Albany Medical
Center's SPD staff use checklists
for consistent process quality.
All
aspects of patient care warrant focused attention to drive quality
assurance, process improvement and, above all, positive outcomes. Nowhere is
that degree of due diligence more crucial than in the sterile processing
department – where the challenges of a perpetually harried pace and
ever-evolving instrumentation are often exacerbated by limited resources and
split-second customer demands from the Operating Room and other healthcare
customers.
"The healthcare field is dynamic.
Scientific advances have brought about some incredible advances in surgical
and medical technology and instrumentation, which has advanced the quality
of care. This new technology is more complex than ever before and thus
presents a great challenge to SPDs, relative to care, reprocessing and
sterilization," said Ray Taurasi, MBA, CRCST, CHL, FCS, ACE, director of
clinical sales and service, eastern region,
Healthmark Industries. "SPD
requires the tools, resources and knowledge to address these new challenges
and ensure quality outcomes."
Process consistency across all functions of
the SPD is essential for driving quality, and it’s even more critical given
the numerous technicians and multiple shifts that must address
instrumentation in an appropriate and efficient manner, explained Jodi
Rummelhart, marketing manager, V. Mueller IMPRESS products at
CareFusion.
"Key processes include how items are received into decontamination, how
individual sets are assembled, and how sterilization documentation is
managed. The intention is to have items effectively addressed on a
consistent basis in the facility," Rummelhart reasoned.
Despite its importance, not every SPD is
engaging in comprehensive QA initiatives, however. And it’s a significant
shortcoming that can lead to inefficiencies and, even more importantly,
risky shortcuts, experts told Healthcare Purchasing News.
A significant obstacle many SPD staff face
is the lack of understanding by those outside the SPD of just how complex
instrument processing has become, reasoned Chuck Hughes, general manager,
SPSmedical Supply Corp., Rush, NY.
"After cleaning comes inspection, assembly,
packaging, sterilizer loading, sterilization – sometimes an extended cycle –
unloading, and, finally, cooling the package to room temperature before
distribution," he said. "All this takes special resources and time. Many
healthcare facilities have not provided their SPD with enough physical
space, proper environmental controls, cleaning equipment, and/or skilled
personnel to perform these critical tasks in accordance with manufacturers’
IFUs and best practices."
Time and staffing limitations aren’t
helping, either. "There is so much information for SPD staff members to know
as things become more specialized and instruments become more intricate –
and it can be a challenge to understand it all," said Janet Moran, RN, MBA,
CNOR, clinical education consultant for
ASP.
A culture of complacency is another
obstacle standing in the way of SPD success, added educator Angela Lewellyn,
CRCST, of Advantage Support Services Inc.
"You can’t believe how many facilities I
visit that aren’t focused on quality assurance and consistently doing what’s
right each and every time. I often hear from seasoned technicians who say
‘the way we have always done things has worked, so why change now?’ In
reality, the way things have always been done is not working; otherwise, I
would not be there."
Before embarking upon a QA initiative,
Moran suggests that SPDs begin by evaluating current policies, procedures
and practices to determine whether standards, recommended practices and
guidelines (including manufacturer instructions for use) are being followed.
From there, efficiency and work flow should be evaluated to pinpoint wasted
or inefficient steps that are impeding work flow. Worker and patient safety
also play a vital part in any effective QA process, Moran explained, with
SPD professionals taking a close and honest look at whether staff members
have been given adequate supervision and education, and are proficient in
the tasks that they are assigned.
Coming
clean on QA
While quality assurance is often discussed
in the realm of sterilization – that is, following specific steps and
processes to up the odds that the sterilization process was successful –
experts stress that the most effective QA processes are far-reaching, if not
all-encompassing.
Spectrum Surgical
Instruments SpectraMat
and Surgical Instrument Flash Cards
"Quality assurance really involves every
step and function of the department," confirmed Lewellyn, adding that SPD
professionals can think of their department as a sort of high-level,
critically important assembly line, where each step is equally important and
builds upon the last. "If one step is rushed or missed, every other step
that happens thereafter is impacted, and quality is jeopardized."
