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Legal Perils
and Pitfalls of
Wound Care
Heidi Cross, MSN, RN, FNP-BC, CWON, CSWS
Table of Contents
About the Author.........................................................................................................................................................2
Introduction...................................................................................................................................................................3
How to Keep Yourself Out of Court.......................................................................................................................4
Not Documented, Not Done.....................................................................................................................................6
Turning and Positioning.............................................................................................................................................7
Risk Assessments.........................................................................................................................................................9
Is That Ulcer Unavoidable or Not?.......................................................................................................................11
Intrinsic Risk Factors for Unavoidable Pressure Ulcers................................................................................13
Extrinsic Risk Factors for Unavoidable Pressure Ulcers...............................................................................15
Avoiding a Pain and Suffering Allegation.........................................................................................................17
Conclusion....................................................................................................................................................................19
About the Author
Heidi H. Cross, MSN, RN, FNP-BC, CWON, CSWS, is a board-certified Wound and Ostomy Nurse
and a board-certified Family Nurse Practitioner in Syracuse, NY. She is a graduate of
Syracuse University, with a Master of Science degree in Nursing from the State University
of New York Upstate Medical University.
She has extensive experience caring for wound and ostomy patients in acute care as well as in long-term care facilities.
Currently, she is employed by CNY Surgical Physicians, consulting for nursing homes in the Syracuse area, and has her own
practice as an expert witness for plaintiff and defense attorneys.
Ms. Cross is a member of the Wound, Ostomy, and Continence Nurses Society™, the Association for the Advancement of
Wound Care, and the American Nurses Association. She has served on numerous committees related to wound and ostomy
care, including as chair of the Examination Committee of the Wound Ostomy and Continence Nursing Certification Board,
the Credential and Review Committee, and the Marketing Committee. For the Wound and Ostomy Nurses Society, she has
been the co-chair of the National Conference Planning Committee ostomy track, has done peer review for the Journal of
Wound Ostomy and Continence Nursing (JWOCN), and was the recipient of a grant from the Center for Clinical Investigation
Research. The United Ostomy Associations of America honored her with the UOAA Ostomy Nurse of the Year in 2008, and
ConvaTec awarded her the Ostomy Nurse of the Year award in 2011. She participated in developing the National Pressure
Ulcer Advisory Panel’s Clinical Practice Guidelines for Prevention and Treatment of Pressure Ulcers in 2014.
Disclaimer:
The Content of this white paper is for informational purposes only. The Content is not intended to be a substitute for professional medical
advice, diagnosis, or treatment, nor should it be used as a substitute for professional legal advice. Always refer to your facility protocol in the
assessment and treatment of patients and for documentation standards. The views and opinions expressed in this white paper are solely those
of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.
2Legal Perils and Pitfalls of Wound Care
Copyright © 2019 WoundSource & Kestrel Health Information, Inc. All rights reserved.
Legal Perils and Pitfalls of Wound Care 33Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
Introduction
This white paper discusses the legal implications of wound care, with an emphasis
on pressure ulcers, which are common catalysts for malpractice litigation against
nursing facilities. Topics include the importance of proper documentation, turning
and positioning of patients, pressure ulcer risk assessments, the issue of unavoidable
pressure ulcers including intrinsic and extrinsic risk factors, and pain and suffering
allegations. Wound care professionals are already attuned to best practice patient
care, but they must also be made equally aware of standards of care as seen
through the lens of the legal process, and the need for meticulous and consistent
documentation, with an eye toward the possibility of pressure ulcer litigation.
Current National Pressure Ulcer Advisory Panel terminology is “pressure injury”.
For this white paper, we have chosen to use the term “pressure ulcer” to be consistent
with most of the literature and acceptance of the term.
Legal Perils and Pitfalls of Wound Care 44Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
How to Keep Yourself out of Court
“Among the duties the defendants and their employees owed to John Doe but failed to perform
was the duty to create and maintain accurate records of John Doe’s care plan, condition, progress,
and treatment.”
No matter the setting in which we practice, as health care providers we constantly are under the
threat of a malpractice lawsuit. In nursing homes, the top targets for litigation are pressure ulcers,
malnutrition, and dehydration. Up to 20% of all U.S. legal medical claims and more than 10% of
settlements are wound related,1
and there are more than 17,000 pressure ulcer-related lawsuits filed
annually in the United States, second only to wrongful death lawsuits.2
So, it behooves us to take the necessary measures to avoid being sued. What are the perils and
pitfalls of wound care that we may encounter in our practice, and how can we best avoid them? This
discussion explores the various elements that potentially can make or break a case, which essentially
starts and ends with the documentation of the care provided.
WOUND DOCUMENTATION BASICS:
Importance of Good Documentation
Adequate and accurate documentation, which is a record of the
care provided, is a critical component. Ideal documentation in the
chart should be comprehensive, consistent, concise, chronological,
continuing, and reasonably complete.3
Unfortunately, over the
course of my time reviewing charts relating to medical malpractice,
I have found that there is no such thing as perfect charting,
and this could be because it can be hard to balance perfect
documentation with perfect patient care. Are we charting, or are
we taking care of patients? This potentially creates an imbalance
and can lead to the fact that the chart can be the best tool that
defense attorneys have, yet it can also be the best tool that
plaintiff attorneys have.
Purpose of Documentation
The primary purpose of documentation is communication.
This includes what care was provided, but also it serves as a
communication tool among current providers. This enables the
entire health care team to share information about the care
and treatment of the patient. Also, it serves to prove to state
and federal surveyors that the facility and staff are meeting
mandated regulations. Communication among staff, of course,
can be verbal or written, but it is mostly written communication
(the chart) that will make its way into court.
Why Consistency in Wound Documentation Matters
Communication is how we as the health care team stay informed
about the patient’s changing condition. Therefore, it becomes
absolutely necessary that within our practice setting we review
what our other team members are documenting and ensure that
all documentation remains consistent between disciplines. For
better or for worse, bedside nurses assume chief responsibility for
skin and wound assessment and documentation, so other providers
within the facility should try to review nurses’ wound care notes.
It never looks good in court when nursing wound documentation
charts “Stage 4 pressure ulcer, necrotic 7 × 8 cm,” and the same-
day physician documentation is “Stage 3, 3 × 4 cm.” Which is the
right one, and why are they not documenting the same thing? This
throws the entire wound documentation, and possibly the entire
chart, into doubt.
Consistency in our wound care documentation is key. Consistency
will build trust that what is in the chart is an accurate depiction
of the wound and the care provided and will hold up much better
in court when presented to a judge and jury. Having a dedicated
wound team and/or a certified wound specialist conducting regular
wound assessments should accomplish much greater consistency
than relying on bedside nurses, who may not have received
thorough wound assessment training. Wound care policies should
dictate who will consistently perform the wound assessments and
at what frequency. Usually weekly is the standard.
Legal Perils and Pitfalls of Wound Care 55Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
WOUND DOCUMENTATION ESSENTIALS
A well-designed wound care documentation form should include all necessary elements. These include:
Location. Often in reading a chart we are not sure exactly what wound is described or where it is.
Know your anatomy and do not confuse right with left.
Measurements, which should be as accurate as possible and measured consistently from week to
week. Measurement parameters should include length, width, and depth, as well as any tunneling and
undermining. Hint: if the true depth of a wound is obscured by necrotic tissue, chart that the depth is
“unknown”. Otherwise, as the wound debrides and the true depth becomes apparent, it may appear as
though the wound has gotten deeper. Plaintiff attorneys love that!
Wound bed description Document the percentage of granulation tissue versus necrotic tissue. Include odor,
drainage type and amount, the condition of the periwound skin, and any signs of infection.
Pain (and what was done about it). The location of the pain is critical, as well as how it was addressed.
“Pain and suffering” allegations are frequently part of a pressure ulcer lawsuit; for more, see the final
section of this white paper, starting on page 15.
Nutrition status and what measures are in place, especially if the patient is at risk for malnutrition or is
already compromised. Make sure that the dietician is involved as needed.
Any pressure reducing/redistributing measures or devices, such as what support surface that the patient
is on, both mattress and seating surface, and heel pressure relief measures.
Turning and positioning measures.
Physician and family notification. Often in a lawsuit, the family will say, “We never knew about the
bedsore, or how bad it was!” Allegation frequently include lack of MD notification.
Current treatment or whether the treatment is being changed. Preferably, have the dressing changes
included in the treatment administration record or appropriate section of the chart.
The latest risk status (i.e., the Braden Scale for Predicting Pressure Sore Risk® score), which should be
performed on admission and then regularly thereafter.
Whether the ulcer was present on admission, or when it was first noted.
The next section of this white paper examines the “Not documented, not done” assumption (often used by plaintiff attorneys) and then drills
down to specifics of wound documentation that either may help you stay out of court or may eventually help you if you find yourself there.
How to Keep Yourself out of Court Continued
Legal Perils and Pitfalls of Wound Care 66Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
Not Documented, Not Done
“Among the duties the defendants and their employees owed to John Doe but failed to perform was the
duty to appropriately chart information concerning his condition, assessment, care planning, history,
monitoring, and pressure ulcer prevention measures so as to enhance his progress and well-being, and
to prevent pressure ulcers.”
Documentation is used by attorneys to ascertain whether the standards of care have been met
in a particular case. As stated previously, documentation ideally needs to be clear, concise,
chronological, continuing, and reasonably complete.3
WOUND DOCUMENTATION
AND LITIGATION
Not Documented, Not Done
Frequently, in the course of legal proceedings, we encounter the
phrase “Not documented, not done” regarding wound care. Plaintiff
(and defense attorneys) scour the chart for evidence of the exact
care provided as documented in the chart and present what they
find as absolute evidence that the facility met the standard of care
or not. What is a “standard of care?” There are many definitions, but
at its core a standard of care is what any reasonable health care
practitioner would do under similar circumstances. If standards of
care have been met, then the defendant prevails; if not, then the
plaintiff does.
Can the absence or paucity of certain documentations be absolute
proof that standards were not met? Can we expect that busy
bedside clinicians chart every single action that they take, and are
capable of 100% perfect documentation? According to Ayello et al.,
“’Not documented, not done’ removes the focus from the patient
care and puts it on creating ‘perfect paperwork.’”3
POOR DOCUMENTATION
Poor documentation related to wound care, but not necessarily
proof of lack of care, may include turning and positioning, feeding
and nutrition measures, the support surface the patient was
on (mattress and seating), any refusals of care, when exactly
the wound dressing was changed and what was used (ideally
charted every time but often not), conversations with physicians
and families, patient transfers out of bed, and many other of the
myriad actions that bedside nurses and other health care providers
perform during the course of their busy day.
ELECTRONIC MEDICAL RECORDS
Electronic records, done properly, can be a step forward,
prompting health care staff to document their wound care more
completely in what is hopefully a more efficient and legible
manner. The danger comes (and this applies to paper records,
as well as electronic records) when areas on forms are left blank.
There is a strong assumption that any blanks are proof that those
interventions did not occur. For example, if there is an area for
“turning and positioning” or for a specialty bed, make sure it is
completed or plaintiff attorneys will pounce.
CHART ANALYSIS
When I look at a chart for attorneys, I, too, look for perfect “Turn Q
2 hour” documentation when a patient is at risk or has an existing
pressure ulcer. Perfection is rarely found. And even if there are perfect
every two-hour documentations, how do we really know these actions
were truly performed, or whether staff sat down at the end of the
shift and filled in their initials every two hours (i.e., created perfect
paperwork but not necessarily performed perfect patient care)?
KEY TAKEAWAYS
The general answer is that when I look at charts, I am looking
for an overall culture of patient care, including turning and
positioning. Clues to a facility’s patient care culture can be found
looking at those measures as well as wound and skin assessments,
risk assessments, physician and family notifications, nutrition
assessments and interventions, management or treatment of skin
and wound issues, and pain assessment and treatment.
Legal Perils and Pitfalls of Wound Care 77Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
Turning and Positioning
“Among the duties the defendants and their employees owed to Mr. John Doe but failed
to perform was the duty to turn and position him every two hours.”
ESSENTIALS OF TURN AND POSITION
DOCUMENTATION
Failure to turn and position (TP) is always part and parcel of a
pressure ulcer lawsuit and a key element of a complaint related
to pressure ulcers, as illustrated in the opening quotation. TP
documentation is a dominant focus in chart analysis and is usually
one of the first things that an attorney and the expert witness look
for. If TP documentation is satisfactory, the defendant is likely
to prevail; if not, then the plaintiff may have a pretty rock-solid
case. Is there such a thing as perfect turning and positioning
documentation? Alas, no, or at least, rarely.
