216-RICR-40-10-11
216-RICR-40-10-11. Licensing Hospice Care (version Amendment, 08/04/2002 to 04/07/2005)
RULES AND REGULATIONS
FOR LICENSING
HOSPICE CARE
(R23-17-HPC)
STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS
Department of Health
February 1984
As amended:
March 1984 (E)
June 1984 (E)
February 1985
January 1987 (E)
May 1987
September 1987
October 1988
December 1993
May 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 Licensing Hospice Care (R23-17-HPC) 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 minimum standards for the licensed hospice
care 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: (1) alternative
approaches to the regulations; (2) duplication or overlap with other state regulations; and (3) significant
economic impact placed on facilities through these amended regulations. No alternative approach,
duplication or overlap, nor significant economic impact was identified. Consequently, the regulations
are adopted in the best interest of the public health, safety and welfare.
These amended regulations shall supercede all previous Rules and Regulations for the Licensing
of Hospice Care promulgated by the Department of Health and filed with the Secretary of State.
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TABLE OF CONTENTS
Page
PART I
Licensure Procedures and Definitions
1
(Section R23-17-HPC)
1.0
Definitions
1
2.0
General Requirements for Licensure
3
3.0
Application for License
3
4.0
Issuance and Renewal of License
4
5.0
Change of Ownership, Operation and/or Location
4
6.0
Initial Licensure and Changes in Owner, Operator, or Lessee
5
7.0
Change in Ownership, Operation and/or Location
8
8.0
Inspections
9
9.0
Denial, Suspension, Revocation of License or Curtailment of Activities
9
PART II
Organization and Management
10
(Section R23-17-HPC)
10.0
Governing Body
10
11.0
Minimum Services Required and Availability and Accessibility of Services
11
12.0
Organization of Services
13
13.0
Administrator
13
14.0
Medical Director
13
15.0
Personnel
14
16.0
Interdisciplinary Team
15
17.0
Written Agreements
15
18.0
Uniform Reporting System
16
19.0
Rights of Patients
17
PART III
Patient Care Management
18
(Section R23-17-HPC)
20.0
Professional Management Responsibilities
18
21.0
Plan of Care
18
22.0
Levels of Care
19
23.0
Services
20
24.0
Clinical Records
22
25.0
Quality Assurance
23
PART IV
Hospice Inpatient Care Units
24
(Section R23-17-HPC)
26.0
General Provisions
24
PART V
Waste Disposal
25
(Section R23-17-HPC)
27.0
Waste Disposal
25
PART VI
Practices and Procedures, Confidentiality and Severability
26
(Section R23-17-HPC)
28.0
Variance Procedure
26
29.0
Deficiencies and Plans of Correction
26
30.0
Rules Governing Practices & Procedures
27
31.0
Confidentiality
27
32.0
Severability
27
PART VII
References
28
1
PART I
LICENSURE PROCEDURES AND DEFINITIONS
Section 1.0 Definitions
Wherever used in these rules and regulations the following terms shall be construed as follows:
1.1
"Bereavement" refers to the extended period of grief preceding the death and following (usually
for one year) the death of a loved one, during which individuals experience, respond and adjust
emotionally, physically, socially and spiritually to the loss of a loved one.
1.2
"Change in operator" means a transfer by the governing body or operator of a hospice program
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 hospice program;
b)
maintain and control the books and records of the hospice program;
c)
dispose of assets and incur liabilities on behalf of the hospice program; or
d)
adopt and enforce policies regarding operation of the hospice program.
This definition is not applicable to circumstances wherein the governing body of a hospice
program retains the immediate authority and jurisdiction over the activities enumerated in
subsection (a) through (d) herein.
1.3
"Change in owner" means:
(1)
in the case of a hospice program 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 a hospice program which is an unincorporated solo proprietorship, the
transfer of the title and property to another person;
(3)
in the case of a hospice program 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
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d)
in the case of a hospice program which is a business corporation, any transfer of
corporate stock which results in a new person acquiring a controlling interest in
such corporation; or
e)
in the case of a hospice program which is a non-business corporation, any change
in membership which results in a new person acquiring a controlling vote in
such corporation.
1.4
"Clergy" refers to individuals ordained for religious service.
1.5
"Director" means the Director of the Rhode Island Department of Health.
1.6
“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 hospice 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.
1.7
"General inpatient care" means short-term general care provided to terminally ill patients in
an inpatient setting (either a licensed hospital or licensed skilled nursing facility) for the control
of pain or management of acute or chronic symptoms.
1.8
"Hospice care" (hereinafter referred to as hospice program) means a distinct and identifiable
program of care of a public or private organization, corporation or person, organized and staffed
by an interdisciplinary team to provide both in the home and in an inpatient setting, palliative
and supportive services to the terminally ill and their family, addressing their physical,
psychological, social and spiritual needs through the stress experience of dying and
bereavement.
