CMS SOM App. PP, Tag F686

§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.

INTENT

The intent of this requirement is that the resident does not develop pressure

ulcers/injuries (PU/PIs) unless clinically unavoidable and that the facility provides care

and services consistent with professional standards of practice to:

• Promote the prevention of pressure ulcer/injury development;

• Promote the healing of existing pressure ulcers/injuries (including prevention of

infection to the extent possible); and

• Prevent development of additional pressure ulcer/injury.

NOTE: CMS is aware of the array of terms used to describe alterations in skin integrity

due to pressure. Some of these terms include: pressure ulcer, pressure injury, pressure

sore, decubitus ulcer and bed sore. Clinicians may use and the medical record may reflect

any of these terms, as long as the primary cause of the skin alteration is related to

pressure. For example, the medical record could reflect the presence of a Stage 2 pressure

injury, while the same area would be coded as a Stage 2 pressure ulcer on the MDS.

CMS often refers to the National Pressure Ulcer Advisory Panel’s (NPUAP) terms and

definitions, which it has adapted, within its patient and resident assessment instruments

and corresponding assessment manuals, which includes the Minimum Data Set (MDS).

We intend to continue our adaptation of NPUAP terminology for coding the resident

assessment instrument while retaining current holistic assessment instructions definitions

and terminology. The adapted terminology was used in the development of this

guidance.

Additional information can be found on the NPUAP website at

https://www.npuap.org/resources/educational-and-clinical-resources.

NOTE: References to non-CMS/HHS sources or sites on the Internet included above or

later in this document are provided as a service and do not constitute or imply

endorsement of these organizations or their programs by CMS or the U.S. Department of

Health and Human Services. CMS is not responsible for the content of pages found at

these sites. URL addresses were current at the date of this publication.

DEFINITIONS

Definitions are provided to clarify clinical terms related to pressure injuries and their

evaluation and treatment.

“Pressure Ulcer/Injury (PU/PI)” refers to localized damage to the skin and/or

underlying soft tissue usually over a bony prominence or related to a medical or other

device. A pressure injury will present as intact skin and may be painful. A 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. Soft tissue damage related to pressure and shear may

also be affected by skin temperature and moisture, nutrition, perfusion, co-morbidities

and condition of the soft tissue.

Avoidable/Unavoidable

• “Avoidable” means that the resident developed a pressure ulcer/injury and that the

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” means that the resident developed a pressure ulcer/injury even

though the facility had evaluated the resident’s clinical condition and risk factors;

defined and implemented interventions that are consistent with resident needs,

goals, and professional standards of practice; monitored and evaluated the impact

of the interventions; and revised the approaches as appropriate.

Colonized/Infected

• “Colonized” refers to the presence of micro-organisms on the surface or in the

tissue of a wound without the signs and symptoms of an infection.

• “Infected” refers to the presence of micro-organisms in sufficient quantity to

overwhelm the defenses of viable tissues and produce the signs and symptoms of

infection.

Debridement- Debridement is the removal of devitalized/necrotic tissue and foreign

matter from a wound to improve or facilitate the healing process. Debridement methods

may include a range of treatments such as the use of enzymatic dressings to surgical

debridement in order to remove tissue or matter from a wound to promote healing.

Eschar/Slough

• “Eschar” is dead or devitalized tissue that is hard or soft in texture; usually black,

brown, or tan in color, and may appear scab-like. Necrotic tissue and eschar are

usually firmly adherent to the base of the wound and often the sides/ edges of the

wound.

• “Slough” is non-viable yellow, tan, gray, green or brown tissue; usually moist,

can be soft, stringy and mucinous in texture. Slough may be adherent to the base

of the wound or present in clumps throughout the wound bed.

Exudate

• “Exudate” is 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.

• “Purulent exudate/drainage/discharge” is any product of inflammation that

contains pus (e.g., leukocytes, bacteria, and liquefied necrotic debris).

• “Serous drainage or exudate” is watery, clear, or slightly yellow/tan/pink fluid

that has separated from the blood and presents as drainage.

Friction/Shearing

• “Friction” is the mechanical force exerted on skin that is dragged across any

surface.

• “Shearing” occurs when layers of skin rub against each other or when the skin

remains stationary and the underlying tissue moves and stretches and angulates or

tears the underlying capillaries and blood vessels causing tissue damage.

Granulation Tissue - “Granulation tissue” is 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.

Tunnel/Sinus Tract/Undermining - The terms tunnel and sinus tract are often used

interchangeably.

• A “tunnel” is a passageway of tissue destruction under the skin surface that has an

opening at the skin level from the edge of the wound.

• A “sinus tract” is a cavity or channel underlying a wound that involves an area

larger than the visible surface of the wound.

• “Undermining” is 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 and the absence

of a channel or tract extending from the pressure ulcer under the adjacent intact

skin.

GUIDANCE STAGING

Staging of a PU/PI is performed to indicate the characteristics and extent of tissue injury,

and should be conducted according to professional standards of practice. Determining

whether damage to the skin and underlying tissue is a PI or PU depends on the staging of

the damaged tissue. See stages below.

NOTE: Regardless of the staging system or wound definitions used by the facility, the

facility is responsible for completing the MDS utilizing the staging guidelines found in

the RAI Manual.

