902 KAR 20:018.
Operation and services; renal dialysis facilities.
RELATES TO: KRS
216B.010, 216B.015, 216B.040, 216B.042, 216B.045, 216B.050, 216B.055, 216B.075, 216B.085,
216B.105-216B.125, 216B.990(1), (2), 314.035, 314.137
STATUTORY
AUTHORITY: KRS 216B.042(1)
NECESSITY,
FUNCTION, AND CONFORMITY: KRS 216B.042 requires the cabinet to promulgate administrative
regulations necessary for the proper administration of licensure of health
services and facilities. This administrative regulation establishes licensure
requirements for the operation and services of renal dialysis facilities.
Section 1.
Definitions. (1) "Administrator" means a person who:
(a) Holds a
baccalaureate degree or its equivalent; and
(b) Has at least
one (1) year of experience in an ESRD unit.
(2)
"Anti-HBs" means the antibody to the hepatitis B virus conferred
either by vaccination or infection.
(3)
"Dialysis technician" means a person credentialed by the Board of
Nursing as a dialysis technician.
(4) "End
stage renal disease" or ESRD" means that stage of renal impairment
which:
(a) Is
irreversible and permanent; and
(b) Requires
dialysis or kidney transplantation to ameliorate uremic symptoms and maintain
life.
(5)
"Facility" means renal dialysis facility, as included in the definition
of "health facility" at KRS 216B.015(10).
(6)
"HBsAg" means the hepatitis B antigen, present in the blood of
persons who are infected by the hepatitis B virus.
(7) "HBV
negative" means the absence of the hepatitis B virus, the hepatitis B antigen,
and the antibody to the hepatitis B virus.
(8)
"Medical director" means a licensed physician who is a board eligible
or certified nephrologist, internist, or pediatrician with at least twelve (12)
months experience or training in the treatment and management of ESRD patients.
(9)
"Qualified dietician" means a person licensed pursuant to KRS
310.021.
(10)
"Qualified medical record practitioner" means a person who has
graduated from a program for medical record administrators or technicians
accredited by the Council on Medical Education of the American Medical
Association and the American Medical Record Association, and who is certified
as a registered records administrator or an accredited record technician by the
American Medical Record Association.
(11)
"Qualified registered nurse" means a person licensed to engage in
registered nursing practice pursuant to KRS 314.041, who has at least:
(a) Twelve (12)
months experience in clinical nursing plus six (6) months of experience in
nursing care of ESRD patients; or
(b) Eighteen
(18) months experience in nursing care of ESRD patients.
(12)
"Qualified social worker" means a social worker licensed to practice
in Kentucky, who has completed a course of study with specialization in
clinical practice at, and holds a masters degree from, a graduate school of
social work accredited by the Council on Social Work Education.
(13) "Renal
dialysis center" means a hospital unit approved to furnish the full
spectrum of diagnostic, therapeutic, and rehabilitative services required for the
care of ESRD dialysis patients:
(a) Including inpatient dialysis
furnished directly or under arrangement; and
(b) Excluding renal transportation.
(14) "Renal
transplantation center" means a hospital unit approved to provide transplantation
and other medical and surgical specialty services required for the care of the
ESRD transplant patients, including inpatient dialysis furnished directly or
under arrangement. A renal transplantation center may also be a renal dialysis
center.
(15)
"Self-care dialysis training" means a program to train an ESRD
patient or helper, or both, to perform dialysis.
Section 2. Requirement for Service.
A facility shall not be licensed or relicensed as a renal dialysis facility
unless it provides the services required in Section 4 of this administrative
regulation.
Section 3.
Administration and Operation. (1) Licensee.
(a) The licensee
shall be legally responsible for the operation of the facility and for
compliance with federal, state, and local laws and regulations pertaining to
the operation of the facility.
(b) The licensee
shall develop and enforce written policies for the administration and operation
of the facility. Policies shall include:
1. Personnel
practices and procedures;
2. Job
descriptions for each level of personnel, including authority and
responsibilities of each classification;
3.
Qualifications for medical staff membership;
4. Medical care
practices and procedures;
5. Prevention
and control of hepatitis, peritonitis, and other infections, including
appropriate procedures for:
a. Surveillance
and reporting of infections;
b. Housekeeping;
c. Handling and disposal of waste and
contaminants;
d. Sterilization and disinfection; and
e. Sterilization and maintenance of
equipment; and
6. Procedures to
be followed in an emergency, including fire, natural disaster, and equipment
failure.
