Presented by: James G. Spahn, M.D., FACS

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1 Presented by: James G. Spahn, M.D., FACS Copyright EHOB/Woundvision

2 Problem Solving 101 Copyright EHOB/Woundvision

3 FACTS Pressure ulcers are the result of the soft tissue distortion. 1.) Ischemia 2.) Cell Distortion 3.) Abnormal interstitial fluid function 4.) Lymphatic Flow disruption 5.) Reperfusion Injury Copyright 2011, EHOB, Inc. 2

5 Load magnitude and time Both a high load for a short period and a low load applied for a prolonged period can lead to tissue damage *Dr. Cees Oomens- University of Technology 2010 Copyright 2011, EHOB, Inc. 5

6 Recent research suggests a new risk curve Reswick and Rogers Linder Ganz et al. J.Biomech, 2006 Stekelenburg et al. J.Appl.Physiol, 2007 Stekelenburg, Arch. Phys. Med. Rehab (2008) Loerakker, Ann. Biomed. Eng. (2010) Internal strain Time *Dr. Cees Oomens- University of Technology 2010 Copyright 2011, EHOB, Inc. 6

below the threshold no visible damage Time *Dr.

7 Recent research suggests a new risk curve above threshold tissue damages very fast Internal srain below the threshold no visible damage Time *Dr. Cees Oomens- University of Technology 2010 Copyright 2011, EHOB, Inc. 7

8 Above threshold: two causes for damage Relative importance as a cause for damage Direct deformation related damage Ischaemia Time *Dr. Cees Oomens- University of Technology 2010 Copyright 2011, EHOB, Inc. 8

9 Recognize the Problem Awareness by all caregivers at all times. Understand the Problem Understand the pathophysiology. Solve the Problem Develop an individualized pressure ulcer care plan adaptable to all medical settings. Copyright EHOB/Woundvision

10 Recognize the Problem Definition of avoidable vs. unavoidable pressure ulcers according to CMS. Tag F314 Avoidable: means that the resident developed a pressure ulcer and that the facility did not do one or more of the following: evaluate the resident s clinical condition and pressure ulcer risk factors; define and implement interventions that are consistent with resident needs, resident goals, and recognized standards of practice; monitor and evaluate the impact of the interventions; or revise the interventions as appropriate. Copyright EHOB/Woundvision

11 Recognize the Problem Definition of avoidable vs. unavoidable pressure ulcers according to CMS Tag F314 Unavoidable: means that the resident developed a pressure ulcer even though the facility had evaluated the resident s clinical condition and pressure ulcer risk factors; defined and implemented interventions that are consistent with resident needs, goals, and recognized standards of monitored practice; and evaluated the impact of the interventions; and revised the approaches as appropriate. Copyright EHOB/Woundvision

12 Despite the publication of clinical practice guidelines addressing pressure ulcer prevention and treatment by the Agency for Health Care Policy and Research (AHCPR) within the past decade, the length of stay and cost associated with pressure ulcers continues to rise. The Agency for Health Research and Quality (AHRQ) released a survey showing a 80% increase in pressure ulcer occurrence in acute care hospitals from 1993 to 2006 (Russo, 2008) Whittington K, Patrick, M, Roberts JL. A national study of pressure ulcer prevalence and incidence in acute care hospitals. JWOCN2000;27(4):209. Allman RM, Goode PS, Burst N, Bartolucci AA, Thomas DR. Pressure ulcers, hospital complications, and disease severity: impact on hospital costs and length of stay. Adv Wound Care 1999; 12: Hospitalizations Related to Pressure Sores, 2003 C. Allison Russo, MPH and Anne Elixhauser, PhD H-Cup Statistical Brief #3 Copyright EHOB/Woundvision

