Ariz. Admin. Code § R9-10-1018 - Dialysis Services
A. In addition
to the definitions in A.R.S. § 36-401,
R9-10-101, and
R9-10-1001, the
following definitions apply in this Section:
1. "Caregiver" means an individual designated
by a patient or a patient's representative to perform self-dialysis in the
patient's stead.
2. "Chief clinical
officer" means a physician appointed to provide direction for dialysis services
provided by an outpatient treatment center.
3. "Long-term care plan" means a written plan
of action for a patient with kidney failure that is developed to achieve
long-term optimum patient outcome.
4. "Modality" means a method of treatment for
kidney failure, including transplant, hemodialysis, and peritoneal
dialysis.
5. "Nutritional
assessment" means an analysis of a patient's weight, height, lifestyle,
medication, mobility, food and fluid intake, and diagnostic procedures to
identify conditions and behaviors that indicate whether the patient's
nutritional needs are being met.
6.
"Patient care plan" means a written document for a patient receiving dialysis
that identifies the patient's needs for medical services, nursing services, and
health-related services and the process by which the medical services, nursing
services, or health-related services will be provided to the patient.
7. "Peritoneal dialysis" means the process of
using the peritoneal cavity for removing waste products by fluid
exchange.
8. "Psychosocial
evaluation" means an analysis of an individual's mental and social conditions
to determine the individual's need for social work services.
9. "Reprocessing" means cleaning and
sterilizing a dialyzer previously used by a patient so that the dialyzer can be
reused by the same patient.
10.
"Self-dialysis" means dialysis performed by a patient or a caregiver on the
patient's body.
11. "Social worker"
means an individual licensed according to A.R.S. Title 32, Chapter 33 to engage
in the "practice of social work" as defined in A.R.S. §
32-3251.
12. "Stable means" that a patient's blood
pressure, temperature, pulse, respirations, and diagnostic procedure results
are within medically recognized acceptable ranges or consistent with the
patient's usual medical condition so that medical intervention is not
indicated.
13. "Transplant surgeon"
means a physician who:
a. Is board eligible or
board certified in general surgery or urology by a professional credentialing
board, and
b. Has at least 12
months of training or experience performing renal transplants and providing
care for patients with renal transplants.
B. A governing authority of an outpatient
treatment center that is authorized to provide dialysis services shall:
1. Ensure that the administrator appointed as
required in
R9-10-1003(B)(3)
has at least 12 months of experience in an outpatient treatment center
providing dialysis services; and
2.
Appoint a chief clinical officer to direct the dialysis services provided by or
at the outpatient treatment center who is a physician who:
a. Is board eligible or board certified in
internal medicine or pediatrics by a professional credentialing board,
and
b. Has at least 12 months of
experience or training in providing dialysis services.
C. An administrator of
an outpatient treatment center that is authorized to provide dialysis services
shall ensure that:
1. In addition to the
policies and procedures required in
R9-10-1003(D),
policies and procedures are established, documented, and implemented to protect
the health and safety of a patient that cover:
a. Long-term care plans and patient care
plans,
b. Assigning a patient an
identification number,
c. Personnel
members' response to a patient's adverse reaction during dialysis,
and
d. Personnel members' response
to an equipment malfunction during dialysis;
2. A personnel member complies with the
requirements in A.R.S. § 36-423 and
R9-10-114
for hemodialysis technicians and hemodialysis technician trainees, if
applicable;
3. A personnel member
completes basic cardiopulmonary resuscitation training specific to the age of
the patients receiving dialysis from the outpatient treatment center:
a. Before providing dialysis services,
and
b. At least once every 12
months after the initial date of employment or volunteer service;
4. A personnel member wears a name
badge that displays the individual's first name, job title, and professional
license or certification; and
5. At
least one registered nurse or medical practitioner is on the premises while a
patient receiving dialysis services is on the premises.
D. An administrator of an outpatient
treatment center that is authorized to provide dialysis services shall ensure
that:
1. The premises of the outpatient
treatment center where dialysis services are provided complies with the
applicable physical plant health and safety codes and standards for outpatient
treatment centers providing dialysis services, incorporated by reference in
R9-10-104.01, that were in effect on the date listed on the building permit or
zoning clearance submitted, as required by
R9-10-104,
as part of the application for approval of the architectural plans and
specifications submitted before initial approval of the inclusion of dialysis
services in the outpatient treatment center's scope of services;
2. Before a modification of the premises of
an outpatient treatment center where dialysis services are provided is made, an
application for approval of the architectural plans and specifications of the
outpatient treatment center required in
R9-10-104(A):
a. Is submitted to the Department;
and
b. Demonstrates compliance with
the applicable physical plant health and safety codes and standards for
outpatient treatment centers providing dialysis services, incorporated by
reference in R9-10-104.01, in effect on the date:
i. Listed on the building permit or zoning
clearance submitted as part of the application for approval of the
architectural plans and specifications for the modification, or
ii. The application for approval of the
architectural plans and specifications of the modification of the outpatient
treatment center required in
R9-10-104(A)
is submitted to the Department; and
3. A modification of the outpatient treatment
center complies with applicable physical plant health and safety codes and
standards for outpatient treatment centers providing dialysis services,
incorporated by reference in R9-10-104.01 in effect on the date:
a. Listed on the building permit or zoning
clearance submitted as part of the application for approval of the
architectural plans and specifications for the modification, or
b. The application for approval of the
architectural plans and specifications required in
R9-10-104(A)
is submitted to the Department.
