902 KAR 20:380. Operation and services;
residential hospice facilities.
RELATES TO: KRS 216B.010, 216B.015,
216B.040, 216B.042, 216B.045-216B.055, 216B.075, 216B.105-216B.131, 216B.990,
311.560(4), 314.011(8), 314.041, 314.051, Chapter 315, 40 C.F.R. 403
STATUTORY AUTHORITY: KRS 216B.042(1)
NECESSITY, FUNCTION, AND CONFORMITY: KRS
216B.042(1) requires the Cabinet for Health Services to establish and enforce
licensure standards and procedures for health facilities and health services.
This administrative regulation establishes licensure requirements for
residential hospice facility operation and services.
Section 1. Definitions. (1)
"Administrator" means a person who has:
(a) Served as an administrator for a
hospice program in accordance with 902 KAR 20:140, or a residential hospice
facility licensed in accordance with this administrative regulation; or
(b) A bachelor of arts or bachelor of
science degree in a health care, human services, or administrative curriculum;
or
(c) Equivalent administrative work
experience in a health care facility.
(2) "Bereavement" means the
period of time during which a person experiences, responds emotionally and
adjusts to the loss by death of another person.
(3) "Facility" means a
residential hospice facility.
(4) "Palliative care" means
care directed at reducing or abating pain and other symptoms of the disease
process in order to achieve relief of distress.
(5) "Qualified dietitian" means
a person licensed pursuant to KRS 310.021.
(6) "Residential hospice facility"
means a facility licensed pursuant to this administrative regulation and
providing residential care for terminally-ill patients that includes skilled
nursing care for the management of pain and acute and chronic symptoms.
(7) "Respite care patient" means
a patient requiring assistance with daily living activities and medical
management of pain and symptoms who is admitted to the facility in order to:
(a) Provide relief to a patient's normal
caregiver; or
(b) Provide care when the patient does
not have a caregiver to assist him in his home.
(8) "Sanitary sewer" is defined
at KRS 220.010(1).
(9) "Terminally ill" means a
fatal condition for which therapeutic strategies directed toward cure and
control are no longer effective.
(10) "Volunteer" means a person
who contributes time and talent to the facility without economic remuneration.
Section 2. Administration and
Organization. (1) The licensee shall be legally responsible for the operation
of the residential hospice facility and for compliance with federal, state, and
local law pertaining to the operation of the facility.
(2) The licensee shall have permanent
facilities for the care of patients and storage of patient records.
(3) The licensee shall establish and
enforce written policies for the administration and operation of the facility.
The policies shall address the following:
(a) A description of the organizational
structure of the facility, including:
1. Lines of authority;
2. Department organization; and
3. Job descriptions;
(b) Use of volunteers, volunteer
selection criteria, training, and roles in the facility;
(c) Admission of patients;
(d) Quality assurance;
(e) A written disaster preparedness plan
which includes:
1. Procedures to be followed in the event
of an internal or external disaster; and
2. A requirement that the plan is
periodically rehearsed with staff;
(f) Linkage agreements with providers of
services and supplies;
(g) Patient restraint practices to
include:
1. Procedure for obtaining an order from
the patient's physician, physician assistant, or advanced registered nurse
practitioner;
2. Procedure for the assessment and
reassessment of the need for patient restraint, requiring the use of the least
restrictive method;
3. Procedure detailing the methods for
applying a patient restraint;
4. A policy requiring monitoring the use
of a patient restraint; and
5. A policy requiring direct care staff
to receive training on all aspects of the use of patient restraints; and
(h) Discharge, transfer, and termination
of services.
(4) Medical records.
(a) A medical record shall be maintained
for each individual admitted to the facility. The medical record shall include:
1. Written admission order from a
physician;
2. Medical history;
3. Nursing assessment;
4. Social and psychological information
on patient and family;
5. Orders from physicians and other
practitioners acting within their statutory scope of practice;
6. The approved care plan;
7. Documentation of nursing services
provided; and
8. Documentation of medical services
provided.
(b) Retention of medical records.
1. After the death or discharge of an
adult patient, the completed medical record shall be placed in an inactive file
and retained for five (5) years.
2. After the death or discharge of a
minor patient, the record shall be placed in an inactive file and retained for
five (5) years from the date of the event, or three (3) years after the patient
reaches the age of majority, whichever is longer.
(5) Personnel.