1.9
“Initial licensure” means a review conducted pursuant to the provisions contained in section
6.0 herein.
1.10
"Inpatient respite care" means short-term care provided to terminally ill patients in an inpatient
setting (either a skilled nursing or intermediate care 1 facility licensed in Rhode Island) to
provide relief to family members or others caring for the patient.
1.11
"Licensing agency" means the Rhode Island Department of Health.
1.12
"Nurse" means an individual licensed to practice as a professional (registered) nurse in this
state under the provisions of Chapter 5-34 of the General Laws of Rhode Island, as amended.
1.13
"Palliative care" means the reduction or abatement of pain and other troubling symptoms by
appropriate coordination of care to help the terminally ill patient live as fully and comfortably
as possible.
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1.14
"Person" means an individual, trust or estate, partnership, corporation (including associations,
joint stock companies), limited liability company, state or political subdivision or
instrumentality of a state.
1.15
"Physician" means any individual licensed to practice medicine or osteopathy in this state under
the provisions of Chapter 5-37 of the General Laws of Rhode Island, as amended.
1.15.1 "Attending physician" refers to a physician (who may or may not be on the hospice staff)
identified by the terminally ill patient/family as having a significant role in the determination
and delivery of the individual's medical care.
1.16
"Terminally ill" means that an individual has a medical prognosis of a life expectancy of six
(6) months or less.
Section 2.0
General Requirements for Licensure
2.1
No person acting alone or jointly with any other person, shall establish, conduct or maintain a
hospice program in this state without a license in accordance with the requirements of section
23-17-4 of reference 1 and in accordance with the rules and regulations herein.
2.1.1
However, pursuant to section 23-17-2(a) of the Act, any provider of hospice care who
provides hospice care without charge shall be exempt from the licensing provisions
above, but shall meet the "Standards of a Hospice Program of Care" of the National
Hospice Organization.
2.2
A certificate of need is required as a precondition to licensure of any inpatient hospice program,
unless exempt, in accordance with reference 3.
2.3
Any initial licensure of an outpatient hospice program or any change in owner, operator, or
lessee of a licensed hospice program shall require prior review by the Health Services Council
and approval of the licensing agency as provided in sections 6.1 and 6.2 herein, or for expedited
reviews conducted pursuant to sections 6.5 and 6.6 herein, as a condition precedent to the
transfer, assignment or issuance of a new license.
2.4
No facility shall hold itself or represent itself as a hospice program or use the term "Hospice"
or other similar term in its advertising, publicity or any other form of communication, unless
licensed as Hospice Care in accordance with the provisions herein.
2.5
Any person and/or facility subject to the provisions of these rules and regulations shall have
ninety (90) days from the date of filing of said rules and regulations within which to comply
with the requirements thereof.
Section 3.0
Application for License
3.1
Application for a license to conduct, maintain or operate a hospice program shall be made to the
licensing agency upon forms provided by the licensing agency and shall contain such
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information as the licensing agency reasonably requires which may include affirmative evidence
of ability to comply with the provisions of reference 1 and the rules and regulations herein.
3.1.1
Each application shall be accompanied by an application fee of three thousand dollars
($3,000), made payable to the Rhode Island General Treasurer.
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 hospice care program or any of the property or assets of the hospice program.
3.3
The list shall also include all officers, directors and other persons of any subsidiary corporation
owning stock, if the hospice program is organized as a corporation and all partners if organized
as a partnership.
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 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. The license issued, 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.
4.1.1
All renewal applications shall be accompanied by a renewal fee of three thousand dollars
($3,000), made payable to the Rhode Island General Treasurer.
4.2
A license issued shall not be transferable or assignable except with the written approval of the
licensing agency.
Section 5.0
Application for Initial Licensure or Changes in Owner, Operator, or Lessee
5.1
Application for review for initial licensure of an outpatient hospice program or changes in the
owner, operator, or lessee of a hospice program 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 to the considerations enumerated in
section 6.2 herein. Twenty-five (25) copies of such applications are required to be provided.
5.1.1
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 6.0
Initial Licensure and Change in Owner, Operator, or Lessee Review
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6.1
Except for expedited reviews conducted pursuant to sections 6.5 and 6.6, reviews of applications
for initial licensure of an outpatient hospice program or for changes in the owner, operator, or
lessee of a licensed hospice program 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 of an outpatient hospice program or for a license in connection with a change
in the owner, operator or lessee of an existing hospice program, 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.
c)
The decision of the licensing agency shall be based upon the findings and
recommendations of the Health Services Council unless the licensing agency shall afford
written justification for variance therefrom.
d)
All applications reviewed by the licensing agency and all written materials pertinent to
licensing agency review, including minutes of all Health Services Council meetings,
shall be accessible to the public upon request
6.2
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 of an
outpatient hospice program or for a license in the case of a proposed change in the owner,
operator, or lessee of a licensed hospice care 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 of Rhode Island, as amended. 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:
6.2.1
The character, commitment, competence, and standing in the community of the proposed
owners, operators or directors of the hospice program 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
6
(C)
The applicant’s proposed and demonstrated financial commitment to the health care
facility.
