1. (a) Maintenance of medical records.

   1. (1) A PACE organization must maintain a single, comprehensive medical record for each participant, in accordance with accepted professional standards.

   2. (2) The medical record for each participant must meet the following requirements:

      1. (i) Be complete.
      2. (ii) Accurately documented.
      3. (iii) Readily accessible.
      4. (iv) Systematically organized.
      5. (v) Available to all staff.
      6. (vi) Maintained and housed at the PACE center where the participant receives services.

2. (b) Content of medical records. At a minimum, the medical record must contain the following:

   1. (1) Appropriate identifying information.

   2. (2) Documentation of all services furnished, including the following:

      1. (i) A summary of emergency care and other inpatient or long-term care services.
      2. (ii) Services furnished by employees of the PACE center.
      3. (iii) Services furnished by contractors and their reports.
   3. (3) Interdisciplinary assessments, reassessments, plans of care, treatment, and progress notes that include the participant's response to treatment.
   4. (4) All recommendations for services made by employees or contractors of the PACE organization, including specialists.
   5. (5) If a service recommended by an employee or contractor of the PACE organization, including a specialist, is not approved or provided, the reason(s) for not approving or providing that service.

   6. (6) Original documentation, or an unaltered electronic copy, of any written communication as described in § 460.200(d)(2) must be maintained in the participant's medical record unless the following requirements are met:

      1. (i) The medical record contains a thorough and accurate summary of the communication including all relevant aspects of the communication,
      2. (ii) Original documentation of the communication is maintained outside of the medical record and is accessible by employees and contractors of the PACE organization when necessary, and in accordance with § 460.200(e), and
      3. (iii) Original documentation of the communication is available to CMS and the SAA upon request.
   7. (7) Laboratory, radiological and other test reports.
   8. (8) Medication records.
   9. (9) Hospital discharge summaries, if applicable.
   10. (10) Reports of contact with informal support (for example, caregiver, legal guardian, or next of kin).
   11. (11) Enrollment Agreement.
   12. (12) Physician orders.
   13. (13) Discharge summary and disenrollment justification, if applicable.
   14. (14) Advance directives, if applicable.
   15. (15) A signed release permitting disclosure of personal information.
3. (c) Transfer of medical records. The organization must promptly transfer copies of medical record information between treatment facilities.

4. (d) Authentication of medical records.

   1. (1) All entries must be legible, clear, complete, and appropriately authenticated and dated.
   2. (2) Authentication must include signatures or a secured computer entry by a unique identifier of the primary author who has reviewed and approved the entry.

[64 FR 66279, Nov. 24, 1999, as amended at 71 FR 71337, Dec. 8, 2006; 86 FR 6135, Jan. 19, 2021; 88 FR 22345, Apr. 12, 2023 ]