With that in mind, here are some suggestions:
Communication: Just like communication, consistency is
key. If mention of TP occurs only sporadically, especially
in the nurse’s notes, a judge and jury are going to have the
impression that it was not high on the staff’s and the facility’s
priorities.
Mobility Score: The need for TP will be largely based
on the mobility score (2 = very limited or 1 = completely
immobile) and activity score (2 = chairfast or 1 = bedbound)
of the Braden Scale. Of course, nothing trumps good nursing
judgment of the patient’s needs and documentation thereof.
Care Plan: Be sure that TP is part of the nursing care plan,
if needed, based on nursing assessments, and is part of the
certified nursing assistant (CNA) care plan. CNAs are crucial
team members, should be on board and educated about
the importance of TP, and should be involved in care plan
development and charting of these measures.
Team Coordination: Be sure ALL team members are aware
of and attuned to the patient’s turning and mobility needs.
This includes physical and occupational therapy, nutrition
services, case management, interdisciplinary care teams, and
physicians.
Physician’s Order: Ideally, there should be a physician’s order
to TP when the patient is at risk or has an existing pressure
ulcer. If your facility has physician order sets, make turning
orders part of them, as well as placing these orders on the
Treatment Administration Record.
What is the ideal frequency of documenting TP? In a lawsuit,
there has to be a balance between expecting too much and
accepting what may be perceived as too little. A lot of it depends
on a facility’s documentation process and expectations. When I
look at a chart, I look for what appears to be a “culture” of TP.
Free text nursing notes often tell a better story than “check box”
flowsheets. There is also a danger to “check box” flowsheets
because if boxes are left blank there will be strong presumption
that those interventions did not take place.
Legal Perils and Pitfalls of Wound Care 88Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
WHAT DO THE PRESSURE ULCER GUIDELINES
SAY ABOUT “Q2H”?
The 2014 National Pressure Ulcer Advisory Panel*
does not
recommend a frequency but suggests that we “consider the
pressure redistribution surface in use” and also “tissue tolerance,
level of activity and mobility, general medical condition, overall
treatment objectives, skin condition, and comfort.”4
Similarly, the
Wound, Ostomy and Continence Nurse Pressure Ulcer guidelines
state, “schedule regular repositioning and turning for bedbound
and chairbound individuals.”5
IS THERE ANY RESEARCH UPON WHICH TO
BASE EVIDENCE?
Research is definitely lacking, mostly due to reasonable concerns
about not turning patients and the inherent possible consequences.
Nursing lore has it that the whole “TP Q2” harks back to Florence
Nightengale’s time; it is said that it took two hours for her nurses
to get from one end of the room to the other to turn patients.
Hence, every two hours! However, in 2013 the TURN study by
Nancy Bergstrom and associates found no difference in pressure
ulcer development between “those at moderate and high risk of
developing pressure ulcers turned at 2-, 3-, or 4-hour intervals...
using high-density foam mattresses.”6
So, there is nothing evidence-
based or magic about the two hours of “Q2H” turning!
WHAT ABOUT PATIENTS’ NON-ADHERENCE OR
REFUSALS?
Refusing any medical interventions falls squarely under patient’s
rights and it is their right to refuse turning and repositioning. (Of
course, it also is their right to sue if they subsequently develop a
pressure ulcer!) Documentation of refusals becomes crucial.
Document:
• The reason that patients refuse TP. For added impact, chart
exact quotes from patients. Is it because of pain and the need
for a reassessment of their pain regimen? Are they close to
end of life and do not wish to be disturbed? Maybe they just
do not understand the dangers of immobility and the risk
for skin breakdown. Sometimes it may be a control issue,
understandable when everything else in their life seems out
of their own control.
• What actions you took as a result and the education you
provided about the need for adherence.
• Patients’ reactions to the education. This demonstrates
patients’ understanding and, implicitly, patients’ consent,
assuming cognition is intact.
• Education of family members about the need for
repositioning and their reaction to the teaching, enlisting
their help.
Hearing it from multiple providers may help, so be sure to involve
all staff in reinforcing the need for turning and positioning.
KEY TAKEAWAYS
Questions remain about appropriate turning intervals, with
nothing specific in the guidelines that would absolutely point to
poor care if “perfect” documentation of every two-hour turning is
lacking. Nevertheless, all patients need to be assessed for pressure
ulcer risk factors and those factors addressed with timely and
necessary interventions and measures, with good staff and family
involvement.
Turning and Positioning Continued
*Updated NPUAP updates will be available in November of 2019; however, they were not available at time of this publication.
Legal Perils and Pitfalls of Wound Care 99Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
  Risk Assessments
“Among the duties the defendants and their employees owed to John Doe but failed to perform
was the duty to timely, accurately, and adequately assess his risk for skin breakdown and the
development of a pressure ulcer.”
WHY DO A RISK ASSESSMENT FOR
PRESSURE ULCERS?
When looking at medical charts from a legal perspective, another
of the areas closely scrutinized is the risk assessment for skin
breakdown and pressure ulcer development. Completing a
pressure ulcer risk assessment is considered a standard of care.
Was the patient adequately assessed for risk factors, and was this
done in a timely fashion? Was it repeated at regular intervals,
with a change in condition, or on readmission? Do scores seem
appropriate for the patient’s condition? Is there consistency
among health practitioners? Were the results used to institute
evidence-based and appropriate pressure ulcer prevention and
treatment measures and care plans? Or do the results seem to
simply languish in the chart? What are the standards of care
related to this?
The most commonly used scale in the United States is the
Braden Scale for Predicting Pressure Sore Risk® (Braden Scale).7
Developed in 1987 by Barbara Braden and Nancy Bergstrom, it has
been extensively tested for reliability and validity. Used correctly
and completed as designed, it is an excellent metric for the risk of
skin breakdown.
WHAT DO THE GUIDELINES SAY?
The 2014 National Pressure Ulcer Advisory Panel (NPUAP)
Guidelines state, “Conduct a structured risk assessment as soon as
possible (but within a maximum of eight hours after admission) to
identify individuals at risk,” “Repeat the risk assessment as often as
required by the individual’s acuity,” and “Undertake a reassessment
if there is any significant change in the individual’s condition.”4
The
Guidelines also include recommendations about documentation
and developing a plan.
WHAT ARE THE PITFALLS, AND WHAT
WILL NOT BODE WELL FOR THE DEFENSE?
Not assessing pressure ulcer risk on admission. The NPUAP calls
for risk assessment within eight hours, but this may at times be a
lofty goal. It should, however, be a goal we all endeavor to meet.
Not repeating at regular intervals. How often the risk assessment
should be repeated depends on the setting and the patient’s con-
dition. Usually, in the intensive care unit, it is conducted on every
shift. On acute care units, generally every 24 hours is sufficient.
In long-term care facilities, the Braden Scale website suggests
conducting risk assessment on admission, weekly for the first four
weeks, and then quarterly.
Inconsistencies among those completing the Braden Scale.
What does it say about the staff and the facility if the scores
vary widely? One day the patient may be a 12, only to be a 20
the next day, without any change in condition. Here are some of
the possible reasons:
• Inadequate staff training and familiarity. Be sure staff has
been well trained, with periodic updates and in-services,
and that scores are consistent from shift to shift.
• Truncating or altering the Braden Scale. Reliability and
validity were established using the scale in its entirety,
exactly as published. Changes without re-establishing
reliability and validity negate its effectiveness.
• The Braden Score is completed by the night shift. How can
the night shift truly know how well a patient eats and moves?
Also, it is more difficult to assess sensory perception on a
sleepy or sleeping patient.
So, what can go wrong relative to subscores?
Sensory perception. Often overlooked and overscored are
patients with diabetes and arterial disease, who inevitably have
neuropathies with altered sensation. Also, how can a resident
with paraplegia or quadriplegia score any more than a 2?
Moisture. It is not just incontinence. Moisture issues occur with
diaphoresis, obesity, highly exudative wounds, weepy legs from
venous insufficiency, etc.
Activity and mobility. Be sure to read the exact detail of the
descriptions. Important: nursing scores on the Braden Scale should
match physical therapy and occupational therapy assessments. If
the Braden subscale is documented a 3 or 4, but physical therapy
and occupational therapy are documenting “max assist” or “total
dependence” in this area, there is a disconnect and will not reflect
well on the facility.
Nutrition. Pay attention to the exact details on the Braden
scale, and score accordingly. Any recent, unintended weight loss
Legal Perils and Pitfalls of Wound Care 1010Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
should be a red flag, with a low score, as should consistently low
meal intake or low BMI. Tube feedings and TPN complicate our
assessments as to how adequately patients are nourished. Check
with your dietitian if in doubt.
Friction/shear. Any bedbound patient or one with a low mobility
score will likely have a “problem” or a “potential problem.”
KEY TAKEAWAYS
Conducting the Braden Scale is only the beginning and, unless
translated into action, will amount only to busywork on the part
of the nurses. Nurses need to be well-trained and familiar with
the scale. Based on the subscores, an individualized and evidence-
based care plan needs to be implemented, with interventions
specifically targeted at needed areas. This is something that
attorneys actively scrutinize.
10
Risk Assessments Continued
Legal Perils and Pitfalls of Wound Care 1111Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
Is That Ulcer Unavoidable or Not?
“Among the duties the defendants and their employees owed to John Doe but failed to perform
was the duty to implement appropriate measures to avoid skin breakdown and multiple Stage 4
pressure ulcers, which, but for the lack of care, could have been avoided.”
“If a patient is cold, if a patient is feverish, if a patient is faint, if he is sick after taking food, if he
has a bed sore, it is generally the fault not of the disease, but of the nursing.”8
—Florence Nightingale
We have a lot to thank Florence Nightingale for—a brilliant woman
considered to be the founder of nursing and nursing standards and
the first to ever put statistics to health care, among other valuable
contributions. But if the health department is coming to a facility
near you or a lawyer is scrutinizing your facility with a lawsuit,
make sure Florence has the day off because with a statement like
that we don’t stand a chance to prevail!
Florence or not, over the years all pressure ulcers were generally
considered avoidable. If a patient developed a pressure ulcer in
our facility it was time to throw on the sackcloth and the ashes;
we own “this one” and are liable for its development. Fortunately,
we have now come to realize that pressure ulcers can and do
occur despite best treatment and prevention measures and may be
unavoidable. Official recognition of this was a huge gift to defense
attorneys and, more importantly, to the facilities they represent.
RECOGNITION OF UNAVOIDABLE
PRESSURE ULCERS
Along Comes F-Tag 314, Now F-Tag 686
The first government recognition of unavoidability occurred in 2004
with the publication by the Centers for Medicare  Medicaid Services
of F-Tag 314, titled “Pressure Sores.”9
F-Tags are federal regulations
for nursing homes and represent guidance for surveyors of long-term
care. In F-Tag 314, facilities are required to “evaluate an individual’s
clinical condition and pressure ulcer risk factors; define and implement
interventions consistent with resident needs, resident goals, and
professional standards of practice; monitor and evaluate the impact
of the interventions; and revise the interventions as appropriate.” If a
resident develops a pressure ulcer and the facility has performed (and
documented) all these, the ulcer may be determined unavoidable.
Wound, Ostomy and Continence Nurses Society™ (WOCN®)
Position Paper: Avoidable Versus Unavoidable Pressure
Ulcers (Injuries)
The purpose of this document was to “lend support to the theory
that some pressure ulcers are unavoidable.”10
This document
contains “Supportive Statements” related to unavoidability that
include risks and comorbidities, medical device–related pressure
ulcers, end-of-life changes, prevention strategies, role of documen-
tation, quality improvement programs, and education. It concludes
with recommendations for needed research related to this topic.
National Pressure Ulcer Advisory Panel
The NPUAP has published numerous documents related to
unavoidability. In 2014, it published an article detailing the results
of a consensus panel related to unavoidable pressure injuries and
coming to a consensus that “unavoidable pressure ulcers do occur.”11
This article details the multiple risk factors, intrinsic and extrinsic,
for unavoidable pressure ulcer development. These risk factors are
detailed later in this white paper.
Skin Changes at Life’s End (SCALE)
In 2009, a consensus panel was convened with the goal of
establishing a consensus statement about skin changes at life’s
end.12
Conclusions were that:
• The skin is the body’s largest organ and like any other
organ is subject to a loss of integrity.
• Our current comprehension of skin changes that can
occur at life’s end is limited.
• The SCALE process is insidious and difficult to determine
prospectively.
• Additional research and expert consensus are necessary.
