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Comprehensive Review of Regulations & Interpretive Guidance for Top F-Tags Pressure Ulcers F686 Objectives 1. Identify the regulatory requirements related 3. Identify examples of how F686 is to Pressure Ulcers commonly cited in the new LTCSP 2. Identify survey procedures that describe 4. Identify tools for the leadership team to use how Pressure Ulcers are reviewed for for monitoring compliance with Pressure compliance during the annual survey Ulcer requirements process 4. Explain strategies for incorporating survey preparedness related Pressure Ulcers into facility QAPI processes 2 2 Housekeeping Announcements Handouts are posted on the toolbar at the right of your screen. Technical problems during the webinar Contact Proactive Medical Review Office at 812-471-7777 or Contact the State Association with whom you registered All phone lines are muted All questions will be held until the end of the session If you have a question/comment type your question using the Go-To webinar toolbar Contact the association with whom you registered for any questions regarding continuing education credits & certificates. 3 3 www.proactivemedicalreview.com 1

Pressure Ulcers Overview of F-Tag Regulations & Interpretive Guidance 4 F686- Treatment/Services to Prevent/Heal Pressure Ulcers 5 F686 - Regulatory Language 483.25(b) Skin Integrity 483.25(b)(1) Pressure ulcers. Based on the comprehensive assessment of a resident, the facility must ensure that (i) A resident receives care, consistent with professional standards of practice, to prevent pressure ulcers and does not develop pressure ulcers unless the individual 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, prevent infection and prevent new ulcers from developing. 6 www.proactivemedicalreview.com 2

Pressure Ulcer Terms Pressure Ulcer Pressure Injury Pressure Sore Decubitus Ulcer Bed Sore Any of these terms may be used, as long as primary cause is related to pressure Definitions Pressure Ulcer/Injury (PU/PI) Localized damage to the skin and/or underlying soft tissue usually over a bony prominence or related to a medical or other device. Pressure injury will present as intact skin and may be painful. Pressure ulcer will present as an open ulcer, the appearance of which will vary depending on the stage and may be painful. The injury occurs as a result of intense and/or prolonged pressure or pressure in combination with shear. The tolerance of soft tissue for pressure and shear may also be affected by skin temperature and moisture, nutrition, perfusion, comorbidities and condition of the soft tissue. 8 8 Definitions Avoidable Resident developed a pressure ulcer/injury and facility did not do one or more of the following: evaluate the resident s clinical condition and risk factors; define and implement interventions that are consistent with resident needs, resident goals, and professional standards of practice; monitor and evaluate the impact of the interventions; or revise the interventions as appropriate. Unavoidable Developed pressure ulcer/injury despite facility Evaluation of clinical condition & risk factors Implementation of appropriate interventions Monitoring & evaluating impact of the interventions Revision of approaches as appropriate www.proactivemedicalreview.com 3

Definitions Colonized Infected Debridement Eschar Slough Exudate Presence of micro-organisms on surface or in wound tissue without s/s of infection Presence of micro-organisms in sufficient quantity to overwhelm defenses of viable tissues & produce s/s of infection Removal of devitalized/necrotic tissue & foreign matter from wound to improve or facilitate healing process Dead or devitalized tissue that is hard or soft in texture. Usually black, brown, or tan in color, and may appear scab-like. Usually firmly adherent to the base of the wound & often the sides/ edges of the wound Non-viable yellow, tan, gray, green or brown tissue; usually moist, can be soft, stringy and mucinous in texture. May be adherent to the base of the wound or present in clumps throughout the wound bed Any fluid that has been forced out of tissues or capillaries because of inflammation or injury. 10 10 Definitions Friction Shearing Granulation Tissue Tunnel Sinus Tract Undermining Mechanical force exerted on skin that is dragged across any surface Occurs when layers of skin rub against each other or when skin remains stationary & underlying tissue moves & stretches & angulates or tears the underlying capillaries & blood vessels causing tissue damage. The pink-red moist tissue that fills an open wound, when it starts to heal. It contains new blood vessels, collagen, fibroblasts, and inflammatory cells. Passageway of tissue destruction under the skin surface that has an opening at the skin level from the edge of the wound A cavity or channel underlying a wound that involves an area larger than the visible surface of the wound Destruction of tissue or ulceration extending under the skin edges so that the pressure ulcer is larger at its base than at the skin surface. 11 11 Staging Stage I -Intact Skin -Localized nonblanchable erythema Stage II -Partial-thickness loss of skin with exposed dermis Stage III - Full-thickness loss of skin Subcutaneous fat may be visible Stage IV -Full-thickness skin and tissue loss with exposed or directly palpable fascia, muscle, tendon, ligament, cartilage or bone in the ulcer Unstageable -Full-thickness skin and tissue loss in which the extent of tissue damage within the ulcer cannot be confirmed because the wound bed is obscured by slough or eschar 12 www.proactivemedicalreview.com 4