E. An administrator of an outpatient
treatment center that is authorized to provide dialysis services shall ensure
that for a patient receiving dialysis services:
1. The dialysis services provided to the
patient meet the needs of the patient;
2. A physician:
a. Performs a medical history and physical
examination on the patient within 30 calendar days before admission or within
48 hours after admission, and
b.
Documents the medical history and physical examination in the patient's medical
record within 48 hours after admission;
3. If the patient's medical history and
physical examination required in subsection (E)(2) is not performed by the
patient's nephrologist, the patient's nephrologist, within 30 calendar days
after the date of the medical history and physical examination:
a. Reviews and authenticates the patient's
medical history and physical examination, documents concurrence with the
medical history and physical examination, and includes information specific to
nephrology; or
b. Performs a
medical history and physical examination that includes information specific to
nephrology;
4. The
patient's nephrologist or the nephrologist's designee:
a. Performs a medical history and physical
examination on the patient at least once every 12 months after the date of the
patient's admission to the outpatient treatment center, and
b. Documents monthly notes related to the
patient's progress in the patient's medical record;
5. A registered nurse responsible for the
nursing services provided to the patient receiving dialysis services:
a. Reviews with the patient the results of
any diagnostic tests performed on the patient;
b. Assesses the patient's medical condition
before the patient begins receiving hemodialysis and after the patient has
received hemodialysis;
c. If the
patient returns to another health care institution after receiving dialysis
services at the outpatient treatment center, provides an oral or written notice
of information related to the patient's medical condition to the registered
nurse responsible for the nursing services provided to the patient at the
health care institution or, if there is not a registered nurse responsible, the
individual responsible for the medical services, nursing services, or
health-related services provided to the patient at the health care
institution;
d. Informs the
patient's nephrologist of any changes in the patient's medical condition or
needs; and
e. Documents in the
patient's medical record:
i. Any notice
provided as required in subsection (E)(5)(c), and
ii Monthly notes related to the patient's
progress;
6. If
the patient is not stable, before dialysis is provided to the patient, a
nephrologist is notified of the patient's medical condition and dialysis is not
provided until the nephrologist provides direction;
7. The patient:
a. Is under the care of a
nephrologist;
b. Is assigned a
patient identification number according to the policy and procedure in
subsection (C)(1)(b);
c. Is
identified by a personnel member before beginning dialysis;
d. Receives the dialysis services ordered for
the patient by a medical practitioner;
e. Is monitored by a personnel member while
receiving dialysis at least once every 30 minutes; and
f. If the outpatient treatment center
reprocesses and reuses dialyzers, is informed that the outpatient treatment
center reprocesses and reuses dialyzers before beginning
hemodialysis;
8.
Equipment used for hemodialysis is inspected and tested according to the
manufacturer's recommendations or the outpatient treatment center's policies
and procedures before being used to provide hemodialysis to a
patient;
9. The equipment
inspection and testing required in subsection (E)(8) is documented in the
patient's medical record;
10.
Supplies and equipment used for dialysis services for the patient are used,
stored, and discarded according to manufacturer's recommendations;
11. If hemodialysis is provided to the
patient, a personnel member:
a. Inspects the
dialyzer before use to ensure that the:
i.
External surface of the dialyzer is clean;
ii. Dialyzer label is intact and
legible;
iii. Dialyzer, blood port,
and dialysate port are free from leaks and cracks or other structural damage;
and
iv. Dialyzer is free of visible
blood and other foreign material;
b. Verifies the order for the dialyzer to
ensure the correct dialyzer is used for the correct patient;
c. Verifies the duration of dialyzer storage
based on the type of germicide used or method of sterilization or disinfection
used;
d. If the dialyzer has been
reprocessed and is being reused, verifies that the label on the dialyzer
includes:
i. The patient's name and the
patient's identification number,
ii. The number of times the dialyzer has been
used in patient treatments,
iii.
