2007 Scope Reprocessing Competency Package

Program-wide Scope Reprocessing
Competency Package
NOTE: THIS DOCUMENT APPLIES TO Respiratory, GI, Cardiology, Anesthesia, OB/GYN, ENT,
Surgery and Urology and any other departments where scopes are used and reprocessed.
Copyright 2001
Kaiser Foundation Hospitals
Created by: National Disinfection and Sterilization Task Force
(last revised: August 2007)
Created: National Interregional Disinfection and Sterilization Task Force 2001 1

Last Revised: 2007
KAISER PERMANENTE
Program-wide Scope Reprocessing Competency Package
TABLE OF CONTENTS
1. Overview/CEU Credit Page 3
2. Position Statement/References Page 4
3. Behavioral Goal/Objectives Page 5
4. Scope Reprocessing Policy Page 6
5. Scope Reprocessing Procedure Page 7 - 11
6. Scope Reprocessing Quick Reference Grid Page 12
7. About the APIC Endoscope Reprocessing Guidelines Page 13
8. About the SGNA Endoscope Reprocessing Chart Page 14
9. About the SGNA Endoscope Reprocessing Video Page 15
10. Staff Competency Tools
Scopes:
 Rigid Scopes Page 17 - 19
 TEE Page 20 - 22
 Channeled Scope Reprocessing – Manual Page 23 - 26
 Channeled Scope Reprocessing – Steris Page 27 - 30
 Channeled Scope Reprocessing – Custom Ultrasonic Page 31 - 34
 Non-channeled Scope Reprocessing – Manual Page 35 - 37
 Non-channeled Scope Reprocessing – Steris Page 38 - 41
 Non-channeled Scope Reprocessing – Custom Ultrasonic Page 42 - 44
 Single Channeled Scope Reprocessing Sterilization Sterrad NX Page 45 - 48
AERs:
 Custom Ultrasonics Page 50 - 51
 Olympus DSD Page 52
 Steris Page 53 - 54
 MV-1 Page 55
Sterilizers:
 Sterrad NX Page 59 - 60
11. Post Test Page 61
12. Post Test Answer Sheet Page 62
13. Documentation of Employee Completion of Competency Package Page 63
14. Preventative Maintenance Checklists
 Custom Ultrasonics: Medical Assistant Checklist Page 65 - 66

 Custom Ultrasonics: Engineer Checklist Page 67 - 73
 ASP: Engineer Checklist Page 74 - 75
 Medivator DSD 201/Olympus: Engineer Checklist Page 76 - 79
 Medivator DSD 91E/Olympus: Engineer Checklist Page 80 - 82
15. Sample Scope Procedure Log Page 83

Last Revised: 2007
16. Definitions Page 84

Last Revised: 2007
KAISER PERMANENTE
OVERVIEW
In order to ensure competency in scope reprocessing, each staff person should accomplish the following steps.
This should be done at the time of hire and annually thereafter to demonstrate competency according to the 1999
FDA Recommendations:
1. Staff must review Scope Reprocessing Policy and Procedure and Quick Reference Grid (attached).
2. Managers must review the APIC Guidelines for Infection Prevention and Control in Flexible Endoscopy;
American Journal of Infection Control, 1999; 28:138-155 (2 copies were originally provided for each facility in
2001 with the hard copy of this Scope Competency Package; additional copies can be downloaded from the
following website: http://www.APIC.org/pdf/gdendosc.pdf ). This should be available for staff to reference.
3. Staff must read the following SGNA Chart for the types of scopes that pertain to their department: “Steps
Necessary to Thoroughly Clean and High Level Disinfect Flexible Endoscopes”; Society of Gastroenterology
Nurses and Associates, Inc – 1997. (2 copies were originally provided for each facility in 2001 with the hard
copy of this Scope Competency Package; additional copies available through SGNA at 1-800-245-7462 or 312-
321-5165 or their website: http://www.sgna.org ). Additional scope specific information for Olympus and Pentax
scopes available at: http://healthcare.olympusamerica.com/msg_section/cds/index.asp and
http://www.pentaxmedical.com/products.asp
4. Staff must watch the SGNA video: “Endoscope Cleaning and High Level Reprocessing of Flexible Endoscopes”
(1 copy of the updated SGNA video was provided in 2007 for each facility; additional copies available through
SGNA at 1-800-245-7462 or 312-321-5165 or their website: http://www.sgna.org ); please see list of
inconsistencies with KP protocol reflected in the video on page: 15.
5. Staff must provide return demonstration/proof of competency by: Completing Competency Tool with
observer/trainer and successfully perform all reprocessing tasks in compliance with Medical Center Policies
and Procedures, including:
 PPE: Personal Protective equipment
 Point of Use Pre-cleaning
 Leak Test
 Cleaning
 Disinfection
 Rinsing/Drying
 Accessories
 Storage
 Appropriate Preventative Maintenance and Record Keeping
6. Staff must complete documentation of competency by:
Completing post test; reviewing answers with observer/trainer; completing Documentation Form included in this
package.
NOTE ON CEU CREDIT: Continuing education credit should be available at the local level for any employee who
completes this competency package. Contact your local training/education staff or department manager.
NOTE: For information regarding fees and scheduling of intensive training classes on Custom Ultrasonics machine
use, contact CU staff at 215-364-1477. For information on Custom Ultrasonics Training by Kaiser Permanente,
contact: Teresa McLaren at: 510-559-5129 or teresa.mclaren@kp.org

Last Revised: 2007
KAISER PERMANENTE
POSITION STATEMENT
The Kaiser Permanente Interregional Disinfection and Sterilization Work Group supports a national standardized
approach to scope reprocessing in an effort to ensure appropriate, safe and effective reprocessing of this
equipment. The attached policy, procedure, quick reference grid and competency tool were developed to this end.
These documents were written in accordance with the references listed below, and were designed to be utilized as
standard reference guidelines for the Kaiser Permanente organization. These attached documents should be
placed in manuals for staff reference in departments where scopes are utilized and reprocessed. A copy of these
documents will also be referenced in the standardized Infection Prevention and Control Ambulatory Care Manual,
which was distributed nationally in 1998, and is updated every 2 years.
REFERENCES:
Alvarado, C.J., Reichelder, M., "APIC Guideline for Infection Prevention and Control in Flexible Endoscopy";
American Journal of Infection Control (AJIC). April 2000, Vol. 28, No.2.
American Society of Gastroenterologists. "Position Statement: Reprocessing of Flexible Gastrointestinal

Endoscopes". December 1995.
Association for the Advancement of Medical Instrumentation, American National Standards Institute. Reuse of
hemodialyzers. ANSI/AAMI RD47-1993. Arlington (VA): Association for the Advancement of Medical
Instrumentation, American National Standards Institute; 1993.
CDC Guidelines for Environmental Infection Control in Health-Care Facilities

http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Enviro_guide_03.pdf
Davis DA, Zadinsky JR, Carrel C, "Flexible Endoscopy: Compliance Training Program", Infection Control and
Sterilization Technology (ICST), September 1998, pp. 24-34.
FDA and CDC Public Health Advisory: Infections from Endoscopes Inadequately Reprocessed by an Automated
Endoscope Reprocessing System, September 10, 1999.
FDA Alert: Liquid Chemical Germicide Residue Causes Burns, August 26, 2002
My Endo Site: http://www.myendosite.com/search_by_topic.htm
International Association of Healthcare Central Service Materials Management: http://iahcsmm.org/
Nelson, D et al, “SHEA Position Paper - Multi-society guideline for reprocessing flexible gastrointestinal
endoscopes”; Infection Control and Hospital Epidemiology (ICHE). July 2003, Vol. 24, No. 7.
Occupational Safety and Health Administration. "Occupational Exposure to Bloodborne Pathogens Final Rule", 29
C.F.R., Part 1910.1030, Federal Register (December 6, 1991).
Spaulding EH. "Chemical Disinfection of Medical and Surgical Materials", Disinfection, Sterilization and
Preservation, Philadelphia, PA: Lea & Febiger, 1968.
Society of Gastroenterology Nurses and Associates, Inc. "Standards for Infection Control and Reprocessing of
Flexible Gastrointestinal Endoscopes", SGNA Monograph Series, 1999.
Association of Perioperative Registered Nurses (AORN). “AORN Standards, Recommended Practices and
Guidelines”. 2003.

Last Revised: 2007
KAISER PERMANENTE
BEHAVIORAL GOAL/OBJECTIVES
Goals:
1. Ensure that all employees who handle scopes comply with manufacturer’s instructions and community standard
guidelines for cleaning and disinfection or sterilization of scopes by the manual or automatic reprocessor
method as outlined by the procedures following.
2. Ensure consolidation of scope reprocessing processes wherever possible, in order to improve patient and
employee outcomes. Consolidation of reprocessing improves outcomes by minimizing employee exposure to
chemical disinfectants and by helping to ensure that reprocessing is performed by a core group of fully trained
employees only.
Objectives:
After completion of the Scope Reprocessing Competency Package, employees will be able to:
 Perform all reprocessing activities using appropriate personal protective equipment.
 Perform leak testing either manually or automated.
 Correctly disassemble and clean a scope as described in the procedure.
 Perform proper disinfection procedures (e.g. 2% glutaraldehyde) appropriate to the scope being processed.
 Perform proper drying procedures using alcohol and forced air after each scope reprocessing.
 Demonstrate understanding of the process monitors (i.e. test strips, monitoring tapes, records, etc).
 Demonstrates understanding of required preventative maintenance on automated reprocessing machine if
used.
 Store and clean equipment appropriately and record activities.

Last Revised: 2007
KAISER PERMANENTE
Program- Wide Manual and Automated Scope Reprocessing
POLICY
1. When scopes are used on animals, these instruments should be reserved for future use only on animals.
2. Scopes that pass through normally sterile tissue should be subjected to a sterilization procedure before each use; if this is not
feasible, they should receive at least high-level disinfection.
3. Scopes that come in contact with mucous membranes are classified as semi-critical items and should receive at least high-level
disinfection.
4. Scopes should be repeat reprocessed prior to use if stored for > 30 days between uses (unless sterilized).
5. Personal protective equipment should be used to protect workers from exposure to infectious agents (e.g. HIV, Hepatitis B virus,
Hepatitis C virus, M. tuberculosis, etc.) and toxic chemicals.
6. Reprocessing of scopes should begin with Point of Use Pre-cleaning. Pre-cleaning should be done prior to transporting the scope
to the reprocessing area. Pre-cleaning should include wiping the exterior and suctioning the channels of the scope with an
approved enzymatic detergent solution recommended by the scope manufacturer.
7. Follow manufacturer dilution instructions for enzymatic detergent solution. Care should be taken when diluting the solution to avoid
splashing or aerosolization of the product. The scope should always be submerged when flushing with detergent to prevent
spraying detergent into the air.
8. Scope should next be transported to the reprocessing area in covered container.
9. Leak testing is required before immersion. For cystoscopes follow manufacturer recommendations regarding whether or not to do
leak testing.
10. Cleaning of the scope should include flushing and brushing all channels with enzymatic detergent solution, to remove particulate
matter. The scope should always be submerged when flushing to prevent spraying detergent into the air. Irrigation adapters,
where applicable, should be used to facilitate cleaning of all channels. All parts of the scope should then be rinsed with tap water.
Enzymatic detergent solutions should be discarded after each scope.
11. Cleaning brushes should be disposable or, if re-usable, they must be thoroughly cleaned and receive high-level disinfection or
sterilization after each use. Cleaning brushes should be examined to ensure they are intact after use and piece(s) have not broken
off inside scope.
12. As an alternative to manual flushing during cleaning prior to disinfection, automated flushing may be accomplished via use of a
“pre-processing sink” using enzymatic detergent solution. This should be followed by manual brushing and then a “cleaning” cycle
in an automated scope reprocessing (AER) machine (e.g. Custom Ultrasonics). Ensure that rinsing after cleaning and proper
dilution of enzymatic detergent is accomplished manually if not with an automated by pre-processing sink. Manual or automated
cleaning should be done following manufacturer and KP procedures.
13. After cleaning, scopes must be disinfected. If a high level disinfectant is used, all internal and external surfaces should be in
contact with the disinfectant for not less than the time indicated by Kaiser policy (e.g. 20 minutes for 2% glutaraldehyde).
14. Run a diagnostic cycle on the AER to ensure flow through all channels as the first cycle of the day. For Custom Ultrasonics
machines ensure that F8 “wash/disinfect” is engaged for reprocessing of scopes.
15. Following manual chemical disinfection, scopes must be thoroughly rinsed with copious amounts of sterile/tap water - exterior of
scope plus 100 ml each lumen/each rinse. For manual disinfection use three water rinses - if using a container, discard water after
each rinse. For automated disinfection use two rinses with the minimum default cycle time (e.g. Olympus= three minutes, CU =
two and a half minutes).
16. All water rinses should be followed by 5ml of 70% ethyl or isopropyl alcohol flush per lumen followed by drying the scope and all of
its channels using forced air. For automated endoscopic reprocessors, follow manufacturer guidelines for introducing the alcohol
and air into the channels. Visually check that all ports have flow during alcohol purge. If no flow is noted then the AER
must be inspected (by facility engineering, third party contractors or Biomedical Engineering).
17. Scopes should be hung in a vertical position with valves removed to further facilitate drying.
18. Scope accessories that penetrate mucosal barriers (e.g., biopsy forceps) should be soaked in an enzymatic detergent solution,
cleaned in an ultrasonic cleaner and steam sterilized between each patient or used once and discarded.
19. Sterile water should be used to fill the water bottle (used for cleaning the lens and irrigation during the procedure). The water bottle
and its connecting tube should be sterilized at least daily (unless disposable).
20. Personal protective equipment should be used to protect workers from exposure to infectious agents (e.g. HIV, Hepatitis B virus,
Hepatitis C virus, M. tuberculosis, etc.) and toxic chemicals.
21. Filter changes and routine maintenance should be accomplished and documented (e.g. every 6 weeks for Custom Ultrasonics,
every 6 months for Steris) on all automated endoscopic reprocessors. Clinicians are responsible for changing “adapter filters” every
6 weeks. Local Facility Engineers, third party contractors or Biomedical Engineers are responsible for changing all other filters and
additional preventative maintenance on automated reprocessors. Instructions applicable to specific scope models in use should be
made available to all staff responsible for reprocessing. See preventative maintenance section.
22. A log should be maintained including MR#, patient name, procedure date, ID# of scope, MD, scope type, AER#/cycle used.
23. Notify local Risk Management if reprocessing deficiencies are identified. Risk Management is responsible for reporting deficiencies
to the Department of Health Services.
24. A system should be in place to clearly identify which scopes have been reprocessed, and which still need reprocessing.
NOTE: Steris uses bacteria filtered, not sterile, water in the rinse cycle and the final product is a wet scope. For these reasons effective
2006 Steris will be considered a method of disinfection not sterilization in all KP medical centers. As such scope lumens should be
flushed with alcohol and forced air as the final steps after a Steris cycle in order to facilitate drying and minimize microbial growth that
might result in disease transmission. Also note that Olympus America does not list STERIS SYSTEM 1® as a compatible product for
use in reprocessing Olympus bronchoscopes and GI endoscopes.

Last Revised: 2007
KAISER PERMANENTE
Program-wide Manual and Automated Scope Reprocessing
PROCEDURE
NOTE: Instructions applicable to specific scope models in use should be made available
to all staff responsible for reprocessing.
1. Point of Use Pre-cleaning
a) Don personal protective equipment including at a minimum gloves and chemical splash goggles.
b) Follow manufacturer dilution instructions for enzymatic detergent solution. Care should be taken when diluting
the solution to avoid splashing or aerosolization of the product.
c) Immediately after removing the scope from the patient, suction/flush all lumens and elevator channel with
copious amounts of enzymatic detergent solution and water to eject any refluxed patient material. Ensure
flushing of elevator wire channel for duodenoscopes.
d) “Use lint free cloth/sponge to wipe exterior of scope with enzymatic detergent solution, and thoroughly
rinse. Do not use gauze sponges. They are not lint free.
e) Clear the air and water channels according to manufacturer’s instructions.
f) Transport scope in covered container to reprocessing room.
2. Leak Test (Prior to Manual or Automated Disinfection) NOTE: For cystoscopes follow manufacturer
recommendations regarding whether or not to do leak testing.
a) Visually inspect the scope for holes, tears or other damage after each patient use.
b) Leak test the scope after each patient use.
1) Attach water cap (or immersion cap) to video scopes
2) Tighten light guide prong prior to immersion.
3) Remove suction, air/water and biopsy valves.
4) First, attach leak tester and pressurizer to the scope. Inspect the bending rubber to insure the
scope is pressurized either visually or by touch.
5) Submerge the tip of the scope and check for bubbles. Angulate the bending section looking for leaks
for a minimum of 30 seconds to one minute.
6) Curl the light guide and insertion tube and submerge the entire scope.
Look for leaks, checking the following areas:
 Observe control knob
 Observe insertion tube
 Observe all channels including the distal tip, the valve ports and the connectors
 Observe elevator channel at both proximal and distal ends
7) Massage four video switches while scope is under water
8) Remove scope from water.
 For manual leak tester, press the pressure release valve to fully deflate scope prior
to disconnecting leak tester from scope
 For automated leak tester, turn off machine, detach leak tester connector from the
machine, wait 20 -25 seconds to allow scope to depressurize.
c) When a leak is detected, (e.g., bubbles coming from the scope), do not soak the scope. If the scope
remains inflated with air per the leak tester, it is safe to wash the outside of the scope and suction the
enzymatic detergent and rinse water through the channels prior to sending for repair. Remove from service
and send for repair. A scope sent for repair should be considered a contaminated medical device and
labeled as such for shipping. Labeling should be accomplished with a biohazard label and supplemental
label. The supplemental label must indicate which portions of the scope remain contaminated. Consult
with your manufacturer; some companies (e.g. Olympus) recommend disinfection prior to shipping.
3. Cleaning
a) Don personal protective equipment including impervious long sleeved gown, gloves, hair cover, mask, chemical
splash goggles.
b) Wipe any non-critical parts of the scope that cannot be processed in high level disinfectant such as the hand
control and light guide with a lint free pad lightly soaked with enzymatic detergent solution followed by 70%
isopropyl or ethyl alcohol. If accidentally immersed, even for a few seconds, remove from service until
repaired.

Last Revised: 2007
KAISER PERMANENTE
Page 2 of 5 PROCEDURE
3. Cleaning continued
c) Soak all removable parts of the scope in an enzymatic detergent solution and clean these parts using a brush.
Pass brush through holes in valves. The control knobs, distal tip of scope and holes of valves should be
washed manually with valve brush to remove debris. Cleaning brushes should be disposable or if reusable,
thoroughly cleaned and then high level disinfected or sterilized. After cleaning, rinse parts with tap water.
d) Keep the scope submerged in the enzymatic detergent solution during cleaning and flushing to prevent
splashing of contaminated fluid.
e) Manually clean the insertion tube, channels, and accessories using cleaning brushes. Brush every
biopsy/suction channel.
1) Brush in the direction of the distal tip from the biopsy port.
2) Brush the channel between the suction valves.
3) Brush the channels in the direction of the light guide connector.
4) Massage the bristles of the brush each time exiting the scope before retracting.
5) Repeat brushing until no debris is visible on the brush.
6) For the ERCP scope, deflect and clean around the elevator channel.
e) Cleaning brushes should be disposable; if reusable, they must be thoroughly cleaned and then high level
disinfected or sterilized after each use.
f) Cleaning brushes should be examined to ensure they are intact after use and piece(s) have not broken off
inside scope.
e) For manual cleaning of multi-channeled scopes, attach the irrigation adapters to the scope, flush the enzymatic
detergent solution through the air, suction, water, elevator, wire, and all other channels. Flush a minimum of 90
ml enzymatic detergent solution through each channel or as directed by manufacturer. Attach suction tubing to
suction port and suction enzymatic detergent solution through suction channel (suction for 30 seconds or
approximately 500ml).
f) Discard enzymatic detergent solution after each scope.
g) Prior to manual high level disinfection, rinse all channels with tap water use irrigation adapters as needed
following cleaning to remove all traces of enzymatic detergent solution. Attach suction tubing to suction port and
aspirate approximately 500ml water through suction channel or use a syringe.
h) Dry all channels with forced air and dry the exterior of the scope and all accessories before disinfecting to
prevent dilution of the disinfectant.
NOTES:
 As an alternative to manual flushing, automated flushing may be accomplished via use of a “pre-
processing sink”. This does not eliminate the requirement for manual brushing as detailed in 3.d.
 If using an automated scope reprocessing machine, ensure that a detergent solution approved by the
scope reprocessing machine manufacturer is used for the cleaning cycle.
4. High Level Disinfection – Automated

a) Don personal protective equipment including impervious long sleeved impermeable gown, gloves, hair cover,
mask and chemical splash goggles. Visually confirm flow through all AER channel adapters prior to scope
disinfection by running a diagnostic cycle (i.e. wash only cycle for a Custom Ultrasonic unit).
b) Ensure disinfectant solution has met the minimum effective concentration level – most solutions will
change
color when activated.
c) Use test strips following manufacturer instructions. Ensure that test strip container is tightly covered prior to
and after use and that the test strips have not expired. Test high level disinfectant solution for minimum
effective concentration, and document test results. If solution does not show adequate concentration discard.
New solution must be used. Test the minimum effective concentration of the new solution before processing
scopes. Daily testing is sufficient if documented testing over time shows that the solution maintains an
effective concentration for the full period suggested by the manufacturer (e.g. 14 days for Cidex). If loss of
effective concentration is documented over time to occur sooner than the full period of time suggested by the
manufacturer, testing is recommended prior to each use, instead of daily. Do not use solution longer than
manufacturer’s recommendations even if test strip shows concentration is still effective. Any scope processed
with expired solution will have to be recalled and repeat reprocessed.
Last Revised: 2007
d) Follow the manufacturer’s instructions for connecting the scope to the automated reprocessor.

