University of Michigan Health System
Program and Operations Analysis (POA)
Analysis of Endoscope Reprocessing
Final Project Report
To:
Lisa Sturm, Managing Director, Infection Control & Epidemiology
Mary Duck, Industrial Engr. Expert & Lean Coach, POA
Matthew Claysen, Industrial Engr. Intermediate, Operating Rooms
Rama Mwenesi, Fellow, POA
Mark Van Oyen, Instructor, Industrial and Operations Engineering
From:
IOE 481 Project Team 7
Danielle Hedden
Alexandra Keyser
Dominic Lefere
Date:
December 10, 2013
1
Table of Contents –FIX THIS
Executive Summary
Introduction 5
Background
3
6
Key Issues 7
Goals and Objectives
Project Scope
Methodology
Findings
7
7
7
11
Conclusions 13
Recommendations 13
Expected Impact
14
References 15
Appendices 16
Appendix B: External Audit
19
Appendix B: Internal Audit
19
Appendix B: Matrix/Data sheets 19
2
Executive Summary
Endoscopes are used in approximately 32 sites in the University of Michigan Health System
(UMHS). These tools touch patients’ mucus membranes, and as such, have to be high-level
disinfected, which is a process of chemical exposure that removes and/or renders inactive
bacteria, viruses, and most spores. The process of removing viruses is especially important,
so that viruses such as HIV and hepatitis B and C, are not transferred to a patient. High
Level Disinfection is critical when reprocessing endoscopes. The Managing Director of
Infection Control stated that The Joint Commission (TJC) cited UMHS on their scope
reprocessing, thus elevating this to a high priority for the institution [1]. Infection Control
needs better auditing tools to focus their efforts on problem areas in the reprocessing
process. The Managing Director asked a student team from Industrial and Operations
Engineering (IOE) 481 at the University of Michigan to trace the life cycle of the endoscopes
at some of the operating sites and develop internal and external audit tools for the
institution to use when evaluating its endoscope reprocessing.
After examining the current situation, the team developed a comparison matrix for
comparing the different sites visited to the institutional endoscope reprocessing standards
put forth in a policy by Infection Control [2]. This matrix helped build the audit tools that
the team is recommending.
Background
The Managing Director of Infection Control stated [1] that there have been occasional
problems with unprocessed endoscopes being mistaken for clean and being present in the
procedure room. Due to precautionary flushing done before procedures, this issue has
never reached the patient. The Director believes there are many possible reasons why
unprocessed endoscopes in the procedure room could occur: complicated endoscope
reprocessing process, fast paced and crowded work environment, variations in training, and
infrequently performed task at some sites.
Methods
The team performed six types of tasks to evaluate the reprocessing process and develop
audit tool recommendations.
•
Selected key sites in UMHS to observe. The team worked with the Managing Director of
Infection Control to determine which of the 32 sites that handle and reprocess
endoscopes the team would visit. Sites with high volume (high volume is considered to
be around 50-80 scopes a day, while low volume is considered to be only a couple a
week) of endoscopes were selected, as well as sites that represent the clinic
environment (low volume). The selected sites were Medical Procedures Unit (MPU),
Medical Procedure Center (MPC), CS Mott’s Children’s Hospital Operating Room (OR),
University Hospital’s (UH) OR, Taubman Otolaryngology Clinic, Taubman Urology
Clinic, and the Cancer Center Urology Clinic. Out of these, the sites of main focus were
the MPU, MPC, and Mott OR. UH OR, Taubman Otolaryngology Clinic, Taubman Urology
Clinic, and the Cancer Center Urology Clinic were sites that did not have a high volume
of endoscopes used each day, so they were a secondary focus, and would not have as
many observations.
3
•
Observed and interviewed staff at each selected key site. At the sites of main focus, the
team observed at least three times. The sites that the team visited that were not high
volume were only observed once or twice. The team completed a total of 40 hours of
observation. The team observed the set up and take down of the endoscopes in the
procedure rooms, and then the reprocessing of the endoscopes in decontamination.
While observing, the team also asked the staff questions.
•
Conducted surveys at all UMHS endoscope sites. Since the team was unable to visit and
observe at all 32 sites due to time constraints, the team developed and distributed a
survey to all of the 32 sites that handle and reprocess endoscopes. The purpose of the
survey was to provide baseline data for sites not observed, and provide additional data
for observed sites. The survey questions were linked with the observation findings.
•
Performed literature and internet searches for endoscope reprocessing guidelines and
audit tool formats. The team researched and found many useful references from journal
articles and manufacturers instructions on endoscope reprocessing guidelines and
typical audit tools off which to base their recommendations.
•
Compared observed sites’ endoscope reprocessing to best practices found in Infection
Control’s endoscope reprocessing policy [2]. Using the detailed observation data
gathered, the team compared each site to the best practices and determined a percent
of best practice that each site was following.
•
Formulate internal and external audit tools. Based on the reprocessing areas that had
the most deviations from the best practices, the team formulated an audit tool that
focused on those problem areas.
Findings
After completing observations the team analyzed results from each site and compared these
to Infection Control’s policy. The team observed that most of the high traffic scope
reprocessing sites achieved percent compliance ratings of 87% or greater, however each
still had at least one category of the process that needs improvement. Sites that reprocess
scopes on a less frequent basis received, for the most part, much lower percent compliance
ratings, as shown in Table E-1.
Survey responses uncovered many of the same areas that deviated from the policy. Based
on the surveys, inconsistencies exist across sites in the following areas:
• Reprocessing Room:
o Brush reprocessing
o PPE requirements (especially glove use)
• Transport of scopes from room to room
• Set up procedures within the procedure room
4
Table E-1. Percent compliance to Infection Control’s policy across visited sites
MPU
Overall
91%
Set Up
91%
Pre-Cleaning
100%
Transportation 100%
Reprocessing
92%
Storage
100%
Miscellaneous
70%
MPC
91%
55%
100%
75%
100%
100%
100%
Mott-OR
86%
100%
100%
100%
84%
100%
83%
UH-OR
97%
100%
50%
100%
100%
100%
100%
Oto
73%
100%
100%
25%
88%
100%
50%
Cancer
Center
94%
75%
100%
75%
100%
100%
100%
Overall
89%
87%
92%
79%
94%
100%
84%
The team researched endoscope reprocessing guidelines from the Community and Hospital
Infection Control Association (CHICA) – Canada. Documents from this source emphasized
the importance of specific steps within the reprocessing process and helped the team better
target potential sources of error. These findings were used to formulate better questions for
use within the audit tools.
Conclusions
From these findings, the team concludes that most errors in the reprocessing occur in the
reprocessing room itself during high-level disinfection. The team also noted that more
errors tend to occur at locations that reprocess a smaller volume of endoscopes. Additional
sources of common error include:
 Scope transportation
 Brush reprocessing
 Setup procedures
Recommendations
During observations, the team saw most deviations from best practice to occur during highlevel disinfection. The audit tools that the team developed focus on these areas and can be
used to accurately pinpoint where deviations from best practice occur. By doing regular
audits with the audit tool, Infection Control can identify errors in the process and focus
their improvement efforts on the areas with the most errors. The internal audit will be used
by sites to track their compliance with Infection Control’s policy on a more frequent basis.
5
Introduction
Endoscopes are used in approximately 32 sites in the University of Michigan Health
System (UMHS). These tools touch patients’ mucus membranes, which classifies
them as semi-critical medical devices, according to the Spaulding Classification of
Medical Devices. According to this classification system, all semi-critical medical
devices must be high-level disinfected [3], which is a process of chemical exposure
that removes and/or renders inactive bacteria, viruses, and most spores. The
process of removing viruses is especially important, so that viruses such as HIV and
hepatitis B and C, are not transferred to a patient. High Level Disinfection is critical
when reprocessing endoscopes. The Managing Director of Infection Control stated
that The Joint Commission (TJC) cited UMHS on their scope reprocessing, thus
elevating this to a high priority for the institution [1].
