The New F-tag 314: Prevention and Management of Pressure Ulcers David R. Thomas, MD

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1 CLINICAL PRACTICE IN LONG-TERM CARE The New F-tag 314: Prevention and Management of Pressure Ulcers David R. Thomas, MD Saint Louis University Medical Center, Saint Louis, MO. Address correspondence to David R. Thomas, MD, Saint Louis Medical Center, Saint Louis, MO Copyright 2006 American Medical Directors Association DOI: /j.jamda Two Congressional acts, the Omnibus Budget Reconciliation Act of 1987 (OBRA 87) and the Balanced Budget Act of 1997 (BBA 97), contained regulations governing practices in the nursing home. OBRA 87 had a major impact on general nursing care, including the Minimum Data Set (MDS), requirements for a medical director, and reduction of physical and chemical restraints. Regulations based on BBA 97 initiated the Prospective Payment System and consolidated billing. These federal regulations have in effect created a standard of care in nursing facilities. The regulations resulting from OBRA 87 are divided into 2 parts. First, the regulation is stated. These statements are labeled by F-tags and a number. An F-tag is jargon for the actual regulation published in the Federal Register. The second part consists of an Interpretive Guideline. The Interpretive Guideline is derived by the agency responsible for enforcing the regulation. It consists of an explanation of the intent of the law, definitions of terms, and instructions on determining compliance with the law. The guideline is supplemented by an Investigative Protocol that is used to document compliance. The Center for Medicare Services continually produces revisions of the Interpretive Guidelines for Surveyors for use in nursing homes. New guidelines for the prevention and treatment of pressure ulcers were introduced in November State and federal surveys in nursing homes performed since then have used the new interpretive guidelines. The guidelines were produced by a consensus committee and thus will engender some disagreement over individual items. However, the new guidelines are much more evidence-based and an improvement over the previous versions. The original law published in the Federal Register is simple and unchanged: Based on the comprehensive assessment of a resident, the facility must ensure that (1) A resident who enters the facility without pressure sores does not develop pressure sores unless the individual s clinical condition demonstrates that they were unavoidable; and, (2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. The extensive revisions to the new Interpretive Guideline derive from this regulation. This review will focus on the changes to the guidelines for the prevention and management of pressure ulcers. Tables 1 and 2 list the definitions of 4 types of chronic wounds and definitions of terms associated with pressure ulcers. The effect of Table 1 is to define and limit the investigation of F314 only to pressure ulcers. Other wounds are now grouped under F309, the regulation for quality of care. Thus, it is critical for physicians to accurately perform a differential diagnosis of chronic wounds. The effect of Table 2 is to fix the definitions of descriptors used in clinical charting. Thus, failure to understand the accepted definition of these terms in documentation is likely to cause confusion between the surveyors and the clinical staff. PREVENTION The guideline states that The comprehensive assessment, which includes the Resident Assessment Instrument (RAI), evaluates the resident s intrinsic risks, the resident s skin condition, other factors (including causal factors) which place the resident at risk for developing pressure ulcers and/or experiencing delayed healing, and the nature of the pressure to which the resident may be subjected. The assessment should identify which risk factors can be removed or modified. Risk factors for the development of pressure ulcers are listed in Table 3. Risk assessment for development of pressure ulcers can include these factors, or an alternative risk assessment instrument can be used. There are a number of pressure ulcer risk assessment tools available, such as the Braden or Norton scale, but the sensitivity, specificity, and positive predictive value of some tools has been problematic in the long-term care setting. 2 In the guidelines, no instrument other than the Resident Assessment Protocol is mandated. The frequency of risk assessment is described here (and in other places) begins with the words Many clinicians recommend... The use of this term Many clinicians recommend... may be viewed as a polite way of saying that the evidence base is not strong, and that the recommendation rests on the consensus panel s opinion. Thus, Many clinicians recommend using a standardized pressure ulcer risk assessment tool to assess pressure ulcer risks at admission, weekly for the first four weeks after admission for CLINICAL PRACTICE IN LONG-TERM CARE Thomas 523

