence to adoptedguidelines being used by the center, and monitors utilizationthrough review of a random sample of cases for which theseguidelines are applicable. The monitoring activity is reportedto the BPL on a regular basis. The BPL addresses compliancelevels that fall below the established concordance rates.

DocumentationThe center completes the online SAR and provides thefollowing in the text box and drop-down choices provided:

Submit a list of breast care evaluation and managementguidelines utilized by the center; identifying the originatinorganization, such as, institutional, national, and so on.

Identify your most commonly utilized management andtreatment guidelines.

At the time of survey, the center provides the surveyor withdocumentation related to the monitoring of, and compliance

with, the patient management and treatment guidelinescurrently required by the NAPBC, as well as others adopteduse by the center. Additionally, the surveyor will ask to revieany documentation presented at the breast cancer conferencereferencing national guidelines.

Rating1. Compliant The BPL identies and references evidence

based breast care evaluation and management guidelines

2. Non-compliant The BPL does not identify and/or doesnot references evidence-based breast care evaluation andmanagement guidelines.


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Clinical Management

Purpose: The standards identify the scope of clinical services neededto provide quality breast care to patients. The managing physician is essential

to coordinating a multidisciplinary team approach to patient care.

C H A P T E R 2


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3 0 / C L I N I C A L M A N A G E M E N T / N A P B C S T A N D A R D S M A N U A L

Interdisciplinary Patient Management

Standard 2.1 Ater a diagnosis o breast cancer, the patient management is conducted by aninterdisciplinary team.

Defnition and RequirementsBreast cancer is a disease requiring multidisciplinaryevaluation and management. The NAPBC has identied17 components in the spectrum of breast cancer diagnosis,treatment, surveillance, and rehabilitation/support. A moredetailed description can be found underAppendix A.

DocumentationThe center completes the online SAR and providesthe following:

Select the specialty of the physician(s) that conduct theinitial patient evaluation and management, and indicate ifservices are provided on-site or by referral (check all thatapply).

The surveyor will discuss the process for interdisciplinarypatient management at the time of survey.

Rating1. Compliant After a diagnosis of breast cancer, the patient

management is conducted by an interdisciplinary team.

2. Non-compliant After a diagnosis of breast cancer,the patient management is not conducted by aninterdisciplinary team.


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N A P B C S T A N D A R D S M A N U A L / C L I N I C A L M A N A G E M E N T

Patient Navigation

Standard 2.2 A patient navigation process is in place to guide the patient with a breast abnormalitythrough provided and reerred services.

Defnition and RequirementsPatient navigation refers to individualized assistance offeredto patients, families, and caregivers to help overcome healthcare system barriers and facilitate timely access to qualityhealth and psychosocial care throughout the continuum of care.Breast cancer patient navigation works with a patient from pre-diagnosis through all phases of the cancer experience.

Breast cancer patient navigation can and should take ondifferent forms in different communities as dictated by theneeds of the patient, their family, and their community. Withineach patient navigation program, the health care system,community system, navigators, consumers, and relatedentities should ensure that they have agreed upon how patientnavigation will be dened and operationalized.

The patient navigation process includes consistent carecoordination throughout the continuum of care and anassessment of the physical, psychological and social needsof the patient. The anticipated results are enhanced patientoutcomes, increased satisfaction, and reduced costs of care.This may involve different individuals at each point of care.

The following organizations provide patient navigationinformation and resources:

O R G A N I Z A T I O N L I N K

Association o Community Cancer

Centers

www.accc-cancer.org/education/

education-patientnavigation.asp

American Cancer Society (ACS) www.cancer.org

Association o Oncology SocialWork

www.aosw.org

C-Change www.cancerpatientnavigation.org/

EduCare www.educareinc.com

Harold P. Freeman PatientNavigation Institute

www.hpreemanpni.org/

National Consortium o BreastCenters

www.bpnc.org/index.cm

Oncology Nursing Society (ONS) www.ons.org/

Patient Navigation in Cancer Care www.patientnavigation.com/public/home/index.asp

Examples of patient navigation include, but are not limited,to the following:

Provide education, support, and coordination to assistpatients in securing appointments.