The date of the last use of the dialyzer by the patient, and
iv. The date of the last reprocessing of the
dialyzer;
e. If the
patient's name is similar to the name of another patient receiving dialysis in
the same outpatient treatment center, informs other personnel members,
employees, and volunteers, of the similar names to ensure that the name or
other identifying information on the label corresponds to the correct patient;
and
f. Ensures that a patient's
vascular access is visible to a personnel member during dialysis;
12. A patient receiving dialysis
is visible to a nurse at a location used by nurses to coordinate patients and
treatment;
13. If the patient has
an adverse reaction during dialysis, a personnel member responds by
implementing the policy and procedure required in subsection
(C)(1)(c);
14. If the equipment
used during the patient's dialysis malfunctions, a personnel member responds by
implementing the policy and procedure required in subsection (C)(1)(d);
and
15. After a patient's discharge
from an outpatient treatment center, the nephrologist responsible for the
dialysis services provided to the patient documents the patient's discharge in
the patient's medical record within 30 calendar days after the patient's
discharge and includes:
a. A description of
the patient's medical condition and the dialysis services provided to the
patient, and
b. The signature of
the nephrologist.
F. If an outpatient treatment center provides
support for self-dialysis services, an administrator shall ensure that:
1. A patient or the patient's caregiver is:
a. Instructed to use the equipment to perform
self-dialysis by a personnel member trained to provide the instruction,
and
b. Monitored in the patient's
home to assess the patient's or patient caregiver's ability to use the
equipment to perform self-dialysis;
2. Instruction provided to a patient as
required in subsection (F)(1)(a) and monitoring in the patient's home as
required in subsection (F)(1)(b) is documented in the patient's medical
record;
3. All supplies for
self-dialysis necessary to meet the needs of the patient are provided to the
patient;
4. All equipment necessary
to meet the needs of the patient's self-dialysis is provided for the patient
and maintained by the outpatient treatment center according to the
manufacturer's recommendations;
5.
The water used for hemodialysis is tested and treated according to the
requirements in subsection (N);
6.
Documentation of the self-dialysis maintained by the patient or the patient's
caregiver is:
a. Reviewed to ensure that the
patient is receiving continuity of care, and
b. Placed in the patient's medical record;
and
7. If a patient uses
self-dialysis and self-administers medication:
a. The medical practitioner responsible for
the dialysis services provided to the patient reviews the patient's diagnostic
laboratory tests;
b. The patient
and the patient's caregiver are informed of any potential:
i. Side effects of the medication;
and
ii. Hazard to a child having
access to the medication and, if applicable, a syringe used to inject the
medication; and
c. The
patient or the patient's caregiver is:
i.
Taught the route and technique of administration and is able to administer the
medication, including injecting the medication;
ii. Taught and able to perform sterile
techniques if the patient or the patient's caregiver will be injecting the
medication;
iii. Provided with
instructions for the administration of the medication, including the specific
route and technique the patient or the patient's caregiver has been taught to
use;
iv. Able to read and
understand the directions for using the medication;
v. Taught and able to self-monitor the
patient's blood pressure; and
vi.
Informed how to store the medication according to the manufacturer's
instructions.
G. An administrator of an outpatient
treatment center that is authorized to provide dialysis services shall ensure
that a social worker is employed by the outpatient treatment center to meet the
needs of a patient receiving dialysis services including:
1. Conducting an initial psychosocial
evaluation of the patient within 30 calendar days after the patient's admission
to the outpatient treatment center;
2. Participating in reviewing the patient's
need for social work services;
3.
Recommending changes in treatment based on the patient's psychosocial
evaluation;
4. Assisting the
patient and the patient's representative in obtaining and understanding
information for making decisions about the medical services provided to the
patient;
5. Identifying community
agencies and resources and assisting the patient and the patient's
representative to utilize the community agencies and resources;
6. Documenting monthly notes related to the
patient's progress in the patient's medical record; and
7. Conducting a follow-up psychosocial
evaluation of the patient at least once every 12 months after the date of the
patient's admission to the outpatient treatment center.
H. An administrator of an outpatient
treatment center that is authorized to provide dialysis services shall ensure
that a registered dietitian is employed by the outpatient treatment center to
assist a patient receiving dialysis services to meet the patient's nutritional
and dietetic needs including:
1. Conducting an
initial nutritional assessment of the patient within 30 calendar days after the
patient's admission to the outpatient treatment center;
2. Consulting with the patient's nephrologist
and recommending a diet to meet the patient's nutritional needs;
3. Providing advice to the patient and the
patient's representative regarding a diet prescribed by the patient's
nephrologist;
4. Monitoring the
patient's adherence and response to a prescribed diet;
5. Reviewing with the patient any diagnostic
test performed on the patient that is related to the patient's nutritional or
dietetic needs;
6. Documenting
monthly notes related to the patient's progress in the patient's medical
record; and
7. Conducting a
follow-up nutritional assessment of the patient at least once every 12 months
after the date of the patient's admission to the outpatient treatment
center.