The Managing Director stated [1] that there have been occasional problems with
unprocessed endoscopes being mistaken for clean and being present in the
operating room. Due to precautionary flushing done before procedures, this issue
never reaches the patient. The director believes there are many reasons this could
occur: endoscope reprocessing is a complicated process, the work environment is
fast paced and crowded, there may be variations in training, and for some sites the
task is not done very often. Infection Control needs better auditing tools to detect
errors in the process, so that they know where to focus their improvement efforts.
The Managing Director has asked the Industrial and Operations Engineering (IOE)
481 student team to trace the life cycle of the endoscopes, from the time they are
taken out of the cabinet for use, to the time they are put back in the cabinet after
being cleaned. The team has documented the reprocessing process for eight sites
within UMHS, and has developed auditing tools to target deviations from Infection
Control’s policy for the sites and Infection Control. This report presents the team’s
data collection and analysis, findings, conclusions and recommendations and
includes project deliverables.
Background
According to the Managing Director of Infection Control, endoscopes must be highlevel disinfected according to the Spaulding Classification scheme, which states
anything that comes in contact with a mucus membrane must be high-level
disinfected [1]. Failure to correctly follow endoscope reprocessing guidelines, or
using damaged endoscopes accounts for all of the reported cases of bacterial and
viral transmissions. The reprocessing of endoscopes is crucial to preventing
infection. The transmission of bacteria and viruses from an endoscope procedure is
rare; it happens in 1 in 1.8 million cases according to M. Juan Day, M.E. [2].
However, the types of diseases a person may contract can be dangerous, such as HIV
and hepatitis B and C.
UMHS has a policy for endoscope reprocessing which should be followed, but
according to the Managing Director of Infection Control [1], there are occasional
incidences where unprocessed endoscopes are mistaken for reprocessed. To
prevent the unprocessed scope from being used in a procedure, the instrument is
flushed with water before use, and at this step a dirty scope is identified. Based on
the UMHS Infection Control Committee’s policy on endoscope reprocessing and
high-level disinfection, “it must be clearly indicated that the endoscope is dirty”
after it has been used; however, this step is not always followed [4]. Infection
Control at UMHS is introducing a new policy that will use a visual cue to determine if
an endoscope has been high-level disinfected. The cue will have to be removed
before the endoscope can be used to error-proof the process. An endoscope will
only be used if a visual cue is attached.
Infection Control conducted a root-cause analysis [1] on why unprocessed
endoscopes are being mistaken for reprocessed. They found in some instances
departments were unclear on who was responsible for reprocessing the scopes and
assumed another department was accountable. Variations in training could also
account for discrepancies across sites. The Managing Director of Infection Control
feels a tool to help identify where deviation from the standard procedure is needed.
This project sought to decrease the number of dirty instruments being mistaken for
clean by developing audit tools to be used internally by the sites, as well as
externally by Infection Control.
Key Issues
The following issues were the primary reasons for this project:
•Occasions have occurred where endoscopes that were not properly reprocessed
are mistaken for clean
•No visual audit system exists to differentiate between endoscopes that have
been high-level disinfected and those that have not
•Responsibility for cleaning endoscopes is unclear
•Party responsible for cleaning endoscope is not fully trained
Goals and Objectives
To determine the best questions for an audit tool for endoscope reprocessing for
UMHS, the team accomplished the following tasks:
• Observed the steps in the current endoscope usage and reprocessing
• Identified areas for improvement
This information has helped the team develop recommendations to:
• Have fewer instances of dirty scopes
• Develop audit process
Project Scope
The main focus of this project was tracing the lifecycle of an endoscope including:
selecting an endoscope for a procedure, transporting the scope, using in procedure,
cleaning, high-level disinfecting, and returning the endoscope to storage. The team
has determined best practices and observed endoscope reprocessing for eight sites
throughout UMHS.
This project did not focus on how the endoscopes are used or stored. The quality of
the cleaning at the micro level was not focused on in this project. Any concerns with
which chemicals should be used were also not a focus for this project.
Due to the large number of sites, only eight were visited during this project.
Methodology
The team used two data collection techniques to ensure successful completion of the
project. Observations served as the main type of data collection, but survey data was
also used to document the endoscope reprocessing process, especially for those
sites the team was not able to visit.
Observations
The team logged 40 hours of observation data at eight sites within UMHS. To
perform observations, the team worked with the Managing Director of Infection
Control, Intermediate Industrial Engineer, and Infection Control Practitioners (ICPs)
to arrange the dates and times of observations. The team sent its availability for
observations each week to its ICP contact, who distributed the availability to all the
other ICPs so that observations could be arranged.
The team observed the current endoscope lifecycle. Lifecycle is defined as the time
from when the scope is taken from storage until it is returned to storage. The
following activities were tracked with observations by using a standard collection
form found in Appendix A:
 Transportation of scopes to procedure room
 Set up of the scope
 Pre-cleaning
 Transportation from procedure room to reprocessing room
 Reprocessing
 Transportation from reprocessing room to storage
The main areas where the team collected observations are:
 Medical Procedures Unit
 East Ann Arbor Medical Procedures Center
 C.S. Mott OR
These areas are high traffic endoscope reprocessing areas, and the Managing
Director of Infection Control requested the team focus on these areas. The team also
collected limited observations at a few other endoscope reprocessing locations at
the request of the Managing Director of Infection Control. These areas do not do
endoscopic procedures often, and therefore the team only visited these areas once
or twice. These areas are:
 UH OR
 Cardiovascular Center (CVC)
 Taubman Center Otolaryngology Clinic
 Taubman Center Urology Clinic
 The Cancer Center
The team planned on collecting 10 observations from each of the main areas, and
one to two observations from each secondary site. Table 1 shows the number of
observations collected from each visited site.
Table 1. Observation sample size at visited sites
Site
Sample Size (n)
5
MPU
5
MPC
3
Mott-OR
1
Cancer Center
1
CVC
1
Oto
1
UH-OR
1
Urology
Obtaining the desired number of observations was important for the team to better
understand endoscope reprocessing for individual sites in the current state. The
team used the observational data to determine where discrepancies exist between
best practice and observed practice. The areas of discrepancies allowed the team to
develop an audit to identify these issues in other sites, by determining what
questions the team should ask in the audits to reveal the problems at other sites.
To ensure that the team received unbiased data, the team would return to the main
observational areas for multiple observations. The managers would then let the
team observe unsupervised, which allowed for better data because with no
managers in the room, the staff was more likely to reprocess the scopes as they
normally would in an empty room.
Surveys
The team used survey data to supplement observations. Due to time constraints, the
team was unable to visit all 32 sites, so surveys were used to extend the project
reach to those sites the team did not physically visit. Infection Control facilitated
distributing surveys and returning surveys to the team. Both paper and online
surveys were used. Two different surveys were distributed, both electronically and
manually, to all 32 sites, and each site was to complete the survey either
electronically or on paper, which ever they preferred. One survey was for the
employees that set up the endoscopes in the procedure room, and the other survey
was for employees that reprocess the endoscopes. 50 surveys were returned from
the medical assistants and reprocessing technicians. 31 of these surveys were
procedure room surveys, and 19 surveys were reprocessing room surveys.
SDS meetings
The Sterilization/Disinfection Subcommittee meets every other week to discuss
ways to improve infection control processes. The scope of these meetings goes
beyond just endoscopes. By attending, the team gained more exposure and visibility
throughout the departments they were observing. With this attention, staff
throughout the departments had a better understanding of what the team was doing
and were more willing to schedule observations.