6.2.2
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 Hospice services as evidenced by:
(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;
6.2.3
The extent to which the program will provide or will continue to provide safe and
adequate treatment for individuals receiving the Hospice 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 applicant’s demonstrated record in providing safe and adequate treatment to
individuals receiving services at facilities owned, operated, or directed by the applicant;
and
(B)
The credibility and demonstrated or potential effectiveness of the applicant’s proposed
quality assurance programs;
6.2.4
the extent to which the program will provide or will continue to provide appropriate
access with respect to traditionally under served 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 underserved
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.
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6.2.5
In consideration of the proposed continuation or termination of health care services by
the hospice program:
(A)
The effect(s) of such continuation or termination on access to safe and adequate
treatment of individuals, including but not limited to traditionally under served
populations.
6.2.6
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.
6.3
Subsequent to reviews conducted under sections 6.1, 6.2, 6.5, and 6.6 of these regulations, the
issuance of a license by the licensing agency may be made subject to any consideration,
provided that no condition may be made unless it directly relates to the statutory purpose
expressed in section 23-17-3 of the General Laws of Rhode Island, as amended, or to the review
criteria set forth in section 6.2 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 hospice program by the
licensing agency.
6.4
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.
6.5
Applicants for initial licensure may, at the sole discretion of the licensing agency, be reviewed
under expedited review procedures established in section 6.6 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 6.2 herein.
6.6
Expedited reviews of applications for initial licensure of outpatient hospice programs 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 6.2 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.
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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 6.2. 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 6.5 and 6.6. The Health Services Council shall take under
advisement all objections both to the merits of the application and to the proposed
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 6.1 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 7.0
Change of Ownership, Operation and/or Location
7.1
When a change of ownership or operation or location of a hospice program or when
discontinuation or addition of a service(s) is contemplated, the licensing agency shall be notified
in writing.
7.2
A license shall immediately become void and shall be returned to the licensing agency when
operation of a hospice program is discontinued or when any changes in ownership occur in
accordance with the rules and regulations herein and section 23-17-6 of reference 1.
a)
When there is a change in ownership or in the operation or control of the program, the
licensing agency reserves the right to extend the expiration date of such license,
allowing the program to operate under the same license which applied to the prior
license for such time as shall be required for the processing of a new application or
reassignment of patients, not to exceed six (6) weeks.
Section 8.0
Inspections
8.1
The licensing agency shall make, or cause to be made, such inspections and investigations,
including medical records, as deemed necessary in accordance with section 23-17-10 of
reference 1 and the rules and regulations herein.
9
8.1.1
Such inspections and investigations may include on-site visits to patients, either in their
homes or in the inpatient care facilities, provided however, that a signed statement of
approval for such visitation has been obtained by the licensing agency from the
patient/family.
8.2
Refusal to permit inspections, other than on-site visits referred to in section 8.1.1 above, shall
constitute a valid ground for license denial, suspension or revocation.
8.3
Every hospice program shall be given notice by the licensing agency of all deficiencies reported
as a result of an inspection or investigation.
Section 9.0
Denial, Suspension, Revocation of License or Curtailment of Activities
9.1
The licensing agency is authorized to deny, suspend or revoke the license or curtail activities
of any hospice program which: (1) has failed to comply with the rules and regulations
pertaining to the licensing of hospice care programs; or (2) has failed to comply with the
provisions of reference 1.
9.1.1
Reports of deficiencies 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 hospice program.
9.2
Whenever an action shall be proposed to deny, suspend or revoke a license for a Hospice Care
or curtail its activities, the licensing agency shall notify the hospice program 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 2, General Laws of Rhode Island, as amended, and in accordance
with the provisions of section 30.0 herein.
9.2.1
However, if the licensing agency finds that public health, safety or welfare of patients
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
42-35-14(c) and 23-1-21 of the General Laws of Rhode Island, as amended.
9.3
The appropriate state and federal agencies shall be notified of any action taken by the licensing
agency pertaining to either denial, suspension, or revocation of license, or curtailment of
activities.
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PART II
ORGANIZATION AND MANAGEMENT
Section 10.0
Governing Body
10.1
There shall be an organized governing body or equivalent legal authority ultimately responsible
for: (1) the management, fiscal affairs, and operation of the hospice program; (2) the assurance
of quality care and services; and (3) compliance with all federal, state and local laws and
regulations pertaining to hospice program and the rules and regulations herein.