Stage 1 Pressure Injury: Non-blanchable erythema of intact skin

Intact skin with a localized area of non-blanchable erythema (redness). In darker skin

tones, the PI may appear with persistent red, blue, or purple hues. The presence of

blanchable erythema or changes in sensation, temperature, or firmness may precede

visual changes. Color changes of intact skin may also indicate a deep tissue PI (see

below).

Stage 2 Pressure Ulcer: Partial-thickness skin loss with exposed dermis

Partial-thickness loss of skin with exposed dermis, presenting as a shallow open ulcer.

The wound bed is viable, pink or red, moist, and may also present as an intact or

open/ruptured blister. Adipose (fat) is not visible and deeper tissues are not visible.

Granulation tissue, slough and eschar are not present. This stage should not be used to

describe moisture associated skin damage including incontinence associated dermatitis,

intertriginous dermatitis (inflammation of skin folds), medical adhesive related skin

injury, or traumatic wounds (skin tears, burns, abrasions).

Stage 3 Pressure Ulcer: Full-thickness skin loss

Full-thickness loss of skin, in which subcutaneous fat may be visible in the ulcer and

granulation tissue and epibole (rolled wound edges) are often present. Slough and/or

eschar may be visible but does not obscure the depth of tissue loss. The depth of tissue

damage varies by anatomical location; areas of significant adiposity can develop deep

wounds. Undermining and tunneling may occur. Fascia, muscle, tendon, ligament,

cartilage and/or bone are not exposed. If slough or eschar obscures the wound bed, it is an

Unstageable PU/PI.

Stage 4 Pressure Ulcer: Full-thickness skin and tissue loss

Full-thickness skin and tissue loss with exposed or directly palpable fascia, muscle,

tendon, ligament, cartilage or bone in the ulcer. Slough and/or eschar may be visible on

some parts of the wound bed. Epibole (rolled edges), undermining and/or tunneling often

occur. Depth varies by anatomical location. If slough or eschar obscures the wound bed,

it is an unstageable PU/PI.

Unstageable Pressure Ulcer: Obscured full-thickness skin and tissue loss

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. Stable

eschar (i.e. dry, adherent, intact without erythema or fluctuance) should only be removed

after careful clinical consideration and consultation with the resident’s physician, or nurse

practitioner, physician assistant, or clinical nurse specialist if allowable under state

licensure laws. If the slough or eschar is removed, a Stage 3 or Stage 4 pressure ulcer will

be revealed. If the anatomical depth of the tissue damage involved can be determined,

then the reclassified stage should be assigned. The pressure ulcer does not have to be

completely debrided or free of all slough or eschar for reclassification of stage to occur.

Other staging considerations include:

• Deep Tissue Pressure Injury (DTPI): Persistent non-blanchable deep red,

maroon or purple discoloration

Intact skin with localized area of persistent non-blanchable deep red, maroon,

purple discoloration due to damage of underlying soft tissue. This area may be

preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as

compared to adjacent tissue. These changes often precede skin color changes and

discoloration may appear differently in darkly pigmented skin. This injury results

from intense and/or prolonged pressure and shear forces at the bone-muscle

interface. The wound may evolve rapidly to reveal the actual extent of tissue

injury, or may resolve without tissue loss. If necrotic tissue, subcutaneous tissue,

granulation tissue, fascia, muscle or other underlying structures are visible, this

indicates a full thickness pressure ulcer. Once a deep tissue injury opens to an

ulcer, reclassify the ulcer into the appropriate stage. Do not use DTPI to describe

vascular, traumatic, neuropathic, or dermatologic conditions.

• Medical Device Related Pressure Ulcer/Injury: Medical device related PU/PIs

result from the use of devices designed and applied for diagnostic or therapeutic

purposes. The resultant pressure injury generally conforms to the pattern or shape

of the device. The injury should be staged using the staging system.

• Mucosal Membrane Pressure Ulcer/Injury: Mucosal membrane PU/PIs are

found on mucous membranes with a history of a medical device in use at the

location of the injury. Due to the anatomy of the tissue, these ulcers cannot be

staged.

PREVENTION OF PRESSURE ULCERS/NJURIES

A pressure ulcer/injury (PU/PI) can occur wherever pressure has impaired circulation to

the tissue. A facility must:

• Identify whether the resident is at risk for developing or has a PU/PI upon

admission and thereafter;

• Evaluate resident specific risk factors and changes in the resident’s condition that

may impact the development and/or healing of a PU/PI;

• Implement, monitor and modify interventions to attempt to stabilize, reduce or

remove underlying risk factors; and

• If a PU/PI is present, provide treatment and services to heal it and to prevent

infection and the development of additional PU/PIs.

The first step in the prevention of PU/PIs, is the identification of the resident at risk of

developing PU/PIs. This is followed by implementation of appropriate individualized

interventions and monitoring for the effectiveness of the interventions.

ASSESSMENT

An admission evaluation helps identify residents at risk of developing a PU/PI, and

residents with existing PU/PIs. Because a resident at risk can develop a PU/PI within

hours of the onset of pressure, the at-risk resident needs to be identified and have

interventions implemented promptly to attempt to prevent PU/PI. The admission

evaluation helps define those initial care approaches.