Literature search
The team gathered research on endoscope reprocessing methods and audit tools.
The team used the references to base its recommendations for audit tools. Based on
the research of reprocessing method standards, the team formulated questions for
the audits to target critical steps in reprocessing. The questions regarding the
reprocessing steps were modeled after the audit tool research, so as to ask
questions in a way that does not bias the answers of the staff to the correct answer.
The team researched endoscope reprocessing practices from other institutions to
compare UMHS’ policy to others and gain a deeper understanding of the
expectations for this process. The team specifically looked at best practices of the
Community and Hospital Infection Control Association (CHICA) – Canada, as
resources were easily accessible. By comparing UMHS’s policy to that of CHICA, the
team formulated pointed questions to ask while the team was observing.
Before constructing the internal or external audit tools, the team researched similar
tools at other institutions. One such tool designed by CHICA-Canada served as a
basis for the development of the team’s audit tools [5].
Data analysis
The team analyzed their observations by determining the percentage of best
practice each observed site is following. From Infection Control’s policy on
endoscope reprocessing, best practices were determined for each step of
reprocessing. The team constructed an observation matrix as a tool to compare each
visited site to Infection Control’s policy. Deviations from the policy were noted on
the main page of the matrix document, as can been seen in Appendix B. The team
also created individual tracking sheets for each of the visited sites that further track
compliance with the policy. These tools revealed the most common sources of error
to the team as well as which sites were farthest from meeting the standards set by
Infection Control.
Within each site tracking sheet, the team recorded observations for each visit. By
using a binary scale, zero meaning an element of the policy that was not complied
with, the team determined a site’s percent compliance by step in the reprocessing
process and by trial. Use of these results yielded an overall percent compliance that
was used as a comparison between sites.
Findings
From the team’s analysis of the observations and surveys, the team gathered the
following findings.
Policy Breakdown
The team obtained a thorough understanding of Infection Control’s policy for
reprocessing flexible endoscopes. These findings were used to create a structured
approach to the observation data collection. The observation data collection sheet
can be found in Appendix A. The policy can be broken up into five different sections:
Setup, Pre-Cleaning, Reprocessing, Transportation/Storage, and miscellaneous.
Setup
Before a procedure takes place, scope setup should occur. The following steps are
characteristic of this section:
 Obtaining scope (either from within room or cabinets outside rooms)
 Plugging in scope
 Connecting suction and drainage
 Checking the scope function (white balance, suction, flushing)
Pre-Cleaning
Immediately following a procedure pre-cleaning must take place. Skipping this step
can cause organic tissue to dry and become fixated to the scope, causing a scope to
be incorrectly reprocessed [6]. Pre-cleaning is made up of these steps:
1. Wiping scope exterior
2. Flushing channels with detergent or water
Reprocessing
The largest portion of time for endoscope reprocessing occurs in the reprocessing
room. This room is separated from sites of patient care. Within the reprocessing
room these steps occur:
1. Conducting a leak test
2. Suctioning detergent
3. Brushing all channels (even those not used during the procedure)
4. Attaching adapters
5. Flushing all channels with an enzymatic detergent solution
6. Immersing the scope in detergent solution
7. Wiping/washing scope with pad
8. Brushing ports and buttons with soft brushes
9. Purging all water and drying scope exterior
10. Disinfecting
a. Manual
i. Suctioning/injecting disinfectant into all channels
ii. Immersing scope in disinfectant and cover
iii. Soaking a minimum of 20 minutes using a timing device
iv. Removing scope and purging disinfectant from all channels
v. Rinsing with sterile, filtered, or tap water (in specified clean
sink)
vi. Purging water with forced air
vii. Flushing channels with alcohol (30-60 cc)
viii. Drying with 2 minutes forced air
ix. Drying exterior with clean cloth
x. Attaching green visual cue
b. Automatic Endoscope Reprocesser (AER)
i. Checking chemicals in machine to ensure correct pH
ii. Entering patient and scope information into machine and/or
record on log
iii. Putting endoscope in machine with correct connections
iv. Placing buttons and brushes in machine
v. Running cycle
vi. Injecting 30-60 cc alcohol after final rinse
vii. Attaching green visual cue
Transportation/Storage
Scopes must be transported from room to room and stored according to the policy
to prevent damage and the risk of infection. When scopes are transported they
should be clearly indicated as “dirty-do not use” or “HLD-ready for patient use.”
Following a procedure scopes should be transported to the reprocessing room in a
covered tote or bin. After the dirty scope is removed from the bin, a disinfectant
cleaner should be used to clean the container.
Endoscopes should be stored in dry, clean, and well-ventilated cabinets. Scopes
should not touch the bottom of the cabinets, however if this is unavoidable due to
the length of the scope then the scope tip must be protected and the bottom of the
cabinet must be regularly cleaned or be covered with a clean towel or pad.
Miscellaneous
Personal protective equipment, brush use, and chemical considerations are crucial
to proper endoscope reprocessing. It is imperative that anyone that comes in
contact with a scope be aware of the proper PPE requirements for handling it.
Reprocessing technicians within the reprocessing room should wear a face shield or
goggles and mask at all times during the process. Gowns are required both in the
reprocessing and procedure room. Employees should be conscious of when
changing gloves and/or hand washing is required.
Brushes should be disinfected after each use (between scopes). Chemicals
(Metricide) used in the AERs should be changed every 14 days, but strips should be
used to check their pH once a day.
Institutional Comparisons
The team researched endoscope reprocessing practices from other institutions to
compare UMHS’ policy to others and gain a deeper understanding of the
expectations for this process. The team specifically looked at best practices of the
Community and Hospital Infection Control Association (CHICA) – Canada, as
resources were easily accessible. A variety of errors that can cause an endoscope to
be improperly reprocessed including: policy breaches, issues with chemicals,
improper drying, using damaged endoscopes, reusing rinse water, using
contaminated germicide, and lack of scrubbing to kill biofilms [7]. The student team
was able to use this knowledge to perform more pointed observations that focused
on uncovering the mentioned issues within UMHS sites. This source stressed the
importance of each part of the endoscope reprocessing policy; failing to comply with
any part creates a risk of infection.
Accreditation Canada’s updated Qmentum Infection Prevention and Control
Standards [6] states:
• The importance of reviewing the competencies of staff involved in the
process of endoscope reprocessing
• All endoscope reprocessing areas should be physically separate from client
care areas and should be cleaned daily
• Endoscope reprocessing areas should possess separate and clean areas for
storage (cleaned/disinfected weekly) and should have dedicated plumbing
and adequate air ventilation
• Qualified staff members should reprocess endoscopes immediately after a
procedure
o Failing to immediately reprocess may allow bio material to harden to
the scope and be resistant to the remaining reprocessing steps
• Leak tests are required to ensure scopes are functioning properly
• Manual cleaning is required before disinfection can occur
o Accepted cleaning agent must be used
o Correct concentration of cleaning agent to solution must be used for
immersing endoscope
o Correct brushes must be used and must be either disposable or
cleaned between each scope
o If brushes are not changed frequently enough, ineffective cleaning or
channel damage can occur [8]
• Scopes must be stored vertically, not coiled in a case
• Endoscope reprocessing must be logged and kept
o Includes: scope identification number, type of scope, AED identifier,
date/time of reprocessing, client identifier, leak test results, and
name of person responsible for reprocessing
Compliance by Site
Figure 1 shows the results of the analysis of the matrix. Sites that see a high scope
volume, like MPU and MPC, appear to have higher percent compliance, while sites
that do not regularly reprocess endoscopes, such as the clinics, have low percent
compliance; the overall percent compliance. The Taubman Center Urology Clinic
was not included in this analysis due to insufficient data. The CVC clinic was not
included in this analysis because the collected observation targeted TEE probe
reprocessing, which is not identical to flexible endoscope reprocessing.
