36C24219R0002-007.pdf

Department of Veterans Affairs Standard Operation Procedure 114-18 VA Healthcare Network June 14, 2019 Upstate New York at Albany

Mammography Result Communication to the Patient and Provider

1. PURPOSE: To ensure verbal and written mammography results are communicated to the patient in terms easily understood by a lay person within 30 days from the date of the procedure and to the provider as a verbal and written report using the appropriate National Diagnostic Code corresponding to the BI-RADS assessment category. All mammography images, regardless of where the procedure(s) are performed, are entered in Vista Imaging Display as a scanned or uploaded document in CPRS.

2. RESPONSIBILITY: Mammography program is responsible for:

a. Communication of mammography results to the ordering provider.

(1) Prepared written reports will contain results of the examination in addition to the name of the patient with an additional identifier, date of the exam, name of the interpreting physician and an overall assessment using the below FDA-approved Breast Imaging Reporting and National Diagnostic Code (BI-RADS) final assessment categories and follow up standardized for mammography listed below:

(a) Category 0: Recall for additional imaging and /or comparison with prior exams

(b) Category 1: Negative Routine screening

(c) Category 2: Benign Routine screening

(d) Category 3: Probably Benign Short interval (6 month) follow-up or continue surveillance imaging.

(e) Category 4: Suspicious Tissue diagnosis needed

(f) Category 5: Highly Suggestive of Malignancy Tissue diagnosis needed

(g) Category 6: Known Biopsy- Proven Malignancy Surgical excision when clinically appropriate

(2) Providing the interpreting physician’s written report from the mammogram exam to the ordering provider as soon as possible, but no later than 30 days from the date of the mammography exam, consistent with FDA requirements of 21 CFR Part 900.12 (c).

(3) BI-RADS category 0 assessments are incomplete evaluations where additional mammographic views or imaging, ultrasound, or previous studies are needed to assign a final assessment category. When additional imaging is recommended, the facility should:

(a) have capacity to perform recommended examination(s); or

(b) arrange for a cooperating facility to perform the recommended examination(s); or

(c) refer the patient to a facility to perform the recommended examination(s)

(4) For final assessment of BI-RAD category 4 or 5, the interpreting physician is to make a reasonable attempt to ensure the ordering provider is contacted with mammography results and recommended course of action within 3 working days from the date of interpretation

D.12 TRACKING AND CARE COORDINATION

Upstate New York at Albany consistent with FDA and VHA policies of communication and documentation of abnormal results. If the ordering provider is not available, efforts to contact a surrogate must be made and documented in the radiologist’s report. Verbal communication with the ordering provider does not obviate the need to also provide a written report to the ordering provider within 30 days of the date of the mammogram.

b. Communication of mammography results to patients.

(1) The patient is sent a written summary of examination results, in lay terms, no later than 30 days from the date of the mammographic examination.

(2) If results are a BI-RADS 4 or 5, the interpreting physician will make a reasonable attempt to communicate directly with the patient as soon as possible and should be within 5 working days from date of interpretation.

(3) For self-referred patients, the facility must directly give or send the patient both the physician’s mammography report and a written summary of results in lay terms, no later than 30 days from the date of the mammographic examination.

(4) Reports with assessments of BI-RADS 0, 3, 4, or 5 should be communicated as soon as possible to the self-referred patient; this should occur within 5 working days from date of interpretation. The actual or attempted communication will be documented.

(a) Facilities must have procedures for referring such patients to a health care provider with documentation that this has occurred. The radiologist may act as an ordering provider if she/he is willing to accept responsibility for the patient’s medical care and the patient agrees.

3. PROCEDURES:

a. Reporting System through CPRS Normal and Abnormal

(1) Lay result letters that are simply worded and easy to understand (Attachment A) are sent to all patients who have screening or diagnostic procedures within 30 days (per MQSA regulation).

(2) The mammography technologist:

(a) matches the generated CPRS template letter to the RADIOLOGIST interpreted BI-RADS report.

(b) enters correct lay result letter into CPRS and sends to the interpreting radiologist for review and electronic signature.

(c) prints out the lay result letter and sends to the patient within 30 days of the date of examination.

(d) enters a “mammography note” indicating any additional breast history and date letter was sent.

(3) The mammography report in CPRS is signed by the interpreting radiologist and sends an alert to the ordering provider that serves as proof of communication of results within 48 hours of a signed radiology report.

b. Screening Patients (BI-RADS 1,2,0) (Normal and Abnormal Report)

(1) BI-RADS 1 OR 2 – Negative or Benign; will receive “normal” report letter.

(2) BI-RADS 0 - Recall for additional imaging and /or comparison with prior exams; will receive return for additional imaging letter.

(a) A lay result letter of the “Addendum or “Comparison” report must be provided even if there is no change in the findings or recommended course of action. For the case where there is no significant change in the report, a statement that the comparison has been performed and that there is no overall change would satisfy the requirement.