Staging Deep Tissue Injury -Intact skin with localized area of persistent nonblanchable deep red, maroon, purple discoloration due to damage of underlying soft tissue. Medical Device Related Pressure Injury -Results from the use of devices designed and applied for diagnostic or therapeutic purposes Mucosal Membrane Pressure Ulcer/Injury -Found on mucous membranes with a history of a medical device in use at the location of the injury 13 Pressure Ulcer Prevention Risk Assessment Evaluation of resident specific risk factors Implement, monitor, & modify interventions Standardized admission & ongoing process using risk assessment tools or scales Assessment Used to: Identify patients with pressure injury or at risk for development of pressure injury Aid in clinical decision making Allow selective targeting of preventive interventions Facilitate care planning Facilitate communication www.proactivemedicalreview.com 5

Assessment Key areas to address: Intrinsic risks Skin condition Pressure Points Under-nutrition Hydration deficits Moisture Organ failure End of life condition Refusal of care Risk Factors Impaired/Decreased Mobility Decreased Functional Ability Co-Morbid Conditions Medications Impaired Blood Flow Refusal of care/ treatment Cognitive Impairment Incontinence Nutrition/Hydration Deficits 17 Risk Factors Use validated instrument to assess risk for pressure ulcer development Upon admission Weekly for first 4 weeks after admission Monthly When change in condition occurs Implement interventions promptly upon admission 80% of pressure ulcers develop within 2 weeks of admission 96% of pressure ulcers develop within 3 weeks of admission 18 www.proactivemedicalreview.com 6

Pressure Points & Tissue Tolerance 19 Nutrition & Hydration Considerations for care planning Severity of nutritional compromise Rate of weight loss or appetite decline Probable causes Prognosis & projected clinical course Resident s wishes & goals Risk for hydration deficit or imbalance 20 Moisture Incontinence leads to greater susceptibility to breakdown & moisture-related skin damage Differentiation of dermatitis related to incontinence from partial thickness pressure ulcer should be based on the clinical evidence & review of presenting risk factors 21 www.proactivemedicalreview.com 7

Prevention & Treatment Strategies Redistribute pressure Minimize exposure to moisture Pressure-redistributing support surfaces Non-irritating surfaces Maintain or improve nutrition/hydration status Identify & address adverse drug reactions 22 Resident Choices Involve resident in discussions regarding: Resident s condition Treatment options Expected outcomes Consequences of refusing treatment 23 Pressure Injuries at End of Life Kennedy Terminal Ulcer (KTU) Appear suddenly & within hours Usually appear on sacrum & coccyx Edges usually irregular & are red, yellow, & black as ulcer progresses Often appear as an abrasion, blister, or darkened area May develop rapidly to Stage 2-4 24 www.proactivemedicalreview.com 8

Repositioning Determine repositioning frequency with consideration to the individual s: Level of activity and mobility General medical condition Overall treatment objectives Skin condition Comfort Repositioning considerations: Limit time spent seated in chair without pressure relief Teach to shift weight while seated in chair Position change off-loading every hour for dependent residents Individualized care plan for repositioning Stable wheelchair seating surface Avoid placing directly on greater trochanter Support Surfaces & Pressure Redistribution Pressure redistribution Function or ability to distribute a load over a surface or contact area Shifting pressure from one area to another Concepts of pressure reduction & pressure relief Static pressure redistribution devices May be indicated when at risk for PU/PI or delayed healing Dynamic pressure reduction surfaces Helpful when: Resident cannot assume a variety of position without bearing weight on PU/PI Resident completely compresses a static device Pressure contributing to PU not healing as expected 26 Monitoring Evaluate, report, & document changes in skin condition as soon as identified Develop care plan with measurable goals for prevention & management of PU with appropriate interventions Evaluate skin condition at least weekly Implement defined interventions Monitor interventions for effectiveness 27 www.proactivemedicalreview.com 9