Last Revised: 2007
KAISER PERMANENTE
e) Place the valves and other removable parts in the reprocessor when possible.
For Duodenoscope/ERCP scopes, the elevator wire channel must be flushed manually (unless reprocessor has
received FDA 510(k) clearance to process these scopes).
f) Confirm that all documentation has been logged and/or has been entered.
g) Refer to manufacturer instructions for high level disinfectant process time.
h) Start machine following manufacturer written instructions.
i) Upon completion of cycle, verify that cycle parameters have been met. Initial documentation.
5. High Level Disinfection - Manual

a) All high level disinfection containers must be labeled with solution name, active ingredient, primary hazard (e.g.
“toxic by inhalation,” “respiratory sensitizer,” “causes contact dermatitis”), expiration date, and initials of person
who prepared the solution. All other containers should have the contents properly labeled. Keep containers
tightly covered. Use GUS (glutaraldehyde use station) to reduce the exposure of employees to liquid chemical
disinfectants.
b) Ensure disinfectant solution has met the minimum effective concentration level – most solutions will
change
color when activated.
c) Use test strips following manufacturer instructions. Ensure that test strip container is tightly covered prior to and
after use and that the test strips have not expired. Test strip containers should be labeled with expiration date 90
days from date of opening or what ever the manufacturer requires . Test high level disinfectant solution for
minimum effective concentration, and document test results. If solution does not show adequate concentration
discard. New solution must be used. Test the minimum effective concentration of the new solution before
processing scopes . Daily testing is sufficient if documented testing over time shows that the solution maintains
an effective concentration for the full period suggested by the manufacturer (e.g. 14 days for Cidex). Do not use
solution longer than manufacturer’s recommendations even if test strip shows concentration is still effective. Any
scope processed with expired solution will have to be recalled and repeat reprocessed.
d) Don personal protective equipment including impervious long sleeved gown, gloves, hair cover, mask, chemical
splash goggles and immerse the scope in disinfectant solution.
e) Use cleaning adapters or syringes to fill all channels completely until no bubbles are seen. All channels must be
reprocessed, even if not used in a given procedure.
f) Place all valves and removable parts in disinfectant solution.
g) Two percent glutaraldehyde solutions require a minimum of 20 minutes soak time at 20-25C (room
temperature). Submerge and soak the scope and accessories in high level disinfectant. Soak time begins after
full immersion and all channels are completely filled with high level disinfectant.
h) Refer to manufacturer’s guidelines/recommendations for other disinfectants.
i) As of 2006, Steris has been formally defined for KP purposes as a method of achieving high level disinfection
instead of sterilization due to the use of bacteria filtered instead of sterile water in rinse cycle and resulting
condition of a wet scope at the completion of the Steris cycle. Consequently, alcohol flush and forced air
through scope lumens must be completed on all scopes as the final reprocessing steps to facilitate drying and
discourage microbial growth.
MANUAL DISINFECTION AUTOMATED REPROCESSORS
1. Immerse the scope in disinfectant 1. Follow the manufacturer’s instructions to connect the scope to the
solution. reprocessor.
2. Use the cleaning adapters to fill all 2. Place the valves and other removable parts in the reprocessor when
channels completely until no possible.
bubbles are seen. 3. At the beginning of the day, visually confirm flow through all channel
3. Place all valves and removable adapters prior to reprocessing scope, by running “wash only” cycle.
parts in disinfectant solution. 4. For Custom Ultrasonics machines ensure that F8 “wash/disinfect” cycle is
4. All high-level disinfection selected.
containers must be labeled with 5. Attach channel-cleaning connectors.
solution name, active ingredient, 6. For Duodenoscope/ERCP scopes, the elevator wire channel must be
primary hazard, expiration date flushed manually (unless reprocessor has been cleared by the FDA).
and initials of person who

Last Revised: 2007
prepared the solution.
KAISER PERMANENTE
MANUAL DISINFECTION AUTOMATED REPROCESSORS

5. Keep containers tightly covered. 7. Refer to manufacturer’s instructions for high level disinfectant.
6. Follow manufacturer’s high level 8. Verify the machine setting for the recommended time and correct cycle.
disinfectant instructions for the 9. Validation of completed cycle for Custom Ultrasonics machines as
immersion time and set timer. follows:
7. All channels must be a) Press F1 to enter patient information
reprocessed, even if not used in b) Press F2 to print cycle validation; check and place signature on
a given procedure. print of each cycle to verify completed correctly
c) Press F3 to save and/or clear cycle and re-set for next cycle
10. Look at scopes to visually check flow of fluids through channels during
the final alcohol rinse step. All channels must be reprocessed, even if
not used in a given procedure.
6. Rinsing/Drying
After chemical disinfection, wearing gloves and eye protection at a minimum, rinse exterior of scope, and internal
channels and all accessories with sterile/tap water (manual: pour copious amounts of water over exterior of scope
three times and flush all lumens three times – 100ml each rinse/each lumen or rinse under running water for one
minute and flush all lumens three times – 100 ml each; automatic: set machine to rinse interior and exterior two
times with the minimum default cycle time (e.g. Olympus = three minutes, Custom Ultrasonics = two and a half
minutes). Discard sterile/tap water after each rinse.
a) After water rinse, flush all channels with 5 ml 70%- 90% ethyl or isopropyl alcohol to facilitate drying.
b) Purge all channels with forced air including insertion tube and inner channels.
c) Visually check that all ports have flow during alcohol purge.
d) Purge all channels with forced air to facilitate drying.
e) Remove all cleaning adapters and devices.
f) A new syringe should be used each day for alcohol flushing; the tubing/adapter should be high level
disinfected once a day.
g) Dry the exterior and accessories with a soft, dry lint-free cloth.
h) Remove personal protective gear.
i) Wash hands before leaving reprocessing room.
7. Storage
a) Channeled scopes after high level disinfection (including Steris): Hang scopes vertically in a ventilated closet or
cabinet specifically designed for scopes, to facilitate drying. Remove control valves, distal hoods, caps, etc.,
and store removable parts separately. When storing fiberoptic scopes the ETO valve should be in place. Some
video scopes made by Pentax need a venting cap in place during storage. There should be adequate space to
keep the scopes and other equipment from coming into contact with each other. Cabinet fan must by in the ON
position. Fan is activated when doors are closed. Doors must remain closed at all times.
NOTE: if not stored per these guidelines, scope must be repeat reprocessed just prior to use.
b) Non-channeled scopes: After thoroughly drying, may be stored in a manner that prevents recontamination
before next use. Vertical storage not required.
c) Channeled scopes that have been sterilized (e.g. ETO, Sterrad NX) may be stored in sterile wrapping/package
instead of hanging vertically.
d) Scopes should be repeat reprocessed prior to use if stored for > 30 days between uses.
e) A closed container should be used if transporting HLD scopes between rooms, e.g. from reprocessing area
to storage cabinets that may be in the procedure rooms.
f) Decontaminate transport container between scopes using a manufacturer approved product.
NOTE: A system should be in place to clearly identify which scopes have been completely reprocessed. This is recommended
in order to prevent a scope being used in more than one procedure without reprocessing between uses.
8. Biopsy Forceps
Last Revised: 2007
a) Soak re-usable biopsy forceps in an enzymatic detergent solution as soon as possible after procedure.
KAISER PERMANENTE
b) After soaking, assure that biopsy forceps are cleaned in an ultrasonic cleaner then dried and packaged for
steam sterilization after each patient use or per manufacturer’s recommendations.
c) Disposable biopsy forceps are not reused. Dispose of single use biopsy forceps into appropriate waste
container.
9. Water Bottle
a) Use new sterile water bottle and sterile disposable tubing assembly each day (smart cap).
10. Other Accessories

a) Sterilize or high-level disinfect all non-disposable semi-critical items (items that touch mucous membranes)
with two percent glutaraldehyde for 20 minutes. Follow high level disinfection with three water rinses. A
final alcohol rinse must be done.
 Suction Adapter, Air- Water Adapter, Biopsy Adapter, Door Clamp – large or small
types. Sterilize all non-disposable critical items (items that enter sterile tissue).
 Biopsy forceps (sterilize or use disposable).
NOTE: When using other high level disinfectants, follow manufacturer’s directions.
11. Processing Area

a) Cleaning/disinfection areas should be separate from patient care and supply/storage areas.
b) Wipe counter, and sink with approved surface disinfectant between cleaning and rinse cycles and between
cases.
c) Clean and high level disinfect, or, thermal disinfect final rinse basin at the end of the day.
12. Personal Protective Equipment (PPE)

a) Gowns referenced in this document are long sleeved impervious gown. Gloves referenced in this
document are nitrile or butyl rubber gloves, which cover the wrist. Other PPE referenced in this document
include mask, hair covering and eye protection such as chemical splash goggles or a face shield with
goggles.
b) Personnel with open skin lesions should not perform or assist with any scope procedure or handle
equipment used for procedures.
c) Wash hands after each patient procedure, after each glove removal, and when entering and leaving
endoscopy suite.
13. Record Keeping and Preventative Maintenance

a) Record high level disinfectant concentration monitoring results at least daily in logbook.
b) A log should be maintained indicating for each procedure the patient’s name, medical record number, the
procedure type, the scope type, the endoscopist, and the serial number or other identifier of the scope, the
AER and cycle used (see sample log).
c) Record all filters changes to assure they are changed regularly per manufacturer recommendations
(See Preventative Maintenance Checklists).
d) Notify local Risk Management if reprocessing deficiencies are identified so that they can
determine if DHS should be contacted.

Last Revised: 2007
KAISER PERMANENTE
QUICK REFERENCE GRID
Scopes With Point of Use Pre-cleaning, Leak Testing Rinsing, Disinfection, and Sterilization
Chan and Cleaning
nels
Female Reproductive 1. Immediately wipe outside of scope and flush Scopes entering sterile tissue should be sterilized (e.g.
Hysteroscope inside channels with enzymatic detergent hysteroscope, cystoscope). If this is not possible then
Hysteroscope used solution. they should be high level disinfected. The methods for
with Essure implant 2. Leak test - visually inspect for holes, tears or both are as follows:
damage. Detach valves. NOTE: For
Gastrointestinal cystoscopes follow manufacturer Sterilization:
Colonoscope recommendations regarding whether or not to  ETO (Ethylene Oxide)
Duodenoscope do leak testing.  Sterrad 100S (Hydrogen Peroxide Plasma) – for rigid
ERCP (Endoscopic 3. Immerse the scope into the enzymatic scopes only.
Retrograde detergent solution. Wash all debris from the  Sterrad NX (Hydrogen Peroxide Plasma) – for
Cholangio- exterior by brushing and wiping the instrument scopes with one channel only (ENT, OB/GYN,
Pancreatography) while submersed in solution. UROLOGY)
Gastroscope 4. Detach suction, biopsy channel cover, and all High Level Disinfection (HLD) - Manual or Automated:
Sigmoidoscope other removable parts; use a brush to clean  Manual: Soak in high level disinfectant1 solution for
valves and biopsy port openings. designated time frame (e.g., 20 minutes for 2%
Genitourinary 5. Brush the entire suction/biopsy system (should glutaraldehyde); rinse all channels with sterile water,
Cystoscope be submerged). After each passage rinse the or tap water followed by (Manual/Automated): three
 Flexible brush before retracting it and before reinserting rinses for manual disinfection – exterior of scope plus
 Rigid it. Continue brushing until no debris is left on 100ml water each lumen/each rinse; two rinses for
NOTE: Flexible the brush. Examine brush after use to ensure automated disinfection – default cycles; dry channels
Cystoscope cannot be it is intact. with 5ml of 70% alcohol rinse per lumen and forced
HLD with Cidex OPA 6. Rinse all channels thoroughly with enzymatic air. For automated disinfection visually confirm flow
detergent solution, followed by tap water and through all ports prior to reprocessing scopes. For
Pulmonary then forced air-drying. Towel dry exterior. automated disinfection machines with both buttons,
Bronchoscope 7. As an alternative to manual flushing prior to ensure that the “disinfect/wash” and not the “wash”
manual brushing and then disinfection, cycle is selected.
automated flushing may be accomplished via  Steris: after automated Steris System 1/P6000
use of a “pre-processing sink” followed by process complete, flush channels with alcohol
manual brushing and then a “cleaning” cycle in followed by forced air.
an automated scope reprocessing machine NOTES:
(e.g. Custom Ultrasonics). Detergent and not  Flexible Cystoscope cannot be HLD with Cidex
enzymatic solution must be used in this OPA.
process.  Biopsy forceps must be steam sterilized.
8. Soak biopsy forceps in enzymatic detergent
solution; then use ultrasonic cleaner prior to
sterilization.
9. During cleaning flush elevator wire channel of
duodenoscopes/ERCP scopes.
Abdominal Cavity
Laparoscope As above Sterilization only
Orthopedic
Arthroscope As above Sterilization Only
Scopes Point of Use Pre-cleaning, Cleaning Disinfection, Rinsing, Sterilization
Without Channels
Cardiac 1. Immediately wipe outside of scope with Scopes should be sterilized. If this is not possible then
TEE (Transesophageal enzymatic detergent solution. high level disinfect. The methods for both are as follows:
Echocardiogram) 2. Leak test per manufactures recommendation- Sterilization:
visually inspect for holes, tears or damage.  ETO (Ethylene Oxide)
Upper 3. Immerse the scope into the enzymatic  Sterrad (Hydrogen Peroxide Plasma) – for rigid
Airway/Digestive detergent solution. Wash all debris from the scopes only.
(ENT) exterior by brushing and wiping the instrument High Level Disinfection:
Nasolaryngoscope while submersed in solution.  Soak in high-level disinfectant1 solution for
Nasopharyngeal scope 4. Rinse thoroughly with tap water and towel dry. designated time frame (e.g., 20 minutes for 2%
glutaraldehyde); rinse with tap water (three rinses for
manual disinfection; two rinses for automated
disinfection with default cycles and wipe with scope
with alcohol soaked lint free cloth as final step. Store
dry between uses.
 After Steris System 1/P6000 (Peracetic Acid)
complete reprocessing cycle – wipe with scope with
alcohol soaked lint free cloth as final step; store dry
between uses.

Last Revised: 2007
APIC GUIDELINES
Two copies of the “APIC (Association for Practitioners in Infection Control) Guideline for Infection Prevention and
Control in Flexible Endoscopy” were provided for each facility in 2001 along with the hard copy of this Scope
Reprocessing Competency Package. Additional copies can be downloaded from the following website:
http://www.APIC.org/pdf/gdendosc.pdf or can be referenced in the journal where originally published: AJIC Am J
Infect Control 2000;28:138-55.

Last Revised: 2007
SGNA CHART
Two copies of the SGNA Chart: “Steps Necessary to Thoroughly Clean and High Level Disinfect Flexible
Endoscopes”, were provided to each facility with the hard copy of this Scope Reprocessing Competency Package
in 2001. Additional copies can be purchased from SGNA for $9.95 each. Orders can be placed on-line using their
web site: http://www.sgna.org or by contacting them directly at:
Society for Gastroenterology Nurses and Associates, Inc.

401 North Michigan Avenue
Chicago, IL 60611-4267
Voice: 800-245-7462; in Illinois: 312-321-5165
FAX: 312-527-6658

Last Revised: 2007
SGNA VIDEO
“Endoscopy Cleaning and High Level Reprocessing of Flexible Endoscopes” is the title of a video created by SGNA
(Society of Gastroenterology Nurses and Associates, Inc). This video is 20 minutes long. It covers cleaning,
reprocessing, and graphs. One copy of this video was provided to each facility with the hard copy of this Scope
Reprocessing Competency Package in 2001, and an updated copy of the video was distributed to all sites in 2006.
Additional copies can be purchased from SGNA for $43.95 each (member’s price) or $168.95 (non-members price).
Orders can be placed on-line using their web site: http://www.sgna.org or by contacting them directly at:
Society for Gastroenterology Nurses and Associates, Inc.

401 North Michigan Avenue
Chicago, IL 60611-4267
Voice: 800-245-7462; in Illinois: 312-321-5165
FAX: 312-527-6658
PLEASE NOTE: A number of inconsistencies with KP protocol have been reported in the SGNA video. These are
listed below. Please share this list with staff who view the video. As an alternative to the SGNA video you might
consider purchasing the videos available from Olympus:
(http://www.olympusamerica.com/olympusuniversity/ou_home.aspx). These training videos do match the scope
processing standards established by KP. Olympus has separate videos for GI multi-channel
endoscopes and for single-lumen scopes such as bronchoscopes or cystoscopes.
Inconsistencies noted in the SGNA Video “Cleaning and High Level Reprocessing of Flexible Endoscopes”:
(The approximate time in the video where the inconsistencies occur is noted in parentheses)
1. The intended audience for this video is the GI department. This is not truly appropriate for processing scopes from
urology, RT, anesthesia, ED, etc.
2. Although the voice-over advises that staff should comply with OSHA Bloodborne Pathogens Standard for wearing
Personal Protective Equipment (PPE), the actress does not mask on, wears patient care latex gloves instead of
decontamination weight gloves, and wears an Isolation gown rather than an impervious gown. (5:30)
3. Transport of scope is performed without covering the container. (6:45)
4. KP policy for Leak Testing requires that the distal end of the scope be checked before immersing the entire scope. The
actress immerses the entire scope without first checking the distal end for leaks. (8:05)
5. Voice-over states that an enzymatic detergent be used for cleaning the scope. The bottle of blue solution used in the
video is labeled as Endozyme, however, Endozyme is yellow/brown/gold, not a blue detergent. (9:05)
6. When brushing multiple port openings, the brush bristles are not cleaned before moving on to a new port opening.
(9:40)
7. When cleaning the port openings, the Olympus recommendation is to rotate the brush, either clockwise or
counterclockwise. The actress uses an in-and-out motion while cleaning the port openings. (9:45)
8. Rather than massaging the brush bristles with fingers to clean the bristles after the brush has passed through a lumen,
the actress violently shakes the endoscope to clean the brush bristles that have passed through the lumen. Staff should
be discouraged from activities that aerosolize either enzymatic cleaners or high level disinfectants. (10:25)
9. The voice-over advises to keeping the endoscope under the surface of the fluid during cleaning, however, the video
shows the scope held above the surface of the fluid for cleaning. (10:40)
10. The voice-over instructions are to soak the scope in enzymatic detergent after all brushing is completed. The purpose
of soaking the endoscope in enzymatic detergent is to soften and loosen the debris before brushing the endoscope
lumens. (11:25)
11. After brushing, and then soaking in an enzymatic detergent, the SGNA instructions are to flush the lumens to remove
the debris from the lumens. KP instructions are to soak the endoscope in enzymatic detergent for the recommended
time, and then brush the lumens until no debris remains in the lumens. (12:30)
12. Latex patient procedure gloves rather than Nitrile gloves are worn while working in glutaraldehyde. (13:30)
13. Debate remains among viewers whether the fingernail polish on the long fingernails of the actress is truly chipped, or if
the white spots seen in the fingernail polish are reflections from the camera lights. (16:25)
14. For the final alcohol flush after disinfection, the scope is placed on a dirty towel. Instead the scope should be held in the
air for the alcohol rinse rather than laying the disinfected scope on any counters. Alternately, the alcohol rinse can be
performed at the end of the cycle while the endoscope remains inside the Automated Endoscope Reprocessor (AER).
(18:00)
15. Drying the exterior of the scope after disinfection is not performed with a lint-free cloth. (18:43)
Last Revised: 2007
COMPETENCY TOOLS

Last Revised: 2007
KAISER PERMANENTE
Rigid Scopes – Sterrad/Steam/ETO Sterilization
Employee’s name (PRINT): Date:
Department: Facility:
Manager: Results:
Performance Criteria Met Not

Met
Point of Use Pre-Cleaning in OR/Procedure Room Suite/Department:
Follow existing department policy for pre-cleaning instruments.
Point of Use Pre-Cleaning in Out-Patient Treatment Suite/Department: pre-cleaning is a
critical step in ensuring appropriate sterilization. Any body fluids or debris left on the
instrument may prevent sterilization.
1. Wears a minimum of gloves and eye protection such as chemical splash goggles.
2. Follows manufacturer dilution instructions for enzymatic detergent solution. Care should be
taken when diluting the solution to avoid splashing or aerosolization of the product.
3. Immediately following procedure, wipes the exterior of scope with a lint-free cloth or sponge
moistened with enzymatic detergent solution.
4. Flushes all lumens with enzymatic solution until solution is clear.
5. Transports scope and instruments in covered, appropriately labeled container to reprocessing
room.
Manual Cleaning:
1. Wears personal protective equipment including long sleeved impervious gown, gloves, mask,
and eye protection such as chemical splash goggles or face shield.
2. Keeps the scope submerged in the enzymatic detergent solution during cleaning and flushing
to prevent splashing of contaminated fluid.
3. Detaches all removable parts. Soaks removable parts in enzymatic detergent and scrub with
brushes, sponges, or lint-free cloth to remove debris.
4. Cleans inside the stopcocks and all other channel openings, with a brush or lint-free applicator.
5. Brushes the entire lumen/channel system:
 Brushes in the direction of the distal tip.
 Brushes the channels between the suction valves / stopcocks.
 Rinses the bristles of the brush each time exiting the lumen before retracting brush back
through the channel.
 Repeats brushing until no debris is visible on the brush.
6. Rinses all removable parts with tap water.
7. Immerses the scope and soak in the enzymatic detergent solution for the time recommended by
the enzymatic detergent manufacturer.
8. Thoroughly cleans the exterior of the endoscope, leaving submerged in solution to prevent
9. Discards enzymatic detergent solution after each individual scope.
10. Cleaning brushes may be disposable. If reusable, they must be thoroughly cleaned, rinsed with
tap water, discard brushes if unable to clean or when they show signs of wear.
Manual Rinsing and Drying:
1. Wears gloves and eye protection at a minimum.
2. Rinses the endoscope and all removable parts thoroughly with tap water to remove residual
enzymatic detergent solution.
3. Rinses all channels with tap water.

