Editorial Note on Part 460
Editorial Note: Nomenclature changes to part 460 appear at 67 FR 61504, Oct. 1, 2002.

§ 460.210 Medical records. ( a ) *Maintenance of medical records.* ( 1 ) A PACE organization must maintain a single, comprehensive medical record for each participant, in accordance with accepted professional standards.
( 2 ) The medical record for each participant must meet the following requirements: ( i ) Be complete.
( ii ) Accurately documented.
( iii ) Readily accessible.
( iv ) Systematically organized.
( v ) Available to all staff.
( vi ) Maintained and housed at the PACE center where the participant receives services.
( b ) *Content of medical records.* At a minimum, the medical record must contain the following: ( 1 ) Appropriate identifying information.
( 2 ) Documentation of all services furnished, including the following: ( i ) A summary of emergency care and other inpatient or long-term care services.
( ii ) Services furnished by employees of the PACE center.
( iii ) Services furnished by contractors and their reports.
( 3 ) Interdisciplinary assessments, reassessments, plans of care, treatment, and progress notes that include the participant's response to treatment.
( 4 ) All recommendations for services made by employees or contractors of the PACE organization, including specialists.
( 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 ) 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: ( i ) The medical record contains a thorough and accurate summary of the communication including all relevant aspects of the communication,
( 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
( iii ) Original documentation of the communication is available to CMS and the SAA upon request.
( 7 ) Laboratory, radiological and other test reports.
( 8 ) Medication records.
( 9 ) Hospital discharge summaries, if applicable.
( 10 ) Reports of contact with informal support (for example, caregiver, legal guardian, or next of kin).
( 11 ) Enrollment Agreement.
( 12 ) Physician orders.
( 13 ) Discharge summary and disenrollment justification, if applicable.
( 14 ) Advance directives, if applicable.
( 15 ) A signed release permitting disclosure of personal information.
( c ) *Transfer of medical records.* The organization must promptly transfer copies of medical record information between treatment facilities.
( d ) *Authentication of medical records.* ( 1 ) All entries must be legible, clear, complete, and appropriately authenticated and dated.
( 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 ]