Section 940. Efficacy testing protocols

A. Methodology employed to determine treatment efficacy of the technology will need to assure required microbial inactivation and assure the protocols are congruent with the treatment method. Protocols developed for efficacy testing shall incorporate, as applicable, recognized standard procedures such as those found in Test Methods for Evaluating Solid Waste, Physical/Chemical Methods and Standard Methods for the Examination of Water and Waste Water.

B. The department shall prescribe those types and compositions of medical wastes that present the most challenge to treatment effectiveness under normal operating conditions of the equipment reviewed.

C. Dependent on the treatment process and treatment efficacy mechanisms utilized, protocols evaluating medical waste treatment systems shall specifically delineate or incorporate, as applicable:

1. Waste compositions that typify actual waste to be processed;

2. Waste types that provide a challenge to the treatment process;

3. Comparable conditions to actual use (i.e., process time, temperature, chemical concentration, pH, humidity, load density, load volume);

4. Assurances that biological indicators (i.e., ampules, strips) are not artificially affected by the treatment process;

5. Assurances of inoculum traceability, purity, viability and concentration;

6. Dilution and neutralization methods that do not affect microorganism viability;

7. Microorganism recovery methodologies that are statistically correct (i.e., sample collection, number of samples/test, number of colony forming units/plate); and

8. Appropriate microbial culturing methods (i.e., avoidance of microbial competition, the selection of proper growth media and incubation times).

Historical Notes

Derived from VR672-40-01:1 § 11.11, eff. June 29, 1994.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.