AUTHORITY: Implementing and authorized by the Hospice Program Licensing Act [210 ILCS 60].

SOURCE: Adopted at 2 Ill. Reg. 31, p. 77, effective August 2, 1978; emergency amendment at 3 Ill. Reg. 38, p. 314, effective September 7, 1979, for a maximum of 150 days; amended at 3 Ill. Reg. 40, p. 153, effective October 6, 1979; emergency amendment at 4 Ill. Reg. 18, p. 129, effective April 21, 1980, for a maximum of 150 days; amended at 4 Ill. Reg. 40, p. 56, effective September 23, 1980; emergency amendment at 6 Ill. Reg. 5855, effective April 28, 1982, for a maximum of 150 days; amended at 6 Ill. Reg. 11006, effective August 30, 1982; amended at 7 Ill. Reg. 13665, effective October 4, 1983; codified at 8 Ill. Reg. 16829; amended at 9 Ill. Reg. 4836, effective April 1, 1985; amended at 14 Ill. Reg. 2382, effective February 15, 1990; amended at 15 Ill. Reg. 5376, effective May 1, 1991; amended at 18 Ill. Reg. 2414, effective January 22, 1994; emergency amendments at 20 Ill. Reg. 467, effective January 1, 1996, for a maximum of 150 days; amended at 20 Ill. Reg. 10003, effective July 15, 1996; Part repealed and new Part adopted at 22 Ill. Reg. 10625, effective June 1, 1998; emergency amendment at 23 Ill. Reg. 6913, effective June 1, 1999, for a maximum of 150 days; amended at 23 Ill. Reg. 13232, effective October 20, 1999; amended at 28 Ill. Reg. 14121, effective October 15, 2004; amended at 32 Ill. Reg. 2330, effective January 23, 2008; amended at 34 Ill. Reg. 7936, effective May 25, 2010; amended at 44 Ill. Reg. 12582, effective July 2, 2020; amended at 48 Ill. Reg. 2531, effective January 30, 2024.

SUBPART A: LICENSURE

 

Section 280.1000  Definitions

 

Act – the Hospice Program Licensing Act [210 ILCS 60].

 

Attending Physician – a physician who is a doctor of medicine or osteopathy and is identified by an individual, at the time the individual elects to receive hospice care, as having the most significant role in the determination and delivery of the individual's medical care.  (Section 3(a-10) of the Act) A Certified Nurse Practitioner can function in the role of attending physician as specified in section 408 of the federal Medicare Prescription Drug Improvement and Modernization Act of 2003.

 

Bereavement – the period of time during which the hospice patient's family experiences and adjusts to the death of the hospice patient. (Section 3(a) of the Act)

 

Bereavement Services –  counseling services provided to an individual's family after the individual's death.  (Section 3(a-5) of the Act)

 

Advanced Nurse Practitioner – a registered nurse who meets the requirements for licensure as an advanced practice nurse in the category of Certified Nurse Practitioner under the Nurse Practice Act.  According to section 408 of the Medicare Prescription Drug Improvement and Modernization Act of 2003, a nurse practitioner may not serve as a medical director or as the physician member of the interdisciplinary group.  The advanced nurse practitioner, acting as the attending physician, would be prohibited from certifying the terminal diagnosis.

 

Comprehensive Hospice – a program that provides hospice services and meets the minimum standards for certification under the Medicare program set forth in the Conditions of Participation in 42 CFR 418 but is not required to be Medicare-certified.  (Section 3(h-10) of the Act)

 

Counselor – a person who has earned at a minimum a bachelor's degree in counseling, psychology, or social work from an accredited college or university and who has one year of counseling experience in a health care setting; or a religious professional (clergy, religious or theologically trained lay person) who has a combination of documented formal training in pastoral counseling and supervised counseling experience in a health care or clinical setting.  The total of supervised work experience must equal at least one year in a clinical or health care setting.  Any person employed as a "counselor" in an Illinois Licensed Hospice Program prior to September 1, 1985 may continue to serve in that capacity at that agency only, even though he or she may not meet the qualifications for "counselor" as set forth in this Part.

 

Department – the Illinois Department of Public Health.  (Section 3(b) of the Act)

 

Director – the Director of the Illinois Department of Public Health or designee. (Section 3(c) of the Act)

 

Employee – a paid or unpaid member of the staff of a hospice program, or, if the hospice program is a subdivision of an agency or organization, of the agency or

organization, who is appropriately trained and assigned to the hospice program.  "Employee" also means a volunteer whose duties are prescribed by the hospice program and whose performance of those duties is supervised by the hospice program.  (Section 3(l-5) of the Act)

 

Geographic Service Areas – the counties, cities, census track, etc., that the hospice identifies in the license application as required in Section 280.1020(a)(10) of this Part.

 

Governing Body – the policy-making authority, whether an individual or a group, that exercises general direction over the affairs of a hospice program and establishes policies concerning its operation and the welfare of the individuals it serves.

 

Home Health Agency – an agency licensed under the Home Health, Home Services, and Home Nursing Agency Licensing Act.

 

Hospice Aide – a person who provides assistance with meals, dressing, movement, bathing or other personal needs or maintenance.  Hospice aides must meet the requirements for Home Health Aides in 77 Ill. Adm. Code 245.70 or Nursing Assistants in 77 Ill. Adm. Code 300.660.

 

Hospice Care – a program of palliative care that provides for the physical, emotional, and spiritual care needs of a terminally ill patient and his or her family.  The goal of such care is to achieve the highest quality of life as defined by the patient and his or her family through the relief of suffering and control of symptoms.  (Section 3(d) of the Act)

 

Hospice Care Team – an interdisciplinary group or groups composed of individuals who provide or supervise the care and services offered by the hospice.  (Section 3(e) of the Act)

 

Hospice Patient – a terminally ill person receiving hospice services. (Section 3(f) of the Act)

 

Hospice Patient's Family – a hospice patient's immediate family consisting of a spouse, sibling, child, parent, and those individuals designated as such by the patient for the purposes of the Act.  (Section 3(g) of the Act)

 

Hospice Program – a licensed public agency or private organization, or a subdivision of either of those, that is primarily engaged in providing care to terminally ill individuals through a program of home care or inpatient care, or both home care and inpatient care, utilizing a medically directed interdisciplinary hospice care team of professionals or volunteers, or both professionals and volunteers.  A hospice program may be licensed as a comprehensive hospice program or a volunteer hospice program.  (Section 3(h-5) of the Act)

 

Hospice Residence –a separately licensed home, apartment building, or similar building providing living quarters:

 

that is owned or operated by a person licensed to operate as a comprehensive hospice; and

 

at which hospice services are provided to facility residents.

 

A building that is licensed under the Hospital Licensing Act or the Nursing Home Care Act is not a hospice residence.  (Section 3(g-1) of the Act)

 

Hospice Service Plan – a plan detailing the specific hospice services offered by a comprehensive or volunteer hospice program, and the administrative and direct care personnel responsible for those services.  The plan shall include but not be limited to those items specified in Section 280.2000 of this Part.  (Section 3(j) of the Act)

 

Hospice Services – a range of professional and other supportive services provided to a hospice patient and his or her family.  These services may include, but are not limited to, physician services, nursing services, medical social work services, spiritual counseling services, bereavement services, and volunteer services.  (Section 3(h) of the Act)

 

Hospital – a location licensed under the Hospital Licensing Act.

 

            Long-Term Care Facility – a location licensed under the Nursing Home Care Act.

 

Multiple Hospice Location – a location or site from which the hospice program provides non-residential nursing, social, pastoral/counseling, bereavement or dietary services within a portion of the total geographic area served by the hospice program.  The multiple hospice location is part of the hospice program and is located sufficiently close to share administration, supervision and services in a manner that renders it unnecessary for the multiple hospice location to independently require a hospice license.  Multiple hospice locations are not hospice residences and shall not provide inpatient care.

 

Not-for-Profit Agency – any hospice program that is operated:  by a not-for-profit corporation incorporated under, or qualified as a foreign corporation under, the General Not For Profit Corporation Act of 1986; or by a county pursuant to Division 5-22 of the Counties Code; or pursuant to a trust or endowment established for nonprofit, charitable purposes.

 

Nurse – a registered nurse or a licensed practical nurse as defined in the Nurse Practice Act.

 

Palliative Care – the management of pain and other distressing symptoms that incorporates medical, nursing, psychosocial, and spiritual care according to the needs, values, beliefs, and culture or cultures of the patient and his or her family.  The evaluation and treatment is patient-centered, with a focus on the central role of the family unit in decision-making.  (Section 3(i) of the Act)

 

Physician – any person licensed to practice medicine in all its branches as provided in the Medical Practice Act of 1987.

 

Representative – an individual who has been authorized under State law to terminate an individual's medical care or to elect or revoke the election of hospice care on behalf of a terminally ill individual who is mentally or physically incapacitated.  (Section 3(l-10) of the Act)

 

Research or Experimental Programs – use of patients receiving services in the systematic study, observation, or evaluation of factors related to the prevention, assessment, treatment, and understanding of an illness.  This involves all behavioral and medical experimental research that involves human beings as experimental subjects.