(a) The facility shall have:
1. A medical director who is a licensed
physician, available on at least a consultative basis, who shall:
a. Direct medical aspects of the
facility's services; and
b. Participate in the development of
medical policy and procedure;
2. An administrator who shall:
a. Direct the daily operation of the
facility; and
b. Implement policies and procedures for
activities and services provided by facility personnel or by contract; and
3. A patient-care coordinator who is a
registered nurse who:
a. Shall have education or experience in
skilled nursing services for the terminally ill; and
b. May serve as the facility
administrator.
(b) The facility shall employ or have
access to a sufficient number of qualified personnel as necessary to provide
the services required by this administrative regulation, and as indicated by
patient needs.
(c) Current employee records shall be
maintained. Each record shall include the employee's:
1. Name, address, and Social Security
number;
2. Record of training and experience;
3. Proof of current licensure,
certification, or registration, if required by law;
4. Results of most recent skin test for
tuberculosis; and
5. Performance evaluations.
(d) Supportive personnel, assistants and
volunteers shall be supervised and shall function within the policies and
procedures of the facility.
(e) An employee or volunteer shall have a
test for tuberculosis prior to or within the first week of work and annually
thereafter. An employee or volunteer with evidence of an infectious disease
shall not be present in the facility until the infectious disease can no longer
be transmitted.
(f) The facility shall conduct an
orientation for new employees and volunteers.
(g) An employee of the facility who has
direct patient care responsibilities shall have current cardiopulmonary
resuscitation (CPR) certification from either the American Heart Association or
the American Red Cross.
(6) Infection control.
(a) Each facility shall implement an
infection control policy consistent with current Centers for Disease Control
and Prevention (CDC) recommendations. The policy shall include:
1. Procedures for prevention, monitoring,
and control of infection and communicable disease;
2. Measures for assessing and identifying
a patient or health care worker at risk for infection and communicable disease;
3. Procedures for isolation of an
infected or immunosuppressed patient, if applicable, which shall:
a. Implement the least restrictive method
possible;
b. Protect others from pathogens; and
c. Maintain the patient's privacy and
dignity.
(b) A facility choosing to offer services
to a patient requiring isolation pursuant to CDC guidelines shall have at least
one (1) private isolation room available. The room shall:
1. Have a separate toilet room with
bathtub or shower and lavatory for the exclusive use of the patient, and
allowing for direct entry from the patient bed area;
2. Have a ceiling that is readily
washable, and without crevices that can retain dirt particles; and
3. Have an anteroom outside and
immediately adjacent to the patient room with facilities for maintaining
aseptic conditions, including a sink suitable for handwashing;
4. Have a ventilation system adequate for
reduction of the risk of transmission of an airborne pathogen, with filter
efficiency of at least ninety (90) percent, and meeting the following
requirements:
Isolation
Room
Anteroom
Toilet
Room
Air
Movement Relationship
to
Adjacent Area
In
In/Out
In
Minimum
Changes of Out-
door
Air Per Hour
2
--
--
Minimum
Total Air
Changes
Per Hour
12
10
10
All
Air Exhausted Directly
To Outdoors?
Yes
Yes
Yes
Recirculated
by Means of
Room
Units?
No
No
--
5. Be approved for use by the Office of
Inspector General prior to being occupied by a patient requiring isolation.
Section 3. Patient Care Requirements. (1)
A patient may be admitted to a facility only upon an order from a physician.
(2) The patient's attending physician or
the medical director shall be responsible for the direct medical care of the
patient's illness.
(3) The facility shall provide the
following services directly:
(a) Coordination of the medical aspects
of the facility;
(b) Assessment, by the interdisciplinary
team, of the patient's physical, psychological, spiritual, social, and economic
needs;
(c) Development and coordination of a
care plan, based on the assessment required in paragraph (b) of this
subsection, which includes the delineation of responsibilities of each
interdisciplinary team member and provides for regularly scheduled
interdisciplinary team meetings for planning, evaluation, and individual case
management. This requirement may be satisfied by the continuation of the plan
of care established for a patient by a hospice program, in accordance with 902
KAR 20:140, if the plan of care is reviewed and revised when the patient is
admitted to the facility.
1. Care plan development shall be the
responsibility of an interdisciplinary team that shall include:
a. The patient;
b. The patient's family, if the patient
wants them to participate;
c. The medical director;
d. A nurse;
e. A social worker;
f. The patient's attending physician; and
g. A representative of the clergy, if the
patient so chooses.
