Work Together to Build Patient Safety

In his editorial for the newsletter, Prescriptions for Excellence
in Health Care
, David B. Nash, MD, MBA, dean of the Jefferson School of
Population Health at Thomas Jefferson University, asked, “Is there a
specific point along the health care delivery continuum at which the risk for
compromising patient safety and quality care is dangerously high?” Nash
concluded that transition of care (TOC), the brief moment when a patient leaves
their primary provider and is received by a specialist, has the greatest
possibility for miscommunication of important patient information and
documents, potentially leading to misdiagnosis or medical error. O&P
practitioners and their patients are certainly a part of that delivery
continuum, working in conjunction with primary care physicians, surgeons and
occupational or physical therapists on a daily basis. O&P professionals
documentation or
medical errors without practicing the necessary patient safety
precautions in a clinical setting.

What is a medical error?

The Institute of Medicine (IOM) defines a medical error as the failure
of a planned action to be completed as intended or the use of a wrong plan to
achieve an aim. Common occurrences of medical errors include adverse drug
events, surgical injuries, falls, burns, improper transfusions or death. Error
rates are most common among intensive care units, operating rooms and emergency
departments, according to IOM’s To Err Is Human: Building a Safer
Health System


The numbers are daunting. According to the IOM landmark report, at least
44,000 people and perhaps as many as 98,000 people die in hospitals each year
as a result of preventable medical errors. Taking into consideration additional
care due to the errors, lost income, household productivity and disability, it
is estimated that the cost of these errors is between $17 billion and $29
billion annually. Most in the patient safety field believe the IOM estimates
are low. The CDC reported that more than 100,000 died in 2006 from hospital
acquired infection alone. New data emerged in April suggesting that medical
errors are ten times what the IOM estimated.

How is medical error prevention taught?

Medical errors and patient safety are covered in different ways. Medical
error prevention is taught in O&P schools and practiced in the clinical
setting. But what is being taught? Can those lessons be improved upon at the
master’s level?

  Dennis E. Clark
  Dennis E. Clark

When an O&P student is in school, at some point he or she will
ambulate a patient on a diagnostic socket and will learn how to dynamically
align the prosthesis. In that process, he or she will be instructed on what to
look for before a transfemoral or transtibial patient applies weight to the
prosthesis. Practitioners must be certain that the device is ready for weight
bearing. Those are critical issues in the process, according to Dennis E.
Clark, CPO, president of the Orthotic and Prosthetic Group of America.

Each practice will have a process that they use — a policy and
procedure for a certain situation. If a practitioner tries a different foot, he
or she can still fall back on their policies and procedures. Are all of the
screws tightened to factory standards? As the practitioner makes changes
throughout the process, they must fall back on those procedures as if it is the
first time.

“When a practitioner gets lax or hurried, they skip a step and that
is when problems occur,” Clark said.

It is important to create a standardized procedure because most
practices employ more than one practitioner. There will be an occasion when
another practitioner examines your patient, even within your own practice.
Clark recommends having a policy in place that is conducive to your
company’s management care style. If documentation is consistent and
thorough then you will not run into problems or miss things from practitioner
to practitioner along the health care line.


Documentation and proper
billing practices are part of the curriculum at Northwestern
University Prosthetics-Orthotics Center (NUPOC). Students are taught to contact
a physician if there are any changes to be made to a prescription.
Practitioners can only fill out a prescriptions if is written. If there is a
problem, they must contact the physician immediately.

  Thomas P. Karolewski
  Thomas P. Karolewski

“I think you get more of a feel for that when you get into a
residency and a private practice,” Clark said. “Different people use
different methods for documentation. I think it is important to be consistent
from patient visit to patient visit so you or anyone in your practice who needs
to can take a look at your patient. This consistency ensures that the
practitioners do not repeat a problem or attempt a solution that has already
been attempted and failed.”

Clark cited
regulatory changes throughout the last decade as one of the
reasons for improved documentation among the O&P industry.

“We are getting better all the time and that leads to a more
professional practice and in turn leading to more consistent quality
outcomes,” he said. “The byproduct of utilizing consistent systems
and protocol is that you have a better chance of realizing what works in your
practice and what is driving the types of outcomes that you are looking for. If
you do not have a protocol, then how do you know if you are maximizing your

Patient safety

Patient safety is a different subject, according to Thomas P.
Karolewski, CP, FAAOP, director of prosthetics at NUPOC and member of the
O&P Business News Practitioner Advisory Council. Model
demonstrators visit NUPOC and the students work with them in a clinical
setting. Karolewski’s number one priority is patient safety.

