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APSIC CSSD Center of Excellence Program Audit Checklist
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APSIC CSSD Center of Excellence Program Audit Checklist
Instrumentation Inspection, Preparation & Packaging
Item reviewed Practice Comments Type of Reference (AAMI,
Yes/No, Observation AORN)
N/A
Instruments:
1 Ensure instruments are cleaned Observe ____ ST79, section 8.4.3
and dried before packaging. Interview ____ ST79, section 8.4.1
Both ____
2/ Inspect instruments for flaws or Observe ____ ST79, section 8.4.3
M damage. Check for rust, pitting, Interview ____
corrosion, burrs, nicks, cracks, Both ____
chipping of plated surfaces.
Lighted magnifying glass
available for instrument
inspection.
3 cleaning verification by users Observe ____ ST79, D.1
should include visual inspection Interview ____
combined with other Both ____
verification methods (ATP) that
allow assessment of instrument
surfaces
4 Instruments: Ensure that Observe ____ ST79, section 8.4.3
-Cutting edges are sharp; Interview ____
-Moving parts move freely, Both ____
without sticking.
-Instruments needing repair are
taken out of service for repair
or replacement.
5 Follow MDMs instructions for Observe ____ ST79, section 7.5.6
instruments requiring Interview ____
lubrication after cleaning or Both ____
prior to sterilization.
Packaging:
15 Packaging materials are held Observe ____ ST79, section 8.3.1
for a min. of 2 hrs. Prior to use Interview ____
at room temp (21°F-24°F) and Both ____
at a relative humidity ranging
from 30-60%. [This is needed
to permit steam sterilization
and prevent superheating.]
16 Packaging materials are Observe ____ ST79, section 8.3.1
/ examined regularly for defects Interview ____
(i.e. holes, warn spots, stains). Both ____
M
17 Wrappers should be kept snug, Observe ____ ST79, section 8.3.1
but not wrapped too tightly or Interview ____
strike-through could occur. Both ____
18 Paper/Plastic Pouches: Observe ____ ST79, section 8.3.2
-labeling is done on plastic side Interview ____
only. Both ____
-Double peel pouch only if
pouch is validated for this use.
19 Wrapped packs: write only on Observe ____ ST79, section 8.3.2
indicator tape or affixed labels. Interview ____
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APSIC CSSD Center of Excellence Program Audit Checklist
Both ____
20 Perforated, wire-mesh-bottom Observe ____ ST79, section 8.4.3
trays, and rigid organizing trays Interview ____
are inspected prior to each use Both ____
to ensure there are no sharp
edges, nicks, or loose wire-
mesh.
21 Tape (other than sterilization Observe ____ ST79, section 8.3.3
indicator tape) should not be Interview ____
Both ____
used to secure packages, nor
should safety pins, ropes.
paper clips, staples, or other
sharp objects
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APSIC CSSD Center of Excellence Program Audit Checklist
Physical monitors,
Chemical indicators,
Biological indicators:
15 Verify parameters of the cycle Observe ____ ST79, section 10.5.1
have been met by reviewing Interview ____
cycle printout tapes. Circle Both ____
minimum temperature and
exposure time, initial/sign, and
date.
16 Bowie-Dick Testing is done Observe ____ ST79, section 10.7.6.1
/ daily in prevacuum sterilizers Interview ____ ST79, section 10.7.6.4
before first processed load. Both ____
M
Process Bowie-Dick at 132°-
134ºC for 3.5 to 4 minutes. One
pack per load in an empty
chamber. Record results. ISO
17 External process indicators Observe ____ ST79, section
/ (indicator tape, labels) are Interview ____ 10.5.2.2.1
Both ____
M affixed to hospital-sterilized
packages and containers.
18 Internal chemical indicator(s) Observe ____ ST79, section
/ (Class 4,5,6) are placed inside Interview ____ 10.5.2.2.2
Both ____
M every package in the most AORN RP: Packaging
challenging location for Systems, Rec. IX,
sterilant to reach. (Refer to
IX.5
Rigid Container Mfr.
