OneWorld Community Health Centers
Policy and Procedure
INFECTION CONTROL
TITLE: Instrument Sterilization Policy
APPLICABLE STANDARDS: Joint Commission on Accreditation of Healthcare Organizations (JCAHO’s)
Comprehensive Accreditation Manual for Ambulatory Care (CAMAC) IC.02.02.01 OSHA Standard 29
CFR 1910.1030
REFERENCES: CDC MMR Volume 42/No RR-8
OBJECTIVE: To remove, transport and sterilize used biomedical instruments properly in order to minimize
the risks of contaminating other instruments or transmitting an infection to a patient or staff member.
PROCEDURE(S):
1. SEPARATION: Once the procedure requiring the instruments has been completed, the patient will be
escorted out of the room, as appropriate.
2. COLLECTION: Nursing Personnel, wearing gloves, will collect all instruments and place them in a
covered, puncture resistant, plastic instrument container with the appropriate bio-hazardous label affixed.
The empty containers should be kept under the sink in each exam/procedure room.
3. TRANSPORTATION: The instrument container, with cover firmly affixed, shall be transported by
appropriately trained and protected personnel to the instrument cleaning area. Metal reusable instruments
will be removed taken directly to the sterile processing room in a covered transport container after the
patient encounter. Dirty speculums will be removed from the exam rooms at the end of the clinic day and
transported directly to the sterile processing room in a covered transport container.
4. LOCATION: The soiled instrument container will be placed at a designated location of the cleaning cycle
area. All speculums and instruments will be kept soaking (completely covered) until they can be put through
the ultrasonic cleaner.
5. PROTECTION: Appropriately trained staff shall wear scrubs, lab coat or plastic apron, rubber utility
gloves when transferring instruments from the transport container to the Ultrasonic cleaner. Protective
eyewear, goggles and/or mask may be during this phase of the cleaning process if the likelihood of
splashing occurs.
6. EVALUATION: Appropriately trained staff shall evaluate each instrument to determine if any of the
instruments are visibly soiled. If they are visibly soiled, then the staff member should try rinsing the
instruments off under running water first, then scrubbing with an appropriate brush, if necessary.
Instruments to be sterilized must be clean, dry and free from any residual matter such as tissue and/or blood.
7. IMMERSION: The container will then be filled with Empower Metrex for one hour. The liquid should
completely submerge all instruments. An Empower Metrex is recommended for this step as it further assists
in the cleaning and disinfection process.
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Policy and Procedure
INFECTION CONTROL
8. DISINFECTION: The instruments will be allowed to soak according to the manufacturer’s guidelines for
destruction of HIV virus, TB, and other infectious agents. However, in the absence of such guidelines, a
minimum soak time of at least 1 hour shall be required.
9. EVACUATION: Once the instruments have been through the ultrasonic cleaning process using Metriclean
2 Metrex, appropriately trained staff shall don new gloves, a lab coat or scrubs. The instruments shall then
be removed one at a time from the ultrasonic machine rinsed under a steady stream of tap water. The
objective in this stage is to evacuate the instruments and remove any remaining debris or visual signs of
contamination. If visual contamination is present, the instrument may be scrubbed with risk of body fluid
exposure.
10. EVAPORATION: Once the instruments have been ultrasonically cleaned and rinsed, they shall be placed
on a towel in a relatively isolated area and allowed to air dry completely.
11. ISOLATION: Appropriately trained staff will then remove their protective equipment used in steps five (5)
though nine (9), wash their hands and don new gloves. The instruments will then be packed as follows:
a. Speculums are placed directly on the tray along with an indicator strip.
b. Other individual instruments will be placed in individual autoclave bags (indicator strip is on the
outside of each bag). Scissors and forceps will be placed in the pouch with pointed end facing up
(the open end).
c. Autoclave bags should then be sealed and placed on the autoclave instrument trays.
