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Sterile processing migrates towards electronic record-keeping
Increased accountability for sterility assurance indicators
by Jeannie Akridge
Ask any sterile processing department manager
who’s had to chase an elusive paper trail after finding a positive
biological indicator or in preparation for a JCAHO visit if they
would like an electronic record keeping system, and you’re sure to
get a resounding yes!
The SPD is centered around processes and
procedures that must be followed precisely, and painstakingly
documented and archived. Those documents speak volumes of the
integrity of the entire department, and even the hospital.
"In a hospital or healthcare delivery environment,
you can’t see if something is sterile, nor can you test for
something that is sterile. Because once you test for it, it’s no
longer sterile and can’t be used," said Janet Prust, marketing
manager for biological indicators, 3M Sterilization Assurance.
To monitor the sterilization process, the SPD uses
a variety of indicators, from chemical to biological to external,
and relies on its workers to use these tools correctly and perform
their jobs up to standard.
"Sterility assurance is looking at all of those
pieces of information, putting it together to have the best level
of confidence that the item indeed is sterile," said Prust. "The
last piece of that program is really the record-keeping aspect of
it. It’s putting all of those pieces of information into a
documentable format that can be used to be able to control those
processes but also to be able to be maintained and accessed in the
future if that sterilization process monitoring information is
Clearly, the need for accurate, up-to-the-minute,
easily accessible sterilization data is paramount. This can be
achieved with traditional, paper-based records, however, as many
facilities are discovering, electronic record keeping systems are
much less time-consuming and provide sizeable benefits.
While professional standards such as those from
the Association for the Advancement of Medical Instrumentation (AAMI)
do not currently specify the use of electronic records, they are
moving in that direction. AAMI first made a reference to
electronic records in its ST46: 2002 standard, (Steam
Sterilization and Sterility Assurance in Healthcare Settings),
stating that both paper and electronic records meet their
recommendations, explained Prust.
"Electronic records are actually preferable to
paper record systems," said Prust. "And that’s for a variety of
reasons: there’s data integrity, security, legibility. Electronic
records are designed in a way to require people to enter the
information before they can complete the process," she explained.
3M’s Record Keeping Software is a customizable
solution that enables hospitals to enter instrument sets,
equipment and parameters that need to be met to be able to release
a load, plus set permission levels for staff access. It also
allows tracking and productivity management reporting capabilities
on both a facility and system-wide basis.
Certainly many hospitals still rely on
labor-intensive, paper record-keeping systems, and when properly
applied, they can be quite effective. But change is imminent for
the SPD on many fronts.
"I think the majority of the hospitals are still
using paper-based [systems]. But many of them are migrating into
an electronic record keeping program because they see the benefits
of that. The other big piece that contributes to that is hospital
IT systems have made significant improvements in the last few
years. If we were talking five years ago, not a lot of sterile
processing departments had computers in them. Now nearly all of
them have computers in areas beyond just the manager’s office,"
said Prust. "Sterile processing departments really recognize, as
we all do in both our personal lives and professional lives, the
benefits of using IT technology to make our jobs easier."
According to Prust, IT support is key. "Facility
IT departments are very capable of meeting the needs of the
sterile processing department. But it is important that sterile
processing be prioritized – first identified and then prioritized
– when hospitals are setting out their IT expansion or improvement
Not only is electronic record keeping becoming
more plausible as the preferred method of documenting the
sterility assurance process, it may soon become a necessity moving
"But the reality is in the U.S. thus far, it’s
often perceived as a luxury and not a necessity," explained Todd
Nielsen, director of sales for infection control, Getinge USA. "In
other words, hospitals with a choice between getting one more
washer or one more sterilizer, and getting a software system,
reluctantly choose to get the other washer or sterilizer because
they must have those.
"Now, we’re seeing a shift in that because both
JCAHO and AAMI are beginning to become much more definitive about
the requirements that goods be traceable to the patient – that an
SPD be able to trace where goods were or to make a near immediate
recall of goods if they find that a BI goes bad," said Nielsen.
Prust agreed. "The standards are heading toward
the direction of a requirement to have all items that are
sterilized be able to be directly traced to the patient," she
noted. "Right now it’s not required except for items that are
implantable devices. But it’s clear that it’s going to be headed
that way in the future, and one of the reasons for that is because
electronic programs such as a record keeping software provide a
mechanism for the hospitals to do that. Electronic record keeping
allows that tracing all the way to the patient. So by implementing
that now, hospitals are really preparing for what will eventually
be needed," she said.
Ultimately, suppliers contend, these sterilization
records will be tied to each patient’s electronic health record (EHR).
"I think that’s the end-game, the Holy Grail," said Nielsen.
