250 R.I. Code R. 250-RICR-140-15-1.12

Current through October 15, 2024

Section 250-RICR-140-15-1.12 - On-Site Treatment and/or Destruction of Regulated Medical Waste

A. Applicability

1. The regulations in this section apply to generators of regulated medical waste that conduct on-site treatment and/or destruction of regulated medical waste, and to generators that accept regulated medical waste for treatment and/or destruction.

2. Generators that accept regulated medical waste from other generators for treatment and/or destruction shall apply for a license, in accordance with the requirements contained in § 1.17 of this Part, from: Rhode Island Department of Environmental Management, Office of Land Revitalization and Sustainable Materials Management, 235 Promenade Street, Providence, RI 02908.

3. Generators are also subject to the requirements of all applicable State solid waste and air emission regulations.

4. Training/Notification Requirement: Generators shall notify in writing all employees involved with on-site treatment and/or destruction of regulated medical wastes of the provisions in § 1.12 of this Part. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials.

B. Recordkeeping Requirements for On-Site Incineration

1. Generators shall keep an operating log at their incineration facility that includes the following information:

a. The date each incineration cycle began;

b. The length of the incineration cycle;

c. The total quantity of waste incinerated per incineration cycle;

d. An estimate of the quantity of regulated medical waste incinerated per incineration cycle;

e. Generators shall compile the operating log required by § 1.12(B)(1) of this Part from the effective date of these regulations;

f. Generators shall retain the operating log for at least three (3) years from the date of the last entry in the log.

2. Generators with on-site incinerators that accept regulated medical waste from generator(s) subject to § 1.13(B)(2) of this Part shall maintain the following information for each shipment of regulated medical waste accepted:

a. The date the waste was accepted;

b. The name and address of the generator who originated the shipment;

c. The total quantity and unit of measure of the regulated medical waste accepted from the originating generator;

d. The signature of the individual accepting the waste.

3. Generators with on-site incinerators that accept regulated medical waste from generators subject to the tracking form requirements shall keep copies of all tracking forms for a period of three (3) years from the date they accepted the waste.

C. Reporting Requirements for On-Site Incineration

1. General: The owner or operator of an on-site incinerator shall prepare and submit copies of the on-site incinerator report to: Rhode Island Department of Environmental Management, Office of Land Revitalization and Sustainable Materials Management, 235 Promenade Street, Providence, RI 02908. The reports shall summarize information collected in the operating log and shall contain the following information:

a. Facility name, mailing address, and location;

b. Facility type (e.g., hospital, laboratory);

c. Contact person;

d. Waste feed information;

e. The total number of incinerators at the facility that incinerate regulated medical waste and information concerning each incinerator.

2. Each report shall contain the following certification, signed by the facility owner or by owner's designee:

a. "I certify that I have personally examined and am familiar with the information submitted in this and all attached documents, and that, based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete."

3. Generators shall retain a copy of the on-site incinerator report form required under § 1.12(C) of this Part for three (3) years from the date of submission. Reports shall cover the period of January 1 to June 30 of each year and from July 1 to December 31 of each year. These reports are due forty-five (45) days after the end of the reporting period.

D. On-Site Steam Sterilization Standards A steam sterilizer used to convert untreated regulated medical waste into treated regulated medical waste shall be operated in accordance with the following requirements. In addition, operators of steam sterilizers shall be familiar with autoclaving techniques and hazards (i.e., burn protection and aerosol minimization).

1. The sterilizers shall be dedicated for waste only. The sterilizers shall be operated in accordance with the manufacturer's specifications for waste in regard to time, temperature, pressure, and capacity, provided that these specifications change the biological character or composition of the regulated medical waste so as to substantially reduce or eliminate its potential for causing disease.

2. If no manufacturer's specifications for waste exist, or if another combination of time, temperature, pressure and capacity is used, such combination shall be proven, on the basis of thorough tests, to render the regulated medical waste treated. These tests shall include a test to determine the capacity of this combination to completely and reliably inactivate Geobacillus stearothermophilus spores at a 4 Log₁₀ reduction or greater. Testing must demonstrate that inactivation is uniform and within containers reasonably likely to be treated in the system.