• And, contrary to popular myth, not all pressure ulcers
are avoidable.
What About the Kennedy Terminal Ulcer?
A Kennedy terminal ulcer is defined as “unavoidable skin
breakdown or skin failure that occurs as part of the dying
process.”13
It is widely acknowledged to represent the
breakdown of skin that can occur at the end of life. End-of-life
skin failure can take many forms, but Kennedy terminal ulcers
most often occur on the sacrococcygeal area and develop and
deteriorate very rapidly. They often have a pear or butterfly
appearance and can be irregularly shaped, red/yellow/black,
and similar in appearance to an abrasion or blister.14
Legal Perils and Pitfalls of Wound Care 1212Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
BUT BACK TO FLORENCE
Nurse Nightingale was dealing with an entirely different set of
patients. People did not live the long lives we do (average life
expectancy was around 50 at that time) and were not prone to
the risk factors and frailties we acknowledge today. Nor were they
intensive care patients, critically ill and depending on technology
to keep them alive. So, if her patients developed a “bed sore,” it
may well have been due to a lack of proper nursing care.
KEY TAKEAWAYS
There is a lot of evidence for and expert opinions about
unavoidable skin breakdown and pressure ulcers, and the fact
that they indeed occur, despite best practice. There are multiple
risk factors, both intrinsic as well as extrinsic, that place a patient
at risk, and these need to be recognized, acknowledged, and
documented.
 
Is That Ulcer Unavoidable or Not? Continued
Legal Perils and Pitfalls of Wound Care 1313Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
Intrinsic Risk Factors for
Unavoidable Pressure Ulcers
With the publication of F-Tag 314, the Centers for Medicare  Medicaid Services (CMS)
finally, in essence, acknowledged that some ulcers can occur despite best care.9
The facility
essentially can maintain, “We did everything we were supposed to, and despite that,
the patient developed that pressure ulcer”—that is, the ulcer was unavoidable. To claim
unavoidability, however, proper documentation needs to be in place in the chart that all
proper prevention and treatment measures were implemented.
TOP ON THE UNAVOIDABLE LIST:
SKIN FAILURE
Intrinsic risk factors include skin failure, which often (but not
always) is associated with end-of-life. Skin failure has been defined
as “an event in which the skin and underlying tissues die due to
hypoperfusion that occurs with severe dysfunction or failure of
one or more organ systems.”15
As we know, skin is an organ just like
the heart, kidney, and liver, and it is the largest organ of the body.
Unless there is actual medical malpractice, how often do we hear
about patients suing cardiologists for heart failure, nephrologists for
kidney failure, and hepatologists for liver failure? Granted, we have
serum laboratory values for failures of the heart (B-type [or brain]
natriuretic peptide), kidney (blood urea nitrogen, serum creatinine),
and liver (liver enzymes); however, none exist for skin failure.
But why so many lawsuits for pressure ulcers, when overall organ
failure may be the causative issue? Why do families and patients
get upset enough with pressure ulcers that they feel compelled to
sue? I believe that in addition to being the largest organ, skin is
outwardly visible, and skin breakdown can be shocking and jolting
to patient family members, unlike the invisibility of other organs.
It can easily be interpreted as a sign of abuse and neglect and has
become the low-hanging fruit of lawsuits and the bread and butter
of many medical malpractice plaintiff attorneys. Just look at some
of the attorney ads out there for “nursing home abuse and neglect.”
WHAT DOES THE NATIONAL PRESSURE
ADVISORY PANEL HAVE TO SAY?
Many experts and expert bodies have weighed in on this issue,
and some of these were detailed in the previous section, “Is That
Ulcer Unavoidable or Not?” Here, the focus is on the consensus
panel article of the NPUAP, published in 2014.11
This article
divides the risk factors into intrinsic and extrinsic factors. Please
see the NPUAP article for more complete information. Extrinsic
risk factors are discussed in the next section of this white paper.
Intrinsic factors:
Intrinsic factors related to pressure ulcer development consist of
“the patient’s comorbidities and physiologic conditions impacting
wound healing.”16
As per the NPUAP, these include:
• Impaired tissue oxygenation or cardiopulmonary dysfunction.
This category applies particularly to patients in the intensive
care unit and includes vasopressor use (blood is being shunted
from the periphery, i.e., skin and underlying tissues, to core
organs), hypotension, hypoxemia, anemia, hypoventilation, and
congestive heart failure.
• Hypovolemia, defined as an inadequate volume of blood in the
circulatory system, thus compromising tissue perfusion not only
to vital organs, but also to peripheral tissues such as the skin.
• Infection, sepsis, and hypoalbuminemia. Invasion and
multiplication of microorganisms cause cellular injury, releasing
toxins and competing with normal metabolism of the body.
Inflammation results, which lowers albumin levels. Shock leads
to inadequate tissue perfusion.
• Body edema and anasarca, leading to compromised tissue perfusion
and fragility and a decreased tolerance to pressure and shear.
• Lower extremity arterial and venous disease, including venous
insufficiency and neuropathic disease. Unless the underlying
factors are corrected, deterioration may be the only expectation.
• Chronic kidney disease. Changes in tissue tolerance as a result of
renal disease, as well as mobility limitations and long times spent
in a sitting position during dialysis, may increase the likelihood of
pressure ulcer development and deterioration.
Legal Perils and Pitfalls of Wound Care 1414Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
• Hepatic dysfunction, which results in hypoalbuminemia, edema
and anasarca, ascites, cerebral dysfunction, and coagulopathies.
• Other factors: sensory impairment, multiple sclerosis, stroke,
coma, spinal cord injury (30% to 50% of all patients with spinal
cord injury develop a pressure ulcer during the first month after
injury17
).
• Anesthesia and operating room time. Anesthesia causes
circulatory issues that increase risk for pressure ulcers and, of
course, alters sensory ability to feel discomfort.
• Age. Increased risk for pressure ulceration occurs at both
ends of life. Neonates, particularly preemies, lack proper skin
structures to avoid pressure ulcers. In older adults, multiple
changes occur in not only the skin but also the underlying
tissues, thus increasing risk. 70% of pressure ulcers occur in
those 70 years and older.11
• End-of-life and end-stage dementia, leading to poor appetite and
nutritional compromise, bedridden status, impaired language and
communication, and risk for contractures.
• Body habitus. Obesity increases the risk for moisture, shear,
friction, immobility, and skin tissue compromise. Cachexia, with
minimal adipose tissue and overall fragility of skin, is a risk factor.
KEY TAKEAWAYS
Not all pressure ulcers are avoidable, despite best care
practices. Contributors to unavoidability include intrinsic risk
factors, skin failure chief among them. These factors need to
be assessed and evaluated and compensated for if possible. If
relief of those factors is not possible, we need to acknowledge
and communicate likely realistic outcomes, which may include
unavoidable pressure ulcers.
Intrinsic Risk Factors for Unavoidable Pressure Ulcers Continued
Legal Perils and Pitfalls of Wound Care 1515Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
Extrinsic Risk Factors for
Unavoidable Pressure Ulcers
“At all times material hereto, defendant failed to develop an adequate care plan and properly
monitor and supervise the care and treatment of John Doe in order to prevent him from suffering
the development and deterioration of bed sores.”
The BEST legal defense in a pressure ulcer lawsuit is if the facility and legal counsel can
effectively show that the pressure ulcer was unavoidable. Unavoidable pressure ulcers occur when
a patient develops an ulcer even though the facility met standards of care related to pressure ulcer
prevention and treatment. These include assessments and interventions such as risk assessment,
nutrition, support surfaces, regular wound assessments, wound treatments, mobilization, turning
and positioning, and physician and family notification. Moreover, in a pressure ulcer lawsuit, a pain
and suffering allegation is almost assuredly a part of the complaint, so the presence of pain and
subsequent interventions need to be addressed as well.
EXTRINSIC RISK FACTORS FOR PRESSURE
ULCER DEVELOPMENT
The previous section of this white paper discussed intrinsic risk
factors, using predominantly the NPUAP consensus panel article of
2014.11
This list was quite lengthy and included tissue oxygenation,
age, end of life, infection and immunosuppression, body habitus,
and multiple other underlying chronic conditions. Extrinsic risk
factors, on the other hand, include “external or environmental
sources that disrupt the wound healing process.”16
That is the
subject of this section, and, once again, the NPUAP article is used
as a guide.
• Head of bed (HOB) elevation. Elevating the HOB 30o
to 40o
is a
recommendation to prevent aspiration and ventilator-acquired
pneumonia. Patients who have tube feedings are particularly
at risk for aspiration. This directly contradicts all pressure ulcer
recommendations, which state that HOB elevations significantly
increase shear and interface pressures, despite all turning practices.
Ideally, all patients with HOB elevations should be put on higher-
level surfaces sooner rather than later to address the increased
pressures that result and document the reason for the HOB
elevation. Having a doctor’s order in place strengthens the case.
• Hip fracture. Hip fractures are associated with significantly
increased morbidity and mortality and an increased risk
of pressure ulcer development by virtue of long periods of
immobility. Patients with hip fractures generally are frail older
adults with multiple comorbidities.
• Prone positioning. Pressure ulcer incidence rates as high as 65%
have been reported among patients in a prone position.18
• Nutrition. Malnutrition is a well-known risk factor for pressure
ulcer development and is a frequent focus of pressure ulcer
lawsuits. Protein-energy malnutrition (lack of protein and
calories) causes the body to break down muscle tissue for energy
(defined as maintenance of normal body functions), resulting in
sarcopenia (loss of lean body mass). Unintended weight loss is a
common indicator of malnutrition. Keeping track of weight loss
is a critical intervention and something that attorneys closely
scrutinize, as well as what other nutritional interventions and
supplements have been implemented.
• Hospital length of stay (LOS). Several studies are listed in the
NPUAP article citing the relationship between hospital LOS and
adverse events such as pressure ulcer development. One study
found that 97% of all pressure ulcers occurred among study
participants whose LOS was greater than seven days.19
It makes
sense, doesn’t it? The sicker patients are, the longer they are in
the hospital, the more they are at risk.
• Smoking. The nicotine in cigarettes causes vasoconstriction and
tissue ischemia, not to mention the deleterious effect of carbon
monoxide, which displaces oxygen from hemoglobin. Multiple
studies as well as plain old common sense tell you that cigarette
smoking is a huge risk factor for pressure ulcer development,
and attorneys have successfully used a smoking history to prove
contributory negligence.
Legal Perils and Pitfalls of Wound Care 1616Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
• Medical devices. Often very necessary and lifesaving, medical
devices nevertheless are responsible for between 20% and 40%
of all new pressure ulcers. These include continuous positive
airway pressure devices, urinary catheters, restraints, cervical
collars, nasogastric tubes, nasal cannula oxygen tubing, and
external fixators. Or how about when a leg cast comes off and
everyone has been wondering what the smell was, only to
discover a stage 4 pressure ulcer underneath?
• Non-adherence. Patient rights dictate that patients have the
right to make informed decisions and refuse treatment, which can
impact cooperation with pressure ulcer prevention and treatment
measures. Refusals can result in an unavoidable pressure ulcer.
See the turning and positioning section of this white paper for
more on non-adherence. Just as with smoking, contributory
negligence may become a factor in the lawsuit, thereby reducing
the facility’s liability.
KEY TAKEAWAYS
Pressure ulcer development is multifactorial and complex.
Patients need to be assessed for any “external or environmental
sources” that may cause skin breakdown and pressure ulcers,
in the process balancing risk versus benefit of any procedures
and interventions. If those cannot be modified, we need to
acknowledge the unavoidability of the skin issues. Ultimately,
whether the cause is extrinsic or intrinsic, good documentation
of assessments and risk factors is a necessary component of
limiting liability in a lawsuit.
Extrinsic Risk Factors for Unavoidable Pressure Ulcers Continued
Legal Perils and Pitfalls of Wound Care 1717Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
Avoiding a Pain and Suffering Allegation:
Must it be Peas and Carrots?
“As a direct and proximate result of the negligence of the defendants, individually and
vicariously through their nurses, staff, employees, and medical personnel, John Doe developed
a pressure ulcer, severe dehydration, and malnutrition with resulting pain and suffering, loss of
quality of life, premature death, and medical expense.”
“Me and Jenny goes together like peas and carrots.” – Forrest Gump
INTRODUCTION
Just like Forrest’s peas and carrots, a pressure ulcer lawsuit and a
pain and suffering allegation inevitably “goes together.” For good
reason, because pain is an ever-present problem in patients with
pressure ulcers, venous and arterial ulcers, and even diabetic ulcers,
despite sensory issues. How do you, as a health care provider, best
protect and defend yourself against a pain and suffering allegation?