In addition, the admission evaluation may identify pre-existing signs suggesting that

tissue damage has already occurred and additional tissue loss may occur. For example, a

deep tissue pressure injury identified on admission could lead to the appearance of an

unavoidable Stage 3 or 4 pressure ulcer. A Stage 1 PI can progress to an ulcer with

eschar or exudate within days after admission. Some situations, which may have

contributed to this tissue damage prior to admission, include pressure resulting from

immobility during hospitalization or surgical procedures, during prolonged ambulance

transport, or while waiting to be assisted after a debilitating event, such as a fall or a

cerebral vascular accident.

It may be harder to identify erythema in a resident with darkly pigmented skin, putting

those residents more at risk for developing PU/PIs. It may be necessary, in darker skinned

residents to focus more on other evidence of PU/PI development such as changes in

sensation, skin temperature or firmness.

Multiple factors, including pressure intensity, pressure duration, and tissue tolerance,

significantly affect the potential for the development and healing of PUs/PIs. The

comprehensive assessment, which includes the RAI, evaluates the resident’s intrinsic

risks, the resident’s skin condition, and other factors (including causal factors) which

place the resident at risk for the development of or hinder the healing of PU/PIs. An

individual may also have various intrinsic risks due to aging, such as decreased

subcutaneous tissue and lean muscle mass, decreased skin elasticity, and impaired

circulation or sensation.

The comprehensive assessment should address those factors that have been identified as

having an impact on the development, treatment and/or healing of PU/PIs, including, at a

minimum: risk factors, pressure points, under-nutrition and hydration deficits, and

moisture and the impact of moisture on skin. The assessment also helps identify the

resident who has multi-system organ failure or an end-of-life condition or who is refusing

care and treatment. If the resident is refusing care, an evaluation of the basis for the

refusal, and the identification and evaluation of potential alternatives is indicated.

Risk Factors

Not all risk factors are fully modifiable or can be completely addressed. Some risk

factors, such as a permanent lack of sensation to an area, may not be modifiable. Some

potentially modifiable risk factors, such as malnutrition or uncontrolled blood sugars,

may take time to correct, despite prompt intervention. Other risk factors, such as

pressure, can be modified promptly. Many studies and professional literature identify

risk factors that increase a resident’s susceptibility to develop or to not heal pressure

PU/PIs.

Examples of these risk factors include, but are not limited to:

• Impaired/decreased mobility and decreased functional ability;

• Co-morbid conditions, such as end stage renal disease, thyroid disease or diabetes

mellitus;

• Drugs such as steroids that may affect healing;

• Impaired diffuse or localized blood flow, for example, generalized atherosclerosis

or lower extremity arterial insufficiency;

• 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; and

• The presence of a previously healed PU/PI. The history of any healed PU/PI, its

origin, treatment, its stages [if known] is important assessment information, since

areas of healed Stage 3 or 4 PU/PIs are more likely to have recurrent breakdown.

Although the requirements do not mandate the use of any specific assessment tool (other

than the RAI), many validated instruments are available to aid in assessing the risk for

developing PU/PIs. It is important to keep in mind that research has shown that in a

skilled nursing facility, 80 percent of PU/PIs develop within two weeks of admission and

96 percent develop within three weeks of admission. (Reference: Lyder CH, Ayello EA.

Pressure Ulcers: A Patient Safety Issue. In: Hughes RG, editor. Patient Safety and

Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for

Healthcare Research and Quality (US); 2008 Apr. Chapter 12. Available from:

http://www.ncbi.nlm.nih.gov/books/NBK2650/

)

Many clinicians utilize a standardized pressure ulcer/injury risk assessment tool to assess

a resident’s PU/PI risks upon admission, weekly for the first four weeks after admission,

then quarterly or whenever there is a change in the resident’s condition.

A resident’s risk may increase due to an acute illness or condition change (e.g., upper

respiratory infection, pneumonia, or exacerbation of underlying congestive heart failure)

and may require additional evaluation. The frequency of assessment should be based

upon each resident’s specific needs.

Regardless of any resident’s total risk score on an assessment tool, clinicians are

responsible for evaluating each existing and potential risk factor for developing a

pressure injury and determining the resident’s overall risk. It is acceptable if the

clinician’s assessment places the resident at a higher risk level than the overall score of

the assessment tool based on assessment factors that are not captured by the tool.

Documentation of the clinician’s decision should be placed in the medical record.

Pressure Points and Tissue Tolerance

Assessment of a resident’s skin condition helps define prevention strategies. The skin

assessment should include an evaluation of the skin integrity.

Tissue closest to the bone may be the first tissue to undergo changes related to pressure.

PU/PIs are usually located over a bony prominence, such as the sacrum, heel, the greater

trochanter, ischial tuberosity, fibular head, scapula, and ankle (malleolus).

An at-risk resident who sits too long in one position may be more prone to developing an

ulcer/injury over the ischial tuberosity. Slouching in a chair may predispose an at-risk

resident to pressure ulcers/injuries of the spine, scapula, or elbow. Elbow pressure injury

is often related to arm rests or lap boards. Friction and shearing are also important

factors in tissue ischemia, necrosis and PU/PI formation.

PU/PIs may develop at other sites where pressure has impaired the circulation to the

tissue, such as pressure from positioning or use of medical devices applied for diagnostic

or therapeutic purposes. The resultant PU/PI generally conforms to the pattern or shape of

the device. Mucosal membrane PU/PIs are found on mucous membranes with a history of

a medical device in use at the location of the injury. Due to the anatomy of mucous

membranes, these ulcers cannot be staged.