Figure 1. Overall percent pompliance to Infection Control’s endoscope reprocessing
policy by site
Dates collected: 9/25/13 – 11/13/13
Sample size located in Table 1
The compliance ratings can be broken down by reprocessing category. The
categories are: setup, pre-cleaning, transportation, reprocessing, storage, and
miscellaneous. Setup includes all steps that occur within the procedure room before
the scope is used by the patient. Pre-cleaning looks at steps that occur in the
procedure room immediately following the procedure. Transportation specifically
looks at how scopes are transported from the procedure room to the reprocessing
room. Reprocessing includes all steps that occur within the reprocessing room.
Storage looks at how scopes are stored as well as how the green visual cues are
used. The miscellaneous category includes PPE, brush use and reprocessing, and
chemical maintenance.
Figure 2 shows the overall percent compliance by reprocessing category.
Specifically, transportation, miscellaneous, and set up should be the primary focus
areas for improvement as they had the three lowest overall percent compliance
across observed sites. Check about Oto**
Figure 2. Overall percent compliance to Infection Control’s endoscope reprocessing
policy by category
Dates collected: 9/25/13 – 11/13/13
Sample size by category: Setup, n =15; Pre-cleaning, n = 13; Transportation, n = 15; Reprocessing, n =
16; Storage, n = 15; Miscellaneous, n = 16
Table 2 shows overall percent compliance for each visited site and the breakdown
by category. Overall percent and percent by category are also included. Table 2
shows that even sites with high overall percent compliance have problem areas that
need to be addressed. Overall, an 85% compliance was obtained by UMHS across the
sites observed.
Table 2. Percent compliance to Infection Control’s policy across visited sites
Cancer
MPU
MPC
Mott-OR UH-OR
Oto
Center Overall
Overall
91% 91%
86%
97%
73%
94%
89%
Set Up
91% 55%
100%
100% 100%
75%
87%
Pre-Cleaning
100% 100%
100%
50%
100% 100%
92%
Transportation 100% 75%
100%
100%
25%
75%
79%
Reprocessing
92% 100%
84%
100%
88%
100%
94%
Storage
100% 100%
100%
100% 100% 100%
100%
Miscellaneous
70% 100%
83%
100%
50%
100%
84%
Similarities Across Sites
From the surveys, the team found that most sites are flushing their scopes at setup,
as well as removing their green zip tie and white balancing the cameras, as seen in
Table 3. However, only 61% are wiping down the scope as part of the cleaning that
happens in the procedure room before transporting to reprocessing. And only 76%
are doing a precautionary flush of water at setup.
Table 3. Procedure Room Tasks
Dates collected: 11/20/13 – 12/3/13, Sample size=33 technicians, 9 sites
Practice
Setup
Flush scope with water
76%
Wipe down scope with alcohol/enzyme soaked pads
3%
Flush with aseptizyme
0%
Label scope as dirty
12%
Remove green zip tie
91%
White balance camera on scope
91%
PreNot
cleaning done
48%
0%
61%
39%
94%
3%
73%
15%
6%
0%
3%
0%
It is necessary for the endoscopes to be carried into the room in a bin if the
endoscope is coming from a cabinet outside of the procedure room in which it will
be used. 18% of sites are not conforming to this practice, as shown in Figure 2.
Figure 2. Endoscope retrieval for procedure: “How is the scope brought into
procedure room?”
Dates collected: 11/20/13 – 12/3/13
Sample size=33 technicians, 9 sites
Figure 3 below shows that most sites are transporting their dirty endoscopes into
the reprocessing room in a bin, as they should. 27% of sites are not covering these
bins.
Figure 3. Endoscope transportation to reprocessing room: “How is the scope carried
to the reprocessing room?”
Dates collected: 11/20/13 – 12/3/13
Sample size=33 technicians, 9 sites
Table 4. Reprocessing Room Best Practice Summary
Dates collected: 11/20/13 – 12/3/13
Sample size=21 technicians, 9 sites
Best Practice
Scope labeled dirty
Fresh water and detergent for each scope
Disinfect brushes
Disinfect brushes after every scope
% follow
76%
43%
100%
14%
In the reprocessing room, all reported sites are reprocessing their brushes;
however, only 14% are high level disinfecting the brushes after every scope, which
is the requirement. 71% of sites are only reprocessing their brushes daily.
Conclusions
Based on the team’s findings, problem areas were identified. A problem area is
defined as a category in the endoscope reprocessing process that does not achieve a
100% compliance rating. Problem areas discussed are both those unique to certain
sites and those needing attention across UMHS. These areas will provide the basis
for the team’s conclusions.
Common Areas for Improvement
Based on the findings from the team’s observations, comparison matrix, and survey
results, the following problem areas were identified, as all had overall percent
compliance ratings less than 100%.
 Setup
 Pre-cleaning
 Transportation
 Reprocessing
 Miscellaneous
Within these problem areas it was determined common deviations from best
practice include:
• Lack of flushing during scope setup
• Failure to change water/detergent mix between scopes
• Procedures for reprocessing buttons
• Lack of proper brush reprocessing
• Use of bins for transportation
• Labeling of bins as dirty during transportation
• Proper PPE/glove use
Sites that do not reprocess endoscopes on a regular basis are of particular concern
as the team observed large deviations from Infection Control’s policy throughout
endoscope reprocessing.
Both observation and survey data revealed common deviations between sites and
Infection Control’s policy.
Site-based Areas for Improvement
-
Mott: when scopes are set up and doctor wants different one, must
reprocess scope even though they know is clean (WASTE)
UH OR: scope sits in room after use until after procedure without
flushing, maybe allow organic material to dry and harden
MPU: maybe use comment from survey about “clean” bags/bins
MPU: clean rack is easier to access than dirty rack, potential hazard
Recommendations
Each step in the endoscope reprocessing process is critical to affectively
reprocessing a scope. Failure to comply with even one practice creates a risk of
infection and a potentially dirty scope.
Target Areas
Specific problem areas were identified within the conclusions. These areas will be
looked at in more detail below.
Setup
Many sites were performing the set up and take down (or pre-cleaning) of the scope
differently. Set up itself does not have a documented policy for how it should be
done, so it is being compared to the best practices the team saw at the majority of
sites visited. The team recommends that all sites perform a flush test as standard
practice for scope setup as the team is aware that this practice has caught potential
hazards in the past.
Pre-cleaning
Immediately following a procedure the scope’s exterior should be wiped down with
a cloth or sponge soaked in a fresh detergent solution [2]. All channels should then
be flushed with detergent solution or water to prevent organic material from
hardening to the endoscope. Failure to comply with this practice will allow the
material to harden to the scope and prevent the endoscope from being properly
reprocessed.
Transportation
Scopes should be transported into and out of both the procedure room and
reprocessing room via a covered and clearly labeled bin [9]. As shown by survey
data, this area varies greatly across sites and even within sites. To target this issue,
pointed questions are used in the audit whenever the scope is moved from room to
room. The team recommends that different colored bins be used for clean and dirty
scopes as an extra safety check. This would create an easy and very visual way to
distinguish between dirty and reprocessed endoscopes.
Reprocessing Room
Leak tests should be done immediately when the scopes are being reprocessed to
ensure they are working properly before being sent to the procedure room. Each
channel in the endoscope also must be suctioned and brushed with detergent, even
if they were not used, because fluid or debris may be present in these channels [8].