2 Table 1. Type Arterial ulcer Definitions of Chronic Wounds Diabetic neuropathic ulcer Venous insufficiency ulcer (previously known as stasis ulcer) Pressure ulcer Description An ulceration that occurs as the result of arterial occlusive disease when non pressure-related disruption or blockage of the arterial blood flow to an area causes tissue necrosis. The arterial ulcer is characteristically painful, usually occurs in the distal portion of the lower extremity, and may be over the ankle or bony areas of the foot (eg, top of the foot or toe, outside edge of the foot). The wound bed is frequently dry and pale with minimal or no exudate. The affected foot may exhibit diminished or absent pedal pulse, coolness to touch, decreased pain when hanging down (dependent) or increased pain when elevated, blanching upon elevation, delayed capillary fill time, hair loss on top of the foot and toes, or toenail thickening. Requires that the resident be diagnosed with diabetes mellitus and have peripheral neuropathy. The diabetic ulcer characteristically occurs on the foot, eg, at mid-foot, at the ball of the foot over the metatarsal heads, or on the top of toes with Charcot deformity. An open lesion of the skin and subcutaneous tissue of the lower leg, usually occurring in the pretibial area of the lower leg or above the medial ankle. Venous ulcers are reported to be the most common vascular ulceration and may be difficult to heal, may occur off and on for several years, and may occur after relatively minor trauma. The ulcer may have a moist, granulating wound bed, may be superficial, and may have minimal to copious serous drainage unless the wound is infected. The resident may experience pain, which may be increased when the foot is in a dependent position, such as when a resident is seated with her or his feet on the floor. Any lesion caused by unrelieved pressure that results in damage to the underlying tissue(s). Although friction and shear are not primary causes of pressure ulcers, friction and shear are important contributing factors to the development of pressure ulcers. each resident at risk, then quarterly or whenever there is a change in cognition or functional ability. Nutrition The new guidelines address several questions about nutritional interventions. The guidelines specifically recognize that there are no wound-specific nutritional interventions. Nutritional goals should be directed at the whole person and not at the pressure ulcer itself. Protein intake is specifically addressed: Unless contraindicated, nutritional goals for a resident with nutritional compromise who has a pressure ulcer or is at risk of developing pressure ulcers should include a protein intake of approximately gm/kg body weight daily, suggesting that the higher end of the range should be used for those with larger, more extensive, or multiple wounds. A simple multivitamin is appropriate, but unless the resident has a specific vitamin or mineral deficiency, supplementation with additional vitamins or minerals may not be indicated. Thus, the guidelines support the clinical data indicating that supplemental vitamin C, zinc, or specific amino acids have not been shown to accelerate pressure ulcer healing. 3 The guidelines acknowledge that no specific laboratory value is useful or required for serial testing in prevention of pressure ulcers. While serum albumin, prealbumin, and cholesterol may be useful to help establish overall prognosis (for mortality or morbidity), these markers do not correlate well with clinical observation of nutritional status. Specifically, A low albumin level combined with the facility s lack of supplementation, for example, is not sufficient to cite a pressure ulcer deficiency. Hydration status is referenced to F327, in conjunction with problems in nutritional status. Moisture, Urinary and Fecal Incontinence Both urine and feces are recognized to contain substances that may irritate the epidermis or may make the skin more susceptible to breakdown. However, the guidelines incorporate newer evidence that Some studies have found that fecal incontinence may pose a greater threat to skin integrity. 4 The guidelines specifically caution the surveyors that dermatitis related to urinary incontinence (or other factors) is not equivalent to a stage 1 pressure ulcer. PREVENTION AND TREATMENT/MANAGEMENT GUIDELINES Resident Choice The right of a resident to refuse therapy or to be noncompliant with therapy is addressed in the new guidelines. The facility is expected to address the resident s concerns and offer relevant alternatives, if the resident has refused specific treatments. A violation of resident rights is referenced to F154 and F155. Mere refusal or noncooperation is not an excuse for worsening of a pressure ulcer. In general, the documentation should include the resident s right to refuse therapy, but informed refusal should be documented and alternative treatment should be discussed with the resident. Advanced Directives The fact that a patient is a do-not-resuscitate or end-of-life care or on hospice cannot be used as a reason to withhold pressure ulcer care or to explain a worsening pressure ulcer. A do-not-resuscitate order alone does not mean that ulcer care can be discontinued or limited. However, If the facility has implemented individualized approaches for end-of-life care in 524 Thomas JAMDA October 2006

