Ariz. Admin. Code § 9-10-2003

Current through Register Vol. 30, No. 49, December 6, 2024

Section R9-10-2003 - Administration

A. A licensee is responsible for the organization and management of a pain management clinic.

B. A licensee shall:

1. Adopt policies and procedures for the administration and operation of a pain management clinic;

2. Designate a medical director who:

a. Is licensed:

i. As a physician according to A.R.S. Title 32, Chapter 13 or 17; or

ii. As a nurse practitioner according to A.R.S. Title 32, Chapter 15 with advanced pain management certification from a nationally recognized accreditation or certification entity; and

b. May be the same individual as the licensee;

3. Ensure that there are a sufficient number of personnel members and employees with the required knowledge and qualifications to:

a. Meet the requirements of this Article,

b. Ensure the health and safety of a patient, and

c. Meet the needs of a patient based on the patient's medical evaluation; and

4. Ensure the following are conspicuously posted on the premises:

a. The current pain management clinic license issued by the Department;

b. The current telephone number and address of the unit in the Department responsible for licensing the pain management clinic;

c. An evacuation map posted in all hallways; and

d. A phone number for:

i. An opioid assistance and referral hotline, and

ii. A poison control hotline.

C. A medical director shall ensure that:

1. Pain management services are provided under the direction of:

a. A physician, or

b. A nurse practitioner licensed according to A.R.S. Title 32, Chapter 15 with advanced pain management certification from a nationally recognized accreditation or certification entity;

2. A record that includes cardiopulmonary resuscitation training is maintained for each personnel member, employee, volunteer, or student who is required by policies and procedures to obtain cardiopulmonary resuscitation training; and

3. A personnel member certified in cardiopulmonary resuscitation is available on the pain management clinic's premises while patients are present.

D. A medical director shall ensure that policies and procedures are established, documented, and implemented to protect the health and safety of a patient that:

1. Cover personnel member qualifications, duties, and responsibilities, including who may order, prescribe, or administer an opioid and the required knowledge and qualifications of those personnel members;

2. Cover cardiopulmonary resuscitation training, including:

a. The method and content of cardiopulmonary resuscitation training, including a demonstration of an individual's ability to perform cardiopulmonary resuscitation;

b. The qualifications required for an individual to provide cardiopulmonary resuscitation training;

c. The time-frame for renewal of cardiopulmonary resuscitation training; and

d. The documentation that verifies that an individual has received cardiopulmonary resuscitation training;

3. Cover the storage, accessibility, disposal, and documentation of a medication;

4. Cover the prescribing or ordering of an opioid:

a. Including how, when, and by whom:

i. A patient's profile on the Arizona Board of Pharmacy Controlled Substances Prescription Monitoring Program database is reviewed;

ii. An assessment is conducted of a patient's substance use risk;

iii. The potential risks, adverse outcomes, and complications, including death, associated with the use of opioids are explained to a patient or the patient's representative;

iv. Alternatives to a prescribed or ordered opioid are explained to a patient or the patient's representative;

v. Informed consent is obtained from a patient or the patient's representative;

vi. A patient receiving an opioid is monitored; and

vii. The actions taken according to subsections (D)(4)(a)(i) through (vi) are documented;

b. Addressing conditions that may impose a higher risk to a patient when prescribing or ordering an opioid, including:

i. Concurrent use of a benzodiazepine or other sedative-hypnotic medication,

ii. History of substance use disorder,

iii. Co-occurring behavioral health issue, or

iv. Pregnancy;

c. Addressing the criteria for co-prescribing a short-acting opioid antagonist for a patient;

d. Including the frequency of the following for a patient prescribed an opioid for longer than a 30-calendar-day period:

i. Face-to-face interactions with the patient,

ii. Assessment of a patient's substance use risk,

iii. Urine drug testing,

iv. Renewal of an opioid prescription without a face-to-face interaction with the patient, and

v. Monitoring the effectiveness of the treatment;

e. If applicable according to A.R.S. § 36-2608, including documenting a dispensed opioid in the Arizona Board of Pharmacy Controlled Substances Prescription Monitoring Program database;

f. Addressing the criteria and procedures for tapering opioid prescription or ordering;

g. Addressing the criteria and procedures for offering or referring a patient for treatment for substance use disorder; and

h. If opioids are administered at the pain management clinic, including how, when, and by whom:

i. A patient's need for opioid administration is assessed,

ii. A patient receiving an opioid is monitored, and

iii. The actions taken according to subsections (D)(4)(h)(i) and (ii) are documented;

5. Cover accessibility and security of medical records;

6. Cover infection control, including methods for sterilizing equipment and supplies and methods for identifying, storing, and disposing of biohazardous medical waste; and

7. Cover emergency treatment, including:

a. A list of the medications, supplies, and equipment kept on the premises to provide treatment in response to an emergency caused by a procedure or medication administered at the pain management clinic;

b. A requirement that a cart or a container is available for emergency treatment that contains the medications, supplies, and equipment specified in the policies and procedures according to subsection (D)(7)(a);

c. A method to verify and document that the contents of the cart or container are available for emergency treatment; and

d. A method for ensuring a patient is transferred to a hospital or other health care institution to receive treatment for a medical emergency that the pain management clinic is not authorized or not able to provide.

E. As applicable and except when contrary to medical judgment for a patient, a medical director shall ensure that the policies and procedures in subsection (D)(4) are consistent with the Arizona Opioid Prescribing Guidelines or national opioid-prescribing guidelines, such as guidelines developed by the:

1. Centers for Disease Control and Prevention, or

2. The U.S. Department of Veterans Affairs and the U.S. Department of Defense.

F. A medical director shall, except as prohibited by Title 42 Code of Federal Regulations, Chapter I, Subchapter A, Part 2, ensure that:

1. If an opioid may have contributed to a patient's death:

a. Written notification of the patient's death is provided to the Department in a Department-provided format if:

i. A personnel member of the pain management clinic prescribed, ordered, or administered the opioid that may have contributed to the patient's death, or

ii. The patient's death occurred while the patient was on the premises of the pain management clinic; and

b. The written notification required by subsection (F)(1)(a)(i) is provided within one working day:

i. After the patient's death, if an opioid administered as part of treatment may have contributed to the death; or

ii. After a personnel member of the pain management clinic learns of the patient's death, if a prescribed opioid may have contributed to the patient's death; and

c. The written notification required by subsection (F)(1)(a)(ii) is provided according to R9-4-602; and

2. Written notification of a suspected opioid overdose is provided to the Department according to R9-4-602.

G. If the Department requests a patient's medical record for review, the licensee:

1. May provide the patient medical record to the Department either in paper or in an electronic format that is acceptable to the Department, and

2. Shall ensure that documentation required by this Article is provided to the Department within two hours after a Department request.

H. The Department may take enforcement action as specified in R9-10-111 if a pain management clinic:

1. Is not in substantial compliance with applicable requirements in 9 A.A.C. 10, Article 1 or this Article; or

2. Is in substantial compliance, but refuses to carry out a plan of correction acceptable to the Department.

Ariz. Admin. Code § R9-10-2003

Adopted by final rulemaking at 24 A.A.R. 3020, effective 1/1/2019.