 

Social Worker – a person who is a licensed social worker or a licensed clinical social worker under the Clinical Social Work and Social Work Practice Act  and has a minimum of one year of social work experience in a health care setting.  An exception to the one-year experience requirement may be allowed upon approval by the Department of Public Health.  The Department's decision to grant an exception will be based on, but not be limited to, the hospice's efforts to employ a social worker who meets this requirement.

 

Staff – paid employees of a hospice, individuals working under contractual agreements, and volunteers.

 

Terminally Ill – a medical prognosis by a physician that a patient has an anticipated life expectancy of one year or less. (Section 3(k) of the Act)

 

Volunteer – a person who offers his or her services to a hospice without compensation.  Reimbursement for a volunteer's expenses in providing hospice service shall not be considered compensation.  (Section 3(l) of the Act)

 

Volunteer Hospice – a program which provides hospice services to patients regardless of their ability to pay, with emphasis on the utilization of volunteers to provide services, under the administration of a not-for-profit agency.  This does not prohibit the employment of staff.  (Section 3(m) of the Act) 

 

Workstation – an office provided for an employee's convenience and not identified in advertising or used for providing hospice services.

 

(Source:  Amended at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.1010  Incorporated and Referenced Materials

 

a)         The following regulations and standards are incorporated by reference in this Part:

 

1)         Private and Professional Association Standards

The following standards of the National Fire Protection Association (NFPA), which may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, Massachusetts  02169:

 

A)        For new facilities, NFPA 101, Life Safety Code (2012), Chapter 18, New Health Care Occupancies and all appropriate references under Chapter 2, Referenced Publications.

 

B)        For existing facilities, NFPA 101, Life Safety Code (2012), Chapter 19, Existing Health Care Occupancies, and all appropriate references under Chapter 2, Referenced Publications.

 

C)        NFPA 101-A (2013), Guide on Alternative Approaches to Life Safety.

 

2)         Federal Regulations

 

A)        Department of Health and Human Services

Centers for Medicare and Medicaid Services

42 CFR 2.52 (Research) (October 1, 2022).

 

B)        Department of Health and Human Services

Food and Drug Administration

21 CFR 178.1010 (Sanitizing Solutions) (April 1, 2023).

 

C)        Department of Health and Human Services

Centers for Medicare and Medicaid Services

42 CFR 418 (Hospice Care) (October 1, 2022).

 

b)         All incorporations by reference of federal regulations and the standards of nationally recognized organizations refer to the regulations and standards on the date specified and do not include any amendments or editions subsequent to the date specified.

 

c)         The following State and federal statutes are referenced in this Part:

 

1)         Hospital Licensing Act [210 ILCS 85];

 

2)         Nursing Home Care Act [210 ILCS 45];

 

3)         Illinois Administrative Procedure Act [5 ILCS 100];

 

4)         Health Care Worker Background Check Act [225 ILCS 46];

 

5)         Nurse Practice Act [225 ILCS 65];

 

6)         Home Health, Home Services, and Home Nursing Agency Licensing Act [210 ILCS 55];

 

7)         General Not For Profit Corporation Act of 1986 [805 ILCS 105];

 

8)         Counties Code [55 ILCS 5];

 

9)         Medical Practice Act of 1987 [225 ILCS 60];

 

10)         Clinical Social Work and Social Work Practice Act [225 ILCS 20];

 

11)         Alzheimer's Disease and Related Dementias Services Act [410 ILCS 406]; and

 

12)         Medicare Prescription Drug Improvement and Modernization Act of 2003 (42 U.S.C. 1395w-101).

 

d)         The following Department of Public Health rules are referenced in this Part:

 

1)         Practice and Procedure in Administrative Hearings (77 Ill. Adm. Code 100);

 

2)         Home Health, Home Services, and Home Nursing Agency Code (77 Ill. Adm. Code 245);

 

3)         Skilled Nursing and Intermediate Care Facilities Code (77 Ill. Adm. Code 300);

 

4)         Control of Notifiable Diseases and Conditions Code (77 Ill. Adm. Code 690);

 

5)         Food Code (77 Ill. Adm. Code 750);

 

6)         Illinois Plumbing Code (77 Ill. Adm. Code 890);

 

7)         Health Care Worker Background Check Code (77 Ill. Adm. Code 955); and

 

8)         Alzheimer's Disease and Related Dementias Services Code (77 Ill. Adm. Code 973).

 

(Source:  Amended at 48 Ill. Reg. 2531, effective January 30, 2024)

 

Section 280.1015  Licensure Applicability

 

a)         A hospice program may be licensed as a comprehensive hospice program or a volunteer hospice program.  Throughout this Part, standards that apply only to comprehensive or volunteer hospice providers will be noted.  The use of "hospice" or "hospice programs" applies to both comprehensive hospice programs and volunteer hospice programs.

 

b)         No person shall establish, conduct or maintain a comprehensive or volunteer hospice program without first obtaining a license from the Department.  (Section 4(a) of the Act)

 

c)         No public or private agency shall advertise or present itself to the public as a hospice program without obtaining a license from the Department.

 

d)         A hospice residence may be operated only at the locations listed on the license.  A comprehensive hospice program owning or operating a hospice residence is not subject to the provisions of the Nursing Home Care Act in owning or operating a hospice residence.  (Section 4(a) of the Act)

 

e)         Every licensed hospice program in operation on August 12, 2005 that does not meet all of the requirements for a comprehensive hospice program or volunteer hospice program as set forth in the Act shall be deemed to hold a provisional license to continue that operation on and after that date. (Section 4.5 of the Act)

 

f)         The provisional license shall remain in effect for one year after August 12, 2005 or until the Department issues a regular license under Section 4 of the Act, whichever is earlier.  (Section 4.5 of the Act)

 

(Source:  Added at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.1020  Licensure Procedures

 

a)         An application for an initial license or a renewal license to operate as a comprehensive or volunteer hospice program shall be in writing on forms provided by the Department.  (Section 5 of the Act)  The application shall be made under oath and shall contain the following information:

 

1)         The name, address, and telephone number of the hospice program location.

 

2)         The type of hospice licensure sought by the program, either volunteer or comprehensive.  If the program is a volunteer hospice, a complete listing of the hospice services to be provided during the term of the license shall be included.

 

3)         If multiple hospice locations are used, the address and phone number of the central office and the address and phone number of each multiple hospice location.

 

4)         A statement of ownership in accordance with Section 280.1030.

 

5)         The name and address of the registered agent or other individual authorized to receive Service of Process for the hospice program.

 

6)         The name of the person under whose management or supervision the program will be operated.

 

7)         A listing of professional staff, including their names, titles, license or registration numbers, whether they are full or part time, and whether they are paid or volunteer employees.

 

8)         Number of volunteers and (approximate) total combined volunteer hours of care and service per week.

 

9)         Source of income.

 

10)         A designation of the proposed geographic area to be served by the hospice.

 

11)         Hospice census report for the fiscal year (for renewals only).

 

12)         A listing of outside contractors.

 

13)         A copy of the annual hospice service plan.

 

14)         A copy of the current annual budget and financial audit for the current fiscal year.

 

15)         If the central office is used by patients and the public, a certification from the local fire authority or State Fire Marshal that the location meets fire and safety ordinances and laws.

 

b)         An application for licensure as a comprehensive hospice shall be accompanied by a fee of $500.  An application for a volunteer hospice shall be accompanied by a fee of $250.

 

c)         An applicant will have 90 days following notification by the Department that the Department has completed its initial review of an application to submit additional revisions or supporting documentation to the Department.

 

d)         Upon receipt and review of a complete application for initial licensure, the Department will conduct an inspection to determine compliance with the Act and this Part.  Incomplete applications will be denied by the Department in accordance with Section 280.1060(a).

 

e)         If the hospice program is found to be in substantial compliance with the Act and this Part, the Department will issue a license for a period of one year.

 

f)         An application for license renewal shall be filed annually with the Department, 60 days prior to the expiration of the license, on forms provided by the Department.

 

1)         The renewal application shall comply with the requirements of subsections (a)(1) through (6), (a)(10) and (a)(11) and subsection (b).  The fee shall be $500.

 

2)         Pursuant to Section 10-65 of the Illinois Administrative Procedure Act, licensees who are individuals are subject to denial of renewal of licensure if the individual is more than 30 days delinquent in complying with a child support order.

 

3)         Upon receipt and review of a complete application for license renewal, the Department may conduct a survey. The Department's decision to conduct a survey will be based on, but not be limited to, compliance history, changes in key personnel, complaints, and the length of time since the last survey.  The Department will renew the license in accordance with subsection (e).

 

g)         The licensee shall report changes in the information on the application to the Department within 10 days after the change.  The following changes need not be reported: number of volunteers and total hours; sources of income for the fiscal year; hospice census report numbers; staff changes for other than program supervisors.

