All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility's staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility's staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions.

(a) Standard: Medical director. (1) The medical director must be a board-certified physician in internal medicine or pediatrics by a professional board who has completed a board-approved training program in nephrology and has at least 12-months of experience providing care to patients receiving dialysis.

(2) If a physician, as specified in paragraph (a)(1) of this section, is not available to direct a certified dialysis facility another physician may direct the facility, subject to the approval of the Secretary.

(b) Standard: Nursing services—(1) Nurse manager. The facility must have a nurse manager responsible for nursing services in the facility who must—

(i) Be a full time employee of the facility;

(ii) Be a registered nurse; and

(iii) Have at least 12 months of experience in clinical nursing, and an additional 6 months of experience in providing nursing care to patients on maintenance dialysis.

(2) Self-care and home dialysis training nurse. The nurse responsible for self-care and/or home care training must—

(i) Be a registered nurse; and

(ii) Have at least 12 months experience in providing nursing care and an additional 3 months of experience in the specific modality for which the nurse will provide self-care training.

(3) Charge nurse. The charge nurse responsible for each shift must—

(i) Be a registered nurse, a licensed practical nurse, or vocational nurse who meets the practice requirements in the State in which he or she is employed;

(ii) Have at least 12 months experience in providing nursing care, including 3 months of experience in providing nursing care to patients on maintenance dialysis; and

(iii) If such nurse is a licensed practical nurse or licensed vocational nurse, work under the supervision of a registered nurse in accordance with state nursing practice act provisions.

(4) Staff nurse. Each nurse who provides care and treatment to patients must be either a registered nurse or a practical nurse who meets the practice requirements in the State in which he or she is employed.

(c) Standard: Dietitian. The facility must have a dietitian who must—

(1) Be a registered dietitian with the Commission on Dietetic Registration; and

(2) Have a minimum of 1 year professional work experience in clinical nutrition as a registered dietitian.

(d) Standard: Social worker. The facility must have a social worker who—

(1) Holds a master's degree in social work with a specialization in clinical practice from a school of social work accredited by the Council on Social Work Education; or

(2) Has served at least 2 years as a social worker, 1 year of which was in a dialysis unit or transplantation program prior to September 1, 1976, and has established a consultative relationship with a social worker who qualifies under § 494.140(d)(1).

(e) Standard: Patient care dialysis technicians. Patient care dialysis technicians must—

(1) Meet all applicable State requirements for education, training, credentialing, competency, standards of practice, certification, and licensure in the State in which he or she is employed as a dialysis technician; and

(2) Have a high school diploma or equivalency;

(3) Have completed a training program that is approved by the medical director and governing body, under the direction of a registered nurse, focused on the operation of kidney dialysis equipment and machines, providing direct patient care, and communication and interpersonal skills, including patient sensitivity training and care of difficult patients. The training program must include the following subjects:

(i) Principles of dialysis.

(ii) Care of patients with kidney failure, including interpersonal skills.

(iii) Dialysis procedures and documentation, including initiation, proper cannulation techniques, monitoring, and termination of dialysis.

(iv) Possible complications of dialysis.

(v) Water treatment and dialysate preparation.

(vi) Infection control.

(vii) Safety.

(viii) Dialyzer reprocessing, if applicable.

(4) Be certified under a State certification program or a national commercially available certification program, as follows—

(i) For newly employed patient care technicians, within 18 months of being hired as a dialysis patient care technician; or

(ii) For patient care technicians employed on October 14, 2008, within 18 months after such date.

(f) Standard: Water treatment system technicians. Technicians who perform monitoring and testing of the water treatment system must complete a training program that has been approved by the medical director and the governing body.

The dialysis facility must have a medical director who meets the qualifications of § 494.140(a) to be responsible for the delivery of patient care and outcomes in the facility. The medical director is accountable to the governing body for the quality of medical care provided to patients. Medical director responsibilities include, but are not limited to, the following:

(a) Quality assessment and performance improvement program.

(b) Staff education, training, and performance.

(c) Policies and procedures. The medical director must—

(1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; and

(2) Ensure that—

(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; and

(ii) The interdisciplinary team adheres to the discharge and transfer policies and procedures specified in § 494.180(f).

The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility.

(a) Standard: Protection of the patient's record. The dialysis facility must—

(1) Safeguard patient records against loss, destruction, or unauthorized use; and

(2) Keep confidential all information contained in the patient's record, except when release is authorized pursuant to one of the following:

(i) The transfer of the patient to another facility.

(ii) Certain exceptions provided for in the law.

(iii) Provisions allowed under third party payment contracts.

(iv) Approval by the patient.

(v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program.

(3) Obtaining written authorization from the patient or legal representative before releasing information that is not authorized by law.

(b) Standard: Completion of patient records and centralization of clinical information. (1) Current medical records and those of discharged patients must be completed promptly.

(2) All clinical information pertaining to a patient must be centralized in the patient's record, including whether the patient has executed an advance directive. These records must be maintained in a manner such that each member of the interdisciplinary team has access to current information regarding the patient's condition and prescribed treatment.

(3) The dialysis facility must complete, maintain, and monitor home care patients' records, including the records of patients who receive supplies and equipment from a durable medical equipment supplier.

(c) Standard: Record retention and preservation. In accordance with 45 CFR § 164.530(j)(2), all patient records must be retained for 6 years from the date of the patient's discharge, transfer, or death.

(d) Standard: Transfer of patient record information. When a dialysis patient is transferred, the dialysis facility releasing the patient must send all requested medical record information to the receiving facility within 1 working day of the transfer.

The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients' personal and property rights, and to the general operation of the facility.

