216-RICR-40-10-9
216-RICR-40-10-9. Licensing of Freestanding Emergency Care Facilities (version Amendment, 08/04/2002 to 04/07/2005)
RULES AND REGULATIONS
FOR THE LICENSING OF
FREESTANDING EMERGENCY CARE FACILITIES
(R23-17-FECF)
STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS
Department of Health
December 1981
As amended:
June 1981 (E)
October 1981(E)
April 1982
August 1982
February 1984 (E)
June 1984 (E)
February 1985
September 1987
January 1991 (E)
April 1991
December 1993
February 1998
January 2000
January 2002 (re-filing in accordance with
the provisions of section 42-35-4.1 of the
Rhode Island General Laws, as amended)
July 2002
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INTRODUCTION
These Rules and Regulations for the Licensing of Freestanding Emergency Care Facilities
(R23-17-FECF) are promulgated pursuant to the authority conferred under section 23-17-10 of the
General Laws of Rhode Island, as amended, and are established for the purpose of adopting minimal
standards for the licensing of Freestanding Emergency Care Facilities in this State.
Pursuant to the provisions of section 42-35 3(C) of the General Laws of Rhode Island, as
amended, the following were given consideration in arriving at the regulations: (a) alternative
approaches to the regulations; (b) duplication or overlap with other state regulations; and (c) significant
economic impact on facilities. No alternative approach was identified. The protection of the health,
safety and welfare of the public necessitates the adoption of the regulations despite the economic impact
which may be incurred as a result of the regulations.
These rules and regulations shall supercede any previous rules and regulations promulgated by
the Department of Health and filed with the Secretary of State.
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TABLE OF CONTENTS
Page
PART I
Licensing Procedures and Definitions
1
1.0
Definitions
1
2.0
General Requirements for Licensure
2
3.0
Application for License
3
4.0
Issuance and Renewal of License
3
5.0
Inspections
7
6.0
Denial, Suspension, Revocation of License or Curtailment of Activities
7
PART II
Organization and Management
9
7.0
Governing Body and Management
9
8.0
Administrator
9
9.0
Medical Director
10
10.0
Personnel
10
11.0
Rights of Patients
11
12.0
Disaster Preparedness
11
13.0
Administrative Records
11
14.0
Uniform Reporting System
12
PART III
Emergency Care Services
13
15.0
Management Services
13
16.0
Supportive Services
14
17.0
Medical Records
14
18.0
Medical Equipment and Supplies
15
PART IV
Physical Plant and Equipment
16
19.0
New Construction
16
20.0
Physical Facility
16
21.0
Environmental Maintenance
16
PART V
Practices and Procedures, Confidentiality and Severability
18
22.0
Variance Procedure
18
23.0
Deficiencies and Plans of Correction
18
24.0
Rules Governing Practices and Procedures
18
25.0
Confidentiality
19
26.0
Severability
19
PART VI
References
20
1
PART I
LICENSING PROCEDURES AND DEFINITIONS
Section 1.0 Definitions
Wherever used in these rules and regulations the following terms shall be construed as follows:
1.1
"Freestanding Emergency Care Facility" hereinafter referred to as FECF, means an
establishment, place or facility which may be a public or private organization, structurally
distinct and separate from a hospital, staffed, equipped and operated to provide prompt
emergency medical care as defined in section 1.2 herein.
1.2
"Emergency Medical Care" shall mean services provided for a medical condition that is
manifested by symptoms of sufficient severity that, in the absence of immediate medical
attention, could result in placing health in jeopardy, serious impairment to bodily functions,
serious dysfunction of any bodily organ or part, or development or continuance of severe pain.
1.3
"Director" shall mean the Director of the Rhode Island Department of Health.
1.4
"Licensing Agency" shall mean the Rhode Island Department of Health.
1.5
"Person" shall mean any individual, trust or state, partnership, corporation (including
associations, joint stock companies) state, or political subdivisions or instrumentality of the
state.
1.6
"Physician" shall mean an individual licensed under the provisions of Chapter 5-37 of the
General Laws of Rhode Island, as amended, to practice medicine or osteopathy in this state.
1.7
"Change in owner" means:
(1)
in the case of an FECF which is a partnership, the removal, addition or substitution of
a partner which results in a new partner acquiring a controlling interest in such
partnership;
(2)
in the case of an FECF which is an unincorporated solo proprietorship, the transfer of
the title and property to another person;
(3)
in the case of an FECF which is a corporation;
a)
a sale, lease, exchange or other disposition of all, or substantially all of the
property and assets of the corporation; or
b)
a merger of the corporation into another corporation; or
c)
the consolidation of two or more corporations, resulting in the creation of a new
corporation; or
d)
in the case of an FECF which is a business corporation, any transfer of corporate
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stock which results in a new person acquiring a controlling interest in such
corporation; or
e)
in the case of an FECF facility which is a non-business corporation, any change
in membership which results in a new person acquiring a controlling vote in
such corporation.
