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2/20/2018OHCAPresentsUnavoidable Pressure Ulcer/Injury, Kennedy Terminal Ulcer,Skin Failure:The Clinical and Regulatory Perspectives as We Know ItTodayFACULTY:PAMELA SCARBOROUGHPT, DPT, MS, CWS, CEEAADIRECTOR OF PUBLIC POLICY & EDUCATIONAMERICAN MEDICAL TECHNOLOGIESCopyright 2018 GordianMedical, Inc. dba AmericanMedical Technologies.AMT Education DivisionDisclaimerThe information presented herein is provided for the general well‐being and benefitof the public, and is for educational and informational purposes only. It is for theattendees’ general knowledge and is not a substitute for legal or medical advice.Although every effort has been made to provide accurate information herein, lawschange frequently and vary from state to state. The material provided herein is notcomprehensive for all legal and medical developments and may contain errors oromissions.If you need advice regarding a specific medical or legal situation, please consult amedical or legal professional. Gordian Medical, Inc. dba American MedicalTechnologies shall not be liable for any errors or omissions in this information.Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.1

2/20/2018ObjectivesAt the end of this presentation participants will be able to: Recognize the different terms for patient/resident compromisedphysiology leading to failure of skin integrity as defined by CMS andwound prevention and care research/best practices. Verbalize CMS regulatory guidelines related to the unavoidable failureof skin integrity aka the Unavoidable Pressure Ulcer/Kennedy TerminalUlcer. Describe signs of physiological changes in skin integrity when there ischronic organ failure. List goals for treatment when failure of skin integrity is “unavoidable”.Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comIntroduction Skin is largest organ of the bodyFails same as other organs: heart, kidneys, liver, etc.With acute and chronic illnesses body systems canfail, sometimes suddenlySkin failure is an unavoidable conditionOlder adults have higher risk for skin failure due tomore fragile overall organ physiology, including theskinWhen patients/residents are deterioratingphysically, particularly in the presence of multiorgan failure, skin failure may not be preventableCopyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.2

2/20/2018Difficult to Tell theDifference Between PU/PI and Skin FailurePressure Ulcer/Injury NecrosisUlcerationBlisteringUsually over bony prominencesSkin Failure re on the bodyCopyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comSkin Mottling. Pt. inrespiratory failureand hypotensionAvoidability/Unavoidability of Skin BreakdownTerminal (end of life) ulceration is NOT a new concept Concept over 100 years old and documented in historical medicalliterature Lack of complete understanding of skin failure Some people think, erroneously, that ALL PU/PIs are avoidable CMS agrees not all PU/PIs are avoidable Research needed on topic of terminal skin failure/ulcerations Shared terminology needed that defines process of skinfailure/KTU/unavoidable PU/PI Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.3

2/20/2018Terms to Describe Unavoidable Skin Changes Several classifications/terms for similar/overlapping clinical syndromes Kennedy Terminal Ulcer (CMS recently recognized-F686) Trombley-Brennan Terminal Tissue Injury Skin Changes at Life’s End Skin Failure Unavoidable pressure ulcer/injuries (CMS SOM F686) Allof these terms may be a component of multi-organ failure where the skinis failing in concert with other body systems. Similar meaning of these different terms creates confusion for clinicians tryingto communicate and design plans of care that are appropriate for end of lifeskin deteriorationCopyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comDecubitus OminoususCourtesy of Jeffrey M Levine MDCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies. Skin breakdown heralding impending death ofthe patient decubitus ominosus. This nomenclature (name) was forgotten until thelate 20th century when Karen Kennedyrecognized and published information on thewhat became known as the Kennedy TerminalUlcer in 1980s.4

2/20/2018The Kennedy Terminal Ulcer (KTU)Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comKennedy Terminal Ulcer Unavoidable skin breakdown or skin failure that occurs as part of the dyingprocessNot a cause of a patient's deathOccurs in spite of good quality careAppears quickly and progresses rapidly sometimeswithin hoursMay start out superficially as a blister or whatappears to be a Stage 2May have early characteristics of a DTPICopyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.5

2/20/2018Kennedy Terminal Ulcer Described as pear-butterfly-horseshoe or irregular-shaped red/yellow/black ulcerDescribed as an abrasion with small blackalmost vasculitic spotsOften appear on the sacrum/coccyx area,but have been reported in other anatomicalareas (eg. calf/thigh)Rapidly progresses to a full-thickness ulcerInstructed by CMS to call this a Stage 3 orStage 4 PrU per the SOM and report as a PU/PI on the MDSCopyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comThe Kennedy Terminal Ulcer (KTU) per SOM The facility is responsible for accurately assessing and classifying anulcer as a KTU or other type of PU/PI and demonstrate thatappropriate preventative measures were in place to prevent non-KTUpressure ulcers.Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.6