Pressure Ulcer Assessment & Treatment Documentation of pressure ulcer assessment Type of injury Stage Description of PU/PI s characteristics Progress toward healing Identification of potential complications If infection is present Presence of pain, what done to address it, & effectiveness of intervention Description of dressings & treatments 28 Types of Injuries Arterial Ulcer Non-pressure related disruption or blockage of the arterial blood flow to an area causes tissue necrosis Diabetic Neuropathic Ulcer Must have diagnosis of diabetes mellitus & peripheral neuropathy Venous/Stasis Ulcer Open lesion of the skin and subcutaneous tissue of the lower leg Pressure Ulcer Characteristics Daily monitoring should include: Evaluation of PU/PI, if no dressing present Evaluation of status of dressing, if present Status of area surrounding PU/PI Presence of possible complications Presence of pain & if it is being adequately controlled 30 www.proactivemedicalreview.com 10

Pressure Ulcer Characteristics With each dressing change or at least weekly evaluate & document: Location & staging Size Depth Presence, location, & extent of undermining or tunneling Exudate type, color, odor, amount Pain nature & frequency Wound bed color, tissue type Description of wound edges & surrounding tissue 31 Healing Pressure Ulcers Do not heal in reverse sequence Healing process varies depending on stage Evaluate & modify interventions Avoid or minimize pressure on the area Modify sitting time schedules & re-evaluate seating surface & individual s posture if area worsens or fails to improve. If fails to show some evidence of progress toward healing within 2-4 weeks, the area & resident s overall clinical condition should be reassessed 32 Infections Increase in amount or change in characteristics of exudate Decolorization & friability of granulation tissue Undermining Abnormal odor Epithelial bridging at base of the wound Sudden pain 33 www.proactivemedicalreview.com 11

Pain Assessment & treatment of pain is integral component of pressure ulcer prevention & management Can contribute to immobility & lead to development of pressure ulcers or delayed healing of existing wounds 34 F686 Interpretive Guidance Dressings & Treatments Treatment based on: Clinical judgment Facility protocols Current professional standards of practice Wound characteristics Treatment goals Manufacturer s recommendations Assess wound characteristics throughout healing process to assure treatment remains appropriate to nature of wound 35 Pressure Ulcers LTC Survey Procedures Survey procedures for assessing compliance with the F-Tag and citation examples 36 www.proactivemedicalreview.com 12

New LTC Survey Initial Pool Process Resident/Representative Interviews- Pressure Ulcers Do you have any sores, open areas, or pressure ulcers? Where is your pressure ulcer? When did you get it? How did you get it? Are staff here treating it? How often do they reposition you? Do you know if it is getting better 37 37 New LTC Survey Initial Pool Process Resident Observations- Pressure Ulcers For residents at risk (e.g., vulnerable residents) or who have a pressure ulcer, are any of the following observed? If visible, is the wound covered with a dressing, and is drainage present on the dressing (document color/amount/type/odor)? Is the resident positioned off the pressure ulcer? Are pressure relieving devices observed (e.g., heel protectors, w/c cushion, padding between bony prominences)? If so, are they used correctly? 38 New LTC Survey Initial Pool Process Limited Record Review For any resident marked as non-interviewable, refused, unavailable or out of facility the following will be reviewed in the record regardless of whether the area is an indicator for the resident. Did the resident develop a pressure ulcer in the facility that has not healed? Did the resident have a pressure ulcer that worsened and hasn t improved recently? Note: Exclude Stage 1 pressure ulcers 39 www.proactivemedicalreview.com 13