One of the most critical – yet
oft-overlooked – steps is diligent instrument cleaning and cleaning
validation, vendor experts noted. "The focus has always been on
sterilization QA, and there are countless recommendations, requirements and
tools to monitor and document the outcome of the sterilization process,"
Taurasi explained. "Yet we all know that if adequate cleaning of medical
devices is not achieved, soil and microbial residuals will impede
sterilization."
Proper cleaning takes time – often, plenty
of it. Cleaning alone can take more than one hour to complete for complex
instrumentation, noted Hughes, and cleaning requirements may become even
more stringent in the near future. "Having attended and presented at the
recent AAMI/FDA Summit on Medical Device Reprocessing, I can tell you that
even more complex cleaning instructions for use are coming," he said.
Recognizing that such gaps in cleaning
widely exist, both the Association for the Advancement of Medical
Instrumentation and the Association for periOperative Registered Nurses now
recommend the implementation of a QA program to ensure the efficacy of the
cleaning process. Unfortunately, many healthcare organizations have been
slow to heed the recommendations, according to Taurasi – a shortcoming he
says is particularly problematic given the countless media reports of
cleaning failures on all types of medical instrumentation, devices and
endoscopes.
Keen visual inspection isn’t always enough,
either, warned Hughes. "Visual inspection can be done for many routine
instruments; however, some devices need specialized inspection tools," he
said, adding that lumened devices are one example that fall into the latter
category.
Vendor experts contend that one important
step SPD professionals can take to drive quality and promote patient safety
is to rely on the range of cleaning verification tools that can help them
assess cleaning processes, machines and methods. "Implementing a system for
monitoring washer performance, such as routine washer verification tests or
directly testing a sample of instruments for cleanliness using ATP, protein
or other methods after they come from decontamination would be an important
step," stressed Don Socha, CSPDT, product marketing manager, washers,
Getinge USA, Rochester, NY.
Despite the value of such products, experts
stressed that they’re only beneficial when used properly. "Users must choose
carefully and select the proper testing method and device for the cleaning
application and process they are monitoring," Taurasi stressed.
Decontamination and tray audits can also go
a long way toward improving quality and identifying performance issues that
can then be addressed through targeted, continued education. To provide an
accurate "read" on overall quality, these internal audits must be ongoing
and consistent, and – for tray audits – should be based on a consistent
sample of total reprocessing volume. Decontamination audits should be based
on case volume, according to Scott Kaczmarek, clinical operations director
for IMS.
"Any significant fluctuations in the
percentage of data sampled can skew the results and invalidate the initial
baseline," he warned. For tray audits, he recommends that a minimum of 5
percent of average total reprocessing volume be sampled, and the same
minimum percentage also applies to average case volume for decontamination
audits. Conducting "post-case" audits on the condition of instruments coming
from the end user to the SPD prior to decontamination can offer further QA
benefits. As Kaczmarek explained, these audits offer valuable insight into
how customer departments are preparing instruments post-case. "Improperly
handled instruments at the point of use heavily impact the job of any SPD."
Audits have played a key role in the SPD’s
QA process at Albany Medical Center. Sterile processing manager Carmen J.
Ferriero III, MBA, implemented both pre- and post-decontamination checklists
that are checked and double-checked (and include staff initials, as well as
their printed and signed name) to ensure that important steps in the process
have not been overlooked. "They consist of five to ten simple, but important
checks," such as whether the tape has turned, locks are on containers,
filters are in place, and so on, said Ferriero.
"We have a zero tolerance for dirty
instruments showing up on the clean side."
At the heart of Ferriero’s QA focus lies an
understanding that quality must always trump quantity.
"If you process 100 sets and 80 are
perfect, that should never be okay. I’ll take 80 sets where each one is done
correctly any day of the week. Speed means nothing if quality suffers." If
errors do occur, he takes corrective action and provides targeted education,
using guidelines and standards for support. Cameras serve as a supplemental
educational tool, allowing Ferriero and his team to capture shortcuts,
missteps, damage, and other instrumentation- and processing-related
shortcomings that impact quality and safety.
ASP’s STERRAD NX100
Pushing the
boundaries of quality
The same due diligence required for
decontamination also applies to sterilization – and every step in-between
and thereafter. On the sterilization side, monitoring every sterilization
load with a biological indicator process challenge device and holding load
items until the BI result is available is one important best practice that
can be implemented to promote quality assurance in the SPD, noted Susan
Flynn, technical service specialist for
3M Infection Prevention.