10.2
The governing body or other legal authority shall furthermore be responsible to:
a)
make services available on a twenty-four (24) hour basis to meet the needs of
patients/family as required under the provisions of section 11.5 herein;
b)
to provide a sufficient number of appropriate personnel, physical resources and
equipment to facilitate the delivery of prescribed services.
10.3
The governing body or other legal authority shall designate: (a) an administrator who shall be
responsible for the management and operation of the hospice program; and (b) a medical
director who assumes overall responsibility for the medical component of patient care and to
ensure achievement and maintenance of quality standards of professional practice.
10.4
The governing body or equivalent legal authority shall adopt and maintain bylaws or acceptable
equivalent which defines responsibilities for the operation and performance of the organization,
identifies purposes and means of fulfilling such. In addition, the governing body or equivalent
legal authority shall establish administrative policies pertaining to no less than the following:
a)
responsibilities of the administrator and the medical director;
b)
conflict of interest on the part of the governing body, professional staff and employees;
c)
the services to be provided;
d)
criteria for the selection, admission and transfer of terminally ill patient/families;
e)
patient/family consent and involvement in the development of patient care plan;
f)
developing support network when relatives are not available and patient needs and wants
that support;
g)
linkages and referrals with community and other health care facilities or agencies which
shall include a mechanism for recording, transmitting and receiving information
essential to the continuity of patient/family care.
Such information must contain no less than the following:
11
i.
patient identification data; such as name, address, age, gender, name of next of
kin, health insurance coverage, etc.
ii.
diagnosis and prognosis, medical status of patient, brief description of current
illness, medical and nursing plans of care including such information as
medications, treatments, dietary needs, baseline laboratory data;
iii.
functional status;
iv.
special services such as physical therapy, occupational therapy, speech therapy
and such other;
v.
psychosocial needs; and
vi.
such other information pertinent to ensure continuity of patient care.
h)
professional management responsibilities for contracted services;
i)
reports of patient's condition and transmission thereof to patients' physician; and
j)
such other matters, as may be relevant to the organization and operation of hospice care.
Section 11.0
Minimum Services Required/Availability and Accessibility of Services
11.1
Any service available through a hospice program shall be provided to patients/families, only if
acceptable to the terminally ill patient and family.
11.2
Services which are to be provided directly through staff personnel of a hospice program shall
include the following core services:
a)
physician services (which may include attending physicians' services in accordance with
section 23.1.1 herein);
b)
nursing services;
c)
social services;
d)
bereavement counseling services;
e)
spiritual counseling services; and
f)
services of volunteers.
11.2.1 In those agencies where designated hospice care staff personnel are also assigned to other
patients in addition to hospice care patients, the governing body or other legal authority shall
ensure that only hospice care staff be assigned and render services to hospice care
patients/families.
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11.2.2 A hospice program may use contracted staff if necessary to supplement hospice staff personnel
in order to meet the needs of patients during periods of peak patient loads or under extraordinary
circumstances. If contracting is used, the hospice shall maintain professional management
responsibility for the services and shall assure that the qualifications of staff and services
provided meet the requirements herein.
11.3
In addition to the core services listed in 11.2 above, a hospice program must ensure that the
following services are provided to patients/families directly by hospice staff personnel or under
written arrangement as specified in section 17.0 herein.
a)
home health aide and homemaker services;
b)
short-term inpatient care which includes inpatient respite care and general inpatient care;
c)
therapeutic services (physical, occupational, and speech & hearing);
d)
medical supplies and appliances, including drugs and biologicals; and
e)
counseling services such as dietary, mental health, etc.
11.4
Additional health services or related services may be provided as may be deemed appropriate
to meet patient/family needs and such services must be rendered in a manner consistent with
acceptable standards of practice.
11.5
Availability of Services:
A hospice program shall make:
a)
nursing services, physicians services, drugs and biologicals routinely available on a
twenty-four (24) hour basis, seven (7) days a week, as may be required in accordance
with the plan of care;
b)
all other services available on a twenty-four (24) hour basis to the extent necessary to
meet the needs of individuals for care that is reasonable and necessary for the palliation
and management of terminal illness and related conditions in accordance with the plan
of care; and
c)
patient visiting and assessment capability available on a twenty-four (24) hour basis,
seven (7) days a week to respond to acute and urgent patient/family needs.
11.6
Accessibility to Hospice Care:
13
Each hospice program shall establish a mechanism to enable patients/families to make telephone
contact with responsible staff personnel on a twenty-four (24) hour basis, seven (7) days a week.
Mechanical answering devices shall not be acceptable.
11.7
Accessibility to Pharmacy Services:
Each hospice program shall provide on a twenty-four (24) hour basis, seven (7) days a week,
accessibility to pharmacy services to enable patient/family to obtain prescription drugs and
biologicals, for the palliative care and management of the terminally ill patient.