3 Table 2. Term Pressure ulcer Avoidable Unavoidable Cleansing Irrigation Colonized Infected Definitions Autolytic debridement Enzymatic (chemical) debridement Mechanical debridement Sharp or surgical debridement Maggot debridement therapy (MDT) or medicinal maggots Eschar Slough Exudate Purulent exudate/drainage/discharge Serous drainage or exudate Granulation tissue Tunneling Sinus tract Undermining Definition Any lesion caused by unrelieved pressure that results in damage to the underlying tissue(s). The resident developed a pressure ulcer and 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. 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 practice; monitored and evaluated the impact of the interventions; and revised the approaches as appropriate. The use of an appropriate device and solution to clean the surface of the wound bed and to remove the looser foreign debris or contaminants in order to decrease microbial growth. A type of mechanical debridement, which uses an appropriate solution delivered under pressure to the wound bed to vigorously attempt to remove debris from the wound bed. The presence of bacteria on the surface or in the tissue of a wound without the signs and symptoms of an infection. The presence of micro-organisms in sufficient quantity to overwhelm the defenses of viable tissues and produce the signs and symptoms of infection. The use of moisture-retentive dressings to cover a wound and allow devitalized tissue to self-digest by the action of enzymes present in the wound fluids. The topical application of substances, eg, enzymes to break down devitalized tissue. The removal of foreign material and devitalized or contaminated tissue from a wound by physical rather than by chemical or autolytic means. The removal of foreign material or devitalized tissue by a surgical instrument. A type of sterile intentional biological larval or biosurgical debridement that uses disinfected (sterile) maggots to clean wounds by dissolving the dead and infected tissue and by killing bacteria. Thick, leathery, frequently black or brown in color, necrotic (dead) or devitalized tissue that has lost its usual physical properties and biological activity. Eschar may be loose or firmly adhered to the wound. Necrotic/avascular tissue in the process of separating from the viable portions of the body and is usually light colored, soft, moist, and stringy (at times). Any fluid that has been forced out of the tissues or its capillaries because of inflammation or injury. It may contain serum, cellular debris, bacteria, and leukocytes. Any product of inflammation that contains pus (eg, leukocytes, bacteria, and liquefied necrotic debris) Watery, clear, or slightly yellow/tan/pink fluid that has separated from the blood and presents as drainage. Pink-red moist tissue that fills an open wound when it starts to heal. It contains new blood vessels, collagen, fibroblasts, and inflammatory cells. A 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. The destruction of tissue or ulceration extending under the skin edges (margins) so that the pressure ulcer is larger at its base than at the skin surface. Undermining often develops from shearing forces and is differentiated from tunneling by the larger extent of the wound edge involved in undermining and the absence of a channel or tract extending from the pressure ulcer under the adjacent intact skin. accordance with the resident s wishes, and has implemented appropriate efforts to try to stabilize the resident s condition or indicated why the condition cannot or should not be stabilized, and provides care to prevent or treat the pressure ulcer including pertinent, routine, lesser aggressive approaches, such as, cleaning, turning, or repositioning, then the development, continuation, or progression of a pressure ulcer may be consistent with regulatory requirements. CLINICAL PRACTICE IN LONG-TERM CARE Thomas 525

4 Table 3. Risk Factor Examples of Risk Factors Impaired/decreased mobility and decreased functional ability Co-morbid conditions Drugs that may affect wound healing Impaired diffuse or localized blood flow Resident refusal of some aspects of care and treatment Cognitive impairment Exposure of skin to urinary and fecal incontinence Under nutrition, malnutrition, and hydration deficits A healed ulcer Example End-stage renal disease, thyroid disease or diabetes mellitus Steroids Generalized atherosclerosis or lower extremity arterial insufficiency Repositioning Repositioning should be performed for any resident with limited mobility. The frequency of optimum repositioning is not known, 5,6 but the guidelines suggest at least every two hours or more frequently. Prevention of progression of a stage 1 pressure ulcer may