1.8
"Change in operator" means a transfer by the governing body or operator of an FECF to any
other person(excluding delegations of authority to the medical or administrative staff of the
facility) of the governing body's authority to:
a)
hire or fire the chief executive officer of the FECF;
b)
maintain and control the books and records of FECF;
c)
dispose of assets and incur liabilities on behalf of the FECF; or
d)
adopt and enforce policies regarding operation of the FECF.
This definition is not applicable to circumstances wherein the governing body of an FECF
retains the immediate authority and jurisdiction over the activities enumerated in subsections
(a) through (d) herein.
1.9
“Equity” means non-debt funds contributed towards the capital costs related to an initial
licensure or change in owner or change in operator of a freestanding emergency care facility
which funds are free and clear of any repayment or liens against the assets of the proposed
owner and/or licensee and that result in a like reduction in the portion of the capital cost that is
required to be financed or mortgaged.
Section 2.0 General Requirements for Licensure
2.1
No person acting severally or jointly with any other person, shall establish, conduct or maintain
a FECF in this state without a license in accordance with the requirements of section 23-17-4
of reference 1 and section 23-15-4 of reference 14, and shall meet the requirements of the rules
and regulations herein.
2.2
a)
No person or facility shall represent itself as a Freestanding Emergency Care Facility or
except in the case of licensed hospitals, shall use the term "emergency" in its title,
advertising, publications or other form of communication, unless licensed as a
freestanding emergency care facility in accordance with the provisions herein.
b)
A facility licensed as a Freestanding Emergency Care Facility must include in a
prominent manner in all its advertising, publications, signs or other forms of
communication the following:
i.
the term "freestanding", to distinguish the emergency care facility from that of
a hospital emergency care service of reference 15; and
ii.
days and hours of the facility's operation.
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2.3
Pursuant to section 23-17-26 of reference 1, a freestanding emergency care facility shall provide
to every person prompt lifesaving medical care treatment in an emergency without
discrimination on account of economic status or source of payment and without delaying
treatment for the purpose of prior discussion of source of payment unless such delay can be
imposed without material risk to the health of the person.
Section 3.0 Application for License, Initial License, or Changes in Owner, Operator, or Lessee
3.1
Application for a license to conduct, maintain or operate, a FECF shall be made to the licensing
agency upon forms provided by it, and shall contain such information as the licensing agency
reasonably requires, including but not limited to evidence of ability to comply with the
provisions of reference 1 and the rules and regulations herein.
3.2
A notarized listing of names and addresses of direct and indirect owners whether individual,
partnership or corporation with percentages of ownership designated shall be provided with the
application for licensure and shall be updated annually. The list shall include each owner (in
whole or in part) of any mortgage, deed or trust, note or other obligation secured (in whole or
in part) by the FECF or any of the property or assets of the FECF. The list shall also include
all officers, directors and other persons or any subsidiary corporation owning stock, if the FECF
is organized as a corporation, and all partners if the FECF is organized as a partnership.
3.3
Application for initial licensure or change in owner, operator, or lessee of an FECF shall be
made on forms provided by the licensing agency and shall contain but not be limited to
information pertinent to the statutory purpose expressed in section 23-17-3 of Chapter 23-17 or
the considerations enumerated in section 4.4 herein. Twenty-five (25) copies of such
applications are required to be provided.
3.3.1
Each application filed pursuant the provisions of this section shall be accompanied by
an application fee, made payable to the Rhode Island General Treasurer, as follows:
applicants shall submit a fee equal to one tenth of one percent (0.1%) of the projected
annual facility net operating revenue contained in the application; provided, however,
that the minimum fee shall be five hundred dollars ($500) and the maximum fee shall
not exceed ten thousand dollars ($10,000).
Section 4.0 Issuance and Renewal of License
4.1
Upon receipt of an application for a license, the licensing agency shall issue a license or renewal
thereof for a period of no more than one (1) year, if the applicant meets the requirements of
reference 1 and the rules and regulations herein. Said license, unless sooner suspended or
revoked, shall expire by limitation on the 31st day of December following its issuance and may
be renewed from year to year subject to inspection and approval by the licensing agency.
4.2
A license shall be issued to a specific licensee for a specific location and shall not be
transferable. The license shall be issued only for the premises and the individual owner,
operator or lessee, or to the corporate entity responsible for its governance.
