Ariz. Admin. Code § R18-13-1412 - Treatment Facilities; Application Requirements; Design and Operation

A. An operator who applies for facility plan approval shall comply with subsections (1) and (2) as well as all of the requirements in subsection (B):

1. Submit to the Department the following documentation:

a. Equipment specifications that identify the proper type of medical waste to be treated in the equipment and any design or equipment restrictions.

b. Manufacturer's specifications and operating procedures for the equipment that describe the type and volume of waste to be treated, monitoring data of the treatment process, and calibration and testing of the equipment, providing specific details about the capability of the equipment to achieve the treatment standards prescribed in R18-13-1415.

c. Instructions for equipment maintenance, testing, and calibration that ensure the equipment achieves the treatment standards prescribed in R18-13-1415.

d. Training manual for the equipment.

e. Written certification from the manufacturer stating that the equipment, when operated properly, is capable of achieving the treatment standards prescribed in R18-13-1415.

2. Submit to the Department and have readily available at the facility, an operations procedure manual describing how the waste will be handled from the time it is accepted by the treater through the treatment process and final disposition of the treated waste. The operations procedure manual shall include all of the following:

a. Provisions for treating biohazardous medical waste within 72 hours of receipt or refrigerating at 40° F. or less upon determination that treatment or disposal will not occur within 72 hours. Nonputrescible biohazardous medical waste that is not immediately treated may be stored for up to 90 days unrefrigerated.

b. A contingency plan if the treatment equipment is out of service for an extended period of time. The plan shall address the manner and length of time for storage of the waste. An operator shall not store biohazardous medical waste more than 90 days. The plan shall be based on the capacity of the treatment equipment to treat all waste at the facility, including any backlog of stored waste and any new waste intake. If the 90-day time-frame will be exceeded, the operator shall either stop accepting waste until the backlog is treated, or contract with another treatment facility for treating the waste.

c. Procedures for handling hazardous chemicals, radioactive waste, and chemotherapy waste. The plan shall provide for scanning biohazardous medical waste with a Geiger counter and handling waste that measures above background level in a manner that complies with state and federal law.

3. Have on hand written procedures stating that biohazardous medical waste is to be accepted from a transporter only if the waste is accompanied by a tracking form, and written procedures that require compliance with both of the following:

a. The treater or the treater's authorized agent shall sign the tracking document and keep a copy of the acceptance documentation for one year.

b. If a biohazardous medical waste container is damaged or leaking, improperly labeled, or otherwise unacceptable, a treater shall do one of the following:

i. Reject the waste and return it to the transporter.

ii. Accept the waste and transfer it directly from the transporting vehicle to the treatment processing unit.

iii. If the waste will not be treated immediately, repackage the waste for storage.

4. Assure that the facility is designed to meet both of the following requirements:

a. Any floor or wall surface in the processing area of the facility which may come into contact with biohazardous medical waste is constructed of a smooth, easily cleanable non-porous material that is impervious to liquids.

b. The floor surface in the treatment and storage area either has a curb of sufficient height to contain spills or slopes to a drain that connects to an approved sanitary sewage system, septic tank system, or collection device.

5. Store biohazardous medical waste as required in R18-13-1408 .

6. Comply with all of the following if the treatment method is incineration:

a. Reduce the incinerated medical waste, excluding metallic items, into carbonized or mineralized ash by incineration.

b. Determine whether the ash is hazardous waste as required under R18-8-262 .

7. Conduct any autoclaving according to the manufacture's specifications for the unit.

8. Use only alternative medical waste treatment methods that achieve the treatment standards in R18-13-1415(A) .

9. Treat animal waste, chemotherapy waste, and cultures and stocks as prescribed in R18-13-1420 .

10. Treat medical sharps as prescribed in R18-13-1419 .

11. Keep records of equipment maintenance and operational performance levels for three years. The records shall include the date and result of all equipment calibration and maintenance. Operational performance level records shall indicate the duration of time for each treatment cycle and:

a. For steam treatment and microwaving treatment records, both the temperature and pressure maintained in the treatment unit during each cycle and the method used for confirmation of temperature and pressure.

b. For chemical treatment, a description of the solution used.

c. For incineration, the temperature maintained in the treatment unit during operation.

d. Any other operating parameters in the manufacturer's specifications.

e. A description of the treatment method used and a copy of the maintenance test results.

12. Not open the red bag prior to treatment unless opening the bag is required to treat the contents. Transfer of the entire contents, when performed as part of the treatment process, is permitted.

B. An operator of a department-approved facility shall comply with all of the following:

1. Have readily accessible written procedures stating that biohazardous medical waste is to be accepted from a transporter only if the waste is accompanied by a tracking document, and written procedures that require compliance with both of the following:

a. The treater or the treater's authorized agent shall sign the tracking document and keep a copy of the acceptance documentation for the period required under the USDOT requirements, as listed in 49 CFR 172.201.

b. If a biohazardous medical waste container is damaged or leaking, improperly labeled, or otherwise unacceptable, a treater shall do one of the following:

i. Reject the waste and return it to the transporter or self-hauling generator.

ii. Accept the waste and transfer it directly from the transporting vehicle to the treatment processing unit.

iii. If the waste will not be treated immediately, repackage the waste for storage.

2. Assure that the facility is designed to meet both of the following requirements:

a. Any floor or wall surface in the processing area of the facility which may come into contact with biohazardous medical waste is constructed of a smooth, easily cleanable non-porous material that is impervious to liquids.

b. The floor surface in the treatment and storage area either has a curb of sufficient height to contain spills or slopes to a drain that connects to an approved sanitary sewage system, septic tank system, or collection device.

3. Store biohazardous medical waste as required in R18-13-1408.

4. Comply with all of the following if the treatment method is incineration:

a. Reduce the incinerated medical waste, excluding metallic items, into carbonized or mineralized ash by incineration.

b. Determine whether the ash is hazardous waste as required under R18-8-262.

5. Conduct any autoclaving according to the manufacturer's specifications for the unit.

6. Use only alternative medical waste treatment methods that achieve the treatment standards in R18-13-1415(A).

7. Treat animal waste, chemotherapy waste, and cultures and stocks as prescribed in R18-13-1420.

8. Render medical sharps incapable of creating a stick hazard by using an encapsulation agent or any other process that prevents a stick hazard.

9. Keep records of equipment maintenance and operational performance levels for three years. The records shall include the date and result of all equipment calibration and maintenance. Operational performance level records shall indicate the duration of time for each treatment cycle and:

a. For steam treatment and microwaving treatment records, both the temperature and pressure maintained in the treatment unit during each cycle and the method used for confirmation of temperature and pressure.

b. For chemical treatment, a description of the solution used.

c. For incineration, the temperature is maintained in the treatment unit during operation.

d. Any other operating parameters in the manufacturer's specifications.

e. A description of the treatment method used and a copy of the maintenance test results.

10. Not open a sealed biohazardous medical waste container prior to treatment unless opening the container is required to treat the contents. Transfer of the entire contents, when performed as part of the treatment process, is permitted.

11. Clean the storage and treatment areas as necessary to protect the public health and employee health and safety.

C. The treater shall make treatment records available for Departmental inspection upon request.

Notes

Ariz. Admin. Code § R18-13-1412

New Section adopted by final rulemaking at 5 A.A.R. 3776, effective September 17, 1999 (Supp. 99-3). Amended by final rulemaking at 27 A.A.R. 2801, effective 1/4/2022.