D.30 SOP COS -21 Community Breast Imaging Program SOP, 36C25522R0052.pdf

COMMUNITY BREAST IMAGING PROGRAM

Truman VA Medical Center Columbia, MO 65201

SOP COS-21

Service Line(s):

Chief of Staff

Signatory Authority: Effective Date:

Chief of Staff May 13, 2022

Responsible Owner: Recertification Date:

Chief of Staff May 31, 2027

1. PURPOSE AND AUTHORITY

a. The purpose of this standard operating procedure (SOP) is to establish procedures regarding access and reporting results for mammogram services for eligible Veterans in the community for the detection of breast cancer. This SOP must be followed by ordering providers, nursing staff, radiology (technologists), the Office of Community Care (OCC), members of the Women's Health Program (Women Veterans Program Manager (WVPM), Women's Health Nurse Navigator / Mammogram Care Coordinator (WHNN/MCC), and Women's Health Medical Director (WHMD), and the Health Information Management Services (HIMS) staff who are involved in the coordination and reporting of mammogram services and results.

b. This SOP sets forth mandatory procedures and processes to ensure compliance with VHA Directive 1330.01 (4) Health Care Services for Women Veterans, dated January 8, 2021, VHA Directive 1105.03, Mammography Program Procedures and Standards, dated May 21, 2018, VHA Directive 1088, Communicating Test Results dated October 7, 2015.

c. Mammography will be offered to Veterans in accordance with guidelines from the American Cancer Society. VA recommends the actions below at each age milestone reached:

(1) At age 40: The decision to start annual screening with mammography for average risk women aged 40 to 44 will be an individual decision and take the patients values into account, including values about specific benefits and harms.

(2) By age 45: Begin yearly mammograms through age 54.

(3) At age 55: Get mammograms every other year, or continue with annual mammography, depending on the patient's preferences and risk.

(4) At age 75+: If a woman is in reasonably good health and would be a candidate for treatment, she should continue to be screened with mammography. However, if an individual has an estimated life expectancy of less than 10 years, severe functional limitations, and/or multiple or severe comorbidities likely to limit life expectancy, it may

D.30 SOP COS -21 Community Breast Imaging Program SOP, 36C25522R0052

May 13, 2022 SOP COS-21 be appropriate to consider cessation of screening. Chronological age alone should not be the reason for the cessation of routine screening mammography.

(5) Benefits and harms of screening mammography will be discussed between patients and their assigned Primary Care Provider (PCP) during routine clinical appointments.

(6) Risk will be determined by the PCP during scheduled appointments.

(7) Clinical breast examination for breast cancer screening among average-Risk women of any age are not recommended.

(8) Patients will be encouraged to report any breast changes or abnormalities that they discover to their PCP.

2. PROCEDURES

a. Consults for Mammography. Community Care Consults for mammogram services and imaging consults are completed by the appropriate staff member for eligible Veterans.

(1) The appropriate staff member will identify the need for and place a consult for the mammogram service which includes the imaging order.

(2) The consult is received by RN Clinical Navigator in the Office of Community Care

(OCC).

b. Scheduling. The Advanced Medical Support Assistant (AMSA) or the License Practical Nurse (LPN) in the OCC will schedule the Veteran for a mammogram with an American College of Radiology (ACR) accredited community provider. Once vetted, the Veteran has the option to self-schedule, if desired. If the Veteran should no-show their initial appointment, The Veteran may reschedule the appointment independently or with the assistance of the OCC. The consult will be valid form 90-days from the clinical indicated date.

c. Records. If records are not received from the community provider for the service, a request for records is made by the OCC staff, Women's Health Nurse Navigator (WHNN/ MCC) or other appropriate staff member.

(1) The records are to be uploaded to RightFax within 72 hours and placed in the women's health electronic folder in HIMS for processing. The fax number for incoming breast imagining faxes is (573) 814-6288.

(2) The receiving staff member must ensure that the report contains the Bl-RADS code. If the report does not contain this information, the receiving staff member must request an addendum that includes the code.

(3) After receipt of record from Imaging, the Health Information Management Services (HIMS) staff will scan results into the electronic medical record (EMR) and close the consult with 72 hours of receipt of records.

(4) The appropriate staff member will be alerted by the imaging being attached to the consult; The Ordering Provider/Primary Care Provider, Radiology Department, WHCN/ MCC and possible PACT RN.

d. Results Notification. After results are obtained, the appropriate staff member will mail the test result letter, call the patient and/or send secure messaging through My HealtheVet with the Plan of Care to the Veteran within 30 days of the procedure and within 14 days of receiving a normal result.

(1) Results that are assessed to be "suspicious", or "highly suggestive of malignancy", or "known biopsy proven malignant" require prompt verbal communication by the Primary Care Provider within 3-5 business days of the results being received from the community care provider (or another designee). This communication will be documented in the Veteran's electronic medical records per VHA Directive 1105.03.

