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Title 42Chapter IVSubchapter EPart 460 → Subpart H

Title 42: Public Health

Subpart H—Quality Improvement

§460.130   General rule.
§460.132   Quality improvement plan.
§460.134   Minimum requirements for quality improvement program.
§460.136   Internal quality improvement activities.
§460.138   Committees with community input.

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§460.130   General rule.

(a) A PACE organization must develop, implement, maintain, and evaluate an effective, data-driven quality improvement program.

(b) The program must reflect the full range of services furnished by the PACE organization.

(c) A PACE organization must take actions that result in improvements in its performance in all types of care.

(d) A PACE organization must meet external quality assessment and reporting requirements, as specified by CMS or the State administering agency, in accordance with §460.202.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]

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§460.132   Quality improvement plan.

(a) Basic rule. A PACE organization must have a written quality improvement plan that is collaborative and interdisciplinary in nature.

(b) Annual review. The PACE governing body must review the plan annually and revise it, if necessary.

(c) Minimum plan requirements. At a minimum, the plan must specify how the PACE organization proposes to meet the following requirements:

(1) Identify areas to improve or maintain the delivery of services and patient care.

(2) Develop and implement plans of action to improve or maintain quality of care.

(3) Document and disseminate to PACE staff and contractors the results from the quality improvement activities.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]

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§460.134   Minimum requirements for quality improvement program.

(a) Minimum program requirements. A PACE organization's quality improvement program must include, but is not limited to, the use of objective measures to demonstrate improved performance with regard to the following:

(1) Utilization of PACE services, such as decreased inpatient hospitalizations and emergency room visits.

(2) Caregiver and participant satisfaction.

(3) Outcome measures that are derived from data collected during assessments, including data on the following:

(i) Physiological well being.

(ii) Functional status.

(iii) Cognitive ability.

(iv) Social/behavioral functioning.

(v) Quality of life of participants.

(4) Effectiveness and safety of staff-provided and contracted services, including the following:

(i) Competency of clinical staff.

(ii) Promptness of service delivery.

(iii) Achievement of treatment goals and measurable outcomes.

(5) Nonclinical areas, such as grievances and appeals, transportation services, meals, life safety, and environmental issues.

(b) Basis for outcome measures. Outcome measures must be based on current clinical practice guidelines and professional practice standards applicable to the care of PACE participants.

(c) Minimum levels of performance. The PACE organization must meet or exceed minimum levels of performance, established by CMS and the State administering agency, on standardized quality measures, such as influenza immunization rates, which are specified in the PACE program agreement.

(d) Accuracy of data. The PACE organization must ensure that all data used for outcome monitoring are accurate and complete.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]

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§460.136   Internal quality improvement activities.

(a) Quality improvement requirements. A PACE organization must do the following:

(1) Use a set of outcome measures to identify areas of good or problematic performance.

(2) Take actions targeted at maintaining or improving care based on outcome measures.

(3) Incorporate actions resulting in performance improvement into standards of practice for the delivery of care and periodically track performance to ensure that any performance improvements are sustained over time.

(4) Set priorities for performance improvement, considering prevalence and severity of identified problems, and give priority to improvement activities that affect clinical outcomes.

(5) Immediately correct any identified problem that directly or potentially threatens the health and safety of a PACE participant.

(b) Quality improvement coordinator. A PACE organization must designate an individual to coordinate and oversee implementation of quality assessment and performance improvement activities.

(c) Involvement in quality improvement activities. (1) A PACE organization must ensure that all interdisciplinary team members, PACE staff, and contract providers are involved in the development and implementation of quality improvement activities and are aware of the results of these activities.

(2) The quality improvement coordinator must encourage a PACE participant and his or her caregivers to be involved in quality improvement activities, including providing information about their satisfaction with services.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]

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§460.138   Committees with community input.

A PACE organization must establish one or more committees, with community input, to do the following:

(a) Evaluate data collected pertaining to quality outcome measures.

(b) Address the implementation of, and results from, the quality improvement plan.

(c) Provide input related to ethical decisionmaking, including end-of-life issues and implementation of the Patient Self-Determination Act.

[64 FR 66279, Nov. 24, 1999, as amended at 84 FR 25676, June 3, 2019]

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