Last Revised: 2007
Met
4. For Sterrad sterilization: Air-dries all channels and wipes dry the exterior of the endoscope and
all accessories. This is required to prevent the Sterrad sterilizer from aborting the sterilization
cycle.
For Steam sterilization: Flushes lumens with water to moisten the lumen so that steam can be
generated from within the lumen to assist in sterilizing the inside of the lumen.
For ETO Sterilization: Thoroughly air dries all channels and wipes dry exterior.
Packaging:
1. Items which can be disassembled should be disassembled for sterilization.
2. All items processed must include a sterilization indicator strip inside the package.
3. All items processed must have an external process indicator such as Sterrad or autoclave
closure tape.
4. Peel packaging must be closed with no creases in the seals.
5. Wrapped items should not have any gaps or openings. Peel packs are not permitted inside any
wrapped tray.
6. For Sterrad sterilization: The load control sticker should be applied after Sterrad sterilization
cycle is complete.
For Steam sterilization: The load control sticker may be applied before sterilization.
7. Ensures that all documentation is complete: (All elements below must be documented).
 Date, time
 Scope i.d.
 Sterilizer Machine number
 Operator initials
 Name of scope
 Load #
Manufacturer’s Manual:
1. Staff can locate manufacturer’s manual for each scope and sterilizer in department.
Biologic Monitoring:
1. Performs Biologic Monitoring each day the sterilizer is used.
2. For Sterrad sterilization: Obtains a STERRAD CycleSure Biological Indicator (BI), peel pack in
a Tyvek/Mylar pouch. Places BI test pack in the back/rear on the bottom shelf toward the back
chamber wall.
For Steam Sterilization: Obtains a BI Process Challenge Device (PCD) and place in the front
of the chamber over the drain.
EO Sterilization Obtains a BI Process Challenge Device (PCD) and place in the center of the
load
3. Processes the BI test pack and instrument sets through the sterilization cycle.
4. Starts sterilization cycle.
7. After the sterilization cycle is complete, immediately removes the BI Test Pack from the
sterilizer.
6. Checks the chemical indicator for color change from red to yellow (STERRAD) or beige to black
. (Steam). Presses cap down until firmly seated in order to seal vial.
7. Using the tube crusher, squeezes the vial until media ampoule has been crushed. Do not crush
by hand.
8. Keeps vial in a vertical position after it has been crushed.
9. Labels vial with date and load number and place in incubator.
10. Incubates the biological test in an approved incubator. Follows manufacturer written
instructions for proper incubation times, i.e., Sterrad 48 hours, Steam Rapid-Readout 3 hours,
EO Rapid-Readout 4 hours.
11. Crushes an unprocessed vial to serve as a test Control, label with date, and place in same
incubator as the processed vial.
12. After forty eight (48) hours (STERRAD) or three (3) hours (Steam Rapid-Readout) or four (4)
hours EO Rapid-Readout interprets results and records in log book. Discards the processed
biological and the control in a biohazardous waste container. Records the temperature of the
STERRAD incubator. Calibrates incubator only if required by manufacturer.
13. Interpret s results per manual.
14. Records results on log sheet and store record for a minimum of seven (7) years.

Last Revised: 2007
Met
Maintenance:
1. Facility Services is responsible for preventive maintenance of sterilizers.
2. Biomed Department and Material Management are responsible for arranging rigid scope repairs
with designated repair vendor.
3. Routine maintenance is to be monitored, documented and saved on all sterilizers according to
manufacturer’s guidelines by Facility Services. Depending on warrantee or Service Agreement,
work may be performed by either Facility Services or outside vendor.
Overall Evaluation of Demonstration
Observer: ___________________________________________
Goal: Meets expectations 100%: (calculations) # of yes responses ’ = % compliance

Total # of questions (- # of N/A questions)
Meets expectations (100% criteria completed)
Does not meet expectations (less than 100% criteria completed)
List criteria not met
Manager Follow-up:______________________________________________________Date:_________
Educational Plan: _____________________________________________________________________
Employee competency signature _________________________________________________________

Last Revised: 2007
KAISER PERMANENTE
Ultrasound Probe - TEE
Manager: Results:
Policy/Performance Criteria Met Not

Met
Point of Use (Patient Treatment Suite/Department) Pre-Cleaning:
2. Disconnects the transducer from the system
4. Immediately following procedure, wipes the exterior of transducer with enzymatic detergent
solution.
5. Places used transducer in covered container for transport to reprocessing room
Cleaning in Decontamination area:
NOTE: Nitrile gloves are preferred over latex gloves when working with glutaraldehyde.
CAUTION: Do not immerse the transducer intracavity cable past the last depth mark. Its
electrical safety features may be compromised and the transducer may be damaged
beyond repair.
1. Wears personal protective equipment including long sleeved impervious gown, gloves,
mask, and chemical splash goggles.
2. Soaks TEE Transducer in Medical Center approved low sudzing enzymatic detergent to
remove all organic following manufacturer recommendations, discard enzymatic solution
after each TEE probe. Uses a lint-free cloth or sponge to wipe the distal tip and flexible
shaft up to the control housing. Soaks and scrubs with soft brushes to remove debris.
Keep the probe submerged in the enzymatic detergent solution during cleaning to prevent
3. Non-disposable brush MUST be cleaned by placing in an ultrasonic cleaner with enzymatic
detergent for the recommended time and then high level disinfected or sterilized after each
use (Single use is an additional option.)
Rinsing:
1. Rinses the distal tip and flexible shaft with tap water & wipe non-critical parts that cannot be
processed by soaking in enzymatic detergent, followed by rinsing to remove residual
enzymatic detergent.
2. Wipes with clean/dry lint free cloth to remove excess of water.
Disinfecting:
1. Wears personal protective equipment including long sleeved impervious gown, gloves,
mask and chemical splash goggles.
0. Completely immerses TEE transducer intracavity cable up to the last depth mark in
Medical Center approved high level disinfectant (e.g. glutaraldehyde/Cidex)
3. Follow s all manufacturer recommendations for mixing or dilution. Labels soaking
bin/machine with initials, name of chemical, primary hazard (e.g. “toxic by inhalation”,
“respiratory system sensitizer”, “causes contact dermatitis”),and the expiration date.
4. Checks the efficacy of the solution in the soaking bin with a test strip prior to use to verify
concentration records on daily log (once/day when used).
5. Immerses transducer for time set by KP policy or manufacturer’s instructions (e.g. 20
minutes glutaraldehyde), sets timer, covers/closes bin. When using a GUS unit,
makes certain that the fan is ‘ON’. Completes documentation logs with Time In/Out of
disinfectant information.
Rinsing/Drying:
1. Wears gloves and safety glasses, goggles or face shield at a minimum.

Last Revised: 2007
Met
2. Thoroughly rinses TEE transducer with sterile or tap water. If using trays to rinse with
sterile water, performs three separate one minute immersions. If using running tap water,
thoroughly rinse all surfaces in the running water for at least one minute.
3. Lightly wipes the steering mechanism with a pad moistened with 70% alcohol. Dries with
lint-free soft cloth or let air dry for 30 minutes.
IMPORTANT: Performs a leakage current test on the TEE transducer at the end of each
transducer high-level disinfection procedure. Retests prior to use if the transducer has
not been used for an extended period of time. Reprocesses if the transducer has been
in storage for more than 30 days.
Preparation for Leak Testing:
1. Using manufacturer suggested compatible leakage current tester (Dale 800B for V5M
models) prepares the following. Connects the probe to the compatible transducer adapter.
Places the probe in a saline bath, with the entire critical area of the TEE transducer fully
immersed.
2. Places the dual conductivity electrodes in the saline bath to a depth of at least 1 inch. Plugs
the TEE transducer adapter and electrode into the tester (connections are
interchangeable).
Leakage Current Testing:
1. Checks the tester battery. Pushes the Leakage/Conductivity switch down to select
Conductivity. Turns tester ON. When the self-test routine ends, the Ready LED will glow to
indicate successful battery test.
2. If the tester automatically powers off, turns it on again and allow to complete routine self-
check then reinitiate the test. Presses the On/Test button to perform a conductivity
measurement. The measurement cycle should last about two seconds and indicate either
a Pass (green) or Fail (red) LED result. NOTE: If test fails, checks all connections and
retest. If it fails again replaces the saline solution and retest. If it still fails, sends out for
service.
3. If the conductivity test passes, pushes the Leakage/Conductivity switch up to select
Leakage. Presses the On/Test button to perform a leakage measurement. If the
transducer passes the leakage test proceeds to dry and either store or use the TEE
transducer. If the transducer fails the red LED will flash for a low reading (i.e. an open
circuit) or glow red if the test fails with a high reading (i.e. faulty insulation). Checks
connections and retest. If failure repeats, does not use the TEE transducer and sends for
repair.
4. Cleans the tester and adapter as needed utilizing a damp cloth and mild detergent.
5. Rinses saline bath container with water and wipe with 70% alcohol.
6. Wipes with clean/dry lint free cloth
7. Assures designated cover container is properly reprocessed before transportation.
8. Ensures that all documentation is complete: (all elements below must be
documented)
 Date, time and type of procedure
 Patient name and medical record number
 Physician name
 Scope I.D.
 Time In / Time Out of disinfectant (glutaraldehyde)
 Operator initials
 Name of scope
 Load number
Storage:
1. All disinfected TEE probes must be handled with clean or sterile gloves to reduce
recontamination of the scope or instrument.
2. Follows manufacturer written instructions for proper storage
3. An enclosed container should be used if transporting HLD scopes between rooms, e.g.,
from reprocessing area to storage cabinets that may be in the procedure rooms.
4. Decontaminates transport container between scopes using a manufacturer approved
product.

Last Revised: 2007
Met
Disinfectant Neutralization:
NOTE: Ortho-phthalaldehyde (OPA) must be neutralized prior to disposal even if it failed the
Minimum Effective Concentration test using Test Strips. Some areas may also require
neutralization of glutaraldehyde prior to drain disposal. Verify local restrictions with your
Safety Officer.
1. Wearing personal protective equipment including long sleeved impervious gown, gloves,
and chemical splash goggles, employee demonstrates neutralization competency by
explaining the manufacturer’s recommended steps.
2. Disposes of expired disinfectant solution AFTER neutralizing as directed by local Safety
Department. Confirms color change for neutralization completion and five minutes before
discarding.
3. Employee demonstrates that neutralization has occurred prior to discharge into the sewer
by placing on the daily test log: "neutralized," date, and initials of the person completing this
task.
1. Manufacturer’s Manual for each probe/scope is available in department.
2. Employee can locate appropriate manuals.
Emergency Spill Procedure:
Rationale: Ensure protection of staff and member from exposure to hazardous agents.
Following the process:
S = Safety, puts on protective face wear, gloves and non permeable gown and uses the
chemical spill kit to neutralize and contain the spill.
I = Isolate, closes the door, prevents others from entering the area.
N = Notify, the hospital operators, who will notify the appropriate person(s) e.g. chemical spill
team which should include Environmental Health & Safety.
Refers to Med Center specific spill procedures
Maintenance:
1. Biomedical Engineering is responsible for arranging repair of ultrasound endocavity probes
with designated repair vendor.
2. Biomed Department and Material Management will arrange ultrasound probe repairs with
designated repair vendor.
Observer: ___________________________________________


Last Revised: 2007
KAISER PERMANENTE
Channeled Scope Reprocessing - Manual
Manager: Results:

Met
3. Immediately following procedure, wipes the exterior of scope with enzymatic detergent solution.
4. Suctions/flushes the enzymatic detergent solution through the scope until the solution is visibly
clear. Alternate suctioning/flushing the solution and suctioning/flushing air, followed by forced
air-drying (syringe or compressed air source).
5. Depresses the air/water adapter button during flushing of channels.
6. Clears the air and water channels according to manufacturer’s instructions.
7. For duodenoscopes/ERCP scopes, flushes elevator wire channel with enzymatic detergent, as
radiographic media and bile can dry quickly.
8. Transports scope in covered, appropriately labeled container to reprocessing room.
Note: Pre-cleaning is a critical step in ensuring appropriate high-level disinfection. Any body fluids
or debris left on the instrument may prevent adequate disinfection.
Dry and Wet Leak testing (if applicable) in reprocessing room: (after each patient use)
and safety glasses, goggles or face shield.
2. Visually inspects the scope for holes, tears, or other gross damage.
3. Assures water/soaking cap is attached.
4. Detaches all removable parts. Soaks (in enzymatic detergent)
5. Turns on leakage tester if powered. Attaches leakage tester and pressurizer.
6. Inspects the bending rubber to insure the scope is pressurized – either visually, or by touch.
7. If no leak is apparent, submerges the tip of the scope in fresh clean water and check for
bubbles. Angulates the bending section looking for leaks, for a minimum of 30-60 seconds.
8. Curls the light guide and insertion tube and submerge the entire scope for a minimum of 30-60
seconds. Looks for leaks. Checks the following areas: A. Control knob: B. Insertion tube: C.
All channels, including the distal tip, the valve ports, and the connectors: D. Observe elevator
channel at both proximal and distal ends.
9. If no leak is detected, adds detergent to water after removing scope from water, releasing air
pressure and disconnecting leak tester.
10. When a leak is detected, follows manufacturer’s recommended procedures for disinfecting the
scope, removes from service and sends for repair. If scope is not properly disinfected, it should
be considered a contaminated medical device by attaching biohazard and supplemental label
“contaminated medical device”.
Manual Cleaning:
and chemical splash goggles.
2. Scrubs and brush all removable parts. Scope should have been previously soaked (in enzymatic
detergent) to loosen debris.
4 Immerses the scope and soak in the enzymatic detergent solution for the time recommended
by the enzymatic detergent manufacturer.
5. Brushes control knobs, distal tip of scope and holes of valves to remove debris.

Last Revised: 2007
Met
6. Cleans inside the suction valve, air water valve, biopsy port openings and all other channel
openings, with a disposable scrub brush or lint-free cloth. Keeps the scope submerged in the
enzymatic detergent solution during cleaning to prevent splashing of contaminated fluid.
8. Brushes the entire biopsy/suction channel system.
a. Brushes in the direction of the distal tip from the biopsy port.
b. Brushes the channels between the suction valves.
c. Brushes the channels in the direction of the light guide connector.
d. Rinses the bristles of the brush each time exiting the scope before retracting brush
back through
e. the channel.
f. Repeats brushing until no debris is visible on the brush.
g. For the ERCP scope, deflects and cleans around the elevator.
9. Attaches cleaning adapters to the scope and cover the biopsy port. Flushes all channels with
enzymatic detergent (following manufacturer’s recommended number and volume, usually a
minimum of 90ml per channel).
10. Thoroughly cleans the exterior of the scope, leaving under solution to prevent splashing of
contaminated fluid.
11. Discards enzymatic detergent solution after each individual use.
12. Cleaning brushes should be disposable. If reusable, they must be thoroughly cleaned, rinsed
with tap water, run through an ultrasonic washer, and then high level disinfected or sterilized
after each use (discard brushes if unable to clean or when they show signs of wear).
Manual Rinsing:
1. Wearing gloves and chemical splash goggles at a minimum, rinses the scope and all removable
parts thoroughly with tap water to remove residual enzymatic detergent solution.
3. Force air-dries all channels and wipes dry the exterior of the scope and all to prevent dilution of
disinfectant.
4. Removes used PPE. Follows Hand Hygiene Protocol.
Disinfecting – Testing solution:
1. Wears personal protective equipment including long sleeved impervious gown, gloves, and
chemical splash goggles.
Note: Nitrile gloves are preferred over latex gloves when working with glutaraldehyde.
2. Tests the high level disinfectant solution once per day prior to use to be sure it is above the
minimum effective concentration of high level disinfectant, i.e., Cidex strips.
NOTE: If disinfectant fails, staff notifies Department Manager. An action plan must be initiated
by department manager, and approved by Infection Control and the Scope Reprocessing
Oversight Manager.
3. Test strip container must be dated with expiration date and initialed when opened.
4. Labels container with solution, expiration date and initials of person who prepared the solution.
5. Documents test results.
Minimum Effective Concentration test using Test Strips. Some areas may also require neutralization
of glutaraldehyde prior to drain disposal. Verify local restrictions with your Safety Officer.
mask, and chemical splash goggles, employee demonstrates neutralization competency
by explaining the manufacturers recommended steps.
2. Disposes of expired disinfectant solution AFTER neutralizing as directed by local Safety Dept.
Confirm color change for neutralization completion and five minutes before discarding.
3. Employee demonstrates that neutralization occurs prior to discharge into the sewer by placing
on the daily test log: "neutralized", date, and initials of the person completing this task.

Last Revised: 2007
Met
Manual Disinfection:
1. Wears clean/new personal protective gear (long long sleeved impervious gown, gloves, mask
and safety glasses, goggles or face shield).
Note: Nitrile gloves are preferred over latex gloves when working with liquid chemical
disinfectants.
2. Immerses the scope in high level disinfectant solution.
3. Uses the cleaning adapters to fill all channels completely until NO bubbles are seen. Flushes
disinfectant through all lumens to make certain that all surfaces and lumens are in direct
contact with the solution.
4. Places all valves and removable parts in disinfectant solution.
5. Covers the disinfectant solution tray securely and soak device for the time specified by KP
policy or manufacturer’s instructions (e.g. for glutaraldehyde a minimum of 20 minutes).
6. Removes scope and removable parts from disinfectant and proceed to manual rinsing.
8. Ensures that the high level disinfectant container is tightly covered at all time.
Manual Rinsing:
1. Wearing at least gloves and safety glasses, goggles or face shield, thoroughly rinses the
exterior surface and internal channels with copious amounts of sterile water or tap water (three
water rinses of exterior of scope plus 30 ml water each lumen for each of three rinses or
amount recommended by manufacture per size of scope). 3-2-1 rinses means three rinses with
two gallons of water for one minute soak time. Contact with enzymatic detergents’ and high
level disinfectants’ liquid and vapor can severely irritate the eyes and mucus membranes, and
at higher concentrations burns the skin. Discards sterile water after each scope.
2. Follows water rinses with alcohol rinse:
a. For tap water rinse, flushes all channels with 5ml 70-90% alcohol after each use
b. For sterile water rinse, flushes all channels with 5ml 70-90% alcohol prior to storage.
3. Visually checks that all channels have flow during alcohol purge.
4. Purges all channels with forced air including insertion tube and inner channels
5. Removes all cleaning adapters and devices.
6. Dries the exterior with a soft, dry lint-free cloth.
7. Removes personal protective gear.
8. Follows KP Hand Hygiene Protocol.
 Physician name
 Scope i.d.
 Scope Type
 Load #
Scopes used for sterile procedures must be reprocessed just prior to use:
 must include pre-cleaning through the disinfection and rinse steps
 must be reprocessed no longer than 2 hours prior to procedure
Storage:
1. All disinfected scopes and instruments must be handled with clean or sterile gloves to reduce
recontamination of the scope or instrument.
2. An enclosed container should be used if transporting high level disinfected scopes between
rooms, e.g., from reprocessing area to storage cabinets that may be in the procedure rooms.
3. Decontaminates transport container between scopes using a manufacturer approved product.
4. Disinfected instruments should be used immediately, or stored in a manner to minimize

recontamination.
5. Hangs flexible scopes vertically in a ventilated closet or cabinet. Does not store in case.
Note: If not stored appropriately, scope must be reprocessed just prior to use starting from pre-
cleaning through the disinfection and rinse steps.