(2) Should a letter return undeliverable, attempts will be made to contact the Veteran through any means available, to meet or exceed the local community standard of care, or comply with other VHA policy documents, especially when results are "suspicious", " highly suggestive or malignancy', or known biopsy proven malignant".

e. Documentation. A radiology staff member, designated by the chief of Imaging or imaging supervisor, will enter the ACR Bl-RADS code into the electronic medical record to ensure the Breast Care Registry and EMR is updated with the results. This designated staff member needs to understand the Bl-RADS coding system and its significance.

f. Preventative Care. Appropriate staff member places a consult for future care based on American Cancer Society guidelines for mammogram screenings.

3. ASSIGNMENT OF RESPONSIBILITIES

a. Facility Chief of Staff. VA Medical Facility Chiefs of Staff are responsible for ensuring that each facility has a process in place to ensure tracking and timely follow-up of findings from breast cancer screening.

b. Chief of Radiology. The Chief of Radiology is responsible for ensuring the appropriate radiology staff member is available and has sufficient time to ensure Bl RADS codes are documented in the electronic medical record for timely patient result notification.

c. Chief of Office of Community Care. The Chief of the Office of Community Care is responsible for ensuring Veterans are scheduled in a timely manner with facilities that have current ACR accreditation.

d. Women's Health Medical Director. The Women's Health Medical Director will serve as a clinical resource for patient aligned care (PACT) teams.

e. Women Veterans Program Manager. The Women Veterans Program Manager will be responsible for reviewing and updating the SOP.

f. PACT Teamlet. The PACT teamlet is responsible for identifying the need for mammogram services and placing consults.

g. Primary Care Provider. The primary care provider is responsible for reviewing results and interpreting results. He/she or a designee must communicate all results to the Veteran.

h. Women's Health Clinical Navigator/Mammogram Care Coordinator. The Women's Health Clinical Navigator may also identify the need for and place consults for mammogram services. He/she will assist eligible men, women, and transgender Veterans with clinical and administrative services necessary to facilitate mammogram services and results.

i. RN Clinical Navigator in the Office of Community Care. The RN Clinical Navigator in the Office of Community Care is responsible for receiving mammogram consults and reviewing the consult for appropriateness.

j. Medical Support Assistant or License Practice Nurse in the Office of Community Care. The Medical Support Assistant or Licenses Practice Nurse is responsible for faxing relevant information to the community provider, scheduling the Veteran's appointment, notifying the Veteran of the appointment date, and entering the "scheduled appointment " date to retrieve records based on the date of service.

k. Imaging Staff. The radiology staff member, designated by the chief of Imaging or imaging supervisor, will enter the ACR Bl-RADS code into the electronic medical record to ensure the Breast Care Registry and EMR is updated with the results. This designated staff member needs to understand the Bl-RADS coding system and its significance. The qualified, designated radiology staff member will be responsible for receiving the radiology order; placing the order "On hold for Community Care"; receiving alert via HIMS of scanned report into the "VISTA for Imagining'; registering the radiology order; edit/case the radiology order; entering the Bl RADS Diagnostic code.

I. QUALITY MANAGEMENT STAFF. QM staff will assist WVPM with quality assurance of both abnormal and normal results. The review may be conducted by members of the QM staff, Women's Health Committee or other assigned staff members that will perform audits of mammography consults and results and submit the findings quarterly to Facility Leadership and key stakeholders by way of appropriate committee(s) (i.e., Clinical Executive Board, Quality Assurance Committee, and Women Veterans Health Committee).

(1) Audits to include all appropriate documents/templates located on SharePoint.

(2) Reports will be communicated to the designated committees and uploaded the VISN 15 Women's Health- Facility mammogram Audits SharePoint.

(3) The Local VAMC is not responsible for follow up or intervention for patients who received mammogram testing because of an order from an outside provider. If Truman VA receives the report, it will be included in the EMR, and the provider will be made aware of.

4. DEFINITIONS

a. Full Field Digital Mammography. A full field digital mammography (FFDM) is a method for breast radiography using low energy x-rays recorded by an electronic digital detector instead of film. This electronic image can be displayed on a video monitor. The radiologist can manipulate the digital mammogram electronically to magnify an area, change contrast, or alter the brightness.

b. Diagnostic Mammography. A diagnostic mammogram is ordered for patients that have clinical signs or symptoms of breast disease, or if the radiologist detected findings of concern on a screening mammogram and ordered additional mammographic views.

c. Digital Breast Tomosynthesis. A digital breast tomosynthesis (DBT) is a 3-dimensional (3-D) mammogram that involves acquiring images of a stationary compressed breast at multiple angles during a short scan. The individual images are then reconstructed into a series of thin high-resolution slices that are displayed individually or in a dynamic cine mode. Tomosynthesis can reduce or eliminate the tissue overlap effect.

d. Breast Ultrasound. Ultrasound imaging (sonography) uses high-frequency sound waves to view inside the body (FDA, 2019). Because ultrasound images are captured in real-time, they can also show movement of the body's internal organs as well as blood flowing through the blood vessels (FDA. 2019). Unlike X-ray imaging, there is no ionizing radiation exposure associated with ultrasound imaging, in an ultrasound exam, a transducer (probe) is placed directly on the skin or inside a body opening (FDA, 2019). A thin layer of gel is applied to the skin so that the ultrasound waves are transmitted from the transducer through the gel into the body (FDA, 2019).

e. Breast MRI. Magnetic resonance imaging (MRI) of the breast -or breast MRI - is a test used to detect breast cancer and other abnormalities in the breast (Mayo Clinic, 2019). A breast MRI captures multiple images of your breast (Mayo Clinic. 2019).