I. An
administrator of an outpatient treatment center that is authorized to provide
dialysis services shall ensure that a long-term care plan for each patient:
1. Is developed by a team that includes at
least:
a. The chief clinical officer of the
outpatient treatment center;
b. If
the chief clinical officer is not a nephrologist, the patient's
nephrologist;
c. A transplant
surgeon or the transplant surgeon's designee;
d. A registered nurse responsible for nursing
services provided to the patient;
e. A social worker;
f. A registered dietitian; and
g. The patient or patient's representative,
if the patient or patient's representative chooses to participate in the
development of the long-term care plan;
2. Identifies the modality of treatment and
dialysis services to be provided to the patient;
3. Is reviewed and approved by the chief
clinical officer;
4. Is signed and
dated by each personnel member participating in the development of the
long-term care plan;
5. Includes
documentation signed by the patient or the patient's representative that the
patient or the patient's representative was provided an opportunity to
participate in the development of the long-term care plan;
6. Is signed and dated by the patient or the
patient's representative; and
7. Is
reviewed at least once every 12 months by the team in subsection (I)(1) and
updated according to the patient's needs.
J. An administrator of an outpatient
treatment center that is authorized to provide dialysis services shall ensure
that a patient care plan for each patient:
1.
Is developed by a team that includes at least:
a. The patient's nephrologist;
b. A registered nurse responsible for nursing
services provided to the patient;
c. A social worker;
d. A registered dietitian; and
e. The patient or the patient's
representative, if the patient or patient's representative chooses to
participate in the development of the patient care plan;
2. Includes an assessment of the patient's
need for dialysis services;
3.
Identifies treatment and treatment goals;
4. Is signed and dated by each personnel
member participating in the development of the patient care plan;
5. Includes documentation signed by the
patient or the patient's representative that the patient or the patient's
representative was provided an opportunity to participate in the development of
the patient care plan;
6. Is signed
and dated by the patient or the patient's representative;
7. Is implemented;
8. Is evaluated by:
a. The registered nurse responsible for the
dialysis services provided to the patient,
b. The registered dietitian providing
services to the patient related to the patient's nutritional or dietetic needs,
and
c. The social worker providing
services to the patient related to the patient's psychosocial needs;
9. Includes documentation of
interventions, resolutions, and outcomes related to treatment goals;
and
10. Is reviewed and updated
according to the needs of the patient:
a. At
least once every six months for a patient whose medical condition is stable,
and
b. At least once every 30
calendar days for a patient whose medical condition is not stable.
K. In addition to the
requirements in
R9-10-1009(C),
an administrator of an outpatient treatment center that is authorized to
provide dialysis services shall ensure that a medical record for each patient
contains:
1. An annual medical
history;
2. An annual physical
examination;
3. Monthly notes
related to the patient's progress by a medical practitioner, registered
dietitian, social worker, and registered nurse;
4. If applicable, documentation of:
a. The equipment inspection and testing
required in subsection (E)(9), and
b. The self-dialysis required in subsection
(F)(2); and
5. If
applicable, documentation of the patient's discharge.
L. For a patient who received dialysis
services, an administrator shall ensure that after the patient's discharge from
an outpatient treatment center that is authorized to provide dialysis services,
the nephrologist responsible for the dialysis services provided to the patient
documents the patient's discharge in the patient's medical record within 30
calendar days after the patient's discharge and includes:
1. A description of the patient's medical
condition and the dialysis services provided to the patient, and
2. The signature of the
nephrologist.
M. If an
outpatient treatment center reuses dialyzers or other dialysis supplies, an
administrator shall ensure that the outpatient treatment center complies with
the guidelines adopted by the Association for the Advancement of Medical
Instrumentation in Reuse Reprocessing of Hemodialyzers, ANSI/AAMI RD47:2002
& RD47:2002/A1:2003 ANSI/AAMI RD47:2008/(R)2013, incorporated by reference,
available through http://my.aami.org/store/, on file with
the Department, and including no future editions or amendments. Copies may be
purchased from the Association for the Advancement of Medical Instrumentation,
1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795.
N. A chief clinical officer shall ensure that
the quality of water used in dialysis conforms to the guidelines adopted by the
Association for the Advancement of Medical Instrumentation in Hemodialysis
systems ANSI/AAMI RD5:2003 Dialysis Water and Dialysate Recommendations: A User
Guide, incorporated by reference, available through
http://my.aami.org/store/, on
file with the Department, and including no future editions or amendments.
Copies may be purchased from the Association for the Advancement of Medical
Instrumentation, 1110 N. Glebe Road, Suite 220, Arlington, VA
22201-4795.
Notes
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