12. STERILIZATION: Once the instruments have been properly packed, they should be placed directly into the
autoclave and run through a complete cycle, as follows:
a. Packages with sharp instruments in them should not be allowed to touch each other. Use sterile
gauze or cotton between the instruments to protect each other from puncture during the
sterilization process.
b. Any items that might hold water should be placed in a manner which facilitates drainage
c. DO NOT overload sterilizer tray.
d. Operating the Sterilizer (note: staff operating the sterilizer should also be familiar with the
manufacturer’s instructions for safely running the equipment):
I. Make sure unit is plugged into electrical outlet
II. Check the distilled water level in the sterilizer, the water line should be in the GREEN
zone. If the water line is not in the GREEN zone, add more distilled water until the water
level raises into the green zone.
III. Load autoclave and place an indicator strip in with load to be sterilized. DO NOT PUT
PLASTIC INSTRUMENTS IN THE AUTOCLAVE.
IV. Shut the door (pull up on the handle to close tight).
V. Press the “On/Standby” button (bottom right).
VI. Select either the “unwrapped” button or the “pouches” button (bottom left)
VII. Push the green “start” button (bottom right)
VIII. When the cycle is done, the door will automatically open between the sterilizing and dry
cycles.
IX. When the door opens the autoclave is cooling down the load.
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Policy and Procedure
INFECTION CONTROL
X. When the instruments are cool, remove the load.
XI. Check sterilization indicator strips If the indicator strip has changed from pale yellow to black then the item is now
sterilized.
 If the indicator strip has not changed from pale yellow to black (that is, it is still yellow),
resterilze the instruments using a new package. DO NOT REUSE THE SAME
PACKAGE.
XII. Autoclave cleaning to be done monthly using 1 oz of Speed-Clean Midmark per
gallon of water.
13. INDICATOR TESTING: A sterilizer indicator test will be run with each load.
14. RESTORATION: The newly sterilized packs should be removed carefully from the autoclave and
distributed to the appropriate storage area. (See attachment A)
PLEASE NOTE: Sterilized Autoclave packs are assumed to be sterile indefinitely unless the packaging has
been damaged in some way (i.e. package tear, water stains, etc.). This “Event Related Sterilization” process
means that autoclave packets do not need to be dated. Additionally, nursing staff should monthly visually
review the instruments to determine if they must be sterilized again. ** Instrument sterilization packs will be
dated, but this date will be used for batch inventory purposes only.
15. SPORE TESTING OF STERILIZER: An internal spore test indicator will be performed weekly. All
spore-testing results will be maintained for reference and tracking purposes. All results must be logged in the
white “Biological Indicator Monitoring Log Book.”
To effectively monitor the performance of the organization’s sterilizers Spore Testing is performed to ensure
that patient assessment and care equipment are safe for use on other patients.
The CDC MMR Volume 42/No RR-8 (1993) and subsequent revisions dating up to the current year (2000),
states the following:
“Proper functioning of sterilization cycles should be verified by the periodic use (at least weekly) of
biologic indicators (i.e., spore tests) (3, 9)-. Heat-sensitive chemical indicators (e.g., those that change
color after exposure to heat) alone do not ensure adequacy of a sterilization cycle but may be used on the
outside of each pack to identify packs that have been processed through the heating cycle.”
Therefore, OneWorld staff will perform biological (spore) testing of every sterilizer in the organization at least
weekly following this established procedure:
A. Exposure:
1. Place one or more ProSpore2 vials in a horizontal position in the most difficult to sterilize locations per
manufacturer’s instruction along with a normal instrument load. Run a normal sterilization cycle. DO
NOT PROCESS CONTROL AMPOULE.
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Policy and Procedure
INFECTION CONTROL
2. Sterilize according to the normal procedure.
3. After the sterilization cycle is completed, remove the test ampoule(s) from the autoclave after cooled 1015 minutes.
B. Activation:
Items needed: Processed vial(s) that have been cooled but not longer than 15 minutes. One unprocessed
(control) vial.