2. The care plan shall be reviewed by the
patient's attending physician or the medical director, in consultation with
facility personnel:
a. At such intervals as the change in the
patient's condition requires; or
b. At least once every two (2) weeks.
3. The care plan shall be reviewed by the
interdisciplinary team to ensure that a patient receives palliative care.
4. Verbal authorization to change the
medical orders shall be reviewed and signed by the patient's attending
physician or the medical director within seven (7) days after the order is
issued.
5. Verbal authorization to change
nonmedical orders of the care plan shall be reviewed and signed by the medical
director within seven (7) days after the order was issued.
(d) Patient counseling and family
bereavement counseling; and
(e) Education and training services for
staff, volunteers, and family members.
Section 4. Services. (1) Nursing
services.
(a) The facility shall provide
twenty-four (24) hour nursing services that shall:
1. Be sufficient to meet total nursing
needs;
2. Be provided in accordance with the
patient's plan of care;
3. Ensure a patient receives prescribed:
a. Treatments;
b. Medications; and
c. Diets; and
4. Ensure a patient shall be:
a. Comfortable;
b. Clean;
c. Well groomed; and
d. Protected from accident, injury and
infection.
(b) A registered nurse shall be on duty
at all times.
(2) Pharmaceutical services.
(a) The facility shall provide
appropriate methods and procedures for obtaining, directly or by contract,
dispensing, and administering drugs and biologicals.
(b) If the facility has a pharmacy
department it shall be operated pursuant to the requirements of KRS Chapter
315.
(c) If the facility does not have a
pharmacy department it shall have an agreement for obtaining prescribed drugs
and biologicals from a pharmacy holding a valid pharmacy permit issued by the
Kentucky Board of Pharmacy operated pursuant to the requirements of KRS Chapter
315.
(d) Medication services.
1. Except in a circumstance that requires
or permits a verbal order, a medication shall not be given without a written
order signed by a physician, or other ordering personnel acting within their
statutory scope of practice.
a. A verbal order for a medication shall
be given only to a licensed practical or registered nurse or a pharmacist and
shall be signed by a member of the medical staff or other ordering practitioner
as soon as possible after the order is given.
b. A verbal order for a medication, at
the time received, shall be:
(i) Immediately transcribed by the person
receiving the order;
(ii) Repeated back to the person
requesting the order to ensure accuracy; and
(iii) Annotated on the patient’s medical
record, by the person receiving the order, as repeated and verified.
2. Administration of medication.
Medication shall be administered by licensed medical or nursing personnel in
accordance with their statutory scope of practice, or by personnel who have completed
a state-approved training program. An intramuscular injection shall be
administered by a licensed nurse, physician's assistant, or physician. An
intravenously-administered medication shall be administered by a licensed
physician, physician's assistant, registered nurse, or a licensed practical
nurse to whom the task has been properly delegated. Each dose administered
shall be recorded in the medical record.
a. A medication prescribed for one (1)
patient shall not be administered to any other patient.
b. Self-administration of a medication by
a patient shall not be permitted except on special order of the patient's
physician.
c. A medication error shall be
immediately reported to the patient's physician and recorded in the patient's
medical record and on an incident report.
d. A drug reaction shall be immediately
reported to the patient's physician and the dispensing pharmacist recorded in
the patient's medical record.
e. An up-to-date medication reference
text and source of information shall be provided for use by the nursing staff,
for example: the American Hospital Formulary Service of the American Society of
Hospital Pharmacists, or the Physicians Desk Reference.
3. Labeling and storing medications.
a. A medication shall be clearly labeled
with the patient's name, the name of the drug, strength, name of pharmacy,
prescription number, date, physician name, caution statements and directions
for use, except where a modified unit dose system, conforming to federal and
state law, is used. The medication of each patient shall be kept in the
original container; transferring between containers shall be prohibited. A
medicine stored by the facility shall be kept in a locked place. A medication
requiring refrigeration shall be kept in the medication area's refrigerator, in
a separate locked box. A drug for external use shall be stored separately from
those administered by mouth, suppository, or injection. Provisions shall be
made for the locked, separate storage of medication prescribed for a deceased
or discharged patient until the medication is surrendered or destroyed in
accordance with federal and state law.
b. A medication container having a
soiled, damaged, incomplete, illegible, or makeshift label shall be returned to
the issuing pharmacist or pharmacy for relabeling or disposal. A container having
no label shall be destroyed in accordance with state and federal law.
c. A medication cabinet shall be well
lighted and of sufficient size to permit storage without crowding.
d. Medication no longer in use shall be
disposed of or destroyed in accordance with federal and state law.
e. A medication with an expired date
shall be removed from usage and properly discarded.
f. Controlled substances.