PU/PIs on the sacrum and heels are most common. PU/PIs may also develop from

pressure on an ear lobe related to positioning of the head; on areas (for example, nares,

urinary meatus, extremities) caused by tubes, casts, orthotics, braces, cervical collars, or

other medical devices; pressure on the labia or scrotum related to positioning (for

example, against a pommel type cushion); the foot related to ill-fitting shoes causing

blistering; or on legs, arms and fingers due to contractures or deformity.

Nutrition and Hydration

Adequate nutrition and hydration are essential for overall functioning. Nutrition provides

vital energy and building blocks for all of the body’s structures and processes. Any organ

or body system may require additional energy or structural materials for repair or

function. The skin is the body’s largest organ system. It may affect, and be affected by,

other body processes and organs. Skin condition reflects overall body function therefore,

the presence of skin breakdown may be the most visible evidence of a health issue.

Weight reflects a balance between intake and utilization of energy. Significant

unintended weight loss may indicate under-nutrition or worsening health status. Weight

stability (in the absence of fluid excess or loss) is a useful indicator of overall caloric

balance. Severely impaired organs (heart, lungs, kidneys, liver, etc.) may be unable to

use nutrients effectively. A resident with a PU/PI who continues to lose weight either

needs additional caloric intake or correction (where possible) of conditions that are

creating a hypermetabolic state. Continuing weight loss and failure of a PU/PI to heal

despite reasonable efforts to improve caloric and nutrient intake may indicate the resident

is in multi-system failure or an end-stage or end-of-life condition warranting an

additional assessment of the resident’s overall condition.

Before instituting a nutritional care plan, it helps to summarize resident specific evidence,

including: severity of nutritional compromise, rate of weight loss or appetite decline,

probable causes, the individual’s prognosis and projected clinical course, and the

resident’s wishes and goals. Because there are no wound-specific nutritional measures,

the interdisciplinary team should develop nutritional goals for the whole person and

address nutritional status and needs in the care plan as appropriate.

NOTE: Although some laboratory tests may help clinicians evaluate nutritional issues

in a resident with PU/PIs, no laboratory test is specific or sensitive enough to

warrant serial/repeated testing. A practitioner may order test(s) that provide

useful additional information or help with management of treatable conditions

at their discretion

Water is essential to maintain adequate body functions. As a major component of blood,

water dissolves vitamins, minerals, glucose, amino acids, etc.; transports nutrients into

cells; removes waste from the cells; and helps maintain circulating blood volume as well

as fluid and electrolyte balance. It is critical that each resident at risk for hydration deficit

or imbalance, including the resident who has or is at risk of developing a PU/PI, be

identified and assessed to determine appropriate interventions.

NOTE: The surveyor should refer to the Guidance at 42 CFR 483.25(g), F692, Assisted

Nutrition and Hydration, for investigation of potential non-compliance with the nutrition

and hydration requirements. A low albumin level combined with the facility’s lack of

supplementation, for example, is not by itself sufficient to cite a nutrition related

deficiency.

Moisture

Both urine and feces contain substances that may irritate the epidermis and may make the

skin more susceptible to breakdown and moisture-related skin damage. Fecal

incontinence may pose a greater threat to skin integrity, due to bile acids and enzymes in

the feces. Irritation or maceration resulting from prolonged exposure to urine and feces

may hasten skin breakdown, and moisture may make skin more susceptible to damage

from friction and shear during repositioning.

It may be difficult to differentiate dermatitis related to incontinence from partial thickness

PU/PI. This differentiation should be based on the clinical evidence and review of

presenting risk factors. The dermatitis may occur in the area where the incontinence brief

or underpad has been used.

Prevention and Treatment Strategies

The comprehensive assessment should provide the basis for defining approaches to

address residents at risk of developing or already having a PU/PI. A determination that a

resident is at risk for developing a PU/PI has significant implications for preventive and

treatment strategies, but does not by itself indicate that development of a PU/PI was

unavoidable. Effective prevention and treatment are based upon consistently providing

routine and individualized interventions.

Based upon the assessment and the resident’s clinical condition, choices and identified

needs, basic or routine care could include, but is not limited to, interventions to:

• Redistribute pressure (such as repositioning, protecting and/or offloading heels,

etc.);

• Minimize exposure to moisture and keep skin clean, especially of fecal

contamination;

• Provide appropriate, pressure-redistributing, support surfaces;

• Provide non-irritating surfaces; and

• Maintain or improve nutrition and hydration status, where feasible. Adverse drug

reactions related to the resident's drug regimen may worsen risk factors for

development of, or for non-healing PU/PIs (for example, by causing lethargy or

anorexia or creating/increasing confusion) and should be identified and addressed.

These interventions should be incorporated into the plan of care and revised as the

condition of the resident indicates.

Resident Choices

In the context of the resident’s choices, clinical condition, and physician input, the

resident’s care plan should establish relevant goals and approaches to stabilize or improve

co-morbidities, such as attempts to minimize clinically significant blood sugar

fluctuations, and other interventions aimed at limiting the effects of risk factors

associated with PU/PIs. Alternatively, facility staff and practitioners should document

clinically valid reasons why such interventions were not appropriate or feasible.

