Current through Register Vol. 41, No. 3, September 23, 2024
A.
Prior to using any treatment system, the facility must conduct validation
testing that employs the use of process controls, biological indicators, and
process monitoring to establish operating parameters to demonstrate effective
treatment of regulated medical waste.
B. Prior to validation testing, the owner or
operator shall submit to the department a treatment plan containing the
information required by
9VAC20-121-330 E. The plan shall
demonstrate that the validation protocols for each treatment unit meet the
standards of this section and shall indicate any additional protocols specific
to the regulated medical waste to be treated, such as the use of packaging
types that may affect treatment of the waste. Validation testing must be
conducted in accordance with an approved treatment plan and the requirements of
this section. The validation test results and operating parameters must be
submitted to the department for review prior to acceptance of regulated medical
waste for treatment.
C. To
demonstrate reproducibility, a minimum of three separate treatment runs must be
performed on three separate days, using three distinct loads, during which the
department is present to witness at least one complete validation test run. All
test runs shall meet the following requirements:
1. Operating parameters used during the tests
must be consistent with the parameters that will be used during routine
operation of the treatment process (e.g., cycle duration, temperature,
pressure, chemical concentration, irradiation exposure time, or other treatment
parameters as applicable).
2.
Surrogate waste load composition (e.g., porosity, liquids, solids, moisture
content, organic matter, thermal resistance, and type of packaging or
containers) and waste load configuration (e.g., packing density and
orientation) used during the tests must be consistent with the waste properties
and loading process that will be used during routine operation. The surrogate
waste load shall represent the most difficult waste anticipated to be treated
during routine operation.
3. The
weight and volume of the surrogate waste loads used during the tests must be
consistent with the amount of waste that will be treated during routine
operation. Validation testing must be performed at the treatment unit's full
capacity unless an alternate load size is approved.
D. To assess treatment performance, the
system must employ commercially-prepared biological indicators from the same
lot or batch, each containing spores that demonstrate the necessary resistance
for the treatment method, as determined by the department. The indicators must:
1. Have a minimum concentration of 6
log10 spores per biological indicator. The concentration
must be higher and more thermally resistant than the bioburden routinely
associated with the waste;
2.
Include a supplier's certificate of performance (or certificate of analysis)
that identifies the organism (genus, species, strain, and population) and, for
thermal treatment systems (including autoclaves), the D-value and Z-value. The
D-value must be 1.5 to 3.0 minutes, unless otherwise approved by the
department, and the Z-value must be no less than 50°F (10°C);
3. Be appropriate for the type of waste and
device (i.e., self-contained, suspension, or spore strip), including the shelf
life, the carrier material and primary packaging, the culture medium (for
self-contained biological indicators) and the media, growth, and culture
conditions (for non-self-contained biological indicators);
4. Be compatible with the treatment process
and have a resistance relative to the temperature, pressures, conditions,
chemicals, or irradiation used in the process; the infectious agents on a
substrate; the type and density of the waste to be treated; and its
packaging;
5. Be placed in a
carrier system (e.g., net bags, wrapped in a paper towel and encased in cotton
batting or inside tennis balls, socks, or alloy containers with holes in them)
designed to mimic the thermal resistance of the waste before placement into the
package to be treated. Materials used to hold biological indicators must be
similar to the waste to be treated, provide effective protection from damage or
breakage or from otherwise being compromised, be loose in the bulk of the
waste, and be easily retrievable at the end of each validation test run.
Indicators shall not be placed in carrier systems that would enhance treatment
or produce erroneous results (such as metal containers that would conduct
heat);
6. Be placed throughout the
waste load during each validation test at the coldest or most challenging
locations within the treatment unit, where the sum of all influences on the
microorganisms results in minimal inactivation for a defined waste
load;
7. Be used in accordance with
the quantity specified as follows, for each test run:
a. Three biological indicators per cycle for
0 to 110 pounds of waste per load;
b. Five biological indicators per cycle for
111 to 550 pounds of waste per load;
c. Seven biological indicators per cycle for
551 to 1,100 pounds of waste per load;
d. Nine biological indicators per cycle for
1,101 to 1,650 pounds of waste per load;
e. Eleven or more biological indicators per
cycle, as determined by the department, for greater than 1,650 pounds of waste
per load; and
f. One or more
biological indicators from the same lot or batch to be left untreated and used
as a control;
8. Be
stored in accordance with the manufacturer's specifications when not in use.