Last Revised: 2007
Met
6. Store removable parts separately (not attached to scope), i.e., air/water & suction bottles, biopsy
caps, water-resistant caps.
Accessories:
1. Soaks re-usable biopsy forceps in enzymatic detergent solution, cleans in ultrasonic cleaner
and sterilizes after each patient use.
2. Sterilizes water bottles daily (when used).
3 Fills water bottle with sterile water only (when used).
4. High level disinfects all non-disposable semi-critical items i.e., suction adapter, biopsy adapter,
door clamp.
5. Sterilizes all non-disposable critical items, i.e., biopsy forceps.
1. Manufacturer’s Manual for each scope and reprocessing machine is available in department.
S = Safety, puts on chemical splash goggles, gloves and non permeable gown and uses the
I = Isolate, closes the door, prevent others from entering the area.
N = Notify, the hospital operators, who will notify the appropriate person(s) e.g. chemical spill team
which should include Environmental Health & Safety.
Refer to Med Center specific spill procedures.
Maintenance:
1. Biomedical Engineering is responsible for arranging repair of flexible scopes with
2. Biomed Department and Material Management arranges rigid scope repairs with designated
repair vendor.
Observer: ___________________________________________


Last Revised: 2007
KAISER PERMANENTE
Channeled Scope Reprocessing - Steris
Manager: Results:

Met
clear. Alternates suctioning/flushing the solution and suctioning/flushing air, followed by forced
Note: pre-cleaning is a critical step in ensuring appropriate high-level disinfection. Any body fluids or
debris left on the instrument may prevent adequate disinfection.
Dry and Wet Leak testing (if applicable) in Reprocessing room: (after each patient use)
1. Wears personal protective equipment including long sleeved impervious gown, gloves, mask, and
safety glasses, goggles or face shield..
7. If no leak is apparent, submerges the tip of the scope in fresh clean water and checks for
seconds. Look for leaks. Checks the following areas: A. Control knob: B. Insertion tube: C. All
channels, including the distal tip, the valve ports, and the connectors: D. Observes elevator
scope, removes from service and send for repair. If scope is not properly disinfected, it should be
considered a contaminated medical device by attaching biohazard and supplemental label
Manual Cleaning:
1. Wears personal protective equipment including long sleeved impervious gown, gloves, mask, and
2. Scrubs and brushes all removable parts. Scope should have been previously soaked (in
enzymatic detergent) to loosen debris. The scope should always be submerged when flushing.
openings, with a disposable scrub brush or lint-free applicator.
Last Revised: 2007
Met
d. Rinses the bristles of the brush each time exiting the scope before retracting brush back
e. Repeats brushing until no debris is visible on the brush.
f. For the ERCP scope, deflect sand cleans around the elevator.
8. Attaches cleaning adapters to the scope and covers the biopsy port. Flushes all channels with
enzymatic detergent (following manufacturer’s recommended number # of times and solution
amount, usually a minimum of 90ml per channel).
contaminated fluid.
11. Cleaning brushes should be disposable. If reusable, they must be thoroughly cleaned,
rinsed
with tap water, run through an ultrasonic washer, and then high level disinfected or sterilized
after each use (discards brushes if unable to clean or when they show signs of wear).
Manual Rinsing:
1. Wearing gloves and safety glasses, goggles or face shield at a minimum, rinses the scope and all
removable parts thoroughly with tap water to remove residual enzymatic detergent solution.
3. Force air-dries all channels and wipes dry the exterior of the scope and all accessories to prevent
dilution of disinfectant.
HLD-Disinfection – Steris System 1:
1. Wears new set of personal protective equipment including gloves and safety glasses, goggles or
face shield.
2. Assures diagnostic test was performed and successful.
3. Places device in container or tray and attaches properly labeled adapters to channels.
4. Places chemical monitoring strip on container using clip. Chemical monitoring strip container
must be dated with expiration date when first opened.
5. Aligns fluid ports and places container in tray.
6. Adds Steris 20 Sterilant Concentrate, ensures container lid is flush with tray, and inserts aspirator
probe.
7. Ensures probe assembly is in working condition, ensures aspirator probe assembly is flush with
tray and ensures tubing is not kinked.
8. Closes lid, checks for resistance (do not force).
9. Presses “Start”. Cycle time typically runs about 32 minutes. Once started the cycle should not be
interrupted.
10. Waits for display to show “CYCLE COMPLETE PRESS CANCEL,” presses cancel once only.
Opens lid, and compares chemical monitoring strip to reference color block on strip container.
11. Removes aspirator probe, removes empty sterilant container and discards (ensuring container is
empty, if container is not empty the load cannot be considered disinfected – follows directions for
disposal of residual STERIS 20 Sterilant Concentrate which is considered a hazardous waste.
Contact your Safety Officer for proper disposal).
12. Places aspirator probe assembly in sterilant compartment between uses.
13. Reviews cycle printout, ensure all parameters are met.
14. Dries the exterior of scope with a soft, dry, clean, lint-free cloth.
15. Flushes each channel with a minimum of 5 ml. 70-90% alcohol prior to storage.
16. To dry all channels, purges all channels with air including insertion tube and inner channels until
no liquid comes out of the channels.

Last Revised: 2007
Met
 Date, time and type of procedure
 Patient name and medical record number
 Physician name
 Scope i.d.
 Reprocessing Machine number (if applicable)
 Scope Type
 Load #
 Must include pre-cleaning through the disinfection and rinse steps
 Must be reprocessed no longer than 2 hours prior to procedure
Storage:
1. All disinfected scopes and instruments must be handled with clean or sterile gloves to
reduce recontamination of the scope or instrument.
recontamination.
3. Hangs flexible scopes vertically in a ventilated closet or cabinet. Do not store in case.
NOTE: If not stored appropriately, scope must be reprocessed just prior to use starting from pre-
4. Stores removable parts separately (not attached to scope), i.e., air/water & suction bottles,
biopsy caps, water-resistant caps.
5. An enclosed container should be used if transporting HLD scopes between rooms, e.g., from
reprocessing area to storage cabinets that may be in the procedure rooms.
6. Decontaminates transport container between scopes using a manufacturer approved product.
Accessories:
1. Soaks re-usable biopsy forceps in enzymatic detergent solution, clean in ultrasonic cleaner and
sterilize after each patient use.
door clamp.
1. Performs Biologic Monitoring preferably daily and a minimum of weekly.
2. Appropriate PPE worn.
3. Properly handles open culture media vials and spore strips.
4. Places clip and spore strip in center of flexible or rigid container.
6. At cycle completion, dons sterile gloves and open one culture media vial, keeping vial cap in hand.
7. Keeps one hand sterile.
8. Removes orange Vascu-Stat clip; insert spore strip into vial.
9. Caps vial and label per P&P
10. Places second unprocessed spore strip into a second culture media vial using Vascu-Stat clip
and label per P&P.
11. Incubates per manufacturer recommendations.
12. Observes for color and turbidity daily.
13. Interprets results per manual.
14. Records results on log sheet and store in department for minimum of seven (7) years.

Last Revised: 2007
Met
I = Isolate, closes the door, prevent other from entering the area.
Refers to Med Center specific spill procedures.
Maintenance:
1. Facility Services is responsible for preventive maintenance of automated processors.
2. Biomedical Engineers are responsible for arranging repair of flexible scopes with designated
repair vendor.
repair vendor.
4. Filter changes and routine maintenance is to be performed and documented and saved on all
automated endoscopic reprocessors according to manufacturer’s guidelines by Facility Services.
Observer:_________________________________________

Educational Plan:

Last Revised: 2007
KAISER PERMANENTE
Channeled Scope Reprocessing – Custom Ultrasonic
Manager: Results:

Met
Note: pre-cleaning is a critical step in ensuring appropriate high-level disinfection. Any body fluids
seconds. Looks for leaks. Checks the following areas: A. Control knob: B. Insertion tube: C.
All channels, including the distal tip, the valve ports, and the connectors: D. Observes elevator
scope, removes from service and send for repair. If scope is not properly disinfected, it should
Automated Cleaning and Rinsing:
1. A Custom Ultrasonic pre-processing sink may be used to assist in flushing channels while
manually pre-cleaning and brushing the scope lumens. Custom Ultrasonic’s 510(k) clearance
states the pre-processing sink is only for flushing channels while manually cleaning and
brushing a scope, not as an alternative to meticulous cleaning.
Manual Cleaning:
1. Wearing personal protective equipment including long sleeved impervious gown, gloves, mask,
and chemical splash goggles, scrubs and brushes all removable parts. The scope should have
been previously soaked (in enzymatic detergent) to loosen debris. The scope should always be
submerged when flushing.
2. Rinses removable parts with tap water.
Last Revised: 2007
Met
3. Immerses the scope and soaks in the enzymatic detergent solution for the time recommended
d. Rinses the bristles of the brush each time exiting the scope before retracting brush back
e. Repeats brushing until no debris is visible on the brush.
f. For the ERCP scope, deflects and cleans around the elevator.
8. Attaches cleaning adapters to the scope and covers the biopsy port. Flushes all channels with
enzymatic detergent. (Follows manufactures recommendation as to the number of times and
amount of solution per scope, usually a minimum of 90ml per channel).
contaminated fluid.
11. Cleaning brushes should be disposable. If reusable, they must be thoroughly cleaned, run
through an ultrasonic washer, and then high level disinfected and rinsed with tap water or
sterilized after each use (discards brushes if unable to clean or if shows signs of wear).
Manual Rinsing:
3. Force air-dries all channels and wipes dry the exterior of the scope and all accessories to
prevent dilution of disinfectant.
minimum effective concentration of high level disinfectant, i.e., Cidex test strips.
Oversight Manager.
3. Chemical monitoring strip container must be dated with expiration date when first opened.
4. Labels container with solution name, active ingredient and primary hazard (e.g. “toxic by
inhalation” or “respiratory system sensitizer,” and “causes contact dermatitis”), expiration date
and initials of person who prepared the solution.
Minimum Effective Concentration test using Test Strips. Some areas may also require neutralization
of glutaraldehyde prior to drain disposal. Verify local restrictions with your Safety Officer. Nitrile
gloves are preferred over latex gloves when working with glutaraldehyde.
mask, and chemical splash goggles, employee demonstrates neutralization
competency by explaining the manufacturer’s recommended steps.

Last Revised: 2007
Met
3. Employee demonstrates that neutralization occurs prior to discharge into the sewer
by placing
on the daily test log: "Neutralized", date, and initials of the person completing this
task.
Automated Endoscope Reprocessor (AER) Disinfection –Custom Ultrasonic:
1. Follow the manufacturer’s instructions to connect the scope to the reprocessor.
2. Ensures that AER’s manufacturer approved detergent and not an enzymatic solution is used in
the cleaning cycle of the automated reprocessing machine.
3. Places the valves and other removable parts in the reprocessor when possible.
4. Attaches channel-cleaning connectors, all channels must be reprocessed (even if not used in a
given procedure.
5. For ERCP scopes, the elevator wire channel must be accessed manually (unless reprocessor
has high pressure capability – two channels under the main bank of connectors).
6. Refers to manufacturer’s instructions for high level disinfectant soaking time.
7. Ensures that the “wash/disinfect” and not the “wash” cycle is selected.
8. Verifies the machine disinfection cycle is set for the recommended time.
9. Verifies two rinses are performed by the reprocessor.
Note: Wears new/clean protective gear.
10. After the water rinse, flushes with minimum of 5ml 70-90% alcohol per lumen.
11. Purges all channels with forced air including insertion tube and inner channels
13. Dries the exterior with a clean soft, dry lint-free cloth.
15. Performs hand hygiene per protocol.
 Physician name
 Scope i.d.
 Reprocessing machine cycle used—i.e. wash/disinfect
 Scope type
 Load #
Storage: All disinfected scopes and instruments must be handled with clean or sterile gloves
to reduce recontamination of the scope or instrument.
recontamination.
biopsy caps, water-resistant caps.
Accessories:
and sterilizes after each patient use.
door clamp.

Last Revised: 2007
Met
Maintenance:
1. Facility Services are responsible for preventive maintenance of automated processors.
repair vendor.
3. Biomed Department or Material Management arranges rigid scope repairs with designated
repair vendor.
automated endoscopic reprocessors according to manufacturer’s guidelines by Facility
Services.
Observer: ___________________________________________


Last Revised: 2007
KAISER PERMANENTE
Non-Channeled Scope Reprocessing – Manual
Manager: Results:

Met
4 Transports scope in covered container to reprocessing room.
Dry and Wet Leak testing (if applicable) in reprocessing room: (after each
patient use)
mask, and safety glasses, goggles or face shield, employee visually inspects the scope for holes,
tears, or other gross damage.
5. If no leak is apparent, submerges the tip of the scope in fresh clean water and check for bubbles.
Angulates the bending section looking for leaks, for a minimum of 30-60 seconds.
6. Curls the light guide and insertion tube and submerge the entire scope for a minimum of 30-
60 seconds. Looks for leaks. If applicable, checks the following areas: A. Control knob: B.
Insertion tube: C. Distal tip, the valve ports, and the connectors .
7. If no leak is detected, adds detergent to water after removing scope from water and
disconnecting leak tester.
Manual Cleaning:
mask, and chemical splash goggles, scrubs and brushes all removable parts. Scope should
have been previously soaked (in enzymatic detergent) to loosen debris. Pays special attention to
all small areas that might be easy to miss. Leaves scope under solution to prevent splashing of
contaminated fluid.
4. Brushes control knobs and distal tip of scope to remove debris.

Last Revised: 2007
Met
5. Thoroughly cleans the exterior of the scope, leaving scope under solution to prevent splashing of
contaminated fluid.
7. Cleaning brushes should be disposable. If reusable, they must be thoroughly cleaned, run through
an ultrasonic washer, and then high level disinfected and rinsed with tap water or sterilized after
each use (discard brushes if unable to clean or when they show signs of wear).
Manual Rinsing:
2. Wipes dry the exterior of the scope and all accessories to prevent dilution of disinfectant.
minimum effective concentration of high level disinfectant, i.e., Cidex strips.
Oversight Manager.
4. Labels container with solution name, active ingredient, primary hazard (e.g. “respiratory system
sensitizer” or “Toxic by inhalation” and “can cause contact dermatitis”), expiration date and
initials of person who prepared the solution.
neutralization of glutaraldehyde prior to drain disposal. Verify local restrictions with your Safety
Officer.
1. Wearing personal protective equipment including long sleeved impervious gown, gloves, and
chemical splash goggles, employee demonstrates neutralization competency by explaining
the manufacturers recommended steps.
3. Employee demonstrates that neutralization occurs prior to discharge into the sewer
by placing
on the daily test log: "Neutralized", date, and initials of the person completing this
task.
Manual Disinfection:
1. Wears clean/new personal protective gear.
Note: Nitrile gloves are preferred over latex gloves when working with glutaraldehyde.
2. Immerses cleaned scope, valves and removable parts completely in disinfectant solution.
3. Immerses scope for time established by KP policy or manufacturer’s instructions (set timer),
cover/close bin. When using a GUS unit makes certain that the fan is ‘ON’. Completes
documentation logs with Time In/Out of disinfectant information.
4. When immersion is complete removes scope and removable parts from disinfectant and proceed
to manual rinsing
5. Ensures that all disinfectant containers are tightly closed after use
Manual Rinsing:
1. Wearing gloves and safety glasses, goggles or face shield at a minimum , thoroughly rinses the
exterior surface three times with copious amounts of sterile/tap water. 3-2-1 rinses means 3
rinses with 2 gallons of water for 1 minute soak time. Contact with enzymatic detergents and
disinfectant liquid and vapor can severely irritate the eyes and mucus membranes, and at higher
concentrations burns the skin. Discards sterile water after each scope.
Last Revised: 2007
Met
4. Follows hand hygiene protocol.
 Physician name
 Scope i.d.
 Operator initials
 Scope Type
 Load #
Storage:
1. All disinfected scopes and instruments must be handled with clean or sterile gloves to reduce
recontamination of the scope or instrument
2. An enclosed container should be used if transporting high level disinfected scopes
between rooms, e.g., from reprocessing area to storage cabinets that may be in the
procedure rooms.
product.
recontamination.
If not stored appropriately, scope must be reprocessed just prior to use starting from pre-cleaning
through the disinfection and rinse/drying steps.
6. Stores removable parts separately.
S = Safety, puts on chemical splash goggles, gloves and non permeable gown and use the chemical
spill kit to neutralize and contain the spill.
Maintenance:
1. Biomedical engineering is responsible for arranging repair of flexible scopes with designated
repair vendor.
2. Biomed department and Material Management arranges rigid scope repairs with designated
repair vendor.
Observer: ________________________________________________________________

Manager Follow-up:________________________________________________________Date:_________

Last Revised: 2007
Last Revised: 2007
KAISER PERMANENTE
Non-Channeled Scope Reprocessing – Steris
Manager: Results:

Met
Dry and Wet Leak testing (if applicable) in Reprocessing room: (after each
patient use)
mask, chemical splash goggles, visually inspects the scope for holes, tears, or other gross
damage.
2. Detaches all removable parts. Soak (in enzymatic detergent)
3. Turns on leakage tester if powered. Attach leakage tester and pressurizer.
5. If no leak is apparent, submerges the tip of the scope in fresh clean water and check for bubbles.
Angulates the bending section looking for leaks, for a minimum of 30-60 seconds.
8. Curls the light guide and insertion tube and submerge the entire scope for a minimum of 30-
60 seconds. Looks for leaks. If applicable, checks the following areas: A. Control knob: B.
Insertion tube: C. Distal tip, the valve ports, and the connectors
Manual Cleaning:
mask, and chemical splash goggles, scrubs and brushes all removable parts. Scope should have
been previously soaked (in enzymatic detergent) to loosen debris. Pays special attention to all
small areas that might be easy to miss. Leaves under solution to prevent splashing of
contaminated fluid.

Last Revised: 2007
Met
contaminated fluid.
7. Cleaning brushes should be disposable. If reusable, they must be thoroughly cleaned, run through
an ultrasonic washer, and then high level disinfected and rinsed with tap water or sterilized after
each use (discards brushes if unable to clean or when they show signs of wear).
Manual Rinsing:
Automated Endoscope Reprocessor (AER) Disinfection – Steris System 1:
1. Wears new set of personal protective equipment including gloves and safety glasses and goggles
or face shield at a minimum.
2. Assures diagnostic test was performed and successful
3. Places device in container or tray and attach properly labeled adapters to channels.
4. Places chemical monitoring strip in container using clip. Chemical monitoring strip container must
be dated with expiration date when first opened.
5. If scope is not placed directly in tray, places container in tray.
6. Adds Steris 20 Sterilant Concentrate, ensures container lid is flush with tray, and inserts aspirator
probe.
7. Ensures probe assembly is in working condition, ensures aspirator probe assembly is flush with
tray and ensure tubing is not kinked.
8. Closes lid, checks for resistance (do not force).
9. Presses “start”. Cycle time typically runs about 32 minutes. Does not interrupt cycle once started.
10. Waits for display to show “CYCLE COMPLETE PRESS CANCEL”, presses cancel once only.
Opens lid, within 30 seconds following completion of cycle compare chemical monitoring strip to
reference color block on strip container. Records results.
11. Removes aspirator probe, removes empty sterilant container and discards (ensuring container is
empty; if container is not empty the load cannot be considered sterile —unused S-20 Sterilant is
a hazardous waste, contact your Safety Officer for proper disposal.)
12. Places aspirator probe assembly in sterilant compartment between uses.
13. Reviews cycle printout, ensure all parameters are met.
14. Dries the exterior of scope with a soft, dry, clean, lint-free cloth.
 Physician name
 Scope i.d.
 Scope type
 Load #
 must be reprocessed no longer than two hours prior to procedure

Last Revised: 2007
Storage:
procedure rooms.
product.
recontamination.
biopsy caps, water resistant caps.
1. Performs Biologic Monitoring preferably daily and a minimum of weekly.
2. Wears sterile gloves.
3. Properly handles open culture media vials and spore strips.
4. Places clip and spore strip in center of flexible or rigid container.
6. At cycle completion, dons sterile gloves and opens one culture media vial, keeping vial cap in
hand.
7. Keeps one hand sterile.
8. Removes orange Vascu-Stat clip; insert spore strip into vial.
9. Caps vial and label per P&P
10. Places second unprocessed spore strip into a second culture media vial using Vascu-Stat clip
and label per P&P.
11. Incubates per manufacturer recommendations.
12. Observes for color and turbidity daily.
13. Interprets results per manual.
14. Records results on log sheet and store in department for minimum of seven (7) years.
Maintenance:
1. Engineers are responsible for preventive maintenance of automated processors.
repair vendor.
repair vendor.
automated endoscopic reprocessors according to manufacturer’s guidelines by engineering.
Observer: ________________________________________________________________

Last Revised: 2007
Goal: Meets expectations 100%: (calculations) # of yes responses = % compliance
Educational Plan:

Last Revised: 2007
KAISER PERMANENTE
Non-Channeled Scope Reprocessing – Custom Ultrasonics
Manager: Results:

Met
Dry and Wet Leak testing (if applicable) in reprocessing room: (after each
patient use)
mask, and chemical splash goggles, visually inspects the scope for holes, tears, or other gross
damage.
5. If no leak is apparent, submerges the tip of the scope in fresh clean water and check for
seconds. Looks for leaks. If applicable, checks the following areas: A. Control knob: B.
Insertion tube: C. Distal tip, the valve ports, and the connectors
scope, removes from service and sends for repair. If scope is not properly disinfected, it should
Manual Cleaning:
mask, and chemical splash goggles, scrub and brush all removable parts. Scope should have
been previously soaked (in enzymatic detergent) to loosen debris.
contaminated fluid.
sterilized after each use (discards brushes if unable to clean or when they show signs of wear).
Manual Rinsing:

Last Revised: 2007
Met
minimum effective concentration of high level disinfectant, i.e., Cidex test strips.
NOTE: If disinfectant fails, staff to notify Department Manager. An action plan must be initiated
Oversight Manager.
4. Labels container with solution name, active ingredient, primary hazard warnings (e.g. “toxic by
inhalation” or “respiratory system sensitizer” and “may cause contact dermatitis”), expiration
date and initials of person who prepared the solution.
neutralization of glutaraldehyde prior to drain disposal. Verify local restrictions with your Safety
Officer.
mask, and chemical splash goggles, employee demonstrates neutralization
competency by explaining the manufacturers recommended steps.
3. Employee demonstrates that neutralization occurs prior to discharge into the sewer by placing in
the test log: "Neutralized", date, and initials of the person completing this task.
Automated Endoscope Reprocessor (AER) Disinfection – Custom Ultrasonic:
1. Follows the manufacturer’s instructions to process scope.
2. Ensures that AER’s manufacturer approved detergent not an enzymatic solution, is used in the
cleaning cycle of the automated reprocessing machine.
3. Places scope and any removable parts in the reprocessor per manufacturer’s recommendations.
4. Refers to manufacturer’s instructions for high level disinfectant.
5. Ensures that the “wash/disinfect” cycle is selected, and not the “wash” cycle.
6. Verifies the machine for the recommended time and correct cycle.
7. Verifies two rinse cycles are performed by the reprocessor.
8. Dries the exterior of the scope with a soft, dry lint-free cloth.
11. Ensures that Scope Reprocessing Log is complete: (All elements below must be
documented).
 Physician name
 Scope i.d.
 Reprocessing Machine number (if applicable)
 Reprocessing machine cycle used, i.e. wash/disinfect
 Scope type
 Load #
Storage:
procedure rooms.
product.

