Ariz. Admin. Code § 9-9A-301

Current through Register Vol. 30, No. 50, December 13, 2024

Section R9-9A-301 - Environmental and Physical Plant Standards

A. A licensee of a non-accredited procurement organization shall ensure that the procurement organization:

1. Is in a building that:

a. Has a commercial occupancy according to the local zoning jurisdiction;

b. Is free of any plumbing, electrical, ventilation, mechanical, or structural hazard that may jeopardize:

i. The security or quality of non-transplant anatomical donations or non-transplant anatomical material, or

ii. The health or safety of a personnel member or the public; and

c. Provides a separate and designated area for tissue recovery;

2. Has premises that are:

a. Sufficient to provide for a procurement organization's services and activities;

b. Cleaned and disinfected according to the procurement organization's standard operating procedures to prevent, minimize, and control illness and infection and mitigate potential cross-contamination between non-transplant anatomical donations and non-transplant anatomical material;

c. Clean and free from accumulations of dirt, garbage, and rubbish; and

d. Free from a condition or situation that may cause an individual to suffer physical injury;

3. Provides a restroom for clients that:

a. Is free from contamination from a non-transplant anatomical donation or non-transplant anatomical material;

b. Does not contain any items, materials, or devices associated with the preparation of non-transplant anatomical donations or non-transplant anatomical material; and

c. Is not used by technicians or other personnel members unless personal protective equipment is removed before entering; and

4. If the non-accredited procurement organization owns or maintains a vehicle for transporting non-transplant anatomical donations and non-transplant anatomical material:

a. Maintains the vehicle in a clean and sanitary condition,

b. Ensures that the floor of the vehicle or other locations on which non-transplant anatomical donations and non-transplant anatomical material are placed during transport have a surface capable of being cleaned and sanitized or disinfected, and

c. Requires that the vehicle is locked and secured at all times during transport of non-transplant anatomical donations or nontransplant anatomical material.

B. A licensee of a non-accredited procurement organization shall ensure that:

1. A pest control program is implemented and documented that requires:

a. A pest control service that uses certified applicators as specified in 3 A.A.C. 8, Article 2; and

b. Annual pest control service records to be retained for at least 12 months after the date of service; and

2. The procurement organization does not engage in any practice or create any condition that would constitute a public health nuisance, as specified in A.R.S. § 36-601, or is contrary to the health laws of this state.

C. A licensee of a non-accredited procurement organization shall ensure that:

1. Areas used to receive or prepare non-transplant anatomical donations or to label or package non-transplant anatomical material:

a. Are properly ventilated;

b. Have sanitary flooring and drainage;

c. Are protected from dust, dirt, flies, and other contamination;

d. Are only used, as applicable, for examining and preparing non-transplant anatomical donations or for labeling or packaging non-transplant anatomical material;

e. Are thoroughly cleansed and disinfected with a 1% solution of chlorinated soda, or other suitable and effective disinfectant, immediately after an obvious spill of blood or other potentially infectious bodily fluid or material;

f. Contain the equipment, instruments, and supplies necessary for accomplishing the tasks for which the areas are used that are:

i. Sufficient to accomplish the tasks;

ii. Maintained in working condition;

iii. Maintained in a clean and sanitary condition and disinfected or sanitized, as applicable, after each use;

iv. Used according to the manufacturer's recommendations; and

v. If applicable, tested and calibrated according to the manufacturer's recommendations or, if there are no manufacturer's recommendations, as specified in standard operating procedures;

g. Are disinfected after each use to protect the health and safety of technicians and other personnel members;

h. Are maintained in a clean and sanitary condition at all times; and

i. Have proper and convenient receptacles for refuse, bandages, and all other waste materials; and

2. All refuse and waste products produced from receiving, preparing, packaging, distributing, and transporting non-transplant anatomical donations or non-transplant anatomical material are removed from the premises as needed.

D. A licensee of a non-accredited procurement organization shall ensure that the procurement organization has refrigerated areas for storing non-transplant anatomical donations and non-transplant anatomical material that:

1. Are only used for non-transplant anatomical donations or non-transplant anatomical material;

2. Are maintained in working order;

3. Are kept in a clean and sanitary condition;

4. If a walk-in cooler, maintains a temperature between 36°F and 45°F;

5. If a freezer, maintains a temperature at or below 32°F; and

6. Are monitored by a temperature sensor system that:

a. Measures temperatures continuously and documents when a unit is out of the required temperature range, and

b. Alerts technicians or other designated individuals when temperatures are outside of the acceptable limits.

E. A licensee of a non-accredited procurement organization shall maintain documentation of equipment tests, calibrations, and repairs for at least 12 months after the date of testing, calibration, or repair.

F. A licensee of a non-accredited procurement organization shall ensure that:

1. Biohazardous material or medical waste and other potentially hazardous materials are removed and disposed of by a facility licensed by the Arizona Department of Environmental Quality pursuant to 18 A.A.C. 8 and 13; and

2. Combustible or flammable liquids are stored in labeled containers or safety containers in a secured area and properly identified to ensure the health and safety of personnel members and the public.

Ariz. Admin. Code § R9-9A-301

New Section made by final expedited rulemaking at 30 A.A.R. 3658, effective 11/5/2024.