Current through Register Vol. 41, No. 3, September 23, 2024
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.
