16 Del. Admin. Code § 3330-4.0

Current through Register Vol. 28, No. 5, November 1, 2024

Section 3330-4.0 - Governing Body

4.1 Each dialysis center shall have an identified, organized governing body (governing authority, owner or person(s) designated by the owner) fully responsible for the organization, management, control, and operation of the facility.

4.2 The governing body responsibilities include, but are not limited to:

4.2.1 Appointing an administrator in writing;

4.2.1.1 The administrator exercises the responsibility for the management of the dialysis center and the provision of dialysis services, including but not limited to:

4.2.1.1.1 Maintenance of sound fiscal operations;

4.2.1.1.2 The relationship with the ESRD Network 4; and

4.2.1.1.3 Allocation of necessary staff and resources for the dialysis center's quality assessment and performance improvement program.

4.2.2 Appointing a qualified medical director (refer to subsection 5.2) in writing;

4.2.3 Appointing members of the medical and clinical staff, ensuring their competence and delineating their job responsibilities;

4.2.4 Ensuring all staff, including the medical director and medical staff, have appropriate orientation to the dialysis center and their work responsibilities;

4.2.5 Ensuring an adequate number of qualified personnel are present in the dialysis center whenever patients are undergoing dialysis;

4.2.6 Ensuring the registered nurse, social worker and dietitian of the interdisciplinary team are available to meet the patients' clinical needs;

4.2.7 Offering opportunities for continuing education and related development activities for all employees;

4.2.8 Establishing, adopting, implementing, and enforcing written policies and procedures for the total operation of and all services provided by the dialysis center;

4.2.9 Documentation of annual review and evaluation of the dialysis center policies and services;

4.2.10 Ensuring that all services, whether furnished directly or under contract, are provided in a safe and effective manner that permits the facility to comply with all applicable rules and standards;

4.2.11 Conducting meetings, when the governing body is more than one person, at least annually and maintaining written minutes of the meetings;

4.2.12 Adopting governing body and medical staff bylaws for the orderly development and management of the dialysis center;

4.2.12.1 Bylaws shall be reviewed annually by the governing body and so dated. Revisions shall be completed as necessary.

4.2.13 Ensuring a physical environment that protects the health and safety of patients, personnel, and the public;

4.2.14 Ensuring that all equipment utilized by dialysis center staff or by patients is properly used and maintained per manufacturer's recommendations;

4.2.15 Adopting, implementing and enforcing policies and procedures related to emergency planning and disaster preparedness. The governing body shall review the dialysis center's emergency preparedness plan, and associated policies and procedures at least annually;

4.2.16 Ensuring there is a quality assessment and performance improvement (QAPI) program to evaluate the provision of patient care. The governing body shall review and monitor QAPI activities quarterly;

4.2.17 Implementing an internal grievance process for patients to file an oral or written grievance with the dialysis center.

4.2.17.1 The dialysis center must ensure that there will be no reprisal or denial of services for any patient or patient representative that files a grievance.

4.2.17.2 The grievance process must include:

4.2.17.2.1 The procedure to submit a grievance;

4.2.17.2.2 Timeframes for the review of the grievance; and

4.2.17.2.3 An explanation of how the patient or patient representative will be informed of the steps taken to resolve the grievance.

4.2.18 Ensuring that all staff follow the dialysis center's involuntary discharge and transfer policies.

4.2.19 Ensuring emergency coverage;

4.2.19.1 The dialysis center must:

4.2.19.1.1 Provide patients and staff with written instructions for obtaining emergency medical care;

4.2.19.1.2 Have a written plan for physician coverage and contact numbers to be called for emergencies;

4.2.19.1.3 Have an agreement with a hospital that can promptly provide inpatient care, routine and emergency services which is available 24 hours a day, 7 days a week.

4.3 The governing body shall provide for full disclosure of ownership to the Department.

16 Del. Admin. Code § 3330-4.0

22 DE Reg. 853( 4/1/2019) (final)