12.4.1
Governing 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.
12.4.2
Administrator
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.
12.4.3
Medical
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.
12.4.4
Technical 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.
12.4.5
Personnel
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.
12.4.6
Affiliation 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.
12.4.7
Rights 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.
12.4.8
Disaster 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.
12.4.9
Uniform 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.