Last Revised: 2007
Met
recontamination.
6. Stores removable parts separately.
Maintenance:
repair vendor.
repair vendor.
automated endoscopic reprocessors according to manufacturer’s guidelines by Facility Services.
Observer: _______________________________________________________________

Educational Plan:

Last Revised: 2007
KAISER PERMANENTE
Single Channeled Scope Sterilization – Sterrad NX
Manager: Results:

Met
3. Immediately following procedure, wipes the exterior of scope with enzymatic detergent
solution.
Note: pre-cleaning is a critical step in ensuring appropriate high-level disinfection. Any body fluids
1. Wears personal protective equipment including long sleeved impervious gown, gloves, mask
4. Detaches all removable parts. Soaks (in enzymatic detergent).
8. Curls the light guide and insertion tube and submerges the entire scope for a minimum of 30-
60 seconds. Looks for leaks. Checks the following areas: A. Control knob: B. Insertion tube:
C: Distal tip, the valve ports, and the connectors
scope, removes from service and send for repair. If scope is not properly disinfected, it should
Automated Cleaning and Rinsing:
1. A Custom Ultrasonic pre-processing sink may be used to assist in flushing channels while
manually pre-cleaning and brushing the scope lumens. Custom Ultrasonic’s 510(k) clearance
states the pre-processing sink is only for flushing channels while manually cleaning and
brushing a scope, not as an alternative to meticulous cleaning.
Manual Cleaning:
1. Wears personal protective equipment including long sleeved impervious gown, gloves, mask
and chemical splash goggles. Scrubs and brush all removable parts. Scope should have
been previously soaked (in enzymatic detergent) to loosen debris. The scope should always
be submerged when flushing.
3. Immerses the scope and soaks in the enzymatic detergent solution for the time recommended
Last Revised: 2007
Met
 Brushes in the direction of the distal tip from the biopsy port.
 Rinses the bristles of the brush each time exiting the scope before retracting brush back
 Repeats brushing until no debris is visible on the brush.
8. Attaches cleaning adapters to the biopsy port. Flushes all channels with enzymatic detergent
(follows manufactures recommendations number of times and solution amount per scope,,
usually a minimum of 90 ml per channel).
contaminated fluid.
sterilized after each use (discard brushes if unable to clean or when they show signs of
wear).
Manual Rinsing:
1. Wearing gloves and chemical splash goggles at a minimum, rinse the scope and all
removable parts thoroughly with tap water to remove residual enzymatic detergent solution.
2. Rinses channel with tap water.
3. Forces air-dry through channel and wipes dry the exterior of the scope and all accessories is
recommended. Scope must be thoroughly dry before STERRAD NX sterilization
Automated Endoscope Reprocessor (AER) Cleaning –Custom Ultrasonic:
1. Follows the manufacturer’s instructions to connect the scope to the reprocessor.
2. Ensures that AER’s manufacturer approved detergent and not an enzymatic solution is used in
the cleaning cycle of the automated reprocessing machine.
3. Places the valves and other removable parts in the reprocessor when possible.
4. Attaches appropriate channel-cleaning connectors.
5. Refers to manufacturer’s instructions for high level disinfectant.
7. Ensures “wash” cycle is selected.
9. Verifies two rinses are performed by the reprocessor.
Note: Wears a new/clean protective gear.
10. After the water rinse, flushes with minimum of 5ml 70-90% alcohol per lumen.
11.Purges all channels with forced air including insertion tube and inner channels
14. Assures scope is thoroughly dry before STERRAD NX sterilization
16. Follows Hand Hygiene Protocol.
17. Ensures that all documentation is complete: (All elements below must be
documented).
 Physician name
 Scope i.d.
 Reprocessing machine cycle used—i.e. wash/disinfect
 Scope Type
 Load #
Packaging:
1. Items which can be disassembled should be disassembled for sterilization.
2. All items processed must include a sterilization indicator strip inside the package.
3. All items processed must have an external process indicator such as Sterrad or autoclave
closure tape.
4. Peel packaging must be closed with no creases in the seals.
Last Revised: 2007
Met
5. Wrapped items should not have any gaps or openings. Peel packs are not permitted inside any
wrapped tray.
6. Loads Control Sticker should be applied after Sterrad sterilization cycle is complete.
1. Performs Biologic Monitoring each day the sterilizer is used.
2. Obtains a STERRAD CycleSure Biological Indicator (BI), peel pack in a Tyvek/Mylar pouch.
Place BI test pack in the back/rear on the bottom shelf toward the back chamber wall.
3. Processes the BI and instrument sets through the sterilization cycle.
ASP recommends processing only lumens that conform to the dimensions that have been
validated for the STERRAD NX Sterilizer. Approved lumen dimensions are:
Standard Cycle
 Stainless steel lumens with inside diameter 1mm or larger, length 150mm or shorter
 Stainless steel lumens with inside diameter of 2mm or larger, length 400mm or
shorter
 Polyethylene or Teflon medical tubing with inside diameter of 1mm or larger, length
350mm or shorter
Advanced Cycle
 Stainless steel lumens with inside diameter of 1mm or larger, length of 500mm or
shorter
 Single-channel flexible scopes with a polyethylene or Teflon  lumen, inside diameter
of 1mm or larger and length of 850mm or shorter.
Please refer to your STERRAD NX User’s Guide or call the ASP Customer Care Center for
additional assistance. Telephone Number 1-888-STERRAD
5. After the sterilization cycle is complete, immediately remove the BI Test Pack from the
sterilizer.
6. Checks the chemical indicator for color change from red to yellow (STERRAD). Presses cap
down until firmly seated in order to seal vial.
7. Using the tube crusher, squeezes the vial until media ampoule has been crushed. Do not
crush by hand.
8. Keeps vial in a vertical position after it has been crushed.
9. Labels vial with date and load number and places in incubator.
10. Incubates ampoule in an approved incubator. (55-60 degrees Centigrade for (48) hours
(STERRAD),
11. Crushes an unprocessed vial to serve as a test Control, label with date, and place in same
incubator as the processed vial.
12. After forty eight (48) hours (STERRAD) interprets results and record in log book. Discards the
ampoules in a Sharps container. At this time the temperature of the STERRAD incubator will
be recorded.
Accessories:
and sterilize after each patient use.
2. Sterilize water bottles daily (when used).
3 Fill water bottle with sterile water only (when used).
4. High level disinfect all non-disposable semi-critical items i.e., suction adapter, biopsy adapter,
door clamp.

Last Revised: 2007
Met
Rationale: Ensures protection of staff and member from exposure to hazardous agents.
S = Safety, puts on chemical splash goggles, gloves and non permeable gown and use the
Maintenance:
2. Biomedical Engineers are responsible for arranging repair of flexible scopes with
3. Biomed Department and Material Management arrange rigid scope repairs with designated
repair vendor.
automated endoscopic reprocessors according to manufacturer’s guidelines by Facility
Services.
Observer: ___________________________________________


Last Revised: 2007
AUTOMATED SCOPE REPROCESSOR (AER)
COMPETENCY TOOLS

Last Revised: 2007
KAISER PERMANENTE
CUSTOM ULTRASONICS Staff Competency Evaluation Tool
Aspect of Care/Skill Custom Ultrasonics Reprocessor Competency for Staff

Employee’s name (PRINT):
Competency Performance Check List MET NOT MET

“MET” means the individual independently performs each responsibility
2. Wears PPE’s (Impervious long sleeve gown, gloves, cap, mask and safety glasses,
goggles or face shield).
3. Removes from power source and (after point of use pre-cleaning – see scope
reprocessing competency tools) & transports to decontamination area.
4. Attaches the waterproof cap on the video scope.
5. Removes all valves (air/water, suction, CO2, biopsy caps, selector mechanism, etc.).
6. After manual cleaning (see scope reprocessing competency tools), places the scope in
the processing chamber & attaches the appropriate instrument adapters as follows: Air
adapter, water adapter to water port, suction adapter to suction port, biopsy adapter to
biopsy port, auxiliary port, & valve cover to processing the scope.
7. Ensures all adapters are laying flat & nothing is sticking out of machine. Checks
adapter filter for debris. Closes lid.
8. Presses F6 for “WASH” (machine performs additional cleaning).
9. Checks the detergent bottle(Tergal only) daily to ensure solution present prior to
running machine.
10. Confirms the flow of solution through the channel(s) & air bubbles have evacuated the
lines.
11. At completion of program follows the screen prompt to F3..
12. Presses F6 for “WASH” .
13. Checks the detergent bottle(s) daily to ensure solution present prior to running
machine.
14. Confirms the flow of solution through the channel(s) & air bubbles have evacuated the
lines.
15. At completion of program follows the screen prompt to F3..
Disinfection/Rinsing:
16. Verifies that glutaraldehyde test completed prior to use of machine by checking
logbook. If not complete, dip w/ test strip & documents results in log .
17. Opens the front door of cabinet & engages the Computer ON/OFF switch.
18. Allows the computer to “Boot Up”. Verifies correct time & date.
19. Holds down the ALT button & presses the letter U.
20. Single chambered system: scrolls through guidelines and presses ENTER..
21. Divided screen: highlights the desired bay # using left & right arrow keys, presses
ENTER after selecting.
22. Uses F1 for PATIENT INFORMATION then presses ALT Key & E keys simultaneously.
23. Types patient’s name, presses TAB key.
24. Types Patients MR#, presses TAB key.
25. Uses arrow key until provider name is highlighted, presses ENTER.
26. Uses arrow key until scope # highlighted, presses ENTE.R
27. Presses TAB & ENTER, repeat above steps for 2nd patient.
28. Upon completion holds down the ALT key & presses O key. Note: this will exit the
Last Revised: 2007
“Patient List and System Data” screens.
29. Presses F8 “Wash & D/S/P (High level disinfectant)
 Verifies the D/S/P Level is above the Low Level mark and presses F1
 Confirms the flow of glutaraldehyde through the channels.
Drying:
30. Alcohol purge & Forced air drying:
Machines with alcohol injection port:
 Inserts syringe adapter into gray alcohol injection port on top of machine & injects.
 Removes syringe adapter & verifies processing chamber lid is closed.
 Turns “On” the air switch (checks for light indicating pump operating). Runs for two
minutes.
 Turns the Air switch “Off”.
 ERCP scope: uses a 3ml syringe full of air & injects. Next attaches a three ml syringe
full of alcohol to the ERCP cleaning adapter & injects into channel. Follows with three
ml of air, total of three times.
31. Alcohol purge & Forced air drying:
Machines without alcohol injection port:
 Fills a 60ml syringe w/ 30ml of 70% alcohol.
 Inserts the syringe adapter into the bulkhead closest to the left & injects alcohol.
 Removes syringe adapter & verifies processing chamber lid is closed.
 Turns “on” the air switch and observes for light, allows to run for two minutes.
 Turns the Air switch “off”.
 ERCP: same procedure as machine with port.
32. Prints results. Checks times If Error is noted: scope must be repeat reprocessed.
33. Removes scope from processing chamber.
34. Wipes compartment of any residual fluid.
35. Verbalizes the frequency for chemical and filter changes:
 Glutaraldehyde – every 14 days
 OPA every 14 days
 5 or 25 micron sediment pre-filter – every 3 months
 0.1 Micron bacteria filter – every 6 months
Note: Cleans canisters w/ soap & water, rinse thoroughly. The canisters, O-rings &
aluminum frame, w/ the new FDA cleared 0.1 micron filter needs to be heat sterilized at
121oC or 252oF for 30 minutes. The plastic covering that the replacement 510K 0.1 filter
comes in must be removed prior to sterilization.
36. Demonstrates or verbalizes how to fill reservoirs:
 aldehyde ( encompasses glut and OPA) - 8 gallons per compartment
 Detergent solution
Validated by: Date:

Last Revised: 2007
KAISER PERMANENTE
OLYMPUS DSD DISINFECTOR Staff Competency Evaluation Tool
Aspect of Care/Skill Olympus DSD Scope Reprocessor Staff Competency

Competency Performance Check List MET NOT

“MET” means the individual independently performs each responsibility MET
Point of Use Pre-cleaning:
1. Follows hand hygiene protocol.
2. Wears PPE’s (Impervious long sleeve gown, gloves, cap, mask and safety glasses,
goggles or face shield).
3. Follow manufacturer dilution instructions. Care should be taken when diluting the
enzymatic to avoid splashing or aerosolization of the product.
4. Prior to removing scope from treatment room suctions water through scope and wipes
exterior with enzymatic detergent soaked lint free cloth.
5. Removes light source and attaches immersion cap.
Cleaning:
Manual process – see scope reprocessing competencies
Disinfecting and Rinsing (in Olympus):
6. Verifies that glutaraldehyde test completed prior to use of machine. If not complete,
dips test strip in glutaraldehyde solution.
7. Places scope and buttons in Olympus DSD according to the manufacturer’s
recommendation. (Either compartment A or B)
8. Verifies glutaraldehyde solution and alcohol levels.
9. Pushes PROGRAM 1button and chooses appropriate compartment (either A or B as
indicated)
10. When cycle complete removes scope from disinfector.
Drying/Storage/PM:
10. Wipes scope with clean cloth.
11. Wipes Olympus compartment of any residual fluid.
12. Flushes lumens with alcohol and blows compressed air through biopsy port covers and
buttons. Places them in containers in storage location.
procedure rooms.
product.
15. Checks the number of cycles for Quality Control Procedures.
16. Verbalizes the frequency for air and glutaraldehyde filters:
 Air – every 3 months
 Glutaraldehyde – every 14 days
 OPA every 14 days
 Sediment – every 45 days
 0.2 Micron water filter – every 6 months
17. Demonstrates or verbalizes how to fill reservoirs:
 Alcohol & Glutaraldehyde (2 gallons per compartment)
 Medical Center approved enzymatic solution (50% concentration)
Validated by: Date:

Last Revised: 2007
KAISER PERMANENTE
STERIS System 1 or P6000 Staff Competency Evaluation Tool
Aspect of Care/Skill Steris 1 Scope Reprocessor Staff Competency


1. Removes tray and uses towel to soak up excess water under top tray, then replaces
with tray for flexible scopes.
2. Runs a diagnostic test before use each morning. Documents initials on test and puts in
Steris log book. (If diagnostic test fails, see manufacturer’s guidelines for
troubleshooting.)
3. Using orange clip, puts one chemical-monitoring strip in the Steris with each cycle load.
 Checks the expiration date on bottle prior to using.
 Puts on clean gloves and grasping spore strip envelope with one hand, tears
envelope crosswise, or otherwise follow manufacturer’s instructions, to expose
strip. Using orange Vascu-Stat clip removes strip from envelope. (Use of
hemostats or other clamps not recommended). Places spore strip in accessory
rack or processing container/tray channel. Performed with first processing of the
day. (Biological indicator MUST be stored between 36 o – 40o F in designated
refrigerator). Checks the expiration date on bottle prior to using.
POINT OF USE PRE-CLEANING:
4. Prior to removing scope from light source, removes blue button (air/water valve) and
replaces it with a green/blue button. Performs Point of Use Pre-cleaning (see scope
reprocessing competencies), then removes green/blue button.
CLEANING - MANUAL:
5. Dons PPE’s (gloves, impervious long sleeve gown, mask and safety glasses, goggles
or face shield).
6. Removes scope from light source and places water cap over electrical connector.
Removes all port caps. Cleaning per scope reprocessing protocol/competency.
7. Places port caps (and distal tip of scope on old scope only) into mesh bag.
8. Places mesh bag in tray.
DISINFECTION/RINSING (AUTOMATED):
9. Wedges scope in Steris tray following visual aide for placement and connections. Uses
appropriate channel connectors per manufacturers guidelines. Verbalizes the
difference in connections when cleaning old vs. new scopes.
10. Adds Steris 20 sterilant cup, positioning lid flush with the tray. Then inserts aspirator
probe into cup making sure tubing is not crimped. (5 o’clock position is recommended)
10. Checks to ensure scope is in the tray correctly.
 Closes lid, checks for resistance to lid closing—does not force lid closed.
11. Presses start—verifies cycle light appears.
 Observes for green cycle light
 Observes for light frothy yellow color change of sterilant
12. When cycle complete opens Steris and removes biological monitor. Places in culture
media without contamination.
13. Chemical Monitoring strip results: Looks for color loss (change from purple to
white) within 30 seconds of opening Steris chamber, record results in log. Note: In the
event the chemical monitoring indicator DOES NOT CHANGE color, follow the Infection
Control policy IV, section IV-9 on recall of sterile supplies. If color change is incomplete
repeat processing with new indicator strip.
15. Holding culture media at an angle in one hand, grasps vial cap with little finger of the
other hand. Removes cap from vial. Continues holding vial at an angle.
Last Revised: 2007
16. Touching only the orange Vascu-Stat clip, transfers spore strip into vial. Screws vial
into cap. If necessary, taps bottom of vial lightly on hard surface to completely
immerses the strip in culture media (Tryptic-soy Broth).
17. Marks “test” box on vial and places vial in incubator. Vial held for 7 days
(verbalizes).
18. Verifies tap water level (6ml in test tube located in 5 th well of incubator)
 Places thermometer with “O” ring into test tube & documents thermometer in water
 Documents incubator with in  2 degrees C. of 56 degrees C.
 If thermometer not  2o C ~ adjusts calibration by adjusting the screw located at the
rear of the unit. (While facing rear of incubator – turn clockwise to  &
counterclockwise to  the temperature).
19.Control Culture:
A. Grasps spore strip envelope with one hand, tears envelope crosswise, or otherwise
follows manufacturer’s instructions, to expose strip.
B. Using orange Vascu-Stat clip, grasps strip and removes from envelope.
C. Transfers spore strip directly into a fresh vial of culture medium.
D. Prepares label for vial. Marks “control” and places in incubator for 24 hours.
(Temperature of incubator should be 56o C)
Note: A control culture should be run at least once when a new package of spore strips is
opened.
20. Reviews cycle printout. Documents cycle number, date, time, chemical strip results
and initials on record. (Verbalizes need to re-run cycle if incomplete cycle exists).
21. Documents on printout and posts in log book:
Patient’s medical record #, scope serial #, procedure performed, provider, & date
22. Removes aspirator probe and places in sterilant compartment between uses. Discards
empty sterilant cup.
DRYING/STORAGE:
23. Removes scope, flushes blue, red and biopsy ports with alcohol.
24. Hangs scope to air dry. Ensures scope ends are protected from damage when
hanging to dry.
procedure rooms.
product.
27. Places Steris printouts in log book at end of day. (verbalizes)
Validated by: Date:

Last Revised: 2007
KAISER PERMANENTE
MV-1 Staff Competency Evaluation Tool
Aspect of Care/Skill MV-1 Scope Reprocessor Staff Competency