Provide educational resources on breast health, breast cancer,and breast care.

Connect patients and families to resources and supportservices.

Promote communication between the patient and healthcare providers.

Coordinate services throughout the continuum of breast ca

Enhance the patients quality of life, sense of autonomy,and self-determination for managing her own health.

Reinforce physician-patient relationship

Patient navigation may be provided by a professional, usuallnurse or social worker, who is trained to provide individualizassistance to cancer patients, families, and caregivers at riskIt is recognized that some patient navigation is provided bytrained, nonprofessional, or volunteer staff. Nonprofessionaltrained and volunteer staff are required to have documented

patient navigation training from a recognized professionalorganization. Although navigation may be provided bynonprofessional trained and volunteer staff, it is importantthat patient assessment, program management, and patienteducation be determined with the assistance of a professiona

Documentation

The center completes the online SAR and provides thefollowing:

Identify the individual(s) that provide patient navigation inthe center along with their qualications and role (Use thetext box provided or upload a document.).

Indicate the number of patient navigators and the professioof your primary navigator through a series of drop-downchoices.

The surveyor will discuss the patient navigation process,and will review the credentials and/or documentation ofthe individual(s) providing patient navigation, at the timeof survey.

Rating

1. Compliant A patient navigation process is in placeto guide the patient with a breast abnormality through

provided and referred services.

2. Non-compliant A patient navigation process is not inplace to guide the patient with a breast abnormality throuprovided and referred services.


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Breast Conservation

Standard 2.3 A proportion o at least 50 percent o all patients diagnosed with early stage breastcancer (Stage 0, I, II) are treated with breast conserving surgery, and compliance is evaluated annuallyby the BPL.

Defnition and RequirementsBreast conserving surgery for patients with early stage breastcancer is a nationally accepted standard of care in appropriatelyselected patients. Most centers exceed the 50 percent leveland this level should not be used as benchmark. Fifty percentis considered the minimum standard in order to meet NAPBCcompliance. Published data conrm high utilization rates forbreast conserving surgery and are all in excess of 50 percent.

Compliance is evaluated annually by BPL.

Guidelines for breast conserving surgery are available fromthe American Cancer Society and the American College

of Radiology:


American Cancer Society(ACS)

caonline.amcancersoc.org/cgi/con-tent/ull/52/5/256

caonline.amcancersoc.org/cgi/con-tent/ull/52/5/277

American College o Radiology(ACR)

www.acr.org/SecondaryMainMenu-Categories/quality_saety/guidelines/breast.aspx

DocumentationThe center completes the online SAR and providesthe following:

Calculate and record performance rate for breastconservation (Measure #1) included in the PerformanceMeasure tab (see Annual Data Submission Requirementsection). Performance rate for Standard 2.3 BreastConservation is required to be calculated annually during theCall for Data period.

Document when the annual evaluation of compliance wasconducted by the BPL.

Provide a de-identied accession (case) list of breast cancercases diagnosed and treated during the last complete year(calendar year or most current 12 month period) to includeaccession or medical record number, patient age, histology,date of diagnosis, and denitive surgical resection for allmalignant breast diagnoses. This list should not include

patient identiers. (This list will be referenced in severalother standards.)

The surveyor will review a random sample of breast cancerpatient medical records to evaluate compliance with the useof breast conserving surgery at the time of survey.

Rating1. Compliant A proportion of at least 50 percent of all

patients diagnosed with early stage breast cancer (Stage0, I, II) are treated with breast conserving surgery, andcompliance is evaluated annually by the BPL.

2. Non-compliant A proportion of at least 50 percent of allpatients diagnosed with early stage breast cancer (Stage 0,I, II) are not treated with breast conserving surgery, and/orcompliance is not evaluated annually by the BPL.


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N A P B C S T A N D A R D S M A N U A L / C L I NI C A L M A N A G E M E N T

Sentinel Node Biopsy

Standard 2.4 Axillary sentinel lymph node biopsy is considered or perormed or patients with earlstage breast cancer (Clinical Stage I, II), and compliance is evaluated annually by the BPL.