"Where you can electronically sit down at any PC in the hospital
and find a way in to determine which set of instruments was used
on Mrs. Jones’ hip surgery last August. On paper that’s an arduous
process at best, maybe impossible."
Regardless of the method, there will be obstacles
to overcome in tying these records to patients. "The greatest
challenge to complete sterilization record-keeping will be the
requirements of HIPPA law," predicted Mike Duckett, vice president
of operations, SterilTek Inc., a wholly owned subsidiary of STERIS
Corp. "It will be challenging for hospitals to protect patient
privacy while tying all sterilization data to each patient. Some
facilities have assigned neutral reference numbers that can
maintain the anonymity of the patient, but this requires
additional steps to retrieve the information if it is needed,
through an approved intermediary. The more complex process would
require a strong commitment and investment of time, money and
effort on the part of the hospital," said Duckett.
Systems that combine instrument tracking with
sterility assurance record-keeping will prove especially valuable
when tying instruments to patients. As with the 3M solution, most
of these systems use bar code tracking technology.
TGX Medical’s Alex Gold system tracks instruments
from the operating room through decontamination, set assembly and
sterilization to storage, ensuring that they have been properly
cleaned, assembled and maintained.
Getinge offers its T-DOC (Total Documentation)
productivity management system that tracks the location of
instrument sets, who’s handled them, what machines they’ve gone
into, their sterility and disinfection status, as well as
maintenance status, for example, whether the instrument is sharp
or the batteries need changing, explained Nielsen. "The key
hallmark that we have at Getinge is that we integrate the software
to the equipment. The washer- disinfectors and the sterilizers
speak in real-time to T-DOC and the database archives that
information for future reference."
Hand in hand with linking sterilized items to
individual patients is the push by states to instate legislation
mandating hospital reporting of infections. SPD record-keeping
will play a key role in this area as well.
"Mandatory reporting simply means more scrutiny in
all of the practices around reducing infection," said Prust.
"Sterilization is considered a sentinel event around surgical site
infections. So for a facility to be able to document and prove
that they did all of those things the right way via an electronic
record keeping system is a tremendous value for a facility."
By the same token, if a hospital has a high level
of reported infections, inadequate record keeping can "cast
suspicion on that sterile processing area relative to the
effectiveness of their sterilization practice," Prust added.
Getinge’s Nielsen explained that the European
regulatory environment is such that software systems are becoming
a necessity in the SPD. "The way we see that here in the U.S. is
that they’ve had more Mad Cow incidences and more prion outbreaks.
It’s those sorts of things unfortunately that get people’s
attention and cause change.
"Nosocomial infections don’t ordinarily get traced
back to SPD. But in reality, it may take one bad infection
incident to change the whole environment, whether it be for
training and resources that go to training, things like
certification, or whether they go to investing in things like
better record keeping systems or automation for those systems,"
Yet another prime motivation for hospitals to
implement an electronic record-keeping program in the SPD is that
the Joint Commission on Accreditation of Healthcare Organizations
(JCAHO) is starting its unannounced inspections this month.
"The level of interest in our record-keeping
software has quadrupled this year compared to where it was last
year," said Prust. "A lot of that is driven from this recognition
that hospitals need to be in a continuous state of compliance
versus, ‘we know the Joint Commission is coming in next June so
therefore we’re going to start preparing for it in March’. They
realize now, with the Joint Commission moving to unannounced
audits in 2006, that they need to be compliant, and they need to
be in a continuous state of compliance.
"And for sterile processing, one of the key things
an accrediting organization will look at is the records. Their
records are what they have to prove that they’ve done things the
right way – the only information that they have to prove that
they’ve done things the right way. Their policies and procedures
prove an intent to do it a certain way, but the records prove that
it was actually done," said Prust.
Getinge is helping facilities gain an advantage
for unannounced inspections with its Verified Performance Program
that centers around the SPD’s washing processes. "One of the
thought processes of why we developed the Getinge Verified
Performance Program was so that folks would be ready for those
unscheduled inspections," said Bob Hammond, director of consumable
operations, Getinge USA.
"Based upon the AAMI standards that are in place
today, the scale of measurement here after instruments are washed
is visual inspection. I think most of us would agree that a method
of visually inspecting the instrument is not a very good method,"
"So we really wanted to offer some means for the
customer to verify the performance of their washers. And that
really starts out with a thorough survey of their current
operations. We look at your product and processes, make
recommendations for improvement, look at the chemicals that you’re
using to wash your instruments and see if they’re really doing the
Hammond explained that one of the ways in which
Getinge verifies equipment performance is through a test from
Healthmark Industries called TOSI. In addition, the Getinge
Verified Performance Program can help hospitals to determine
whether they are over-using chemicals and wasting money, or
under-using to the point that they’re not getting instruments
"The Verified Performance is a bit of a seal of
approval, if you will," said Nielsen. "That doesn’t necessarily
insulate you from JCAHO inquiry, but certainly helps. It shows
that you’ve got a concerted system and you’ve taken steps." In the
same way, said Nielsen, "buying a software system…is equally
helpful in terms of helping JCAHO or any other inspector – state
inspector or national inspector – understand the level of effort
and investment that your hospital has made. It helps expedite that
Productivity, efficiency boost
Beyond regulations and mandates, an electronic
record-keeping system provides obvious productivity benefits both
in terms of daily SPD tasks and in record retrieval.