PRIOR TO DISINFECTION:
1. Examines the level of the disinfectant in the reservoir to ensure it is at the FILL LINE. An
increase in the level could indicate the disinfectant has been diluted; a decrease in the
level could indicate a loss of disinfectant.
2. If the level is decreased, the disinfectant must be changed, otherwise, inaccurate efficacy
strip testing may occur. The volume of disinfectant must not be “topped off”.
3. Performs test strip efficacy check daily or every 10 uses, whichever comes first,
according to manufacturer’s directions and log appropriately.
4. Lifts top off disinfectant reservoir and dip strip deeply into disinfectant using an
appropriate long handled tool.
5. If strip fails efficacy test, opens a new bottle of strips and repeat. If test is successful,
immediately disposes of previous test strip bottle. If test is unsuccessful, changes the
disinfectant and perform efficacy testing from start of step 2.
6. Ensures the water source is turned on.
 Checks the water flow:
 Attaches channel connector to each port or verify existing connections.
POINT OF USE PRE-CLEANING. LEAK TESTING, CLEANING and RINSING:
7. Each scope must be manually pre-cleaned, leak tested, cleaned, and rinsed according to
Scope Reprocessing Competency tools, prior to placement in the MV-1.
PLACING SCOPE IN THE DISINFECTOR
9. Loads the scope into the MV-1 (Refer to Manufacturer’s Figure 9, if necessary); Places
the control section of the scope with the control knobs facing UP, over the drain cover.
10. Loops the insertion tube clockwise and the universal cord counterclockwise, assuring
connectors and controls do not rest on scope itself.
11. The light guide connector will fit the outside of the dome
12. Places PVC tubing tip over scope tip to prevent damage.
13. Tucks the scope tip gently under another section of the scope to prevent splashing and
loss of solution volume during cycles.
14. Attaches connector(s) to scope adapters.
15. Closes top, ensuring connectors are always kept inside the machine to prevent damage.
DISINFECTION/RINSING: AUTOMATIC CYCLE CONTROL SETTINGS
Full Automatic Cycle must be used at all times:
16. Turns the power switch ON. Disinfector is ready for operation when the red LEDs are lit
on the ‘FULL’, ‘3’, and ‘20’ switches
 The default cycle is a three minute wash (–to be used ONLY as an automated rinse for
the manual scope cleaning procedure. Presses ‘5’ if a longer cycle is desired); 20minute
disinfectant exposure time (presses required cycle time if disinfectant requirements
differ), automatic final rinse cycle, and air purge cycle.
17. Once the desired times have been selected, presses START. The cycles will proceed
automatically
18. CAUTION: Turning the power switch OFF or pressing STOP during any portion of
an automated cycle will cancel all preset programs.
 When power is turned back ON and the START button is pressed, the disinfector will
proceed from the beginning of a Full Automatic Cycle.
 Therefore, before resuming operation, uses the MANUAL controls to remove all
Last Revised: 2007
liquid from the basin and prevent overflow.
 Then presses START.
MANUAL CYCLE CONTROL SETTINGS
MANUAL selections are to be used for aborted processing only in order to reset the
machine for AUTOMATIC CYCLES.
19. Turns the power switch ON.
20. Presses the MANUAL switch to set manual operation. The LED on the manual button will
light.
21. Selects the desired manual function:
 LCG/In: Pumps disinfectant from the reservoir into the basin of the disinfector
 LCG/Out: Pumps disinfectant from the basin of the disinfector into the reservoir
CAUTION: Do not use if there is rinse water in the basin. It will be pumped into
the reservoir where it could overfill and/or dilute disinfectant concentration
 DRAIN: Pumps liquid from the basin of the disinfector down the drain. Do not use
this function when disinfectant is in the basin unless you want to discard it
 AIR: Pumps air through all channel connectors and scope channels
22. presses START to begin the manual function selected.
DRYING:
23. An alcohol flush MUST be completed after each reprocessing.
24. Leaves the scope in the basin at the completion of the cycle(s) with the lid closed.
25. Ensures the “STOP” light is lit indicating completion of all AUTOMATIC cycles.
Scope must be reprocessed if “STOP” light is not lit or there is any other
indication of incomplete or inadequate reprocessing.
26. Connects the Alcohol Flushing Adapter to the fitting on the front of the disinfector.
27. Fills the Alcohol Flushing Adapter with 60ml of isopropyl alcohol by aspirating it into the
syringe through the vertical tubing.
28. Presses MANUAL, then AIR 10, then START.
29. After air flow begins, forcefully injects the alcohol into the disinfector, applying sufficient
pressure to force fluid through smaller diameter scope channels.
 After alcohol is injected, aspirates air into syringe and inject in order to clear alcohol
from channels.
30. Does not interrupt the “AIR 10” cycle (or scope lumens may not thoroughly dry).
31. “LCG LEVEL FAIL” light indicates cycle failure
Fluid running out of a scope at completion of alcohol cycle may indicate a failure of any
reprocessing cycle. Scope must be reprocessed after verification of adequate machine
function. If problem repeats, removes machine from service.
FILLING THE DISINFECTANT RESERVOIR
32. Always wears appropriate PPE: chemical splash goggles, mask and impervious gown
latex or nitrile gloves.
33. Plugs the Transfer Pump into a power outlet.
34. Connects the transfer tube set to the inlet and outlet connectors of the Transfer Pump
 Places the rigid end of one tube into the solution container and connect the opposite
end to the INLET of the Transfer pump.
 Connects the remaining tube to the outlet of the Transfer Pump and connects the
opposite end to the reservoir.
 There must be a total of 4 to 5 gallons of disinfectant in the reservoir.
35. Turns on the Transfer pump.
36. Operates the Transfer Pump until the reservoir is filled to the FILL LINE.
37. With the inlet/outlet transfer tube still connected to the Transfer pump, flushes it with
clean water and air-dry before storage.
EMPTYING THE DISINFECTANT RESERVOIR
38. Always wears appropriate PPE: chemical splash goggles, mask, impervious gown, latex
or nitrile gloves .

Last Revised: 2007
39. Always empties the reservoir manually:
 Presses MANUAL” , then “LCG/IN”, then “START”.
 Places the rigid end of one of the tubes into the solution container and connects the
opposite end to the OUTLET of the Transfer Pump.
40. Connects the remaining tube to the INLET of the transfer pump and connects the
opposite end to the reservoir.
38. Turns ON the Transfer Pump; operates the Transfer Pump until all the disinfectant has
been pumped out of the reservoir.
39. One end of the disinfector may need to be lifted to allow all the disinfectant to be pumped
out.
40. With the inlet/outlet transfer tube still connected to the Transfer pump, flushes it with
clean water and air-dry before storage.
MAINTENANCE GUIDELINES
41. Maintenance should be performed on the unit whenever the Quality assurance
procedures fail to yield the expected results.
 Follows Facility procedures for contacting Biomedical Engineering for evaluation,
service.
42. CHANGING THE WATER FILTERS: Water filters must be changed every 3 to 6 months
depending upon water quality and must be dry when installed.
 Contacts Biomedical Engineering for facility specific procedures.
43. Has the appropriate User’s Manual available.
 Can appropriately reference the “Troubleshooting Guide”, Chapter 6.
44. Has appropriate replacement parts and supplies available.
Validated by: Date:

Last Revised: 2007
STERILIZER (STERRAD NX)
COMPETENCY TOOL

Last Revised: 2007
KAISER PERMANENTE

STERRAD NX Sterilizer Staff Competency Evaluation Tool
Name of Employee ____________________ Date Training Started:_____________________
COMPETENCY DEMONSTRATION RETURN VERIFYING

DEMONSTRATION INITIALS
Locates and describes the use of the
Operator’s User’s Guide
Locates power on/off and state electrical
requirements
Locates serial number
Describes Screen messages
MAIN SCREEN
LOAD DATA SCREEN
CYCLE NOTES
START CYCLE
SYSTEM FUNCTIONS
DATE/TIME
CYCLE HISTORY
EXIT
CANCEL
Close Door
Open Door
Paper Advance
Inserts new cassette
States materials guidelines and lumen claims
States the reasons for the two most common,
preventable cancellations
Prepares a flexible scope for processing in
the STERRAD NX Sterilizer
States rationale for use of the EtO venting
cap in flexible scope reprocessing
States STERRAD NX Sterilizer loading
guidelines
Placement of the STERRAD CycleSure
Biological Indicator (BI)
Demonstrates incubation process
States CycleSure BI Chemical Indicator color
guidelines
STERRAD Chemical Indicator Strip / Tape/
Pouches
STERRAD NX Cassette
Defines the STERRAD NX cycles
 Standard
 Advanced 

Last Revised: 2007
Page 2 of 2 STERRAD NX Sterilizer Staff Competency Tool
Name:________________________________ Date: _________________
Instructor’s
Check-Off Demonstration Activities YES NO Initials
Cassette Insertion _____ _____ _____

Cassette Expiration Date _____ _____ _____
Panel Indicators _____ _____ _____
Cassette Storage Area _____ _____ _____
Locate Sterilizer Serial Number _____ _____ _____
Locate Screen/Printer Messages _____ _____ _____
Locate Operator’s Manual _____ _____ _____
Locate Phone Number for Technical/Clinical Help _____ _____ _____
Change Printer Paper _____ _____ _____
Examples of Absorbent Materials to Avoid _____ _____ _____
Substitutes For Above _____ _____ _____
10 Minute Plasma Phase, if Cancellation _____ _____ _____
Why Critical to NOT Put Mylar/Tyvek Into Steam _____ _____ _____
Two Most Common Reasons For Cancellations _____ _____ _____
Documentation of Load _____ _____ _____
Validated by:
Date:

Last Revised: 2007
KAISER PERMANENTE
POST TEST
Aspect of Care/Skill: Scope Reprocessing Dept/Facility:
Multiple choice: Circle letter of each answer
1. What universal/standard precautions should be followed by those reprocessing scopes?
a) wear gloves; b) wear long sleeved impermeable gown or apron; c) wear mask, goggles, or face shield;
d) all of the above.
2. What is the first thing you need to do with the scope following the procedure?
a) wipe the scope exterior down with an enzymatic detergent solution; b) submerge entire scope in enzymatic
detergent solution; c) brush channel
3. Following wiping down the scope with enzymatic detergent solution and suctioning enzymatic solution through
channels, what is the next process?
a)clear air/water channels according to the manufacturer; b) submersing scope in high level disinfectant;
c) drying scope with alcohol and air.
4. The most important step after clearing the air/water channels of the scope, in preventive maintenance of the
flexible scope is:
a) drying the scope; b) brushing the scope; c) leak testing the scope
5. What parts of the scope should be submerged for leak testing?
a) distal tip only; b) distal tip, followed by the insertion tube; c) the entire scope
6. Point of Use Pre-cleaning & manual cleaning of the scope must be done before submersing the scope in high
level disinfectant.
a) yes; b) no
7. After cleaning the scope with brushes and other cleaning devices, what procedure should be used for cleaning
channels?
a) flush with tap water and purge with air; b) flush with enzymatic detergent solution followed by tap water &
purge with air; c) manual: fill channels with enzymatic detergent solution & allow to soak; flush with tap water
and purge with air; automated: detergent solution and not enzymatic solution is used
8. What step comes after Point of Use Pre-cleaning the scope:
a) leak testing b) high level disinfecting the scope; c) fill with enzymatic detergent solution, rinse with tap water,
& purge with air.
9. According to the SGNA guidelines, if proper Point of Use Pre-cleaning has taken place, what is the proper
amount of time the scope must be submerged in high level disinfectant?
a) Glutaraldehyde for 30 minutes; OPA for 12 minutes (5 minutes if automated) b) Glutaraldehyde for 20
minutes; OPA for 12 minutes.
10. Following high level disinfection, what is the next step?
a) putting scope in storage cabinet; b) rinsing the scope with sterile water; or tap water followed by rinsing with
70% alcohol (manual disinfection: three water rinses – exterior of scope plus 100 ml each lumen/each rinse;
automated disinfection: two rinses of interior and exterior with minimum default cycle time);
c) drying the scope
11. Following the final rinse phase after every tap water rinse and prior to storage after sterile water rinsing, a 70%
alcohol flush is required. The main purpose for the alcohol flush is ?
a) to ensure rinsing is thorough; b) kill any remaining microorganisms; c) facilitate drying
12. What is the proper method for reprocessing reusable biopsy forceps?
a) clean with enzymatic detergent solution, use brush on tips to clean, rinse, ultrasonically clean, then steam
sterilize; b) clean with enzymatic detergent solution, use brush on tips to clean, rinse, ultrasonically clean, then
high level disinfect; c) clean with enzymatic detergent solution, use brush on tips to clean, rinse, ultrasonically
clean, then ETO (sterilize).
13. Should biopsy forceps be reprocessed with flexible scopes in the same container?
a) yes; b) no
14. With what frequency should high level disinfectant solution be tested for effective concentration?
a) daily b) prior to each use
15. What is one of the most important considerations when using the Automated Reprocessor?
a) attach channel-cleaning connectors; b) ensure that two rinses are performed by the processor (for all
scopes) and ensure flow through all ports during alcohol rinse step (for channeled scopes); c) set the machine
for the recommended time
Last Revised: 2007
KAISER PERMANENTE
POST TEST – ANSWER SHEET
Aspect of Care/Skill Scope Reprocessing
Multiple Choice:
1. What universal/standard precautions should be followed by those reprocessing scopes?
d. All of the above
2. What is the first thing you need to do with the scope following the procedure?
a. Wipe the exterior scope down with an enzymatic detergent solution.
3. Following wiping down the scope with enzymatic detergent solution and suctioning enzymatic detergent solution
through channels, what is the next process?
a. Clear air/water channels according to the manufacturer
4. The most important step after cleaning the air/water channels of the scope, in preventive maintenance of the
flexible scope is:
c. Leak testing the scope
5. What parts of the scope should be submerged for leak testing?
c. The entire scope
6. Point of Use Pre-cleaning & manual cleaning of the scope must be done before submersing the scope in high
level disinfectant.
a. Yes
7. After cleaning the scope with brushes, sponges, and other cleaning devices, what procedure should be used for
cleaning channels?
c. manual: fill channels with enzymatic detergent solution & allow to soak; flush with tap water and
purge with air; automated: use detergent solution not enzymatic solution.
8. What step comes after Point of Use Pre-cleaning the scope?
a. Leak testing the scope
9. According to the SGNA guidelines, if proper Point of Use Pre-cleaning has taken place, what is the proper
amount of time the scope must be submerged in high level disinfectant?
b. Glutaraldehyde for 20 minutes; OPA for 12 minutes (5 minutes if automated).
10. Following high level disinfection, what is the next step?
b. Rinsing the scope with sterile water, or tap water followed by 70% alcohol rinse. Rinsing should be
done three times after manual disinfection – exterior plus 100 ml water per lumen/per rinse; and two
times after automated disinfection – interior and exterior with four minute cycles. All rinsing should
be followed by forced air-drying. Sterile water must be discarded after use.
11. Prior to storage, and after tap water rinsing, a 70% alcohol flush is required. The main purpose for the alcohol
flush is:
c. Facilitate drying
12. What is the proper method for reprocessing reusable biopsy forceps?
a. Clean with enzymatic detergent solution, use brush on tips to clean, rinse, ultrasonically clean, then
steam sterilize.
13. Should biopsy forceps be reprocessed with flexible scopes in the same container?
b. No
14. With what frequency should high level disinfectant solution be tested for effective concentration?
a. and b. Daily testing is sufficient if documented testing over time shows that the solution maintains an
effective concentration for the full period suggested by the manufacturer (e.g. 14 days for Cidex). If
loss of effective concentration is documented over time to occur sooner than the full period of time
suggested by the manufacturer, testing is recommended prior to each use, instead of daily.
15. What is the most important consideration when using an automated reprocessor?
b. Ensure that two rinses are performed by the processor (for all scopes) and ensure flow through all
ports during alcohol rinse step (for channeled scopes).

Last Revised: 2007
KAISER PERMANENTE
DOCUMENTATION FORM
EMPLOYEE NAME: DATE: DEPT:
OBSERVER/TRAINER NAME:
In order to ensure competency in scope reprocessing, each staff person should accomplish the steps below. This
should be done at the time of hire and annually thereafter to demonstrate competency according to the 1999 FDA
Recommendations. Please indicate completion of scope reprocessing competency package by placing a check
next to each item below, once completed by employee:
 Review Scope Reprocessing Policy and Procedure and Quick Reference Grid
 Review the APIC Guidelines for Infection Prevention and Control in Flexible Endoscopy; American Journal of
Infection Control, 1999; 28:138-155 or comparable information.
 Review the SGNA Chart: Steps Necessary to Thoroughly Clean and High Level Disinfect Flexible Endoscopes;
Society of Gastroenterology Nurses and Associates, Inc – 1997: 1-800-245-SGNA or comparable information.
 Watch the SGNA video: “Endoscope Cleaning and High Level Reprocessing of Flexible Endoscopes” or
alternative video
 Provide Return Demonstration/Proof of Competency by: Completing Competency Tool with observer/trainer and
successfully performing all reprocessing tasks in compliance with Medical Center Policies and Procedures,
including:
 PPE: Personal Protective equipment
 Point of Use Pre-cleaning
 Leak Test
 Cleaning
 Disinfection
 Rinsing/Drying
 Accessories
 Storage
 Appropriate Preventative Maintenance and Record Keeping
 Complete Proof of Competency by:
 Completing post test and reviewing answers with observer/trainer

Last Revised: 2007
PREVENTATIVE MAINTENANCE CHECKLISTS

Last Revised: 2007
KAISER PERMANENTE
Reprocessing Personnel Preventative Maintenance Guidelines
Custom Ultrasonics 83 Plus
FREQUENCY: EVERY DAY
Flow Confirmation and Inline Filter Change:
 Observe flow through the bulkhead adapter tubing at beginning of each day by running a wash only cycle. Confirm the
flow of solution through the channel(s). If no flow is noted then O-ring(s) must be inspected (by facility engineering, 3rd
party contractors or Biomedical Engineering).
 In line disposable filters should be placed on the connectors for all water and air channels. Replace a minimum of every 6
weeks. Order info: TIMS# 10323; Part# 16030.
FREQUENCY: Every time the disinfectant solution in the AER is changed.

Overnight Decontamination of the Internal Plumbing:
Before completion of the good housekeeping methods, implement decontamination of the internal plumbing of your System 83
Plus™, after first checking with your local EH&S Officer to determine what regulations are in place regarding discharging
untreated glutaraldehyde. This procedure should be used when the chemical is about to expire do to the fact that the chemical
will all be discarded out of the machine. After determining that the level of active ingredient in the germicide chemical is
adequate, the internal plumbing and the associated mechanical components of the System may be filled with the germicide.
Note: D/S/P has to be above minimum effective concentration.
1. Connect at least three (3) scope adapters to the BULKHEADS from the right to the left if the manifold is inside the
chamber. If the machine is equipped with high-pressure ports, make certain one of the adapters is connected to the high
pressure, port and is lying on the bottom of the chamber.
2. Press F4 to enter “SPECIAL PROGRAMS”.
3. Press F6 Purge to start the emptying process of the chemical.
4. Allow the chemical agent to exit the chemical reservoir until 1 to 2 inches remain in the reservoir then Press F1 Stop
Maintenance.
5. Shut the device off and allow the chemical to remain in the lines for the required time period. Follow the label directions of
the chemical agent to achieve the level of decontamination/sterilization desired.
6. Upon completion of the proper soak time, turn ON the device and enter into the special screen. Follow the instructions on
Page 40, F6 Purge the system.
Maintenance of the Adapters:

 The following applies to machines with white plug in adapters. To maintain the adapters in good working order, place
a drop of silicone or silicone like lubricant once every two weeks on the “O” ring on the outside of one adapter. Insert
the adapter and twist it around several times in all the bulkheads.
 When replacing any adapter or bulkhead parts make certain the replacement parts have viton o-rings. Custom
Ultrasonics supplies all adapters and machine parts with viton o-rings. Check the nature of the “O” ring: it should be
soft and pliable. Lubricate with a small amount of silicon the “O” ring on the water bottle hook up, leak tester adapter,
and alcohol injection port-if applicable. Video scope EtO cap “O” rings should also be lubricated with a small
amount of silicon.
Maintenance of the Valve Covers:

 To assure proper flow of solution through the channels during the STANDARDIZED PROCESS, check adequacy of
the valve covers sponges-if applicable. If excess wear is noted or if there is leakage around the value cover during
operation, the sponge(s) must be replaced. Sponge material is available through Custom Ultrasonics (Part #18009).
 All new valve covers (since approximately June, 2000) do not have the sponge material affixed to the lids. The
sponges are not replaced. With this type, periodically inspect the silicone rubber material for wear and tear
and report any unusual findings to Custom Ultrasonics.
 For ordering information, call Customer Service at Custom Ultrasonics, 215-364-1477.

Last Revised: 2007
Page 2 of 2 – Medical Assistant Preventative Maintenance Guidelines for Custom Ultrasonic Reprocessing Machine
Cleaning the Metal Filter Screen:

In the float compartment located on the side of the processing chamber, a small mesh screen is located behind a square stainless
frame protector or within a round frame protector. This screen acts as a filter to prevent large debris from circulating through
the channels of the device(s) being processed, and must be cleaned on a routine basis.
1. Remove stainless frame float protector. If the screen is located within a round frame protector the entire housing can be un-
screwed in order to perform the cleaning steps below.
2. With a dull pointed object, push the screen out to remove it from its housing.
3. While holding under a detergent solution, brush the screen to remove entrapped sediment. Rinse the screen under running
warm water.
4. Replace the screen into its housing being certain that it is completely seated within its housing, well below the top edge.
5. DO NOT place scope(s) in the processing chamber until you have secured the screen completely within the confines of its
housing. The improper placement of the screen within its housing may lead to equipment damage.
6. Re-install stainless frame float protector, make certain it is not leaning against the floats.

