S02_Attachment_8_11C-11_Breast_Cancer_Screening.docx

MEDICAL CENTER POLICY MEMORANDUMS

NUMBER/TITLE OF POLICY: 11C-11 Breast Cancer Screening Policy

CHANGES FROM PREVIOUS MCM: Changes are: Policy updated in order to be in compliance with the American Cancer Society guidelines and update the mammogram tracking process.

POINT OF CONTACT FOR FURTHER INFORMATION: Dr. Charmin Thomas ext. 6612

POLICY MEMORANDUM

VA Medical Center 1030 Jefferson Avenue Memphis, TN 38104

Number: 11C-11

Dated: April 19, 2018

Expires: April 30, 2023

Title: BREAST CANCER SCREENING

1. PURPOSE: To establish policy, assign responsibilities, and provide procedural guidelines for providing breast cancer screening for male and female veterans.

2. POLICY: It is the policy of the Department of Veterans Affairs (VA) and the Memphis VA Medical Center to provide breast cancer screening which includes screening and diagnostic mammography for eligible Veterans. It is the policy of this medical center to provide quality, comprehensive breast cancer detection services. Clinical breast examination, screenings, mammography diagnostic breast imaging, education and counseling will be available to eligible veterans through the Office of Care Community (OCC). Mammography services will be accessible within 50 miles distance of a Veteran’s residence.

3. RESPONSIBILITIES:

a. The Medical Center Director is responsible for ensuring this policy is implemented throughout the VA Medical Center.

b. The Chief of Staff (COS) is responsible for ensuring that all service/section chiefs comply with guidelines; providing guidance, education and logistical support for the breast cancer screening program.

c. The ordering VA Health Care Provider (HCP) is responsible for ordering appropriate accurate breast health studies (see appendix A) and for ensuring that patient receives timely notification of results and appropriate referrals are entered when further follow-up is indicated.

d. The Women Veteran Program Manager (WVPM) and the Women’s Health Medical Director (WHMD) are responsible for ensuring all primary care providers caring for Women Veterans are familiar with the mammogram policy and for addressing any issues or concerns from patients and staff in a timely manner. The WVPM is available as a resource to both staff and patients regarding the aspects of this policy.

e. The Women’s Health Liaison (WHL) is responsible for timely tracking of all results and follow-up studies as well as breast care coordination for patient receiving breast care in the community.

f. The CITC and Business Office (BO) are responsible for timely authorization, scheduling and care in the community consult management. The CITC office receives the report and scans into the Vista imaging. An administrative note is entered in CPRS stating that the report has been received, a view alert is sent to the ordering provider and the ordering provider is added as an additional signer to the note. The report is e-mailed to a designated radiology e-mail group titled VHAMEM Radiology PACS (See Appendix C).

g. Radiology services is responsible for timely entering the Bi-Rads into the VistA radiology package system and completing the imaging order to link exam information in PACS to Breast Cancer Registry (BCR).

4. REFERENCES:

1) American Cancer Society, https://www.cancer.org/latest-news/special-coverage/american-cancer-society-breast-cancer-screening-guidelines.html

2) American College of Radiology’s (ACR) Mammography Accreditation Program Requirements, 12-7-15.

3) American College of Radiology (ACR) BI-RADS Assessment Categories, https://www.acr.org/~/media/ACR/Documents/PDF/QualitySafety/Resources/BIRADS/Ma mmoGlossary.pdf

4) VA Memphis Medical Center Policy 11-65 Consult Management, 2016

5) VHA Directive 1330.01, Health Care Services for Women Veterans, 2017

6) VHA Handbook 1105.3, Mammography Program Procedures and Standards, 2011

7) VHA National Center for Health Promotion Disease Prevention (NCP) Breast Cancer Screening Guidelines: http://vaww.prevention.va.gov/CPS/Screening_for_Breast_Cancer.asp

5. EXPIRATION/RESPONSIBILITY:

This policy expires March 31, 2018 and is the responsibility of Radiology Service in collaboration with the Women Veterans Program.

