Administrative Code

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Virginia Administrative Code
Title 9. Environment
Agency 20. Virginia Waste Management Board
Chapter 121. Regulated Medical Waste Management Regulations

9VAC20-121-270. Periodic challenge testing.

A. After initial validation testing and during routine operation, a regulated medical waste treatment facility shall perform periodic challenge testing under full loading to evaluate the effectiveness of each treatment device in accordance with procedures outlined in the facility's approved treatment plan.

B. Periodic challenge testing shall be performed in accordance with the following requirements:

1. Biological indicators shall be used to periodically challenge test a load of regulated medical waste and must comply with all requirements of 9VAC20-121-260 D, with the exception of the quantity of biological indicators required under 9VAC20-121-260 D 7.

2. Periodic challenge testing must include at least one-third of the number of appropriate biological indicators that are required for the validation test, or two indicators, whichever is greater, unless otherwise determined by the department. One or more additional biological indicators from the same lot or batch shall be left untreated and used as a control.

3. The results of all periodic challenge testing shall be maintained for three years in accordance with 9VAC20-121-340 and shall include:

a. Date and time of all challenge tests, including the operator's name and cycle start and end times;

b. Number, type, batch or lot number, expiration date, and placement of biological and thermochemical indicators; and

c. Results of all methods used to monitor operating parameters achieved throughout the treatment cycle, including copies of charts, graphs, or other read-outs from the treatment equipment and growth results of all treated indicators and untreated controls.

4. Effective treatment of regulated medical waste must be demonstrated by a 6 Log10 or greater reduction of spore concentrations in all biological indicators in each periodic challenge test. A challenge test is considered a failure if any of the following occurs:

a. Failure of any treatment process to achieve operational parameters such as time, temperature, or pressure;

b. Failure to achieve microbial inactivation in any biological indicator during any treatment cycle. All biological indicators must show passing results (no growth in the viable spore concentration) after treatment or the challenge test is considered a failure; or

c. Failure of the untreated control indicator to show growth of the viable spore concentration.

C. Any regulated medical waste treated during or after a challenge test shall be stored temporarily until challenge test results are obtained. Regulated medical waste shall not be shipped offsite until the challenge test is complete and shows passing results for all biological indicators.

D. Unless otherwise approved by the department, for the first 30 days of actual operation, each treatment unit shall undergo challenge testing twice per day. The first load of each day shall be used for one of the required challenge tests.

E. Following the first 30 days of actual operation, periodic challenge testing must be conducted at a minimum of once per week or every 40 hours of operation, whichever is greater.

F. After six months of successful operation with no challenge test failures in weekly or 40- hour testing, challenge testing shall be conducted at least once per month.

G. Any challenge test failures during the first six months of actual operation shall require a return to daily challenge testing for at least 30 operating days. After the first six months of actual operation, any challenge test failure shall require a return to challenge testing once per week or every 40 hours of operation, whichever is greater.

H. Following any challenge test failure:

1. The waste shall continue to be managed as regulated medical waste and shall be retreated, stored temporarily until retreatment, or diverted to another approved facility for treatment or disposal. Regulated medical waste shall not be considered treated until a subsequent challenge test is conducted with passing results;

2. The facility shall evaluate and correct any issues with the treatment cycle and unit prior to treating any additional waste;

3. The facility shall notify the department of the failure in accordance with 9VAC20-121-340; and

4. The facility shall increase the frequency of challenge testing in accordance with subsection G of this section.

Statutory Authority

§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.

Historical Notes

Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.

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