Last Revised: 2007
KAISER PERMANENTE
Engineer Preventative Maintenance Checklist
Custom Ultrasonics 83 Plus
Developed by Custom Ultrasonics: Sept 2004 ; last revised March 2007
TOTAL TIME FOR PM: 3-4 hours
FILTER CHANGES AS FOLLOWS:

Every 90 days (or when filter gauge reads 20 pounds difference between gauges when filling);
0.1 micron filter change every 6 months or when the gauges read 20 pound difference when
filling.
PERFORM COMPLETE PREVENTATIVE MAINTENANCE EVERY 6-12 WEEKS

04/11/2005, VER1.4, KP ROUTINE MAINTENANCE CHECK LIST PER BAY
FOR TECH SUPPORT DO NOT HESITATE TO CALL (215) 364-1477 FOR ASSISTANCE
NOTE* BEFORE TURNING THE MACHINE OFF, VERIFYTHE FLOW OF ALL ADAPTERS.
A: ADAPTER FLOW OUTPUT CHECKED {NOTE ANY OCCLUSIONS}

Low pressure ___1 ___2 ___3 ___4 ___5 ___6 ___7 ___8 ___9 ___10
High pressure ____1____2
DATE: _________ Routine maintenance check list for (CU) machines
B: Inspect and clean
1. ____ Drain solenoid
2. ____ Residual drain solenoid
3. ____ H/L/D feed solenoid
4. ____ H/L/D Return solenoid
5. ____ Water (H2O) solenoid
6. ____ Rinse solenoid (if equipped)
7. ____ Air solenoid(s)
8. ____ Detergent Solenoid (if equipped)
9. ____ Purge screen
10. ____ DATE:________H/L/D feed pump (6 months)
11. ____ DATE: _______ Drain pump (6 months)
12. ____ DATE: _______ Flow probe (6 months)
13. ____ DATE: _______ Air pump hepa filters (3 months)
14.____ DATE: _______ Air pump particulate filter (1 year)
C: Tubing and plumbing inspection
1. ____ Are all clamps secure?
2. ____ Are all compression fittings secure?
3. ____ Are all unions on PVC plumbing tight?
D: Cables integrity
Computer Interface MUX BOX
____ Power cord ____ Twist lock ____ Thermocouple(s)
____ Video ____ 110VAC 24 pin ____ 37 Pin A/D
____ Printer ____ 5vdc 24 PIN
____ Keyboard ____ 37 Pin I.O.
____ I.O. and A/D Cards
____ Power strip
UNIT: ___________ BAY: _____________

Last Revised: 2007
ENGINEER CU PM CHECKLIST - Page 2 of 7
E: Inspect all pumps for leaks

1. ____ H/L/D feed pump
2. ____ Drain pump
3. ____ Purge pump (oscillating or aquatech)
4. ____ Residual drain pump
5. ____ Flow jet (hp) (if equipped) if purge pump is oscillating type
6. ____ Detergent pump
7. ____ Air pump (check air flow thru all adapters)
8. DATE: _______ Vacuum pump (replace back pack and floor filters)
F: Sensors
1. ____ Do the vent sensors turn off the vacuum pump?
2. ____ Clean vent sensors (do not use alcohol or abrasives)
3. ____ Inspect and clean all floats (do not use alcohol)
4. ____ Make sure red wire and grounds for flow probe are tight
5. ____ Inspect pressure switch(s) for leaks and connections
G: Ultrasonics
1. ____ Check wires on crystals
2. ____ Check ground between generator box and processing chamber
3. ____ Clean louvers on generator box
H: External hoses and tubing

1. ____ Disinfect detergent line with 1/50 ratio bleach and water (H2O)
and allow to soak (30 minutes min. to 60 minutes max)
whenever the .1 micron filter is replaced.
2. ____ Check water (H2O) inlet hose for rust and wear
3. ____ Check drain hose for rust or wear
4. ____ Inspect rinse gun for leaks once the water is turned back on
5. ____ Check all scope adapter “O” rings for wear
** NOTE ** INSTRUCTIONS FOR DISINFECTING THE
Disinfecting Detergent Line
When replacing the (.1 micron) filter, you must disinfect the detergent line(s) with a bleach solution
consisting of a 1/50 ratio bleach and water (H2O). Allow the line to soak (30 minutes min. to 60
minutes max.) Prior to performing the steps below, unscrew the detergent bottle from the pump
assembly. In a one gallon container filled half way with bleach solution, connect it to the pump
assembly. The following steps will be performed on the computer in the service program:
____ 1: The entire system is turned “On” by opening front door of unit and engaging On/Off switch on
CPU located in
lower right hand corner of the machine. Allow the computer to perform the “Boot Up” procedure. When
the
computer is ready, a gray MASTER MENU screen will appear.
____ 2: Red highlighted letters on menu are the activation keys. Hold down the ALT key and press the C
key. Press the down
arrow key and highlight SERVICE, press Enter. A blue selection bar will appear on the bottom.
____ 3: Use arrow key and highlight DIGITAL I/O. Press Enter. A component screen will appear (see
below) the highlighted cursor will be located on 1-1. This cursor is controlled by the arrow keys.

Last Revised: 2007
Bay Outputs Bay Inputs

12341234
ultrasonics 1 O O O O O O O O 1 flow
drain pump 2 O O O O O O O O 2 float
drain sol. 3 O O O O O O O O 3 safety
water in sol. 4 O O O O O O O O 4 lubrication
oscillating pump 5 O O O O O O O O 5 water channel
disinfectant pump & sol. 6 O O O O O O O O 6 reservoir pump
disinfectant feed sol 7 O O O O
disinfectant return sol. 8 O O O O
residual drain pump & sol. 9 O O O O
air pump & sol. 10 O O O O
lub pump and sol; (83 det) 11 O O O O
____ 4: To activate the detergent pump, highlight the circle next to number 11 detergent 83 and
press the SPACE BAR. Allow the bleach solution to be pumped into the round processing
chamber. Once the bleach solution is coming through the detergent line, de-activate the
component by pressing the SPACE BAR. NOTE: Bleaching the lines should be done when
changing the 0.1 micron filter and not with every bottle change.
____ 5: Allow the bleach solution to sit in the detergent lines for at least 30 minutes and no more
than 60 minutes to achieve disinfection.
____ 6: On completion of the soak time remove the bottle filled with bleach solution from the
pump assembly and place a new bottle of detergent on to the pump assembly.
____ 7: To activate the detergent pump, highlight the circle next to number 11 Detergent 83 and
press the SPACE BAR. Allow the bleach solution to be pumped out of the detergent lines into
the round processing chamber. Once the detergent is coming through the detergent line, de-
activate the component by pressing the SPACE BAR.
____ 8: To remove any liquid out of the processing chamber before processing a scope, move
the cursor up to number 9 residual drain pump & sol. and allow it to run until the liquid is no
longer present. Next, press the space bar a second time to deactivate the residual drain pump.
____ 9: To exit service program, reset computer.
I: replace water (H2O) filters as needed

*NOTE* Whenever the .1 micron bacterial filter(s) are replaced, you must
follow both CUSTOM ULTRASONICS AND HOSPITAL PROTOCOL for sterilizing /
disinfecting [ e.g., steam autoclave @ 121 degrees C, for 30 min.] the filter
housings, and sterilizing / disinfecting the (SYSTEM 83) internal copper
lines. This includes the water (H2O) inlets and the rinse gun (if equipped).
(Please follow the instructions)

INSTALLATION & REPLACEMENT PROCEDURE FOR WATER INLET FILTER ASSEMBLY
Note: During this procedure, the term “processing chamber” refers to all available
processing chambers. A System 83 Plus™ -2 has one chamber while an 83 Plus™ -9 has two,
etc. Also, “water supply” refers to all available water supplies, both hot and cold, which are
hooked up to this machine, and fed through a 5 micron pre-filter and a 0.1 micron bacterial
filter system.

Last Revised: 2007
Important: Position one scope adapter in each of the manifold’s eight (8) female
bulkheads and direct them into the processing chamber (failure to attach at least three
adapters WILL result in purge pump failure). Connect 3 adapters when running the cycle
because this simulates two scopes – connect eight adapters when bleaching the system.
This procedure must be performed:
a) At initial set-up, and/or
b) When a pressure differential of 20 to 25 psi exists between the inlet and outlet sides
of the 0.1 micron filter. (Measured during processing chamber fill cycle.) Verify that
static water pressure is maintained between 35 and 50 psi.
c) For added assurance, you should replace the 5 micron sediment filter at three month
intervals and replace the 0.1 micron filters and perform this procedure at six month
intervals during routine preventative maintenance of the System.
_____1: Turn water supply valves “OFF’.
_____2: Relieve water pressure in filter housing and system by engaging the rinse switch and
activating the spray hose into the processing chamber.
_____3: 0.1 filter housing bowl/covers (5 micron pre-filter and 0.1 micron bacterial filter), remove
and dispose of cartridges. Empty contents. (Filters are not re-useable)
_____4: Fill 5 micron pre-filter housing bowl 1/2 full of water, add one (1) cup of household
bleach, and reattach to assembly.
_____5: Reattach 0.1 micron housing bowl to assembly. Leave this bowl EMPTY.
_____6: Turn water supply valves and MAIN POWER switch “ON, and initiate WASH cycle
simultaneously on each processing chamber by pressing <F6> (wash) on the computer
keyboard.
____7: While processing chamber is filling, engage RINSE switch and activate SPRAY HOSE,
directing the flow into the processing chamber.
____8: When ultrasonics engage use a tongue depressor to raise the SAFETY FLOAT high
liquid level indicator, located in processing chamber behind the removable shield, to shut down
the system.
____9: Press <Fl> (clear) to clear the error and reset the system.
___10: Engage RINSE switch and activate SPRAY HOSE. Fill processing chamber until
the safety float is activated.
____11: Allow system to soak (30 minutes min. -60 minutes max.).
____12: Initiate EMPTY PROGRAM. by pressing <F4> (Special Screen) then <F5> (empty) on
the computer keyboard.
____13: When processing chamber is completely empty, press <Fl> (Stop Maintenance) then
<F3> (Standard Screen)
____14: Turn water supply valves “OFF. Relieve pressure (as in step 2). Open filter housing
bowls and empty
____15: Install NEW filter cartridges according to the following steps:
If desired, the 0.1 micron filter may be autoclaved prior to initial use.
_____ a) Carefully remove approximately 3 inches of plastic from the 0-ring end of the
cartridge. DO NOT cut filter (damage to cartridge could result in filter system
failure). DO NOT remove plastic from entire cartridge (plastic will serve as
protective barrier during installation).
_____ b) Forcefully push new cartridge up into the head of the housing. Use a twisting
motion until the filter cartridge is firmly in place. This ensures proper seating of the
filter O-ring
Last Revised: 2007
_____ c) Remove remaining plastic from filter cartridge, and replace housing bowl/covers.
Note: Before replacing 5 micron pre-filter bowl, fill it to half fill with water and 1
1/2 ounces of household bleach. Before replacing 0.1 micron filter bowl, fill to half full with
water. DO NOT ADD BLEACH to the 0.1 micron bacterial filter bowl at this time (doing so could
result in irreparable damage to the filter).
____16: Initiate WASH cycle by pressing <F6> (wash) on the computer keyboard Then slowly
turn water supply valves “ON”
____17: When the domed stainless steel mesh basket in the processing chamber is
covered with water, use a tongue depressor to raise the SAFETY FLOAT (high
liquid level indicator, located in processing chamber behind removable shield) to
shut down the system. Press <Fl> (clear) to clear the error and reset the system.
____18: Allow System to soak 30 minutes (60 max.).
____19: Initiate WASH cycle. (<F6> (wash)).
____20: Repeat the WASH cycle (<F6> (wash)) 3 times to remove residual bleach from the
System.
____21: To clear any residual bleach from the spray rinse assembly, activate and direct spray
rinse into processing chamber during the complete drain phase of the second wash cycle.
NOTE: Part 2 may also be performed without removing the 0.1 micron filter. Begin with step #14
but disregard any reference or action to the 0.1 micron filter or its housing
1. DATE: _______ 25 micron sediment filter(s) (If equipped)
2. DATE: _______ 5 micron sediment filter(s)
3. DATE: _______ 0.1 Micron bacterial filter(s)
If the water (H2O) filters do not need to be replaced at this time, please note above when
they were replaced.
J: FUNCTION TEST
1. ____ Ultrasonics (minimum of 2 “(inches) of water (H2O) in the round chamber)
2. ____ Function test all of the solenoids, pumps, and sensors
3. ____ Reservoir heating pad (heat float must be listed)
4. ____ Processing chamber heating pad
5. ____ Check for leaks on all components that were worked on
K: Test run a full cycle{(F8) wash and D/S/P

1. ____ Plug an adapter into every port and check each one for flow
2. ____ Check during cycle for leaks
3. ____ During the cycle, try to achieve a water (H2O) temperature of 110-120 degrees F _____
temperature)
4. ____During the cycle, try to achieve a fill time of 40 –50 seconds
5. ____ After the cycle completes, press F2 to print. Check the date and time.

Last Revised: 2007
ALSO CHECK THE DISINFECT OR CHEMICAL IMMERSION TIME.

(Time ________minutes)- Chemical immersion
(Time ________minutes)- Total cycle time
Facility: ________________________________
Name: ________________________________
Department: ________________________________
Model #: ________________________________
Serial #: _________________________________
{1 check list per bay}
Bay(s) 1 2 3
Send PM card to: Custom Ultrasonics
144 Railroad drive
Ivyland, PA. 18974
Fax# (215) 364-8760
UNIT#:_________________ BAY#:________________
Page 7 of 7
04/11/2005, VER1.4, KP
L: Check Read Log

1. From the main screen Hold the (ALT) and press the “x” key
2. Type the following: CD\cudata and then press enter
3. Type the following: readlog bay1
4. Repeat the previous for all bays (changing the bay #) for the
corresponding bay
5. Record all data
_____ other
_____ Safety float _____Wash only
_____ Start invalid _____Wash / Chem
_____ Check water channel _____ Chem. immersion
_____ Invalid state temperature
_____ Not enough pasteurization
_____ Abort due to temperature
TOTAL: __________ TOTAL: ___________
M: SIGN OFF
I have performed the preventative maintenance, as recommended by the
equipment manual and vendor training, and have verified the proper flow
through each port on unit #_______ on (date) ______________________
Signature__________________________________
FOR FACILITY ENGINEERS:

*Present all documentation to the Asst. Chief Engineer. Signature of Asst.
Chief Engineer, below, will verify that documentation was received and that
mechanic was interviewed to ensure that proper procedures were followed.
I have interviewed the mechanic, and am confident proper procedure was
followed during performance of this maintenance.

Last Revised: 2007
**Signature________________________________
Date________________
**For third party contractors, this signature is adequate
documentation that the pm was completed as outlined.
THIRD PARTY CONTRACTOR:
NAME:_________________________PHONE:______________
ADDRESS:______________________STATE:_______________
UNIT#:__________________ BAY#:__________________

Last Revised: 2007
ADVANCED STERILIZATION PRODUCTS (ASP)
AUTOMATIC ENDOSCOPE REPROCESSOR
PREVENTIVE MAINTENANCE CHECKLIST FORM
ASP Automated Endoscope Reprocessor Inspection Checklist

Reprocessor Location: Date:
Control Number: Asset Number: Date Due:
Serial Number: Department:
Preventive Checks Section A Pass Fail - Action Needed

Equipment Operation, Safety, & Integrity (See Notes Below)
Visual Inspection - All Physical Aesthetics & Components
Operation Inspection - Overall Check Of All Functions
Electrical Safety - Plugs, Cords, Leakage Current, Grounding
Electrical Safety - Controls, Indicators, Displays
Mechanical Safety - Lids, Latches, Housing, Wheels
Mechanical Safety - Water Supply, Filters, Hoses, Connectors
Operation Safety - Interlocks, Staff Protection
Preventive Checks Section B Pass Fail - Action Needed

Operation of Pump, Air Compressor, and Heater (See Notes Below)
Water Supply Verification - Between 40 and 60 PSI Normal
Water Supply Verification - Minimum 3 Gallons Per Minute
Proper Operation of Pump, Air Compressor, and Heater
Verification of Channel Fluid Flow
Verification of Compressor Air Flow
Verification of Heater Temperature - 25° C (77° F)
System Wide Leak Check - Hoses, Connectors, Components
Preventive Checks Section C Pass Fail - Action Needed

Operation of Inlets, Outlets, Filters Drains, Hoses, and (See Notes Below)
All Valves
Check Drains - Remove Any Obstructions If Necessary
Check Hoses - Verify Proper Connections and Conditions
Check Valves - Verify Proper Operation and Indications
Check Inlet and Inlet Pressure - Approximately 50 PSI
Check Inlet Filter - 1 Micron
Check Outlet and Outlet Pressure - Approximately 30 PSI
Check Outlet Filter - 0.2 Micron
Preventive Checks Section D Pass Fail - Action Needed

Operational Cycle Time Check Verifications (See Notes Below)
Wash Cycle - Programmable Range - 1 to 166 Minutes
Wash Cycle Time Check at Use Time Setting

Last Revised: 2007
ASP PREVENTATIVE MAINTENANCE CHECKLIST PAGE 2 OF 2
Pre-Rinse (Rinse 1) Cycle Time Check - Preset Time - 6 Minutes

Disinfect Cycle - Programmable Range - 1 to 166Minutes
Disinfect Cycle Time Check at Use Time Setting
Post-Rinse (Rinse 2) Cycle Time Check - Preset Time - 3 Minutes
Air Cycle Time Check - Preset Time - 1 Minute
Preventive Checks Section E Pass Fail - Action Needed

Operation of Displays, Controls, Battery, and Printer (See Notes Below)
Operation of Displays
Operation of Status Information Code Display
Operation of AER Controls
AER Control Functioning
Operation of Backup Battery
Operation of Printer
Printer Ribbon and Print Quality Check
ACTION NEEDED NOTES: ______________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
OTHER NOTES: ________________________________________________________
________________________________________________________________________
________________________________________________________________________
Inspection and Checklist Completed By: _____________________________________
Date: _____________________________________

Last Revised: 2007
Olympus DSD 201/MedivatorAutomated Endoscope Reprocessor (AER)
**Refer to Service manual for more detailed procedures and pictures.
Critical Behavior Met Not Met

1. **If replacing pumps or pump head assemblies (12 month PM check), purge
disinfectant lines.
a. Disconnect the disinfectant filters.
b. Attach the adaptor restrictors for both stations.
c. Enter the diagnostic mode. Setup 88, enter, 135, and enter.
d. Press 8, enter, 18, enter, and then 7 to purge the disinfectant out of the pumps.
e. Press 0 and then enter to deactivate all components.
f. Repeat steps d and e for the other station.
g. Press cancel twice to exit the diagnostic mode.
h. Start the flush cycle for both stations and then press the cancel and then the
enter key during the air purge phase.
2. Unplug the DSD 201 AC power cord from the wall outlet.
3. Close the external incoming water valve.
4. Bleed the 0.2-micron filter by opening the valve for a few seconds. Place a small
container under the bleeder hose to collect the water.
5. Drain condensation from air chamber:
a. Locate the air chamber on the back panel inside the cabinet between the
reservoir and side “A” main module.
b. Pull the ring attached to the relief valve located at the bottom of the air chamber.
c. Ensure that the purged air is free of condensation.
d. Release the ring.
6. Air filter replacement
a. Locate the air filters.
b. Disconnect the quick-connect fittings.
c. Replace the old filter with the new filter.
d. Verify that the inlet of the filter faces the compressor.
e. Discard the old filters.
f. Record the date of change in the log book.
7. ¾-inch valve maintenance
a. Using a small, flat-bladed screwdriver, slide the solenoid-fastening clips off of
the valve plunger posts to remove the valve solenoids. Identify all three
solenoid valves to ensure that they are returned to their specific location after
inspection.
b. Ensure that the scope basins are completely drained of all fluid. Place some
rags underneath the ¾-inch valves in order to catch any remaining fluid that is
trapped within the valves.
c. Using a 7/16-inch nut driver or socket wrench, loosen the four retaining bolts
from the valve body of the drain valves, disinfectant return valves, and the
disinfectant overflow valves.
d. Inspect the valve seal, the plunger, the O-ring and the spring for signs of
swelling, distortion, wear, tears, or abrasions that would prevent the valve from
operating properly.
e. Replace any damaged parts.
f. Using a lint free cloth, wipe clean the valve housing to remove any debris
(especially around the circular valve seal seat).
g. Reattach the valve plunger assembly to the valve body, ensuring that the O-ring
is in the groove. Tighten the four retaining bolts to the valve body. Do not over
tighten.
h. Reattach the valve solenoid to the valve body ensuring that the metal circular
retention ring is in place between the valve body and solenoid.
i. Reattach the solenoid clip.
8. Inspect and replace as needed main manifold valve seals.
a. **Precaution should be taken to prevent spillage of disinfectant solution when
dismantling the valve assembly. Personnel should wear the appropriate PPE
Last Revised: 2007
when handling disinfectants.
b. Ensure water supply is off.
c. The main air actuated water valve should be closed in ‘B’ station diagnostics.
1. Type 88 on the keypad and press “enter”.
2. Type 135 and press “enter”.
d. Disconnect the unit from the main power.
e. Start with the ‘A’ side air valve and work upwards.
f. Place an absorbent cloth beneath the lowest valve to catch any fluid that may
drip during the dismantling process.
g. Using the 9/64” allen wrench, loosen the four retaining screws on the valve
actuator. Evenly remove to avoid distortion of the manifold or actuator.
h. Taking care not to bend, stretch, or kink the air tubing, rotate the actuator so that
the valve seal is uppermost.
i. Use the calve stem wrench to hold the valve shaft and using the 3/32” allen
wrench, loosen the retaining screw in the center of the valve seal. If the screw
does not easily release, do not attempt to remove with the wrench. Firmly grasp
the valve seal and pull off over the retaining screw. Still holding the valve stem,
grip the edges of the screw with the pliers and unscrew. Once released, use the
3/32” allen wrench to remove the screw completely.
j. Ensure that the valve area is completely clean; remove any traces of Loctite
from the screw mounting area.
k. Assemble a new valve seal. Apply one drop of Loctite to the screw threads and
re-assemble the valve seal to the valve shaft.
l. Tighten the valve seal retaining screw.
m. Re-fit the actuator to the main manifold. Tighten the screws in a uniform
diagonal manner to minimize deformation. Do not over tighten the retaining
screws.
n. Repeat the above procedure for each valve.
o. When all valve seals have been replaced, restore power to the unit. The main
water inlet valve should be reopened in ‘B’ side diagnostics.
1. Press the setup key
5. The water valve is now open. Exit diagnostics and run a test cycle to check
for proper operation. While the cycle is running, check all valves for signs of
leaks.
9. Disinfectant pump replacement

a. Disconnect from AC power.
**Side “A”:
b. Remove the disinfectant reservoir by removing the retaining screws from the
front of the reservoir.
c. Remove the disinfectant return tube from the top of the tank.
d. Disconnect, remove and replace the disinfectant filter.
e. Prior to removing the reservoir, disconnect the thermistor, level sensor and
heater harnesses.
f. Disconnect the pump harness connection.
g. Disconnect the pump outlet tube from the John Guests on both ends and discard
the tube.
h. Remove the heat sink from the pump.
i. Remove the hour mounting screws that hold the disinfectant pump to the main
module.
j. Remove the pump.
**For units with serial numbers below 600525 refer to the following:
k. Use a 5/16” nut driver to remove the mounting plate from the bottom of the
pump by removing the two retaining screws.