13 Recognize the Problem Provider Preventable Conditions (PPC) List of HA, HCA Acquired plus OPPCs Foreign Object Retained After Surgery Air Embolism Blood Incompatibility Pressure Ulcer Stages III & IV Falls and Trauma: Fracture Dislocation Intracranial Injury Crushing Injury Burn Electric Shock Catheter-Associated Urinary Tract Infection (UTI) Vascular Catheter-Associated Infection Manifestations of Poor Glycemic Control Surgical Site Infection, Mediastinitis, Following Coronary Artery Bypass Graft Surgical Site Infection Following Certain Orthopedic Procedures Surgical Site Infection Following Bariatric Surgery for Obesity Deep Vein Thrombosis and Pulmonary Embolism -Associated with certain orthopedic procedures Other OPPCs Copyright EHOB/Woundvision

14 Recognize the Problem The CDC has recently updated the ICD-9-CM coding guidance for pressure ulcers. 1. Code assignments for pressure ulcer stages may be based on medical record documentation from clinicians who are not the patient s provider. 2. Diagnoses subsequently confirmed after admission are considered present on admission if at the time of admission they are documented as suspected, possible, rule out, differential diagnosis, or constitute an underlying cause of a symptom that is present at the time of admission. 3. The diagnosis must be documented by the patient s provider (per the definition of provider used in these guidelines). 4. There is no required time frame as to when a provider (per the definition of provider used in these guidelines) must identify or document a condition to be present on admission. The coding guidelines are available at ICD-9-CM Official Guidelines for Coding and Reporting Effective October 1, 2008, narrative changes appear in bold text, items underlined have been moved within the guidelines since October 1, 2007 Copyright EHOB/Woundvision

15 Recognize the Problem Fiduciary Responsibilities The same type of acts may form the basis for negligence or malpractice. If performed by a non-professional person, the result is negligence; if performed by a professional person, the acts could be the basis for a malpractice lawsuit. In order to prove negligence or malpractice, the following elements must be established: Duty owed the patient Breach of duty owed the patient Foreseeability Causation Injury Damages Copyright EHOB/Woundvision

16 Understand the Problem Physiology is the bridge between basic science and clinical medicine. Basic Science Anatomy Macro Micro Cellular Biology Chemistry Inorganic Organic Mechanics Static Dynamic Physics Clinical Medicine Healthy state Homeostasis Unhealthy state Disease Copyright EHOB/Woundvision 2010 Copyright 2008, EHOB, Inc.16

Effect Cause Marieb EN. Human anatomy & physiology.

FACTS Pressure ulcers are the result of a soft tissue distortion, and not a crush injury (traumatic wound). Soft tissue distortion leads to ischemic necrosis (pressure ulcer).

18 FACTS Pressure ulcers are the result of a soft tissue distortion, and not a crush injury (traumatic wound). Soft tissue distortion leads to ischemic necrosis (pressure ulcer). Contact with a support surface or medical device/object causes either volumetric support of the body or distortion of the soft tissue trapped between the bony prominence and the support surface. Since the body is three-dimensional, volumetric support (flotation) is needed to maintain proper tissue orientation. Nutritionally and mobility impaired patients are at risk for developing pressure ulcers. Pressure ulcers may start immediately, but often are not recognized until 2-7 days later. High incidence of pressure ulcers may occur on bed, surgery, ER, transportation cart, and seating surfaces. Continuum of care is needed during the acute, sub-acute, and chronic levels of care. Copyright EHOB/Woundvision

19 Solve the Problem Fulfill Regulatory Requirements Fulfill Legal Responsibilities Be Cost Effective Best Practice Copyright EHOB/Woundvision

20 Solve the Problem Best Practice Fulfill Regulatory Requirements Fulfill Legal Responsibilities Be Cost Effective Copyright EHOB/Woundvision

21 Solve the Problem HOW? Develop an Individualized Care Plan Protocol Copyright EHOB/Woundvision

22 Solve the Problem WHY? Because a basic protocol does not address: 1. Individuals 2. Various Medical Settings 3. Staffing Needs 4. Device Needs Copyright EHOB/Woundvision

23 Solve the Problem Awareness of the Pressure Ulcer Problem a. Education b. Visual prompts c. Directives from higher ups Copyright EHOB/Woundvision

