Policy and Procedure (P&P) Template: Communication with Self-Referred Patients for Breast Imaging Procedures

Below is an example of a Policy and Procedure (P&P) Template that you can use as a foundation for your Breast Imaging Center's Policy Manual, particularly for policies related to FDA MQSA (Mammography Quality Standards Act) compliance. This specific example focuses on communicating with self-referred patients for breast imaging procedures such as mammograms. It is designed to ensure that self-referred patients receive the same level of communication, care, and follow-up as those referred by a healthcare provider while also addressing the unique considerations that apply to self-referred patients as prescribed within the FDA MQSA regulations.

Policy Name:

Communication with Self-Referred Patients for Breast Imaging Procedures

Effective Date:

[Insert date here]

Policy Number:

[Insert policy number here]

Review Date:

[Insert review date here]

Approved By:

[Insert name and title of approver here]

1. Purpose:

This policy establishes clear guidelines for communicating with self-referred patients undergoing breast imaging procedures such as mammograms at the Breast Imaging Center. It ensures that self-referred patients are informed of their rights, receive their mammography results in compliance with FDA MQSA (Mammography Quality Standards Act) regulations, and are guided in accessing follow-up care when needed.

2. Scope:

This policy applies to all patients who self-refer to breast imaging services at the Breast Imaging Center. It covers the process of patient communication before and after the procedure, including delivering mammography results, advising patients on follow-up care, and documenting communications.


3. Policy:

The Breast Imaging Center's policy is to ensure that all self-referred patients receive the same level of care and communication as patients referred by healthcare providers. Self-referred patients will be fully informed of their mammogram results in a timely manner, in compliance with MQSA requirements, and will be provided guidance on how to pursue any necessary follow-up care.


Key Points:

  • Self-referred patients will be informed of their mammography results through lay letters that contain all required components, including the facility name, address, and contact information, and a clear explanation of the results.
  • A copy of the radiologist's test results report typically dispatched to a healthcare provider-referred patient, will be mailed with the lay letter.
  • Self-referred patients are responsible for seeking medical follow-up based on their results. The Breast Imaging Center will provide guidance on how to establish care with a primary healthcare provider or specialist if needed.
  • All communications with self-referred patients, including the delivery of results and follow-up guidance, will be documented.

4. Definitions:

Self-Referred Patient: A patient who schedules and undergoes a mammogram or other breast imaging procedure without a referral from a primary care physician or specialist.

Lay Letter: A letter written in plain language that communicates mammography results to the patient.

MQSA: The Mammography Quality Standards Act, a federal law that sets national standards for mammography services and requires that patients receive clear and timely communication of their results.

5. Procedures:

5.1 Pre-Procedure Communication

  • Patient Consent and Education: Before the procedure, the self-referred patient must sign a consent form acknowledging that they are self-referred. The form should explain:
    • The nature of the self-referral.
    • The responsibility of the patient is to seek medical follow-up based on their results.
    • The center’s role in providing results not ongoing treatment.
    • The procedure for obtaining results and any follow-up steps.
  • Patient Information: The Breast Imaging Center staff will inform self-referred patients about the importance of sharing their results with a healthcare provider for continued breast health management, especially if further diagnostic work is needed.

5.2 Lay Letter Communication

  • Content Requirements: The lay letter sent to self-referred patients will contain:
    • The name of the facility, address, and telephone number.
    • A clear explanation of the mammography results in lay language.
    • Specific follow-up recommendations based on the result (e.g., routine screening in one year, additional diagnostic imaging, or referral to a specialist).
    • A statement advising the patient to contact a healthcare provider for further evaluation, especially if the results are abnormal.
  • Timing of Lay Letter Delivery:
    • Negative/Benign Results: Lay letters must be sent within 30 days of the mammogram.
    • Abnormal Results: For patients with suspicious findings, lay letters must be sent within 7 days. The Breast Center will also make a reasonable effort to contact the patient by phone to ensure they receive their results promptly.

5.3 Follow-Up Guidance for Self-Referred Patients

  • Routine Follow-Up: For self-referred patients with normal results, the lay letter will recommend routine annual screenings and advise the patient to share the results with their primary care provider.
  • Abnormal Results: For patients with suspicious or abnormal results, the lay letter and phone communication will include:
    • A clear description of the abnormality.
    • Recommendations for further diagnostic testing (e.g., additional mammogram views, ultrasound, biopsy).
    • Strong encouragement for the patient to consult a healthcare provider or specialist for follow-up care.
    • If the patient does not have a provider, the Breast Imaging Center will offer assistance in identifying local healthcare providers or specialists.
  • Patient Responsibility: While the Breast Imaging Center will communicate the results and provide follow-up recommendations, the patient is responsible for pursuing follow-up care.

5.4 Documentation

  • Patient Records: All communications, including the mailing of lay letters, phone calls, and any assistance provided to the patient in seeking follow-up care, will be documented.
  • Tracking Delivery:
    • A record of the lay letter, including a copy of the letter itself.
    • Documentation should include proof of production and mailing via a letter tracking number.
    • In cases where a letter is undeliverable, reasonable attempts will be made to contact the patient via phone or other methods, and these attempts must also be documented.

6. Responsibilities:

Patient Navigator/Coordinator: A designated staff member (e.g., patient navigator or coordinator) will be responsible for overseeing communications with self-referred patients, including ensuring that results are delivered in a timely manner and that the patient is provided with resources for follow-up care if needed.

Administrative Staff: The administrative team is responsible for preparing, sending, and documenting the delivery of lay letters to self-referred patients.

Medical Director/Radiologist: The interpreting radiologist or Medical Director will review any letters associated with abnormal findings to ensure clarity and accuracy before they are sent to the patient.

7. Quality Assurance:

Audit of Self-Referred Patient Communication: Regular audits will be conducted to ensure that communications with self-referred patients are timely, compliant with MQSA regulations, and properly documented.

Patient Feedback: Self-referred patients may be surveyed for feedback on the clarity and usefulness of the lay letter and follow-up recommendations.

8. Training and Education:

  • All staff involved in the management and communication of results to self-referred patients will receive training on:
    • The specific needs and responsibilities associated with self-referred patients.
    • MQSA requirements for patient communication.
    • Procedures for documenting communications and follow-up assistance.

9. Patient Privacy and HIPAA Compliance:

All communication with self-referred patients, including lay letters and follow-up calls, will comply with HIPAA regulations to ensure the confidentiality of patient information.

10. References:

FDA MQSA Guidelines: [Link to relevant FDA guidelines]

HIPAA Regulations: [Link to relevant HIPAA information]

11. Related Policies:

Policy on HIPAA Compliance and Patient Privacy

Policy on Breast Density Notification

Policy on Mammography Result Communication


12. Appendices:

Appendix A: Example Lay Letter for Self-Referred Patient (Normal Results)

Appendix B: Example Lay Letter for Self-Referred Patient (Abnormal Results)

Appendix C: Consent Form for Self-Referred Patients

Review and Update History:

[Insert dates of past reviews and updates]

Did this answer your question? Thanks for the feedback There was a problem submitting your feedback. Please try again later.

Still need help? Contact Us Contact Us