Section 12.0
Organization of Services
12.1
The governing body or other legal authority shall organize hospice program services to provide
an integrated continuum of care for terminally ill patients/families and to ensure that such care
is rendered under the professional management responsibility of the hospice program.
12.1.1 An organizational chart with written description of the organization, authorities,
responsibilities, accountabilities and relationships shall be maintained, which shall
include but not be limited to:
a)
a description of each level of care and services;
b)
policies and procedures pertaining to each level of care and services;
c)
a description of the system for the maintenance of patient records; and
d)
such other related provision as deemed appropriate.
Section 13.0
Administrator
13.1
The governing body or other legal authority shall appoint an individual who possesses
appropriate education and experience to serve as administrator of the hospice program, and who
shall be responsible for: (1) the management and operation of the program; (2) the enforcement
of policies, rules and regulations and statutory provisions pertaining to the program; (3) serving
as liaison between the governing body and staff; and (4) the planning, organizing and directing
of such other activities as may be delegated by the governing body.
Section 14.0
Medical Director
14.1
The overall responsibility for the medical component of patient care shall be under the direction
of a physician, qualified by training and experience in hospice care, who shall also be
responsible for no less than the following:
a)
ensuring and maintaining quality standards of professional practice;
b)
the achievement and maintenance of quality assurance of professional practices through
a mechanism for the assessment of patient/family care outcomes;
14
c)
the certification of terminally ill patients admitted to the hospice program;
d)
participation as a member of the interdisciplinary team, in the development,
implementation and assessment of patient/family plan of care; and
e)
consulting with attending physician regarding patient care plans.
Section 15.0
Personnel
15.1
A nurse with training and experience in hospice care shall be designated to coordinate the
overall plan of care for each patient/family.
15.2
Each hospice program shall designate a sufficient number of staff personnel (including
volunteers) with training and experience in hospice care and whose qualifications are
commensurate with their duties and responsibilities to provide care services to patients/families.
15.2.1 Staff personnel shall provide evidence of current registration, certification or licensure
as may be required by law.
15.3
A job description for each classification of position shall be established, clearly delineating
qualifications, duties, authority and responsibilities inherent in each position.
15.4
An ongoing program for the training of all personnel shall be conducted by the hospice program,
which shall include: (1) an orientation program for new staff personnel (including volunteers);
and (2) a continuing program for the development and improvement of skills of staff to ensure
the delivery of quality hospice care services.
15.5
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.
Health Screening
15.6
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 hospice. 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 16.0
Interdisciplinary Team
16.1
The governing body or other legal authority shall designate an interdisciplinary team composed
of staff personnel which includes:
15
a)
patient/family;
b)
physician; (may include the Medical Director or physician designee and the attending,
see section 23.1.1 herein);
c)
professional (registered) nurse;
d)
social worker;
e)
volunteer;
f)
clergy; and
g)
such other staff and non-staff personnel as may be deemed appropriate.
16.2
The interdisciplinary team shall be responsible to develop, implement and assess patient/family
plans of care, and in addition:
a)
the supervision of care, personnel and services provided;
b)
the provision of direct patient care as may be required and appropriate;
c)
the review on an ongoing regularly scheduled basis of patient/family plans of care, and
the revision of such plans of care as may be required;
d)
the development of policies and procedures governing patient/family care and services;
and
e)
such other duties as may be deemed appropriate.
Section 17.0
Written Agreements
17.1
There shall be written agreements for the provision of those services required in section 11.3
herein, which are not provided directly by the hospice program. The agreement shall clearly
delineate the responsibilities of the parties involved and shall include no less than the following
provisions:
a)
a stipulation that services may be provided only with the express authorization of the
hospice;
b)
the responsibility of the licensed hospice program for the admission of patients/families
to service;
c)
identification of services to be provided which must be within the scope and limitations
set forth in the 'plan of care' and which must not be altered in type, amount, frequency
or duration (except in case of adverse reaction) by the individual, agency, or institution;
16
d)
the manner in which the contracted services are coordinated, supervised and evaluated
by the hospice program;
e)
assurance of compliance with the patient care policies of the licensed hospice program;
f)
establishment of procedures for and frequency of patient/family care assessment;
g)
furnishing the hospice plan of care to inpatient care facilities upon transfer of patient;
h)
assurance that personnel and services contracted for meet the requirements specified
herein pertaining to personnel and services, including licensure, personnel qualifications,
functions, supervision, orientation, inservice training and attendance at case conferences;
i)
reimbursement mechanism, charges, and terms for the renewal or termination of the
agreement; and
j)
such other provisions as may be mutually agreed upon.
Section 18.0
Uniform Reporting System
18.1
Each hospice program shall establish and maintain records and data in such a manner as to make
uniform a 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.
18.2
Each hospice program shall report to the licensing agency detailed statistical data pertaining to
its operation and services. Such reports and data shall be made at such intervals and by such
dates as determined by the Director.