require more frequent repositioning. Except for residents with both sacral and ischial pressure ulcers, the resident should not be positioned on the trochanter for more than momentary placement. Finally, the guidelines recognize that the head of the bed should not be elevated more than 30 degrees without the same considerations regarding repositioning as those for a dependent resident who is seated. Sling-type wheelchairs should not be used except for transport, and pressure-reducing devices in a wheelchair should be considered. Don t forget to document that the resident received instruction about why repositioning is important and how to do it, encouragement to change positions regularly, and monitoring of frequency of repositioning. Support Surfaces and Pressure Reduction Surveyors are instructed to consider the support surface. Static pressure redistribution devices (eg, solid foam, convoluted foam, gel mattress) may be indicated when a resident is at risk for pressure ulcer development or delayed healing. A dynamic pressure reduction surfaces may be helpful when (1) The resident cannot assume a variety of positions without bearing weight on a pressure ulcer, (2) The resident completely compresses a static device that has retained its original integrity, or (3) The pressure ulcer is not healing as expected, and it is determined that pressure may be contributing to the delay in healing. Wheelchair cushions should be used for seating, but this does not remove the necessity for repositioning. The new guidelines recognize that some devices do not relieve pressure (sheepskin, heel and elbow protectors, pillows, or foam wedges), but may improve comfort for the resident. 7 Monitoring The guidelines suggest that the staff should remain alert to skin changes on a daily basis. Again the recommendation is prefaced with the term, Many clinicians recommend... that evaluating the skin weekly when a medical device that might cause pressure is present. After completing a thorough evaluation, the interdisciplinary team should develop a relevant care plan to include prevention and management interventions with measurable goals. ASSESSING THE ULCER Clinicians are expected to differentiate the type of ulcer (pressure-related versus non pressure-related) since interventions may vary depending on the specific type of ulcer. They are expected to determine the ulcer s stage, describe and monitor the ulcer s characteristics, monitor the progress toward healing, and for potential complications, determine if infection is present, assess, treat, and monitor pain, if present, and monitor dressings and treatments, as described in the protocol in Table 4. Mandated daily monitoring is shown in Table 5. Table 6 specifies the minimum weekly documentation when a pressure ulcer is present. Parameters should include the date observed; location and staging; size (perpendicular measurements of the greatest extent of length and width of the ulceration); depth; presence, location, and extent of any undermining or tunneling/sinus tract; exudate, if present: type (such as purulent/serous), color, odor, and approximate amount; the nature and frequency of pain if present (eg, whether episodic or continuous); the color and type of tissue/ character including evidence of healing (eg, granulation tissue) or necrosis (slough or eschar) of the wound bed; and a description of wound edges and surrounding tissue (eg, rolled edges, redness, hardness/induration, maceration) as appropriate. Since these wound characteristics are considered mini- Table 4. Protocol for Assessment Differentiate the type of ulcer (pressure-related versus non pressure-related) Determine the ulcer s stage Describe and monitor the ulcer s characteristics Monitor the progress toward healing and for potential complications Determine whether infection is present Assess, treat, and monitor pain, if present Monitor dressings and treatments 526 Thomas JAMDA October 2006

5 Table 5. Mandated Daily Monitoring An evaluation of the ulcer, if no dressing is present An evaluation of the status of the dressing, if present The status of the area surrounding the ulcer The presence of possible complications, such as signs of increasing area of ulceration or soft tissue infection Whether pain, if present, is being adequately controlled Whether it is intact and whether drainage, if present, is or is not leaking That can be observed without removing the dressing For example, increased redness or swelling around the wound or increased drainage from the wound Table 6. Mandated Weekly or Dressing Change Monitoring Location and Staging Size, depth, and the presence, location, and extent of any undermining or tunneling/sinus tract Exudate, if present: type, color, odor and approximate amount Pain, if present: nature and frequency Wound bed: color and type of tissue/character including evidence of healing, or necrosis Description of wound edges and surrounding tissue, as appropriate Perpendicular measurements of the greatest extent of length and width of the ulceration For