Endoscopes must be soaked for 20 minutes in disinfectant to decrease the risk of
transferring diseases. Soaking a scope for longer than 20 minutes can damage the
endoscope. High level disinfection of buttons was a practice that varied across sites
as well. Buttons should be high level disinfected along with the scope. AER
machines are equip to handle the smaller accessories associated with scopes,
including buttons. If a site reprocesses endoscopes manually, buttons should be
soaked in disinfectant for 20 minutes.
Miscellaneous
A variety of current practices exist for the use of brushes to clean endoscopes. The
team observed four different practices. The policy states that brushes must be
disinfected between scopes [9], but the team found this to not be the case for seven
out of eight sites. The audit asks specific questions about the type of brushes used
(disposable vs. reused) as well as the reprocessing procedure for reusable brushes
to reveal where the policy is not being followed.
Audit Tools
The team’s data collection and analysis greatly assisted in creating both an external
and internal audit for endoscope reprocessing. Both audits focus on following a
scope throughout its lifecycle. By analyzing both the observation and survey data,
the team created two audit tools that target observed problem areas and known
inconsistencies with Infection Control’s policy.
The external audit should be performed by Infection Control at each site on an
annual basis. Use of this tool will reveal potential risks in the endoscope
reprocessing process at each site. Topics will cover all steps contained in Infection
Control’s policy. Additionally, setup procedures, training, documentation of
reprocessing steps, and other topics will be included.
The internal audit was designed to be used by managers within each site. This tool
should be used on a quarterly basis and should make sure to include all employees
responsible for any portion of endoscope reprocessing. The internal audit is a
simplified version of the external audit to allow for easy use and a short time
commitment for managers.
Expected Impact
The team expects that the audit tool developed will assist Infection Control in
evaluating the reprocessing capability at each of the 32 locations in the University of
Michigan Health System. The audit tool will show areas in the reprocessing of
endoscopes that could be improved, and this information can be used to help
prevent future errors and citations from occurring. The audit tools developed target
common errors seen by the team during observations, which should better uncover
errors at future locations.
References
[1] L. Sturm, private communication. September 2013.
[2] M.E. Day, M. Juan, et al. “Standards of Infection Control in Reprocessing of
Flexible
Gastrointestinal Endoscopes.” Society of Gastroenterology Nurses
and Associates, Inc.: Chicago, Illinois. Report. 2012.
[3] American Society for Gastrointestinal Endoscopy, “Multi-society Guideline on
Reprocessing Flexible Gastrointestinal Endoscopes,” Gastrointestinal Endoscopy,
vol. 73, no. 6, pp. 1075-1084, 2011.
[4] Infection Control Committee. “Endoscopy: Reprocessing and High-Level
Disinfection.” University of Michigan Hospitals and Health Centers: Ann Arbor,
Michigan. Report. 15 Apr. 2013.
[5] CHICA-Canada, “Infection Prevention and Control Audit for Medical Device
Reprocessing in Ambulatory Clinic or Physician’s Office,” Audit Toolkit Version 2,
September 2009.
[6] Accreditation Canada, Qmentum Infection Prevention and Control Standards,
CHICA-Canada, 2013 March 22. [Online]. Available:
http://www.chica.org/pdf/13May02_Accred_Stds.pdf. [Accessed: 23 November,
2013].
[7] Truscott, Biofilms in Medicine: Patients Threatened by Highly Organized Militant
Pathogens, CHICA-Canada. [Online]. Available: http://www.chica.org/CHICANS/2012_Truscott.pdf. [Accessed: 23 November, 2013].
[8] Bradley Catalone, Ph.D., and George Koos, Reprocessing Flexible Endoscopes.
Olympus America, June 2005. [Online]. Available:
http://www.olympusamerica.com/msg_section/files/mic0605p74.pdf.
[Accessed: 1 November, 2013].
[9] M. Bachman. “Endoscope and Ancillary Equipment Reprocessing Competency.”
University of Michigan Health System, Medical Procedures Center: Ann Arbor,
Michigan. Audit. 4 Oct. 2013.
Appendix A – Data collection tool
Process Step
Setup
Pre-cleaning (after procedure)
Wipe?
Suction?
Flush/rinse?
Container placed in?
Reprocessing
Inspect/leak test?
Suction detergent?
Brush?
Attach adapters and flush?
Immerse in detergent?
Wash with pad?
Rinse?
Clean valves?
Purge water and wipe dry?
Either connect to machine or manual
Manual:
Suction disinfectant
Totally immerse in disinfectant
Soak min 20 min?
After done: flush with water?
Flush with alcohol?
Force air (2 min)?
Dry external with clean cloth?
Handle with clean hands?
Attach visual cue?
Transport?
Notes
Appendix B – Matrices and survey results, by site
Appendix B.1 – Medical Procedures Units
Matrix Summary Notes – MPU
Steps
Setup
Best Practice
Using clean hands or gloves, attach scope
and irrigation
Remove green tag, and put on buttons
Do flush test
White balance
Coil scope and place to be ready for doctor
Pre-cleaning
1. Wipe exterior surface
2. Flush channels with detergent OR water
Transportation Needs to be in a bin to transport, with
gloves. Bin must be clearly indicated that
scope is dirty. Put bin on "dirty rack"
Reprocessing
1. Leak test after each use
2. Suction detergent
3. Brush all channels
4. Attach adapters
5. Flush all channels
6. Immerse scope in detergent in sink
7. Wipe/wash scope with pad
8. Rinse with tap water
9. Brush ports and buttons with soft brushes
10. Purge all water and dry exterior
11. Disinfecting
11a. Manual
-Suction/inject disinfectant into all
channels
-Totally immerse scope in disinfectant
and cover
-Soak minimum 20 minutes using a
timing device
-Remove scope and purge disinfectant
from all channels
-Rinse with sterile, filtered, or tap
water (in a sink specified for clean scopes)
-Purge water with forced air
-Flush channels with alcohol (syringe
of 30-60 cc)
MPU: 9/25/13, 10/4/13,
10/17/13
Carried scope in from another
room not in a bin (10/23)
Didn't flush second time observing
(maybe due to lack of time --are
techs aware of importance of set
up procedures?)
Flushed with both aseptizyme
AND water - suctioned both, put in
high pressure flush button, and
held button for 30 sec, then
released button and flushed for 30
sec (10/23)
5 AERs, 4 soaking bins
Sometimes uses same disinfectant
for two scopes (not at same time)
-Dry with 2 minutes forced air
-Dry exterior with clean cloth
-Handle with clean hands and attach
visual cue
11b. AER
-Check chemicals in machine
-Enter patient and scope information
and/or record on log
-Put endoscope in machine
-Wait for two endoscopes to one
machine before connecting
-Attach hoses, put buttons (and
brushes) in machine
-Run cycle
-After final rinse, inject 30-60 cc alcohol
Attach Green Custom Tags
Transportation
/Storage
Storage areas should be labeled with "High
Level Disinfected: Ready for Patient Use" on
a rack specifically for clean endoscopes.
Green Custom Tags still attached.
Miscellaneous
(PPE, brushes,
buttons)
Brushes should be disposable or high level
disinfected.
Buttons must be high level disinfected
Metricide needs to be changed every 14
days, check with strips once/day.
Easier to get to clean rack than
dirty rack. Clean rack is outside
room
Bin not wiped down before next
use
Only throw away brushes when
the bristles get bad (patchy). Only
HLD brushes at the end of the day
Weren't wearing face shield
and/or goggles and mask (10/21)
NOTE: Operators hate green tags.
Matrix Individual Tracking Sheet – MPU
Trial
Steps
Setup
Pre-cleaning
Transportation
to reprocessing
room
Reprocessing
Transportation
/Storage
Miscellaneous
(PPE, brushes)
Using clean hands/gloves to
handle scope?