Last Revised: 2007
l. Remove and discard the mounting plate from the bottom of the new pump by
removing the two retaining screws.
m. Remove the heat sink from the new pump.
n. Fit the new pump to the main module.
o. Re-attach the heat sink.
p. Connect the new outlet tube on the pump and the main manifold to the
appropriate John Guest fittings
q. Reconnect the pump to the harness connection.
**Side “B”
r. Disconnect the pump harness connection and remove the tube connection from
the John Guest fitting on the pump outlet.
s. Remove the heat sink from the pump.
t. Remove the four mounting screws that hold the disinfectant pump to the main
module.
u. Remove the pump.
v. For units with serial numbers below 600525 refer to step m above
w. Remove the heat sink from the new pump.
x. Fit the new pump to the main module and re-attach heat sink.
y. Re-attach the outlet tube to the 3-way valve on the pump.
z. Reconnect the pump to the harness connection.
aa. Refit the disinfectant reservoirs ensuring that the thermistor, level sensor and
heater harness plugs are reconnected.
bb. Secure the reservoirs in place using the 3/8” screws.
cc. Refit the disinfectant return tube into the top of the reservoir.
dd. Refill the unit with disinfectant.
ee. Reconnect or replace the disinfectant filters.
10. Peristaltic pump tube replacement
a. Place a small container under each of the tubing connections when
disconnecting.
b. Replace the tubing one pump at a time to avoid confusion. To assist with
reassembly, label each tube before disconnection.
c. Identify and disconnect the inlet and outlet tubing from the pump you are
servicing.
d. Identify and remove four screws from pump cover.
e. Remove the tubing from the pump head by pulling the tube out of the support
recess, rotate the pinch roller by hand while gently pulling the tube, keep
rotating and pulling until the tube is completely released.
f. Remove the new tube set from the packaging.
g. Position the new tube over the pump head so that the inlet and outlet are of
equal length.
h. Lay the new tube in the recess and rotate the roller as you feed the tube into
place until the new tube is completely installed.
i. Replace the cover using the screws that were removed in step d.
j. Re-connect the inlet and outlet screws that were disconnected is step c.
k. Ensure that a scope hookup or simulator is connected to the basin fitting
and enter diagnostics. Open the appropriate valve (detergent or alcohol)
for the side of the machine you are working on. Using diagnostics run the
appropriate pump to prime the system. Continue running the pump until
fluid appears from the scope hookup or simulator. Once fully primed, turn
off the pump and close the valve.
l. Repeat the above process for the three remaining pumps.
11. Maintenance Checks

a. Plug DSD-201 AC power cord back into power outlet.
b. Ensure machine powers on correctly and is in the idle state.
c. Open incoming water supply valve.
d. Place the restrictor adaptor into each basin.
e. Fill the reservoirs with disinfectant using setup 1.
f. During the rinse cycle, ensure that there are no leaks inside and bleed any air

Last Revised: 2007
from the housing using the bleeder valve.
g. Commence a cycle on both sides, performing the following:
1. Cycle parameters are adjusted to the appropriate settings
2. Sensors are set to work properly.
3. Proper operation of the cycle.
4. No leaks occur during the rinse cycle.
5. The external water pressure during the flush mode meets the installations
requirements (35-40 PSI)
6. The alcohol and detergent solutions are injected as desired.
7. The basins fill to the appropriate levels during both the disinfectant and the
rinse phases.
8. There is no loss of disinfectant.
9. No excessive noise, fumes or odors are noted.
10. When the disinfect cycle begins, press the TEST button on the GFI breaker
which is located on the inside back wall of the cabinet and has the printer
transformer plugged into it. Wait 5 seconds, the depress the RESET button
on the GFI in order to re-apply the AC power. The DSD should resume the
disinfect cycle from the step where it stopped.
h. Ensure that the DSD completes one full disinfection cycle without any alarms.
i. Check the accuracy of the LCD display for the date and time, reset values if
necessary.
j. Clean any fluid or residue from the cabinet assembly and secure both reservoirs
in original position.

Last Revised: 2007
Olympus DSD 91E Medivator Automated Endoscope Reprocessor (AER)
** Refer to Service Manual for more detailed instructions and pictures of procedures.
** Not all procedures need to be performed at the same time. Each section should be treated as a
separate procedure.
1. Replace the Pre-Filtration System Water Cartridges
**The pre-filtration system filters must be checked periodically (every 30-45 days) for particle
saturation. Particles at the bottom of the base also indicate that the filter should be changed.
a. Shut off the water supply to the system.
b. To relieve pressure, open the 0.2 Domnick Hunter filter bleed valve inside the machine.
c. Close the bleed valve after pressure is released.
d. Place a container under the pre-filtration system to catch any excess water.
e. Slowly loosen the base of the pre-filtration system using wrench CW03-0000 and unscrew the
base.
f. Remove the old filter cartridge and replace it with a new cartridge.
g. Reinstall the base and tighten it.
h. Ensure the black O-ring is properly seated.
i. Log date of cartridge change.
j. Turn on the water supply and check for leaks.
2. Replace the Internal Water Filter Cartridge
a. Shut off water supply to the system.
b. Place a container under the 0.2-micron Domnick Hunter filter vessel to catch any excess water.
c. Open the air bleed valve on top of the filter housing to relieve the pressure; then close the valve.
d. Loosen the filter assembly thumbscrew by turning it counterclockwise.
e. Remove the vessel and discard any liquid.
f. Remove the old cartridge. Rotate it counterclockwise and pull down.
g. Discard the cartridge.
h. Cut open the packaging on the new cartridge at the end with the O-ring seals.
i. Ensure that the O-ring seals are clean, intact, correctly located in their grooves and free of cuts or
nicks.
j. Lubricate the O-rings by moistening them with water.
k. Using the packaging as protection and holding the cartridge near the open end, press the cartridge
firmly until the O-rings are seated in the housing and are no longer visible.
l. Turn the filter clockwise until the stops on the filter contact the posts on the lid of the filter
housing.
m. Remove the packaging bag without touching the filter itself.
n. Return the vessel to its correct position and reinstall the locking ring.
o. Reconnect or turn on the water supply and check for leaks.
p. Log change of water filter cartridge.
3. High Level Disinfection or Sterilization of the Internal Water Filter.
** Glutaraldehyde solution should be used to high level disinfect or sterilize filters of this type. The
internal water filter must be high level disinfected or sterilized with disinfectant before use.
a. Insert scope hookup fittings into the A and B fittings in the center of the basins.
b. Select station A and B and discard the disinfectant by pressing [DISINFECTANT DUMP], then
[START]. Disinfectant is pumped into the basin and then out of the drain. The total cycle time is
about 14 minutes.
c. Change the disinfectant filters. Log date of change.
d. Pour four gallons of high level disinfectant into each basin. Press [SETUP], [1], [ENTER],
[START] on the control panel. Log date of change.
e. After the disinfectant has completely drained into the lower reservoirs, press [STOP], [CANCEL].
f. Place a container under the pumps red bleeder valves at the outlet of station A and B pumps. Bleed
the air from the pumps until the disinfectant flows from the bleed valves. Then close off the
valves.
g. Disconnect the incoming water line (quick connect) at the bottom of the internal water filter.
h. Place a container under the hose attached to the bleed valve at the top of the filter and open the
valve.
i. Connect the water inlet line to the quick-connect fitting on the red bleeder valve of the Station B

Last Revised: 2007
disinfectant pump.
j. Open the Station B red bleeder valve on the disinfectant pump.
k. Press and hold the water system disinfect switch until the disinfectant begins to flow freely from
the filter bleed valve.
l. Release the switch and close the filter bleed valve.
m. Once again, make sure Stations A and B are selected by choosing [Station Select] A/B.
n. Set the machine to run Program 9 ([PROGRAM], [9], [ENTER]). This program should be set to
have a flush time of 10 minutes at the beginning of the cycle.
**To set up this program, press [Setup], [5], [ENTER], [9], [ENTER], [10], [ENTER], [CANCEL]. Set
the program to 10 minutes on the screen for flush time. Leave the remaining screens at the default
values. Press stop to return to the original screen.
o. Press and hold the water system disinfect switch, the quickly press [START] on the control panel.
p. Continue holding down the switch until disinfectant can be seen flowing out each endoscope
hookup, then release the switch to stop pumping.
q. Press [STOP] on the control panel.
r. Close the red bleed valve on the Station B pump.
s. Disconnect the internal water inlet line from the disinfectant pump bleed valve and leave
disconnected.
t. Allow the system to stand filled with disinfectant for the time recommended on the product label to
achieve high level disinfection or sterilization. Status and indicator lights will blink alternately.
u. After the system has been filled for the prescribed length of time, reattach the incoming water inlet
line to the internal water filter line.
v. Press [START] on the control panel and wait approx. 10 minutes for the flush cycle to complete.
Press [STOP], [CANCEL]. Add disinfectant to side B to bring appropriate level at the bottom of
caution sticker.
w. Return sides A and B to their regular programs. Select A and B, press [PROGRAM] and [desired
program number], press [ENTER].
x. Resume normal use.
4. Replace the Air Filters
a. Remove both quick-connects and discard old filter.
b. Replace with a new filter.
c. Log date of change.
5. Clean a ¾” Solenoid Valve
j. Locate the proper valve assembly.
k. Remove the solenoid to gain access to the four bolts holding the valve assembly together.
l. Remove the four bolts from the valve assembly.
m. Remove the plunger, seal and spring.
n. Clean the plunger and seal with water.
o. Reinstall the plunger, seal and spring.
p. Reassemble the valve housing.
q. Reinstall the four bolts and tighten.
6. Clean the Flow Sensors
a. Remove the Flow Sensor Assembly.
1. Unplug the Sensor Cable from the sensor board.
2. Remove the CPC Elbow from the bottom of the CPC Coupling.
3. Hold the Side Coupling using a wrench.
4. Unscrew the Flow Sensor from the Side Coupling.
5. Remove the Flow Sensor assembly from the machine.
6. Remove the Plug from the top of the Flow Sensor assembly.
7. Remove the Plunger from the inside of the Flow Sensor assembly.
8. Remove the Bottom Coupling from the bottom of the Flow Sensor.
b. Clean the Flow Sensor
1. Wipe the Plunger using a clean cloth.
2. Push a clean cloth through the barrel of the Flow Sensor.
c. Reassemble the Flow Sensor.
1. Replace the plunger into the Flow Sensor with the flat end in first.
2. Inspect the O-rings of the Plug, Side Coupling and Bottom Coupling for damage.
3. Apply silicon grease to each O-ring.
4. Reassemble remaining Flow Sensor parts.

Last Revised: 2007
5. Reinstall Flow Sensor into machine.
7. Replace the Printer Paper.
a. Raise the cover over the printer compartment.
b. Remove the used paper roll.
1. Advance the paper about one inch beyond the paper cutter using the Paper Feed switch.
2. Cut off any remaining paper on the roll from the printer.
**Caution: Never pull the paper out of the back of the printer. It will damage the print mechanism.
3. Pull the remaining paper through the printer mechanism. Be sure to pull the paper from the
top.
c. Insert new paper roll by pressing the Paper Feed button and inserting paper.
1. Unroll several inches of paper from a new roll.
2. Cut the leading edge of the paper roll if it is jagged.
3. Feed the paper through the slot.
4. While holding the paper in place, press and hold the rocker switch in the Paper Feed position
until the paper emerges from the top of the printer.
5. Release the Paper Feed button when an inch of paper has emerged from the top of the printer.
6. Pull the paper through the printer until several inches are exposed.
7. Insert the spindle through the paper roll.
8. Place the paper roll back in the back of the printer.
d. Pull the excess paper through the slot on the printer cover.
e. Lower the Printer Compartment Cover.
8. Replacing the Printer Ribbon.
**Replace the ribbon when the printer becomes difficult to read.
a. Turn the printer switch off.
b. Push down on four small grooves embossed on each side of the printer’s front cover until the cover
tilts.
c. Lift the printer cover completely off.
d. Push down on the right side of the ribbon cartridge where it is marched “PUSH”.
e. Remove the cartridge.
f. Install a new cartridge.
g. Ensure that the ink cartridge is properly seated and aligned.
h. Turn the cartridge “knob” clockwise to stretch the ribbon.
i. Reinstall the printer’s front cover.
9. Replace Fuses.
a. Unplug the unit from the AC power receptacle.
b. Remove the access screw at the front of the control panel lid.
c. Open control panel access to the electronics.
d. Remove the fuse from the board.
e. Inspect visually or electrically to determine if the fuse is damaged.
f. Replace damaged fuses.
g. Close control panel lid.
h. Replace the access screw.
i. Plug the power cord back into the receptacle.

Last Revised: 2007
KAISER PERMANENTE
SAMPLE SCOPE PROCEDURE LOG
Patient Procedure Type of MD Doing Type of Scope Serial Number AER # & Signature of
Name/MR# Date Procedure Procedure of Scope Cycle Clinic or SP
(e.g. AER #1; Staff Date and
Disinfection Time
Cycle)

Last Revised: 2007
KAISER PERMANENTE
CLEANING/DISINFECTION/STERILIZATION DEFINITIONS
AER
Automated endoscope reprocessor
Antiseptic
A chemical germicide formulated for use on skin or tissue and should not be used to decontaminate
inanimate objects
Bactericide
An agent that kills bacteria
Cleaning
The removal of all foreign material (e.g., soil, organic material) from objects
Contaminated
The presence of pathogenic organisms on or in an inanimate object
Critical
Term used to a describe a category for items that will come in contact with sterile tissue
Decontamination
The process of removing disease-producing microorganisms on a surface or item
Disinfectant
A germicide that inactivates virtually all recognized pathogenic microorganisms but not necessarily
all microbial forms (e.g., bacterial endospores) on inanimate objects
Germicide
An agent that destroys microorganisms, particularly pathogenic microorganisms
High-level disinfection
Term used for the process of killing all microorganisms, with the exception of high numbers of
bacterial spores; Abbreviation = HLD
Intermediate-level disinfection
Term used for the process of killing Mycobacterium tuberculosis, vegetative bacteria, most viruses,
and most fungi, but does not necessarily kill bacterial endospores
Low-level disinfection
Term used for the process of killing most bacteria, some viruses, and some fungi, but it cannot be
relied on to kill tubercle bacilli or bacterial endospores
Non-critical
Term used to describe a category for items that may come in contact with intact skin but not with
mucous membranes
Semi-critical
Term used to describe a category for items that will come in contact with mucous membranes or
non-intact skin.
Sterilization
The complete elimination or destruction of all forms of microbial life

Last Revised: 2007

2007 Scope Reprocessing Competency Package

Uploaded by

2007 Scope Reprocessing Competency Package

Uploaded by

Program-wide Scope Reprocessing

Created: National Interregional Disinfection and Sterilization Task Force 2001 1

1. Overview/CEU Credit Page 3

2. Position Statement/References Page 4

3. Behavioral Goal/Objectives Page 5

4. Scope Reprocessing Policy Page 6

5. Scope Reprocessing Procedure Page 7 - 11

6. Scope Reprocessing Quick Reference Grid Page 12

7. About the APIC Endoscope Reprocessing Guidelines Page 13

8. About the SGNA Endoscope Reprocessing Chart Page 14

9. About the SGNA Endoscope Reprocessing Video Page 15

10. Staff Competency Tools

11. Post Test Page 61

12. Post Test Answer Sheet Page 62

13. Documentation of Employee Completion of Competency Package Page 63

14. Preventative Maintenance Checklists

 Custom Ultrasonics: Medical Assistant Checklist Page 65 - 66

15. Sample Scope Procedure Log Page 83

Created: National Interregional Disinfection and Sterilization Task Force 2001 2

Created: National Interregional Disinfection and Sterilization Task Force 2001 3

Created: National Interregional Disinfection and Sterilization Task Force 2001 4

American Society of Gastroenterologists. "Position Statement: Reprocessing of Flexible Gastrointestinal

CDC Guidelines for Environmental Infection Control in Health-Care Facilities

My Endo Site: http://www.myendosite.com/search_by_topic.htm

International Association of Healthcare Central Service Materials Management: http://iahcsmm.org/

Created: National Interregional Disinfection and Sterilization Task Force 2001 5

Created: National Interregional Disinfection and Sterilization Task Force 2001 6

Created: National Interregional Disinfection and Sterilization Task Force 2001 7

Created: National Interregional Disinfection and Sterilization Task Force 2001 8

4. High Level Disinfection – Automated

Created: National Interregional Disinfection and Sterilization Task Force 2001 10

5. High Level Disinfection - Manual

Created: National Interregional Disinfection and Sterilization Task Force 2001 11

MANUAL DISINFECTION AUTOMATED REPROCESSORS

10. Other Accessories

11. Processing Area

12. Personal Protective Equipment (PPE)

13. Record Keeping and Preventative Maintenance

Created: National Interregional Disinfection and Sterilization Task Force 2001 13

Created: National Interregional Disinfection and Sterilization Task Force 2001 15

Created: National Interregional Disinfection and Sterilization Task Force 2001 16

Society for Gastroenterology Nurses and Associates, Inc.

Created: National Interregional Disinfection and Sterilization Task Force 2001 17

Society for Gastroenterology Nurses and Associates, Inc.

Created: National Interregional Disinfection and Sterilization Task Force 2001 19

Performance Criteria Met Not

Created: National Interregional Disinfection and Sterilization Task Force 2001 20

Created: National Interregional Disinfection and Sterilization Task Force 2001 21

Overall Evaluation of Demonstration

Goal: Meets expectations 100%: (calculations) # of yes responses ’ = % compliance

Does not meet expectations (less than 100% criteria completed)

List criteria not met

Educational Plan: _____________________________________________________________________

Employee competency signature _________________________________________________________

Created: National Interregional Disinfection and Sterilization Task Force 2001 22

Policy/Performance Criteria Met Not

Created: National Interregional Disinfection and Sterilization Task Force 2001 23

Created: National Interregional Disinfection and Sterilization Task Force 2001 24

Overall Evaluation of Demonstration

Goal: Meets expectations 100%: (calculations) # of yes responses ’ = % compliance

Does not meet expectations (less than 100% criteria completed)

List criteria not met

Educational Plan: _____________________________________________________________________

Employee competency signature _________________________________________________________

Created: National Interregional Disinfection and Sterilization Task Force 2001 25

Policy/Performance Criteria Met Not

Created: National Interregional Disinfection and Sterilization Task Force 2001 26

Created: National Interregional Disinfection and Sterilization Task Force 2001 27

4. Disinfected instruments should be used immediately, or stored in a manner to minimize

Created: National Interregional Disinfection and Sterilization Task Force 2001 28

Overall Evaluation of Demonstration

Goal: Meets expectations 100%: (calculations) # of yes responses ’ = % compliance

Does not meet expectations (less than 100% criteria completed)

List criteria not met

Educational Plan: _____________________________________________________________________

Employee competency signature _________________________________________________________