4.2.1 Any initial license or any change in owner, operator, or lessee of a licensed FECF shall
require prior review by the Health Services Council and approval of the licensing agency
as provided in section 4.3 and 4.4, or for expedited reviews conducted pursuant to
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sections 4.7 and 4.8, as a condition precedent to the transfer, assignment, or issuance
of a new license.
4.3
Except for expedited reviews conducted pursuant to sections 4.7 and 4.8, reviews of applications
for initial licensure or for changes in the owner, operator, or lessee of licensed FECF shall be
conducted according to the following procedures:
a)
Within ten (10) working days of receipt, in acceptable form, of an application for initial
licensure or for a license in connection with a change in the owner, operator or lessee
of an existing FECF, the licensing agency will notify and afford the public thirty (30)
days to comment on such application.
b)
The decision of the licensing agency will be rendered within ninety (90) days from
acceptance of the application.
4.4
Except as otherwise provided in Chapter 23-17 of the General Laws of Rhode Island, as
amended, a review by the Health Services Council of an application for an initial license or for
a license in the case of a proposed change in the owner, operator, or lessee of a licensed
Freestanding Emergency Care Facility may not be made subject to any criterion unless the
criterion directly relates to the statutory purpose expressed in section 23-17.3 of the General
Laws. In conducting reviews of such applications the Health Services Council shall specifically
consider and it shall be the applicant’s burden of proof to demonstrate:
4.4.1
the character, commitment, competence, and standing in the community of the proposed
owners, operators, or directors of the FECF as evidenced by:
(A)
In cases where the proposed owners, operators, or directors of the health care facility
currently own, operate, or direct a health care facility, or in the past five years owned,
operated or directed a health care facility, whether within or outside Rhode Island, the
demonstrated commitment and record of that (those) person(s):
(i)
in providing safe and adequate treatment to the individuals receiving the health
care facility's services;
(ii)
in encouraging, promoting and effecting quality improvement in all aspects of
health care facility services; and
(iii)
in providing appropriate access to health care facility services;
(B)
A complete disclosure of all individuals and entities comprising the applicant; and
(C)
The applicant’s proposed and demonstrated financial commitment to the health care
facility;
4.4.2 the extent to which the facility will provide or will continue without material effect on
its viability at the time of change of owner, operator, or lessee to provide safe and
adequate treatment for individuals receiving the FECF services as evidenced by:
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(A) The immediate and long term financial feasibility of the proposed financing plan;
(i)
The proposed amount and sources of owner's equity to be provided by the
applicant;
(ii)
The proposed financial plan for operating and capital expenses and
income for the period immediately prior to, during and after the
implementation of the change in owner, operator or lessee of the health
care facility;
(iii)
The relative availability of funds for capital and operating needs;
(iv)
The applicant's demonstrated financial capability;
(v)
Such other financial indicators as may be requested by the state agency;
4.4.3
the extent to which the facility will provide or will continue to provide safe and adequate
treatment for individuals receiving the FECF services and the extent to which the facility
will encourage quality improvement in all aspects of the operation of the health care
facility as evidenced by:
(A)
the credibility and demonstrated or potential effectiveness of the applicant's proposed
quality assurance programs;
4.4.4
the extent to which the facility will provide or will continue to provide appropriate
access with respect to traditionally undeserved populations as evidenced by:
(A)
In cases where the proposed owners, operators, or directors of the health care facility
currently own, operate, or direct a health care facility, or in the past five years owned,
operated or directed a health care facility, both within and outside of Rhode Island, the
demonstrated record of that person(s) with respect to access of traditionally under served
populations to its health care facilities; and
(B)
The proposed immediate and long term plans of the applicant to ensure adequate and
appropriate access to the programs and health care services to be provided by the health
care facility.
4.4.5
in consideration of the proposed continuation or termination of emergency, primary
and/or other core health care services by the FECF:
(A)
The effect(s) of such continuation or termination on the provision of access to safe and
adequate treatment of individuals, including but not limited to traditionally underserved
populations.
4.4.6
And in cases where the application involves a merger, consolidation or otherwise legal
affiliation of two or more health care facilities, the proposed immediate and long term
plans of such health care facilities with respect to the health care programs to be offered
and health care services to be provided by such health care facilities as a result of the
merger, consolidation or otherwise legal affiliation.