Defnition and RequirementsPatients currently considered candidates for axillary sentinellymph node biopsy include those with:

AJCC Stage I, IIA, and IIB invasive breast cancer with nosuspicious axillary lymph nodes.

Resectable, locally advanced, invasive breast cancer, eitherbefore or after, neoadjuvant systemic therapy.

Extensive DCIS requiring total mastectomy, no suspiciousaxillary nodes.

DCIS requiring wide excision in an anatomic locationinterfering with future, accurate sentinel lymph node

mapping, no suspicious axillary nodes. Unilateral or bilateral prophylactic mastectomy.

Some patients who meet the criteria above may be deemedinappropriate for sentinel node biopsy. An example of such a

patient might be an elderly debilitated patient with a clinicallynegative axilla. When sentinel node biopsy is not offered, therecord should indicate a discussion held among the breastcancer treatment team.

Patients can decline sentinel node biopsy. The record shouldindicate that this procedure has been offered.

This technique most commonly utilizes a combination ofradionuclide and blue dye, although some centers utilizeradionuclide or blue dye alone.

The accuracy of sentinel lymph node biopsy may becompromised in patients that have had previous ipsilateral

breast conserving surgery, axillary surgery, or breast radiationtherapy.

Compliance is evaluated annually by the BPL.

DocumentationThe center completes the online SAR and provides thefollowing:

Complete the table summarizing the number of sentinellymph node biopsies.


The surveyor will review a random sample of breast cancerpatient medical records to evaluate compliance with sentinellymph node biopsy utilization at the time of survey.

Rating1. Compliant Axillary sentinel lymph node biopsy is

considered or performed for patients with early stage brecancer (Clinical Stage I, II), and compliance is evaluatedannually by the BPL.

2. Non-compliant Axillary sentinel lymph node biopsy inot considered or performed for patients with early stage

breast cancer (Clinical Stage I, II), and/or compliance isevaluated annually by the BPL.


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Breast Cancer Surveillance

Standard 2.5 A plan is in place or assuring ollow-up surveillance o breast cancer patients.

Defnition and RequirementsA process should be in place to ensure that patients arereceiving the prescribed treatment and are returning for follow-up care.

Follow-up surveillance includes history and physicalexamination and may include other examinations, such asupper extremity lymphedema measurements and breastimaging studies as appropriate. Frequency of follow-up willvary from patient to patient. Bone scan, PET scan, and othertests are the responsibility of the managing physician and aregenerally ordered for evaluation of symptoms or restaging, notfor routine annual follow-up.

The BPL should design a surveillance plan that can be used formost patients.

Evidence-based guidelines for follow-up surveillance areavailable at:


American Society oClinical Oncology

www.asco.org/ASCOv2/Practice+%26+Guidelines

NationalComprehensive CancerNetwork

www.asco.org/ASCOv2/Practice+%26+Guidelines/Guidelines

DocumentationThe center completes the online SAR and provides thefollowing in the text box provided:

Attach the policy approved by the BPL that denessurveillance by specialty.

Surveillance documentation will be reviewed during themedical records review portion of the survey and shouldreect follow-up outlined in the center surveillance plan.

The surveyor will discuss follow-up surveillance at the timeof survey.

Rating1. Compliant A plan is in place for assuring follow-up

surveillance of breast cancer patients.

2. Non-compliant A plan is not in place for assuring follow-up surveillance for breast cancer patients.


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N A P B C S T A N D A R D S M A N U A L / C L I N IC A L M A N A G E M E N T

Breast Cancer Staging

Standard 2.6 The Breast Program Leadership (BPL) develops a process to monitor physician useo American Joint Committee on Cancer (AJCC) staging in treatment planning or breast cancerpatients. The process and results o such monitoring are discussed among the BPL and breast centesta, and the fndings are documented annually.

