American College of Radiology 261

BI-RADS MAMMOGRAPHY

V. DATA COLLECTION

262 American College of Radiology

Fourth Edition 2003

To facilitate the collection of data across systemsand databases, the American College of Radiol-ogy (ACR) and the Breast Cancer SurveillanceConsortium (BCSC) have collaboratively devel-oped two data collection forms for use within amammography practice. Based on a standard setof core variables and a standard definition ofscreening mammography, data are collectedthrough the use of two data collection forms atthe time of the mammographic study. The firstdata collection form includes information abouta womans personal health history relevant tobreast cancer; the second form includes clinicaland technical information about the imaging per-formed.Standardizing data structure permits comparisonwith national data that are published by theBCSC. Using a set of standard questions in astandard format affords a facility the opportunityto participate as a site, in states that have a BCSCRegistry. The BCSC effort is creating mammog-raphy data that are being used to build databasesthat can be linked with each other and withpathology data on cancer outcomes from popu-lation based registries. For more information onthe BCSC go to:http://breastscreening.cancer.gov/elements.html.

The ACR seeks to improve the measurement ofmammography performance through technicaland interpretive practice. Data collection andanalysis, whether for internal audit or participa-tion in registry and national database activities,is the responsibility of every practice. The ACRencourages all facilities to participate in qualitydatabases to assess performance. It is throughstandardized reporting and data exchange thatpractices can compare their own performancefrom year to year, and compare their practiceto aggregated practice data on a regional andnational level. This promises to enhance thepractice of screening mammography for all whoparticipate.

DATA COLLECTION

Please note that these forms are to assist indata collection for participation in databaseand registry activities and do not constitutea written mammography report.

American College of Radiology 263

BI-RADS MAMMOGRAPHY

First MI Last

1. Todays date: ___ ___ /___ ___ /___ ___ ___ ___ (mm/dd/yyyy)

2. Date of examination (if different from todays date) ___ ___ /___ ___ /___ ___ ___ ___ (mm/dd/yyyy)

3. Name __________________________ _____ _________________________________

4. Previous last name that may have been used when having a mammogram? _________________________

5. Address: Street or PO Box ________________________________________________ Apt. _________

City _________________________________________ State _______ Zip Code ________ - _____

Day Time Phone _______ - ______ - _________

6. Date of birth: ___ ___ /___ ___ /___ ___ ___ ___ (mm/dd/yyyy)

7. Health care provider: ___________________________________________________________________________________

Address: __________________________________________________________________________________________

__________________________________________________________________________________________

8. What health care coverage is paying for your mammogram? (check all that apply)

Medicare Managed Care (HMO, Health Plan, PPO) Medicaid (Medi-Cal) Not Sure Private Insurance I have no coverage Other: ___________________________________Note: This item could have selections specific to the state where the practice is located.

9. Height _____ feet _____ inches 10. Weight ______ pounds

11. Are you of Hispanic or Latino origin? Yes No12. What is your racial/ethnic identity? (check all that apply)

White Native Hawaiian or other Pacific Islander Black/African American American Indian or Alaska Native Asian Other: __________________________________

13. What is the highest level of education you have completed? (check one)

Less than high school graduate Some college or technical school High school graduate or GED College or post-college graduate

14. Breast problems or breast changes in the last 3 months? (check None, or all that apply)

None Palpable Lump Both Left Right Nipple discharge Both Left Right Describe: ____________________________________________ Pain Both Left Right Skin thickening or retraction Both Left Right Large axillary lymph node Both Left Right Breast implant problem Both Left Right Abnormal nipple Both Left Right Presence of other cancer Both Left Right Difficult clinical examination Both Left Right Other Both Left Right If other, describe: ____________________________________

15. What is the main reason for your mammogram today? (check one box only and fill in below)

Routine screening Additional evaluation as follow-up for a recent routine screening exam Evaluation of a symptom or a finding at clinical examination Follow-up at short interval (less than 9 months) from prior exam History of breast augmentation (no current complaints) Prior to breast reduction surgery Prior to radiation therapy Additional evaluation as follow-up for a non-screening exam from another facilityDescribe in your own words: ____________________________________________________________________________________________

Patient Information Form

Developed collaborativly and Copyright 2003 by the American College of Radiology and the Breast Cancer Surveillance Consortium.

16. When was your last mammogram? Date __ __ /__ __ __ __ (mm/yyyy)(If unknown check one below)

Never had a mammogram before today More than 1 year ago up to 2 years ago Within the past 6 months Longer than 2 years ago 7 months to about 1 year ago Not sure

17. Where did you have your last mammogram?

At this facility At another facility: Name and city of facility ______________________________________________________________________________

18. When did a health care provider last examine your breasts? (check one)

Never More than 1 year ago Within the past 3 months Not sure 4 months to 1 year ago

19. Have you ever been diagnosed with breast cancer? (check one)

No Yes Both Left RightIf Yes: Year of breast cancer diagnosis: right __ __ __ __ (yyyy); left __ __ __ __ (yyyy), or

Age when first diagnosed with breast cancer: right __ __ years old; left __ __ years old.

