Ariz. Admin. Code § 9-10-1018

Current through Register Vol. 30, No. 25, June 21, 2024

Section 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.

Ariz. Admin. Code § R9-10-1018

Adopted as an emergency effective November 17, 1983, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 83-6). Former Section R9-10-1018 adopted as an emergency now adopted and amended as a permanent rule effective February 15, 1984 (Supp. 84-1). Repealed by summary action interim effective date July 21, 1995 (Supp. 95-3). The proposed summary action repealing R9-10-1018 was remanded by the Governor's Regulatory Review Council which revoked the interim effectiveness of the summary rule. The Section in effect before the proposed summary action has been restored (Supp. 97-1). Section repealed by final rulemaking at 5 A.A.R. 1222, effective April 5, 1999 (Supp. 99-2). New Section made by exempt rulemaking at 19 A.A.R. 2015, effective October 1, 2013 (Supp. 13-2). Amended by exempt rulemaking at 20 A.A.R. 1409, effective 7/1/2014. Amended by final rulemaking at 25 A.A.R. 1583, effective 10/1/2019. Amended by final expedited rulemaking at 25 A.A.R. 3481, effective 11/5/2019.