18.3
The licensing agency is authorized to make the reported data available to any state or federal
agency concerned with or exercising jurisdiction over the hospice program.
18.4
The directives promulgated by the Director pursuant to these regulations shall be sent to each
hospice program 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.
Section 19.0
Rights of Patients
19.1
Each hospice program shall adopt applicable "rights of patients" pursuant to the provisions of
section 23-17-19.1 of reference 1 and shall make such available to patients/families.
17
PART III PATIENT CARE MANAGEMENT
Section 20.0
Professional Management Responsibilities
20.1
The hospice program shall retain professional management responsibility for all hospice care
services including those services specified in section 11.3 herein, which may be provided under
arrangements. Furthermore, the hospice program shall ensure that all services, including
arranged services, are rendered in a safe and effective manner consistent with acceptable
standards of practice and the requirements herein.
20.2
Continuity of Care: The hospice program shall assure the continuity of patient/family care in
the home and inpatient settings through written policies, procedures and criteria pertaining to
no less than the following:
a)
admission criteria and initial assessment of the patient/family need and decision for care;
b)
signed informed consent;
c)
ongoing assessment of patient/family needs;
d)
development and review of the plan of care by the interdisciplinary team;
e)
transfer of patients to inpatient care facilities for inpatient respite care and general
inpatient care;
f)
the provision of appropriate patient/family information at the point of transfer between
levels of care settings;
g)
community or other resources to insure continuity of care and meet patient/family needs;
h)
management of symptom control through palliative care and utilization of therapeutic
services (see section 11.3 herein):
i)
constraints imposed by limitations of services, family conditions; and
j)
such other criteria as may be deemed appropriate.
Section 21.0
Plan of Care
21.1
After an initial assessment of patient/family needs, a written plan of care shall be established
by the Medical Director or physician designee, the attending physician and the Interdisciplinary
Team for each patient/family admitted to the hospice program. Such plan of care shall be
developed with the participation of the patient and family, and shall include only those services
which are acceptable to the patient and family. Furthermore, the family shall be involved
whenever possible in the implementation and continuous assessment of the plan of care. Such
plan shall include provisions pertaining to:
18
a)
pertinent diagnosis and prognosis;
b)
identification of patient/family needs addressing the physical, psychological, social, and
spiritual needs of the patient/family; the scope of services required; the frequency of
visits; the need for inpatient care (respite and/or general inpatients); nutritional needs;
medications; management of discomfort and symptom control; management of grief;
and
c)
consent of patient/family; and
d)
such other relevant modalities of care and services as may be appropriate to meet
patient/family care needs.
21.2
The plan of care shall be reviewed and updated at periodic intervals as specified in the plan of
care by the interdisciplinary team. This provision also applies to hospice care patients in
inpatient care facilities.
Section 22.0
Levels of Care
22.1
Home Care: Home care services shall be provided to hospice patients/families either as routine
home care or continuous home care during periods of crisis, in order to maintain the terminally
ill patient at home.
22.2
General Inpatient Care: Short-term general inpatient care for the control of pain or
management of acute and severe clinical problems which cannot be managed in a home setting
shall be provided only in licensed hospitals or licensed skilled nursing facilities, and which meet
the requirements of section 26.0 herein and with whom the hospice care has entered into a
binding written agreement. Such agreement includes, in addition to the provisions of section
17.0 herein, the following mutually agreed upon terms:
a)
that the inpatient provider has established policies consistent with those of the hospice
program and that the inpatient care facility agrees to abide by the patient care plan and
protocol established by the hospice program;
b)
the medical record to include a record of all inpatient services and events, and a copy of
the discharge summary and, if requested, a copy of the medical record to be provided
to the hospice program;
c)
hospice program to be responsible for the appropriate hospice care training of personnel
who provided the care under the agreement;
d)
the party responsible for the implementation of the provisions of the agreement; and
e)
such other provisions as may be relevant and deemed necessary.
22.3
Inpatient Respite Care: inpatient respite care may be provided for short periods of time to
relieve family members or others caring for the terminally ill patient. Such care shall be
19
provided only in a licensed skilled nursing or intermediate care I facility which meets the
requirements of section 26.0 herein, and with whom hospice program has entered into a binding
agreement as provided in section 17.0 herein.
22.3.1 This provision does not preclude hospice program from providing respite care in the
home in accordance with section 11.4 herein.
Section 23.0
Services
23.1
Physician Services: shall be provided by a physician to meet the general medical needs of
patients for the management of the terminal illness and related conditions, through palliative and
supportive care and in accordance with hospice policies.
23.1.1 Such policies shall include provisions governing the relationship of the attending
physician to the Medical Director, and the interdisciplinary team.