example, purulent/serous For example, whether episodic or continuous For example, granulation tissue, slough, or eschar For example, rolled edges, redness, hardness/induration, maceration mum and because facilities have been cited for having all data documented except for depth, a weekly flow sheet, such as the one in Table 7, should be completed. If eschar and necrotic tissue are covering and preventing adequate staging of a pressure ulcer, the Resident Assessment Instrument (RAI) User s Manual Version 2 instructs the assessor to code the pressure ulcer as a Stage IV. The guidelines recognize that this is not compatible with current evidence, but because of reimbursement issues, insist that these Table 7. Minimal Weekly Flowsheet Date Now Yes No Location Sacrum Stage 4 L W D cm Tunnel Exudate Mod yellow Pain Wound bed Granulation Wound edge Normal Table 8. Dressings and Treatments Caveats Stage III and Stage IV ulcers should be covered Determination of the need for a dressing for a Stage I or Stage II ulcer is based upon the individual practitioner s clinical judgment and facility protocols based upon current clinical standards of practice. Current literature does not indicate significant advantages of any single specific product over another. Current literature suggests that pressure ulcer dressing protocols may use clean technique rather than sterile. Appropriate sterile technique may be needed for those wounds that recently have been surgically debrided or repaired. instructions must be followed for Minimum Data Set (MDS) coding purposes until they are revised. Although the AH- CPR and NPUAP system for staging pressure ulcers indicates that the presence of eschar precludes accurate staging of the ulcer, the facility must use the RAI directions in order to code the MDS, but not necessarily to render treatment. The issue of reverse staging has been controversial and intense. Wounds do not progress toward healing in a manner that is consistent with down staging. Rather, wounds heal by contraction and scar formation. The guidelines recognize that validated instruments to describe the healing of a pressure ulcer, the PUSH tool do exist. 8,9 However, the guidelines insist that although such instruments are appropriate for making treatment decisions, they may not be used for coding the MDS. Until the MDS is revised, the present coding system Table 9. Debridement Caveats A variety of debridement methods (eg, mechanical, sharp or surgical, enzymatic, autolytic) are available. Many clinicians believe that stable, dry, adherent, and intact eschar on the foot/heel should not be debrided, unless signs and symptoms of local infection or instability are detected. Some facilities may use wet-to-dry gauze dressings or irrigation with chemical solutions to remove slough. The use of wet-to-dry dressings or irrigations may be appropriate in limited circumstances, but repeated use may damage healthy granulation tissue in healing ulcers and may lead to excessive bleeding and increased resident pain. A facility should be able to show that its treatment protocols are based upon current standards of practice and are in accord with the facility s policies and procedures as developed with the medical director s review and approval. CLINICAL PRACTICE IN LONG-TERM CARE Thomas 527

6 Table 10. Investigative Guideline: Use If the resident has an ulcer, determine whether it was identified as non pressure-related, eg, vascular insufficiency or a neuropathic ulcer. If record review, staff and/or physician interview, and observation (unless the dressing protocol precludes observing the wound) support the conclusion that the ulcer is not pressurerelated, do not proceed with this protocol unless the resident is at risk for developing, or also has, pressure ulcers. Evaluate care and services regarding non pressure-related ulcers at F309, Quality of Care. (reverse staging) must be used for completion of the RAI. Hopefully, further progress on this issue will be made in future revisions. A pressure ulcer should progress toward healing in 2 to 4 weeks. If not, the reason for continuing with the present treatment must be documented. DRESSINGS AND TREATMENTS Certain issues related to the treatment of pressure ulcers have been further clarified, based on published evidence. 10 Dry gauze dressings are recognized as potentially damaging to granulation or healing tissue. The presence of infection is diagnosed by signs and symptoms of infection. The swab culture is finally laid to rest as not being reliable. The definition of an infection includes clinical signs, but may also be defined by a wound culture obtained in accord with accepted standards, such as a sterile tissue aspirate, a quantitative surface swab using the Levine technique, or semiquantitative swab containing 100,000 (10 5 ) or greater microorganisms per gram of tissue. Among dressings, the current literature does not indicate significant advantages of any single specific product over another, but does confirm that not all products are appropriate for all pressure ulcers. Unfortunately, there is no further definition of what products might be inappropriate. Published systematic reviews of dressings for pressure ulcers are available. 