(i) A controlled substance shall be kept
under double lock, for example, in a locked box in a locked cabinet.
(ii) There shall be a controlled
substances record maintained by the:
i. Staff pharmacist;
ii. Consultant pharmacist; or
iii. Nursing care coordinator.
(iii) The record shall contain the
following information: the name of the patient, the date, time, kind, dosage,
balance remaining and method of administration; the name of the physician who
prescribed the medication; and the name of the nurse who administered it, or
staff member who supervised the self-administration.
(iv) The staff pharmacist, consultant
pharmacist, or nursing care coordinator shall complete a Schedule II controlled
substances count at least daily, and Schedule III, IV and V controlled substances
count at least once per week. Controlled substances remaining after the
discharge or death of the patient shall be destroyed in accordance with federal
and state law.
(3) Dietary services.
(a) The facility shall provide dietary
services directly or through a written contractual agreement.
(b) If the dietary services are
contracted, the facility shall ensure that the contractor complies with the
requirements of this subsection.
(c) If dietary services are provided
directly, the facility shall have a dietary department, organized, directed and
staffed to provide quality food service and optimal nutritional care.
1. The dietary department shall be
directed on a full-time basis by an individual who, by education or specialized
training and experience, is knowledgeable in food service management.
2. The dietary service shall have at
least one (1) qualified dietitian working full-time, part-time, or on a
consultative basis, to supervise the nutritional aspects of patient care.
3. Sufficient additional personnel shall
be employed to perform assigned duties to meet the dietary needs of all
patients.
4. The dietary department shall have
current written policies and procedures for food storage, handling, and
preparation. Written dietary policy and procedure shall be available to dietary
personnel.
5. An in-service training program, which
shall include the proper handling of food, safety and personal grooming, shall
be given at least quarterly for new dietary employees.
(d) Menus shall be planned, written and
rotated to avoid repetition. Nutritional needs shall be met in accordance with
recommended dietary allowances of the Food and Nutrition Board of the National
Research Council of the National Academy of Sciences and in accordance with
medical orders.
(e) Each meal shall correspond with the
posted menu. When a change is necessary, substitution shall provide equal
nutritive value and the change shall be recorded on the menu. Each menu shall
be kept on file for thirty (30) days.
(f) Every diet, regular and therapeutic,
shall be prescribed in writing, dated, and signed by the attending medical
staff member or other ordering personnel acting within their statutory scope of
practice. Information on the diet order shall be specific and complete and shall
include the title of the diet, modifications in specific nutrients stating the
amount to be allowed in the diet, and specific problems that may affect the
diet or eating habits.
(g) Food shall be prepared by methods
that conserve nutritive value, flavor, and appearance, and shall be served at
the proper temperatures and in a form to meet individual needs; for example,
food shall be cut, chopped, or ground to meet individual patient needs.
(h) If a patient refuses foods served,
nutritious substitutions shall be offered.
(i) Unless contraindicated in a patient's
plan of care, at least three (3) meals or their equivalent shall be served
daily.
(j) There shall not be more than a
fifteen (15) hour span between a substantial evening meal and a breakfast unless
otherwise directed by the attending medical staff member.
(k) Meals shall be served at regular
times with between-meal or bedtime snacks of nourishing quality offered.
(l) If dietary services are provided
directly, there shall be at least a three (3) day supply of food available in
the facility at all times to prepare well-balanced palatable meals for all
patients.
(m) If the dietary services are
contracted, the facility shall develop a contingency plan to ensure the
provision of dietary services in the case of an emergency.
(n) There shall be an identification
system for each patient meal, and methods used to assure that each patient
receives the appropriate diet as ordered.
(o) The facility shall comply with
applicable provisions of KRS 219.011 to 219.081 and 902 KAR 45:005, the Retail
Food Code.