 

h)         The hospice program license shall be displayed in a conspicuous place inside the hospice program office.  (Section 4(e) of the Act)

 

i)          The license shall be valid only in the possession of the hospice and licensure applicant to which it was originally issued and shall not be transferred or assigned to any other person, agency, or corporation. (Section 4(c) of the Act)  This subsection does not prohibit the use of workstations throughout the geographic service areas.

 

j)          Change of Ownership or Sale

 

1)         Each license is valid only for the specific licensee and hospice named in the application and shall not be transferred or assigned to any other person, hospice or corporation.

 

2)         Sale, assignment, lease or other transfer of a hospice, whether voluntary or involuntary, requires the new owner/licensee to obtain a new license from the Department prior to maintaining, operating or conducting a hospice.

 

3)         In the case of hospices operating under a franchise arrangement, each unique business entity shall obtain and maintain a distinct license and shall not share licensure based on franchised name status.

 

4)         A licensee shall notify the Department in writing, at least 30 days in advance, of any intention to:

 

A)        Change ownership; or

 

B)        Sell its hospice.

 

5)         A change of ownership happens when one of the following transactions occurs:

 

A)        In an unincorporated sole proprietorship, when the property is transferred to another party;

 

B)        A material change in a partnership that is caused by the removal, addition or substitution of a partner;

 

C)        In a corporation, when the provider corporation merges into another corporation, or the consolidation of two or more corporations, one of which is the licensee, resulting in the creation of a new corporation;

 

D)        The transfer of any corporation stock that results in a change of the person or persons who control the agency; or

 

E)        The transfer of any stock in excess of 75% of the outstanding stock.

 

6)         Pursuant to subsection (j)(5)(C), the transfer of corporate stock or the merger of another corporation into the licensee corporation does not constitute a change of ownership if the licensee corporation remains in existence. In these transactions, the name of the corporation, its officers, its independent subsidiaries, and any other relevant information that the Department may require shall be made available to the Department upon request.

 

7)         Whenever ownership of a hospice is proposed to be transferred from the person or organization named on the license to another person or organization, or the hospice will be undergoing any other change of ownership described in subsection (j)(5), the new owner shall apply for a new license.  The new owner shall submit a hospice license application to the Department at least 30 days prior to the sale or change of ownership.

 

8)         The Department will issue a new license to a new owner who meets the requirements for licensure under this Part.  The transactions described in this Section shall not be complete until the Department issues a new license to the new person, legal entity or partnership.

 

9)         Upon the completion of the sale or change of ownership, the former licensee shall return its license to the Department by certified mail.

 

(Source:  Amended at 48 Ill. Reg. 2531, effective January 30, 2024)

 

Section 280.1030  Statement of Ownership

 

a)         As a condition of issuance or renewal of a license to operate a hospice program, the applicant shall file a statement of ownership.

 

b)         The licensee shall notify the Department of any change in the information required in the statement of ownership within 30 days before the change.

 

c)         The statement of ownership shall include the following:  name, address, telephone number, occupation or business activity, and percent of direct or indirect financial interest of any person having a direct or indirect interest of five percent or more in the legal entity designated as the operator/licensee of the hospice program.

 

(Source:  Amended at 44 Ill. Reg. 12582, effective July 2, 2020)

 

Section 280.1040  Inspections and Investigations

 

a)         The Department shall perform licensure inspections, as deemed necessary, to ensure compliance with the Act and this Part.

 

b)         All services and facilities to which this Part applies shall be subject to and shall be deemed to have given consent to all inspections by properly identified personnel of the Department, or by other such properly identified persons as the Department might designate.  In addition, representatives of the Department shall have access to and may reproduce or photocopy any books, records and other documents maintained by or for the licensee to the extent necessary to carry out the Act and this Part.

 

c)         The Department may, upon its own motion, and shall, upon receiving a verified complaint in writing of any persons setting forth facts which if proven would constitute grounds for the denial of an application or refusal to renew a license or revocation of a license, investigate the applicant or licensee.  (Section 11(a) of the Act)

 

Section 280.1050  Notice of Violation and Plan of Correction

 

a)         Upon determination that the licensee or applicant is in violation of the Act or this Part, the Department shall issue a written Notice of Violation and request a plan of correction.  The notice shall specify the violations, and shall instruct the licensee or applicant to submit a plan of correction to the Department within 10 days after receipt of the Notice.

 

b)         Each plan of correction shall be based on an assessment by the hospice program of the conditions or occurrences that are the basis of the violation and an evaluation of the practices, policies, and procedures that have caused or contributed to the conditions or occurrences.  Evidence of such assessment and evaluation shall be maintained by the hospice program.  Each plan of correction shall include:

 

1)         A description of the specific corrective action the hospice program is taking, or plans to take, to abate, eliminate, or correct the violation cited in the Notice.

 

2)         A description of the steps that will be taken to avoid future occurrences of the same and similar violations and the parties responsible for the correction.

 

3)         A specific date by which the corrective action will be completed.

 

c)         Submission of a plan of correction shall not be considered an admission by the hospice program that the violation has occurred.

 

d)         The Department shall review each plan of correction to ensure that it provides for the abatement, elimination, or correction of the violation.  The Department shall reject a submitted plan only if it finds any of the following deficiencies:

 

1)         The plan does not appear to address the conditions or occurrences that are the basis of the violation and an evaluation of the practices, policies, and procedures that have caused or contributed to the conditions or occurrences.

 

2)         The plan is not specific enough to indicate the actual actions the hospice program will be taking to abate, eliminate, or correct the violation.

 

3)         The plan does not provide for measures that will abate or eliminate, or correct the violation.

 

4)         The plan does not provide steps that will avoid future occurrences of the same and similar violations.

 

5)         The plan does not provide for timely completion of the corrective action, considering the seriousness of the violation, any possible harm to the patients, and the extent and complexity of the correction action.

 

e)         The Department shall notify the licensee or applicant in writing of the rejection of the plan of correction, including specific reasons for the rejection of the plan.  The hospice program shall have 10 days after receipt of notice of rejection in which to submit a modified plan that addresses the requirements of subsection (b) of this Section.

 

f)         If a licensee or applicant fails to make a timely submission of a modified plan of correction, or such modified plan is not acceptable to the Department, a plan of correction may be specified and imposed by the Department.

 

g)         The Department shall verify the completion of the corrective action required by the plan of correction within the specified time period during subsequent investigations, surveys and evaluations of the facility.

 

Section 280.1060  Adverse Licensure Actions

 

a)         Before denying an application or refusing to renew a license or revoking a license, the Department shall notify the applicant or licensee in writing.  (Section 11(a) of the Act)

 

b)         Such notice shall be effected by registered mail or by personal service setting forth the particular reasons for the proposed action and fixing a date, not less than 15 days from the date of such mailing or service, at which time the applicant or licensee shall be given an opportunity for a hearing.  (Section 11(b) of the Act)

 

c)         Such hearing shall be conducted by the Director or designee in conformance with the Department's Rules of Practice and Procedure in Administrative Hearings and Section 11 of the Act.  (Section 11(b) of the Act)

 

d)         A license may be revoked or suspended for any of the following reasons:

 

1)         A violation of any provision of the Act or this Part; or

 

2)         The loss of a license held by the affiliated Agency under its applicable licensing Act.  (Section 10 of the Act)

SUBPART B: HOSPICE SERVICES

 

Section 280.2000  Hospice Service Plan

 

a)         Each hospice program shall develop an annual hospice service plan detailing the specific hospice services offered, and the administrative and direct care personnel responsible for those services.  The hospice service plan shall include, but not be limited to:

 

1)         Identification of the person or persons administratively responsible for the program.

 

2)         The estimated average monthly patient census.

 

3)         The proposed geographic area the hospice will serve.

 

4)         A listing of those hospice services provided directly by the hospice, and those hospice services provided indirectly through a contractual agreement.

 

5)         The names and qualifications of those persons or entities under contract to provide indirect hospice services.

 

6)         The name and qualifications of those persons providing direct hospice services, with the exception of volunteers.

 

7)         A description of how the hospice plans to utilize volunteers in the provision of hospice services.

 

8)         A description of the program's clinical record-keeping system for the licensed hospice program location and any multiple hospice locations. (Section 3(j) of the Act)

 

b)         Comprehensive hospices that operate from multiple hospice locations shall comply with the following:

 

1)         The hospice must be able to exert the supervision and control necessary at each location to assure that all hospice care and services continue to be responsive to the needs of the patient/family at all times and in all settings;

 

2)         Each location must provide the same full range of services that is required of the hospice to which the license was issued;

 

3)         Each patient must be assigned to a specific hospice care team responsible for ongoing assessment, planning, monitoring, coordination and provision of care;

 

4)         The hospice medical director must assume overall responsibility for the medical component of the hospice's patient care program at all locations;

 

5)         Each location must be responsible to the same governing body and central administration that governs the hospice to which the license was issued, and the governing body and central administration must be able to manage the location adequately and to assure quality of care at the location; and

 

6)         All hospice patients' clinical records requested by the surveyor must be available at the hospice site to which the license was issued.