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4.5
Subsequent to reviews conducted under sections 4.3, 4.4, 4.7, and 4.8 of these regulations, the
issuance of a license by the licensing agency may be made subject to any condition, provided
that no condition may be made unless it directly relates to the statutory purpose expressed in
section 23-17-3 of the Rhode Island General Laws, as amended, or to the review criteria set
forth in section 4.4 herein. This shall not limit the authority of the licensing agency to require
correction of conditions or defects which existed prior to the proposed change of owner,
operator, or lessee and of which notice has been given to the FECF by the licensing agency.
4.6
A license issued hereunder shall be the property of the state and loaned to such licensee and it
shall be kept posted in a conspicuous place on the licensed premises.
4.7
Applicants for initial licensure may, at the sole discretion of the licensing agency, be reviewed
under expedited review procedures established in section 4.8 if the licensing agency determines
(a) that the legal entity seeking licensure is the licensee for one or more health care facilities
licensed in Rhode Island pursuant to the provisions of Chapter 23-17 whose records of
compliance with licensure standards and requirements are deemed by the licensing agency to
demonstrate the legal entity’s ability and commitment to provide quality health services; and
(b) that the licensure application demonstrates complete and satisfactory compliance with the
review criteria set forth in set forth in section 4.4 herein.
4.8
Expedited reviews of applications for initial licensure of freestanding emergency care facilities
shall be conducted according to the following procedures:
a)
Within ten (10) working days of receipt, in acceptable form, of an application for initial
licensure the licensing agency will determine if such application will be granted
expedited review and the licensing agency will notify the public of the licensing
agency’s initial assessment of the application materials with respect to the review
criteria in section 4.4 as well as the licensing agency’s intent to afford the application
expedited review. At the same time the licensing agency will afford the public a twenty
(20) day period during which the public may review and comment on the application
and the licensing agency’s initial assessment of the application materials and the
proposal to afford the application expedited review.
b)
Written objections from affected parties directed to the processing under the expedited
procedures and/or the satisfaction of the review criteria shall be accepted during the
twenty (20) day comment period. Objections must provide clear, substantial and
unequivocal rationale as to why the application does not satisfy the review criteria
and/or why the application ought not to be processed under the expedited review
mechanism. The licensing agency may propose a preliminary report on such application
provided such proposed report incorporates findings relative to the review criteria set
forth in section 4.4. The Health Services Council may consider such proposed report and
may provide its advisory to the Director of Health by adopting such report in amended
or unamended form. The Health Services Council, however, is not bound to recommend
to the Director that the application be process under the provisions for expedited review
as delineated in sections 4.7 and 4.8. The Health Services Council shall take under
advisement all objections both to the merits of the application and to the proposed
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expedited processing of the proposed application and shall make a recommendation to
the Director regarding each. Should the Health Services Council not recommend to the
Director that the application be processed under expedited review procedures as initially
proposed, such application may continue to be processed consistent with the time frames
and procedures for applications not recommended for expedited review. If expedited
review is not granted, then the comment period may be forthwith extended consistent
with the time frames in section 4.3 for applications not proposed for expedited review.
The Director, with the advice of the Health Services Council, shall make the final
decision either to grant or to deny expedited review and shall make the final decision to
grant or to deny the application on the merits within the expedited review mechanism
and time frames.
Section 5.0 Inspections
5.1
The licensing agency shall make or cause to be made such inspections and investigations, as it
deems necessary, in accordance with section 23-17-10 of reference 1 and the rules and
regulations herein.
5.2
Every FECF shall be given prompt notice by the licensing agency of any deficiencies reported
as a result of an inspection or investigation.
Section 6.0 Denial, Suspension, Revocation of License or Curtailment of Activities
6.1
The licensing agency is authorized to deny, suspend or revoke the license of or to curtail the
activities of any FECF which:
(1)
has failed to comply with the rules and regulations pertaining to the licensing of FECFs;
and
(2)
has failed to comply with the provisions of reference 1.
6.1.1
Reports of deficiencies noted in inspections conducted in accordance with section 5.0
herein shall be maintained on file in the licensing agency, and shall be considered by the
licensing agency in rendering determinations to deny, suspend or revoke the license or
to curtail activities of a FECF.
6.2
Whenever an action shall be proposed to deny, suspend or revoke the license of or to curtail the
activities of a FECF, the licensing agency shall notify the FECF by certified mail, setting forth
reasons for the proposed action, and the applicant or licensee shall be given an opportunity for
a prompt and fair hearing in accordance with section 23-17-8 of reference 1 and section 42-35-9
of reference 11 and in accordance with the provisions of section 23.0 herein.
6.2.1
However, if the licensing agency finds that public health, safety or welfare imperatively
requires emergency action and incorporates a finding to that effect in its order, the
licensing agency may order summary suspension of license or curtailment of activities
pending proceedings for revocation or other action in accordance with section 23-1-21
of reference 12 and section 42-35-14 (c) of reference 11.