23.1.2 In addition to palliation and management of terminal illness and related conditions, staff
physician(s) of the hospice program including the physician member(s) of the
interdisciplinary group shall also meet the general medical needs of the patients to the
extent that these needs are not met by the attending physician.
23.2
Nursing Services: shall be provided under a licensed professional (registered) nurse to meet
the nursing care needs of patients/families as prescribed in the plan of care and in accordance
with acceptable standards of practice and hospice policies.
23.3
Social Services: Social services shall be provided by a person with at least a bachelor's degree
from a school accredited or approved by the Council on Social Work Education. Such service
shall be provided as prescribed in the plan of care and in accordance with acceptable standards
of practice and hospice care policies.
23.4
Bereavement Services: An organized program for the provision of bereavement services shall
be established to meet the needs of the members of families both before and after the death of
the patient. Such services shall be provided by a professional person qualified by training and
experience for the development, implementation and assessment of a plan of care to meet the
needs of the bereaved.
23.5
Counseling Services:
a)
Spiritual counseling by a member of the clergy and other members of religious
organization shall be available. Patients/families shall be notified of the availability of
such services;
b)
Dietary and any other counseling service for the patient/family shall also be available
as may be required, while the individual is enrolled in hospice care.
23.6
Home-Health Aide Services:
20
a)
Each hospice program shall provide home-health aide services pursuant to section 11.3
herein and as prescribed by the patient/family plan of care and consistent with policies
of the hospice program.
b)
The home-health aide shall provide personal care and other related support services
under the supervision of a registered nurse from the licensed hospice program and/or a
therapist when the aide carries out simple procedures as an extension of physical, speech
or occupational therapy or social services. Duties of home-health aides shall include:
i.
the performance of simple procedures as an extension of therapy services;
ii.
personal care;
iii.
ambulation and exercise;
iv.
assistance with medications that are ordinarily self-administered;
v.
preparing meals and assisting patients with eating;
vi.
household services which are essential to the patient's health care at home;
vii.
report change in patient's condition and needs; and
viii.
completing appropriate records.
23.7
Volunteer Services: the development and utilization of specially trained lay and professional
volunteers is integral and vital to a hospice program. Direct patient care rendered by volunteers
shall be provided under the supervision of a qualified and experienced staff member of the
hospice program and shall be consistent with the established patient/family plan of care.
Furthermore, direct patient care volunteers shall:
a)
have the necessary qualifications and skills to provide the prescribed service;
b)
have participated in an appropriate orientation and training program of hospice care; and
c)
be responsible to record patient care services rendered.
23.8
Other Services: such as physical, occupational, speech and hearing therapy services must be
available and when provided, such services must be rendered in accordance with the plan of care
and in a manner consistent with accepted standards of practice.
23.9
Medical Supplies and appliances, including drugs and biologicals as may be needed shall be
provided (either directly or by arrangement) for the palliation and management of the terminal
illness and related conditions in accordance with section 11.3 herein.
23.10 Administration of Drugs and Biologicals:
21
Drugs and biologicals as prescribed by the physician in the plan of care may be administered
by the following individuals:
a)
A licensed nurse or physician.
b)
Selected non-licensed personnel with demonstrated competence who have satisfactorily
completed a State-Approved Program on Drug Administration may administer oral or
topical drugs, if adequate medical and nursing supervision is provided in accordance
with reference 4 and agency policies.
c)
The patient, a member of the family or other care giver may also administer drugs, upon
written approval by the attending physician.
23.11 Accessibility to a pharmacy as required in section 11.7 herein shall insure availability of
necessary drugs and biologicals as may be required.
23.12 Controlled Substances:
Hospice programs shall have policies pertaining to the disposal of controlled substances which
are consistent with the Rules and Regulations Governing the Disposal of Legend Drugs (R21-
31-LEG) of reference 5.
24.0
Clinical Records
24.1
A clinical record shall be established for every individual receiving care and services. The
record shall be completed promptly and accurately documented, readily accessible and
systematically organized to facilitate retrieval.
24.2
Each clinical record shall include a comprehensive compilation of information. Entries shall
be made for all services provided, signed by the staff providing the services. The record shall
include entries on all services rendered whether furnished directly or under arrangements with
the hospice. Each individual's record shall contain no less than:
a)
the initial and subsequent assessment;
b)
the plan of care;
c)
identification data;
d)
consent form;
e)
pertinent medical history; and
f)
complete documentation of all services and events (including evaluations, treatment,
progress notes, etc.).
22
24.3
Records shall be maintained by the agency for a period of at least five (5) years following the
date of discharge and shall be safeguarded against loss or unauthorized use.
24.4
Each program shall establish policies and procedures to govern the use and removal of records
and determine the conditions for release of information in accordance with statutory provisions
pertaining to confidentiality.