 

(Source:  Amended at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.2010  Hospice Services

 

a)         The hospice care team shall be responsible for ensuring that all services are provided in accordance with the patient care plan.  Services shall be provided directly by the hospice or through written contracts with other providers.  A comprehensive or volunteer hospice shall comply with the following:

 

1)         The hospice program shall foster independence of the patient and his/her family by providing training, encouragement and support so that the patient and family can care for themselves as much as possible.  (Section 8(f) of the Act).

 

2)         The hospice program must have functioning hospice care teams that develop the hospice patient plans of care in accordance with the standards for certification under the Medicare program set forth in the Conditions of Participation in 42 CFR 418.  (Section 8(c) of the Act)

 

3)         A hospice patient's plan of care must be established and maintained for each individual admitted to a hospice program, and the services provided to an individual must be in accordance with the individual's plan of care.  The plans of care must be established and maintained in accordance with the standards for certification under the Medicare program set forth in the Conditions of Participation in 42 CFR 418.  (Section 8(c-5) of the Act)

 

A)        Each hospice shall ensure that there is a written plan of care for each patient.  The hospice care team shall complete an assessment of the care needs and evaluate the ability of the patient to be cared for in his/her place of residence.

 

B)        The plan shall be updated based on ongoing assessments by the hospice care team.

 

C)        The patient care plan shall provide for involvement of the family and others in treatment.

 

D)        Each hospice providing services to a patient in both the home setting and the inpatient setting shall have written policies and procedures to share the written plan of care between both settings to facilitate continuity of care.

 

4)         The hospice program's services shall include nursing services, medical social work services, bereavement services, and volunteer services.  These services shall be coordinated with those of the hospice patient's attending physician and shall be substantially provided by hospice program employees.  The hospice program must provide these services in a manner consistent with the standards for certification under the Medicare program set forth in the Conditions of Participation in 42 CFR 418.  (Section 8(a) of the Act)

 

5)         The hospice program must make nursing services, medical social work services, volunteer services and bereavement services available on a 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.  The hospice program must provide these services in a manner consistent with the standards for certification under the Medicare program set forth in the Conditions of Participation in 42 CFR 418.  (Section 8(a) of the Act)

 

6)         Hospice services, as defined in Section 3 of the Act, may be furnished in a home or inpatient setting, with the intent of minimizing the length of inpatient care.  The home care component shall be the primary form of care and shall be available on a part-time, intermittent, regularly scheduled basis.  (Section 8(a) of the Act)

 

7)         The required hospice services are defined as follows:

 

A)        Nursing Services – Nursing services are responsible for developing and implementing the diagnostic, therapeutic, and rehabilitative plan as prescribed by the patient's attending physician.  The nursing staff shall provide care in the patient's place of residence; observe symptoms and reactions; and meet the nursing care needs of the terminally ill. A registered professional nurse shall perform the initial home care assessment. Nursing services shall be provided under the supervision of a registered professional nurse.

 

B)        Medical Social Work Services – Medical social work services shall be made available to the patient/family.  An evaluation of the social needs, such as environment, religious background, financial needs, psychosocial needs, family, special activities, and psychological needs shall be conducted.  Social services shall be delivered by a social worker.

 

C)        Spiritual Counseling Services – The hospice program shall provide, at a minimum, one counselor as defined in Section 280.1000 to provide spiritual counseling services.  Spiritual counseling services shall be made available to the patient and family.  The patient's religious beliefs and practices shall be accommodated either by the hospice or with an outside source.  The hospice program shall not impose the dictates of any value or belief system on its patients.  (Section 8(g) of the Act)

 

D)        Bereavement Services – Each hospice shall provide bereavement services to the families of hospice patients to the extent desired by the family.  Bereavement services may be coordinated with the family's clergy, if any, as well as with other community resources judged by the hospice care team to be useful to the family unless the family declines.  The bereavement services must be provided in accordance with the standards for certification under the Medicare program set forth in the Conditions of Participation in 42 CFR 418.  (Section 8(e) of the Act)

 

E)        Volunteer Services – The hospice program shall use volunteers in day-to-day administration and/or direct patient care roles.  The hospice program shall utilize the services of trained volunteers in accordance with the standards for certification under the Medicare program set forth in the Conditions of Participation in 42 CFR 418.  (Section 8(j) of the Act)

 

F)         Alzheimer's Services – The hospice program shall provide Alzheimer's disease and related dementias services in accordance with the Alzheimer's Disease and Related Dementias Act and the Alzheimer's Disease and Related Dementias Services Code.

 

8)         Nutritional Evaluation – The hospice program shall perform a nutritional evaluation of the patient by a qualified individual, including, but not limited to, a dietitian or nurse.  This evaluation shall be reviewed by the hospice care team.  Consultation by a dietitian shall be available to the patient as determined necessary by the hospice care team.

 

b)         Additional requirements; comprehensive hospice program.  In addition to complying with the standards prescribed by the Department under Section 9 of the Act and complying with all other applicable requirements under the Act and this Part, a comprehensive hospice program must meet the minimum standards for certification under the Medicare program set forth in the Conditions of Participation in 42 CFR 418.  (Section 8.5 of the Act)

 

c)         Additional requirements; volunteer hospice program.  In addition to complying with the standards prescribed by the Department under Section 9 of the Act and complying with all other applicable requirements under the Act and this Part, a volunteer hospice program must do the following:

 

1)         Provide hospice care to patients regardless of their ability to pay, with emphasis on the utilization of volunteers to provide services.  Nothing in this subsection (c)(1) prohibits a volunteer hospice program from employing paid staff, however.

 

2)         Provide services not required under Section 8(a) of the Act in accordance with generally accepted standards of practice and in accordance with applicable local, State, and federal laws.

 

3)         Include the word "Volunteer" in its corporate name and in all verbal and written communications to patients, patients' families and representatives, and the community and public at large.

 

4)         Provide information regarding other hospice care providers available in the hospice program's service area.  (Section 8.10 of the Act)

 

(Source:  Amended at 44 Ill. Reg. 12582, effective July 2, 2020)

 

Section 280.2020  Administration

 

a)         Each hospice program shall have a governing body.  The governing body must ensure that all services are provided in accordance with accepted standards of practice and shall assume full legal responsibility for determining, implementing, and maintaining the hospice program's total operation.  (Section 8(a-5) of the Act)

 

b)         The governing body shall appoint an administrator whose qualifications and duties are defined in writing.  The administrator shall have the following responsibilities:

 

1)         Ensure the completion, maintenance, and submission of all required reports and records to the Department.

 

2)         Assist the governing body in formulating and annually reviewing the hospice program policies and procedures.

 

3)         Maintain a current organizational chart that identifies the lines of authority from clinical supervision to the patient care level.  Shift supervisors and staff members in positions of authority shall be identified.

 

4)         Have authority for the management of the business affairs and overall day-to-day operation of the hospice.

 

5)         Maintain personnel records, administrative records, and all policies and procedures of the hospice.

 

6)         Ensure the provision of an orientation and in-service training program for all staff, covering the physical, emotional, spiritual, bereavement and social needs of hospice patients and their families.

 

7)         Employ personnel who meet the requirements of the written job descriptions of the hospice.

 

8)         Designate in writing the staff member who will act in the absence of the administrator.

 

(Source:  Amended at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.2030  Policies and Procedures

 

a)         The hospice shall have written policies and procedures governing all services provided by the hospice, which shall be formulated with the involvement of the administrator and representatives of the governing body.  The policies shall be available to the staff, patients, patients' families and the public.  These written policies shall be followed in operating the hospice and shall be reviewed annually and revised as necessary.  These policies shall include a written statement:

 

1)         of philosophy, objectives and goals the hospice is striving to achieve;

 

2)         of the hospice services provided and the type of hospice license required;

 

3)         of the relationship of the hospice to the families of its patients;

 

4)         concerning admission, transfer, and discharge of patients;

 

5)         concerning community participation and input, if any; and

 

6)         concerning the planning, evaluation and quality assurance process.

 

b)         The hospice program shall clearly define its admission criteria.  Decisions on admission shall be made by a hospice care team and shall be dependent upon the expressed request and informed consent of the patient or the patient's legal guardian.  For purposes of the Act and this Part, "informed consent" means that a hospice program must demonstrate respect for an individual's rights by ensuring that an informed consent form that specifies the type of care and services that may be provided as hospice care during the course of the patient's illness has been obtained for every hospice patient, either from the patient or from the patient's representative. (Section 8(h) of the Act)

 

(Source:  Amended at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.2035  Health Care Worker Background Check

 

A hospice program shall comply with the Health Care Worker Background Check Act  and the Health Care Worker Background Check Code.

 

(Source:  Added at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.2040  Personnel Policies

 

a)         The hospice shall develop and maintain written personnel policies that are followed in the operation of the program.  These policies shall include policies and procedures regarding the use of volunteers.