Conducting an annual sterilization risk
analysis is another valuable, yet under-practiced exercise – and one that is
recommended in ANSI/AAMI ST79, Flynn pointed out. "By stepping back and
assessing potential causes of sterilization process failures, the
probability of their occurrence and the risk association with each potential
failure, department resources and continuous quality improvement projects
can be prioritized to ensure that critical issues are addressed
proactively."
Vendors offer valuable educational tools,
inservices, resources, and ongoing customer support – often free of charge.
"Many hospitals don’t take advantage of the
educational resources they have with their suppliers," noted Derek Lashua,
marketing director for
Spectrum Surgical Instruments Inc., Stow, OH.
Quality-focused manufacturers are also
there to assist end users with proper interpretation and implementation of
their instructions for use. "SPDs tend to fall short in their knowledge and
utilization of manufacturers’ instructions. With so many vendors moving
instrument sets through the department on a daily basis, it can be
challenging for staff to keep up with each set’s instructions for use;
however, this is a detail that can’t be overlooked," said Lena Burgess,
CRCST, CHL, CSPDM, regional clinical operations director, IMS.
SPDs should also get their customers
(especially those in the OR) involved in the process. Sources stressed that
one of the biggest barriers to SPD quality is the OR customer that lacks an
understanding of the importance of the process and pushes for faster
turnaround time and other shortcuts. "This can be addressed by explaining to
the OR the importance of the complete process, providing them better
visibility to their instrument sets and having them approve any shortcuts to
the process using a form that highlights the risk of patient infection,"
explained Socha.
A similar approach applies to the SPD. One
effective strategy that can improve an SPD’s QA efforts, according to
Lewellyn, involves having SPD staff experience an actual surgical case. "We
usually have a short aseptic technique class that incorporates the culture
inside an OR suite," she said. That way, staff can see firsthand how
instruments are used and how damaged, dirty or otherwise malfunctioning
devices can impact the surgical team and, most importantly, the patient.
Actively engaging the OR in the SPD’s QA
initiatives can garner far-reaching benefits by keeping both departments
focused on the common goals, reasoned Flynn. "For example, compliance with
documentation for immediate-use sterilization, working with vendors on
compliance with loaner instrumentation policies to reduce the incidence of
IUSS cycles, and improving the accuracy of pick lists to minimize OR late
starts caused by unavailability of instrumentation."
Assess,
evaluate, document
Taking the time to carefully assess each
instrument and its components in each step of the process, routinely test
devices to ensure that they’re functioning optimally, and engage in a
preventive instrument maintenance program is equally imperative; however
some of these basics are often overlooked because of the misconception that
they take too much time.
"This is not always true," assured Lashua.
Case in point: Scissor sharpness testing in the department once a week can
drastically improve surgeon satisfaction and patient safety, he said.
To promote enduring quality, those types of
checks and balances should apply across the board, as well. "Institute a
formal mechanism for end-user feedback to ensure that quality issues, such
as missing or malfunctioning instruments, torn wrappers, or failing internal
chemical indicators, are reported back to the CSSD, along with the
associated load identification information," recommended Flynn. "Defect
rates can then be tracked over time and corrective action procedures
implemented when warranted because of risk of frequency of occurrence." She
added that communicating productivity and defect rates by posting charts in
the department can help keep the focus on improving key quality metrics.
Consistent, thorough documentation can also
serve another critical purpose: demonstrating to infection preventionists,
departmental directors and C-level executives the improvements that have
taken place in the SPD, as well as any lingering obstacles that may be
negatively impacting quality, safety and overall efficiencies.
"Hospitals and healthcare organizations
need to recognize the importance that the SPD plays in infection prevention.
They can link the SPD with the surgery cost center so that more emphasis can
be placed on proper care and handling of instruments to save costs on
repairs and, more importantly, to decrease the occurrence of surgical site
infections," said Moran. "Although [the SPD] is not a revenue-producing
area, it is important to highlight that it can be a cost-saving area."
Even more importantly, though, SPD
supervisors and managers must use the QA data collected to engage, empower
and educate technicians.
"A great process is only as good as the
person executing the task," noted Jeff Christie, owner of Advantage Support
Services Inc. "Develop great staff and get great results."
