Policy and Procedure (P&P) Template: Handling and Obtaining Lay Letters and Test Result Reports

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. It also addresses the unique considerations that apply to self-referred patients as prescribed within the FDA MQSA regulations.

Policy Name:

Policy on Handling and Obtaining Lay Letters and Test Result Reports

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 procedures for creating, delivering, and retrieving lay letters and mammogram test result reports, including for patients who are unhoused or lack a valid mailing address. The policy ensures that all patients, regardless of housing status, have access to their results securely, timely, and HIPAA-compliantly.

2. Scope:

This policy applies to all patients of the Breast Imaging Center who undergo mammography and require the delivery of a lay letter summarizing their results. It includes patients without a mailing address and outlines the alternative methods for obtaining their lay letters, such as in-person pick-up, authorized surrogate collection, or online patient portal access.

3. Policy:

It is the policy of the Breast Imaging Center to ensure that all patients receive their lay letter of results in a manner that is secure, accessible, and in compliance with HIPAA regulations. The facility will make reasonable attempts to mail the letter to the patient’s available address. In cases where a patient does not have a valid address, alternative arrangements such as in-person pick-up, authorized surrogate collection, or access through the online patient portal will be offered.

Key Points:

  • Lay letters will be created for every patient following a mammogram, including those without a valid mailing address.
  • A reasonable attempt will be made to mail the lay letter using the United States Postal Service (USPS).
  • Patients without a valid mailing address will be offered the option to pick up their lay letter in person, authorize a surrogate to collect the letter or access their results via the online patient portal.
  • All communications will comply with HIPAA standards to protect patient privacy and confidentiality.

4. Definitions:

  • Lay Letter: A letter communicating the results of a mammogram to the patient in plain language, as required by MQSA regulations.
  • Unhoused Patients: Patients without a permanent mailing address or living in temporary or unstable housing situations.
  • Authorized Surrogate: An individual pre-authorized by the patient to access their health information, in compliance with HIPAA regulations.

5. Procedures:

5.1 Creation of Lay Letters

  • Routine Process:
    • A lay letter summarizing the results and any recommended follow-up actions will be created for every patient who undergoes a mammogram.
    • The lay letter will be stored securely in the patient’s medical record and, where applicable, uploaded to the online patient portal for authorized access.

5.2 Mailing Lay Letters

  • Standard Mailing:
    • The facility will make a reasonable attempt to mail the lay letter to the patient's available address using USPS. This includes:
      • Verifying the patient’s address during the intake process.
      • Noting any known address changes or unstable housing situations.
  • Unhoused Patients:
    • If a patient is identified as unhoused or without a valid mailing address:
      • The facility will attempt to use any last known or temporary address provided by the patient.
      • If no valid address is available, the patient will be offered alternative options for obtaining their lay letter (see Section 5.3).

5.3 Alternative Methods for Obtaining Lay Letters

  • In-Person Pick-Up:
    • Patients can pick up their lay letter directly from the facility by presenting a valid photo ID.
  • Authorized Surrogate Collection:
    • Patients may designate a healthcare surrogate (e.g., family member, caregiver) to pick up their lay letter on their behalf.
    • The patient must provide written authorization, including the surrogate's name, relation to the patient, and a valid photo ID for the surrogate.

    • The authorization must comply with HIPAA regulations, and the surrogate’s information will be documented in the patient’s medical record.

      Referring Clinician Collection:

    • The patient’s referring clinician can be authorized to receive and discuss the lay letter results with the patient.

    • This process requires the patient’s consent, and the details of the arrangement will be documented in the patient’s medical record.

      Online Patient Portal:

    • Patients with online access to the facility’s patient portal can securely view and download their test results.
    • The patient will receive instructions for accessing the portal and any necessary support for setting up their account.

5.4 Documentation and Verification

  • Record-Keeping:
    • The facility will document the method chosen for delivering or obtaining the lay letter in the patient’s medical record, including:
      • The date of mailing, if applicable.
      • The arrangement for in-person pick-up or surrogate collection.
      • The patient’s authorization for the release of information, if applicable.
      • Confirmation of access through the online patient portal.
  • Verification:
    • For in-person pick-up or authorized surrogate collection, staff will verify the identity of the individual collecting the lay letter using a valid photo ID.
    • A log will be maintained to record the date and time of pick-up, the identity of the person collecting the letter, and any additional notes.

5.5 Follow-Up for Unsuccessful Delivery

  • If a mailed lay letter is returned as undeliverable and the patient does not have an address on file:
    • The facility will attempt to obtain an alternative address for delivering the results.
    • The facility will document all attempts to contact the patient and the chosen method for delivering the results.

5.6 Communication with Patients

  • Notification of Options:
    • Patients will be informed of the available options for receiving their lay letter at the time of their appointment, especially if they do not have a stable address.
    • This information will include the option for in-person pick-up, use of an authorized surrogate, or access via the online patient portal.

6. Responsibilities:

  • Facility Staff:
    • Responsible for creating and mailing lay letters and documenting delivery methods in the patient’s medical record.
    • Ensure patients are informed of their options for obtaining their lay letter if they do not have a valid mailing address.
    • Verify the identity of individuals picking up lay letters in person and ensure compliance with HIPAA regulations.
  • Outsourced Service Provider:
    • Responsible for producing lay letters and mailing them via USPS as instructed by the facility.
    • Provides secure access to lay letters through the online patient portal, as authorized by the facility.
  • Patients:
    • Responsible for providing accurate contact information and selecting their preferred method for receiving their lay letter if they do not have a valid mailing address.

7. Quality Assurance:

  • Periodic Review:
    • The facility will conduct periodic reviews of the lay letter delivery process to ensure compliance with this policy and identify opportunities for improvement.
    • Issues such as undeliverable letters or delays in patient access will be documented, investigated, and addressed promptly.

8. Compliance with Regulatory Standards:

  • HIPAA Compliance:
    • All communications and handling of lay letters will comply with HIPAA regulations to ensure patient privacy and confidentiality.
  • FDA MQSA Standards:
    • This policy supports compliance with MQSA requirements for communicating mammography results to patients in a timely manner.

9. Related Policies:

  • Policy on Patient Communication in Lay Letters
  • Policy on Handling Undeliverable Lay Letters
  • Policy on HIPAA Compliance and Patient Privacy

10. References:

  • FDA MQSA Guidelines: [Link to relevant FDA resources]
  • HIPAA Guidelines for Communication with Patients: [Link to HIPAA resources]

11. Appendices:

  • Appendix A: In-Person Pick-Up Authorization Form
  • Appendix B: Patient Portal Access Instructions
  • Appendix C: Sample Communication Options Notice for Patients

Review and Update History:

[Insert dates of past reviews and updates]

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