SOURCES OF WOUND PAIN
First, let’s remember the sources of wound pain, which, according
to Woo et al.,20
can be related to:
• Infection or inflammation, with increasing bioburden or infection
• Moisture balance, with too much or, perhaps more often, too
little moisture, resulting in dressings that stick and cause
bleeding and trauma
• Tissue debridement and trauma, where selection of dressings may
be inappropriate or dressings too frequently changed, or by using
aggressive adhesives, as well as during wound cleansing or irrigation
FREQUENT ISSUES
Facilities have gotten better about requiring routine pain
assessments, but I frequently find problems in reviewing
charts for attorneys. These are:
• Not recording location with each and every pain
assessment. Just as in real estate, location, location, location
is a critical factor in pain assessments and documentation.
If, for instance, a patient has an orthopedic injury such as
a fractured arm or recent hip replacement, or chronic back
pain, the pain may be more due to that factor than to any
existing skin condition. However, if staff is recording a high
pain level but is not giving a location, a plaintiff attorney
will present that as pain from the ulcer, which is the subject
of the lawsuit, thereby strengthening the pain and suffering
allegation.
• Not documenting pain levels routinely as ordered and not
performing pain level reassessments after medication
administration.
• Not reporting high pain levels to health care providers, for
possible readjustment of the care plan or medications.
• Not documenting patient education and discussions
related to pain and not collaborating with patient and
family to optimize pain control. Poor communication
with patients and family can often be the tipping point
between “sue” and “not sue.”
• Not premedicating for pain before dressing changes. Szor and
Bourguignon reported that 87.5% of participants had pain at
dressing change.21
Legal Perils and Pitfalls of Wound Care 1818Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
TIPS THAT MAY HELP TO KEEP YOU OUT OF COURT
Obtain a physician’s order to assess pain at least daily to every shift or more often, depending on patient
condition and need.
Add the order to any treatment administration record or wherever it fits in your documentation system,
and document the pain level and, at the very least, the location of the pain in that part of the record.
Do a pain risk assessment on admission and perform one routinely. How often? Again, this should be
individualized based on patient condition, but at least quarterly seems like a good idea.
Use a valid tool to assess pain levels. Some patient populations require specialized tools, such as the
FLACC scale (Face, Legs, Activity, Cry, and Consolability) for babies and young children, and the PAINAD
scale (Pain Assessment in Advanced Dementia) for cognitively impaired patients. Make sure staff has been
well in-serviced on the use of these tools.
Narrative notes or a well-designed specific pain form often can better describe the patient’s pain issues,
with better descriptors.
Query the patient directly about pain associated with the ulcer, and document! It is helpful to use the
patient’s own words and description of pain.
Include wound pain on all wound documentation forms such as weekly assessments, with full description
and level.
There are numerous mnemonics for performing a comprehensive assessment of pain. One recommendation
is the PQRSTU.1
This stands for Provoking and palliating factors; Quality of pain; Regions (location!) and
radiation; Severity or intensity; Timing or history; Understanding (what is important for you for pain relief?
How would you like to get better?). Another is OLDCART—Onset, Location, Duration, Characteristics,
Aggravating factors, Radiation, Treatment.
Remember that pain often occurs with movement, so ask about pain and document at that time as well.
PT and OT notes frequently conduct comprehensive pain assessments during therapy.
Administer around the clock routine pain medications spaced out evenly over the 24 hours. An order for
three times daily dosing could result in 8 am, 12 pm, and 4 pm administration, potentially leaving the
patient without any pain coverage for 16 hours. Does that make any sense?
Use dressings that don’t cause pain, such as silicone-backed dressings. And certainly, wet-to-dry must die!
Decrease the frequency of dressing changes as much as possible.
Use topical pain treatments such as morphine or EMLA (lidocaine 2.5% and prilocaine 2.5%) instead of or
in addition to systemic drugs.
Document all discussions and patient education related to pain management.
Don’t forget about end of life pain issues and involve hospice in a timely fashion for optimal end of life
pain care.
KEY TAKEAWAYS
Wound-associated pain is complex. A comprehensive assessment and treatment plan are necessary to adequately address pain issues.
Good documentation of all measures employed related to pain will hopefully help you avoid that dreadful pain and suffering allegation!
Avoiding a Pain and Suffering Allegation: Peas and Carrots? Continued
Legal Perils and Pitfalls of Wound Care 1919Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
Conclusion
In conclusion, pressure ulcer litigation and the decision to sue is multifactorial. Here in
the USA, we are a very litigious society, and our expectations of good medical outcomes,
regardless of situation, often exceed the reality of the situation. The facility and staff need
to be sure to include proper pressure ulcer prevention and treatment measures, based on
pressure ulcer risk assessments and good clinical judgement, with good and consistent
documentation thereof. Ultimately, however, whether a family or patient decide to sue may
be based on their overall satisfaction with care.
Often, when asked, patients’ families might reply that they sued because “Mom died
from that horrible bed sore and I don’t want anyone else to go through that.” They report
“insensitive handling and poor communication” and a need for an explanation. Ultimately,
good open communication, availability of staff including physician care, nursing and
administration, and good customer skills and relations with a genuinely caring attitude may
well be the tipping point as to whether a lawsuit is initiated.
19Legal Perils and Pitfalls of Wound Care
Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
Legal Perils and Pitfalls of Wound Care 2020Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
REFERENCES
1.	 Pfaff J, Moore G. ED wound management: identifying and reducing risk. ED Legal Letter. 2005;16:97–108.
2.	 Agency for Healthcare Research and Quality (AHRQ). Preventing pressure ulcers in hospitals: a toolkit for improving quality of care.
Rockville, MD: AHRQ. https://www.ahrq.gov/sites/default/files/publications/files/putoolkit.pdf. Accessed October 14, 2018.
3.	 Ayello EA, Capitulo KL, Fife CE, et al. Legal issues in the care of pressure ulcer patients: Key concepts for healthcare providers. International
Wound Care Advisory Panel. 2009. https://www.medline.com/media/assets/pdf/LegalImplicationsofPressureUlce.... Accessed October 14, 2018.
4.	 National Pressure Ulcer Advisory Panel. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Washington, DC: NPUAP;
2014. Available at https://www.npuap.org. Accessed November 12, 2018.
5.	 Wound, Ostomy, and Continence Nurse Society (WOCN Society). Guideline for Prevention and Management of Pressure Ulcers. WOCN clinical
practice guideline series no. 2. Glenview, IL: WOCN Society; 2016.
6.	 Bergstrom N, Horn SD, Rapp MP, Stern A, Barrett R, Watkiss M. Turning for ulcer reduction: a multisite randomized clinical trial in nursing
homes. J Am Geriatr Soc. 2013;61(10):1705–13.
7.	 Prevention Plus. Braden Scale for Predicting Pressure Sore Risk. www.bradenscale.com. Accessed December 12, 2018.
8.	 Nightingale F. “Notes on Nursing: What It Is and What It Is Not.” (originally published in 1859; still available from multiple publishers).
9.	 Centers for Medicare  Medicaid Services (CMS). F-Tag 314 and F-Tag 686. 2004. www.cms.gov. Accessed January 30, 2019.
10.	 Wound, Ostomy and Continence Nurses Society. WOCN Society Position Paper: Avoidable Versus Unavoidable Pressure Ulcers (Injuries). Mt.
Laurel, NJ: Wound, Ostomy and Continence Nurses Society; 2017.
11.	 Edsberg LE, Langemo D, Baharestani MM, Posthauer ME, Goldberg M. Unavoidable pressure injury: state of the science and consensus
outcomes. J Wound Ostomy Continence Nurs. 2014;41(4):313–334.
12.	 Sibbald RG, et al. Skin Changes at Life’s End (SCALE): final consensus statement. European Pressure Ulcer Advisory Panel. http://www.
epuap.org/wp-content/uploads/2012/07/SCALE-Final-Version-2009. October 1, 2009.
13.	 Schank JE. Kennedy terminal ulcer: the “ah-ha” moment and diagnosis. Ostomy Wound Manage. 2009;55(9):40–44.
14.	 Kennedy KL. The prevalence of pressure ulcers in an intermediate care facility. Decubitus. 1989;2(2):44–45.
15.	 Langemo D, Brown G. Skin fails too: acute, chronic, and end-stage skin failure. Adv Skin Wound Care. 2006;19(4):206–11.
16.	 Netsch D. Refractory wounds: assessment and management. In Doughty D, McNichol L (Eds.), Wound, Ostomy and Continence Nurses Society
Core Curriculum Wound Management. Philadelphia: Wolters Kluwer; 2016:183.
17.	 Consortium for Spinal Cord Medicine. Early acute management in adults with spinal cord injury. A clinical practice guideline for health care
professionals. J Spinal Cord Med. 2008;31:408–79.
18.	 Bajwa AA, Arasi L, Canabel JM, Dramer DJ. Automated prone positioning and axial rotation in critically ill, non-trauma patient with acute
respiratory distress syndrome (ARDS). J Int Care Med. 2010;25(2):121–25.
19.	 Eachempati SR, Hydo LJ, Barie PS. Factors influencing the development of decubitus ulcers in critically ill surgical patients. Crit Care Med.
2001;27(10):1599–605.
20.	 Woo KY, Krasner DL, Sibbald RD. Pain in people with chronic wounds: clinical strategies for decreasing pain and improving quality of life.
In: Krasner DL, ed. Chronic Wound Care: The Essentials. Malvern, PA: HMP Communications; 2014.
21.	 Szor JK, Bourguignon C. Description of pressure ulcer pain at rest and at dressing change. J Wound Ostomy Continence Nurs. 1999;26(3):115-129.
Legal Perils and Pitfalls of Wound Care 2121Copyright © 2019 WoundSource  Kestrel Health Information, Inc. All rights reserved.
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2019 Advisory Board Members
CLINICAL EDITOR
Catherine T. Milne, APRN, MSN, ANP/ACNS-BC, CWOCN-AP
Connecticut Clinical Nursing Associates, LLC, Bristol, CT
EDITORIAL ADVISORY BOARD
Elizabeth A. Ayello, PhD, RN, ACNS-BC, CWON, MAPWCA, FAAN
Ayello, Harris  Associates, Inc., Copake, NY
Sharon Baranoski, MSN, RN, CWCN, APN-CCNS, FAAN
Nurse Consultant, Shorewood, IL
Kara S. Couch, MS, CRNP, CWS , CWCN-AP
George Washington University Hospital Washington, DC
Ferne T. Elsass, MSN, RN, CPN, CWON
Children’s Hospital of The King's Daughter, Norfolk, VA
Michel H.E. Hermans, MD
Hermans Consulting Inc., Miami, FL
Martha Kelso, RN, HBOT
Wound Care Plus, LLC, Lee’s Summit, MO
Diane Krasner, PhD, RN, FAAN
Wound  Skin Care Consultant, York, PA
Samantha Kuplicki, MSN, APRN-CNS, AGNCS-BC, CWCN-AP, CWS, RNFA
UPC General Surgery, Tulsa, OK
Kimberly LeBlanc, PhD, RN, WOCC(C), IIWCC
Canadian Wound Ostomy Continence Institute, In association with the
Nurses Specialized in Wound Ostomy Continence Canada Association
London, Ontario
James McGuire, DPM, PT, LPed, FAPWHc
Temple University School of Podiatric Medicine, Philadelphia, PA
Linda Montoya, RN, BSN, CWOCN, APN
Symphony Post Acute Network, Joliet, IL
Nancy Munoz, DCN, MHA, RD, FAND
Southern Nevada VA Healthcare System, Las Vegas, NV
Marcia Nusgart, R.Ph.