Section 5. Facility Specifications. (1)
Fire protection and security. Each facility shall:
(a) Meet the provisions of the most
current edition of the Life Safety Code of the National Fire Protection Association
that are applicable to a residential hospice facility;
(b) Be inspected and approved by the
local certified building department with jurisdiction of the area;
(c) Not house blind, nonambulatory, or
physically-handicapped patients unless the building is properly equipped with a
comprehensive sprinkler system;
(d) Have portable fire extinguishers
readily available on all floors and in the kitchen and food preparation area;
(e) Have an emergency power source
capable of providing electrical service for communication systems, alarm
systems, egress lighting, and patient care areas;
(f) Install and maintain, in accordance
with the manufacturer's specifications, a single station smoke detector in
every living area, bedroom, corridor, stairwell, and storage area, and in the
basement;
(g) Have an adequate water supply and an
adequate system for sewage disposal;
(h) Maintain sturdy and securely fastened
handrails, measuring thirty-six (36) inches or more above ground or floor
level, on every interior and exterior stairway;
(i) Maintain floors in good repair;
(j) Maintain corridors, entrances, exits,
and outside pathways in good repair and free of obstacles;
(k) Keep sidewalks, fire escape routes,
and entrances free of snow, ice, and debris;
(l) Keep the grounds in an orderly,
litter-free manner, clear of refuse and discarded objects, and mowed;
(m) Provide general outdoor lighting to
adequately illuminate the walkways and drive; and
(n) Establish a procedure to ensure that
exterior doors are locked between the hours of 9 p.m. and 7 a.m.
(2) Patient rooms.
(a) Each patient room shall:
1. Contain a bathroom equipped with:
a. A toilet;
b. A sink suitable for handwashing; and
c. Either a shower or bathtub;
2. Be above grade level;
3. Contain, for each patient, a suitable
bed and other appropriate furniture;
4. Have closet space that provides
security and space for private belongings;
5. Contain no more than two (2) beds in a
room occupied by a respite care patient and no more than one (1) bed in a room
occupied by a nonrespite patient;
6. Measure at least 100 square feet for a
single patient room and at least eighty (80) square feet per patient in a two
(2) patient room; and
7. Be equipped with a suitable device for
the patient to call direct care staff on duty.
(b) The facility shall allow a patient to
place items for the personalization and comfort of his room.
(3) Visitation. The facility shall:
(a) Provide physical space for a patient
to visit in private;
(b) Provide accommodation for family
members to remain with a patient throughout the night;
(c) Provide accommodations for family
privacy after the death of a patient; and
(d) Allow a patient to receive visitors,
including small children, at any hour.
(4) Linens and housekeeping.
(a) The facility shall have available at
all times a quantity of linen essential for proper care and comfort of
patients.
(b) Linens shall be handled, stored,
processed, and transported in such a manner as to prevent the spread of
infection.
(c) Soiled linens and clothing shall be
collected and encased in suitable bags or containers, in a well-ventilated
area, separate from clean linens. Soiled linens and clothing shall not be
permitted to accumulate in the facility.
(d) The facility shall establish and implement
housekeeping and maintenance policies and procedures that assure the
environment is:
1. Safe;
2. Clean; and
3. Sanitary.
(e) Cleaning procedures shall provide for
the prompt, thorough cleaning of:
1. Commodes;
2. Urinals;
3. Bedpans;
4. Bathrooms; and
5. Other sources of contamination or
odor.
(f) Cleaning shall be performed in a
manner to minimize the spread of pathogens.
(5) Waste disposal.
(a) Sharp waste.
1. Sharp waste, including needles,
scalpels, razors, or other sharp instruments used for patient care procedures,
shall be segregated from other waste and placed in puncture resistant
containers immediately after use.
2. A needle or other contaminated sharp
instrument shall not be purposely bent, broken, or otherwise manipulated by
hand as a means of disposal, except as permitted by Occupational Safety and
Health Administration guidelines established in 29 C.F.R. 1910.1030(d)(2)(vii).
3. The containers of sharp waste shall be
incinerated on or off site, or be otherwise rendered nonhazardous.
(b) Disposable waste.
1. Disposable waste shall be placed in
suitable bags or closed containers to prevent leakage or spillage, and shall be
handled, stored, and disposed of minimizing direct exposure of personnel to
waste materials.
2. The facility shall establish specific
written policies regarding handling and disposal of waste.
3. The following wastes shall be disposed
of by incineration, or be autoclaved before disposal, or be carefully poured
down a drain connected to a sanitary sewer: blood, blood specimens, used blood
tubes, or blood products.
4. Wastes conveyed to a sanitary sewer
shall comply with applicable federal, state, and local pretreatment law,
including 40 C.F.R. 403, 401 KAR 5:557, and relevant local ordinances. (29
Ky.R. 614; Am. 1628; eff. 12-18-02.)