Prust explained. "It’s quicker and easier for the
technicians to record the information so there’s staff time
associated with the speed of being able to document the
information. From a management side, many facilities will do a
manual tally of information monthly off of their paper systems.
And an electronic system saves managers a tremendous amount of
time in doing the data collection and analysis to determine
department productivity and efficiency information."
In the event of a recall due to a biological
indicator result, having an electronic system in place can mean
"the difference between doing a search in your computer that can
happen in a split-second versus going to a file cabinet or
archival storage warehouse and digging through paper records,"
said Nielsen. "A good paper record system could get you there if
it’s consistently done day in and day out, but the power of
automation is really no contest."
What’s more, an electronic system can help to
standardize sterilization and record-keeping methods among SPD
employees with varying levels of expertise.
"You’re introducing greater possibility for error
in a paper system," said Tammy Torbert, marketing manager, 3M
Sterilization Assurance. "You’re relying upon each individual to
do it the right way. Do they know what fields they need to fill
in? Is it complete? Is it legible? Versus an electronic system
where you have all of the prompts and you can’t move forward until
you’ve met the requirements that the hospital has set up. So if we
say, where are most hospitals lacking [in their record-keeping
protocols], it’s with that control aspect. Is every employee on
every shift doing it the same way, the right way, the way that it
needs to be done if you have to go back and look for information?"
Similarly, "records directly reflect what is being
performed in the department and so poor or incomplete records can
maybe mask some performance issues or training needs within a
department," said Prust.
"Careful and thorough record-keeping should
provide the SPD manager with data that can be used to proactively
manage all sterilization processes," said SterilTek’s Duckett.
"The data should help the manager resolve quality issues, define
training requirements, help with staffing decisions, and identify
inventory issues and needs. The data should also tie back to the
performance expectations of the O.R. staff and surgeons, who are
the economic engine of the hospital. Overall, high quality
record-keeping should provide valuable data that can help improve
both internal (SPD) and external (O.R.) performance."
Another area tied to employee performance within
the sterilization process that an electronic record-keeping
program can help with is in the selection and use of sterility
assurance indicators such as biological and chemical indicators.
"A software program can help SPD workers with the
complex decisions around placing biological indicators (BIs) in
individual sterilization loads," said Duckett. "Software programs
for load and tray configuration can set the requirement for a BI
as part of the quality control system. If an operator does not
place a BI in a load that requires one, this non-conformance will
become evident in the exception reports that are generated for
implant loads, and may result in a recall of the load and
additional operator training."
Michael Good, CEO, TGX Medical, explained how the
Alex Gold system can help users with indicator verification. "As
sets containing implants are scanned onto the sterilizer load via
the Sterilization module, the program prompts you to add a
biological. Upon confirmation the user can then continue scanning
items onto the load. In addition, by using our software, and
placing a biological onto the load, you will be prompted at the
designated time to read the biological."
The advantages of an electronic record-keeping
system are numerous, with cost-saving and productivity enhancement
even beyond labor-savings.
For example, both Getinge’s T-DOC and TGX
Medical’s Alex Gold system provide powerful inventory management
features. Not only can such systems tell you the exact location of
instruments and what their maintenance and sterility status is,
but can also reveal usage patterns, show where instruments
typically become missing or damaged in the lifecycle process and
flag critical instruments and sets for quick turnaround. This can
help reduce unnecessary purchases due to lost or broken
instruments, reduce excess inventory, as well as help to ensure
that instruments are available when and where they’re needed.
By integrating instrument tracking with
sterilization record keeping, "this further streamlines the
process and adds another level of automation for the end-user. It
is a win/win for all parties involved," said Good.
Reducing or eliminating the number of cancelled or
delayed O.R. procedures is a key savings opportunity. "Imagine a
typical O.R. has about a $30,000/hr. operating run time with the
team and the capital equipment there. If you have to delay a
procedure 30 minutes while goods are being processed or
sterilized, that’s significant," said Nielsen.
In additon, "many hospitals have several
million dollars in instrument inventory and if you can save 3 or 5
percent of that in terms of inventory upkeep or repurchase on an
annual basis, that too is big dollars," Nielsen added.