Alliance of Wound Care Stakeholders, Coalition of Wound Care
Manufacturers, Bethesda, MD
Kathleen D. Schaum, MS
Kathleen D. Schaum  Associates, Inc., Lake Worth, FL
Thomas E. Serena, MD, FACS, FACHM, MAPWCA
SerenaGroup®, Cambridge, MA
Janet Wolfson, PT, CLWT, CWS, CLT-LANA
Wound Care Coordinator, Ocala, FL
FOUNDING CLINICAL EDITOR
Glenda J. Motta, RN, BSN, MPH, WOCN
GM Associates, Inc., Loveland, CO
WoundSource® Team
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Legal Perils of Wound Care

  • 1. Legal Perils and Pitfalls of Wound Care Heidi Cross, MSN, RN, FNP-BC, CWON, CSWS
  • 2. Table of Contents About the Author.........................................................................................................................................................2 Introduction...................................................................................................................................................................3 How to Keep Yourself Out of Court.......................................................................................................................4 Not Documented, Not Done.....................................................................................................................................6 Turning and Positioning.............................................................................................................................................7 Risk Assessments.........................................................................................................................................................9 Is That Ulcer Unavoidable or Not?.......................................................................................................................11 Intrinsic Risk Factors for Unavoidable Pressure Ulcers................................................................................13 Extrinsic Risk Factors for Unavoidable Pressure Ulcers...............................................................................15 Avoiding a Pain and Suffering Allegation.........................................................................................................17 Conclusion....................................................................................................................................................................19
  • 3. About the Author Heidi H. Cross, MSN, RN, FNP-BC, CWON, CSWS, is a board-certified Wound and Ostomy Nurse and a board-certified Family Nurse Practitioner in Syracuse, NY. She is a graduate of Syracuse University, with a Master of Science degree in Nursing from the State University of New York Upstate Medical University. She has extensive experience caring for wound and ostomy patients in acute care as well as in long-term care facilities. Currently, she is employed by CNY Surgical Physicians, consulting for nursing homes in the Syracuse area, and has her own practice as an expert witness for plaintiff and defense attorneys. Ms. Cross is a member of the Wound, Ostomy, and Continence Nurses Society™, the Association for the Advancement of Wound Care, and the American Nurses Association. She has served on numerous committees related to wound and ostomy care, including as chair of the Examination Committee of the Wound Ostomy and Continence Nursing Certification Board, the Credential and Review Committee, and the Marketing Committee. For the Wound and Ostomy Nurses Society, she has been the co-chair of the National Conference Planning Committee ostomy track, has done peer review for the Journal of Wound Ostomy and Continence Nursing (JWOCN), and was the recipient of a grant from the Center for Clinical Investigation Research. The United Ostomy Associations of America honored her with the UOAA Ostomy Nurse of the Year in 2008, and ConvaTec awarded her the Ostomy Nurse of the Year award in 2011. She participated in developing the National Pressure Ulcer Advisory Panel’s Clinical Practice Guidelines for Prevention and Treatment of Pressure Ulcers in 2014. Disclaimer: The Content of this white paper is for informational purposes only. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment, nor should it be used as a substitute for professional legal advice. Always refer to your facility protocol in the assessment and treatment of patients and for documentation standards. The views and opinions expressed in this white paper are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies. 2Legal Perils and Pitfalls of Wound Care Copyright © 2019 WoundSource & Kestrel Health Information, Inc. All rights reserved.
  • 4. Legal Perils and Pitfalls of Wound Care 33Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. Introduction This white paper discusses the legal implications of wound care, with an emphasis on pressure ulcers, which are common catalysts for malpractice litigation against nursing facilities. Topics include the importance of proper documentation, turning and positioning of patients, pressure ulcer risk assessments, the issue of unavoidable pressure ulcers including intrinsic and extrinsic risk factors, and pain and suffering allegations. Wound care professionals are already attuned to best practice patient care, but they must also be made equally aware of standards of care as seen through the lens of the legal process, and the need for meticulous and consistent documentation, with an eye toward the possibility of pressure ulcer litigation. Current National Pressure Ulcer Advisory Panel terminology is “pressure injury”. For this white paper, we have chosen to use the term “pressure ulcer” to be consistent with most of the literature and acceptance of the term.
  • 5. Legal Perils and Pitfalls of Wound Care 44Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. How to Keep Yourself out of Court “Among the duties the defendants and their employees owed to John Doe but failed to perform was the duty to create and maintain accurate records of John Doe’s care plan, condition, progress, and treatment.” No matter the setting in which we practice, as health care providers we constantly are under the threat of a malpractice lawsuit. In nursing homes, the top targets for litigation are pressure ulcers, malnutrition, and dehydration. Up to 20% of all U.S. legal medical claims and more than 10% of settlements are wound related,1 and there are more than 17,000 pressure ulcer-related lawsuits filed annually in the United States, second only to wrongful death lawsuits.2 So, it behooves us to take the necessary measures to avoid being sued. What are the perils and pitfalls of wound care that we may encounter in our practice, and how can we best avoid them? This discussion explores the various elements that potentially can make or break a case, which essentially starts and ends with the documentation of the care provided. WOUND DOCUMENTATION BASICS: Importance of Good Documentation Adequate and accurate documentation, which is a record of the care provided, is a critical component. Ideal documentation in the chart should be comprehensive, consistent, concise, chronological, continuing, and reasonably complete.3 Unfortunately, over the course of my time reviewing charts relating to medical malpractice, I have found that there is no such thing as perfect charting, and this could be because it can be hard to balance perfect documentation with perfect patient care. Are we charting, or are we taking care of patients? This potentially creates an imbalance and can lead to the fact that the chart can be the best tool that defense attorneys have, yet it can also be the best tool that plaintiff attorneys have. Purpose of Documentation The primary purpose of documentation is communication. This includes what care was provided, but also it serves as a communication tool among current providers. This enables the entire health care team to share information about the care and treatment of the patient. Also, it serves to prove to state and federal surveyors that the facility and staff are meeting mandated regulations. Communication among staff, of course, can be verbal or written, but it is mostly written communication (the chart) that will make its way into court. Why Consistency in Wound Documentation Matters Communication is how we as the health care team stay informed about the patient’s changing condition. Therefore, it becomes absolutely necessary that within our practice setting we review what our other team members are documenting and ensure that all documentation remains consistent between disciplines. For better or for worse, bedside nurses assume chief responsibility for skin and wound assessment and documentation, so other providers within the facility should try to review nurses’ wound care notes. It never looks good in court when nursing wound documentation charts “Stage 4 pressure ulcer, necrotic 7 × 8 cm,” and the same- day physician documentation is “Stage 3, 3 × 4 cm.” Which is the right one, and why are they not documenting the same thing? This throws the entire wound documentation, and possibly the entire chart, into doubt. Consistency in our wound care documentation is key. Consistency will build trust that what is in the chart is an accurate depiction of the wound and the care provided and will hold up much better in court when presented to a judge and jury. Having a dedicated wound team and/or a certified wound specialist conducting regular wound assessments should accomplish much greater consistency than relying on bedside nurses, who may not have received thorough wound assessment training. Wound care policies should dictate who will consistently perform the wound assessments and at what frequency. Usually weekly is the standard.
  • 6. Legal Perils and Pitfalls of Wound Care 55Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. WOUND DOCUMENTATION ESSENTIALS A well-designed wound care documentation form should include all necessary elements. These include: Location. Often in reading a chart we are not sure exactly what wound is described or where it is. Know your anatomy and do not confuse right with left. Measurements, which should be as accurate as possible and measured consistently from week to week. Measurement parameters should include length, width, and depth, as well as any tunneling and undermining. Hint: if the true depth of a wound is obscured by necrotic tissue, chart that the depth is “unknown”. Otherwise, as the wound debrides and the true depth becomes apparent, it may appear as though the wound has gotten deeper. Plaintiff attorneys love that! Wound bed description Document the percentage of granulation tissue versus necrotic tissue. Include odor, drainage type and amount, the condition of the periwound skin, and any signs of infection. Pain (and what was done about it). The location of the pain is critical, as well as how it was addressed. “Pain and suffering” allegations are frequently part of a pressure ulcer lawsuit; for more, see the final section of this white paper, starting on page 15. Nutrition status and what measures are in place, especially if the patient is at risk for malnutrition or is already compromised. Make sure that the dietician is involved as needed. Any pressure reducing/redistributing measures or devices, such as what support surface that the patient is on, both mattress and seating surface, and heel pressure relief measures. Turning and positioning measures. Physician and family notification. Often in a lawsuit, the family will say, “We never knew about the bedsore, or how bad it was!” Allegation frequently include lack of MD notification. Current treatment or whether the treatment is being changed. Preferably, have the dressing changes included in the treatment administration record or appropriate section of the chart. The latest risk status (i.e., the Braden Scale for Predicting Pressure Sore Risk® score), which should be performed on admission and then regularly thereafter. Whether the ulcer was present on admission, or when it was first noted. The next section of this white paper examines the “Not documented, not done” assumption (often used by plaintiff attorneys) and then drills down to specifics of wound documentation that either may help you stay out of court or may eventually help you if you find yourself there. How to Keep Yourself out of Court Continued
  • 7. Legal Perils and Pitfalls of Wound Care 66Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. Not Documented, Not Done “Among the duties the defendants and their employees owed to John Doe but failed to perform was the duty to appropriately chart information concerning his condition, assessment, care planning, history, monitoring, and pressure ulcer prevention measures so as to enhance his progress and well-being, and to prevent pressure ulcers.” Documentation is used by attorneys to ascertain whether the standards of care have been met in a particular case. As stated previously, documentation ideally needs to be clear, concise, chronological, continuing, and reasonably complete.3 WOUND DOCUMENTATION AND LITIGATION Not Documented, Not Done Frequently, in the course of legal proceedings, we encounter the phrase “Not documented, not done” regarding wound care. Plaintiff (and defense attorneys) scour the chart for evidence of the exact care provided as documented in the chart and present what they find as absolute evidence that the facility met the standard of care or not. What is a “standard of care?” There are many definitions, but at its core a standard of care is what any reasonable health care practitioner would do under similar circumstances. If standards of care have been met, then the defendant prevails; if not, then the plaintiff does. Can the absence or paucity of certain documentations be absolute proof that standards were not met? Can we expect that busy bedside clinicians chart every single action that they take, and are capable of 100% perfect documentation? According to Ayello et al., “’Not documented, not done’ removes the focus from the patient care and puts it on creating ‘perfect paperwork.’”3 POOR DOCUMENTATION Poor documentation related to wound care, but not necessarily proof of lack of care, may include turning and positioning, feeding and nutrition measures, the support surface the patient was on (mattress and seating), any refusals of care, when exactly the wound dressing was changed and what was used (ideally charted every time but often not), conversations with physicians and families, patient transfers out of bed, and many other of the myriad actions that bedside nurses and other health care providers perform during the course of their busy day. ELECTRONIC MEDICAL RECORDS Electronic records, done properly, can be a step forward, prompting health care staff to document their wound care more completely in what is hopefully a more efficient and legible manner. The danger comes (and this applies to paper records, as well as electronic records) when areas on forms are left blank. There is a strong assumption that any blanks are proof that those interventions did not occur. For example, if there is an area for “turning and positioning” or for a specialty bed, make sure it is completed or plaintiff attorneys will pounce. CHART ANALYSIS When I look at a chart for attorneys, I, too, look for perfect “Turn Q 2 hour” documentation when a patient is at risk or has an existing pressure ulcer. Perfection is rarely found. And even if there are perfect every two-hour documentations, how do we really know these actions were truly performed, or whether staff sat down at the end of the shift and filled in their initials every two hours (i.e., created perfect paperwork but not necessarily performed perfect patient care)? KEY TAKEAWAYS The general answer is that when I look at charts, I am looking for an overall culture of patient care, including turning and positioning. Clues to a facility’s patient care culture can be found looking at those measures as well as wound and skin assessments, risk assessments, physician and family notifications, nutrition assessments and interventions, management or treatment of skin and wound issues, and pain assessment and treatment.
  • 8. Legal Perils and Pitfalls of Wound Care 77Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. Turning and Positioning “Among the duties the defendants and their employees owed to Mr. John Doe but failed to perform was the duty to turn and position him every two hours.” ESSENTIALS OF TURN AND POSITION DOCUMENTATION Failure to turn and position (TP) is always part and parcel of a pressure ulcer lawsuit and a key element of a complaint related to pressure ulcers, as illustrated in the opening quotation. TP documentation is a dominant focus in chart analysis and is usually one of the first things that an attorney and the expert witness look for. If TP documentation is satisfactory, the defendant is likely to prevail; if not, then the plaintiff may have a pretty rock-solid case. Is there such a thing as perfect turning and positioning documentation? Alas, no, or at least, rarely. With that in mind, here are some suggestions: Communication: Just like communication, consistency is key. If mention of TP occurs only sporadically, especially in the nurse’s notes, a judge and jury are going to have the impression that it was not high on the staff’s and the facility’s priorities. Mobility Score: The need for TP will be largely based on the mobility score (2 = very limited or 1 = completely immobile) and activity score (2 = chairfast or 1 = bedbound) of the Braden Scale. Of course, nothing trumps good nursing judgment of the patient’s needs and documentation thereof. Care Plan: Be sure that TP is part of the nursing care plan, if needed, based on nursing assessments, and is part of the certified nursing assistant (CNA) care plan. CNAs are crucial team members, should be on board and educated about the importance of TP, and should be involved in care plan development and charting of these measures. Team Coordination: Be sure ALL team members are aware of and attuned to the patient’s turning and mobility needs. This includes physical and occupational therapy, nutrition services, case management, interdisciplinary care teams, and physicians. Physician’s Order: Ideally, there should be a physician’s order to TP when the patient is at risk or has an existing pressure ulcer. If your facility has physician order sets, make turning orders part of them, as well as placing these orders on the Treatment Administration Record. What is the ideal frequency of documenting TP? In a lawsuit, there has to be a balance between expecting too much and accepting what may be perceived as too little. A lot of it depends on a facility’s documentation process and expectations. When I look at a chart, I look for what appears to be a “culture” of TP. Free text nursing notes often tell a better story than “check box” flowsheets. There is also a danger to “check box” flowsheets because if boxes are left blank there will be strong presumption that those interventions did not take place.