Remove green tag
Flush test
White balance
Coil scope
Wipe exterior surface
Flush channels with
detergent OR water
Scope in bin
Wearing gloves?
Bin marked "dirty"?
Put bin on "dirty rack"
Leak test
Correct concentration
chemical?
Suction detergent
brush all channels
immerse scope in detergent
in sink
wipe/wash scope with pad
rinse with tap water
brush ports and buttons with
soft brushes
purge all water and dry
exterior
Disinfection (AER)
check chemicals in machine
enter patient info in machine
and/or record in log
buttons in machine?
after cycle, 30-60 cc alcohol
attach green tag
Change water b/n scopes
Separate clean/dirty sink
Storage areas labeled "High
Level Disinfected: Ready for
Patient Use"
Green tags still attached
Scopes hung in cabinets
Brushes disposable OR HLD
between scopes
%
Compliance
1
2
3
4
5
1
1
1
1
1
1
0
0
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
0
1
0
0
0
1
0
1
0
1
1
1
1
1
1
1
1
1
100%
1
1
1
1
0
0
0
0
0
70%
91.3%
100%
100%
92%
Wearing correct PPE (gown,
facemask & goggles OR face
shield, bouffant cap) in
reprocessing room
clean hands/gloves when
needed
Metricide changed every 14
days, check with strips once a
day
% Compliance
1
1
0
1
1
1
1
1
1
1
1
1
1
1
1
94%
87%
88%
94%
94%
91%
Procedure Room Survey Results – MPU
3) For each task listed, check whether a
task is either done at setup, after the
procedure (pre-cleaning), both, or not at
all (or not applicable).
# Question
1 Flush scope with water
Wipe down scope with
2 alcohol/enzyme soaked pads
3 Flush with aseptizyme
4 Label scope as dirty
5 Remove green zip tie
6 White balance camera on scope
PreNot
Total
Setup
cleaning done N/A Responses
12
9
0
0
21
0
0
4
13
13
14
14
12
1
1
4) How is the scope brought into
procedure room/OR?
# Answer
1 In an unlabeled bin
2 Carried in with hands
3 In a bin labeled "clean"
4 Gotten from room - no transportation
Total
Response %
4
29%
5
36%
0
0%
5
36%
14
100%
5) How is the scope carried to the
reprocessing room?
# Answer
1 In an unlabeled, uncovered bin
2 In an uncovered bin labeled "dirty"
3 Carried in with hands
4 In an unlabeled, covered bin
5 In a covered bin labeled "dirty"
Total
Response %
0
0%
7
50%
1
7%
0
0%
6
43%
14
100%
0
0
0
0
0
0
0
0
0
0
14
14
16
14
14
93
6) Does the scope have a green HLD zip
tie attached to it when it is brought into
the procedure room/OR? If no, why?
# Answer
1 Yes
2 No
Total
Response %
13
93%
1
7%
14
100%
Reprocessing Room Survey Results – MPU
3) Is scope labeled as
dirty?
# Answer
1 Yes
2 No
Total
4) Is water/detergent
reused for each scope?
# Answer
1 Yes
2 No
Total
5) Are brushes
disposable?
# Answer
1 Yes
2 No
Total
6) If brushes are not
disposable, are they
disinfected?
# Answer
1 Yes
2 No
Total
7) How often are
Response
%
1 33%
2 67%
3 100%
Response
%
1 33%
2 67%
3 100%
Response
%
3 100%
0
0%
3 100%
Response
%
3 100%
0
0%
3 100%
brushes disinfected?
# Answer
1 Never
2 Daily
3 After each scope
4 Weekly
5 N/A
Total
Response
%
0
0%
2 67%
0
0%
0
0%
1 33%
3 100%
8) For each task listed, indicate whether
it is always, often, sometimes, rarely, or
never done in the reprocessing room
(or if not applicable, check "N/A")
# Question
Always
Often Sometimes Rarely Never N/A Total
1 Leak test
3
0
0
0
0
0
3
Wipe down scope
2 exterior
3
0
0
0
0
0
3
3 Brush channels
3
0
0
0
0
0
3
4 Brush buttons
3
0
0
0
0
0
3
5 Flush channels
3
0
0
0
0
0
3
6 Suction aseptizyme
3
0
0
0
0
0
3
7 Rinse with water
3
0
0
0
0
0
3
8 Purge water
3
0
0
0
0
0
3
9 Dry exterior
2
0
0
1
0
0
3
10 Manual disinfection
2
0
0
0
1
0
3
Automatic
11 disinfection (AER)
3
0
0
0
0
0
3
12 Clean sink
3
0
0
0
0
0
3
Flush channels with
13 alcohol
3
0
0
0
0
0
3
14 Dry with forced air
3
0
0
0
0
0
3
Attach custom
15 green zip tie
3
0
0
0
0
0
3
Put scope in
16 unlabeled bin
2
0
0
0
1
0
3
Put scope in bin
17 labeled "clean"
1
0
0
0
2
0
3
51
Appendix B.2 – Medical Procedures Center
Steps
Setup
Best Practice
East Ann Arbor: 10/11/13,
11/1/13, 11/8/13, 11/13/13
Using clean hands or gloves, attach scope
and irrigation
Remove green tag, and put on buttons
Do flush test
White balance
Coil scope and place to be ready for doctor
Observed scope being hand
carried to procedure room
Not sure if they did flush test
Upon second visit, scope was
already set up upon arrival. No
cup of water next on work station
indicated flush test may not have
been done.
Flush test only observed 1/5 times
1. Wipe exterior surface
2. Flush channels with detergent OR water
Needs to be in a bin to transport, with
gloves. Bin must be clearly indicated that
scope is dirty. Put bin on "dirty rack"
Wiped with alcohol pads. Flushed
using just water. This is where key
card was attached.
Bin taken to reprocessing room,
places on unlabeled rack next to
dirty sink
Pre-cleaning
Transportation
Reprocessing
1. Leak test after each use
2. Suction detergent
3. Brush all channels
4. Attach adapters
5. Flush all channels
6. Immerse scope in detergent in sink
7. Wipe/wash scope with pad
8. Rinse with tap water
9. Brush ports and buttons with soft brushes
10. Purge all water and dry exterior
11. Disinfecting
11a. Manual
-Suction/inject disinfectant into all
channels
-Totally immerse scope in disinfectant
and cover
-Soak minimum 20 minutes using a
timing device
-Remove scope and purge disinfectant
from all channels
-Rinse with sterile, filtered, or tap
water (in a sink specified for clean scopes)
-Purge water with forced air
-Flush channels with alcohol (syringe
of 30-60 cc)
-Dry with 2 minutes forced air
-Dry exterior with clean cloth
-Handle with clean hands and attach
visual cue
11b. AER
-Check chemicals in machine
-Enter patient and scope information
and/or record on log
-Put endoscope in machine
-Wait for two endoscopes to one
machine before connecting
-Attach hoses, put buttons (and
brushes) in machine
-Run cycle
-After final rinse, inject 30-60 cc alcohol
Attach Green Custom Tags
Transportation
/Storage
No indication how long scopes sit
in bins in REPO room before being
hung. Operator says people like to
pull from this location because the
scope is already in a bin. People
will pull from different location if
different type of scope or
attachment is needed.
Storage areas should be labeled with "High
Level Disinfected: Ready for Patient Use" on
a rack specifically for clean endoscopes.
Green Custom Tags still attached.
Miscellaneous
(PPE, brushes,
buttons)
Cheaper green tags being used one
week after custom tag launch.
Brushes should be disposable or high level
disinfected.
Buttons must be high level disinfected
NOTE: At end of weekday, scopes
are partially cleaned and not hung
up, except Fridays, where each
scope is HLD and hung up at the
end of the day.