Instructions for CI placement).
19 Implant Loads: Monitor with a Observe ____ ST79, section 10.6.1
/ BI PCD containing a Class 5 Interview ____ ST79, section 10.6.3
Integrating Indicator. Both ____
M AORN RP:
Implants should be quarantined Sterilization, Rec.
until BI results are known,
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APSIC CSSD Center of Excellence Program Audit Checklist
except in emergency situations IV.h
20 Non-Implant Loads: Optional Observe ____ ST79, section 10.5.4
monitoring with a PCD Interview ____
containing either: a BI, a BI and Both ____
Class 5, a Class 5 integrating
indicator, or a Class 6
emulating indicator.
21 Routine sterilizer efficacy Observe ____ ST79, section
/ testing with a BI PCD is Interview ____ 10.5.3.2, 10.7.2.2,
Both ____
M done daily (if sterilizer run 10.7.4.2, and 10.7.3.2
daily):
Sterilizers larger than 60 Litter
–Place BI PCD in first load of
items to be sterilized, on bottom
shelf of sterilizer cart over
drain.
Table Top sterilizers: BI PCD is
ran with first load of the day
and generally placed in center
of load.
Use appropriate BI PCD
depending on type of
sterilizer:
22 Sterilizers larger than 60 Liter. Observe ____ ST79, section 10.7.2.1
/ Use commercially available Interview ____
FDA-cleared BI PCD or AAMI Both ____
M
16-towel pack. [e.g. 3M™
Attest™ Rapid 5 Steam Pack
#41382 or 3M™ Attest™ 1296
Steam Pack to monitor 132°C
Prevacuum and 121°C Gravity
Displacement cycles.] (M)
23 Table Top sterilizers. BI PCD is Observe ____ ST79, section 10.7.3.1
a user assembled challenge test Interview ____
pack which creates the greatest Both ____
challenge (e.g., BI in peel
pouch, BI in wrapped set) and
contains items normally
processed.
BI Test/Control, and Results:
24 Control BI: Incubate a positive Observe ____ ST79, section 10.7.2.3
BI control each day a test vial is Interview ____
incubated and in each Auto- Both ____
reader or incubator. The
Control BI needs to be from the
same lot number as the Test BI.
Record results.
25 Test BI: Incubate Test BI Observe ____ ST79, section 10.7.2.3
according to BI Manufacturers Interview ____
Instructions. Record results. Both ____
Qualification Testing:
26 For sterilization process failures Observe ____ ST79, section 10.7.5.1
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APSIC CSSD Center of Excellence Program Audit Checklist
/ where the cause is not Interview ____ and 10.8.1
M immediately identifiable, and Both ____
after major steam or sterilizer
repairs, run 3 empty cycles with
a BI PCD followed by 3 empty
cycles with a Bowie-Dick test if
prevacuum sterilizer.
Sterilizer Maintenance:
27 Sterilizer “drain strainers” Observe ____ ST79, section 9.4
are inspected daily for Interview ____
Both ____
debris.
28 Sterilizer external and Observe ____ ST79, section 9.4
internal surfaces are Interview ____
Both ____
routinely cleaned.
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APSIC CSSD Center of Excellence Program Audit Checklist
Sterile Storage and Distribution
DISTRIBUTION:
10 Supplies are handled Observe ____ ST79, section
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APSIC CSSD Center of Excellence Program Audit Checklist
carefully. Interview ____ 8.10.1
Both ____
11 Packaging is inspected Observe ____ ST79, section
visually for integrity, and Interview ____ 8.10.1
Both ____
labeling, prior to using items.
11 Transport carts should have a Observe ____ ST79, section
physical barrier between the Interview ____ 8.10.2
Both ____
bottom shelf and the floor.
-Reusable covers should be
cleaned after each use.
