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Columns and Departments
STERILE PROCESSING BENCHMARKS
Designing and Developing a
Central Sterile Supply Department
Donna Swenson
Many healthcare facilities are looking at ways
that they can attract new customers in a
responsible manner. One of the major
money makers in healthcare is surgery. For
many facilities, the challenge becomes how
to attract more surgical patients while
remaining efficient and cost effective. At least
part of the answer lies in looking at support
areas, such as sterile processing, which
provides an indispensable service for surgery.
An increase in the number of surgeries may
lead to a rise in sterile processing volumes.
Changes in sterile processing volumes may
require renovations, additional full-time
equivalent (FTEs), or an entirely new department. For sterile processing departments
(SPDs), the question then becomes, “How do
I accommodate the changes in surgery
effectively and efficiently?” One way to
approach this question is to benchmark your
department to other successful departments.
AAMI’s Sterile Processing Benchmarks
(SPB) tool can help.
Comparison of the healthcare facility, SPD
scope, current sterilization procedures and
practices, productivity analysis, staffing, and
resources can be used to ensure that the
new/renovated department compares
favorably to similar institutions.
By using the filters in the comparison module, one can narrow the comparisons to those
facilities that are most like your own in terms
of type of facility, number of beds, number of
surgical procedures performed, type of
community, geographic region, and peer
cluster. For illustrative purposes, I’ll now
consider facilities of 200-275 beds that
perform 9,400-12,200 surgical procedures per
year. Included are facilities of any type, in any
type of community, from any geographic
region and any peer cluster. The example
includes seven facilities.
Comparing Healthcare Facilities
A comparison of the characteristics of
healthcare facilities that are similar to the
example shows that 57 of them have continuous hours of operation.
One facility has 24-hour coverage Monday
About the Author
Donna Swenson,
CSPDM, CRCST,
CHL, works for
Synergy Health,
PLC as the onsite
clinical operations
manager of the
Sterile Processing Department
at Mount Sinai Hospital in
Chicago. She is co-chair of AAMI’s
committee for the ANSI/AAMI/ISO
17665 series and PB70. E-mail:
donna.swenson@att.net
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ing facility is planning on implementing a
formal system to handle complaints and
other issues.
A review of the information under the
compliance tab reveals that the majority of
facilities review policies and procedures to
ensure compliance with regulatory agencies
and professional organizations. Eighty-six
percent ensure compliance with the U.S.
Food and Drug Administration (FDA), the
Occupational Safety and Health Administration (OSHA), and state and local agencies.
One hundred percent ensure compliance
with AAMI standards and 86% with practices
from the Association of Perioperative
Registered Nurses (AORN). These figures
offer strong support for the argument that a
new or renovated department of similar size
and volume needs to:
1. Provide 24 hours of continuous coverage
2. Have a formal, documented system to log,
investigate, and resolve complaints/issues
reported by clinical users
3. Ensure that policies and procedures are in
compliance with FDA, OSHA, state and
local agencies, AAMI, and AORN.
SPD Scope
through Friday only. The need for continuous
coverage holds across all types of facilities—
urban, suburban, and rural—and in all
regions represented. Under the clinical
relationships tab, the results show that 86%
of the facilities have a formal, documented
system to log, investigate, and resolve
complaints from clinical users. The remain260
Biomedical Instrumentation & Technology May/June 2013
Although 57% of the facilities indicate that
they try to incorporate best practices into
department activities, a comparison of these
practices reveals that 71% have only a partial
continuous quality improvement process in
place. One facility is planning a future
program and one facility has a comprehensive quality process in place. This finding
indicates that most hospitals in this group
are struggling to implement a comprehensive
quality improvement process. A department
that does have such a process in place, then,
has a best practice in this area. Depending on
the culture of the hospital administration, it
may be difficult to get agreement on developing a comprehensive quality improvement
process at a new or renovated facility.
Additional work may be needed to justify
implementation of a comprehensive quality
improvement process.
Current Sterilization Procedures
And Practices
A review of the information under the
performance tab indicates that the majority
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of facilities are monitoring traffic control,
temperature and humidity, area cleanliness,
lighting, and error rates in each of the major
areas: cleaning and decontamination,
preparation and packaging, sterilization, and
sterile storage.