6.3
The appropriate state and federal agencies shall be notified of any action taken by the licensing
8
agency pertaining to either denial, suspension, or revocation of license or curtailment of
activities.
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PART II
ORGANIZATION AND MANAGEMENT
Section 7.0 Governing Body and Management
7.1
Each facility shall have an organized governing body or equivalent legal authority ultimately
responsible for: (1) the management and control of the operation; (2) the assurance of the
quality of care and services; (3) the compliance with all federal, state and local laws and
regulations; and (4)other relevant health and safety requirements including the rules and
regulations herein.
7.2
The governing body or equivalent legal authority shall provide appropriate personnel, physical
resources, and equipment for the delivery of safe and effective emergency medical care.
7.3
The governing body or equivalent legal authority shall designate; (a) an administrator who shall
be responsible for the management and operation of the facility; and (b) a medical director to
ensure achievement and maintenance of quality standards of professional practice.
7.4
The governing body or equivalent legal authority shall adopt and maintain by-laws defining
responsibilities for the operation and performance of the organization, identifying purposes and
means of fulfilling each. In addition, the governing body shall establish administrative policies
pertaining to no less than the following:
a)
qualifications and responsibilities of the medical director and administrator;
b)
the plan of the governing body for the implementation of long and short range plans as
prescribed by the Director in accordance with reference 1; and
c)
such other matters as may be relevant to the organization and operation of the FECF.
7.5
The governing body or other legal authority shall be responsible through the organization's
by-laws, policies, or other mechanism to determine the qualifications of physicians and other
professionals as required herein, considering such factors as education, training, experience,
board certification, eligibility to sit for examination of specialty board, evidence of current
professional practice and licensure as may be required by law or regulation, the relevant
qualifications required in section 10.0 herein and such other relevant factors as may be deemed
necessary.
Section 8.0 Administrator
8.1
The governing body or equivalent legal authority shall appoint an administrator (who may also
be the medical director), who shall be operationally responsible for: (1) the management and
operation of the FECF; (2) the compliance with 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.
Section 9.0 Medical Director
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9.1
The FECF shall have a physician licensed in this state, who shall serve as Medical Director and
be responsible for no less than the following:
a)
coordination and supervision of emergency medical care services;
b)
the achievement and maintenance of quality assurances of professional practice through
a mechanism of peer review; and
c)
the establishment of policies and procedures for emergency medical care services and
other related emergency health care services.
Section 10.0 Personnel
10.1
Each FECF shall be staffed by a licensed physician(s) who has certification, as defined in section
10.2 herein, and full licensure and who shall be present within the facility during the hours of
operation.
10.2
At least one physician on duty during the hours of operation shall be:
a)
Certified or Board Eligible by the American Board of Emergency Medicine or the
American Board of Osteopathic Emergency Medicine; OR
b)
Certified or Board Eligible to sit for the examination of one of the following boards:
Internal Medicine, Family Practice, or Surgery; AND must hold a certificate from the
following approved programs: Advanced Coronary Life Support; Advanced Trauma Life
Support; Pediatric Advanced Life Support.
10.3
No less than one licensed registered nurse who has training and experience in emergency care
shall be on duty during the hours of operation.
10.4
Every freestanding emergency care facility shall have a person qualified by training and
experience on the premises during the hours of operation who shall determine the nature, level
and urgency of care required of all persons seeking treatment and to categorize them
accordingly, assuring that serious cases are accorded priority treatment. If such person is a
non-physician, he or she shall serve under the supervision of the physician-in-charge and in
accordance with policies and procedures acceptable to the governing body or other legal
authority.
10.5
Each FECF shall establish a protocol to govern the interpretation by a radiologist, of diagnostic
images produced by x-ray or other modalities, including a procedure for the prompt
communication of the radiologist's interpretation to the facility.
10.6
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.
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Health Screening
10.7
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 freestanding
emergency care facility. Such health screening shall be conducted in accordance with the Rules
and Regulations Pertaining to Immunization, Testing, and Health Screening for Health Care
Workers (R23-17-HCW) promulgated by the Department of Health.
Section 11.0 Rights of Patients
11.1
Each FECF shall observe the standards of section 23-17-19.1 of reference 1 with respect to each
patient.
11.2
Each facility shall display in a conspicuous place in the licensed FECF a copy of the "Rights of
Patients."