13 Carts are decontaminated/ dried Observe ____ ST79, section
before reused for transporting Interview ____ 8.10.2
sterile supplies. Both ____
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APSIC CSSD Center of Excellence Program Audit Checklist
Documentation
Item reviewed Practiced Comments Type of Reference (AAMI,
Yes/No, Observation AORN)
N/A
EQUIPMENT & CYCLE
DOCUMENTATION:
1 Documentation for each Observe ____ ST79, section 10.2
mechanical washer is Interview ____
Both ____
maintained: Monitor and
verify cleaning processes
(e.g. digital readouts, and
cycle printouts)
2/ Documentation for each Observe ____ ST79, section 9.7 and
M sterilizer is maintained, and Interview ____ 10.3.2
Both ____
includes results from each AORN RP:
load. (e.g monitoring results; Sterilization, Rec.
sterilizer repair records) IV.c.1 - IV.c.3
3 For each cycle printout tape: Observe ____ ST79, section 10.5.1
*Verify cycle start was Interview ____ AORN RP:
Both ____
initiated Sterilization, Rec.
*Ensure cycle selected was IV.c.1
appropriate for load contents
*Verify correct Time &
Temp. was met
*Ensure there were no cycle
aborts or warnings
4/ Record for each cycle: Observe ____ ST79, section 10.3.2
M *Lot number; Interview ____ AORN RP:
Both ____
*Load contents; Sterilization, Rec.
*Exposure time/temp; XIV
*Name/initials of sterilizer
operator;
*Results of BI testing, if
applicable;
*Results of Bowie-Dick
testing, if applicable;
*Results of CIs in test packs;
reports of non-conclusive or
non-responsive CIs found in
the load
PRODUCT RECALLS:
5/ *Policies & Procedures are Observe ____ ST79, section 10.11.1
M clear and concise Interview ____ AORN RP:
Both ____
*Records are maintained Sterilization, Rec.
* Lot control labels are used, XVI, IVI.d
to include: Sterilizer ID, lot
number, sterilization date,
expiration date, name of
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APSIC CSSD Center of Excellence Program Audit Checklist
pack and initials.
6/ Sterilization Process Failure: Observe ____ ST79, section 10.7.5
M – When cannot immediately Interview ____ AORN RP:
Both ____
identify cause of failure (e.g. Sterilization, Rec.
selected incorrect cycle XVI.c.1
setting), reprocess the load
and recall/reprocess all items
dating back to last load in
sterilizer with negative BI
results.
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APSIC CSSD Center of Excellence Program Audit Checklist
Facility Design
Item reviewed Practiced Comments Type of Reference (AAMI,
Yes/No, Observation AORN)
N/A
1 All instrumentation Observe ____ ST79, section 3.1
reprocessing is centralized Interview ____
Both ____
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APSIC CSSD Center of Excellence Program Audit Checklist
Personnel Considerations
Item reviewed Practiced Comments Type of Reference (AAMI,
Yes/No, Observation AORN)
N/A
1 CS supervisory personnel meet Observe ____ ST79, section 4.2.1
minimum recommended Interview ____
qualifications Both ____
2 CS supervisory personnel Observe ____ ST79, section 4.2.1
maintain competency and Interview ____
participate in departmental Both ____
continuing education
4 CS technicians meet minimum Observe ____ ST79, section 4.2.2
recommended qualifications Interview ____
Both ____
5 All new CS personnel receive Observe ____ ST79, section 4.3.1
initial and comprehensive Interview ____
facility and department Both ____
orientation.
6/ All CS personnel receive a Observe ____ ST79, section 4.3.1
M minimum annual training on Interview ____
department policies and Both ____
procedures All CS personnel
demonstrate competency
annually.
7 Written policy on personal Observe ____ ST79, section 4.4
hygiene. Interview ____
Both ____
M: Mandatory
Source Documents:
1. Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance
in health care facilities. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 (Consolidated Text).
2. Association of periOperative Registered Nurses (AORN): Perioperative Standards and Recommended Practices 2012 Edition.
AORN Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment (RP: Care of
Instruments)
3. Occupational Safety & Health Administration. OSHA’s Medical and First Aid Standard (29 CFR 1910.151)
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