NOTE: Operators hate green tags
Metricide needs to be changed every 14
days, check with strips once/day.
Trial
1
2
3
4
%
5 Compliance
Using clean
hands/gloves to handle
scope?
1
1
1
0
1
Remove green tag
Flush test
0
0
0
1
0
Steps
Setup
55%
White balance
0
0
0
1
0
1
1
1
1
1
1
1
1
Flush channels with
detergent OR water
Transportation Scope in bin
Wearing gloves?
to
reprocessing
Bin marked "dirty"?
room
Put bin on "dirty rack"
Leak test
1
1
1
1
0
1
1
1
1
1
0
1
1
1
1
1
0
1
1
1
1
0
1
1
1
1
0
1
Correct concentration
chemical?
Suction detergent
brush all channels
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Coil scope
Wipe exterior surface
100%
Pre-cleaning
immerse scope in
detergent in sink
wipe/wash scope with
pad
rinse with tap water
brush ports and buttons
with soft brushes
Reprocessing
purge all water and dry
exterior
Disinfection (AER)
check chemicals in
machine
enter patient info in
machine and/or record
in log
buttons in machine?
after cycle, 30-60 cc
alcohol
attach green tag
Change water b/n
scopes
Separate clean/dirty
sink?
Storage areas labeled
Transportation "High Level Disinfected:
/Storage
Ready for Patient Use"
Green tags still attached
75%
100%
100%
Scopes hung in cabinets
Miscellaneous
(PPE, brushes)
Brushes disposable OR
HLD between scopes
Wearing correct PPE
(gown, facemask &
goggles OR face shield,
bouffant cap) in
reprocessing room
clean hands/gloves
when needed
Metricide changed
every 14 days, check
with strips once a day
% Compliance
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
90% 90% 90% 93% 90%
100%
91%
Appendix B.3 – Mott OR
Steps
Setup
Pre-cleaning
Transportation
Reprocessing
Best Practice
Using clean hands or gloves, attach scope
and irrigation
Remove green tag, and put on buttons
Do flush test
White balance
Coil scope and place to be ready for doctor
1. Wipe exterior surface
2. Flush channels with detergent OR water
Needs to be in a bin to transport, with
gloves. Bin must be clearly indicated that
scope is dirty. Put bin on "dirty rack"
Mott OR: 11/4/13,
1. Leak test after each use
2. Suction detergent
3. Brush all channels
4. Attach adapters
5. Flush all channels
6. Immerse scope in detergent in sink
7. Wipe/wash scope with pad
8. Rinse with tap water
9. Brush ports and buttons with soft
brushes
10. Purge all water and dry exterior
11. Disinfecting
1st Observation: Use the same
gloves throughout shift.
Use the same detergent and
"clean" water until it looks dirty probably change 4-5 times a day
2nd Observation: Detergent
solution changed between
scopes/tools
Very aware of when to change
gloves (questioning if "double
gloves" idea is okay)
Brought up in "Soiled" elevator in
a red "dirty" bin
11a. Manual
-Suction/inject disinfectant into all
channels
-Totally immerse scope in disinfectant
and cover
-Soak minimum 20 minutes using a
timing device
-Remove scope and purge disinfectant
from all channels
-Rinse with sterile, filtered, or tap
water (in a sink specified for clean scopes)
-Purge water with forced air
-Flush channels with alcohol (syringe
of 30-60 cc)
-Dry with 2 minutes forced air
-Dry exterior with clean cloth
-Handle with clean hands and attach
visual cue
11b. AER
-Check chemicals in machine
-Enter patient and scope information
and/or record on log
-Put endoscope in machine
-Wait for two endoscopes to one
machine before connecting
-Attach hoses, put buttons (and
brushes) in machine
-Run cycle
-After final rinse, inject 30-60 cc
alcohol
Attach Green Custom Tags
Transportation
/Storage
Storage areas should be labeled with "High
Level Disinfected: Ready for Patient Use" on
a rack specifically for clean endoscopes.
Green Custom Tags still attached.
Miscellaneous
(PPE, brushes,
buttons)
Brushes should be disposable or high level
disinfected.
Buttons must be high level disinfected
Metricide needs to be changed every 14
days, check with strips once/day.
1st Observation: did not check
chemical levels in machine (policy
for Mott says check every time?)
2nd Observation: did not inject
alcohol, went straight to air
1st Observation: Take scope over
to "clean" side with dirty gloves.
Window between rooms is open
2nd Observation: Clean gloves to
transport scope to window.
Window was closed
New brush at the beginning of the
day.
Supposed to run through washer
but not confident that happens
Brushes accumulate in bin until
full enough to put in AER
New brushes/rag for each scope
Says check Metricide every scope,
but observed skipping this step
with one scope
Trial
2
%
3 Compliance
1
1
1
1
1
1
Coil scope
Wipe exterior surface
1
1
1
1
1
1
Flush channels with
detergent OR water
Scope in bin
Wearing gloves?
Bin marked "dirty"?
Put bin on "dirty rack"
Leak test
1
1
1
1
1
1
1
1
1
1
1
1
1
Correct concentration
chemical?
Suction detergent
brush all channels
0
1
1
0
1
1
0
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
0
1
1
1
1
1
1
1
1
1
0
0
1
Steps
1
Using clean
hands/gloves to handle
scope?
Setup
Pre-cleaning
Transportation
to reprocessing
room
Remove green tag
Flush test
White balance
immerse scope in
detergent in sink
wipe/wash scope with
pad
rinse with tap water
brush ports and buttons
with soft brushes
Reprocessing
purge all water and dry
exterior
Disinfection (AER)
check chemicals in
machine
enter patient info in
machine and/or record
in log
buttons in machine?
after cycle, 30-60 cc
alcohol
attach green tag
Change water b/n
scopes
1
100%
100%
100%
84%
Separate clean/dirty
sink?
Transportation
/Storage
Miscellaneous
(PPE, brushes)
0
1
1
1
1
1
1
1
1
100%
0
1
1
83%
1
1
1
0
1
1
1
1
1
Storage areas labeled
"High Level Disinfected:
Ready for Patient Use"
Green tags still attached
Scopes hung in cabinets
Brushes disposable OR
HLD between scopes
Wearing correct PPE
(gown, facemask &
goggles OR face shield,
bouffant cap) in
reprocessing room
clean hands/gloves
when needed
Metricide changed
every 14 days, check
with strips once a day
% Compliance
68% 94% 97%
86%
3) For each task listed, check whether a task is either done at setup, after
the procedure (pre-cleaning), both, or not at all (or not applicable).
PreNot
Total
# Question
Setup
cleaning done N/A Responses
Flush scope with
1 water
4
2
0
0
6
Wipe down scope
with
alcohol/enzyme
2 soaked pads
0
3
1
0
4
Flush with
3 aseptizyme
0
4
0
0
4
Label scope as
4 dirty
0
3
1
0
4
Remove green zip
5 tie
4
0
0
0
4
White balance
6 camera on scope
3
0
0
1
4
26
4) How is the scope brought into procedure room/OR?
# Answer
Response %
1
2
3
4
In an unlabeled
bin
Carried in with
hands
In a bin labeled
"clean"
Gotten from room
- no transportation
Total
0
0%
1
25%
0
0%
3
4
75%
100%
5) How is the scope carried to the reprocessing room?
# Answer
Response %
In an unlabeled,
1 uncovered bin
0
0%
In an uncovered
2 bin labeled "dirty"
1
25%
Carried in with
3 hands
0
0%
In an unlabeled,
4 covered bin
0
0%
In a covered bin
5 labeled "dirty"
3
75%
Total
4
100%
6) Does the scope have a green HLD zip tie attached to it when it is
brought into the procedure room/OR? If no, why?