6. RESCISSION: Medical Center Policy Memorandum 11C-11dated May 12, 2015.

MEDICAL STAFF CONCURRENCE: Date: April 19, 2018

/s/

Thomas C. Ferguson, MD Chief of Staff, VAMC Memphis

/s/

David K. Dunning, MPA Attachment 8 – 36C24919R0003

Medical Center Director

GUIDELINES:

1. The VA Memphis follows the recommendations of the American Cancer Society (ACS) mammogram screening guidelines.

2. Preventive screening for average risk individuals include mammograms and breast exams, and will be provided to eligible women Veterans following the ACS guidelines for breast cancer screening. Requirements for the early detection of cancer in asymptomatic, average risk individuals are as follows:

a. Women should have the opportunity to begin annual screening between the ages of 40 and 44 years (qualified recommendation).

b. The ACS recommends that women with an average risk of breast cancer should undergo regular screening mammography starting at age 45 years (strong recommendation).

c. Women aged 45 to 54 years should be screened annually (qualified recommendation).

d. Women 55 years and older should transition to biennial screening or have the opportunity to continue screening annually (qualified recommendation).

e. Women should continue screening mammography as long as their overall health is good and they have a life expectancy of 10 years or longer (qualified recommendation).

f. ACS does not recommend clinical breast examination for breast cancer screening among average-risk women at any age (qualified recommendation).

3. Individuals considered to be at increased risk include:

a. Women with a personal history of invasive breast cancer;

b. Women with a personal history of non-invasive breast cancer or prior abnormal breast biopsy;

c. Women with an increased risk of breast cancer by virtue of a known genetic mutation such as BRCA1 or BRCA2;

d. Women with a specific maternal or paternal family history pattern of breast and/or ovarian cancer;

e. Women with a history of chest irradiation;

f. A history of gender alteration from male to female; and

APPENDIX A

g. Women who have had bilateral mastectomies

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DEFINITIONS:

1. American College of Radiology (ACR) BI-RADS Codes

a. Category 0: Mammography: Incomplete – Need Additional Imaging Evaluation and/or Prior Mammograms for Comparison

b. Ultrasound & MRI: Incomplete – Need Additional Imaging Evaluation

c. Category 1: Negative

d. Category 2: Benign

e. Category 3: Probably Benign

f. Category 4: Suspicious Mammography & Ultrasound:

i. Category 4A: Low suspicion for malignancy

ii. Category 4B: Moderate suspicion for malignancy

iii. Category 4C: High suspicion for malignancy

g. Category 5: Highly Suggestive of Malignancy

h. Category 6: Known Biopsy-Proven Malignancy

2. A screening mammogram is a radiological examination to detect unsuspected breast cancer at an early stage in asymptomatic women. The goal is to generate the best possible image quality at the minimal radiation dose necessary to give sufficient image information for accurate interpretation.

3. A diagnostic mammogram is intended to provide specific analytic evaluation of patients who have clinical signs or symptoms of breast disease, or screening-detected findings of concern. The diagnostic breast evaluation leads to definitive conclusions about the patient’s symptoms or findings to enable specific management recommendations.

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APPENDIX B

PROCEDURE:

1. When mammography services are obtained through contractual arrangements or sharing agreements, or through CITC, the referring VA medical facility must ensure, prior to services to services being rendered, that the provider is certified by the FDA, or a state that has been approved by FDA under 21 C.F.R 900.12 to certify mammography facilities.

2. All screening mammograms, diagnostic mammograms, breast cyst aspirations, breast biopsies, breast MRIs and breast surgery will be completed in the community through community care referral. A mammogram imaging order must be entered into CPRS, regardless of where the mammogram is performed.

3. The ordering VA HCP will include pertinent physical findings based on breast examination when placing the community care diagnostic mammogram consult to assist with localization of suspected abnormalities

4. The CITC office and BO will authorize and schedule mammogram consults. Ordering providers should contact the CITC office if a referral requires expediting such as concern for malignancy. Patients should also be given the CITC phone number to follow up on questions related to authorization and scheduling.

5. The ordering VA HCP must communicate normal results (BI-RADS 1 and 2) to the patient by letter or phone call within 30 calendar days of the procedure. A mammography report summary, in terms easily understood by a lay person, must be communicated to the patient within 30 days from the date of the procedure by the ordering provider’s team and notification documented in CPRS.