 

b)         Employment application forms shall be completed on each employee and kept on file in the program's central office.  The file shall contain, at a minimum, home address; telephone number; Social Security number; educational background; documentation of current professional certification, licensure or registration, as applicable; past employment history, including dates, positions held, reasons for leaving.  The date of employment and position held shall be documented in each file.

 

c)         Each employee shall have an accurate written job description.  Employees shall be assigned only duties directly related to their job functions, as identified in the job descriptions.  Exceptions may be made when unplanned events, such as severe weather, limit staffing temporarily.

 

d)         Where applicable, every hospice program employee must be licensed, certified, or registered in accordance with federal, State and local laws.  (Section 8(n) of the Act)

 

e)         All personnel shall have either training or experience, or both, in the job assigned them.  The hospice program shall provide an ongoing program for the training and education of its employees, appropriate to their responsibilities, including training in Alzheimer's care in accordance with 77 Ill. Adm. Code 973.

 

f)         All new employees shall complete an orientation program covering, at a minimum:

 

1)         The program's philosophy and goals; and

 

2)         Job orientation, emphasizing allowable duties of the new employee, safety, and appropriate interactions with patients and families.

 

g)         All employees shall attend in-service training programs pertaining to their assigned duties at least annually.  Written records of program content and personnel attending each session shall be maintained.

 

h)         The hospice shall document all arrangements for each consultant's services in a written agreement setting forth services to be provided.

 

i)          The hospice shall retain professional and supervisory responsibility for all services provided under arrangements and shall ensure that all services are:

 

1)         Authorized by the hospice;

 

2)         Furnished in a safe and effective manner by qualified personnel; and

 

3)         Delivered in accordance with the patient's plan of care.

 

j)          The hospice program shall utilize the services of trained volunteers in accordance with the standards for certification under the Medicare program set forth in the Conditions of Participation in 42 CFR 418.  (Section 8(j) of the Act)

 

1)         Volunteer application forms shall be completed on each volunteer and kept on file in the program's central office.  The file shall contain, at a minimum, home address; telephone number; educational and employment background relating to the volunteer position; and documentation of current professional certification, licensure or registration relating to the volunteer position.  The date of acceptance as a volunteer and position held shall be documented in each file.

 

2)         Each volunteer shall have an accurate written job description.  Volunteers shall only be assigned duties directly related to their job functions, as identified in the job description.

 

3)         All volunteers shall have training or experience in the job assigned them.

 

4)         All volunteers shall complete an orientation program covering, at a minimum:

 

A)        The program's philosophy and goals; and

 

B)        Job orientation, emphasizing allowable duties of the volunteer, safety, and appropriate interactions with patients and families.

 

(Source:  Amended at 44 Ill. Reg. 12582, effective July 2, 2020)

 

Section 280.2045  Initial Health Evaluation for Employees

 

a)         Each employee shall have an initial health evaluation, which shall be used to ensure that employees are not placed in positions that would pose undue risk of infection to themselves, other employees, patients, or family members.

 

b)         The initial health evaluation shall include a health inventory.  This inventory shall be obtained from the employee and shall include the employee's immunization status and any available history of conditions that would predispose the employee to acquiring or transmitting infectious diseases in the course of performing anticipated job functions.  It shall include any history of exposure to, or treatment for, tuberculosis, any history of hepatitis, dermatologic conditions, chronic draining infections or open wounds.

 

c)         The initial health evaluation shall include a physical examination.  The examination shall include at a minimum any procedures needed to:

 

1)         Detect any unusual susceptibility to infection and any conditions that would increase the likelihood of the transmission of disease, and

 

2)         Determine that the employee appears to be physically able to perform the job functions that the hospice program intends to assign to the employee.

 

d)         The health inventory and physical examination shall be completed no more than 30 days prior to and no more than 30 days after the date of initial employment.

 

e)         The initial health evaluation shall include a tuberculin skin test, which is conducted in accordance with the requirements of Section 690.720 of the Control of Communicable Diseases Code.

 

Section 280.2050  Patient Rights

 

a)         Each hospice program shall have written policies and procedures that support, enhance and protect the human, civil, constitutional and statutory rights of all patients. Rights shall include but not be limited to:

 

1)         The right to informed consent that specifies the type of care and services that will be provided in the hospice program.

 

2)         The right to information regarding diagnosis and prognosis and any change in either.

 

3)         The right to review and participate in his or her plan of care.

 

4)         The right to privacy.

 

b)         A copy of patient rights shall be provided to the patient upon admission to the hospice.

 

Section 280.2060  Clinical Records

 

Each hospice must establish and maintain a clinical record for every individual receiving services.

 

a)         The hospice program shall keep accurate, current and confidential records on all hospice patients and their families in accordance with the standards for certification under the Medicare program set forth in the Conditions of Participation in 42 CFR 418, except standards or conditions in connection with Medicare or Medicaid election forms do not apply to patients receiving hospice care at no charge.  (Section 8(i) of the Act)

 

b)         A standardized format shall be used for documenting:

 

1)         Hospice care team services;

 

2)         Home care services; and

 

3)         Inpatient services.

 

c)         Record entries shall be made by hospice staff members or individuals providing services under contract.

 

d)         All entries into the medical record shall be authenticated by the individual who made or authorized the entry.  "Authentication", for purposes of this Section, means identification of the author of a medical record entry by the author, and confirmation that the contents are what the author intended.

 

e)         The medical record may include entries that are transmitted by facsimile machine, provided that the faxed copies will be maintained on non-thermal paper and that the faxed copies will be dated and authenticated in accordance with hospice policy.

 

f)         Written signatures or initials and electronic signatures or computer-generated signature codes are acceptable as authentication.  All signatures or initials, whether written, electronic, or computer-generated, shall include the initials of the signer's credentials.

 

g)         In order for a hospice to employ electronic signatures or computer-generated signature codes for authentication purposes, the hospice shall adopt a policy that permits authentication by electronic or computer-generated signature.  The policy shall identify those categories of the staff or other personnel within the hospice who are authorized to authenticate patient records using electronic or computer-generated signatures.

 

h)         At a minimum, the policy shall include adequate safeguards to ensure confidentially, including, but not limited to, the following:

 

1)         Each user shall be assigned a unique identifier that is generated through a confidential access code.

 

2)         The hospice shall certify in writing that each identifier is kept strictly confidential.  This certification shall include a commitment to terminate a user's use of a particular identifier if it is found that the identifier has been misused.  "Misused" shall mean that the user has allowed another person or persons to use his or her personally assigned identifier, or that the identifier has otherwise been inappropriately used.

 

3)         The user shall certify in writing that he or she is the only person with user access to the identifier and the only person authorized to use the signature code.

 

4)         The hospice shall monitor the use of identifiers periodically and take corrective action as needed.  The process by which the hospice will conduct the monitoring shall be described in the policy.

 

i)          Progress notes shall be signed and dated by the person providing the services.

 

j)          The record shall include a conclusion or evaluation at the termination of hospice care, including a referral of the patient, and the hospice patient's family to another resource, if applicable.

 

k)         The record for each patient and the hospice patient's family receiving hospice home care services shall include:

 

1)         The names of persons who are assuming responsibility for the care of the patient at home; and

 

2)         The suitability or adaptability of the residence for the provision of required services.

 

l)          The documentation must reflect the physical condition of the patient, the psychosocial status of the patient and the hospice patient's family, and the care provided from admission through discharge.

 

m)        Each hospice must have a written policy to identify how it will safeguard clinical records against loss, destruction and unauthorized use.

 

n)         A patient's clinical records shall be maintained by the hospice for at least five years beyond the last date of service.

 

(Source:  Amended at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.2070  Medical Director and Physician Services

 

a)         The hospice program shall have a medical director who shall be a doctor of medicine or osteopathy and licensed to practice medicine in all of its branches. (Section 8(d) of the Act)  In his/her absence, the medical director or governing body shall designate another physician to serve as hospice physician designee.

 

b)         The medical director shall have overall responsibility for medical direction of the patient care component of the hospice program and shall consult and cooperate with the patient's attending physician.  (Section 8(d) of the Act)

 

c)         Duties of the medical director shall include but not be limited to:

 

1)         Reviewing the clinical material of the referring physician to document basic disease process; the drug regimen; and assessment of the patient's health and prognosis at time of admission.

 

2)         Performing an admission history and physical for each patient who has no other physician.

 

3)         Assisting in developing the plan of care for each patient/family with the coordination of the patient's attending physician.

 

4)         Attending and actively participating in patient/family care conferences, when requested to do so by the hospice care team coordinator.

 

5)         Reviewing the active medical care and palliative care in patients' homes, and in any inpatient setting in which the hospice has provided patient services.

 

6)         Maintaining a regular schedule of participation in all components of the hospice care program; and maintaining 24-hour, seven days a week coverage of and ready availability to the hospice program through himself/herself or his/her hospice physician's designee.

 

7)         Acting as a consultant to patient's attending physicians and other members of the hospice care team; helping to develop and review patient/family care policies and procedures; and serving on the hospice care team.