Breast MRI images are combined, using a computer, to create detailed pictures (Mayo Clinic, 2019). A breast MRI usually is performed after you have a biopsy that's positive for cancer and your doctor needs more information about the extent of the disease (Mayo Clinic, 2019). For some people, a breast MRI may be used with mammograms as a screening tool for detecting breast cancer (Mayo Clinic, 2019). That group of people includes women with a high risk of breast cancer, who have a very strong family history of breast cancer or carry a hereditary breast cancer gene mutation (Mayo Clinic, 2019).

f. Breast Imaging-Reporting and Data System Category (Bl-RADS}. The standard system of describing breast imaging findings and results categorized from O to 6 ranging from incomplete to known malignancy.

g. ACR Bl-RADS CODES.

(1) ACR Bl-RADS Codes (and FDA standard nomenclature) are:

(a) Bl-RADS code 1 (Negative), indicates there is no mammographic evidence of malignancy.

(b) Bl-RADS code 2 (Benign), indicates there is no mammographic evidence of malignancy.

(c) Bl-RADS code 3 (Probably Benign) according to ACR, this is reserved for findings that are almost certainly benign, having less than a 2 percent risk of malignancy. NOTE:

Published studies emphasize the need to conduct a complete diagnostic imaging evaluation before assigning a code 3 assessment; it is, therefore, inadvisable to render such an assessment when interpreting a screening examination. Shott term follow-up is usually suggested.

(d) Bl-RADS code 4 (Suspicious) and Bl-RADS code 5 (Highly Suggestive of Malignancy), both codes are considered by FDA to be positive mammograms. As such, each program is required to track and trend this data in the (mammography) medical outcomes audit for IPs to be able to evaluate the appropriateness and accuracy of their image interpretation. (1) Bl-RADS code 4 (Suspicious) is reserved for findings that do not have the classic appearance of malignancy but have a wide range of probability of malignancy that is greater than those in Bl-RADS code 3. Thus, most recommendations of breast interventional procedures would be placed within this category. While further subdivision of Bl- RADS code 4 is encouraged by ACR, it cannot be substituted for specific FDA Final Assessment Category wording.

(e) Bl-RADS code 5 (Highly Suggestive of Malignancy) has a high probability (greater than or equal to (�) 95 percent) of being cancer. This category contains lesions for which one-stage surgical treatment could be considered without preliminary biopsy.

(f) Bl-RADS code 6 (Known Biopsy Proven Malignancy) is the code that is reserved for lesions identified on the imaging study with biopsy proof of malignancy prior to definitive therapy.

(g) Bl-RADS code O (Incomplete: Need Additional Imaging Evaluation) is the code which may be used to indicate that additional imaging is necessary, or that prior comparison of films or images are needed to complete the interpretation.

5. REFERENCES

a. VHA Directive 1088, Communicating Test Results to Providers and Patients dated October 7, 2015, https://www.va.gov/vhapublicationsNiewPublicatron.asp?pub 10=3148

b. VHA Directive 1105.03, Mammography Program Procedures and Standards, dated May 21, 2018, https://www.va.gov/vhapublications/publications.cfm?pub= 1 &order=asc&orderby=pub Number

c. VHA Directive 1330.011 Health Care Services for Women Veterans, dated January 8, 2021, https://www.va.gov/vhapublicationsNiewPublfcation.asp?pub 10=5332

d. AMERICAN CANCER SOCIETY (2017). American Cancer Society recommendations for the early detection of breast cancer, https://www.cancer.org/cancer/breast-cancer/screeninq-tests-and-early detection/american-cancer-society-recommendatrons-for-the-early-detectlon-of-breast cancer. html

e. FDA. (2019). Ultrasound imaging. Retrieved from https://www.fda.gov/radiation emitting-products/medical-imaging/ultrasound-imaging.

f. Mayo Clinic. (2019). Breast MRI. Retrieved from https:/lwww.mayoclinic.org/tests proced u res/b reast-m ri/aboutlpac-20384809.

g. B&C 031 Women Veterans Health Program dated January 2, 2018.

6. REVIEW

Review will take place every five years. When there are changes to the governing document or changes in any regulatory requirement, a review will take place when this information becomes available.

7. RECERTIFICATION

This SOP is scheduled for recertification on or before the last working day of May 2027.

In the event of contradiction with national policy, the national policy supersedes and controls.

8. SIGNATORY AUTHORITY

If\[)

RER, MD

C aff Date Approved: May 13, 2022

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

DISTRIBUTION: This SOP will be distributed via email to all the following departments and disseminated to involved staff; Office of Community Care, Primary Care, Release of Information, Radiology, and Health Information Management Systems.