24 Solve the Problem Soft Tissue Assessment Visual (Pressure Ulcer Stages I-V and unstageable) Palpation Sensation Temperature } Deep Tissue Injury Copyright EHOB/Woundvision

25 Solve the Problem Right Diagnosis of Existing Lesion (Wound or Discoloration) Pressure Ulcer Vascular Ulcer Neuropathic Trauma Surgical Other Arterial (ischemic) Venous Lymphedema Copyright EHOB/Woundvision

26 Solve the Problem Address Nine Risk Factors 1. Cognition 2. Mobilization & Ambulation ( motor and/or sensory) 3. Nutrition and Hydration 4. Moisture (excessive or dryness) and Incontinence (urinary/fecal/combination) 5. General Medical Co-Morbidities (Medication Use) 6. Existing Pressure Ulcers (Suggested DTI, Stage I, II, III, IV, and Unstageable) 7. Previous Pressure Ulcers (Closed Stage III, IV, Unstageable and DTI) 8. Contact with medical devices (i.e., braces, orthotics, cannulas, tubing), and/or any object in contact with the body 9. Patient chooses not to accept part or all of the suggested medical treatment Tag 314 Requirements, Braden Scale, Norton Scale, Waterloo, ADLS, CDS, AMDA Guidelines (2008) Copyright EHOB/Woundvision

27 Pressure Ulcer Risk Determination in MDS 3.0 Resident has a Stage 1 or greater, a scar over a bony prominence, or a non-removable dressing or device. Formal assessment instrument/tool (eg, Braden, Norton, or other) Clinical assessment; many medical factors that do not appear on the roster of entries on either the Braden or Norton Scales need consideration as contributors to PrUs risk. Copyright EHOB/Woundvision

28 Solve the Problem Address each risk factor separately Define parameters for each risk factor Severity of medical condition Medical setting of care Diagnosis of patient Prognosis of patient Evaluate each risk factor History and physical Consultant reports Nursing notes Copyright EHOB/Woundvision

29 Solve the Problem Evaluate each risk factor (Cont) Lab X-Ray Other Tests Make Diagnosis Define Prognosis Define medical care based on best practice format Consult patient or legal advocate Copyright EHOB/Woundvision

30 Solve the Problem After your specific risk care plan has been defined Determine the appropriate staffing levels needed to meet the patient s needs. Select appropriate support surface and lower extremity unloading device based on the individual specific needs. Copyright EHOB/Woundvision

31 Solve the Problem Combine the specific risk factor care plans with the appropriate staffing, support surface and lower extremity unloading device to develop the individualized pressure ulcer care plan in all medical settings. Copyright EHOB/Woundvision

32 Solve the Problem Combine the specific risk factor care plans with the appropriate staffing, support surface and lower extremity unloading device to develop the individualized pressure ulcer care plan in all medical settings. Copyright EHOB/Woundvision

33 Copyright EHOB/Woundvision

34 Solve the Problem Document the plan, expectations and results. Revise plan as needed. Reassessments. Scheduled Change in patient s condition Change in medical setting REMEMBER: Medical Records are Legal Documents Copyright EHOB/Woundvision

35 Epithelial - covering skin-epidermis/dermis endothelium-lining of the vessels Adipose tissue Connective - support Muscle - movement Nervous - control Weight of the Body Support Surface Copyright EHOB/Woundvision

36 Keep it simply Scientific Physiology is the bridge between basic science and clinical medicine. Basic Science Anatomy Macro Micro Cellular Biology Chemistry Inorganic Organic Mechanics Static Dynamic Physics Clinical Medicine Healthy state Homeostasis Unhealthy state Disease 36 Copyright 2008, EHOB, Inc.