Section 12.0 Disaster Preparedness
12.1
Each FECF shall develop and maintain a written disaster preparedness plan which shall include
specific provisions and procedures for the emergency medical care of patients in the event of
an external disaster or internal functional failure of equipment.
a)
Such plan shall be developed in cooperation with appropriate state and local agencies.
b)
A copy of the plan shall be submitted to the licensing agency.
Section 13.0 Administrative Records
13.1
Each FECF shall maintain such administrative records as may be deemed necessary by the
licensing agency. These records shall include but not be limited to:
a)
monthly statistical summary of numbers of patients seen appropriately classified as to
the nature of the conditions;
b)
a copy of the long and short range plans;
c)
an administrative record of log book containing pertinent data such as patient's name,
record number, age, sex, date and time of arrival and discharge, type of care, diagnosis
and disposition, and provider of service.
d)
a record of all transfers to other health facilities.
Section 14.0 Uniform Reporting System
14.1
Each FECF shall establish and maintain records and data in such a manner as to make uniform
12
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.
14.2
Each FECF shall make available for review upon request of the licensing agency detailed
statistical data pertaining to its operations, services, and facility. Such reports and data shall be
made at such intervals and by such dates as determined by the Director.
14.3
The licensing agency is authorized to make the reported data available to any state or federal
agency concerned with or exercising jurisdiction over the FECF.
14.4
The directives promulgated by the Director pursuant to these regulations shall be sent to each
FECF to which they apply. Such directives shall prescribe the form and manner in which the
statistical data required shall be furnished to the licensing agency.
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PART III
EMERGENCY CARE SERVICES
Section 15.0 Management Services
15.1
Each FECF shall provide emergency care service with professional and ancillary staff to ensure
that all persons treated are released or transferred within a reasonable and appropriate length of
time. No patient shall be held over-night.
15.2
Policies and procedures pertaining to the provision of emergency medical care services and
supported by appropriate manuals and reference material shall be established by the Medical
Director and approved by the governing body. Such policies and procedures shall pertain to no
less than the following:
a)
the responsibility of the medical staff for emergency patient care;
b)
medical circumstances under which definitive care cannot be provided and procedures
for referral;
c)
procedures that may and may not be performed in the FECF;
d)
procurement, storage and administration of drugs and medications in accordance with
references 8 and 9;
e)
disposal of hypodermic needles, syringes and instruments in accordance with the
requirements of reference 10;
f)
handling of persons who are emotionally ill, under the influence of drugs or alcohol,
dead on arrival, or other categories of special care;
g)
procedures for early transfer of severely ill or injured to hospital;
h)
written instructions to be given to the patient to assure continuity of care;
i)
notification of patient's personal physician and transmission of relevant reports per
written consent of patient;
j)
disclosure of patient information in accordance with federal and state law;
k)
location and storage of supplies and special equipment; and
l)
pursuant to section 23-17-26 of reference 1 the provision of prompt emergency medical
care for every person in an emergency without discrimination on account of economic
status or source of payment and without delaying treatment for the purpose of prior
discussion of source of payment unless such delay can be imposed without material risk
to the health of the person.
Section 16.0 Supportive Services
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16.1
Each FECF shall provide on the premises during hours of operation, the following:
a)
clinical laboratory services: - must be provided on the premises of the FECF subject to
the provisions of section 23-16.2-3 of the General Laws of Rhode Island, as amended;
and
b)
diagnostic radiology services which meet the requirements of section 10.4 herein and
reference 3.
i)
Mammography
All aspects of mammography services shall be managed in accordance with the
provisions of the Rules and Regulations Related to Quality Assurance Standards
for Mammography (R23-1-MAM) of the Rhode Island Department of Health.
Section 17.0 Medical Records
17.1
A medical record shall be maintained on every patient provided emergency care.
17.2
For each visit to the emergency facility the medical record shall contain documentation relating
to the following:
a)
patient identification (name, address, age and sex);
b)
time and means of arrival;
c)
pertinent medical history of the illness or injury and physical findings;
d)
emergency care given before arrival;
e)
diagnostic and therapeutic orders;
f)
reports of procedures, tests and findings;
g)
diagnostic impression;
h)
conclusion at termination of evaluation/treatment, including final disposition of patient's
condition on discharge or transfer and any instructions given for follow-up care;
i)
a patient's leaving against medical advice; and
j)
origin of incoming patient and destination of patient at discharge.
17.3
All medical records either original or accurate reproductions shall be preserved for a minimum
of five (5) years, except that records of minors shall be kept for at least five (5)years after such
minor shall have reached the age of 18 years.