  • 9. Legal Perils and Pitfalls of Wound Care 88Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. WHAT DO THE PRESSURE ULCER GUIDELINES SAY ABOUT “Q2H”? The 2014 National Pressure Ulcer Advisory Panel* does not recommend a frequency but suggests that we “consider the pressure redistribution surface in use” and also “tissue tolerance, level of activity and mobility, general medical condition, overall treatment objectives, skin condition, and comfort.”4 Similarly, the Wound, Ostomy and Continence Nurse Pressure Ulcer guidelines state, “schedule regular repositioning and turning for bedbound and chairbound individuals.”5 IS THERE ANY RESEARCH UPON WHICH TO BASE EVIDENCE? Research is definitely lacking, mostly due to reasonable concerns about not turning patients and the inherent possible consequences. Nursing lore has it that the whole “TP Q2” harks back to Florence Nightengale’s time; it is said that it took two hours for her nurses to get from one end of the room to the other to turn patients. Hence, every two hours! However, in 2013 the TURN study by Nancy Bergstrom and associates found no difference in pressure ulcer development between “those at moderate and high risk of developing pressure ulcers turned at 2-, 3-, or 4-hour intervals... using high-density foam mattresses.”6 So, there is nothing evidence- based or magic about the two hours of “Q2H” turning! WHAT ABOUT PATIENTS’ NON-ADHERENCE OR REFUSALS? Refusing any medical interventions falls squarely under patient’s rights and it is their right to refuse turning and repositioning. (Of course, it also is their right to sue if they subsequently develop a pressure ulcer!) Documentation of refusals becomes crucial. Document: • The reason that patients refuse TP. For added impact, chart exact quotes from patients. Is it because of pain and the need for a reassessment of their pain regimen? Are they close to end of life and do not wish to be disturbed? Maybe they just do not understand the dangers of immobility and the risk for skin breakdown. Sometimes it may be a control issue, understandable when everything else in their life seems out of their own control. • What actions you took as a result and the education you provided about the need for adherence. • Patients’ reactions to the education. This demonstrates patients’ understanding and, implicitly, patients’ consent, assuming cognition is intact. • Education of family members about the need for repositioning and their reaction to the teaching, enlisting their help. Hearing it from multiple providers may help, so be sure to involve all staff in reinforcing the need for turning and positioning. KEY TAKEAWAYS Questions remain about appropriate turning intervals, with nothing specific in the guidelines that would absolutely point to poor care if “perfect” documentation of every two-hour turning is lacking. Nevertheless, all patients need to be assessed for pressure ulcer risk factors and those factors addressed with timely and necessary interventions and measures, with good staff and family involvement. Turning and Positioning Continued *Updated NPUAP updates will be available in November of 2019; however, they were not available at time of this publication.
  • 10. Legal Perils and Pitfalls of Wound Care 99Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved.   Risk Assessments “Among the duties the defendants and their employees owed to John Doe but failed to perform was the duty to timely, accurately, and adequately assess his risk for skin breakdown and the development of a pressure ulcer.” WHY DO A RISK ASSESSMENT FOR PRESSURE ULCERS? When looking at medical charts from a legal perspective, another of the areas closely scrutinized is the risk assessment for skin breakdown and pressure ulcer development. Completing a pressure ulcer risk assessment is considered a standard of care. Was the patient adequately assessed for risk factors, and was this done in a timely fashion? Was it repeated at regular intervals, with a change in condition, or on readmission? Do scores seem appropriate for the patient’s condition? Is there consistency among health practitioners? Were the results used to institute evidence-based and appropriate pressure ulcer prevention and treatment measures and care plans? Or do the results seem to simply languish in the chart? What are the standards of care related to this? The most commonly used scale in the United States is the Braden Scale for Predicting Pressure Sore Risk® (Braden Scale).7 Developed in 1987 by Barbara Braden and Nancy Bergstrom, it has been extensively tested for reliability and validity. Used correctly and completed as designed, it is an excellent metric for the risk of skin breakdown. WHAT DO THE GUIDELINES SAY? The 2014 National Pressure Ulcer Advisory Panel (NPUAP) Guidelines state, “Conduct a structured risk assessment as soon as possible (but within a maximum of eight hours after admission) to identify individuals at risk,” “Repeat the risk assessment as often as required by the individual’s acuity,” and “Undertake a reassessment if there is any significant change in the individual’s condition.”4 The Guidelines also include recommendations about documentation and developing a plan. WHAT ARE THE PITFALLS, AND WHAT WILL NOT BODE WELL FOR THE DEFENSE? Not assessing pressure ulcer risk on admission. The NPUAP calls for risk assessment within eight hours, but this may at times be a lofty goal. It should, however, be a goal we all endeavor to meet. Not repeating at regular intervals. How often the risk assessment should be repeated depends on the setting and the patient’s con- dition. Usually, in the intensive care unit, it is conducted on every shift. On acute care units, generally every 24 hours is sufficient. In long-term care facilities, the Braden Scale website suggests conducting risk assessment on admission, weekly for the first four weeks, and then quarterly. Inconsistencies among those completing the Braden Scale. What does it say about the staff and the facility if the scores vary widely? One day the patient may be a 12, only to be a 20 the next day, without any change in condition. Here are some of the possible reasons: • Inadequate staff training and familiarity. Be sure staff has been well trained, with periodic updates and in-services, and that scores are consistent from shift to shift. • Truncating or altering the Braden Scale. Reliability and validity were established using the scale in its entirety, exactly as published. Changes without re-establishing reliability and validity negate its effectiveness. • The Braden Score is completed by the night shift. How can the night shift truly know how well a patient eats and moves? Also, it is more difficult to assess sensory perception on a sleepy or sleeping patient. So, what can go wrong relative to subscores? Sensory perception. Often overlooked and overscored are patients with diabetes and arterial disease, who inevitably have neuropathies with altered sensation. Also, how can a resident with paraplegia or quadriplegia score any more than a 2? Moisture. It is not just incontinence. Moisture issues occur with diaphoresis, obesity, highly exudative wounds, weepy legs from venous insufficiency, etc. Activity and mobility. Be sure to read the exact detail of the descriptions. Important: nursing scores on the Braden Scale should match physical therapy and occupational therapy assessments. If the Braden subscale is documented a 3 or 4, but physical therapy and occupational therapy are documenting “max assist” or “total dependence” in this area, there is a disconnect and will not reflect well on the facility. Nutrition. Pay attention to the exact details on the Braden scale, and score accordingly. Any recent, unintended weight loss
  • 11. Legal Perils and Pitfalls of Wound Care 1010Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. should be a red flag, with a low score, as should consistently low meal intake or low BMI. Tube feedings and TPN complicate our assessments as to how adequately patients are nourished. Check with your dietitian if in doubt. Friction/shear. Any bedbound patient or one with a low mobility score will likely have a “problem” or a “potential problem.” KEY TAKEAWAYS Conducting the Braden Scale is only the beginning and, unless translated into action, will amount only to busywork on the part of the nurses. Nurses need to be well-trained and familiar with the scale. Based on the subscores, an individualized and evidence- based care plan needs to be implemented, with interventions specifically targeted at needed areas. This is something that attorneys actively scrutinize. 10 Risk Assessments Continued
  • 12. Legal Perils and Pitfalls of Wound Care 1111Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. Is That Ulcer Unavoidable or Not? “Among the duties the defendants and their employees owed to John Doe but failed to perform was the duty to implement appropriate measures to avoid skin breakdown and multiple Stage 4 pressure ulcers, which, but for the lack of care, could have been avoided.” “If a patient is cold, if a patient is feverish, if a patient is faint, if he is sick after taking food, if he has a bed sore, it is generally the fault not of the disease, but of the nursing.”8 —Florence Nightingale We have a lot to thank Florence Nightingale for—a brilliant woman considered to be the founder of nursing and nursing standards and the first to ever put statistics to health care, among other valuable contributions. But if the health department is coming to a facility near you or a lawyer is scrutinizing your facility with a lawsuit, make sure Florence has the day off because with a statement like that we don’t stand a chance to prevail! Florence or not, over the years all pressure ulcers were generally considered avoidable. If a patient developed a pressure ulcer in our facility it was time to throw on the sackcloth and the ashes; we own “this one” and are liable for its development. Fortunately, we have now come to realize that pressure ulcers can and do occur despite best treatment and prevention measures and may be unavoidable. Official recognition of this was a huge gift to defense attorneys and, more importantly, to the facilities they represent. RECOGNITION OF UNAVOIDABLE PRESSURE ULCERS Along Comes F-Tag 314, Now F-Tag 686 The first government recognition of unavoidability occurred in 2004 with the publication by the Centers for Medicare Medicaid Services of F-Tag 314, titled “Pressure Sores.”9 F-Tags are federal regulations for nursing homes and represent guidance for surveyors of long-term care. In F-Tag 314, facilities are required to “evaluate an individual’s clinical condition and pressure ulcer risk factors; define and implement interventions consistent with resident needs, resident goals, and professional standards of practice; monitor and evaluate the impact of the interventions; and revise the interventions as appropriate.” If a resident develops a pressure ulcer and the facility has performed (and documented) all these, the ulcer may be determined unavoidable. Wound, Ostomy and Continence Nurses Society™ (WOCN®) Position Paper: Avoidable Versus Unavoidable Pressure Ulcers (Injuries) The purpose of this document was to “lend support to the theory that some pressure ulcers are unavoidable.”10 This document contains “Supportive Statements” related to unavoidability that include risks and comorbidities, medical device–related pressure ulcers, end-of-life changes, prevention strategies, role of documen- tation, quality improvement programs, and education. It concludes with recommendations for needed research related to this topic. National Pressure Ulcer Advisory Panel The NPUAP has published numerous documents related to unavoidability. In 2014, it published an article detailing the results of a consensus panel related to unavoidable pressure injuries and coming to a consensus that “unavoidable pressure ulcers do occur.”11 This article details the multiple risk factors, intrinsic and extrinsic, for unavoidable pressure ulcer development. These risk factors are detailed later in this white paper. Skin Changes at Life’s End (SCALE) In 2009, a consensus panel was convened with the goal of establishing a consensus statement about skin changes at life’s end.12 Conclusions were that: • The skin is the body’s largest organ and like any other organ is subject to a loss of integrity. • Our current comprehension of skin changes that can occur at life’s end is limited. • The SCALE process is insidious and difficult to determine prospectively. • Additional research and expert consensus are necessary. • And, contrary to popular myth, not all pressure ulcers are avoidable. What About the Kennedy Terminal Ulcer? A Kennedy terminal ulcer is defined as “unavoidable skin breakdown or skin failure that occurs as part of the dying process.”13 It is widely acknowledged to represent the breakdown of skin that can occur at the end of life. End-of-life skin failure can take many forms, but Kennedy terminal ulcers most often occur on the sacrococcygeal area and develop and deteriorate very rapidly. They often have a pear or butterfly appearance and can be irregularly shaped, red/yellow/black, and similar in appearance to an abrasion or blister.14
  • 13. Legal Perils and Pitfalls of Wound Care 1212Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. BUT BACK TO FLORENCE Nurse Nightingale was dealing with an entirely different set of patients. People did not live the long lives we do (average life expectancy was around 50 at that time) and were not prone to the risk factors and frailties we acknowledge today. Nor were they intensive care patients, critically ill and depending on technology to keep them alive. So, if her patients developed a “bed sore,” it may well have been due to a lack of proper nursing care. KEY TAKEAWAYS There is a lot of evidence for and expert opinions about unavoidable skin breakdown and pressure ulcers, and the fact that they indeed occur, despite best practice. There are multiple risk factors, both intrinsic as well as extrinsic, that place a patient at risk, and these need to be recognized, acknowledged, and documented.   Is That Ulcer Unavoidable or Not? Continued
  • 14. Legal Perils and Pitfalls of Wound Care 1313Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. Intrinsic Risk Factors for Unavoidable Pressure Ulcers With the publication of F-Tag 314, the Centers for Medicare Medicaid Services (CMS) finally, in essence, acknowledged that some ulcers can occur despite best care.9 The facility essentially can maintain, “We did everything we were supposed to, and despite that, the patient developed that pressure ulcer”—that is, the ulcer was unavoidable. To claim unavoidability, however, proper documentation needs to be in place in the chart that all proper prevention and treatment measures were implemented. TOP ON THE UNAVOIDABLE LIST: SKIN FAILURE Intrinsic risk factors include skin failure, which often (but not always) is associated with end-of-life. Skin failure has been defined as “an event in which the skin and underlying tissues die due to hypoperfusion that occurs with severe dysfunction or failure of one or more organ systems.”15 As we know, skin is an organ just like the heart, kidney, and liver, and it is the largest organ of the body. Unless there is actual medical malpractice, how often do we hear about patients suing cardiologists for heart failure, nephrologists for kidney failure, and hepatologists for liver failure? Granted, we have serum laboratory values for failures of the heart (B-type [or brain] natriuretic peptide), kidney (blood urea nitrogen, serum creatinine), and liver (liver enzymes); however, none exist for skin failure. But why so many lawsuits for pressure ulcers, when overall organ failure may be the causative issue? Why do families and patients get upset enough with pressure ulcers that they feel compelled to sue? I believe that in addition to being the largest organ, skin is outwardly visible, and skin breakdown can be shocking and jolting to patient family members, unlike the invisibility of other organs. It can easily be interpreted as a sign of abuse and neglect and has become the low-hanging fruit of lawsuits and the bread and butter of many medical malpractice plaintiff attorneys. Just look at some of the attorney ads out there for “nursing home abuse and neglect.” WHAT DOES THE NATIONAL PRESSURE ADVISORY PANEL HAVE TO SAY? Many experts and expert bodies have weighed in on this issue, and some of these were detailed in the previous section, “Is That Ulcer Unavoidable or Not?” Here, the focus is on the consensus panel article of the NPUAP, published in 2014.11 This article divides the risk factors into intrinsic and extrinsic factors. Please see the NPUAP article for more complete information. Extrinsic risk factors are discussed in the next section of this white paper. Intrinsic factors: Intrinsic factors related to pressure ulcer development consist of “the patient’s comorbidities and physiologic conditions impacting wound healing.”16 As per the NPUAP, these include: • Impaired tissue oxygenation or cardiopulmonary dysfunction. This category applies particularly to patients in the intensive care unit and includes vasopressor use (blood is being shunted from the periphery, i.e., skin and underlying tissues, to core organs), hypotension, hypoxemia, anemia, hypoventilation, and congestive heart failure. • Hypovolemia, defined as an inadequate volume of blood in the circulatory system, thus compromising tissue perfusion not only to vital organs, but also to peripheral tissues such as the skin. • Infection, sepsis, and hypoalbuminemia. Invasion and multiplication of microorganisms cause cellular injury, releasing toxins and competing with normal metabolism of the body. Inflammation results, which lowers albumin levels. Shock leads to inadequate tissue perfusion. • Body edema and anasarca, leading to compromised tissue perfusion and fragility and a decreased tolerance to pressure and shear. • Lower extremity arterial and venous disease, including venous insufficiency and neuropathic disease. Unless the underlying factors are corrected, deterioration may be the only expectation. • Chronic kidney disease. Changes in tissue tolerance as a result of renal disease, as well as mobility limitations and long times spent in a sitting position during dialysis, may increase the likelihood of pressure ulcer development and deterioration.