(2)
Administrator. The facility shall have an administrator responsible for the
management of the facility, including enforcement of written policies and
protection of patients' personal and property rights.
(3) The facility
shall:
(a) Have a
permanent site of operation; and
(b) Maintain
regularly scheduled hours during which dialysis services are available.
(4) Affiliation
agreements. A renal dialysis facility shall have affiliation agreements or
arrangements, in writing, with renal dialysis centers and renal transplantation
centers which provide the following:
(a) A renal
transplantation centers agreement shall provide for medical and surgical specialty
services required for the care of ESRD patients, including transplantation and
inpatient dialysis furnished directly or under arrangement.
(b) A renal
dialysis centers agreement shall provide for working relationships under which
inpatient hospital care or other hospital services are available promptly to
the dialysis facility's patients when needed, as follows:
1. Timely
transfer or referral of patients between the renal dialysis facility and the
renal dialysis center shall be effected if it is determined to be medically
appropriate by the physicians at the facility and the center.
2. The following
information shall be provided to the recipient facility within one (1) working
day of a patient's transfer or referral:
a. Patient care plan;
b. Medical information;
c. Other information necessary or useful
in the care and treatment of the patient.
(5) Personnel.
An adequate number of personnel shall be present to meet the needs of patients,
including medical and nonmedical emergencies.
(a) Medical staff.
The facility shall have an organized medical staff responsible for the:
1. Quality of
all medical care provided to patients in the facility; and
2. Ethical and
professional practices of its staff.
(b) There shall
be a medical director responsible for supervising the staff of the facility.
The medical director shall be a full or part-time staff member. In the medical
director's absence a similarly qualified medical staff member shall be either
in the unit or immediately available in the community when a patient is being
dialyzed.
(c) The facility
shall employ at least one (1) full-time qualified registered nurse to be
responsible for nursing services. If a patient is undergoing dialysis, a
qualified registered nurse shall be on duty to oversee patient care.
(d) The facility
shall employ or have contracts for services with the following ancillary
personnel:
1. A qualified
dietician;
2. A qualified
medical records practitioner;
3. A qualified
social worker.
(6) Incident and
accident reports.
(a) A facility shall submit
an incident report to the Cabinet for Health Services, Office of the Inspector
General, within three (3) days of the occurrence of a reportable event.
(b) A facility shall retain a copy of the
report for inspection by the cabinet.
(c) Reportable events include:
1. An incident requiring emergency
treatment or hospitalization;
2. A cleaning agent left in a machine
that is subsequently used on a patient;
3. Contamination of the water supply;
4. Development of infection or communicable
disease; and
5. An accident or other event having a
direct or immediate bearing on the health, safety, or security of a patient or
staff member.
Section 4.
Services. (1) Each patient is admitted on the medical authority of, and is
under the supervision of, the medical director. When absent from the facility
the medical director shall designate a qualified physician to be responsible
for admission and supervision of patients.
(2) Laboratory
services. A renal dialysis facility shall have access to laboratory facilities
and services to meet the needs of each ESRD patient, with the exception of
tissue pathology and histocompatibility testing. The services shall be
performed by:
(a) A laboratory
in a licensed hospital; or
(b) A laboratory
licensed by the Department for Health Services pursuant to KRS Chapter 333.
(3) Medical
records.
(a) A current
and complete medical record shall be maintained for each patient.
(b)
Organization. The supervisor of medical records shall be responsible for the
proper documentation, completion and preservation of all the facility's medical
records.
(c) Indexing.
Medical records shall be properly indexed and systematically filed.
(d) Ownership. A
patient's record shall not be removed from the facility's custody except in
compliance with a court order or subpoena.
(e)
Confidentiality. A patient's record shall be available for inspection only to
members of the professional staff, the patient, or an authorized individual
acting in behalf of the patient. Patient records may be used for research or
statistical investigation, if each patient's anonymity is protected.