15
Section 18.0 Medical Equipment and Supplies
18.1
No less than the following special supplies and equipment shall be available and located within
the emergency service area:
i.
oxygen;
ii.
electrocardiograph;
iii.
cardiac monitor and defibrillator with battery pack;
iv.
pacemaker insertion set-up; external pacemaker
v.
central venous catheter set-up;
vi.
gastric lavage equipment;
vii.
suction device;
viii.
intravenous fluids and administration devices;
ix.
endotracheal intubation, and tracheostomy trays; and
x.
emergency obstetrical pack.
18.2
Medical equipment and supplies for the reception, appraisal, examination, treatment and
observation of patients shall be determined by the amount, type and extensiveness of services
provided.
18.3
The emergency drug cart(s) and adjunctive emergency equipment shall be checked by an
appropriate, designated individual as per written procedures after each use to assure that all
items required for immediate availability are actually contained in the cart and are in usable
condition.
16
PART IV
PHYSICAL PLANT AND EQUIPMENT
Section 19.0 New Construction
19.1
All new construction shall be subject to the provisions of references 2, 4, 5, and 6.
19.2
In addition, any other applicable state and local laws, codes and regulations shall apply. (Where
there is a difference between codes, the code having the more stringent standard shall apply.)
Section 20.0 Physical Facility
20.1
The FECF shall be designed and equipped to facilitate the reception, examination, treatment and
observation of patients, in accordance with prevailing standards, safeguarding the dignity and
privacy of patients and their families to the extent consistent with providing emergency medical
care and with efficient administration.
20.2
In existing facilities, unless a variance is granted by the licensing agency, the same standards
as specified above in section 19.0 for new construction shall apply.
20.3
The entrance of the FECF shall be clearly identified externally and shall be accessible to
emergency vehicles and pedestrian traffic. All entrance doors shall be well lighted, wide enough
to accommodate patients, attendants and equipment. A ramp shall be provided for wheelchair
and stretcher patients when the use of stairs would be required otherwise.
Section 21.0 Environmental Maintenance
21.1
The FECF shall be maintained and equipped to provide a sanitary, safe and comfortable
environment, with all furnishings in good repair, and the premises shall be kept free of hazards.
21.2
Written policies and procedures shall be established to assure comfortable, safe and sanitary
environment and appropriate lighting throughout the facility.
21.3
Appropriate equipment and supplies to clean the facility shall be maintained in a safe, sanitary
condition.
21.4
Hazardous cleaning solutions, compounds and substances shall be labeled, stored in a safe place
and kept in an enclosed section separate from other cleaning materials.
21.5
Smoking shall be permitted only in designated areas.
Section 21.6 Waste Disposal
21.6.1
Infectious Waste
Infectious waste as defined in the Rules and Regulations Governing the Generation, Transportation,
Storage, Treatment, Management & Disposal of Regulated Medical Waste in Rhode Island (DEM-
DAH-MW-01-92),Rhode Island Department of Environmental Management (June 1994), shall be
17
managed in accordance with the provisions of the aforementioned regulations.
21.6.2
Other Waste
Wastes which are not classified as infectious waste, hazardous wastes, or which are not
otherwise regulated bylaw or rule may be disposed in dumpsters or load packers provided the
following precautions are maintained:
a)
Dumpsters shall be tightly covered, leak proof, inaccessible to rodents and animals, and
placed on concrete slabs preferably graded to a drain. Water supply shall be available
within easy accessibility for washing down of the area. In addition, the pick-up schedule
shall be maintained with more frequent pick-ups when required. The dumping site of
waste materials must be in sanitary landfills approved by the Department of
Environmental Management.
b)
Load packers must conform to the same restrictions required for dumpsters and in
addition, load packers shall be:
c)
high enough off the ground to facilitate the cleaning of the underneath areas of the
stationary equipment; and
d)
the loading section shall be constructed and maintained to prevent rubbish from blowing
from said area site.
18
PART V PRACTICES AND PROCEDURES, CONFIDENTIALITY AND SEVERABILITY
Section 22.0 Variance Procedure
22.1
The licensing agency may grant a variance either upon its own motion or upon request of the
applicant from the provisions of any rules and regulation herein, if it finds in specific cases, that
a literal enforcement of such provision will result in unnecessary hardship to the applicant and
that such a variance will not be contrary to the public interest, public health and/or health and
safety of patients.
22.2
A request for a variance shall be filed by an applicant in writing, setting forth in detail the basis
upon which the request is made.
22.2.1 Upon filing of each request for variance with the licensing agency and within thirty (30)
days thereafter, the licensing agency shall notify the applicant by certified mail of its
approval or in the case of a denial, a hearing date, time and place may be scheduled if
the facility appeals the denial. Such hearing must be held in accordance with the
provisions of section 23.0 herein.