1. Seal the cap by pressing down firmly until flush with the tube.
2. Crush the media ampoule with the tool provided, or by squeezing the sides of the plastic tubes.
3. Inspect the unit to make sure that the spore disc is immersed in the growth media. If the spore disc is not
immersed, hold the vial in a vertical position tapping the bottom on a hard surface until the disc becomes
saturated.
C. Incubation:
Place the processed vial(s) labeled with the date, time and autoclave being tested and one unprocessed
(control) vial labeled with the date, time and “control” in a vertical position in an incubator at 55-66 degrees
Celsius for a period of 24 hours.
D. Monitoring:
Examine the vials daily during incubation recording observations. All positive vials will be recorded and
disposed of immediately.
E. Interpretation:
Control: The control vial should exhibit a color change and/or turbidity. If the control ampoule does not
show signs of growth, consider the test invalid.
Test: A failed sterilization cycle is indicated by turbidity and/ or change in color to or toward yellow. A
test ampoule that retains its purple color indicates an adequate sterilization cycle.
1. Test results are logged by the person who performed the test.
2. If the culture is positive, which means it has failed will require that the autoclave be tested again,
repaired if necessary, and a “pass” spore test result must be obtained prior to the autoclave’s reuse.
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Policy and Procedure
INFECTION CONTROL
3. Any failed results will require that ALL instruments that were autoclaved since the last spore test to be
reprocessed. If these instruments cannot be identified separately then ALL instruments will be
resterilized.
4. A log of all spore testing results must be turned in to the review by the Risk Management Committee on
a quarterly basis (see policy, Risk Management Sub-Committee).
5. An Incident report will be filled out and given to the COO or PI nurse.
16. In addition to the weekly internal biological (spore) testing of every sterilizer in the organization, OneWorld
will perform and send a biological spore testing strip monthly to an outside vendor/testing to serve as an
additional infection control measure following this established procedure:
1. Place one test strip (Maxi Test) per manufacturer’s instruction in the center of the sterilizer, and the
other biological test strip in the most difficult to sterilize locations along with a normal instrument load.
Run a normal sterilization cycle. DO NOT PROCESS CONTROL STRIP.
2. Sterilize according to the normal procedure.
3. After the sterilization cycle is completed, remove the test strips from the autoclave.
4. Complete the Sterilization Log and testing paperwork per manufacturer’s guidelines.
5. Place testing packages per manufacturer’s guidelines into the pre-addressed envelope that already
contains the viability control piece and mail the envelope at the earliest possible convenience.
Note: (a) The two test pieces plus the control piece must contain the
same lot control number. (b) Test data must be mailed in the envelopes
provided.
6. Test results will be accessed via Internet.
7. Test results are logged by the person who performed the test using the “Monthly Sterilization and Spore
Testing Log” (Attachment A).
8. If the culture is positive (failed), the vendor/testing lab will notify the clinic by phone and then fax the
results.
9. A failed result will require that the autoclave be tested again, repaired if necessary, and a “pass” spore
test result must be obtained prior to the autoclave’s reuse.
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Policy and Procedure
INFECTION CONTROL
10. Any failed results will require that ALL instruments that were autoclaved since the last spore test to be
reprocessed. If these instruments cannot be identified separately then ALL instruments will be
resterilized.
11. A log of all spore testing results must be turned in to the review by the Risk Management
Committee on a quarterly basis (see policy, Risk Management Sub-Committee).
12. An Incident report will be filled out and given to the COO or PI nurse.
____________________________________________________
SIGNATURE:
Dr. Kristine McVea, MD MPH
CMO, OneWorld CHC
__________________
DATE
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Policy and Procedure
Attachment A
MONTHLY STERILIZATION & SPORE TESTING LOG
DATE
CYCLE TYPE
STERILIZATION
OR SPORE TEST
PACK/SPORE
TEST ID #
CYCLE
COMPLETED
YES OR NO
SPORE
TEST
RESULTS
CONTROL
TEST
RESULTS
INITIALS
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
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