Damage Intravascular coagulation Decreased oxygen Anaerobic metabolism Ischemia Necrosis Inflammatory

37 Pressure ulcer Development Pathophysiology Mechanical stress (Gradient pressure or shear) Soft tissue distortion Change in velocity or character of blood flow Margination of intravascular cells Endothelial Damage Intravascular coagulation Decreased oxygen Anaerobic metabolism Ischemia Necrosis Inflammatory Response Homeostasis Imbalance Copyright 2008, EHOB, Inc. Rhoades R, Pflanzer R. Human Physiology. USA: Saunders;

38 Mechanical Stress Pressure Gradient pressure Non-gradient pressure Shear Soft tissue strain Distortion Volumetric Unequalized Weight Distribution Copyright EHOB/Woundvision

39 Mechanical Stress Pressure Gradient pressure Non-gradient pressure Shear Soft tissue strain Distortion Volumetric Equalized Weight Distribution (FLOTATION THERAPY) Copyright EHOB/Woundvision

40 Basic physics 200 BC o Archimedes 17th Century o Boyle o Pascal o Newton o Hooke s Young s Modulus Shear Modulus Bulk Modulus Physical properties of media Static (non-powered) o Gas minimal molecular bonding o Liquid moderate molecular bonding o Solid strong molecular bonding Dynamic (powered) o Fluid Gas Copyright EHOB/Woundvision

41 Physical Properties of Media Mechanical stress Gradient Pressure and Shear Non-Gradient Pressure Soft Tissue Strain Distortion Solid x x Static Fluid (non-powered) Air Water x x Sol x x Powered Air x x x Volumetric x Copyright EHOB/Woundvision

42 Clinical Protocols Nutrition Mobilization Ambulate Turn Passive Range of Motion Support Surface Bed, Chair, Cart, Emergency Room, Operating Room Incontinence Care Wound Care Continuum of Care Treatment of other general medical conditions Copyright EHOB/Woundvision

STAGE III and IV Epidermis Papillary Dermis

DTI: MAROON DISCOLORATION Epidermis Papillary Dermis

DTI BLOOD FILLED BLISTER Epidermis Papillary Dermis

68 DEEP TISSUE INJURY IN MODERATE TO EXTENSIVE SUBCUTANEOUS TISSUE Ischial tuberosity Lateral Gluteal Muscle In the bariatric population Muscles of the low back and buttock region Skin and soft tissue in skin folds Devices and objects against the body at any location Copyright 2011, EHOB, Inc. 9

76 Predictive Modeling High Frequency Ultrasound Thermography Other Copyright EHOB/Woundvision

77 Copyright EHOB/Woundvision

78 1. Individual caregiver assessment 2. Basic standardized questionnaire process with some weighting of data 3. Solution that takes acquired data and adds it to the unbiased neural network Copyright EHOB/Woundvision

79 Copyright EHOB/Woundvision

80 BRADEN SCALE Research project 52 % 96 % Ostonomy Wound Management, November Copyright EHOB/Woundvision 2010

81 Accurate assessment of patient s acuity level into appropriate care and applicable reimbursement dollars Copyright EHOB/Woundvision

82 Inaccurate assessment of patient s acuity level translates into inappropriate care and incorrect reimbursement to facility Copyright EHOB/Woundvision

83 Unavoidable Means: The individual developed a pressure ulcer even though the provider had evaluated the individual s clinical condition and pressure ulcer risk factors; defined and implemented interventions that are consistent with individual needs goals recognized standards of practice; monitored and evaluated the impact of the interventions; and revised the approaches as appropriate. -NPUAP, NOT ALL PRESSURE ULCERS ARE AVOIDABLE March 3, 2010 Copyright EHOB/Woundvision

84 Copyright EHOB/Woundvision

85 Copyright EHOB/Woundvision

87 RAC audits recovered overpayments to providers: FY 2006 $332.9M FY 2007 $610.9M 40% from claims for services deemed medically unnecessary 35% linked to coding errors 8% linked to insufficient documentation Medicare False Claims Act penalties: $5-10,000 per false claim + damages up to 3X the erroneous payment GAO Report, June 1998 Avg. summary judgment: $274K per pressure ulcer Coloplast Corp, 2002 Copyright EHOB/Woundvision