  • 15. Legal Perils and Pitfalls of Wound Care 1414Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. • Hepatic dysfunction, which results in hypoalbuminemia, edema and anasarca, ascites, cerebral dysfunction, and coagulopathies. • Other factors: sensory impairment, multiple sclerosis, stroke, coma, spinal cord injury (30% to 50% of all patients with spinal cord injury develop a pressure ulcer during the first month after injury17 ). • Anesthesia and operating room time. Anesthesia causes circulatory issues that increase risk for pressure ulcers and, of course, alters sensory ability to feel discomfort. • Age. Increased risk for pressure ulceration occurs at both ends of life. Neonates, particularly preemies, lack proper skin structures to avoid pressure ulcers. In older adults, multiple changes occur in not only the skin but also the underlying tissues, thus increasing risk. 70% of pressure ulcers occur in those 70 years and older.11 • End-of-life and end-stage dementia, leading to poor appetite and nutritional compromise, bedridden status, impaired language and communication, and risk for contractures. • Body habitus. Obesity increases the risk for moisture, shear, friction, immobility, and skin tissue compromise. Cachexia, with minimal adipose tissue and overall fragility of skin, is a risk factor. KEY TAKEAWAYS Not all pressure ulcers are avoidable, despite best care practices. Contributors to unavoidability include intrinsic risk factors, skin failure chief among them. These factors need to be assessed and evaluated and compensated for if possible. If relief of those factors is not possible, we need to acknowledge and communicate likely realistic outcomes, which may include unavoidable pressure ulcers. Intrinsic Risk Factors for Unavoidable Pressure Ulcers Continued
  • 16. Legal Perils and Pitfalls of Wound Care 1515Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. Extrinsic Risk Factors for Unavoidable Pressure Ulcers “At all times material hereto, defendant failed to develop an adequate care plan and properly monitor and supervise the care and treatment of John Doe in order to prevent him from suffering the development and deterioration of bed sores.” The BEST legal defense in a pressure ulcer lawsuit is if the facility and legal counsel can effectively show that the pressure ulcer was unavoidable. Unavoidable pressure ulcers occur when a patient develops an ulcer even though the facility met standards of care related to pressure ulcer prevention and treatment. These include assessments and interventions such as risk assessment, nutrition, support surfaces, regular wound assessments, wound treatments, mobilization, turning and positioning, and physician and family notification. Moreover, in a pressure ulcer lawsuit, a pain and suffering allegation is almost assuredly a part of the complaint, so the presence of pain and subsequent interventions need to be addressed as well. EXTRINSIC RISK FACTORS FOR PRESSURE ULCER DEVELOPMENT The previous section of this white paper discussed intrinsic risk factors, using predominantly the NPUAP consensus panel article of 2014.11 This list was quite lengthy and included tissue oxygenation, age, end of life, infection and immunosuppression, body habitus, and multiple other underlying chronic conditions. Extrinsic risk factors, on the other hand, include “external or environmental sources that disrupt the wound healing process.”16 That is the subject of this section, and, once again, the NPUAP article is used as a guide. • Head of bed (HOB) elevation. Elevating the HOB 30o to 40o is a recommendation to prevent aspiration and ventilator-acquired pneumonia. Patients who have tube feedings are particularly at risk for aspiration. This directly contradicts all pressure ulcer recommendations, which state that HOB elevations significantly increase shear and interface pressures, despite all turning practices. Ideally, all patients with HOB elevations should be put on higher- level surfaces sooner rather than later to address the increased pressures that result and document the reason for the HOB elevation. Having a doctor’s order in place strengthens the case. • Hip fracture. Hip fractures are associated with significantly increased morbidity and mortality and an increased risk of pressure ulcer development by virtue of long periods of immobility. Patients with hip fractures generally are frail older adults with multiple comorbidities. • Prone positioning. Pressure ulcer incidence rates as high as 65% have been reported among patients in a prone position.18 • Nutrition. Malnutrition is a well-known risk factor for pressure ulcer development and is a frequent focus of pressure ulcer lawsuits. Protein-energy malnutrition (lack of protein and calories) causes the body to break down muscle tissue for energy (defined as maintenance of normal body functions), resulting in sarcopenia (loss of lean body mass). Unintended weight loss is a common indicator of malnutrition. Keeping track of weight loss is a critical intervention and something that attorneys closely scrutinize, as well as what other nutritional interventions and supplements have been implemented. • Hospital length of stay (LOS). Several studies are listed in the NPUAP article citing the relationship between hospital LOS and adverse events such as pressure ulcer development. One study found that 97% of all pressure ulcers occurred among study participants whose LOS was greater than seven days.19 It makes sense, doesn’t it? The sicker patients are, the longer they are in the hospital, the more they are at risk. • Smoking. The nicotine in cigarettes causes vasoconstriction and tissue ischemia, not to mention the deleterious effect of carbon monoxide, which displaces oxygen from hemoglobin. Multiple studies as well as plain old common sense tell you that cigarette smoking is a huge risk factor for pressure ulcer development, and attorneys have successfully used a smoking history to prove contributory negligence.
  • 17. Legal Perils and Pitfalls of Wound Care 1616Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. • Medical devices. Often very necessary and lifesaving, medical devices nevertheless are responsible for between 20% and 40% of all new pressure ulcers. These include continuous positive airway pressure devices, urinary catheters, restraints, cervical collars, nasogastric tubes, nasal cannula oxygen tubing, and external fixators. Or how about when a leg cast comes off and everyone has been wondering what the smell was, only to discover a stage 4 pressure ulcer underneath? • Non-adherence. Patient rights dictate that patients have the right to make informed decisions and refuse treatment, which can impact cooperation with pressure ulcer prevention and treatment measures. Refusals can result in an unavoidable pressure ulcer. See the turning and positioning section of this white paper for more on non-adherence. Just as with smoking, contributory negligence may become a factor in the lawsuit, thereby reducing the facility’s liability. KEY TAKEAWAYS Pressure ulcer development is multifactorial and complex. Patients need to be assessed for any “external or environmental sources” that may cause skin breakdown and pressure ulcers, in the process balancing risk versus benefit of any procedures and interventions. If those cannot be modified, we need to acknowledge the unavoidability of the skin issues. Ultimately, whether the cause is extrinsic or intrinsic, good documentation of assessments and risk factors is a necessary component of limiting liability in a lawsuit. Extrinsic Risk Factors for Unavoidable Pressure Ulcers Continued
  • 18. Legal Perils and Pitfalls of Wound Care 1717Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. Avoiding a Pain and Suffering Allegation: Must it be Peas and Carrots? “As a direct and proximate result of the negligence of the defendants, individually and vicariously through their nurses, staff, employees, and medical personnel, John Doe developed a pressure ulcer, severe dehydration, and malnutrition with resulting pain and suffering, loss of quality of life, premature death, and medical expense.” “Me and Jenny goes together like peas and carrots.” – Forrest Gump INTRODUCTION Just like Forrest’s peas and carrots, a pressure ulcer lawsuit and a pain and suffering allegation inevitably “goes together.” For good reason, because pain is an ever-present problem in patients with pressure ulcers, venous and arterial ulcers, and even diabetic ulcers, despite sensory issues. How do you, as a health care provider, best protect and defend yourself against a pain and suffering allegation? SOURCES OF WOUND PAIN First, let’s remember the sources of wound pain, which, according to Woo et al.,20 can be related to: • Infection or inflammation, with increasing bioburden or infection • Moisture balance, with too much or, perhaps more often, too little moisture, resulting in dressings that stick and cause bleeding and trauma • Tissue debridement and trauma, where selection of dressings may be inappropriate or dressings too frequently changed, or by using aggressive adhesives, as well as during wound cleansing or irrigation FREQUENT ISSUES Facilities have gotten better about requiring routine pain assessments, but I frequently find problems in reviewing charts for attorneys. These are: • Not recording location with each and every pain assessment. Just as in real estate, location, location, location is a critical factor in pain assessments and documentation. If, for instance, a patient has an orthopedic injury such as a fractured arm or recent hip replacement, or chronic back pain, the pain may be more due to that factor than to any existing skin condition. However, if staff is recording a high pain level but is not giving a location, a plaintiff attorney will present that as pain from the ulcer, which is the subject of the lawsuit, thereby strengthening the pain and suffering allegation. • Not documenting pain levels routinely as ordered and not performing pain level reassessments after medication administration. • Not reporting high pain levels to health care providers, for possible readjustment of the care plan or medications. • Not documenting patient education and discussions related to pain and not collaborating with patient and family to optimize pain control. Poor communication with patients and family can often be the tipping point between “sue” and “not sue.” • Not premedicating for pain before dressing changes. Szor and Bourguignon reported that 87.5% of participants had pain at dressing change.21
  • 19. Legal Perils and Pitfalls of Wound Care 1818Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. TIPS THAT MAY HELP TO KEEP YOU OUT OF COURT Obtain a physician’s order to assess pain at least daily to every shift or more often, depending on patient condition and need. Add the order to any treatment administration record or wherever it fits in your documentation system, and document the pain level and, at the very least, the location of the pain in that part of the record. Do a pain risk assessment on admission and perform one routinely. How often? Again, this should be individualized based on patient condition, but at least quarterly seems like a good idea. Use a valid tool to assess pain levels. Some patient populations require specialized tools, such as the FLACC scale (Face, Legs, Activity, Cry, and Consolability) for babies and young children, and the PAINAD scale (Pain Assessment in Advanced Dementia) for cognitively impaired patients. Make sure staff has been well in-serviced on the use of these tools. Narrative notes or a well-designed specific pain form often can better describe the patient’s pain issues, with better descriptors. Query the patient directly about pain associated with the ulcer, and document! It is helpful to use the patient’s own words and description of pain. Include wound pain on all wound documentation forms such as weekly assessments, with full description and level. There are numerous mnemonics for performing a comprehensive assessment of pain. One recommendation is the PQRSTU.1 This stands for Provoking and palliating factors; Quality of pain; Regions (location!) and radiation; Severity or intensity; Timing or history; Understanding (what is important for you for pain relief? How would you like to get better?). Another is OLDCART—Onset, Location, Duration, Characteristics, Aggravating factors, Radiation, Treatment. Remember that pain often occurs with movement, so ask about pain and document at that time as well. PT and OT notes frequently conduct comprehensive pain assessments during therapy. Administer around the clock routine pain medications spaced out evenly over the 24 hours. An order for three times daily dosing could result in 8 am, 12 pm, and 4 pm administration, potentially leaving the patient without any pain coverage for 16 hours. Does that make any sense? Use dressings that don’t cause pain, such as silicone-backed dressings. And certainly, wet-to-dry must die! Decrease the frequency of dressing changes as much as possible. Use topical pain treatments such as morphine or EMLA (lidocaine 2.5% and prilocaine 2.5%) instead of or in addition to systemic drugs. Document all discussions and patient education related to pain management. Don’t forget about end of life pain issues and involve hospice in a timely fashion for optimal end of life pain care. KEY TAKEAWAYS Wound-associated pain is complex. A comprehensive assessment and treatment plan are necessary to adequately address pain issues. Good documentation of all measures employed related to pain will hopefully help you avoid that dreadful pain and suffering allegation! Avoiding a Pain and Suffering Allegation: Peas and Carrots? Continued
  • 20. Legal Perils and Pitfalls of Wound Care 1919Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. Conclusion In conclusion, pressure ulcer litigation and the decision to sue is multifactorial. Here in the USA, we are a very litigious society, and our expectations of good medical outcomes, regardless of situation, often exceed the reality of the situation. The facility and staff need to be sure to include proper pressure ulcer prevention and treatment measures, based on pressure ulcer risk assessments and good clinical judgement, with good and consistent documentation thereof. Ultimately, however, whether a family or patient decide to sue may be based on their overall satisfaction with care. Often, when asked, patients’ families might reply that they sued because “Mom died from that horrible bed sore and I don’t want anyone else to go through that.” They report “insensitive handling and poor communication” and a need for an explanation. Ultimately, good open communication, availability of staff including physician care, nursing and administration, and good customer skills and relations with a genuinely caring attitude may well be the tipping point as to whether a lawsuit is initiated. 19Legal Perils and Pitfalls of Wound Care Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved.
