216-40-10 R.I. Code R. § 12.4

Current through June 12, 2024

Section 216-RICR-40-10-12.4 - Organization and management

12.4.1Governing Body and Management

A. Each facility shall have an organized governing body or other legal authority, responsible for:

1. the management and control of the operation;

2. the assurance of quality of care and services;

3. the conformity of the facility with all federal, state and local laws and regulations relating to fire, safety, sanitation, infection control; and

4. other relevant health and safety requirements and with all the rules and regulations herein.

B. The governing body or other legal authority shall provide appropriate physical resources and equipment and personnel required to meet the special needs of patients on chronic dialysis maintenance.

C. The governing body or other legal authority shall designate an administrator who will be responsible for the management and operation of the facility and a medical director to ensure achievement and maintenance of quality standards of professional practice.

D. The governing body shall adopt and maintain by-laws defining responsibilities and identifying purposes and means of fulfilling such, in addition to:

1. A statement relating to development and implementation of long range plans;

2. A statement of qualifications and responsibilities of the medical director and administrator;

3. A statement of the governing body's responsibilities for the quality of care and services;

4. A statement relating to conflict of interest on the part of the governing body, medical staff and employees;

5. A policy statement concerning publication of an annual report including a certified financial statement; and

6. Such other matters as may be relevant to the organization of the facility.

E. Financial Interest Disclosure

1. Any health care facility licensed pursuant to R.I. Gen. Laws Chapter 23-17, which refers clients to another such licensed health care facility or to a residential care/assisted living facility licensed pursuant to R.I. Gen. Laws Chapter 23-17.4, or to a certified adult day care program in which the referring entity has a financial interest shall, at the time a referral is made, disclose in writing the following information to the client:

a. that the referring entity has a financial interest in the facility or provider to which the referral is being made;

b. that the client has the option of seeking care from a different facility or provider which is also licensed and/or certified by the state to provide similar services to the client.

2. The referring entity shall also offer the client a written list prepared by the Department of Health of all such alternative licensed and/or certified facilities or providers. Said written list may be obtained by contacting:

Rhode Island Department of Health,

Division of Facilities Regulation

3 Capitol Hill, Room 306

Providence, RI 02908

401.222.2566

F. Non-compliance with §§12.5.1(E)(1) and (2) of this Part shall constitute grounds to revoke, suspend or otherwise discipline the licensee or to deny an application for licensure by the Director, or may result in imposition of an administrative penalty in accordance with R.I. Gen. Laws Chapter 23-17.10.

G. Pending and Actual Labor Disputes/Actions Health care facilities shall provide the licensing agency with prompt notice of pending and actual labor disputes/actions which would impact delivery of patient care services including, but not limited to, strikes, walk-outs, and strike notices. Health care facilities shall provide a plan, acceptable to the Director, for continued operation of the facility, suspension of operations, or closure in the event of such actual or potential labor dispute/action.

12.4.2Administrator

A. The governing body shall appoint a qualified administrator who may be the medical director, who shall be responsible for:

1. the management and operation of the facility;

2. the enforcement of policies, rules and regulations and statutory provisions pertaining to the health and safety of patients;

3. serving as liaison between the governing body and the staff; and

4. the planning, organizing and directing of such other activities as may be delegated by the governing body.

12.4.3Medical Director

A. The clinical services of the facility shall be under the direction of a physician licensed in Rhode Island who shall be trained in dialysis techniques, has an appointment in that specialty service at the affiliated hospital and who shall be responsible for no less than the following:

1. The coordination and supervision of all services;

2. The selection of patients for dialysis (either for chronic maintenance, self-care, or home dialysis) in accordance with criteria established with the technical advisory committee (see §12.5.4 of this Part);

3. The achievement and maintenance of quality assurance of professional practice;

4. The training of physicians, nurses and paramedical personnel in dialysis techniques; and

5. The establishment of provisions for infection control.

12.4.4Technical Advisory Committee

A. Each facility shall establish a Technical Advisory Committee with representatives from the affiliated hospital as defined in § 12.1 of this Part to serve as an advisory body to:

1. Determine the appropriateness of renal dialysis care, treatment procedures and policies and services delivered to patients;

2. Review adequacy of patient selection for care;

3. Review appropriateness of medical services provided including ancillary services; and

4. Make necessary recommendations to maintain quality care and services.

12.4.5Personnel

A. Each facility shall maintain a sufficient number of qualified personnel to provide effective patient care and other related services.