Additional items specific to each of the
areas are also being monitored by the
majority of facilities. In cleaning and decontamination, the majority of facilities also
monitor cleaning verification, documentation
of cleaning/decontamination, inspection of
decontaminated items, and equipment
repairs. In preparation and packaging, the
majority of facilities also monitor correct
composition of instrument sets, correct
packaging methods, inspection of instruments, and inspection of rigid sterilization
containers. In sterilization, the majority of
facilities also monitor sterilizer loading/
unloading procedures, sterilization parameters, documentation of physical, biological
and chemical monitoring, and incidence of
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positive biological indicators or chemical
indicators (BIs/CIs), incidence of wet pack,
steam quality issues, and equipment repairs.
Based on this information, a new or renovated department will need to ensure that a
comprehensive process is in place to monitor
the majority of aspects of sterile processing.
The current practices tab shows the
percentage of hospitals that are using:
1. Rigid sterilization containers versus
wrapping trays/sets
2. Reusable versus disposable textile packs
3. Reusable versus disposable basins
4. Reusable versus disposable surgical gowns
and drapes
To develop a “green” sustainable culture, a higher percentage
of rigid sterilization containers, reusable textile packs, reusable
basins, and reusable surgical gowns and drapes are needed.
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To develop a “green” sustainable culture, a
higher percentage of rigid sterilization
containers, reusable textile packs, reusable
basins, and reusable surgical gowns and
drapes are needed. This comparison can help
determine space allocation as reusable
products and containers will require more
storage space than disposable alternatives.
The second section on this tab shows the
approximate percentage of sterilization loads
that are run for each modality.
Analysis of this section indicates that all
the hospitals in the comparison have eliminated the use of ethylene oxide and
glutaraldehyde as sterilization processes.
Based on this information, providing either
of these sterilization modalities in a new or
renovated department will most likely not be
needed. If the facility has some items that
require one of these sterilization methods,
this information supports the idea that these
items should be replaced with other product
that can be sterilized by the other processes.
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It is unlikely that these methods need to be
included in a new or renovated department.
The error rate section shows that a maximum of two sterilization loads containing
implants were released without the BI results
in a year. The average is only one such
incident per year. This finding lends strong
support to the idea that processes should be
established to minimize the risk of any
sterilization loads containing an implant being
released without BI results. Such processes
may require additional instrument sets. The
analysis also reveals that single- and multivariable CIs are not being used by the facilities
in the example, thus providing justification on
using the more comprehensive integrating
and emulating type CIs. Overall error rates are
found to be relatively low with a median of 59
incidents in 2011. The calculated error rate is
just over zero. A low error rate indicates that a
comprehensive monitoring program is in
place and provides strong support that a
similar program must be included in a new or
renovated department.
Productivity Analysis
The SPB productivity analysis module can
help predict the number of FTEs needed with
an increase in the number of surgeries. For
example, a facility is intending to recruit a
new orthopedic surgeon who will perform
five total hip and five total knee procedures
per month. The trays and accessory items
needed to perform a total hip and a total knee
procedure are known. In this example, each
case will need:
1. Two peel pack items (intensity value 1)
a. (Two items x 10 procedures per month) x
12 months per year = 240 additional
intensity value 1 items per year;
2. One surgical case cart per procedure per
month (intensity value 2)
a. (One case cart x 10 procedures per month)
x 12 months per year = 120 additional
intensity value 2 items per year;
3. Two basic orthopedic trays are needed for
each total joint procedure (intensity value 2)
a. (Two trays x 10 procedures per month) x
12 months per year = 240 additional
intensity value 2 items per year;
4. Three complex orthopedic trays are needed
for each total joint procedure (intensity
value 3),
a. (Three trays x 10 procedures per month)
x 12 months = 360 additional intensity
value 3 items per year;
5. 10 trays of complex loaner instruments are
needed for each total joint procedure
(intensity value 4),
a. (10 trays x 10 procedures per month) x 12
months = 1200 additional intensity value
4 items per year.
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be added into the program (delete the current
information and replace with the data for the
changes). Keep a record of the current
information so that it can be added back later.