In order for a resident to exercise his or her right appropriately to make informed choices

about care and treatment or to decline treatment, the facility and the resident (or if

applicable, the resident representative) must discuss the resident’s condition, treatment

options, expected outcomes, and consequences of refusing treatment. The facility is

expected to address the resident’s concerns and offer relevant alternatives, if the resident

has declined specific treatments. (See §483.10(c), F552, Planning and implementing

care.)

Pressure Injuries at End of Life

Residents at the end of life, in terminal stages of an illness or having multiple system

failures may have written directions for his or her treatment goals (or a decision has been

made by the resident’s representative, in accordance with State law). The facility’s care

must reflect the resident’s goals for care and wishes as expressed in a valid Advance

Directive, if one was formulated, in accordance with State law. However, the presence of

an Advance Directive does not absolve the facility from giving supportive and other

pertinent care that is not prohibited by the resident’s Advance Directive. It is important

for surveyors to understand that when a facility has implemented individualized

approaches for end-of-life care in accordance with the resident’s wishes, the

development, continuation, or worsening of a PU/PI may be considered unavoidable. If

the facility has implemented appropriate efforts to stabilize the resident’s condition (or

indicted why the condition cannot or should not be stabilized) and has provided care to

prevent or treat existing PU/PIs (including pertinent, routine, lesser aggressive

approaches, such as, cleaning, turning, repositioning), the PU/PI may be considered

unavoidable and consistent with regulatory requirements.

The Kennedy Terminal Ulcer (KTU)

The facility is responsible for accurately assessing and classifying an ulcer as a KTU or

other type of PU/PI and demonstrate that appropriate preventative measures were in place

to prevent non-KTU pressure ulcers.

KTUs have certain characteristics which differentiate them from pressure ulcers such as

the following:

• KTUs appear suddenly and within hours;

• Usually appear on the sacrum and coccyx but can appear on the heels, posterior

calf muscles, arms and elbows;

• Edges are usually irregular and are red, yellow, and black as the ulcer progresses,

often described as pear, butterfly or horseshoe shaped; and

• Often appear as an abrasion, blister, or darkened area and may develop rapidly to

a Stage 2, Stage 3, or Stage 4 injury.

Repositioning

Repositioning or relieving constant pressure is a common, effective intervention for an

individual with a PU/PI or who is at risk of developing one. Assessment of a resident’s

skin integrity after pressure has been reduced or redistributed should guide the

development and implementation of repositioning plans. Such plans should be addressed

in the comprehensive care plan consistent with the resident’s need and goals.

Repositioning is critical for a resident who is immobile or dependent upon staff for

repositioning, as the resident is unable to make small movements on their own that would

help to relieve prolonged pressure to one area. The care plan for a resident at risk of

friction or shearing during repositioning may require the use of lifting devices for

repositioning. Positioning the resident on an existing PU/PI should be avoided since it

puts additional pressure on tissue that is already compromised and may impede healing.

Determine repositioning frequency with consideration to the individual’s:

• Level of activity and mobility,

• General medical condition,

• Overall treatment objectives,

• Skin condition, and

• Comfort.

The resident’s skin condition and general comfort should be regularly assessed. The

efficacy of repositioning must be monitored and revisions to the care plan considered, if

the individual is not responding as expected to the repositioning interventions.

Facilities should consider the following repositioning issues:

1. The time an individual spends seated in a chair without pressure relief should be

limited. Seated individuals should be repositioned so as to maintain stability and full

range of activities. An acceptable seated posture minimizes the pressure and shear

exerted on the skin and soft tissues, which may involve using pressure relieving

devices/cushions or adjusting the seat tilt, foot rests, elevated leg rests and other

support devices to prevent prolonged pressure to areas of the body that may be at

particular risk for developing a PU/PI.

1. If able, the resident should be taught to shift his or her weight while sitting in a

chair. A resident who can change positions independently may need supportive

devices to facilitate position changes. The resident also may need instruction

about why repositioning is important and how to do it, encouragement to change

positions regularly, and monitoring of frequency of repositioning.

2. Many clinicians recommend a position change “off - loading” hourly for

dependent residents who are sitting or who are in a bed or a reclining chair with

the head of the bed or back of the chair raised 30 degrees or more. The resident

may require more frequent position changes based on an assessment of their skin

condition or their comfort. A “microshift,” meaning a small change in the

resident’s position for a short period of time, may not be adequate since this

approach does not allow sufficient capillary refill and tissue perfusion for a

resident at risk of developing PU/PI’s. Ongoing monitoring of the resident’s

skin integrity and tissue tolerance is critical to prevent development or

deterioration of PU/PI’s.

3. Wheelchairs are often used for transporting residents, but they may severely

limit repositioning options and increase the risk of PU/PI development.

Therefore, wheelchairs with sling seats may not be optimal for prolonged sitting

during activities or meals, etc. However, available modifications to the seating

can provide a more stable surface and provide better pressure reduction.

4. The care plan for a resident who is reclining and is dependent on staff for

repositioning should address position changes to maintain the resident’s skin

integrity. This may include repositioning at least every 2 hours or more

frequently depending upon the resident’s condition and specific needs.