Pressure Ulcer CE Pathway (CMS-20078) Triggered Pathway Observations Resident/Representative Interviews Staff Interviews Record Reviews 40 # 11 most frequently cited F-tag (STD) 2,204 citations Complaint Surveys = 695 Standard Surveys = 1,509 Scope & Severity D level = 1,479 E level = 241 G level = 408 H level = 34 J level = 24 K level = 17 L level = 1 F686 Survey Trends The is valid for the subset of providers for which there are survey records in CASPER as of 10/29/18 41 Source: S&C QCOR (11/06/2018) F686 IJ Citation Rhode Island Facility failed to provide necessary treatment and services, consistent with professional standards of practice, to promote healing and prevent new ulcers from developing for 2 residents who triggered an investigation for the risk of developing pressure ulcers or who have actual pressure ulcers Resident with Stage 2 had order for ¼ side rails to increase bed mobility & positioning. Side rails were not on bed during survey. Failed to follow care plan to monitor nutritional status. No evidence wound assessed upon admission Did not assess the wound weekly, document wound measurements, wound bed appearance, odor, drainage, and the surrounding tissue per care plan. Documented Stage 2 wound observed to be Stage 3 by surveyor Heel protectors not on per care plan & surveyors observed an undocumented DTI to heel Another resident at risk for pressure ulcers did not have care plan developed r/t pressure ulcer prevention & was observed with heels flat on bed & both feet pressing against footboard 42 www.proactivemedicalreview.com 14

F686 IJ Citation - Kentucky Facility failed to have an effective system to provide the necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing for one sampled resident Resident was assessed, care planned and had physician orders for dressing changes twice a day (BID). However, the resident failed to receive BID dressing changes for 5 Stage IV Pressure Ulcers, from 04/01-05/18, which promoted increasing and unnecessary pain and a worsening of the resident's pressure areas and condition, causing mental anguish and serious physical harm. The resident was not observed to have been repositioned off her backside, except for 2 brief periods for observation of pressure areas and stayed supine with head of the bed elevated 30 degrees for five days during survey Resident yelling out in pain during dressing changes Staff did not wash hands in between glove changes during treatments Large amount of green, foul smelling drainage with shiny skin at site of surgical wound that never healed 43 F686 IJ Citation North Carolina Facility failed to treat & monitor multiple pressure ulcers & did not implement measures to address a resident's refusals of treatment for 1 resident reviewed for pressure ulcers The facility did not treat & change pressure ulcer dressings as ordered & did not monitor a pressure ulcer to prevent maggots from developing in the wound. When the resident refused treatment the facility did not contact the resident's representative as specified in the resident's care plan to elicit their input. No assessment of resident's pressure ulcers completed on admission From 7/6/18-7/16/18 pressure ulcers were documented for one wound only as being treated & only on one occasion. The TAR specified Resident refused treatment to all of his other pressure ulcers or would not allow staff to check any of his pressure ulcers on the other dates On 7/17/18, facility nurses discovered maggots in wound & resident was transferred to hospital for possible wound debridement 44 F686 IJ Citation Michigan (L level) Failed to prevent the development of pressure ulcers when they did not implement interventions, get doctor's orders, assess and treat 12 current residents & one closed record Resident, who were admitted to the facility without pressure ulcers, resulting in the development of a stage 2-4 pressure ulcers UM had not attended any formal training for wound care, and was often pulled to the floor to work as a nurse due to staffing concerns frequently unable to complete measurements and monitor wounds Wounds not consistently measured weekly. Treatments not documented as completed per orders consistently No treatment order until 9 days after wound identified 45 www.proactivemedicalreview.com 15