Section 25.0
Quality Assurance
25.1
Each hospice program shall conduct an ongoing comprehensive, integrated self-assessment of
the quality and appropriateness of home care services, general inpatient and respite care services
through a mechanism which shall ensure:
a)
patient care monitoring;
b)
audits of patient/family care and services;
c)
assessment of patient/family care outcomes;
d)
identification of problems and measures taken to improve care;
e)
evaluation of program; and
f)
such other measures as may be deemed appropriate.
23
PART IV
HOSPICE INPATIENT CARE UNITS
Section 26.0
General Provisions
26.1
A licensed hospital, a licensed skilled nursing facility or a licensed intermediate care I facility
with whom a hospice program enters into a written agreement for the provision of inpatient care
(general inpatient or respite care) for hospice patients shall be required to meet the following
provisions pertaining to: (1) staffing; and (2) patient areas.
26.1.1 Twenty-four Hour Nursing Service:
a)
The facility provides twenty-four (24) hour nursing services which are sufficient
to meet total nursing needs and which are in accordance with the patient plan of
care. Each patient receives treatments, medications, and diet as prescribed, and
is kept comfortable, clean, well-groomed, and protected from accident, injury
and infection.
b)
Each shift includes a registered nurse who provides direct patient care.
26.1.2 Patient Areas:
The Patient Areas must be designed and equipped for the comfort and privacy of each
patient/family which includes:
a)
physical space for private patient/family visiting;
b)
accommodations for family members, including children, if they wish to remain with
patient overnight;
c)
accommodation for family privacy after a patient's death; and
d)
home-like interior decor.
Patients shall be permitted to receive visitors, including small children, at any hour.
24
PART V
WASTE DISPOSAL
27.1
Medical waste:
Medical 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 managed in accordance with the provisions of the
aforementioned regulations.
27.2
Other Waste:
Wastes which are not classified as infectious waste, hazardous wastes or which are not
otherwise regulated by law 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:
a)
high enough off the ground to facilitate the cleaning of the underneath areas of
the stationary equipment; and
b)
the loading section shall be constructed and maintained to prevent rubbish from
blowing from said area site.
25
PART VI PRACTICES AND PROCEDURES, CONFIDENTIALITY AND SEVERABILITY
Section 28.0
Variance Procedure
28.1
The licensing agency may grant a variance either upon its own motion or upon request of the
applicant from the provisions of any rule or regulation in a specific case if it finds that a literal
enforcement of such provision will result in unnecessary hardship to the applicant and that such
variance will not be contrary to the public interest.
28.2
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.
28.2.1 Upon the 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 hospice program appeals the denial.
Section 29.0
Deficiencies and Plans of Correction
29.1
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.
29.2
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.
29.3
The licensing agency will be required to approve or reject the plan of correction submitted by
a facility in accordance with section 29.2 above within fifteen (15) days of receipt of the plan
of correction.
29.4
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 stipulated in section 29.2 above, 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
9.0 herein. If the facility is aggrieved by the action of the licensing agency, the facility may
appeal the decision and request a hearing in accordance with Chapter 42-35 of the General
Laws.
29.5
The notice of the hearing to be given by the Department of Health shall comply in all respects
with the provisions of Chapter 42-35 of the General Laws. The hearing shall in all respects
comply with the provisions therein.
Section 30.0
Rules Governing Practices and Procedures
26
30.1
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
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).
Section 31.0
Confidentiality
31.1
Disclosure of any health care information relating to individuals shall be subject to the
provisions of the "Confidentiality of Health Care Information" Chapter 5-37.3 of the General
Laws of Rhode Island, as amended, and other relevant statutory and federal requirements.
Section 32.0
Severability
32.1
If any provision of these regulations or the application thereof to any facility or circumstances
shall be held invalid, such invalidity shall not affect the provisions or application or the
regulations which can be given effect, and to this end the provisions of the regulations are
declared to be severable.
27
PART VII
REFERENCES
1.
"Licensing of Hospice Care", Chapter 23-17 of the General Laws of Rhode Island, as amended.
2.
"Administrative Procedures Act", Chapter 42-35 of the General Laws of Rhode Island, as
amended.
3.
Rules and Regulations for Determination of Need for New Health Care Equipment and New
Institutional Health Services (R23-15-CON), Rhode Island Department of Health, July 1999
(E) and subsequent amendments thereto.
4.
"Nurses”, Section 5-34-31 of the General Laws of Rhode Island, as amended.
5.
Rules and Regulations Governing the Disposal of Legend Drugs (R21-31-LEG), Rhode Island
Department of Health, March 1998 and subsequent amendments thereto.
6.
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 and subsequent
amendments thereto.
7.
Rules and Regulations Pertaining to Immunization, Testing, and Health Screening for Health
Care Workers (R23-17-HCW), Rhode Island Department of Health.
Wednesday, July 03, 2002
hospice care-final regs-july02.doc