11,12 Clean, but not sterile, technique for dressing changes is acceptable, with the caveat that some clinicians would use sterile technique in recently debrided wounds (Table 8). The guidelines suggest that removal of necrotic debris should enhance wound healing. This stands in contradiction to a meta-analysis that failed to show improvement in wound healing with debridement, even though debridement is effective in removing necrotic debris. 13 However, the controversy over debridement of heel eschar is recognized. Many clinicians believe that stable, dry, adherent and intact eschar on the foot/heel should not be debrided, unless signs and symptoms of local infection or instability are detected. A facility should be able to show that its treatment protocols are based on current standards of practice and that the facility s policies and procedures were developed with the medical director s review and approval (Table 9). INVESTIGATIVE PROTOCOL The final section of the new guidelines provide a protocol to be used by surveyors to determine facility compliance. The use of this protocol is how surveyors are expected to determine whether the standard is met. The intent to limit F314 to pressure ulcers alone is shown in the caveat in Table 10. Parameters for observation of prevention or treatment is shown in Tables 11 and 12. The surveyors are instructed to interview all caregivers, including the attending physician and medical director, to determine knowledge and compliance with treatment guidelines (Tables 13 and 14). For a resident who developed a pressure ulcer after admission, the facility is in compliance with F314, if staff have: Recognized and assessed factors placing the resident at risk for developing a pressure ulcer, including specific conditions, causes and/or problems, needs, and behaviors; defined and implemented interventions for pressure ulcer Table 11. Investigative Protocol: Observation Observe whether staff consistently implements the care plan over time and across various shifts. Observe erythema or color changes on areas such as the sacrum, buttocks, trochanters, posterior thigh, popliteal area, or heels when moved off an area. Observe previously unidentified open areas. Observe whether the positioning avoids pressure on an existing pressure ulcer(s). Observe measures taken to prevent or reduce the potential for shearing or friction during transfers, elevation, and repositioning. Observe whether pressure-redistributing devices for the bed and/or chair, such as geltype surfaces or overlays, are in place, working, and used according to the manufacturer s recommendations. If erythema or color change are noted, return approximately.5.75 hours later to determine whether the changes or other Stage I characteristics persist. If the changes persist and exhibit tenderness, hardness, or alteration in temperature from surrounding skin, ask staff how they determine repositioning schedules and how they evaluate and address a potential Stage I pressure ulcer. 528 Thomas JAMDA October 2006

7 Table 12. Investigative Protocol: Observation of Existing Ulcer/Wound Care Characteristics of the wound and surrounding tissues, such as presence of granulation tissue, the Stage, presence of exudates, necrotic tissue such as eschar or slough, or evidence of erythema or swelling around the wound The form or type of debridement, if used Whether treatment and infection control practices reflect current standards of practice Based on location, steps taken to cleanse and protect the wound from likely contamination by urine or fecal incontinence Assessed for pain related to the ulcer; addressed and monitored interventions for effectiveness Assessed and took preemptive measures for pain related to dressing changes or other treatments, such as debridement/irrigations, and monitored for effectiveness prevention in accordance with resident needs, goals, and recognized standards of practice; monitored and evaluated the resident s response to preventive efforts; and revised the approaches as appropriate. For a resident who was admitted with a pressure ulcer, who has a pressure ulcer Table 13. Interviews Investigative Protocol: Resident, Family, and Staff Involvement in care plan, choices, goals, and whether interventions reflect preferences Awareness of approaches, such as pressure redistribution devices or equipment, turning/repositioning, weight shifting to prevent or address pressure ulcer(s) Presence of pain, if any, and how it is managed If treatment(s) was refused, whether counseling on alternatives, consequences, and/or other interventions was offered Awareness of current or history of an ulcer(s). For the resident who has or has had a pressure ulcer, identify, as possible, whether acute illness, weight loss, or other condition changes occurred prior to ulcer development Knowledge of prevention and