(f) Content. A
complete medical record shall be prepared for each patient admitted to the
facility, to include at least the following information:
1. Name and address
of the patient, and guardian or committee, if any;
2. Patient
identity data:
a. Name;
b. Address;
c. Date of
birth;
d. Gender; and
e. Marital
status;
3. Date of
admission;
4. Date of
transfer to renal transplantation center, if applicable;
5. Referring and
attending physicians' names;
6. History and
physical examination record prior to the initial treatment;
7. Treatment
plans;
8. Records of
special examinations, consultations, and clinical, laboratory, and x-ray
services;
9. Doctors' orders,
dated and signed;
10. Nurses'
notes;
11. Dialysis
chart including pulse, respiration and blood pressure;
12. Social
evaluation and plan developed by the social worker; and
13. Orders for
medication and treatment written in ink and signed by the prescribing practitioner acting
within the scope of practice;
14. A record of each medication
administered, to include:
a. Date and time of administration;
b. Type of medication administered;
c. Amount of medication administered;
d. Method of administration;
e. Name of practitioner prescribing
medication; and
f. Name of the person who administered
the medication.
(g) Retention of 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.
(4)
Pharmaceutical services.
(a) The facility
shall have provisions for promptly obtaining prescribed drugs and biologicals
from licensed pharmacies.
(b) The facility
shall provide appropriate methods and procedures for storage, control and
administering of drugs and biologicals.
(c) A medication
shall be administered by one (1) of the following professionals, acting within
the relevant statutory scope of practice:
1. A physician;
2. A physician's assistant;
3. An advanced nurse registered
practitioner;
4. A registered nurse;
5. A licensed practical nurse; or
6. A dialysis technician.
(5) Social
services. The qualified social worker shall be responsible for:
(a) Each
patient's social evaluation and treatment;
(b) Participating
in team review of patient progress and recommending changes in treatment based
on the patient's current social needs;
(c) Providing
casework and group work services to patients and their families;
(d) Financial
advice;
(e) Referrals
for vocational rehabilitation; and
(f) Identifying
community social agencies and other resources and assisting patients and their
families to utilize them.
(6) Dietetic
services. The nutritional needs of each patient shall be evaluated by the
attending physician and the qualified dietician. The dietician, in consultation
with the attending physician, shall be responsible for:
(a) Assessing
the nutritional and dietetic needs of each patient;
(b) Recommending
therapeutic diets;
(c) Counseling
patients and their families on prescribed diets; and
(d) Monitoring
adherence and response to diets.
(7) Self-care
dialysis support services.
(a) A renal
dialysis facility offering self-care dialysis training shall make the following
services available either directly, under agreement, or by arrangement with
another ESRD facility, upon completion of patient training:
1. Monitoring
the patient's home adaptation, including provisions for visits to the home or
the facility;
2. Consultation
for the patient with a qualified social worker and a qualified dietician;
3. A
recordkeeping system which assures continuity of care;
4. Installation
and maintenance of dialysis equipment;
5. Testing and
appropriate treatment of the dialysis water;
6. Ordering of
supplies as needed; and
7. Infection
control, including hepatitis and peritonitis;
(b) A nurse
responsible for self-care dialysis training shall have at least three (3)
months of experience in training patients for self-care dialysis.
Section 5.
Physical Environment. (1) Building and equipment.
(a) Equipment
used in the facility shall be maintained free of a condition posing a potential
hazard to patients or personnel. There shall be a program of preventive
maintenance of equipment used in dialysis and related procedures in the
facility.
(b) Water used
for dialysis purposes shall be analyzed periodically and treated as necessary
to maintain a continuous water supply that is biologically and chemically
compatible with acceptable dialysis techniques. Records of test results and
equipment maintenance shall be maintained at the facility.
(2) Routine
disease testing and infection control.
(a) The licensee shall
establish and enforce routine disease testing and infection control policies
which are consistent with the most recent guidelines established by the Centers
for Disease Control and Prevention for preventing the transmission of infection
among chronic hemodialysis patients.
(b) A facility
using a central-batch delivery system shall provide, on the premises or through
affiliation agreements, sufficient individual delivery systems for the
treatment of any patient requiring special dialysis solutions.
(3)
Contamination prevention. A facility shall employ appropriate techniques to
prevent cross contamination between the unit and adjacent hospital or public
areas including food service areas, laundry, disposal of solid waste and
blood-contaminated equipment, and disposal of contaminants into sewage systems.
Waste storage and disposal shall be carried out in accordance with applicable
law and acceptable public health standards. (8 Ky.R. 219; eff. 11-5-81; Am. 12
Ky.R. 62; eff. 8-13-85; 18 Ky.R. 811; eff. 10-16-91; 23 Ky.R. 199; eff.
8-21-96; 2859; eff. 2-19-97; 28 Ky.R. 1697; 2040; eff. 3-14-2002.)