(b) For continuity of care, the mammography technologist will place a courtesy request for diagnostic orders if not received from the provider within 5 days.

c. Diagnostic Patients (BI-RADS 1, 2, 0, 3, 4, 5, 6) (Normal & Abnormal Report)

(1) BI-RADS 1 OR 2 – Negative or Benign; will receive “normal” report letter.

(2) BI-RADS 0 - Recall for additional views or imaging and will receive return for additional imaging letter.

(3) BI-RADS 3 - Probably benign, Short interval (6 month) follow-up or continue surveillance imaging; will receive short interval follow-up letter.

(4) BI-RADS 4 or 5 – Suspicious or Highly Suggestive of Malignancy; will be communicated to the patient and ordering provider or RN manager/designee as soon as possible and within 3 working days from the date of interpretation.

(5) At the completion of all diagnostic mammography imaging and ultrasounds, it is the responsibility of the interpreting radiologist to provide immediate verbal communication of suspicious results along with recommendations to the patient at the completion of the visit.

(6) The interpreting radiologist makes an immediate call to speak to the patient’s referring provider or RN manager and documents that communication in the mammography report.

(7) Communication to the patient MUST be documented into a CPRS note that generates a lay letter to be mailed to the patient within 30 days of the exam date per MQSA regulations.

(8) Negative imaging but with recommendation for further clinical management will receive letter recommending surgical consult and/or clinical follow up.

d. If recommended course of action includes an image guided procedure for (BI-RADS 4 or 5),

(1) the patient will be referred by their ordering provider to the VA Surgical Team to review for non-VA consult of requested imaging.

(2) Chief of Radiology will co-sign for Non-VA consult approval of requested external imaging.

(3) The mammography technologist

(a) prepares CDs for transfer and receives courtesy prescriptions from surgeon to validate concurrence with interpreting physician imaging results.

(b) forwards the prescriptions to Non-VA care where they facilitate the business of scheduling, collection of records, and payment for procedure.

(c) monitors external imaging report receipt.

(d) upon receipt of pathology reports and imaging reports, with CD, requests the mammography radiologist for concurrence of imaging.

(4) The mammographer will

(a) notify the VA surgeon by bringing a paper copy to their office, and

(b) wait until re-cut slides are received,

(c) transport pathology to surgeon,

(d) scan reports for VA surgical, VA pathologists, and referring providers for final communication by the surgeon to the patient of the external imaging.

(5) The surgeon is the final communicator of all results of external imaging.

(6) If the patient has a clinic appointment on the same day, digital images are available after the exam is completed, and an electronic report is available after the interpreting radiologist has completed interpretation of the exam.

3. REFERENCES: FDA Policy Guidance Help System (Mammography Quality Standards Act and Program - 900.12(C)(2)(1) (11).; VHA Mammography Handbook1105.03; VHA Women Veteran Health Program 1330.01.

4. RESCISSIONS: none

5. FOLLOW UP RESPONSIBILITY: Chief of Radiology, and Lead Interpreting Mammography Radiologist

6. REVIEW: June 14, 2022. This SOP will remain in effect until it is renewed or rescinded.

7. CONCURRENCE: ADPNS

Chief of Staff Associate Director Director

Attachment(s):

Attachment A - Result Letter Examples

Attachment A:

“Albany Mammogram Result Letter” template to document and produce letters to send to patients:

Normal/Negative

Probably Benign (not cancer):

Additional Studies:

Previous films from prior mammography sites are needed for comparison to our films:

Abnormal Bi-Rad 4-5:

Abnormal Bi-Rad 6:

Stratton VA Mammography Albany VA Women Health Center 113 Holland Avenue Albany, NY 12208 Phone: 518-626-6337

Date: Feb 28,2019

Dear CPRS EIGHTEEN ZZTEST, We are pleased to let you know that the results of your recent breast imaging examination shows no sign of breast cancer.

A report of your results was sent to your health care provider: Dr. YYYY.

The VA follows the American Cancer Society guidelines for screening mammography:

- Women should have the opportunity to begin (baseline) annual screening between age 40-45.

- Women age 45-54 years should be screened annually.

- Women 55 years and older should transition to screening every other year or have the opportunity to screen annually.

- Women should continue screening mammography as long as their overall health is good, and they have a life expectancy of 10 years of longer.

Your images will become part of your medical record at Samuel Stratton VA Medical Center. They will be on file for your ongoing care. If, in the future, you change health care providers or go to a different location for a mammogram, you should tell them where and when this mammogram was done.

Even though mammograms are the best method we have for early detection, not all cancers are found with mammograms. If you develop a lump or any breast changes before your next rescreening mammogram, contact your physician or health care provider for an exam without delay.

Thank you for allowing us to help meet your health care needs.

Sincerely, /es/ Dr. YYYY, MD

Patient Record Number 00000