treatment, including facilityspecific guidelines/protocols and specific interventions for the resident If nursing assistants know what, when, and to whom to report changes in skin condition Who monitors for the implementation of the care plan, changes in the skin, the development of pressure ulcers, and the frequency of review and evaluation of an ulcer Table 14. Investigative Protocol: Interviews With Healthcare Practitioners and Professionals How it was determined that chosen interventions were appropriate Risks identified for which there were no interventions Changes in condition that may justify additional or different interventions How they validated the effectiveness of current interventions If the attending physician is unavailable, interview the medical director, as appropriate Table 15. Indicators of Compliance or Non-compliance For a resident who developed a pressure ulcer after admission, the facility is in compliance with this requirement, if staff have: Recognized and assessed factors placing the resident at risk for developing a pressure ulcer, including specific conditions, causes and/or problems, needs, and behaviors; Defined and implemented interventions for pressure ulcer prevention in accordance with resident needs, goals, and recognized standards of practice; Monitored and evaluated the resident s response to preventive efforts; and Revised the approaches as appropriate. For a resident who was admitted with a pressure ulcer, who has a pressure ulcer that is not healing, or who is at risk of developing subsequent pressure ulcers, the facility is in compliance with this requirement if they: Recognized and assessed factors placing the resident at risk of developing a new pressure ulcer or experiencing non-healing or delayed healing of a current pressure ulcer, including specific conditions, causes and/or problems, needs, and behaviors; Defined and implemented interventions for pressure ulcer prevention and treatment in accordance with resident needs, goals, and recognized standards of practice; Addressed the potential for infection; Monitored and evaluated the resident s response to preventive efforts and treatment interventions; and Revised the approaches as appropriate. that is not healing, or who is at risk of developing subsequent pressure ulcers, the facility is in compliance with this requirement if they: Recognized and assessed factors placing the resident at risk of developing a new pressure ulcer Table 16. Indicators of Non-compliance Non-compliance for F314 may include (but is not limited to) one or more of the following, including failure to: Accurately or consistently assess a resident s skin integrity on admission and as indicated thereafter; Identify a resident at risk of developing a pressure ulcer(s); Identify and address risk factors for developing a pressure ulcer, or explain adequately why they could not or should not do so; Implement preventive interventions in accord with the resident s need and current standards of practice; Provide clinical justification for the unavoidable development or non-healing/delayed healing or deterioration of a pressure ulcer; Provide appropriate interventions, care, and treatment to an existing pressure ulcer to minimize infections and to promote healing; Implement interventions for existing wounds; Notify the physician of the resident s condition or changes in the resident s wound(s); Adequately implement pertinent infection management practices in relation to wound care; and Identify or know how to apply relevant policies and procedures for pressure ulcer prevention and treatment. CLINICAL PRACTICE IN LONG-TERM CARE Thomas 529

8 Table 17. Potential Tags for Additional Investigation 42 CFR (b)(11)(i)(B)&(C), F157, Notification of Changes Determine whether staff notified the physician of significant changes in the resident s condition or failure of the treatment plan to prevent or heal pressure ulcers; or the resident s representative (if known) of significant changes in the resident s condition in relation to the development of a pressure ulcer or a change in the progression of healing of an existing pressure ulcer. 42 CFR (b)(1), F272, Comprehensive Assessments Determine whether the facility comprehensively assessed the resident s skin condition, including existing pressure ulcers, and resident-specific risk factors (including potential causative factors) for the development of a pressure ulcer or nonhealing of the ulcer. 42 CFR (k)(1), F279, Comprehensive Care Plans Determine whether the facility developed a care plan that was consistent with the resident s specific conditions, risks, needs, behaviors, and preferences and current standards of practice and included measurable objectives and timetables, specific interventions/services to prevent the development of pressure ulcers and/or to treat existing pressures ulcers. 