6. BI-RADS category 0 (“incomplete”) and 3 (“probably benign”) mammogram results must be communicated to the ordering HCP within 30 days of the procedure and to the patient within 14 calendar days from the date the results are available to the ordering HCP. Additional imaging is to be ordered as recommended.

7. BI-RADS category 4 (“suspicious”) and 5 (“highly suggestive of malignancy”) mammogram results must be communicated to the ordering practitioner within 3 business days of the procedure and the recommended course of action should be communicated to the patient as soon as possible with 7 calendar days representing the outer acceptable limit. Communication must be documented in CPRS. If patient is unable to be reached by phone, a certified letter must be sent to the patient advising of needed follow-up and documented in CPRS.

8. According to the Memphis VA Consult Management Policy 11-65, after two (2) no shows or more than one (1) cancellation, the VA HCP may request a phone call to be made to the Veteran by the clerical POC and, if unsuccessful in contacting the Veteran after two (2) documented attempts in CPRS, a “No-Contact” letter will be sent to patient asking him/her to call the VA to schedule an appointment. If the patient does not respond in fourteen (14) days, the consult will be discontinued and returned to the VA HCP for further instructions.

COMMUNITY-BASED OUTPATIENT CLINICS:

1. Contracted Community-Based Outpatient Clinics (CBOCs) are responsible for placing a mammogram order in the CPRS Radiology menu and scheduling the mammogram at a FDA accredited mammogram facility per their contract with the VAMC Memphis. A community care consult does not need to be placed; however, an imaging order will need to be placed either by radiology or provider in order to link results. Documentation of the mammography location and date should be updated with the mammogram order.

2. CBOCs are responsible for tracking their patients’ mammogram reports, notifying patient of results per the VA timeline stated above, and documenting the notification in CPRS using the mammogram template.

3. CBOCs must provide a lay summary of mammography report to the patient within 30 calendar days of the examination date. Reports are submitted via Third Party Administrator (TPA) portal and/or directly faxed to the CITC STREEM fax. If the assessment is “suspicious” or “highly suggestive of malignancy” (BI-RADS codes 4 or 5, respectively), the results and recommended course of action must be communicated to the ordering practitioner or designee as soon as possible by the clinical staff. FDA guidance recommends no more than 5-business days (see VHA Handbook 1105.3) for notification of abnormal results

4. Biopsies guided by ultrasound and needle localization will require a referral through OCC to a contracted mammography facility for the studies.

5. The CBOC is responsible for following MQSA guidelines by faxing completed report to the WHL in order to submit to VA radiology service for scanning into the radiology package immediately after the report is finalized.

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REPORTING REQUIREMENTS:

1. The WHMD will report the status of the mammogram program to the Clinical Executive Board annually.

2. Mammography reports received as a hardcopy must be scanned into VistA Imaging. Mammogram results (BI-RADS codes) must be linked to a radiology order in CPRS. Systems software for tracking and management of mammography and breast cancer will not operate accurately without BI-RADS entered in the VistA radiology package and associated to a radiology imaging order. All outsourced mammogram reports must be returned to the VA HCP within 30 days as per Mammography Quality Standards Act and Program (MSQA). However, if future VA policy or contracts dictate shorter turn-around time for mammograms, those policies will take precedence.

3. Community providers must provide a signed written report to the ordering practitioner within 30 calendar days of the examination date consistent with the requirements of 21 CFR Part 900.12(c). Reports are submitted via TriWest portal and/or directly faxed to the CITC STREEM fax. If the assessment is “suspicious” or “highly suggestive of malignancy” (BI-RADS codes 4 or 5, respectively), the results and recommended course of action must be communicated to the ordering practitioner or designee as soon as possible (within 3 business days) by the clinical staff. FDA guidance recommends no more than 5-business days for notification of abnormal results (see VHA Handbook 1105.3).

4. For patients requiring breast biopsies, the ordering provider will enter a community care consult for the specific type of breast biopsy recommended, a surgery consult if needed and a follow up telephone or clinic appointment is scheduled by provider 4-6 weeks after the breast biopsy to ensure follow up.

5. Patient notification can be in person, telephone, or letter and must be in layman terms and easily understood by the patient. Documentation of all communication/notification in CPRS is required by all providers and administrative staff.

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