Policy and Procedure (P&P) Template: Patient Communication of Mammography Results (Lay Letter) in Compliance with FDA MQSA Regulations

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 the policy for issuing lay letters to patients, which comply with the MQSA requirements regarding the inclusion of key facility information (e.g., name, address, and telephone number).

Policy Name:

Patient Communication of Mammography Results (Lay Letter) in Compliance with FDA MQSA Regulations

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:

Ensure that the Breast Imaging Center complies with the FDA's Mammography Quality Standards Act (MQSA) regulations, specifically, the requirement that each patient receives a lay summary of their mammogram results within the specified time frame. The lay letter will contain all the key components required by the FDA, including the facility name, address, and telephone number, to ensure accurate and effective communication of results.

2. Scope:

This policy applies to all mammography patients who receive services at the Breast Imaging Center, regardless of whether the exam is a screening or diagnostic mammogram. It also applies to all healthcare personnel involved in drafting, reviewing, and issuing mammogram result letters to patients.

3. Policy:

It is the policy of the Breast Imaging Center to comply fully with FDA MQSA regulations by ensuring that every patient receives a lay summary of their mammography results. The lay letter must contain all mandatory elements as required by the MQSA, which includes but is not limited to:

The name of the facility where the mammogram was performed.
The address of the facility, including street, city, and state.
The telephone number of the facility for any patient follow-up or inquiries.
A clear and concise explanation of the mammography results in lay language, including follow-up recommendations if necessary.
The date of the mammography exam.
Information on breast density, if applicable, per MQSA or state requirements.

All lay letters must be sent within 30 days for benign or normal results and within 7 days for suspicious or abnormal findings.

4. Definitions:

Lay Letter: A letter that communicates the results of a mammogram to the patient in clear, non-technical language.

MQSA: The Mammography Quality Standards Act, a federal law that sets national quality standards for mammography.

Breast Density Notification: A notification included in the lay letter if the patient has dense breast tissue, in accordance with MQSA requirements or applicable state laws.

5. Procedures:

5.1 Lay Letter Creation

The radiologist’s interpretation of the mammogram will be summarized in lay language for the patient. The letter must clearly state the result (e.g., negative, benign, or suspicious) and include any necessary follow-up actions.
The lay letter will include all required elements (facility name, address, phone number, results, and recommendations).
The letter should also inform the patient that they should contact a healthcare provider for further discussion, if necessary.

5.2 Facility Information Requirements

Each lay letter must include the following facility details:
Facility Name: The full name of the Breast Imaging Center.
Facility Address: The physical address of the center (street, city, state, ZIP code).
Facility Phone Number: The patient can use the direct phone number for the imaging center to ask questions or schedule follow-up exams.

5.3 Timing and Delivery of Lay Letters

Normal/Benign Results: The lay letter will be sent to the patient within 30 days of the mammogram.
Abnormal/Suspicious Results: For patients with suspicious findings, the lay letter will be sent within 3-5 days, and additional efforts (e.g., phone calls) will be made to ensure timely patient notification.
Depending on patient preference and facility protocol, Lay letters shall be delivered by United States Postal Service First Class or Certified mail service.

5.4 Documentation and Record Keeping

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:

The Lead Mammography Technologist is responsible for ensuring that the templates used for lay letters are accurate and compliant with MQSA requirements.

The Medical Director or Radiologist-in-Charge must review any letters associated with abnormal or suspicious results before they are sent to ensure clarity and accuracy.

The Administrative Staff is responsible for coordinating the sending of lay letters within the specified time frames and for documenting delivery.

7. Quality Assurance:

The Quality Assurance team will perform quarterly audits to verify that all lay letters include the required facility information (name, address, phone number) and meet the regulatory timeline requirements.

Non-compliance issues will be addressed immediately, and corrective actions will be documented and reported to the Breast Imaging Center’s management.

8. References:

FDA MQSA Guidelines: [Link to FDA resources]

State-Specific Breast Density Notification Laws: [Link to state guidelines if applicable]

9. Related Policies:

Policy on Patient Privacy and HIPAA Compliance

Policy on Breast Density Notification

Policy on Radiologist Reporting and Follow-Up

10. Appendices:

Appendix A: Example Lay Letter Template for Normal Results

Appendix B: Example Lay Letter Template for Abnormal Results

Appendix C: Contact Information for Further Questions

Review and Update History:

[Insert dates of past reviews and updates]