42 CFR (k)(2)(iii), F280, Comprehensive Care Plan Revision 42 CFR (k)(3)(i), F281, Services Provided Meet Professional Standards Determine whether the care plan was periodically reviewed and revised as necessary to prevent the development of pressure ulcers and to promote the healing of existing pressure ulcers. Determine whether pressure ulcer care was provided in accordance with accepted professional standards. 42 CFR , F309, Quality of Care Determine whether staff identified and implemented appropriate measures for the management of pain as indicated as related to pressure ulcers and pressure ulcer treatment. 42 CFR (a), F353, Sufficient Staff Determine whether the facility had qualified staff in sufficient numbers to assure the resident was provided necessary care and services, based upon the comprehensive assessment and care plan, to prevent or treat pressure ulcers. 42 CFR (a)(1), F385, Physician Supervision Determine whether the physician has assessed and developed a treatment regimen relevant to preventing or healing a pressure ulcer and responded appropriately to the notice of changes in condition. 42 CFR (i)(2), F501, Medical Director Determine whether the medical director assisted the facility in the development and implementation of policies and procedures for pressure ulcer prevention and treatment, and that these are based on current standards of practice; and whether the medical director interacts with the physician supervising the care of the resident if requested by the facility to intervene on behalf of the resident with a pressure ulcer(s). or experiencing nonhealing or delayed healing of a current pressure ulcer, including specific conditions, causes and/or problems, needs, and behaviors; defined and implemented interventions for pressure ulcer prevention and treatment in accordance with resident needs, goals, and recognized standards of practice; addressed the potential for infection; monitored and evaluated the resident s response to preventive efforts and treatment interventions; and revised the approaches as appropriate (Table 15). If these criteria are not met, the development of the pressure ulcer is considered avoidable, and the facility is cited for noncompliance with F314 (Table 16). 530 Thomas JAMDA October 2006

9 When the facility is in noncompliance with F314, an investigation of other potential noncompliance is undertaken. The F-tags that may be implicated in a deficiency of F314 are illustrated in Table 17. The level of deficiency is determined by a severity grid. SUMMARY An extensive revision of the guidelines for prevention and management of pressure ulcers is now in effect. Overall, the guidelines are an improvement over the previous version. Much more of the current guidelines rests on evidence-based data and is more consistent with current standards. However, there are still areas where the evidence does not yet answer all of the questions. 14,15 Until future research more clearly defines the evidence, clinicians will still have to interpolate the data to manage the difficult problem of prevention and management of pressure ulcers. REFERENCES 1. Department of Health and Human Services. CMS Manual System. State Operations: Provider Certification. Centers for Medicare & Medicaid Services (CMS) Guidance to Surveyors for Long-Term Care Facilities. Transmittal 4. November 12, DHHS Pub Thomas DR. Issues and dilemmas in managing pressure ulcers. J Gerontol Med Sci 2001;56:M Thomas DR. Improving the outcome of pressure ulcers with nutritional intervention: A review of the evidence. Nutrition 2001;17: Thomas DR. Prevention and treatment of pressure ulcers: What works? What doesn t? Cleve Clin J Med 2001;68: , , Clark M. Repositioning to prevent pressure sores what is the evidence? Nurs Stand 1998;13: Defloor T. Less frequent turning intervals and yet less pressure ulcers. Tijdschr Gerontol Geriatr 2001;32: Cullum N, McInnes E, Bell-Syer SEM, Legood R. Support surfaces for pressure ulcer prevention. The Cochrane Database of Systematic Reviews 2004;3:CD Thomas DR, Rodeheaver GT, Bartolucci AA, et al. Pressure ulcer scale for healing: Derivation and validation of the PUSH tool. Adv Wound Care 1997;10: Stotts NA, Rodeheaver GT, Thomas DR, et al. An instrument to measure healing in pressure ulcers: Development and validation of the Pressure Ulcer Scale for Healing (PUSH). J Gerontol Med Sci 2001;56: M795 M Thomas DR. Management of pressure ulcers. J Am Med Dir Assoc 2006;7: Bouza C, Sax Z, Muñoz A, Amate JM. Efficacy of advance dressing in the treatment of pressure ulcers: A systematic review. J Wound Care 2005; 14: Bradley M, Cullum N, Nelson E A, Petticrew M, Sheldon T, Torgerson D. Systematic reviews of wound care management: Dressings and topical agents used in the healing of chronic wounds. Health Technol Assess 1999;3(17 Part 2): Bradley M, Cullum N, Sheldon T. The debridement of chronic wounds: A systematic review. Health Technol Assess 1999;3: Thomas DR. Are all pressure ulcers avoidable? J Am Med Dir Assoc 2001;2: Thomas DR, Osterweil D. Is a pressure ulcer a marker for quality of care? J Am Med Dir Assoc 2005;6: CLINICAL PRACTICE IN LONG-TERM CARE Thomas 531

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