Section 23.0 Deficiencies and Plans of Correction
23.1
The licensing agency shall notify the governing body or other legal authority of a facility of
violations of individual standards through a notice of deficiencies which shall be forwarded to
the facility within fifteen (15) days of inspection of the facility unless the director determines
that immediate action is necessary to protect the health, welfare, or safety of the public or any
member thereof through the issuance of an immediate compliance order in accordance with
Section 23-1-21 of the General Laws of Rhode Island, as amended.
23.2
A facility which received a notice of deficiencies must submit a plan of correction to the
licensing agency within fifteen (15) days of the date of the notice of deficiencies. The plan of
correction shall detail any requests for variances as well as document the reasons therefore.
23.3
The licensing agency will be required to approve or reject the plan of correction submitted by
a facility within fifteen (15) days of receipt of the plan of correction.
23.4
If the licensing agency rejects the plan of correction, or if the facility does not provide a plan of
correction within the fifteen (15) day period, or if a facility whose plan of correction has been
approved by the licensing agency fails to execute its plan within a reasonable time, the licensing
agency may invoke the sanctions enumerated in Section 6.0 herein. If the facility is aggrieved
by the action of the licensing agency, the facility may appeal the decision regarding sanctions
and request a hearing in accordance with Chapter 42-35 of the General Laws.
Section 24.0 Rules Governing Practices and Procedures
24.1
All hearings and reviews required under the provisions of Chapter 23-17 of the General Laws
of Rhode Island, as amended, shall be held in accordance with the provisions of the rules and
regulations promulgated by the Rhode Island Department of Health entitled Rules and
19
Regulations of the Rhode Island Department of Health Regarding Practices and Procedures
Before the Department of Health and Access to Public Records of the Department of Health
(R42-35-PP) of reference 13.
Section 25.0 Confidentiality
25.1
Disclosure of any health care information relating to individuals shall be subject to the
provisions of the Confidentiality Act of reference 7 and other relevant statutory and federal
requirements.
Section 26.0 Severability
26.1
If any provision of the rules and regulations herein or the application to any facility or
circumstances shall be held invalid, such invalidity shall not affect the provisions or application
of the rules and regulations which can be given effect, and to this end the provisions of the rules
and regulations are declared to be severable.
20
PART VI
REFERENCES
1.
"Licensing of Health Care Facilities," Chapter 23-17 of the General Laws of Rhode Island as
amended.
2.
"NFPA Publication 56A, 1975," National Fire Protection Association, 470 Atlantic Avenue,
Boston, Massachusetts 02210.
3.
Rules and Regulations for the Control of Radiation, Radiation Control Agency, Rhode Island
Department of Health.
4.
"Rhode Island State Fire Safety Code," Chapter 23-28.1 of the General Laws of Rhode Island
as amended.
5.
"Rhode Island State Building Code," Chapter 23-27.3 of the General Laws of Rhode Island as
amended.
6.
"The American National Standard Specifications for Making Buildings and Facilities Accessible
to and Usable by the Physically Handicapped," American National Standards Institute, Inc.,
1430 Broadway, New York, New York 10013.
7.
"Confidentiality of Health Care Information, "Chapter 5-37.3 of the General Laws of Rhode
Island, as amended.
8.
"Uniform Controlled Substances Act," Chapter 21-28 of the General Laws of Rhode Island, as
amended.
9.
"Rhode Island Food, Drugs and Cosmetics Act," Chapter 21-31 of the General Laws of Rhode
Island, as amended.
10.
Rules and Regulations for Governing Hypodermic Needles, Syringes and Other Such
Instruments, Rhode Island Department of Health.
11.
"Administrative Procedures Act," Chapter 42-35 of the General Laws of Rhode Island, as
amended.
12.
"Department of Health," Chapter 23-1 of the General Laws of Rhode Island, as amended.
13.
Rules and Regulations of the Rhode Island Department of Health Regarding Practices and
Procedures Before the Department of Health and Access to Public Records of the Department
of Health (R42-35-PP), Rhode Island Department of Health.
14.
"Determination of Need for New Health Care Equipment and New Institutional Health
Services," Chapter 23-15 of the General laws of Rhode Island, as amended.
15.
Rules and Regulations for Licensing of Hospitals (R23-17-HOSP), Rhode Island Department
21
of Health.
16.
Rules and Regulations Pertaining to Immunization, Testing, and Health Screening for Health
Care Workers (R23-17-HCW), Rhode Island Department of Health.
fecf-final regs-july02.doc
Tuesday, July 02, 2002