2/20/2018F684: Quality of LifeKennedy’s Terminal Ulcer: Pressure Ulcer Kennedy Terminal Ulcers are considered PRESSURE ULCER/INJURY per CMSPressure ulcers that generally occur at the end of lifeFor concerns related to Kennedy Terminal Ulcers, refer to F686, 483.25(b) PressureUlcers.NOTE: From Presenter not CMS statement, but reality.These skin changes are not pressure ulcers they are the result of skin failure due tothe dying process or during multi-organ failure.The resident is in the dying process and the skin largest organ of the body begins toalso fail.If you recognize this situation and your MDs/NPs documents accordingly, then you canat least document them as unavoidable pressure ulcer/injuries.Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCharacteristic of Kennedy Terminal Ulcers ‐ F686Know When to Use This Designation!!! “KTUs have certain characteristics which differentiate them from pressureulcers such as the following: KTUsappear suddenly and within hours; Usuallyappear on the sacrum and coccyxbut can appear on the heels, posterior calfmuscles, arms and elbows; Edgesare usually irregular and are red, yellow, and black as the ulcerprogresses, often described as pear, butterfly or horseshoe shaped; and Oftenappear as an abrasion, blister, or darkened area and may developrapidly to a Stage 2, Stage 3, or Stage 4 injury.”Copyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.7

2/20/2018CMS and Avoidable/Unavoidable PU/PICopyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCurrently Pressure Ulcers Considered a QualityMeasure Centers for Medicare and Medicaid Services (CMS)Joint Commission for Accreditation of Healthcare Organizations(JCAHO)Agency for Healthcare Research Quality (AHRQ)National Quality Forum (NQF)Institute for Healthcare Improvement (IHI)Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.8

2/20/2018INTENT of F686 Related to PU/PIs “The intent of this requirement is that the resident does not developpressure ulcers/injuries (PU/PIs) unless clinically unavoidable and thatthe facility provides care and services consistent with professionalstandards of practice to: Promotethe prevention of pressure ulcer/injury development; Promote the healing of existing pressure ulcers/injuries (including preventionof infection to the extent possible); and Prevent development of additional pressure ulcer/injury.”Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comPressure Ulcer/Injury Development More than 100 risk factors have been cited in the literature related toPU/PI developmentAffirms the multifactorial etiology of PU/PI developmentBraden captures SOME of these factors, certainly not allComorbidities listed as contributory include:Diabetes, infection, PAD, cardiovascular disease, anemia, hypotension,advancing age, vasopressor medications, and many more The research, literature, and experience of clinician over the decadesagree that ALL pressure ulcer/injuries are NOT preventableDelmore, Cox, Rolnitzky, Chu, Stolfi, 2015Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.9

2/20/2018Unavoidable Pressure Ulcer in State OperationsManual Guidance to Surveyors F686§483.25(b) Skin Integrity§483.25(b)(1) Pressure ulcers.Based on the comprehensive assessment of a resident, the facility must ensurethat—(i) A resident receives care, consistent with professional standards of practice,to prevent pressure ulcers and does not develop pressure ulcers unless theindividual’s clinical condition demonstrates that they were unavoidable; and(ii) A resident with pressure ulcers receives necessary treatment and services,consistent with professional standards of practice, to promote healing, preventinfection and prevent new ulcers from developing.Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comAvoidable Pressure Ulcer/Injury per CMSpg 261-11/22/17 SOM “Avoidable” means that the resident developed a pressureulcer/injury and that the facility did not do one or more of thefollowing: evaluate the resident’s clinical condition and risk factors; define and implement interventions that are consistent withresident needs, resident goals, and professional standards ofpractice; monitor and evaluate the impact of the interventions; or revisethe interventions as appropriate.Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.10

2/20/2018Unavoidable Pressure Ulcer/Injury per CMSpg 261-11/22/17 SOM “Unavoidable” means that the resident developed a pressureulcer/injury even though the facility had: evaluated the resident’s clinical condition and risk factors; defined and implemented interventions that are consistent withresident needs, goals, and professional standards of practice; monitored and evaluated the impact of the interventions; andrevised the approaches as appropriate.Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comKEY ELEMENTS OF NONCOMPLIANCETo Cite Deficient Practice at F686 Surveyor's investigation will generally show that the facility failedto do one or more of the following: Provide preventive care, consistent with professional standardsof practice, to residents who may be at risk for development ofpressure injuries; or Provide treatment, consistent with professional standards ofpractice, to an existing pressure injury; or Ensure that a resident did not develop an avoidable PU/PI.Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.11

2/20/2018Trombley-Brennan Terminal Tissue Injury(TB-TTI)Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comTrombley-Brennan Terminal Tissue Injury(TB-TTI) Purple maroon discoloration that may appear suddenly at end of lifeFurther description: Patient will exhibit these skin changes on bony and nonbony prominencesThese injuries do not evolve into full thicknesswounds with non viable tissueFrequently characterized by an increase insurface areaNo drainage presentLinear and mirror images may appear on lower extremitiesNo complaints of discomfortDo not follow the same course as the KTUCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.12