Depending on the individualized assessment, more frequent repositioning may

be warranted for individuals who are at higher risk for PU/PI development or

who show evidence that repositioning at 2-hour intervals is inadequate. With

rare exception (such as when both sacral and ischial PU/PI’s are present) the

resident should not be placed directly on the greater trochanter for more than

momentary placement. Elevating the head of the bed or the back of a reclining

chair to or above a 30 degree angle creates pressure comparable to that exerted

while sitting, and requires the same considerations regarding repositioning as

those for a dependent resident who is seated.

Support Surfaces and Pressure Redistribution

Pressure redistribution refers to the function or ability to distribute a load over a surface

or contact area. Redistribution results in shifting pressure from one area to another and

requires attention to all affected areas. Pressure redistribution has incorporated the

concepts of both pressure reduction and pressure relief.

Appropriate support surfaces or devices should be chosen by matching a device’s

potential therapeutic benefit with the resident’s specific situation; such as multiple

injuries, limited turning surfaces, ability to maintain position. The effectiveness of

pressure redistribution devices (such as gel mattresses, air fluidized mattresses, and low

loss air mattresses) is based on their potential to address the individual resident’s risk, the

resident’s response to the product, and the characteristics and condition of the product.

For example, an overinflated overlay product, or one that “bottoms out” (when the

overlay is underinflated or loses inflation creating less than one inch between the resident

and support material) is unlikely to effectively reduce the pressure risk. These products

are more likely to reduce pressure effectively if they are used in accord with the

manufacturer’s instructions. The effectiveness of each product used needs to be

evaluated on an ongoing basis. Surveyors should consider the following pressure

redistribution issues:

• Static pressure redistribution devices (such as a gel mattress) may be indicated

when a resident is at risk for PU/PI development or delayed healing. A

specialized pressure redistribution cushion or surface, for example, might be used

to extend the time a resident is sitting in a chair; however, the cushion does not

eliminate the necessity for periodic repositioning and skin assessment.

• Dynamic pressure reduction surfaces may be helpful when:

o The resident cannot assume a variety of positions without bearing weight on a

PU/PI;

o The resident completely compresses a static device that has retained its

original integrity; or

o The PU/PI is not healing as expected, and it is determined that pressure may

be contributing to the delay in healing.

• Because the heels and elbows have relatively little surface area, it is difficult to

redistribute pressure on these two surfaces. Therefore, it is important to pay

particular attention to reducing the pressure on these areas for the resident at risk

in accord with resident’s overall goals and condition. Pillows used to support the

entire lower leg may effectively raise the heel from contact with the bed, but use

of the pillows needs to take into account the resident’s other conditions. The use

of donut-type cushions is not recommended by the clinicians.

• A resident with severe flexion contractures also may require special attention to

effectively reduce pressure on bony prominences or prevent breakdown from

skin-to-skin contact.

Some products serve mainly to provide comfort and reduce friction and shearing forces,

e.g., sheepskin, heel and elbow protectors. Although these products are not effective at

redistributing pressure, they (in addition to pillows, foam wedges, or other measures)

may be employed to prevent bony prominences from rubbing together or on other

surfaces, such as armrests, the bed, or side rails.

Monitoring

Staff should remain alert to potential changes in the skin condition and should evaluate,

report and document changes as soon as identified. For example, a resident’s complaint

about pain or burning at a site where there has been pressure or observation during the

resident’s bath that there is a change in skin condition should be reported so that the

resident may be evaluated further.

After completing a thorough evaluation, the interdisciplinary team should develop a

relevant care plan that includes measurable goals for prevention and management of

PU/PIs with appropriate interventions. Many clinicians recommend evaluating skin

condition (skin color, moisture, temperature, integrity, and turgor) at least weekly, or

more often if indicated, such as when the resident is using a medical device that may

cause pressure. Defined interventions should be implemented and monitored for

effectiveness.

Assessment and Treatment of Pressure Ulcers/Injuries

It is important that each existing PU/PI be identified, whether present on admission or

developed after admission, and that factors that influenced its development, the potential

for development of additional PU/PIs or the deterioration of the PU/PIs be recognized,

assessed and addressed. Any new PU/PI suggests a need to reevaluate the adequacy of

prevention measures in the resident’s care plan.

When assessing the PU/PI itself, it is important that documentation addresses:

• The type of injury (pressure-related versus non-pressure-related) because

interventions may vary depending on the specific type of injury;

• The PU/PI’s stage;

• A description of the PU/PI’s characteristics;

• The progress toward healing and identification of potential complications;

• If infection is present;

• The presence of pain, what was done to address it, and the effectiveness of the

intervention; and

• A description of dressings and treatments.

Types of Injuries

Three of the more common types of skin injuries are pressure, vascular

insufficiency/ischemia (venous stasis and arterial ischemic ulcers) and neuropathic. See

§483.25, F684, Quality of Care, for definition and description of injury types other than

PU/PIs.

At the time of the assessment, clinicians (physicians, advance practice nurses, physician

assistants, and certified wound care specialists, etc.) should document the clinical basis

(for example, type of skin injury, location, shape, edges and wound bed, condition of

surrounding tissues) for any determination that an injury is not pressure-related,

especially if the injury has characteristics consistent with a pressure injury, but is

determined not to be one.

Pressure Ulcer/Injury Characteristics

It is important that the facility have a system in place to assure that the protocols for daily

monitoring and for periodic documentation of measurements, terminology, frequency of

assessment, and documentation are implemented consistently throughout the facility.