88 Copyright EHOB/Woundvision

89 Copyright EHOB/Woundvision

Nurse completes questionnaire and patient is scanned with camera; Data is stored for improved health tracking and instant transfacility reporting Proven predictive models provide additional insight

90 Nurse completes questionnaire and patient is scanned with camera; Data is stored for improved health tracking and instant transfacility reporting Proven predictive models provide additional insight into early and future wounds and other patient health issues; Real-time reporting gives immediate view to patient health assessment and trends Patient care plan combines scientific data with clinical judgment Copyright EHOB/Woundvision

91 What it does Does not emit radiation Passive not active Measures IR radiation from the patient Defines the heat pattern of the body s skin surface and related subcutaneous tissue Physiologic test vs. anatomical test Copyright EHOB/Woundvision

92 How it works Non-contact Portable Real-time imaging Data can be recorded and analyzed by integrated software bedside Digital and IR images indexed, labeled and stored digitally Imager converts the emitted thermal energy by the patient s body to electrical signals allowing the developed software to display and analyze the data so the temperature profile of the patient can be obtained Copyright EHOB/Woundvision

93 Theory A collection of human brain neurons can perform separate functions simultaneously called a neural network The functional unit of an ANN is an approximated electrical/mathematical model of a human neuron Various ANN s are built by a network of layers The connection strength between the layers is called weight The process of adjustment of weights is called learning or training ANN s address inter-relationship between all the predictors (questions) used in the chosen assessment Copyright EHOB/Woundvision

94 Copyright EHOB/Woundvision

95 Copyright EHOB/Woundvision

96 Positive Negative Test outcome Positive Negative True Positive False Negative (Type II error) False Positive (Type I error, P-value) True Negative Positive predictive value TP / (TP + FP) Negative predictive value TN / (FN + TN) Sensitivity TP / (TP + FN) Specificity TN / (FP + TN) Accuracy TP+TN/TP+TN+FP+FN Copyright EHOB/Woundvision

97 Individual Assessments Multiple Assessments Patients Imaged Original Study Oct 07 Nov 08 Control Study Oct 07 Nov 08 Original Study Feb 09 May 09 Original Study May 09 Aug Midwest Hospital Aug 09 Jan 10 Nursing Home Aug 09 Jan Totals Copyright EHOB/Woundvision

98 NPUAP/EPUAP Consensus Guideline Meeting February 2009 Copyright EHOB/Woundvision

99 Wound Existence Among Patients: Thermographic Imaging for Wounds Research Copyright EHOB/Woundvision

100 Types of Wounds Amongst 132 Imaged Patients *30 patients have a suspected DTI Copyright EHOB/Woundvision

101 Breakdown of Stages from the Pressure Ulcers that Developed from the 30 Suspected DTIs *Stage II s were classified by areas of superficial blistering or broken blisters. Copyright EHOB/Woundvision

102 The sicker the patient is: The more data that needs to be acquired, analyzed and applied Must be done bedside in a timely fashion Be available to caregivers through a seamless continuum of care process Copyright EHOB/Woundvision

103 Get to know the patient proactively Knowledge bedside Physiologic approach to the patient Educational community/family/patient Research future capabilities Comprehensive documentation Fulfills coding requirements Unbiased standardization Assists in evaluating care plan analysis Supports meaningful use of EHR Allows seamless continuum of care Copyright EHOB/Woundvision

104 Improving Patient Care Improved outcomes Improved quality of care Improved tracking of the skin conditions Improve wound management/healing Increasing Efficiencies Decreased cost levels for treatment of wounds related to early detection Improved documentation and tracking of wounds Consistent routine imaging Documentation and records for tracking of changes in patient condition Providing a Better Healthcare Experience Community and patient education Family participation and care Staff education and participation Student participation (Master-level nursing) in research program Increased socialization for patients Copyright EHOB/Woundvision

105 Copyright EHOB/Woundvision

106 Why Thermography and Visual Imaging? Copyright EHOB/Woundvision

Understanding the Thermal Gray Scale And Recognizing The Status of a Wound Unaffected Regional Tissue COLD COOL WARM HOT Necrotic Tissue Wound Bed Circulation Metabolic Activity Oxygen Nutrients