“We make sure that before any prosthesis goes on the patient, the
faculty examines everything from sharp trim lines in the upper limb to exposed
cables that could damage or hurt the patient,” he said.

The students’ interaction and bedside manners are closely
monitored. Bedside manner is just as crucial to patient safety as a crack in a
prosthesis. If there is an interaction that is considered a personality
conflict, the situation is immediately addressed.

The students are also taught spotting techniques and at NUPOC, there is
a therapist who teaches the students how to properly monitor the patients’
first steps with a prosthesis. If there are two students per each patient who
is walking, one person will monitor alignment while the other is spotting.

“When we talk about lower extremity prosthetics, since they are
weight bearing, we really need to pay attention,” Karolewski said.
“If at any point we hear any noises, the patient needs to sit down
immediately. There are certain people we do not let outside the parallel bars
if we do not feel comfortable. We have some younger, more active individuals we
let walk in the hallways after we wrapped the prosthesis in fiberglass

Patient safety is planned to be a part of NUPOC’s master’s
program. They are also discussing the possibility of collaborating with
Feinberg School of Medicine, Northwestern University.

“We are going to offer how to teach bedside manners, for
example,” Karolewski said. “Our medical school has 20 or so treatment
rooms and they have video cameras. We can watch the interaction between the
student and the patient. A professor can critique it afterwards. Patient
interaction is something we have in our plans.”

Error prevention during TOC

Karolewski found that the burden of responsibility regarding gait
training has been thrown onto the O&P industry. His students are taught
more in the realm of initial gait training because O&P practitioners are
the first people with whom the patient takes a step. Due to this increased
responsibility, the onus is on the O&P practitioner to form a good rapport
with the physical therapist, occupational therapist and/or physician.

“Do not complain about the care your patient is receiving if you
are not going in there and setting the standards,” Karolewski said.
“If you want your patient, who just donned this brand new technology, to
get the best care possible, you have to set the standards. Work with the
physical therapist and tell them this is how the prosthesis functions, this is
what I think you should do and these are the muscles or the gait training you
should work on. Maybe the therapy staff has never seen that type of technology
or prosthesis before. If they do not know how it functions, you can not expect
them to teach it properly.”

Team approach

Karolewski recalled his early days in the profession when clinics were
in vogue.

“You do not hear much about it now, but when I was in school, the
team approach was big,” he explained. “We had collaboration between
the practitioner, physician, and therapists, nursing staff and maybe a social
worker or psychologist. I think it is imperative that the other practitioners
have an open house. I tell my students have them come into your office so they
get to see your facility, meet the staff and bring in a patient and show them
how you operate.”

Residents should visit the hospitals and conduct in-services with the
therapists. Do not be afraid to bring a patient with you to show a therapist
how to use a component.

“Show [the therapist] a patient with a C-leg for example,”
Karolewski said. “Show them the modes and capabilities of the knee. Show
the therapist how they can help develop a plan for a solution.”

Fall This Way

Thomas P. Karolewski, CP, FAAOP director of prosthetics, at
NUPOC, emphasizes patient safety to his students. The truth is, the patient
will fall and it is the practitioner’s responsibility to teach their
patients the proper way to fall. NUPOC employs a blended program — 22
weeks online and 11 weeks in clinical setting. Karolewski found that even
though proper fall methods are taught online, NUPOC may need to create a
session in-house on gait training.

“All of this technology is great, but one of the first
things you need to teach the patient is how to fall because they are going to
fall and when they do, they need to know how to get up,” Karolewski said.
“Students view gait training videos that help teach the proper ways for an
amputee to fall and recover. “

Karolewski teaches to his students to temper the
patient’s expectations.

“You do not promise them anything,” he said.
“They will probably fall between now and the time their life ends. But
there is a right way and wrong way to accept the fall. I tell the students you
need to collaborate with the physical therapist to train the patients on proper
fall techniques, how to accept the fall and how to get up from a fall.”

There is a product in the market called the safety knee.
Karolewski advises his students against calling the device a safety knee. The
patient hears that term and assumes their knee is perfectly safe. But when they
fall, they blame the practitioner because they said the knee was safe.
Karolewski and his students call the device a stance control knee and explain
ian. Practitioners can not be afraid to
communicate back to the physicians. They will not think less of us. In fact,
the opposite is true. It is just a matter of being a professional.”