 

8)         Maintaining liaison with the attending physician.  The attending physician is encouraged to provide primary care to his/her patient even though the patient also receives hospice care.

 

9)         Approving written guidelines for symptom control, i.e., pain, nausea, vomiting, or other symptoms.

 

d)         The hospice must ensure that each patient has an attending physician.  The hospice program shall have each patient or his/her representative complete and sign a form indicating the name of the attending physician responsible for his/her care.

           

(Source:  Amended at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.2080  Hospice Program Care

 

a)         The hospice program shall coordinate its services with professional and nonprofessional services already in the community.  (Section 8(b) of the Act)

 

b)         The hospice program may contract out for elements of its services. (Section 8(b) of the Act)  If services are contracted, the hospice care team is responsible for maintaining direct patient contact and overall coordination of hospice services.

 

c)         Any contract entered into between a hospice and a health care facility or service provider shall specify that the hospice care team retains the responsibility for planning and coordinating hospice services and care on behalf of a hospice patient and his/her family.  (Section 8(b) of the Act).

 

d)         All contracts shall be in compliance with the Act.

 

e)         No hospice that contracts for any hospice services shall charge fees for services provided directly by the hospice care team that duplicate contractual services provided to the individual patient or his/her family.  (Section 8(b) of the Act)

 

f)         The hospice program must fully disclose in writing to any hospice patient, or to any hospice patient's family or representative, prior to the patient's admission, the hospice services available from the hospice program and the hospice services for which the hospice patient may be eligible under the patient's third-party payer plan (that is, Medicare, Medicaid, the Veterans Administration, private insurance or other plans).  (Section 8(a-10) of the Act)

 

g)         Each hospice program shall develop written policies and procedures for admissions and discharges, the function of the hospice care team, and the development of the patient care plan.

           

1)         Admissions to the hospice program shall be limited to interested individuals who have been determined by their attending physician as having a terminal illness for which palliative care is considered the appropriate medical regimen.

 

2)         Restrictions by geographic areas must be clearly stated by each hospice program.

 

3)         Upon admission, the hospice care team shall coordinate an evaluation of the patient's physical, medical, spiritual, social and psychological needs. The patient and the hospice patient's family shall be evaluated to determine the unit of care.

 

4)         Hospice services are voluntary and may be refused or stopped in accordance with written policies and procedures.  The patient may request a return to curative treatment, at which time the need for hospice services is to be re-evaluated.

 

h)         Function of the Hospice Care Team

 

1)         Each comprehensive hospice will have, at a minimum, an interdisciplinary working unit called the hospice care team.  This unit shall be composed of, at a minimum, the attending physician, a nurse, a social worker, a counselor, and trained volunteers.  The patient, patient's physician and patient's family are considered members of the hospice care team when development or revision of the patient's plan of care takes place.

 

2)         Each volunteer hospice shall have a hospice care team consisting of staff from each of the services provided.  The patient, patient's attending physician and patient's family are considered members of the hospice care team when development or revision of the patient's plan of care takes place.  The hospice care team must participate in the development of every patient care plan.  The hospice care team must establish a procedure to review each patient care plan on an ongoing basis, but at least monthly.

 

i)          Patient Care Plan

 

1)         Each comprehensive and volunteer hospice shall ensure that there is a written plan of care for each patient.  The hospice care team will complete an assessment of the care needs and evaluate the ability of the patient to be cared for in his/her place of residence.

 

2)         The plan shall be updated based on ongoing assessments by the hospice care team.

 

3)         The patient care plan shall provide for involvement of the family in treatment.

 

4)         Each comprehensive hospice or volunteer hospice providing services to a patient in both the home setting and the inpatient setting must have written policies and procedures to share the written plan of care between both settings to facilitate continuity of care.

                                                                                                 

(Source:  Amended at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.2090  Quality Assurance Program

 

a)         The hospice program must conduct a quality assurance program in accordance with the standards for certification under the Medicare program set forth in the Conditions of Participation in 42 CFR 418.  (Section 8(m) of the Act)

 

b)         Each hospice shall establish a written quality assurance plan for review of the services delivered.  The plan must include:

 

1)         A process for identification of quality assurance issues.  The person or persons responsible for coordinating quality assurance shall review all summaries of individual assessments at least quarterly and prepare a written report addressing any problems with care, treatment services, availability of services, and methods of care delivery.

 

2)         A system to report to the governing body findings and recommendations for improving the quality of care delivered.  The quality assurance reports shall be reviewed by the hospice administrator and the governing body. 

 

3)         The minutes of the meetings of the governing body, which shall indicate that the reports have been reviewed at least annually.

 

(Source:  Amended at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.3000  Research or Experimental Programs

 

Each hospice shall have a written policy concerning initiating and participating in research studies or experimental programs.  Studies conducted only for the hospice quality assurance/performance improvement program are not considered to be research or experimental programs prior to initiation.  The policy shall require that  the Director approve any research study or experimental program. 

 

a)         Hospice policies regarding research studies or experimental programs initiated by the hospice shall include the following:

 

1)         The establishment of appropriate written policies and procedures for all participants, including staff and patients affected.

 

2)         Requirements for written informed consent signed by each subject or patient representative or legal guardian.

 

3)         Procedures for full disclosure to subjects, including disclosures of conventional and experimental procedures, risk and/or potential discomfort, purposes or potential benefits, and alternative procedures.

 

4)         A statement that subjects shall be permitted to withdraw consent and to discontinue participation at any time and for any reason.

 

5)         A statement that subjects shall not be made, or requested, to waive any of their legal rights.

 

6)         A statement that confidentiality shall be maintained regarding identity and clinical records of all participants.

 

7)         A statement that control groups in treatment modalities shall be considered as participants in research and experimentation.

 

8)         The establishment of an interdisciplinary research committee or human rights committee that is composed of both program staff members and persons who are not staff members.  This committee shall include hospice patients or their representatives, or family members of former hospice patients, and persons from outside the facility, such as doctors, nurses, lawyers, parents, friends and advocates.  All deliberations and decisions of the committee shall be documented.

 

9)         A written review procedure for approval by the Institutional Review Board of the sponsoring organization or approval of the hospice Interdisciplinary Review Committee established by the hospice program to assure compliance with the policy for protection of human subjects of the U.S. Department of Health and Human Services (42 CFR 2.52 (2004)).

 

b)        The Director will base approval of research studies or experimental programs upon compliance with the requirements of subsection (a).

                         

(Source:  Amended at 32 Ill. Reg. 2330, effective January 23, 2008)

SUBPART C: INPATIENT CARE

 

Section 280.4000  Inpatient Care Facilities

           

a)         The comprehensive hospice is responsible for placing patients in an inpatient facility that provides 24-hour nursing services in accordance with each patient's plan of care.  Each shift must include a registered nurse who provides or supervises direct patient care to the hospice patient.

 

b)         The inpatient facility shall provide hospice services in an area designed, equipped, and located for the comfort, convenience, and privacy of each patient and family member.  This area shall have:

 

1)         Physical space for private patient/family visiting;

 

2)         Accommodations for family members to remain with the patient throughout the night;

 

3)         Accommodations for family privacy after a patient's death; and

 

4)         Decor that is homelike in design and function.

 

c)         The area of an inpatient facility that is used as the hospice unit shall be located so that the activities of the rest of the facility do not infringe upon the activities of patients, families, staff or visitors in the hospice unit.  Likewise, the presence of the hospice unit within the facility shall not interfere with the usual activities of the facility.

 

1)         The inpatient facility shall have written policies that permit hospice patients to receive visitors, including small children, at any time of the day or night.

 

2)         The inpatient facility shall have written policies that permit the hospice patient's family to participate in providing care to the patient, in accordance with the patient care plan.

 

d)         It is permissible for a room in the designated hospice area to be used for nonhospice curative care, as long as there is written documentation that the nonhospice patient has been informed that the room is located in the hospice unit and the other patients in the unit are receiving palliative care rather than curative care.  Such documentation shall include a statement to this effect, which has been signed by the patient.  Hospice patients and nonhospice patients shall not be placed in the same room.

 

e)         The hospice shall have a written, dated and signed agreement with the inpatient facility that clearly states the responsibilities of each organization.  Such an agreement is not necessary if the inpatient facility is a  hospice residence that is under the jurisdiction of the same governing body as the hospice.

 

(Source:  Amended at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.4010  Licensure of Hospice Residences

 

a)         The number of licensed hospice residences shall not exceed 48. (Section 9(c)(9) of the Act)

 

b)         An applicant shall submit a hospice residence license certificate application on forms provided by the Department.  The application shall be made under oath and shall contain the following information:

 

1)         All information required by Section 280.1020(a)(1) through (15);

 

2)         Proposed staffing;

 

3)         Documentation of a needs assessment and cost analysis of the establishment, licensing and maintenance of the proposed facility; and

 

4)         Documentation of approval by the governing body of the applying licensed hospice program to proceed with application; commitment to expend necessary funds for application and completion of the project; and assignment of responsibility for moving forward with the application/implementation.