After all data for the change is entered, look
at the FTE results tab. The SPB tool will have
calculated the FTEs needed, and a chart can
be printed showing these results. This data
could provide a powerful argument for
obtaining approval for additional FTEs.
Staffing
To calculate the number of FTEs needed,
multiply each of the additional work load
items above by the time needed for each
intensity value.
1. 240 intensity value 1 items x 15 minutes =
3,600 minutes per year
2. 120 intensity value 2 items x 30 minutes =
3,600 minutes per year
3. 240 intensity value 2 items x 30 minutes =
7,200 minutes per year
4. 360 intensity value 3 items x 40 minutes =
14,400 minutes per year
5. 1200 intensity value 4 items x 75 minutes =
90,000 minutes per year
Total minutes needed per year to process
the additional surgical instruments/case carts
for 10 additional total joint procedures per
month are 118,800 minutes or 1,980 hours,
almost 1 FTE. Additional time needs to be
added for vacation and holiday coverage as
well as personal, fatigue, and delay factors.
This information strongly supports the need
to hire additional personnel to handle the
additional work. That was a simple example.
More complex changes in surgical volume
can also be determined by using the SPB
program. The data for expected changes can
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Continuing with the same example, when
looking at staffing for best practices, 25% of
the departments have a quality assurance
(QA) staffer, 25% have an instrument
tracking person, and 50% have a dedicated
SPD educator. It follows then, that for a new
or renovated department, inclusion of these
positions translates into a best practice in
this area. Still, depending on the culture of
the hospital administration, it may be
difficult to reach agreement on the need for
these positions. This is another area where
additional information could bolster the
argument for these positions. This section
also shows information on certification of the
staff and manager. According to the data,
most departments do not have a majority of
certified staff employees or managers.
Seventy-five percent require staff to be
certified within two years of employment, so
these numbers should rise in future years.
All of the managers are certified technicians,
but only 50% have management certification.
When looking at best practices, this information can be used to underscore the need for
requiring certification of both staff and
management personnel.
Resources
In the resources module of the SPB tool, the
most helpful information for designing a new
or renovated department can be found in the
tab on computer resources. According to the
information under this tab, 67% of departments have a computerized management
system for instrument tracking in place. Some
facilities also include computerized management of staffing and payroll. All departments
have access to the organization’s intranet. Most
departments have access to various online
resources: e-mail, internet, AAMI, and the
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International Association of Healthcare
Central Service Material Management
(IAHCSMM). The data suggests that a modern
sterile processing department must have
computerized systems to manage the work
that is performed. This information provides
justification for providing these types of
resources in the new/renovated department.
Conclusion
The discussion above shows many ways in
which the AAMI SPB tool can be used to
help design and staff a new or renovated
department. A majority of departments
provide for 24-hour coverage. Policies and
procedures must be kept up to date and in
compliance with FDA, OSHA, state and local
agencies, AAMI, and AORN. Formal,
documented systems to log, investigate, and
resolve complaints reported by clinical users
are needed. A continuous quality improvement program is needed for the department
to be considered one of the best. A
comprehensive monitoring program is
needed to ensure compliance with regulatory
agencies and department policies and
procedures. Analysis of predicted numbers of
surgical procedures can be used to determine
staffing requirements. Staff also needs to be
well trained and certified. Computerized
management systems are needed to ensure
that the department operates at optimum
efficiency and does so effectively. SPB is a
powerful tool that can be used to justify
decisions made in the design of the new
renovated department. n
A comprehensive monitoring program
is needed to ensure compliance with
regulatory agencies and department
policies and procedures.
AAMI ST79
Sterilization Posters
Colorful, eye-catching, and informative, this
set of five posters are a quick reference guide.
Pulled from ST79, the posters focus on:
 Immediate-Use Steam Sterilization
 Loading the Sterilizer
 Sterilization Cycle Monitoring
 Sterilization Process Failures
 Checklist to Identify Reasons for Steam
Sterilization Process Failures
These 18” x 24” posters are laminated to
extend their life and allow for cleaning.
Order Code: POSTER-S
List: $89 / AAMI member: $59
To order, call +1-877-249-8226 or visit
www.aami.org/publications/posters/posters.html
SOURCE CODE: PB
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