Expired biological indicators shall not be utilized.
9. Biological indicators in the form of paper
strips must not be used in devices or areas where fluids can pool or puddle
around the indicator. Self-contained biological indicators with vent caps must
not be used where liquids may accumulate and contaminate the
indicators.
10. Qualitative or
quantitative biological indicators shall be used provided the operator or
vendor of the technology provides evidence from such sources as peered reviewed
journals that support the use of that particular indicator. Biological
indicators requiring microbial bioassay to confirm effective treatment must be
quantitatively analyzed after the treatment cycle. All self-contained
biological indicators used for test runs must be evaluated for growth (e.g.
qualitatively analyzed for color change) following incubation in accordance
with the manufacturer's instructions.
E. Concurrent with biological indicators, the
process must employ devices or instrumentation that demonstrates the treatment
unit is achieving critical operating parameters for effective treatment.
Process monitoring shall include:
1.
Thermochemical indicators (e.g., tape, paper strips, or integrators) that
demonstrate that the waste has been exposed to a certain temperature or
chemical concentration;
2.
Thermochemical recording devices (e.g., wireless data loggers, thermocouples,
or chemical monitoring probes) that are placed in or on waste packages and that
provide a measurable record of actual treatment conditions of the waste. The
minimum number of thermochemical recording devices to be used during each
validation test shall be at least one device per treatment bin plus one
additional device in the treatment chamber; and
3. Parametric controls or monitoring devices
integral to the treatment system that record critical operational treatment
parameters and provide a record of measurements that can be correlated to
effective treatment.
F.
Effective treatment of regulated medical waste must achieve a 6
log10 or greater reduction of the viable spore
concentrations of the most appropriate bacterial species for the treatment
method. Effective treatment is demonstrated by no growth in all treated
biological indicators and growth in all untreated biological indicators during
each test run. In certain situations where the waste poses a greater risk
(e.g., a higher bioburden waste), the department may require a greater
reduction.
G. The facility shall
submit to the department for approval a summary of the validation test results
demonstrating the treatment effectiveness and specifying the operating
parameters based on the results of all validation test runs. The report shall
describe the results of all validation test runs, including:
1. Date and time of all test runs, including
the operator's name and cycle start and end times;
2. Surrogate waste load composition,
configuration, and size;
3. Number,
type, batch or lot number, expiration date, and placement of biological
indicators, thermochemical indicators, and thermochemical recording devices;
and
4. Results of all methods used
to monitor operating parameters achieved throughout the treatment cycle and the
accuracy of parametric monitoring devices, including copies of charts, graphs,
or other read-outs from the treatment equipment and growth results of all
treated indicators and untreated controls.
H. Validation testing must be repeated when
any of the following occurs:
1. Failure of any
treatment process to achieve operational parameters, such as time, temperature,
or pressure during validation testing;
2. Failure to achieve microbial inactivation
in any biological indicator during any treatment cycle during validation
testing;
3. Failure of the
untreated control indicator to show growth of the viable spore
concentration;
4. Any modifications
to any of the treatment process operational parameters, bioburden, waste mass,
chemical type, concentration, irradiation or exposure time, type of waste to be
treated, or mechanical or engineering changes to the treatment system from
those assessed during the validation testing;
5. A failure identified in subdivision 1, 2,
or 3 of this subsection during periodic challenge testing as identified by
biological or process monitoring that occurs three or more times in a calendar
year or during the first 30 days of actual operation;
6. A treatment device has been operational
without a repeat validation for at least five years; or
7. A treatment device has not been used for
at least one year.
Statutory Authority: § 10.1-1402 of the Code of
Virginia; 42 USC §
6941 et seq.; 40 CFR Part
257.