 

c)         An application for licensure as a hospice residence shall be accompanied by a fee of $500.

 

d)         Upon receipt and review of a complete application for licensure, the Department will award license certificates to applicants who meet the requirements in Section 280.4015, in the following geographic areas, in the order in which completed applications are received by the Department:

 

1)         16 hospice residences located in counties with a population of 700,000 or more;

 

2)         16 hospice residences located in counties with a population of 200,000 or more but less than 700,000; and

 

3)         16 hospice residences located in counties with a population of less than 200,000. (Section 9(c)(9) of the Act)

 

e)         A license certificate shall be valid for two years from the date of issuance and may be renewed by the Department for an additional year, for a total of three years.  Renewal of the license certificate for a third year will be based on but not limited to, submittal of the following information:  

 

1)         Documentation of the obligation of funds for the applicant residence project by the hospice residence organization;

 

2)         Letting of contracts for construction, purchase or renovation of physical space to be licensed as a hospice residence;

 

3)         Architectural or construction certifications as to the percentage of completion of the hospice residence project; and

 

4)         For buildings owned by the full hospice, the name, address, telephone number, occupation, and percentage of direct or indirect financial interest of five percent or more in the legal entity that owns the building or proposed building. For leased buildings, the name, address and telephone numbers.

 

f)         By the end of the third year, any license certificate not converted to a full license will be void.

 

g)         The Department will issue available license certificates to the next complete, geographically appropriate applicant, in the order received by the Department.

 

h)         Upon receipt of the completed application and notification by the hospice residence applicant that the facility is complete and ready for licensure, the Department will conduct an inspection to determine compliance with the Act and this Part.

 

i)          If the hospice residence is found to be in substantial compliance with the Act and this Part, the Department will issue a license that expires on the same date as the comprehensive or volunteer hospice program license.

 

1)         The license is not transferable; it is issued to the licensee and for the specific location; and

 

2)         The license will become automatically void and shall be returned to the Department if a hospice residence's comprehensive or volunteer license is revoked, not renewed, relinquished, denied, forfeited or suspended.

 

j)          An application for license renewal shall be filed with the Department 60 days prior to the expiration of the license, on forms provided by the Department.

 

1)         The renewal application shall comply with the requirements of subsections (b) and (c).

 

2)         A letter from the Office of the State Fire Marshal shall accompany the application certifying that the hospice residence physical plant meets the provisions of Section 280.4040.

 

3)         Pursuant to Section 10-65 of the Illinois Administrative Procedure Act, licensees who are individuals are subject to denial of renewal of licensure if the individual is more than 30 days delinquent in complying with a child support order.

 

4)         Upon receipt and review of a complete application for license renewal, the Department will conduct a survey.  The Department will renew the license in accordance with subsection (i).

 

(Source:  Amended at 48 Ill. Reg. 2531, effective January 30, 2024)

 

Section 280.4015  Hospice Residence Application and Approval Review Criteria

 

a)         Applications received for a hospice residence license will be reviewed by the Department.  Applicants for a hospice residence license will have 30 days following notification of the receipt of their application by the Department to amend the application or provide additional supporting documentation during the review process.  The application as submitted to the Department shall serve as the basis for all standard and prioritization evaluations.

 

b)         The Department will review applications and award license certificates to applicants as applications are received.

 

c)         To be eligible for issuance of a license certificate, an applicant shall meet the following criteria:

 

1)         Proposed Residence Location/Facility

The proposal shall be evaluated for compliance with the following definition: 

 

A)        "Hospice Residence" means a separately licensed home, apartment building, or similar building providing living quarters:

 

i)          That is owned or operated by a person licensed to operate as a comprehensive hospice; and

 

ii)         At which hospice services are provided to facility residents.

 

B)        A building that is licensed under the Hospital Licensing Act, the Nursing Home Care Act, the Specialized Mental Health Rehabilitation Act of 2013, the ID/DD Community Care Act, or the MC/DD Act is not a hospice residence. (Section 3(g-1) of the Act)

 

2)         Application Completeness

All required information for application, as listed in subsection 280.4010(b)(1) through (4), shall be in the application submission, including, but not limited to, appropriate signatures, attestations, oaths, dates and fees.

 

3)         Documentation of completed Needs Assessment and Cost Analysis

The application shall document that an assessment of the need for the hospice residence services and an analysis of the costs involved in the establishment, licensing and maintenance of a hospice residence have been conducted and reviewed for the proposed application.  The documentation submitted shall demonstrate the criteria used and results of the assessments.

 

4)         Documentation of approval for application by the applicant hospice's governing body

The application shall document that the proposed residence application has been thoroughly reviewed, discussed and approved by the governing body of the licensed hospice program applying for the residence license.  "Approval" is defined as an official motion by the governing body to proceed with the application; commitment by the organization to expend the necessary funds for application and completion of the project; and assignment of responsibility for moving forward with the application and implementation of the project.

 

(Source:  Amended at 48 Ill. Reg. 2531, effective January 30, 2024)

 

Section 280.4020  Hospice Residence Admission and Discharge

 

a)         A patient shall be admitted only after receiving a documented terminally ill medical prognosis from a physician that he/she has an anticipated life expectancy of 12 months or less; the patient or patient's representative has elected hospice care; the hospice that owns and operates the hospice residence has accepted the individual as a patient of the hospice program; and in-home care is not practical.

 

b)         Patients of mixed ages, i.e., adults, infants and children under 18 years of age, may be admitted provided that they meet all other facility admission requirements.

 

c)         Before a patient is admitted to a facility or at the expiration of the period of a previous contract, a written contract shall be executed between the facility and the patient or patient's representative.  The contract shall specify the services that will or will not be provided.  The contract shall specify the rights, duties and financial obligations of the patient and the facility.

 

d)         At the time of admission to the facility, a copy of the written contract shall be given to the patient and his/her representative.

 

e)         Facilities shall ensure that all forms, agreements and signage that carry information significant to the patient are available and worded so as not to be confusing to the reader.

 

f)         A facility shall not admit more patients than the number authorized by the license issued to it.

 

(Source:  Amended at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.4030  Hospice Residence Nursing Care and Assistance in Activities of Daily Living

 

a)         Through the hospice care team, the hospice shall be responsible for preparing, revising, documenting and implementing a single individual care plan for each patient.

 

b)         Nursing care and assistance with activities of daily living shall be provided to each patient to meet the total care needs of the patient as determined by the care plan.

 

c)         The hospice shall provide a sufficient number of properly trained and supervised staff to meet the needs of each patient.  At least two staff, one of whom is a nurse, must be on duty when patients are present.  If one of the staff is not a registered nurse, a registered nurse must be on call.

 

d)         Assistance with activities of daily living shall include, but not be limited to, the following:

 

1)         Each patient shall have proper daily personal attention, including skin, nails, hair, and oral hygiene, in addition to treatment ordered by the attending physician.

 

2)         Each patient shall have at least one complete bath and hair wash weekly, if physically able to tolerate, and as many additional baths and hair washes as necessary for satisfactory personal hygiene and comfort.

 

3)         Each patient shall have clean, suitable clothing in order to be comfortable, sanitary, and free of odors.

 

4)         Each patient shall have clean bed linens at least twice weekly and more often as necessary.

 

e)         Patients shall be encouraged to administer their own medications.  If a patient or family member cannot administer the medications, administration shall be by licensed medical or licensed nursing personnel in accordance with their respective licensing requirements.

 

f)         Facilities shall develop and adhere to written medication policies and procedures addressing the procurement, storage, dispensing, administration and disposal of medications in compliance with federal, State and local regulations and the following:

 

1)         A statement of who will administer medications, how the staff will supervise self-administration of medications, whether medications will be self-administered or a combination of staff and self-administration.

 

2)         How the distribution and storage of medications will be handled.

 

3)         If the facility has both staff-administered and family- or self-administered medications, the care plan shall specify who will determine which system each patient will use.

 

4)         Procedures for recording medications that patients are taking.

 

5)         Procedures for storage of prescription and nonprescription medications.

 

6)         Method for refrigeration of biologicals.

 

7)         Procedures for labeling medications.

 

g)         Physicians' Orders & Telephone Orders

 

1)         All medications shall be ordered by the attending physician.  The order shall have the handwritten signature of the attending physician.  The order shall contain the name of the drug, dose, route and frequency.

 

2)         Telephone orders may be taken by a nurse.  All such orders shall be immediately written in the client's medical plan of care record or a "telephone order form" and signed by the nurse taking the order.  These orders shall be countersigned by the physician within 30 working days.

 

3)         Physicians' orders may be faxed.

 

h)         All medications to be released to the patient or to the person responsible for the patient's care at the time of discharge, or when the patient is going to be temporarily out of the facility at medication time, shall be approved by the physician.  A notation concerning their disposition shall be made in the patient's medical plan of care.