An electronic system can also help avert seriously
costly sterilization mistakes. For example, if a technician was
about to steam sterilize a flexible endoscope, the system will
flash a warning message. "The ROI can really accelerate rapidly
when you save someone from burning up a $30,000 scope," said
According to Nielsen, a typical return on
investment for the T-DOC system is achieved in under two years.
Also, because it’s is a modular system, facilities can choose to
implement only the portions they want at that time. Some only
automate the data-logging from the equipment, while others have a
T-DOC station in every O.R. in the hospital, tracking goods down
to the patient level, he said.
Prust believes that the 3M Record Keeping Software
is well within reach for most facilities. "These record keeping
programs are not expensive programs. When you look at some of the
big major software applications in the hospital, whether they be
billing programs, or surgical scheduling programs, or some of the
materials management programs, you’re talking hundreds of
thousands of dollars for those programs. And a record keeping
software program is just a few thousand dollars. It’s a very
minimal expense actually in the scheme of things."
If your facility is not currently in the market
for an electronic record keeping program the thing to keep in mind
is that a good manual process can be a life-saver in any event.
"The best alternative [to an electronic system] is
a thorough manual record-keeping process that includes all the
policies, procedures and work practices that can be automated at a
later time," explained Duckett. "For ease of retrieval, the manual
records should be stored in small ‘packages’ of information,
chronologically. I suggest they be bundled by department, by day.
Most good electronic record-keeping systems are derived from their
manual counterparts, so they should already have a manual system
"The real trick with any of the [processes],
particularly the manual system is to be sure that the people are
trained, know how to use it and follow through," added 3M’s
Conversely, "Poor records can handcuff a facility
and they are at the mercy of their own tracking," said Dan Dwyer,
healthcare director of marketing, Raven Biological Laboratories.
Companies such as STERIS, SPSmedical, 3M and
Getinge all provide traditional paper-based record systems that
are designed to promote consistent, manual record-keeping
processes. Raven Biological Laboratories is just beginning to
provide record keeping products.
"Raven has taken a different approach to this,"
noted Dwyer. "As we have developed greater relationships within
specific facilities, we have asked them what they are looking for,
what do they need. It is not Raven’s goal to produce and sell
record keeping devices and booklets. We will provide as much as we
can as downloads on our website (www.ravenlabs.com) that will
allow the user to print off sheets that they can either place into
a 3-ring binder or keep in another type of log book. We plan to
offer a great variety of sizes and formats to accommodate those
using existing log books. We do not want to offer these as
additional products, however we will offer them as additional
"There’s considerable room for improvement," said
Duckett of current SPD record-keeping practices. "Tracking implies
that you’ve lost something; the goal should instead be to
proactively manage loads and instruments in sterilization
processes, rather than to reactively track them. Hospitals need to
get better at managing their instrument inventory by applying a
method similar to those used by manufacturers to manage their raw
"The SPD managers and technicians are doing a
great job, but they’re fighting a 21st century war with 20th
century tools, and they’re keeping pace, to their credit," Nielsen
The end result
Prust challenges facilities to place greater
emphasis on record-keeping policies. "Record keeping is often kind
of an afterthought. We talk a lot about biological indicators and
chemical indicators, but the key piece with that is that those
types of indicators provide information. And it’s the information
that the hospital actually keeps and uses and it’s important for
them both from a patient safety standpoint and a compliance
standpoint. It shouldn’t be an afterthought at all," reiterated
Prust. "That documentation provides the level of assurance that
they’re doing the right thing."
Certainly as additional mandates and regulations
began to take hold in the SPD, record-keeping policies and
procedures will only strengthen as a result.
"The future holds only good things for those in
SPD," said Dwyer. "The mandatory certification for CS workers
ensures that this profession will begin to get the respect it
deserves and CS will begin to be treated as the life and money
saving department it always has been. Since CS is one of the few
non-revenue generating departments in a hospital, it has been
incorrectly viewed as a department that only costs money. A
dedicated, professional and efficient sterile processing
department can be the most important department to the hospital’s
bottom line because of the reduction of nosocomial infections,
recalls and potential lawsuits. It is time the SPD was treated as
"Hospitals are beginning to realize the importance
of having professionals in these particular key positions. These
professionals will need the tools to help them succeed," said
About TGX Medical Systems
TGX Medical Systems Inc., the Indiana-based development software firm that owns the Alex Software, is headquartered in Carmel,
Indiana, USA. TGX Medical Systems designs, develops and markets software solutions for medical asset management and tracking.
These web-based systems work with specialized hardware supplied by major integrators. They are sold to small, medium and
large-sized hospitals and medical facilities. TGX Medical Systems's systems are distinguished from competition by their
sophisticated interfaces, scalability and ease of modification and are extensively patented. Our markets are worldwide.
The TGX Medical Systems website is www.tgxmedical.com.