216-RICR-40-10-11
216-RICR-40-10-11. Licensing Hospice Care (version Periodic Refile, 01/02/2002 to 08/04/2002)
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)
i
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.
ii
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
4
7.0
Change in Ownership, Operation and/or Location
8
8.0
Inspections
8
9.0
Denial, Suspension, Revocation of License or Curtailment of Activities
8
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
14
17.0
Written Agreements
15
18.0
Uniform Reporting System
15
19.0
Rights of Patients
16
PART III
Patient Care Management
17
(Section R23-17-HPC)
20.0
Professional Management Responsibilities
17
21.0
Plan of Care
17
22.0
Levels of Care
18
23.0
Services
19
24.0
Clinical Records
21
25.0
Quality Assurance
22
PART IV
Hospice Inpatient Care Units
23
(Section R23-17-HPC)
26.0
General Provisions
23
PART V
Waste Disposal
24
(Section R23-17-HPC)
27.0
Waste Disposal
24
PART VI
Practices and Procedures, Confidentiality and Severability
25
(Section R23-17-HPC)
28.0
Variance Procedure
25
29.0
Deficiencies and Plans of Correction
25
30.0
Rules Governing Practices & Procedures
26
31.0
Confidentiality
26
32.0
Severability
26
PART VII
References
27
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
2
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 relie
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.
1.14
"Person" means an individual, trust or estate, partnership, corporation (including associations, join
stock companies), limited liability company, state or political subdivision or instrumentality of a state
3
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, bu
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 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.
4
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 ne
operating revenue contained in the application; provided, however, that the minimum fee shal
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 wil
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 it
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.
6.2.5
In consideration of the proposed continuation or termination of health care services by the
hospice program:
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(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 shal
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 demonstrate
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 initia
assessment of the application materials with respect to the review criteria in section 6.2 as wel
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 ough
8
not to be processed under the expedited review mechanism. The licensing agency may
propose a preliminary report on such application provided such proposed report incorporate
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 gran
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.
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.
9
8.2
Refusal to permit inspections, other than on-site visits referred to in section 8.1.1 above, shal
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 Genera
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.
10
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 achievemen
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 tha
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.
12
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 mee
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 managemen
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:
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:
13
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 bu
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;
c)
the certification of terminally ill patients admitted to the hospice program;
14
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
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:
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;
15
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;
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;
16
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.
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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 service
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 a
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.
19
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 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 shal
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 manne
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.
21
23.10 Administration of Drugs and Biologicals:
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 topica
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 shal
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
22
f)
complete documentation of all services and events (including evaluations, treatment, progress
notes, etc.).
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 (genera
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 applican
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 approva
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 shal
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.
26
Section 30.0
Rules Governing Practices and Procedures
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 shal
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, Managemen
& 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.