 

i)          All Schedule II controlled substances shall be stored so that two separate locks using two different keys must be unlocked to obtain these substances. This may be accomplished by several methods, such as a locked cabinet within a locked medicine room; separately locked, securely fastened boxes (or drawers) within a locked medicine cabinet; locked portable medication carts that are stored in a locked medicine room when not in use; portable medication carts containing a separate locked area within the locked medication cart when such a cart is made immobile; or securely fastened boxes (or drawers) within a locked cabinet in the patient's room.

 

j)          For all Schedule II substances, a controlled substance record shall be maintained that lists on separate sheets, for each type and strength of Schedule II substance, the following information:  date, time administered, name of client, dose, physician's name, signature of person administering dose and number of doses remaining.

 

k)         Discontinued medications and medications of patients who have been discharged or who have died shall be disposed of in accordance with written policies and procedures.  Medications for patients who have been temporarily transferred to home or hospital shall be kept in the facility until such time as the patient dies or is discharged from the facility.  All expired medications shall be disposed of in accordance with written policies and procedures.

 

l)          Medications for each patient shall be kept and stored in the containers in which they were originally received.  Medications shall not be transferred between containers, except that a licensed nurse may remove medications from original containers and place them in other containers to be sent with the patient when the patient will be out of the facility at the time of scheduled administration of medications.

 

m)        Medications prescribed for one patient shall not be administered to another patient.

 

n)         If for any reason the attending physician's medication order cannot be followed, the attending physician shall be notified as soon as it is reasonable, depending upon the situation, and a notification made in the patient's plan of care.

 

o)         Medication errors and drug reactions shall immediately be reported to the patient's attending physician. An entry thereof shall be made in the patient's medical record, and the error or reaction shall also be described in a separate report.

 

p)         Patients for whom the attending physician has given permission to be totally responsible for their own medication shall maintain possession of the key or combination of the lock to their own medication storage area.  A duplicate key or a copy of the combination shall be kept by the facility in a secure place, for emergency use.

 

(Source:  Amended at 32 Ill. Reg. 2330, effective January 23, 2008)

 

Section 280.4040  Hospice Residence Operational Requirements

 

a)         A supply of clean linen, washcloths and towels, available at all times and adequate for the number of residents, shall be provided.  Storage, handling, processing and transportation of clean and soiled linen shall prevent cross-contamination and odors.

 

b)         Nutritional Issues

            If the integrated care plan identifies that patient intake of adequate nutrition or hydration is a problem, a nutritional plan shall be developed that is consistent with the patient's advance directives or the patient's stated choices as noted in the clinical record.

 

c)         Meal Service

            Meals shall be scheduled in accordance with times customary in the community. The hospice residence shall provide a variety of menus that recognize patient preferences.

 

d)         Food Service Sanitation

 

1)         Food shall be free from spoilage, filth, and other contamination, and shall be safe for human consumption.  Scheduled meals shall be prepared in a food service establishment that has been inspected by a local health department.

 

2)         Food shall be protected from potential contamination while being stored, prepared, served, or transported.  Potentially hazardous food shall be maintained at temperatures in accordance with Section 750.10 of the Food Service Sanitation Code.

 

3)         Adequate refrigeration facilities and hot food storage facilities shall be provided to ensure the maintenance of food at the required temperature during storage.

 

4)         No person shall work in food service while infected with a disease in a communicable form that can be transmitted by foods, or who is a carrier of organisms that cause a communicable disease, or while afflicted with a boil or infected wound or an acute respiratory infection.

 

5)         Staff shall wash their hands thoroughly with soap and warm water before starting work, during work as often as necessary to keep the hands clean, and after smoking, eating, drinking, or using the toilet.  Staff shall not use tobacco in any form while engaged in food preparation or service, or while in any equipment or utensil washing or food preparation area.

 

6)         Food contact surfaces shall be easily cleanable, smooth, free of breaks, open seams, cracks, chips, pits, and similar imperfections, and be free of difficult-to-clean internal corners and crevices.  Non-food-contact surfaces of equipment shall be designed and fabricated to be smooth, washable, free of unnecessary ledges, projections, or crevices, and shall be maintained in a clean, sanitary condition.  Food-contact and non-food-contact surfaces shall be maintained in a clean condition.

 

7)         Equipment and utensils shall be washed, rinsed, and sanitized after each use.  For manual cleaning and sanitizing, items shall be washed in a hot detergent solution, rinsed with clear water, and sanitized by one of the following methods:

 

A)        Immersion for at least one-half minute in clean, hot water of at least 170ΊF;

 

B)        Immersion for at least one minute in a clean solution of at least 50 parts per million of available chlorine as a hypochlorite and having a temperature of at least 75ΊF;

 

C)        Immersion for at least one minute in a clean solution containing at least 12.5 parts per million of available iodine and having a pH not higher than 5.0 and a temperature of at least 75ΊF; or

 

D)        Immersion in a clean solution containing any other chemical sanitizing agent allowed under 21 CFR 178.1010 that will provide the equivalent bactericidal effect of a solution containing at least 50 parts per million of available chlorine as a hypochlorite and having a temperature of at least 75ΊF for one minute.

 

8)         Mechanical cleaning and sanitizing may be done by spray-type or immersion dishwashing machines, or by any other type of machine or device demonstrated to thoroughly clean and sanitize equipment and utensils.  Machines shall be installed and maintained in good repair, and shall be operated in accordance with the manufacturer's instructions.  The final sanitizing rinse shall be at least 180ΊF or equivalent.

 

9)         Utensils shall be air dried before being stored or shall be stored in a self-draining position.

 

10)         Garbage and refuse shall be kept in durable, easily cleanable insect- and rodent-proof containers that do not leak or absorb liquid.

 

11)         The facility shall be kept in such a condition as to prevent insects and rodents from harboring or feeding.  Screen doors shall be self-closing, and screening material shall not be less than 16 mesh to the inch.

 

12)         Floors, floor coverings, walls and ceilings shall be easily cleanable and maintained in good repair.

 

13)         Poisonous or toxic materials shall be properly labeled.  Insecticides and rodenticides and detergents, sanitizers, and other cleaning agents shall be stored physically separate from each other and not stored above or intermingled with food, food equipment, and utensils.

 

e)         Physical Plant Requirements

 

1)         New hospice residences shall submit drawings for the proposed hospice residence for review by the Department.  The drawing shall  be in compliance with the requirements of NFPA 101, Chapter 18, New Health Care Occupancies.

 

2)         Existing hospice residences shall comply with the requirements of NFPA 101, Chapter 19, Existing Health Care Occupancies.

 

3)         Each hospice residence shall be in full compliance with local building codes and fire safety/protection requirements.

 

4)         Exits shall not be blocked.

 

5)         The following patient areas shall be designed and equipped for the comfort and privacy of each patient and his or her family members:

 

A)        Physical space for private patient/family visiting;

 

B)        Accommodations for family members to remain with the patient throughout the night;

 

C)        Accommodations for family privacy after a patient's death;

 

D)        A living room with a minimum area of 10 square feet per patient bed; and

 

E)        A dining room with a minimum area of 10 square feet per patient bed.

 

6)         Decor shall be homelike in design and function.

 

7)         Not more than two people shall share a bedroom.  No room commonly used for other purposes, including, but not limited to, a hall, stairway, attic, garage, storage area, shed or similar detached building, shall be used as a sleeping room for any patient.

 

8)         The patient rooms shall be designed and equipped for adequate nursing care and the comfort and privacy of patients and shall comply with the following:

 

A)        Be equipped with or conveniently located near toilet and bathing facilities;

 

B)        Be at or above grade level;

 

C)        Contain a suitable bed for each patient and other appropriate furniture;

 

D)        Have closet space that provides security and privacy for clothing and personal belongings;

 

E)        Contain no more than two beds;

 

F)         Measure at least 100 square feet for a single patient room or 80 square feet for each patient in a multi-patient room; and

 

G)        Be equipped with a device for calling the staff member on duty.

 

9)         Toilets and bathroom facilities shall be conveniently located.  At least one toilet, washbasin, and bathtub or shower shall be provided per six patients. If the bathing area or toilet room contains more than one of each fixture, a means of allowing individual privacy shall be provided.  Toilets and bathroom facilities shall be designed to provide the following:

 

A)        An adequate supply of hot water at all times for patient use; and

 

B)        Plumbing fixtures with control valves that automatically regulate the temperature of the hot water used by patients.

 

10)         Isolation areas.  The hospice shall isolate patients with infectious diseases.

 

11)         Garbage shall be disposed of in accordance with State and local requirements.  Potentially infectious medical wastes shall be disposed of in accordance with State and local requirements.  All solid waste shall be handled in the hospice residence to prevent transmission of disease.  Sharps shall be stored and disposed of in rigid, puncture-resistant containers.

 

12)         Water supply, sewage disposal, and plumbing systems shall comply with all applicable State and local codes and ordinances.

 

13)         Hospice residences shall be limited to 20 patient beds.

 

(Source:  Amended at 44 Ill. Reg. 12582, effective July 2, 2020)