Defnition and RequirementsAccurate clinical staging of breast cancer patients enablesthe physician to determine appropriate treatment. Stagingfacilitates the reliable evaluation of treatment results andoutcomes reported to various institutions on a local, regional,and national basis. AJCC staging is assigned using thecriteria outlined in the current edition of theAJCC CancerStaging Manual(www.cancerstaging.org/products/ajccproducts.html).

The clinical stage assigned by the physician should berecorded. Options include, but are not limited to:

Hospital medical record The de-identied patient roster for the breast cancer

conference

Initial, preintervention clinical evaluation note

Presurgical physical exam

Preoperative diagnosis in the operative report

Physician ofce records

Other

The process and results of the monitoring activity are discussedamong the BPL and breast center staff.

The ndings are documented annually.

DocumentationThe center completes the online SAR and provides thefollowing in the text box provided:

Describe the process in place to monitor physician useof AJCC staging in treatment planning for breast cancer

patients, and the results of the annual monitoring anddiscussion among the BPL and breast center staff.

Rating1. Compliant The BPL develops a process to monitor

physician use of AJCC staging in treatment planning for

breast cancer patients. The process and results of suchmonitoring are discussed among the BPL and breast censtaff, and the ndings are documented annually.

2. Non-compliant The BPL has not developed a processto monitor physician use of AJCC staging in treatment

planning for breast cancer patients, nor is the processdiscussed among the BPL and breast center staff, ordocumented annually.


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Pathology Reports

Standard 2.7 The CAP Committee guidelines are ollowed or all breast cancers, includingestrogen and progesterone receptors, and Her2 status or all invasive breast cancers. Estrogenand progesterone are recommended or DCIS (but not required by CAP).

Defnition and RequirementsPatient management and treatment guidelines promote anorganized approach to providing quality care. The NAPBCrequires that 90 percent of all breast cancer pathology reportswill contain the scientically validated data elements outlinedon the surgical case summary checklist of the College ofAmerican Pathologists (CAP) website Reporting onCancer Specimens.

Estrogen and progesterone receptors, and Her2 studies need tobe performed on only one specimen (such as, the core biopsyor excision specimen).

Guidelines for surgical pathology reporting are available at:O R G A N I Z A T I O N L I N K

College o AmericanPathologists (CAP)

www.cap.org/apps/docs/committees/cancer/cancer_protocols/2009/BreastDCIS_09protocol.pd

www.cap.org/apps/docs/committees/cancer/cancer_protocols/2009/InvasiveBreast_09protocol.pd

National ComprehensiveCancer Network (NCCN)

www.nccn.org/proessionals/physician_gls/_guidelines.asp#breast

American Society oClinical Oncology (ASCO)

www.asco.org

While synoptic reporting is not mandatory, it is strongly

advised. Imaging studies should be correlated with pathologywhen feasible.

DocumentationIndicate whether the pathology reports include synopticreporting (yes/no choices).

The surveyor will review a random sample of breast cancerpatient medical records to evaluate pathology reporting at thetime of survey. The medical records for review will be selectedfrom the de-identied breast cancer patient list.

Rating1. Compliant The CAP Committee guidelines are followed

for all breast cancers, including estrogen and progesteronereceptors, and Her2 status for all invasive breast cancers.

2. Non-compliant The CAP Committee guidelines are notfollowed for all breast cancers, including estrogen and

progesterone receptors, and Her2 status for all invasivebreast cancers.


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Diagnostic Imaging

Standard 2.8 Screening mammography and diagnostic mammography are perormedat Mammography Quality Standards Act (MQSA)-certifed acilities and interpreted byMQSA-certifed physicians.

Defnition and RequirementsFederal law mandates that mammography must be performedat Mammography Quality Standards Act (MQSA)-certiedfacilities and interpreted by MQSA-certied physicians.

MQSA information is available at:


Food and Drug Administration(FDA)

www.da.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094373.htm

Beginning January 1, 2012, the FDA will require that centers

performing advanced diagnostic imaging services (diagnosticmagnetic resonance imaging (MRI), computer tomography(CT), and nuclear medicine, including positron emissiontomography (PET)) meet the regulations of theMedicare

Improvements for Patients and Providers Act (MIPPA).