F686 IJ Citation - Indiana Failed to ensure interventions & treatments were in place for 1 resident who was at an increased risk for developing pressure ulcers & developed, in house, 1 unstageable pressure ulcer to the left heel & 1 stage 4 pressure ulcer to the left medial foot which resulted in an above knee amputation of the left leg; 1 resident with a healed pressure ulcer that reopened to a stage 3 pressure ulcer on the coccyx; & 1 resident who developed a stage 3 pressure ulcer in the right gluteal fold acquired in the facility for 3 residents reviewed for pressure ulcers. On 9/17, family notified staff of a wound on the resident's left heel, which was discolored, intact, and very mushy to touch. Notification was placed in the physician's binder for further evaluation, and a heel protector boot was placed on the left foot to aid in protection. TAR lacked documentation of a weekly skin assessment on 9/22/17 and 9/29/17 or any new treatment orders for the identified area on the heel. Shower sheets indicated the resident had no skin areas of concern. Treatment order not obtained until 10/18, when area was assessed to be open with drainage & foul odor. In Oct. continued to have omissions in TAR and skin assessment documentation 46 F686 IJ Citation - Illinois Failed to document initial skin assessments upon admission, failed to measure identified wounds upon admission, failed to conduct weekly measurements & assessments of pressure ulcers, failed to document dressing changes on the treatment record, failed to implement preventative measures for a resident admitted with pressure ulcers, failed to obtain physician orders for a new admission with a Stage 2 pressure ulcer, failed to develop and implement individualized care plans for residents with known pressure ulcers & the facility failed to identify a pressure ulcer prior to a Stage 4. Identified Stage 4 under leg immobilizer. Failed to perform an initial assessment of the wound when it was reported by the Nurse Practitioner, including obtaining measurements and description of the wound. Pressure ulcer risk assessment was last completed over one year ago. Care plan did not indicate use of a leg immobilizer or interventions to prevent pressure ulcers. The care plan interventions for a Stage 4 pressure ulcer were not implemented. 47 F686 IJ Citation - OH Failed to prevent the development of an avoidable pressure ulcer for one resident identified as requiring assistance with bed mobility and incontinence care. Resident who was admitted with no pressure areas developed an unstageable to sacrum, which was found as unstageable & became infected, caused pain, & resulted in hospitalization On 2/10 staff documented small open area to coccyx with no formal wound assessment, no MD notification, no treatment orders, & no care plan update On 2/26 was noted to have unstageable area to sacrum On 2/27 transferred to hospital & required surgical debridement & discussion of possible bowel diversion to decrease fecal contamination of wound 48 www.proactivemedicalreview.com 16

Pressure Ulcers QAPI Strategies for monitoring compliance and incorporating survey preparedness into facility QAPI processes 49 Communication Communication between staff at all levels Communicate regularly & thoroughly about skin issues Establish mechanism for nurse aides to report skin issues to nurse in written format Establish method for communicating pressure ulcer risk 50 Oversight and Accountability Competency testing Including on evaluations Posting pressure ulcer audit results Educating staff on areas needing improvement Meetings with staff to review pressure ulcer practices 51 www.proactivemedicalreview.com 17

Data Monitoring Routinely assess: Pressure Injury Rates Pressure Injury Prevention Practices Compare rates against organizational, state, & national data Use facility-acquired rates to assess prevention programs Tracking Tools National Nursing Home Quality Campain Pressure Ulcer Tracking Tool https://www.nhqualitycampaign.org/goaldetail.aspx?g=pu#tab2 52 Sustaining Change Make procedures universal Add pressure ulcer communication to other established processes Create visual cues or reminders in physical locations Incorporate changes into routine Share results 53 Resources AHRQ Preventing Pressure Ulcers in Hospitals Toolkit http://www.ahrq.gov/sites/default/files/publications/files/putoolkit.pdf AHRQ s Safety Program for Nursing Homes: On-Time Pressure Ulcer Healing https://www.ahrq.gov/professionals/systems/long-termcare/resources/ontime/pruhealing/index.html The National Pressure Ulcer Advisory Panel (NPUAP) Educational & Clinical Resources http://www.npuap.org/resources/educational-and-clinical-resources/ 54 www.proactivemedicalreview.com 18

References 1.Centers for Medicare and Medicaid Services. (2017). Nursing homes Centers for Medicare and Medicaid Services. Retrieved from https://www.cms.gov/medicare/provider Enrollment and Certification/GuidanceforLawsAndRegulations/Nursing Homes.html 2.Centers for Medicare & Medicaid Services. (2017). S&C QCOR Home Page. Retrieved from https://pdq.cms.hhs.gov/report_select.jsp?which=0 55 Questions? Type your questions using tool bar on right of your screen. Please register to join us in December for the final session in the F-tag series: Bowel/Bladder Incontinence, Catheter, UTI F690 Shelly Maffia, RN, MSN, HFA, MBA, QCP smaffia@proactivemedicalreview.com Proactive partners with SNF providers for regulatory compliance, training, & medical review solutions. 56 56 www.proactivemedicalreview.com 19