Conditions of Participation for Hospitals

Basis and scope.

This provision establishes the statutory basis for Medicare and Medicaid hospital conditions of participation, including requirements for psychiatric hospitals, utilization review, and long-term care services.

Condition of participation: Organ procurement.

Transplant programs must maintain a written agreement with a designated organ procurement organization to define responsibilities for organ recovery and allocation.

Condition of participation: Patient and living donor rights.

Transplant programs must implement written informed consent policies for transplant patients and living donors, and provide specific notifications regarding program status and team availability.

Condition of participation: Additional requirements for kidney transplant programs.

Kidney transplant programs must provide ESRD services, maintain communication with local dialysis facilities, and participate in designated ESRD network activities.

Condition of participation: Compliance with Federal, State and local laws.

Hospitals must comply with applicable health and safety laws and ensure that the facility and its personnel are appropriately licensed or approved.

Condition of participation: Governing body.

There must be an effective governing body that is legally responsible for the conduct of the hospital.

Condition of participation: Patient's rights.

A hospital must protect and promote each patient's rights.

Condition of participation: Emergency preparedness.

The hospital must develop and maintain a comprehensive, all-hazards emergency preparedness program, including an emergency plan, policies and procedures, a communication plan, and a training and testing program.

Provision of emergency services by nonparticipating hospitals.

This provision outlines the conditions under which emergency services provided by non-Medicare participating hospitals may be eligible for reimbursement.

Condition of participation: Quality assessment and performance improvement program.

The hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program.

Condition of participation: Medical staff.

The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital.

Condition of participation: Nursing services.

The hospital must have an organized nursing service that provides 24-hour nursing services.

Condition of participation: Medical record services.

The hospital must have a medical record service that has administrative responsibility for medical records.

Condition of participation: Pharmaceutical services.

This provision establishes the requirements for hospital pharmaceutical services, including management, drug security, medication administration, and error reporting.

Condition of participation: Radiologic services.

This provision mandates that hospitals maintain diagnostic radiologic services that meet safety and personnel qualification standards.

Condition of participation: Laboratory services.

This provision requires hospitals to maintain adequate laboratory services and establishes specific protocols for blood safety, HIV/HCV lookback, and patient notification.

Condition of participation: Food and dietetic services.

This provision mandates that hospitals provide organized dietary services staffed by qualified personnel to meet patient nutritional needs.

Condition of participation: Utilization review.

The hospital must maintain a utilization review plan to evaluate the medical necessity of admissions, duration of stays, and professional services for Medicare and Medicaid patients.

Condition of participation: Physical environment.

The hospital must maintain its physical plant, including fire safety, emergency power, and building facilities, to ensure patient safety and quality of care.

Condition of participation: Infection prevention and control and antibiotic stewardship programs.

Hospitals must maintain active, hospital-wide programs for infection surveillance, prevention, and control, alongside an antibiotic stewardship program, coordinated with quality assessment and performance improvement activities.

Condition of participation: Discharge planning.

Hospitals must implement an effective, patient-centered discharge planning process that includes evaluation of post-hospital needs, coordination with post-acute care providers, and documentation of patient choice.

Condition of participation: Organ, tissue, and eye procurement.

Hospitals must implement protocols for organ, tissue, and eye procurement, including agreements with procurement organizations and donor family notification procedures.

Condition of participation: Surgical services.

Hospitals providing surgical services must ensure they are well-organized, appropriately staffed, and follow established standards of practice including informed consent and operative reporting.

Condition of participation: Anesthesia services.

Hospitals furnishing anesthesia services must provide them in a well-organized manner under the direction of a qualified physician, including pre- and post-anesthesia evaluations.

Condition of participation: Nuclear medicine services.

Hospitals providing nuclear medicine services must ensure they meet patient needs through qualified staffing, safe handling of radioactive materials, and proper equipment maintenance.

Condition of participation: Outpatient services.

Hospitals providing outpatient services must ensure they are appropriately organized, integrated with inpatient services, and ordered by authorized practitioners.

Condition of participation: Emergency services.

The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice.

Condition of participation: Rehabilitation services.

Hospitals providing rehabilitation services must organize and staff them to ensure patient health and safety, requiring services to be provided by qualified professionals under practitioner orders.

Condition of participation: Respiratory care services.

Hospitals providing respiratory care services must ensure they are organized and staffed by qualified personnel to meet patient needs in accordance with acceptable standards of practice.

Special requirements for hospital providers of long-term care services (“swing-beds”).

A hospital that has a Medicare provider agreement must meet the following requirements in order to be granted an approval from CMS to provide post-hospital extended care services, as specified in § 409.30 of this chapter, and be reimburs...

Condition of participation: Obstetrical services.

This provision establishes the requirements for organizing, staffing, and delivering obstetrical services, including equipment, emergency protocols, and staff training.

Special provisions applying to psychiatric hospitals.

This provision outlines the foundational requirements for psychiatric hospitals, including scope of services, record maintenance, and staffing.

Condition of participation: Special medical record requirements for psychiatric hospitals.

This provision mandates specific documentation standards for psychiatric patients, including evaluations, treatment plans, progress notes, and electronic health information notifications.

Condition of participation: Special staff requirements for psychiatric hospitals.

This provision defines the staffing requirements for psychiatric hospitals, including clinical leadership, nursing, psychological services, social services, and therapeutic activities.

Special requirement for transplant programs.

This provision mandates that hospital-based transplant programs meet specific conditions of participation to receive CMS approval.

Definitions.

This provision provides definitions for terms used in the transplant program regulations, including adverse events and specific transplant program types.

Condition of participation: OPTN membership.

Transplant programs must be located in a hospital that maintains membership in and complies with the rules of the Organ Procurement and Transplantation Network.

Condition of participation: Notification to CMS.

Transplant programs must notify CMS of significant changes, including staffing, organ procurement agreements, or program inactivation.

Condition of participation: Pediatric Transplants.

Transplant centers must obtain specific Medicare approval to perform pediatric transplants and meet established clinical and operational criteria.

Condition of participation: Emergency preparedness for transplant programs.

Transplant programs must be integrated into the hospital's emergency preparedness program and maintain specific protocols with organ procurement organizations.

Condition of participation: Data submission, clinical experience, and outcome requirements for initial approval of transplant programs.

Transplant programs must meet specific data submission, clinical volume, and patient outcome standards to receive and maintain Medicare approval.

Condition of participation: Patient and living donor selection.

Transplant programs must use written, non-discriminatory criteria for patient and living donor selection and document these processes in medical records.

Condition of participation: Organ recovery and receipt.

Transplant programs must maintain protocols for verifying donor-recipient compatibility and ensuring the medical suitability of organs.

Condition of participation: Patient and living donor management.

Transplant programs must provide multidisciplinary care, maintain accurate records, and offer social and nutritional services to patients and donors.

Condition of participation: Quality assessment and performance improvement (QAPI).

Transplant programs must maintain a comprehensive, data-driven QAPI program to monitor performance, evaluate outcomes, and address adverse events.

Condition of participation: Human resources.

Transplant programs must ensure that all staff, including surgeons, physicians, and clinical coordinators, are qualified and that multidisciplinary teams are available to provide transplantation services.