American College of Radiology (ACR) Guidelines formammographic screening, diagnostic imaging, and breast MRIare available at:


ACR Guidelines or thePerormance o Screening andDiagnostic Mammography

www.acr.org/SecondaryMainMenu-Categories/quality_saety/guidelines/breast/Screening_Diagnostic.aspx

ACR Guidelines or the

Perormance o MagneticResonance Imaging (MRI) othe Breast

www.acr.org/SecondaryMainMenu-

Categories/quality_saety/guidelines/breast/MRI-Guided-Breast.aspx

The ACR designation of Breast Imaging Center of Excellence(BICOE) shall be awarded to breast imaging centers thatachieve excellence by seeking and earning accreditation in allof the ACRs voluntary breast-imaging accreditation programsand modules, in addition to the mandatory MammographyAccreditation Program. In order to achieve BICOE designationa center must be fully accredited in:

Mammography by the ACR (or an FDA-approved stateaccrediting body)

Stereotactic Breast Biopsy by the ACR

Breast Ultrasound by the ACR (including the Ultrasound-guided Breast Biopsy module)

A BICOE designation will meet and exceed all NAPBCrequirements for this standard.

American College of Radiology Breast Imaging Centers ofExcellence (BICOE) Program requirements can be found at:


Breast Imaging Centers oExcellence (BICOE)

www.acr.org/accreditation/bicoe/requirements.aspx

DocumentationThe center completes the online SAR and indicates thefollowing:

Check all imaging services provided, referred, or notavailable.

Indicate whether the radiology facility that providesscreening and diagnostic imaging for the center is designaas an American College of Radiology Breast Imaging Cenof Excellence.

MQSA certication will be validated by the surveyor at thetime of survey.

Rating1. Compliant Screening mammography and diagnostic

mammography are performed at MQSA-certied facilitiand interpreted by MQSA-certied physicians.

2. Non-compliant Screening mammography and diagnosmammography are not performed at MQSA-certiedfacilities and/or not interpreted by MQSA-certied

physicians.


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Needle Biopsy

Standard 2.9 Palpation-guided or image-guided needle biopsy is the initial diagnostic approachrather than open biopsy.

Defnition and RequirementsEither ne needle aspiration for cytologic evaluation or coreneedle biopsy constitutes the initial diagnostic approach forpalpable or occult lesions. Open surgical biopsy as an initialapproach should be avoided as it does not allow for treatmentplanning and is associated with a high reexcision rate. In thoseinstances, when open surgical biopsy is used, the reason forits use is documented in the medical record. Compliance isreviewed annually by BPL.

Documentation Calculate and record the performance rate for needle

biopsy (Measure #2) included in the Performance Measuretab (see Annual Data Submission Requirement section).Performance rate for Standard 2.9 Needle Biopsy is requiredto be calculated annually during the Call for Data period.


The surveyor will review a random sample of breast cancerpatient medical records to evaluate the utilization of palpation-guided or image-guided needle biopsy and open surgical

biopsy at the time of survey.

Rating1. Compliant Palpation-guided or image-guided needle

biopsy is the initial diagnostic approach rather than openbiopsy.

2. Non-compliant Palpation-guided or image-guided needlebiopsy is not the initial diagnostic approach.


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Ultrasonography

Standard 2.10 Diagnostic ultrasound and/or ultrasound-guided needle biopsy are perormed atan American College o Radiology (ACR) ultrasound-accredited acility or by an American Society oBreast Surgeons (ASBS) Breast Ultrasound-certifed surgeon.

Defnition and RequirementsThe NAPBC requires radiologists who perform breastultrasound and/or ultrasound-guided breast biopsy in a hospitalsetting or breast center setting to provide conrmation thattheir facility is accredited through the American College ofRadiology (ACR) Breast Ultrasound Accreditation Programor working toward breast ultrasound and/or ultrasound-guided

breast biopsy accreditation at the time of initial survey. Also, atthe time of survey, radiologists in facilities performing breastultrasound and/or ultrasound-guided breast biopsy will needto provide documentation of ACR accreditation or vericationof application.