(a) Standard: Designating a chief executive officer or administrator. The governing body or designated person responsible must appoint an individual who serves as the dialysis facility's chief executive officer or administrator who exercises responsibility for the management of the facility and the provision of all dialysis services, including, but not limited to—

(1) Staff appointments;

(2) Fiscal operations;

(3) The relationship with the ESRD networks; and

(4) Allocation of necessary staff and other resources for the facility's quality assessment and performance improvement program as described in § 494.110.

(b) Standard: Adequate number of qualified and trained staff. The governing body or designated person responsible must ensure that—

(1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; and the registered nurse, social worker and dietitian members of the interdisciplinary team are available to meet patient clinical needs;

(2) A registered nurse, who is responsible for the nursing care provided, is present in the facility at all times that in-center dialysis patients are being treated;

(3) All staff, including the medical director, have appropriate orientation to the facility and their work responsibilities; and

(4) All employees have an opportunity for continuing education and related development activities.

(c) Standard: Medical staff appointments. The governing body—

(1) Is responsible for all medical staff appointments and credentialing in accordance with State law, including attending physicians, physician assistants, nurse practitioners, and clinical nurse specialists; and

(2) Ensures that all medical staff who provide care in the facility are informed of all facility policies and procedures, including the facility's quality assessment and performance improvement program specified in § 494.110.

(3) Communicates expectations to the medical staff regarding staff participation in improving the quality of medical care provided to facility patients.

(d) Standard: Furnishing services. The governing body is responsible for ensuring that the dialysis facility furnishes services directly on its main premises or on other premises that are contiguous with the main premises and are under the direction of the same professional staff and governing body as the main premises (except for services provided under § 494.100).

(e) Standard: Internal grievance process. The facility's internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include:

(1) A clearly explained procedure for the submission of grievances.

(2) Timeframes for reviewing the grievance.

(3) A description of how the patient or the patient's designated representative will be informed of steps taken to resolve the grievance.

(f) Standard: Involuntary discharge and transfer policies and procedures. The governing body must ensure that all staff follow the facility's patient discharge and transfer policies and procedures. The medical director ensures that no patient is discharged or transferred from the facility unless—

(1) The patient or payer no longer reimburses the facility for the ordered services;

(2) The facility ceases to operate;

(3) The transfer is necessary for the patient's welfare because the facility can no longer meet the patient's documented medical needs; or

(4) The facility has reassessed the patient and determined that the patient's behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient's interdisciplinary team—

(i) Documents the reassessments, ongoing problem(s), and efforts made to resolve the problem(s), and enters this documentation into the patient's medical record;

(ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge;

(iii) Obtains a written physician's order that must be signed by both the medical director and the patient's attending physician concurring with the patient's discharge or transfer from the facility;

(iv) Contacts another facility, attempts to place the patient there, and documents that effort; and

(v) Notifies the State survey agency of the involuntary transfer or discharge.

(5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure.

(g) Standard: Emergency coverage. (1) The governing body is responsible for ensuring that the dialysis facility provides patients and staff with written instructions for obtaining emergency medical care.

(2) The dialysis facility must have available at the nursing/monitoring station, a roster with the names of physicians to be called for emergencies, when they can be called, and how they can be reached.

(3) The dialysis facility must have an agreement with a hospital that can provide inpatient care, routine and emergency dialysis and other hospital services, and emergency medical care which is available 24 hours a day, 7 days a week. The agreement must:

(i) Ensure that hospital services are available promptly to the dialysis facility's patients when needed.

(ii) Include reasonable assurances that patients from the dialysis facility are accepted and treated in emergencies.

(h) Standard: Furnishing data and information for ESRD program administration. Effective February 1, 2009, the dialysis facility must furnish data and information to CMS and at intervals as specified by the Secretary. This information is used in a national ESRD information system and in compilations relevant to program administration, including claims processing and reimbursement, quality improvement, and performance assessment. The data and information must—

(1) Be submitted at the intervals specified by the Secretary;

(2) Be submitted electronically in the format specified by the Secretary;

(3) Include, but not be limited to—

(i) Cost reports;

(ii) ESRD administrative forms;

(iii) Patient survival information; and

(iv) Existing ESRD clinical performance measures, and any future clinical performance standards developed in accordance with a voluntary consensus standards process identified by the Secretary.

(i) Standard: Relationship with the ESRD network. The governing body receives and acts upon recommendations from the ESRD network. The dialysis facility must cooperate with the ESRD network designated for its geographic area, in fulfilling the terms of the Network's current statement of work. Each facility must participate in ESRD network activities and pursue network goals.

(j) Standard: Disclosure of ownership. In accordance with § 420.200 through § 420.206 of this chapter, the governing body must report ownership interests of 5 percent or more to its State survey agency.

(k) Standard: Disclosure to Insurers of Payments of Premiums. (1) Facilities that make payments of premiums for individual market health plans (in any amount), whether directly, through a parent organization (such as a dialysis corporation), or through another entity (including by providing contributions to entities that make such payments) must—

(i) Disclose to the applicable issuer each policy for which a third party payment described in this paragraph (k) will be made, and

(ii) Obtain assurance from the issuer that the issuer will accept such payments for the duration of the plan year. If such assurances are not provided, the facility shall not make payments of premiums and shall take reasonable steps to ensure such payments are not made by the facility or by third parties to which the facility contributes as described in this paragraph (k).

(2) If a facility is aware that a patient is not eligible for Medicaid and is not eligible to enroll in Medicare Part A and/or Part B except during the General Enrollment Period, and the facility is aware that the patient intends to enroll in Medicare Part A and/or Part B during that period, the standards under this paragraph (k) will not apply with respect to payments for that patient until July 1, 2017.

[73 FR 20475, Apr. 15, 2008, as amended at 81 FR 90228, Dec. 14, 2016]