# Answer
Response %
1 Yes
4
100%
2 No
0
0%
Total
4
100%
Appendix B.4 – UH-OR
Steps
Best Practice
Setup
Using clean hands or gloves, attach scope
and irrigation
Remove green tag, and put on buttons
Do flush test
White balance
Coil scope and place to be ready for doctor
UH OR: 10/15/13
Pre-cleaning
Transportation
1. Wipe exterior surface
2. Flush channels with detergent OR water
Needs to be in a bin to transport, with
gloves. Bin must be clearly indicated that
scope is dirty. Put bin on "dirty rack"
Channels are not flushed until
AFTER the procedure has been
completed and cart is taken to
reprocessing room
1. Leak test after each use
2. Suction detergent
3. Brush all channels
4. Attach adapters
5. Flush all channels
6. Immerse scope in detergent in sink
7. Wipe/wash scope with pad
8. Rinse with tap water
9. Brush ports and buttons with soft
brushes
10. Purge all water and dry exterior
11. Disinfecting
Reprocessing
11a. Manual
-Suction/inject disinfectant into all
channels
-Totally immerse scope in disinfectant
and cover
-Soak minimum 20 minutes using a
timing device
-Remove scope and purge disinfectant
from all channels
-Rinse with sterile, filtered, or tap
water (in a sink specified for clean scopes)
-Purge water with forced air
-Flush channels with alcohol (syringe
of 30-60 cc)
-Dry with 2 minutes forced air
-Dry exterior with clean cloth
-Handle with clean hands and attach
visual cue
Window between dirty and
clean room open
11b. AER
-Check chemicals in machine
-Enter patient and scope information
and/or record on log
-Put endoscope in machine
-Wait for two endoscopes to one
machine before connecting
-Attach hoses, put buttons (and
brushes) in machine
-Run cycle
-After final rinse, inject 30-60 cc
alcohol
Attach Green Custom Tags
Transportation
/Storage
Miscellaneous
(PPE, brushes,
buttons)
Storage areas should be labeled with "High
Level Disinfected: Ready for Patient Use" on
a rack specifically for clean endoscopes.
Green Custom Tags still attached.
Brushes should be disposable or high level
disinfected.
Buttons must be high level disinfected
Metricide needs to be changed every 14
days, check with strips once/day.
Trial
1 % Compliance
Steps
Setup
Buttons are not HLD, just
passed through washer, BUT
are sterilized
Using clean hands/gloves
to handle scope?
Remove green tag
Flush test
White balance
Coil scope
Wipe exterior surface
1
1
1
1
1
1
100%
50%
Pre-cleaning
Flush channels with
detergent OR water
Transportation Scope in bin
Wearing gloves?
to
reprocessing
Bin marked "dirty"?
room
Put bin on "dirty rack"
Leak test
0
1
1
1
1
1
Correct concentration
chemical?
Suction detergent
1
1
Reprocessing
100%
100%
brush all channels
immerse scope in
detergent in sink
wipe/wash scope with
pad
rinse with tap water
brush ports and buttons
with soft brushes
purge all water and dry
exterior
Disinfection (AER)
check chemicals in
machine
enter patient info in
machine and/or record in
log
buttons in machine?
after cycle, 30-60 cc
alcohol
attach green tag
Separate clean/dirty
sink?
Change water b/n scopes
1
1
1
1
1
1
1
1
1
1
1
1
Storage areas labeled
"High Level Disinfected:
Transportation
Ready for Patient Use"
/Storage
Green tags still attached
Scopes hung in cabinets
1
1
1
100%
Miscellaneous
(PPE, brushes)
1
100%
Brushes disposable OR
HLD between scopes
Wearing correct PPE
(gown, facemask &
goggles OR face shield,
bouffant cap) in
reprocessing room
clean hands/gloves when
needed
Metricide changed every
14 days, check with strips
once a day
% Compliance
1
1
1
97%
97%
Appendix B.5 – Taubman Otolaryngology Clinic
Appendix B.6 – The Center Center Urology Clinic
Appendix B.7 – Taubman Urology Clinic
Appendix B.8 – CVC
Appendix B.9 – Livonia Center for Specialty Care
Appendix B.10 – Livonia Center for Specialty Care Urology
Appendix B.11 – CW Peds Oto
Appendix B.12 – OBGYN REE BW01
Appendix B.13 – Mott OBGYN
3) For each task listed, check whether a task is either done at setup, after the
procedure (pre-cleaning), both, or not at all (or not applicable).
PreNot
Total
# Question
Setup
cleaning done N/A Responses
Flush scope with
1 water
0
1
0
0
Wipe down scope with
alcohol/enzyme
2 soaked pads
0
1
0
0
3 Flush with aseptizyme
0
1
0
0
4 Label scope as dirty
0
1
0
0
5 Remove green zip tie
0
1
0
0
6 White balance camera
1
0
0
0
1
1
1
1
1
1
on scope
6
4) How is the scope brought into procedure room/OR?
# Answer
Response %
1 In an unlabeled bin
0
0%
2 Carried in with hands
0
0%
3 In a bin labeled "clean"
1
100%
Gotten from room - no
4 transportation
0
0%
Total
1
100%
5) How is the scope carried to the reprocessing room?
# Answer
Response %
In an unlabeled,
1 uncovered bin
0
0%
In an uncovered bin
2 labeled "dirty"
0
0%
3 Carried in with hands
0
0%
In an unlabeled,
4 covered bin
0
0%
In a covered bin
5 labeled "dirty"
1
100%
Total
1
100%
6) Does the scope have a green HLD zip tie attached to it when it is brought
into the procedure room/OR? If no, why?
# Answer
Response %
1 Yes
1
100%
2 No
0
0%
Total
1
100%
3) Is scope labeled as
dirty?
# Answer
1 Yes
2 No
Total
Response
%
1 100%
0
0%
1 100%
4) Is water/detergent reused for each
scope?
# Answer
1 Yes
2 No
Total
5) Are brushes
disposable?
# Answer
1 Yes
2 No
Total
Response
%
0
1
1
Response
0%
100%
100%
%
0
1
1
0%
100%
100%
6) If brushes are not disposable, are they disinfected?
# Answer
Response
%
1 Yes
1 100%
2 No
0
0%
Total
1 100%
7) How often are
brushes disinfected?
# Answer
1 Never
2 Daily
3 After each scope
4 Weekly
5 N/A
Total
Response
8) For each task listed, indicate
whether it is always, often,
sometimes, rarely, or never done in
the reprocessing room (or if not
applicable, check "N/A")
# Question
Always
1 Leak test
Wipe down scope
2 exterior
3 Brush channels
4 Brush buttons
5 Flush channels
Suction
6 aseptizyme
%
0
0
1
0
0
1
0%
0%
100%
0%
0%
100%
Often Sometimes
Rarely Never N/A Total
1
0
0
0
0
0
1
1
1
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
1
1
1
1
1
0
0
0
0
0
1
7 Rinse with water
8 Purge water
9 Dry exterior
Manual
10 disinfection
Automatic
11 disinfection (AER)
12 Clean sink
Flush channels
13 with alcohol
Dry with forced
14 air
Attach custom
15 green zip tie
Put scope in
16 unlabeled bin
Put scope in bin
17 labeled "clean"
Appendix C – Audit Tools
External Audit Tool
Appendix C continued
External Audit Tool
1
1
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
1
1
1
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
1
1
1
1
1
0
0
0
0
0
1
1
0
0
0
0
0
1
1
0
0
0
0
0
1
1
0
0
0
0
0
1
1
0
0
0
0
0
1