The NAPBC requires surgeons who perform breast ultrasoundand/or ultrasound-guided breast biopsy in a hospital setting,

breast center setting or private practice ofce to becomecertied in these procedures through the American Societyof Breast Surgeons (ASBS) Breast Ultrasound CerticationProgram or demonstrate that they are enrolled in or workingtoward breast ultrasound and/or ultrasound-guided breast

biopsy certication at the time of initial survey. Also at thetime of survey, surgeons performing breast ultrasound and/or ultrasound-guided breast biopsy will need to providedocumentation of ASBS certication or vericationof application.

American College o Radiology

The Breast Ultrasound Accreditation Program administeredby the American College of Radiology accredits facilitiesperforming breast ultrasound and ultrasound-guided breastbiopsy, including all radiologists that perform these procedures,equipment, quality control, quality assurance, accuracy ofneedle placement, and image quality. The Breast UltrasoundAccreditation Program can accommodate a variety of practicesettings. A facility that performs only breast ultrasound shouldhave conrmation for breast ultrasound accreditation; a facilitythat performs both breast ultrasound and ultrasound-guided

breast biopsy must have conrmation for the Ultrasound-Guided Breast Biopsy module.


American College oRadiology (ACR)

www.acr.org

American Collegeo RadiologyBreast UltrasoundAccreditation Program

www.acr.org/accreditation/breast/breast_ul-trasound_reqs.aspx

American Society o Breast Surgeons

The Breast Ultrasound Certication Program administered bthe American Society of Breast Surgeons certies individualsurgeons who meet criteria in the areas of clinical experienctraining, and quality assurance. The framework of the

program is based on the principles for the proper performancand interpretation of diagnostic and interventional breastultrasound, its appropriate clinical application, and use ofinterventions to guide further management.


American Societyo Breast Surgeons(ASBS)

www.breastsurgeons.org

American Societyo Breast SurgeonsBreast UltrasoundCertication Program

www.breastsurgeons.org/certifcation/breast_ultrasound_certifcation.php

www.breastsurgeons.org/statements/PDF_Statements/Per_Guidelines_Breast_US.pd

The ACR designation of Breast Imaging Center of Excellenc(BICOE) shall be awarded to breast imaging centers thatachieve excellence by seeking and earning accreditation in aof the ACRs voluntary breast-imaging accreditation programand modules, in addition to the mandatory MammographyAccreditation Program. In order to achieve BICOE designatia center must be fully accredited in:

Mammography by the ACR (or an FDA-approved state

accrediting body)

Stereotactic breast biopsy by the ACR

Breast ultrasound by the ACR (including the ultrasound-guided breast biopsy module)

A BICOE designation will meet and exceed all NAPBCrequirements for this standard.

American College of Radiology Breast Imaging Centers ofExcellence (BICOE) Program requirements can be found at:


American College oRadiology (ACR)

www.acr.org

Breast ImagingCenters o Excellence(BICOE)

www.acr.org/accreditation/bicoe/require-ments.aspx

DocumentationThe center completes the online SAR and provides thefollowing:

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Indicate whether the radiology department/facility isaccredited by the ACR for breast ultrasound and breastultrasound-guided needle biopsy.

Identify the surgeon(s) performing breast ultrasound andultrasound-guided needle biopsy and indicate whether thesurgeon(s) is certied by the ASBS or in the process ofattaining certication.

The surveyor will review documentation conrmingaccreditation/certication or verication of application, asavailable, at the time of survey.

The surveyor will discuss the process underway for

accreditation/certication of those facilities/physiciansperforming diagnostic ultrasound and/or ultrasound-guidedbiopsy at the time of survey.

Rating1. Compliant Diagnostic ultrasound and/or ultrasound-

guided needle biopsy are performed at an AmericanCollege of Radiology (ACR ) accredited facility or by

an American Society of Breast Surgeon (ASBS) BreastUltrasound-certied surgeon, or, enrollment in anaccreditation or certication program can be documented