B. There shall be written personnel policies and procedures which shall be available to personnel.

C. A health care facility shall require all persons, including students, who examine, observe, or treat a patient or resident of such facility to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure/registration status, if any, and staff position of such person.

D. Health Screening

Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient in the kidney disease treatment center. Such health screening shall be conducted in accordance with the rules and regulations pertaining to "Immunization, Testing, and Health Screening for Health Care Workers" promulgated by the Department of Health.

12.4.6Affiliation and Transfer Agreement

A. There shall be evidence of a current contractual arrangement with a licensed hospital for the provision of services as defined in § 12.1 of this Part. Said contract shall clearly define the mutual responsibilities and relationships of parties involved and shall include reasonable assurance of:

1. Transfer or referral of patients as medically determined with timely acceptance and admission; and

2. Transfer of patient care plans and other necessary medical information.

B. Arrangement with any other agency or facility for the provision of such services, such as laboratory, radiology or other, shall be with a facility which maintains quality standards and is certified or licensed as may be required by statute.

12.4.7Rights of Patients

Each facility shall observe the standards with respect to each patient admitted to its facility as enumerated in R.I. Gen. Laws § 23-17-19.1.

12.4.8Disaster Preparedness

A. Each facility shall develop and maintain a written disaster preparedness plan which shall include specific provisions and procedures for the emergency care of patients in the event of fire, natural disaster or functional failures of internal systems and/or equipment.

1. Such a plan shall be developed and coordinated with appropriate state and local agencies and representatives concerned with emergency safety and rescue and with representatives of the affiliate hospital.

2. A copy of such plan shall be submitted to the licensing agency.

3. Each facility shall develop a plan, approved and adopted by the governing board and consistent with the requirements of this section, to address the year 2000 computer/chip problem ("Y2K") by September 30, 1999 and must test such plan by October 30, 1999.

a. The plan shall include, at a minimum, facility identification of potential problem areas, remediation of identified problems, and testing for functionality, and shall also include consideration of vendor and supplier compliance.

B. Simulated drills testing the effectiveness of the plan shall be conducted at least semi-annually. Written reports and evaluation of all drills shall be maintained by the facility.

C. Fully equipped emergency trays including emergency drugs, and medical supplies sufficient to meet the emergency needs of the facility shall be available at all times on the premises.

D. Emergency steps of action shall be clearly outlined and posted in conspicuous locations throughout the facility.

12.4.9Uniform Reporting System

A. Each facility shall establish and maintain records and data in such a manner as to make uniform the system of periodic reporting. The manner in which the requirements of this regulation may be met shall be prescribed from time to time in directives promulgated by the Director with the advice of the Health Services Council.

B. Each facility shall report to the licensing agency detailed financial and statistical data pertaining to its operation, services, and facility. Such reports shall be made at such intervals and by such dates as determined by the Director and shall include but not be limited to the following:

1. Utilization of services;

2. Unit of cost of services;

3. Charges for services;

4. Financial condition of the kidney disease treatment center; and

5. Quality of care.

C. The licensing agency is authorized to make the reported data available to any state agency concerned with or exercising jurisdiction over the reimbursement of the facility.

D. The directives promulgated by the Director pursuant to these regulations shall be sent to each facility to which they apply. Such directives shall prescribe the form and manner in which the financial and statistical data required shall be furnished to the licensing agency.

216 R.I. Code R. § 216-RICR-40-10-12.4

Amended effective 9/28/2023
Amended effective 12/24/2023