Mitigate the risk

Clark recommended being absolutely certain of a patients’
ambulatory status and ability, along with how much assistance or help they will
need in the clinical setting.

“Be there to help even if the patient doesn’t need help,”
Clark explained. “The utilization of a gait belt is necessary even if the
patient protests a little bit.”

If the patient does protest, Clark recommended citing the
practice’s policy. Explain to the patient that you will only intervene if
necessary. Create a checklist with respect to the fabrication process. How are
things attached? How do you know they were done properly? You can start in the
lab. Patient assessment and consistent reliable processes are crucial in order
to be certain that the diagnostic socket was appropriately handled.

Many patients are using care extenders prior to the practitioner visit.
Clark insisted that the O&P practitioner must train other practitioners on
how to apply safe standards within the practice.

“A socket breaking down in your parking lot is totally avoidable if
you are following guidelines or a set of criteria within your practice,”
Clark said.

Informed consent

In O&P, where there is a certain trial and error embedded in the
landscape of the profession, an informed consent document or process is the
perfect place to reset the patient’s expectations.

“You are giving them the choice to have a new solution that may
help them in ways old solutions can not, but there are new risks
involved,” Martin J. Hatlie, JD, chief executive officer, Project Patient
Care said. “If those risks are explained, people are better empowered to
make the decision best for them and most people will understand them.”

Warning signs

Practitioners must recognize the warning signs. The standards that are
set in the classroom educate future practitioners on recognizing a problem. It
always goes back to proper documentation. Clark said that practitioners tend to
document correctly when things are running smoothly with a patient but are more
hesitant to document when things are not going as planned.

“We need to be just as clear when we are not getting the results we
want,” Clark said. “Document what your change in management is going
to be and your expectations going forward. You would like to make the right
call and have everything go well every time but that is just not the case

Disclosure and honesty

What should a practitioner do if they make the wrong call?

“It is a good idea to start communicating with a patient that is
unhappy or they think is unhappy as soon as possible,” Hatlie explained to
O&P Business News. “Even before you know it is an error,
oftentimes a practitioner or physician can never tell for sure. They just know
something has not gone right.”

Why the procedure or the fitting did not go as planned takes some
investigation. But from the patients’ point of view, they have a right to
know the situation. People are entitled to the information about their own
bodies. That type of language can be found all the way back to the Hippocratic
Oath and is firmly embedded in the modern understanding of human rights,
according to Hatlie.

Physicians and practitioners may think that it is better not to say
something before they have all of the answers. But what they miss is the
opportunity to have a difficult conversation, but one that demonstrates that
there is a communication flow with the patient. Several studies have
consistently shown, according to Hatlie, that patients want to know if
something is wrong and they want hear it from someone they trust.

“It is a perfect role for the doctor to play because that is the
person the patient wants to trust,” Hatlie said. “What I see, way too
often, is that when a doctor thinks there has been a mistake, they let the
patient management staff handle it and that just is not as effective as the
trusted authority figure having a conversation with the patient.”

There is no guarantee that an immediate conversation with a patient will
eliminate litigation. But what Hatlie can say with almost certainty is that a
lawsuit will be easier to settle and the payout will be less significant if a
conversation between a practitioner and patient has taken place. According to
Hatlie, the best case scenario is the communication between practitioner and
patients leads to increased trust even after the event. In the worst case,
communication diffuses the anger of the jury when the physician or practitioner
has followed the proper procedures.

“We must remember our role as a prosthetist and that is to give
function back,” Clark said. “That process has to be safe. Following
standards and a checklist that is part of your policies and procedures will
help maintain that safety. No one is perfect, so if you have these policies in
place and the unthinkable happens, a practitioner can at least go back and say
they did everything to mitigate that risk.” — by Anthony Calabro

For more information:

  • Classen, David. Global trigger tool shows that adverse events in
    hospitals may be ten times greater than previously measured. Health
    . Available at: Accessed April 13, 2011.

  • Kohn L, Korrigan J, Donaldson M, Eds. To Err is Human:
    Building a Safer Health System
    . Committee on Quality of Health Care in
    America, Institute of Medicine. Washington DC: National Academy Press; 2000.

  • Nash, David B., Lost in transition. Prescritptions for
    Excellence in Health Care
    . 2010;10:1-2.

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