2/20/2018Trombley-Brennan Terminal Tissue Injury(TB-TTI) Spontaneously appearing skin alterations (rapid evolution, speed ofenlargement and progression, appearance in areas of little to nopressure such as skins, thighs, and mirror imaging found in patients atthe end of life. Trombley Brennan (TB-TTI) (2010)Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comSkin Failure and Skin Changes at Life’s EndCopyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.13

2/20/2018Pressure Ulcer/Injuries at End of LifeF686 Page 269 –Guidance to Surveyors “It is important for surveyors to understand that when a facility hasimplemented individualized approaches for end‐of‐life care in accordancewith the resident’s wishes, the development, continuation, or worsening of aPU/PI may be considered unavoidable. If the facility has implemented appropriate efforts to stabilize the resident’scondition (or indicated why the condition cannot or should not be stabilized)and has provided care to prevent or treat existing PU/PIs (includingpertinent, routine, lesser aggressive approaches, such as, cleaning, turning,repositioning), the PU/PI may be considered unavoidable and consistentwith regulatory requirements.”Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comSkin Failure Definition “An event in which the skin and underlying tissuedie due to hypoperfusion that occurs concurrentwith severe dysfunction or failure of other organsystems” (Langemo, 2005, Langemo & Brown, 2006) “Skin Failure and pressure ulcers are 2 distinct,yet related clinical phenomena” (Delmore, Cox, Rolnitzkyet al, 2015)Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.14

2/20/2018Physical Manifestations of Skin FailureHemodynamic changes Hypoperfusion of skin – shunting of blood to vital organs topreserve life Impaired thermoregulatory control Metabolic abnormalities of toxic metabolites from catabolism Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.15

2/20/2018Skin Changes at Life’s End Physiologic changes that occur as a result of the dying process(days to weeks) may affect the skin and soft tissues and maymanifest as observable (objective) changes in skin color, turgor, orintegrity, or as subjective symptoms such as localized pain. Thesechanges can be unavoidable and may occur with the applicationof appropriate interventions that meet or exceed the standard ofcare.Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comSkin Changes at Life’s End Skin changes at life’s end are a reflection of compromised skin (reducedsoft tissue perfusion, decreased tolerance to external insults, and impairedremoval of metabolic wastes).Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.16

2/20/2018Skin Failure Based on the SCALE document (2008) and NPUAP positionstatements (2011, 2014), two conditions necessary for establishingthe diagnosis of skin failure are skin hypoperfusion and severeorgan dysfunction or failure (White-Chu & Lagemo, 2012)ICD-10 diagnosis of skin failure: L98.9 Disorders of the skinWhen it appears skin failure/KTU involved in failing skin integrityhave practitioner collaboration a.s.a.p.Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comOrgan Failure StratificationAcuteSkin BarrierFailureEnd-StageChronicCopyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.17

2/20/2018Types of Skin Failure (Langemo & Brown, 2006) Acute Skin Failure: “an event in which skin and underlying tissuedie due to hypoperfusion concurrent with a critical illness” (e.g., MI,sepsis, etc.)Chronic Skin Failure: “an event in which skin and underlying tissuedie due to hypoperfusion with a chronic disease state” (e.g., PAD,MS, neuropathy, kidney disease)End-Stage Skin Failure: “an event in which skin and underlyingtissue dies due to hypoperfusion concurrent with the end of life”(e.g., cancer, MS)Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comEnd of Life Considerations May involve short periods of overwhelming illness (acute) Or slow deterioration lasting months to years (chronic) In both cases, the skin becomes particularly vulnerable tobreakdown Witkowski and Parish concluded that skin breakdown is oftenunavoidable at this pointCopyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.18

2/20/2018INTERVENTIONSto Mitigate Chronic Skin FailureWell documented multidisciplinary interventions-Nutritional support-Hydration-Medical management-Hygiene-Functional rehabilitation-Pressure redistributing surface selectionCopyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comEnd-Stage Skin Failure Skin and underlying tissue die due to hypoperfusion concurrent withend of lifeChallenges to maintaining skin integrityTransition from acute to chronic to end-stage - not easily observablecontinuumCopyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.19

2/20/2018End-Stage Organ Decompensation and FailureLarge and unusual presentations of skin failure Body shunts blood to vital organs Widespread and deep tissue destruction over stressedareas can appear in a matter of hours or less Sacrum Heels Posterior calf muscles Arms Elbows Copyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comConclusions from SCALE Expert ians,Laypeople,Policy MakersCopyright 2018 Gordian Medical, Inc. dba American Medical Technologies. www.amtwoundcare.comCopyright 2018 Gordian Medical, Inc. dbaAmerican Medical Technologies.20

2/20/2018End of Life Phase of life when a person is living with an illness thatwill often worsen and may eventually cause deathOccurrence of skin failure in the chronically ill is atime to establish dialogue with:Patient/resident Family CaregiversTime to discuss Pros and cons of future aggressive medicalinterventions; write POC that meet

Skin failure is an unavoidable condition Older adults have higher risk for skin failure due to more fragile overall organ physiology, including the skin When patients/residents are deteriorating physically, particularly in the presence of multi-organ failure

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