When a PU/PI is present, daily monitoring, (with accompanying documentation, when a

complication or change is identified), should include:

• An evaluation of the PU/PI, if no dressing is present;

• An evaluation of the status of the dressing, if present (whether it is intact and

whether drainage, if present, is or is not leaking);

• The status of the area surrounding the PU/PI (that can be observed without

removing the dressing);

• The presence of possible complications, such as signs of increasing area of

ulceration or soft tissue infection (for example: increased redness or swelling

around the wound or increased drainage from the wound); and

• Whether pain, if present, is being adequately controlled.

The amount of observation possible will depend upon the type of dressing that is used,

since some dressings are meant to remain in place for several days, according to

manufacturers’ guidelines.

With each dressing change or at least weekly (and more often when indicated by wound

complications or changes in wound characteristics), an evaluation of the PU/PI should be

documented. At a minimum, documentation should include the date observed and:

• Location and staging;

• Size (perpendicular measurements of the greatest extent of length and width of the

PU/PI), depth; and the presence, location and extent of any undermining or

tunneling/sinus tract;

• Exudate, if present: type (such as purulent/serous), color, odor and approximate

amount;

• Pain, if present: nature and frequency (e.g., whether episodic or continuous);

• Wound bed: Color and type of tissue/character including evidence of healing

(e.g., granulation tissue), or necrosis (slough or eschar); and

• Description of wound edges and surrounding tissue (e.g., rolled edges, redness,

hardness/induration, maceration) as appropriate.

Photographs may be used to support this documentation, if the facility has developed a

protocol consistent with professional standards and issues related to resident privacy and

dignity are considered and maintained.

Healing Pressure Ulcers/Injuries

Ongoing evaluation and research have indicated that PU/PIs do not heal in a reverse

sequence, that is, the body does not replace the types and layers of tissue (muscle, fat and

dermis) that were lost during development. The healing process varies depending on the

stage of the pressure injury.

There are different types of clinical documentation to describe the progression of the

healing PU/PI. Facilities are required to use the RAI. Directions on describing PU/PIs

can be found in the RAI manual – these are intended for coding purposes of the MDS.

(NOTE: Information on coding for the MDS is located on the CMS MDS website

(

http://www.cms.gov/NursingHomeQualityInits/45_NHQIMDS30TrainingMaterials.asp#Top

OfPage)

It is important to evaluate and modify interventions for a resident with an existing PU/PI

such as the following:

• Residents with PU/PIs on the sacrum/coccyx or ischia should limit sitting to three

times a day in periods of 60 minutes or less. Consult a seating specialist to

prescribe an appropriate seating surface and/or positioning techniques to avoid or

minimize pressure on the PU/PI. While sitting is important for overall health,

every effort should be made to avoid or minimize pressure on the PU/PI.

• Residents with an ischial injury should not be seated in a fully erect posture in

chair or in bed. Modify sitting time schedules and re-evaluate the seating surface

and the individual’s posture if the PU/PI worsens or fails to improve.

If a PU/PI fails to show some evidence of progress toward healing within 2-4 weeks, the

area and the resident’s overall clinical condition should be reassessed. Re-evaluation of

the treatment plan includes determining whether to continue or modify the current

interventions. Results may vary depending on the resident’s overall condition and

interventions/treatments used. The complexity of the resident’s condition may limit

responsiveness to treatment or tolerance for certain treatment modalities. The clinicians,

if deciding to retain the current regimen, should document the rationale for continuing the

present treatment to explain why some, or all, of the plan’s interventions remain relevant

despite little or no apparent healing.

Pressure ulcers/injuries may progress or may be associated with complications, such as

infection of the soft tissues around the wound (cellulitis), infection of the bone

(osteomyelitis), infection of a joint (septic arthritis), abscess, spread of bacteria into the

bloodstream (bacteremia/septicemia), chronic infection, or development of a sinus tract.

Sometimes these complications may occur despite apparent improvement in the PU/PI

itself. The physician’s involvement is integral whenever significant changes in the nature

of the wound or overall resident condition are identified.

Infections

A PU/PI infection may be acute or chronic. In acute wounds, the classic signs of

inflammation (redness, edema, pain, increased exudate, and periwound surface warmth)

persist beyond the normal time frame of three to four days. In residents who are

immunosuppressed, the signs of inflammation often are diminished or masked because of

an ineffective immune response. Often the only observable symptom of infection is a

complaint of pain.

All chronic wounds, including PU/PIs, have bacteria. Since bacteria reside in non-viable

tissue, debridement of this tissue and wound cleansing are important to reduce bacteria

and avoid adverse outcomes such as sepsis.

The first sign of infection may be a delay in healing and an increase in exudates. In a

chronic wound, the signs of infection may be more subtle. Signs may include the

following:

• Increase in amount or change in characteristics of exudate,

• Decolorization and friability of granulation tissue,

• Undermining,

• Abnormal odor,

• Epithelial bridging (a bridge of epithelial tissue across a wound bed) at the base of

the wound, or

• Sudden pain.

The physician diagnosis of infections present in a PU/PI are based on resident history and

clinical findings, such as a wound culture. Pus, slough or necrotic tissue should not be

cultured. Findings such as an elevated white blood cell count, bacteremia, sepsis, or

fever may signal an infection related to a PU/PI area or a co-existing infection from a

different source. The treatment of an infection will depend on the type of infection

present.