20. Have you had any of the following breast procedures? (check None, or all that apply)

None Fine-needle or cyst aspiration Both Left Right Date __ __ /__ __ __ __ (mm/yyyy) Core-needle biopsy Both Left Right Date __ __ /__ __ __ __ (mm/yyyy) Surgical biopsy (benign results) Both Left Right Date __ __ /__ __ __ __ (mm/yyyy) Biopsynot sure what type Both Left Right Date __ __ /__ __ __ __ (mm/yyyy) Lumpectomy for breast cancer Both Left Right Date __ __ /__ __ __ __ (mm/yyyy) Mastectomy Both Left Right Date __ __ /__ __ __ __ (mm/yyyy) Breast reconstruction Both Left Right Date __ __ /__ __ __ __ (mm/yyyy) Radiation therapy Both Left Right Date __ __ /__ __ __ __ (mm/yyyy) Breast reduction Both Left Right Date __ __ /__ __ __ __ (mm/yyyy) Breast implants (still present) Both Left Right Date __ __ /__ __ __ __ (mm/yyyy) Breast implants (been removed) Both Left Right Date __ __ /__ __ __ __ (mm/yyyy)

21. If you have implants currently, what type are they? (check all that apply)

Silicone gel Both Left Right Combination Both Left Right Saline Both Left Right Pre-pectoral Both Left Right Retro-pectoral Both Left Right

22. Have you ever been treated with chemotherapy? (check one)

No Yes Not Sure23. Have any of your close blood relatives been diagnosed with breast cancer?

Family history unknownMother: No Yes Not SureSister: No One 2 or more Not SureDaughter: No One 2 or more Not Sure

If you answered Yes, were any of these relatives diagnosed before age 50?Mother: No Yes Not SureSister: No One 2 or more Not SureDaughter: No One 2 or more Not Sure

24. Have you or a blood relative ever been diagnosed with ovarian cancer? (check one)

No Not Sure Yes (check all that apply) self mother, sister, or daughter more distant blood relative

25. Have you ever given birth? (check one)

No Yes If Yes, how old were you when your first child was born? ___ ___ years old.At what age did you have your first menstrual period? __ __ years old

Patient Information Form (continued)

Developed collaborativly and Copyright 2003 by the American College of Radiology and the Breast Cancer Surveillance Consortium.

Patient Information Form (continued)

26. Have your menstrual periods stopped permanently? (check one)

No Not sure Yes: age when they stopped: __ __ years oldIf you answered No or Not sure, when did your last period begin? __ __ /__ __ /__ __ __ __ (mm/dd/yyyy)

If you answered Yes, what is the reason that your periods stopped? (check one)

Natural menopause Surgical procedure Chemotherapy Other reason

27. Are you currently taking hormone medications? (check None, or all that apply)

None Contraceptive (birth control) age first use ____ age last use ____ # years used ____ Hormone replacement age first use ____ age last use ____ # years used ____ Estrogen only Progesterone only Estrogen and progesterone Tamoxifen or raloxifene age first use ____ age last use ____ # years used ____ Other hormone: age first use ____ age last use ____ # years used ____Describe: ________________________________________________________________________________________________________

Developed collaborativly and Copyright 2003 by the American College of Radiology and the Breast Cancer Surveillance Consortium.

Date of Examination ___ ___ /___ ___ /___ ___ ___ ___ (mm/dd/yyyy)

1. Indication for examination: (check one) Screening: asymptomatic Diagnostic: evaluation of a breast problem Diagnostic: additional evaluation of recent abnormal screening exam Other (core biopsy, or other non-imaging) Diagnostic: short-interval follow-up (e.g., 6 months)

2. Types of examination performed (check all that apply, if performed on same day)

Both Right Left CAD Double Reading Hard-Copy Digital Soft-Copy Digital

Standard views (MLO, CC) Additional views Ultrasound MRI Nuclear medicine Other breast imaging

Note: For this question, if a facility never or always uses CAD, double reading, hard-copy digital, or soft-copy digital mammography, then the additionalchecked boxes for these options should be deleted, and this information should be hard-coded into the system at time of installation.

3. Invasive procedures performed (check all that apply, if performed on same day)

Type of Image Guidance

Both Right Left Mammo Stereo Ultrasound

Cyst aspiration FNA biopsy Core biopsy Needle localization Ductography

4. Comparison with previous mammograms

No (first examination) Yes ___ ___ /___ ___ /___ ___ ___ ___ (mm/dd/yyyy) No (previous films not available) Pending, waiting for outside films

5. Breast density: (check denser breast if left and right differ) Almost entirely fat (75% fibroglandular) Heterogeneously dense (approximately 51%-75% fibroglandular)

6. BI-RADS assessment category (check all that apply)

Category Both Right Left Category Both Right Left

0 Need additional imaging evaluation (Optional) 4 A Low 1 Negative (Optional) 4 B Intermediate 2 Benign (Optional) 4 C Moderate 3 Probably benign 5 Highly suggestive of malignancy 4 Suspicious 6 Known malignancy

7. Management recommendations (check all that apply)Both Right Left

1,2: Routine interval follow-up, next mammogram:1 year Return at age 40 Other: ______________________________________

3: Short-interval follow-up6 months Other: ______________________________________

0: Additional imaging evaluation 4: Consider biopsy 5: Appropriate action should be taken 6: Appropriate action should be taken

8. Specify immediate management (check all that apply, if any apply)

Both Right Left Both Right Left

Compare with previous mammograms FNA biopsy Additional mammographic views Core biopsy Ultrasound Needle localization MRI Clinical examination Nuclear medicine Surgical consult Cyst aspiration Other ______________________________

Reading Radiologist ID __ __ __ Second Reading Radiologist ID __ __ __ Technologist ID __ __ ___(Optional)

Radiologist/Technologist Data

This form is a continuation of the Patient Information form. A computer or tracking system will automatically link thisdata to the Patient Information form. If this data is not to be computerized then the patient identification should beadded to this form.

Developed collaborativly and Copyright 2003 by the American College of Radiology and the Breast Cancer Surveillance Consortium.