3. Regulated medical waste shall be steam sterilized in its primary container. The primary container shall be placed in the sterilization chamber so that sufficient space is provided between the chamber walls and the container to allow the steam to surround the container. The primary container shall be sealed loosely enough to allow the steam to penetrate the contents of the container, unless a self-venting bag is used.

4. Unless a steam sterilizer is equipped to continuously monitor and record temperatures during the entire length of each sterilization cycle, the operator of such sterilizer shall affix to the primary container temperature sensitive tape, which will indicate when the desired temperature is reached.

a. Regulated medical waste shall not be considered treated regulated medical waste unless:

(1) The temperature sensitive tape indicates that a temperature of at least 250 degrees F (121 degrees C) was reached during the sterilization process; or,

(2) A temperature determined in accordance with § 1.12(D)(2) of this Part was reached during the sterilization process; or,

(3) A temperature recommended by the manufacturer of the sterilizer that is sufficient enough to render the infectious agents within the waste treated, was reached during the sterilization process; and,

(4) In addition to attaining the specific temperature determined in accordance with §§ 1.12(D)(4)(a) ((1)), ((2)) and ((3)) of this Part, said temperature shall be maintained for a period of time sufficient to completely and reliably inactivate Geobacillus stearothermophilus spores at a 4 Log₁₀ reduction or greater. Testing must demonstrate that inactivation is uniform and within containers reasonably likely to be treated in the system.

b. A record of this temperature shall be kept as explained in § 1.12(D) (7) of this Part.

c. A steam sterilizer purchased after the effective date of this section, and used for waste sterilization, shall automatically and continuously monitor and record temperatures throughout the entire length of each steam sterilization cycle. This record shall be kept for three (3) years from the date the waste was treated.

5. Spore tests shall be conducted, at a minimum either once every forty (40) hours of operation or weekly, whichever allows for a greater length of time between tests. These tests shall be conducted to evaluate the effectiveness of the sterilization process, including tests of the capacity of such process to completely and reliably inactivate Geobacillus stearothermophilus spores at a 4 Log₁₀ reduction or greater. Each test shall include at least three (3) samples of test organisms placed in the medical waste load. One sample shall be placed approximately one-third of the way from the top of the load, one sample in the center of the load, and one sample approximately one-third of the way from the bottom of the load. A log shall be maintained recording the dates and results of such tests, and shall be kept for at least three (3) years from the date of the last entry in the log.

6. At least once during every forty (40) hours of operation, a sterilization unit shall be evaluated to determine whether it is operating properly with respect to temperature and pressure. A log shall be maintained recording the dates and results of such evaluations and the dates of calibration. The log shall be kept for at least three (3) years from the date of the last entry in the log.

7. For each sterilization unit, a log shall be maintained which contains, at a minimum, the following information for each use:

a. Date;

b. Time;

c. Operator;

d. Type and approximate amount of regulated medical waste treated;

e. Sterilization pressure reading;

f. Maximum temperature obtained during the sterilization process; and,

g. The length of time that the sterilization pressure and temperature determined in accordance with §§ 1.12(D)(1) through (2) of this Part were maintained.

8. The log required by § 1.12(D)(7) of this Part shall be kept at least three (3) years from the date the waste was treated.

E. Recordkeeping for Alternate On-Site Treatment and/or Destruction Methods Any method or process other than incineration or steam sterilization used by a generator for treatment and/or destruction of regulated medical waste on-site shall be approved by the Director in accordance with § 1.15(G)(5) of this Part. Each generator shall maintain the following records:

1. The approximate quantity and unit of measure of regulated medical waste that is subject to the treatment and/or destruction process(es);

2. Approximate percent of total waste treated and/or destroyed that is regulated medical waste;

3. For regulated medical waste accepted from generators meeting the exemption conditions in §§ 1.13(B)(2) and 1.13(B)(4) of this Part, information identifying the generator, the date the waste was accepted, the quantity and unit of measure of waste accepted, and the date the waste was treated and/or destroyed;

4. Results of all required quality assurance monitoring/procedures conducted to demonstrate compliance with the conditions of the approval granted by the Director in accordance with § 1.15(G)(5) of this Part; and,

5. Records shall be maintained by the generator for a period of at least three (3) years from the date the waste was treated and/or destroyed.

250 R.I. Code R. 250-RICR-140-15-1.12

Amended effective 4/22/2020