  • 21. Legal Perils and Pitfalls of Wound Care 2020Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. REFERENCES 1. Pfaff J, Moore G. ED wound management: identifying and reducing risk. ED Legal Letter. 2005;16:97–108. 2. Agency for Healthcare Research and Quality (AHRQ). Preventing pressure ulcers in hospitals: a toolkit for improving quality of care. Rockville, MD: AHRQ. https://www.ahrq.gov/sites/default/files/publications/files/putoolkit.pdf. Accessed October 14, 2018. 3. Ayello EA, Capitulo KL, Fife CE, et al. Legal issues in the care of pressure ulcer patients: Key concepts for healthcare providers. International Wound Care Advisory Panel. 2009. https://www.medline.com/media/assets/pdf/LegalImplicationsofPressureUlce.... Accessed October 14, 2018. 4. National Pressure Ulcer Advisory Panel. Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. Washington, DC: NPUAP; 2014. Available at https://www.npuap.org. Accessed November 12, 2018. 5. Wound, Ostomy, and Continence Nurse Society (WOCN Society). Guideline for Prevention and Management of Pressure Ulcers. WOCN clinical practice guideline series no. 2. Glenview, IL: WOCN Society; 2016. 6. Bergstrom N, Horn SD, Rapp MP, Stern A, Barrett R, Watkiss M. Turning for ulcer reduction: a multisite randomized clinical trial in nursing homes. J Am Geriatr Soc. 2013;61(10):1705–13. 7. Prevention Plus. Braden Scale for Predicting Pressure Sore Risk. www.bradenscale.com. Accessed December 12, 2018. 8. Nightingale F. “Notes on Nursing: What It Is and What It Is Not.” (originally published in 1859; still available from multiple publishers). 9. Centers for Medicare Medicaid Services (CMS). F-Tag 314 and F-Tag 686. 2004. www.cms.gov. Accessed January 30, 2019. 10. Wound, Ostomy and Continence Nurses Society. WOCN Society Position Paper: Avoidable Versus Unavoidable Pressure Ulcers (Injuries). Mt. Laurel, NJ: Wound, Ostomy and Continence Nurses Society; 2017. 11. Edsberg LE, Langemo D, Baharestani MM, Posthauer ME, Goldberg M. Unavoidable pressure injury: state of the science and consensus outcomes. J Wound Ostomy Continence Nurs. 2014;41(4):313–334. 12. Sibbald RG, et al. Skin Changes at Life’s End (SCALE): final consensus statement. European Pressure Ulcer Advisory Panel. http://www. epuap.org/wp-content/uploads/2012/07/SCALE-Final-Version-2009. October 1, 2009. 13. Schank JE. Kennedy terminal ulcer: the “ah-ha” moment and diagnosis. Ostomy Wound Manage. 2009;55(9):40–44. 14. Kennedy KL. The prevalence of pressure ulcers in an intermediate care facility. Decubitus. 1989;2(2):44–45. 15. Langemo D, Brown G. Skin fails too: acute, chronic, and end-stage skin failure. Adv Skin Wound Care. 2006;19(4):206–11. 16. Netsch D. Refractory wounds: assessment and management. In Doughty D, McNichol L (Eds.), Wound, Ostomy and Continence Nurses Society Core Curriculum Wound Management. Philadelphia: Wolters Kluwer; 2016:183. 17. Consortium for Spinal Cord Medicine. Early acute management in adults with spinal cord injury. A clinical practice guideline for health care professionals. J Spinal Cord Med. 2008;31:408–79. 18. Bajwa AA, Arasi L, Canabel JM, Dramer DJ. Automated prone positioning and axial rotation in critically ill, non-trauma patient with acute respiratory distress syndrome (ARDS). J Int Care Med. 2010;25(2):121–25. 19. Eachempati SR, Hydo LJ, Barie PS. Factors influencing the development of decubitus ulcers in critically ill surgical patients. Crit Care Med. 2001;27(10):1599–605. 20. Woo KY, Krasner DL, Sibbald RD. Pain in people with chronic wounds: clinical strategies for decreasing pain and improving quality of life. In: Krasner DL, ed. Chronic Wound Care: The Essentials. Malvern, PA: HMP Communications; 2014. 21. Szor JK, Bourguignon C. Description of pressure ulcer pain at rest and at dressing change. J Wound Ostomy Continence Nurs. 1999;26(3):115-129.
  • 22. Legal Perils and Pitfalls of Wound Care 2121Copyright © 2019 WoundSource Kestrel Health Information, Inc. All rights reserved. FOLLOW US:Facebook “f” Logo CMYK / .eps Facebook “f” Logo CMYK / .eps 2019 Advisory Board Members CLINICAL EDITOR Catherine T. Milne, APRN, MSN, ANP/ACNS-BC, CWOCN-AP Connecticut Clinical Nursing Associates, LLC, Bristol, CT EDITORIAL ADVISORY BOARD Elizabeth A. Ayello, PhD, RN, ACNS-BC, CWON, MAPWCA, FAAN Ayello, Harris Associates, Inc., Copake, NY Sharon Baranoski, MSN, RN, CWCN, APN-CCNS, FAAN Nurse Consultant, Shorewood, IL Kara S. Couch, MS, CRNP, CWS , CWCN-AP George Washington University Hospital Washington, DC Ferne T. Elsass, MSN, RN, CPN, CWON Children’s Hospital of The King's Daughter, Norfolk, VA Michel H.E. Hermans, MD Hermans Consulting Inc., Miami, FL Martha Kelso, RN, HBOT Wound Care Plus, LLC, Lee’s Summit, MO Diane Krasner, PhD, RN, FAAN Wound Skin Care Consultant, York, PA Samantha Kuplicki, MSN, APRN-CNS, AGNCS-BC, CWCN-AP, CWS, RNFA UPC General Surgery, Tulsa, OK Kimberly LeBlanc, PhD, RN, WOCC(C), IIWCC Canadian Wound Ostomy Continence Institute, In association with the Nurses Specialized in Wound Ostomy Continence Canada Association London, Ontario James McGuire, DPM, PT, LPed, FAPWHc Temple University School of Podiatric Medicine, Philadelphia, PA Linda Montoya, RN, BSN, CWOCN, APN Symphony Post Acute Network, Joliet, IL Nancy Munoz, DCN, MHA, RD, FAND Southern Nevada VA Healthcare System, Las Vegas, NV Marcia Nusgart, R.Ph. Alliance of Wound Care Stakeholders, Coalition of Wound Care Manufacturers, Bethesda, MD Kathleen D. Schaum, MS Kathleen D. Schaum Associates, Inc., Lake Worth, FL Thomas E. Serena, MD, FACS, FACHM, MAPWCA SerenaGroup®, Cambridge, MA Janet Wolfson, PT, CLWT, CWS, CLT-LANA Wound Care Coordinator, Ocala, FL FOUNDING CLINICAL EDITOR Glenda J. Motta, RN, BSN, MPH, WOCN GM Associates, Inc., Loveland, CO WoundSource® Team STAFF Publisher/President | Jeanne Cunningham jeanne@kestrelhealthinfo.com Vice President | Brian Duerr brian@kestrelhealthinfo.com Print/Online Production Manager | Christiana Bedard christiana@kestrelhealthinfo.com Editorial Director | Miranda Henry miranda@kestrelhealthinfo.com Editorial Associate | Elizabeth McCalley emmie@kestrelhealthinfo.com Account Manager/ Marketing Event Coordinator | Alexis Padgett alexis@kestrelhealthinfo.com HOW TO REACH US Corporate Office: 1015 Atlantic Blvd., #446, Atlantic Beach, FL 32233 Phone: (800) 787-1931 E-mail: info@kestrelhealthinfo.com WEBSITE: www.kestrelhealthinfo.com, www.woundsource.com Editorial inquiries: editorial@kestrelhealthinfo.com Advertising inquiries: sales@kestrelhealthinfo.com TERMS OF USE All rights reserved. No part of this report may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, faxing, emailing, posting online or by any information storage and retrieval system, without written permission from the Publisher. All trademarks and brands referred to herein are the property of their respective owners. LEGAL NOTICES © 2019 Kestrel Health Information, Inc. The inclusion of any advertise- ment, article or listing does not imply the endorsement of any product, or- ganization or manufacturer by WoundSource, Kestrel Health Information, Inc., or any of its staff members. Although material is reviewed, we do not accept any responsibility for claims made by authors or manufacturers. The contents of this publication are for informational purposes only. While all attempts have been made to verify information provided in this publication, neither the author nor the publisher assumes any responsi- bility for error, omissions or contrary interpretations of the subject matter contained herein. The purchaser or reader of this publication assumes responsibility for the use of these materials and information. Adherence to all applicable laws and regulations, both referral and state and local, governing professional licensing, business practices, advertising and all other aspects of doing business in the United States or any other jurisdiction, is the sole responsibility of the purchaser or reader. The author and publisher assume no responsibility or liability whatsoever on the behalf of any purchaser or reader of these materials. Any perceived slights of specific people or organizations are unintentional. FOR MORE FREE GUIDES,FOR MORE FREE GUIDES,