107 Understanding the Thermal Gray Scale And Recognizing The Status of a Wound Unaffected Regional Tissue COLD COOL WARM HOT Necrotic Tissue Wound Bed Circulation Metabolic Activity Oxygen Nutrients Waste Removal Ischemic Ring Inflammation Infection Circulation Metabolic Activity Oxygen Nutrients Respiratory Burst Cellulitis Immune Response Periwound Wound Tissue Copyright 2011 WoundVisionTM 48

108 Thermal and Visual Images Undetected DTI Venous stasis ulcer with undetected DTI WoundVision 2011

Normal Thermal Image Copyright WoundVision 2011.

) included in these slides are protected by copyright.

109 Normal Thermal Image Copyright WoundVision All data (graphics, logos, photographs, text, etc.) included in these slides are protected by copyright. Redistribution or commercial use is prohibited without express written permission.

Wound Dehiscence Copyright WoundVision 2011.

110 Wound Dehiscence Copyright WoundVision All data (graphics, logos, photographs, text, etc.) included in these slides are protected by copyright. Redistribution or commercial use is prohibited without express written permission.

111 Gout Copyright WoundVision All data (graphics, logos, photographs, text, etc.) included in these slides are protected by copyright. Redistribution or commercial use is prohibited without express written permission.

112 Osteomyelitis Copyright WoundVision All data (graphics, logos, photographs, text, etc.) included in these slides are protected by copyright. Redistribution or commercial use is prohibited without express written permission.

(Training and Certification Required) by WoundVision o Used to analyze digital and thermal images o Digital (Color) o Accurate measurement of wounds of varying shapes and size by

113 (Training and Certification Required) by WoundVision o Used to analyze digital and thermal images o Digital (Color) o Accurate measurement of wounds of varying shapes and size by highlighting wound base o Calculates total area of wound parameters (wound base and periwound) o Calculates area of percentage relating to wound characteristics (granulation tissue, eschar, slough, etc.) o Thermal (Gray scale) o Measures thermal intensity of wound, periwound, and normal tissue o Ability to analyze and trend the physiologic status of wounds by using proprietary techniques o Ratio of wound, periwound, and normal tissue thermal intensity o Calculates area of percentage of thermal intensity gradiency WoundVision 2011

114 WoundVision 2011

115 WoundVision 2011

116 WoundVision 2011

117 WoundVision 2011

118 WoundVision 2011

119 WoundVision 2011

SUPPLEMENTS clinical ELIMINATES DECREASES

chart reviews through the differentiation of

data real-time snapshot ALERTS of patient s you

insight into a multitude CREATES of documents

selection regulatory of care requirements

care patterns ASSESSES at the administrative for

through wounds and other health issues patient

120 SUPPLEMENTS clinical ELIMINATES DECREASES misdiagnosis judgment of unnecessary caregiver chart reviews through the differentiation of wounds ACQUIRES comprehensive, realtime PROVIDES data real-time snapshot ALERTS of patient s you to health potential patient readmission PROVIDES insight into a multitude CREATES of documents health risks and reports that ENABLES address selection regulatory of care requirements PINPOINTS plans utilizing negative risk analysis care patterns ASSESSES at the administrative for immediate risk attention for improved level treatment/prevention DETECTS AND TRACKS progression/regression of MINIMIZES liability through wounds and other health issues patient involvement Evidence-based Medicine, BMJ 1996, 312: Copyright EHOB/Woundvision

121 Thank you! Questions or comments, please contact, Copyright EHOB/Woundvision

DEEP TISSUE INJURY IN THE BARIATRIC POPULATION DEFINITION HOW IS OVERWEIGHT DEFINED?

DEEP TISSUE INJURY IN THE BARIATRIC POPULATION James G. Spahn, MD, FACS 1 DEFINITION Bariatrics The field of medicine that offers treatment for the person that is overweight. 2 HOW IS OVERWEIGHT DEFINED?