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.

The transplant program must ensure that the hospital in which it operates has a written agreement for the receipt of organs with an OPO designated by the Secretary that identifies specific responsibilities for the hospital and for the OP...

Condition of participation: Patient and living donor rights.

In addition to meeting the condition of participation “Patients rights” requirements at § 482.13, the transplant program must protect and promote each transplant patient's and living donor's rights.

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 comply with all applicable Federal, State, and local emergency preparedness requirements.

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.

The hospital must have pharmaceutical services that meet the needs of the patients.

Condition of participation: Radiologic services.

The hospital must maintain, or have available, diagnostic radiologic services.

Condition of participation: Laboratory services.

The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients.

Condition of participation: Food and dietetic services.

The hospital must have organized dietary services that are directed and staffed by adequate qualified personnel.

Condition of participation: Utilization review.

The hospital must have in effect a utilization review (UR) plan that provides for review of services furnished by the institution and by members of the medical staff to patients entitled to benefits under the Medicare and Medicaid programs.

Condition of participation: Physical environment.

The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community.

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

The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship.

Condition of participation: Discharge planning.

The hospital must have an effective discharge planning process that focuses on the patient's goals and treatment preferences and includes the patient and his or her caregivers/support person(s) as active partners in the discharge plannin...

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.

If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice.

Condition of participation: Anesthesia services.

If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy.

Condition of participation: Nuclear medicine services.

If the hospital provides nuclear medicine services, those services must meet the needs of the patients in accordance with acceptable standards of practice.

Condition of participation: Outpatient services.

If the hospital provides outpatient services, the services must meet the needs of the patients in accordance with acceptable standards of practice.

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.

If the hospital provides rehabilitation, physical therapy, occupational therapy, audiology, or speech pathology services, the services must be organized and staffed to ensure the health and safety of patients.

Condition of participation: Respiratory care services.

The hospital must meet the needs of the patients 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.

If the hospital offers obstetrical services, the services must be well organized and provided in accordance with nationally recognized acceptable standards of practice for the health care (including physical and behavioral health) of pre...

Special provisions applying to psychiatric hospitals.

Psychiatric hospital must—

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

The medical records maintained by a psychiatric hospital must permit determination of the degree and intensity of the treatment provided to individuals who are furnished services in the institution.

Condition of participation: Special staff requirements for psychiatric hospitals.

The hospital must have adequate numbers of qualified professional and supportive staff to evaluate patients, formulate written, individualized comprehensive treatment plans, provide active treatment measures, and engage in discharge plan...

Special requirement for transplant programs.

A transplant program located within a hospital that has a Medicare provider agreement must meet the conditions of participation specified in §§ 482.72 through 482.104 in order to be granted approval from CMS to provide transplant services.

Definitions.

As used in this subpart, the following definitions apply:

Condition of participation: OPTN membership.

A transplant program must be located in a transplant hospital that is a member of and abides by the rules and requirements of the Organ Procurement and Transplantation Network (OPTN) established and operated in accordance with section 37...

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.

A transplant center that seeks Medicare approval to provide transplantation services to pediatric patients must submit to CMS a request specifically for Medicare approval to perform pediatric transplants using the procedures described at...

Condition of participation: Emergency preparedness for transplant programs.

A transplant program must be included in the emergency preparedness planning and the emergency preparedness program as set forth in § 482.15 for the hospital in which it is located.

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

Except as specified in paragraph (d) of this section, and § 488.61 of this chapter, transplant programs must meet all data submission, clinical experience, and outcome requirements to be granted initial approval by CMS.

Condition of participation: Patient and living donor selection.

The transplant program must use written patient selection criteria in determining a patient's suitability for placement on the waiting list or a patient's suitability for transplantation.

Condition of participation: Organ recovery and receipt.

Transplant programs must have written protocols for validation of donor-recipient blood type and other vital data for the deceased organ recovery, organ receipt, and living donor organ transplantation processes.

Condition of participation: Patient and living donor management.

Transplant programs must have written patient management policies for the transplant and discharge phases of transplantation.

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

Transplant programs must develop, implement, and maintain a written, comprehensive, data-driven QAPI program designed to monitor and evaluate performance of all transplantation services, including services provided under contract or arra...

Condition of participation: Human resources.

The transplant program must ensure that all individuals who provide services and/or supervise services at the program, including individuals furnishing services under contract or arrangement, are qualified to provide or supervise such se...