Pain

The assessment and treatment of a resident’s pain are integral components of PU/PI

prevention and management. Pain that interferes with movement and/or affects mood

may contribute to immobility and contribute to the potential for developing or for delayed

healing or non-healing of an already existing PU/PI. Refer to §483.25(k), F697, for

additional guidance related to Pain Management.

Dressings and Treatments

Determination of the need for treatment for a PU/PI is based upon the individual

practitioner’s clinical judgment, facility protocols, and current professional standards of

practice.

Product selection should be based upon the relevance of the specific product to the

identified PU/PI(s) characteristics, the treatment goals, and the manufacturer's

recommendations for use. 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 PU/PIs. Wound characteristics should be assessed throughout the

healing process to assure that the treatments and dressings being used are appropriate to

the nature of the wound.

Evidenced-based practice suggests that PU/PI dressing protocols may use clean technique

rather than sterile, but that appropriate sterile technique may be needed for those wounds

that recently have been surgically debrided or repaired. Clean technique (also known as

non-sterile) involves approved hand hygiene and glove use, maintaining a clean

environment by preparing a clean field, using clean instruments, and preventing direct

contamination of materials and supplies. Clean technique is considered most appropriate

for long-term care; for residents who are not at high risk for infection; and for residents

receiving routine dressings for chronic wounds such as venous ulcers, or wounds healing

by secondary intention with granulation tissue.

A facility should be able to show that its treatment protocols are based upon current

professional standards of practice and are in accord with the facility’s policies and

procedures as developed with the medical director’s review and approval.

INVESTIGATIVE PROTOCOL

Use

Use the Pressure Ulcer Critical Element (CE) Pathway, along with the above interpretive

guidelines when determining if the facility meets requirements to ensure a resident

receives care consistent with professional standards of practice, to prevent pressure

ulcers/injuries development, prevent the development of additional pressure

ulcers/injuries, and to promote the healing of existing pressure ulcers/injuries.

Summary of Skin Integrity Investigative Procedure

Briefly review the comprehensive assessments, care plans, and physician orders to

identify whether the facility has practices in place to identify if a resident is at risk for a

pressure ulcer/injury, evaluate a resident for pressure ulcers/injuries, and intervene to

prevent and/or heal pressure ulcers. During this review, identify the extent to which the

facility has developed and implemented interventions in accordance with ensuring a

resident receives care consistent with professional standards of practice. If the resident

has been in the facility for less than 14 days (before completion of all the Resident

Assessment Instrument (RAI) is required), review the baseline care plan which must be

completed within 48 hours to determine if the facility is providing appropriate care and

services based on information available at the time of admission.

This information will guide observations and interviews to be made to corroborate

concerns identified.

NOTE: In addition to actual or potential physical harm, always observe for visual cues

of psychosocial distress and consider whether psychosocial harm has occurred when

determining severity level (See guidance on Severity and Scope Levels and Psychosocial

Outcome Severity Guide located in the Survey Resources zip file located at

https://www.cms.gov/medicare/provider-enrollment-and-

certification/guidanceforlawsandregulations/nursing-homes).

KEY ELEMENTS OF NONCOMPLIANCE

To cite deficient practice at F686, the surveyor's investigation will generally show that

the facility failed to do one or more of the following:

• Provide preventive care, consistent with professional standards of practice, to

residents who may be at risk for development of pressure injuries; or

• Provide treatment, consistent with professional standards of practice, to an

existing pressure injury; or

• Ensure that a resident did not develop an avoidable PU/PI.

NOTE: To cite F686, it is not necessary to prove that a PU/PI developed. F686 can be

cited when it has been determined that the provider failed to implement interventions to

prevent the development of a PU/PI for a resident identified at risk.

DEFICIENCY CATEGORIZATION

Examples of Severity Level 4 Noncompliance: Immediate Jeopardy to Resident

Health or Safety include, but are not limited to:

• The facility failed to implement interventions to prevent PU/PI development for a

resident who was admitted without PU/PIs, but who had multiple co-morbidities

and was totally dependent on staff, placing her at increased risk for PU/PI

development; and failed to provide ongoing skin assessments for the same

resident. The resident developed a stage IV pressure ulcer on her heel within three

weeks of her admission.

• Development of avoidable Stage IV pressure ulcer(s): As a result of the facility’s

non-compliance, permanent tissue damage (whether or not healing occurs) has

compromised the resident, increasing the potential for serious complications

including osteomyelitits and sepsis.

• Admitted with a Stage IV pressure ulcer(s) that has shown no signs of healing or

shows signs of deterioration: As a result of the facility’s non-compliance, a Stage

IV pressure ulcer has shown signs of deterioration or a failure to progress towards

healing with an increased potential for serious complications including

osteomyelitis and sepsis.

• Stage III or IV pressure ulcers with associated soft tissue or systemic infection:

As a result of the facility’s failure to assess or treat a resident with an infectious

complication of a pressure ulcer, the resident developed Stage III or IV pressure

ulcers with associated soft tissue or systemic infection. (See discussion in

guidelines and definitions that distinguishes colonization from infection.)

• Extensive failure in multiple areas of pressure ulcer care: As a result of the

facility’s extensive noncompliance in multiple areas of pressure ulcer care, the

resident developed recurrent and/or multiple, avoidable Stage III or Stage IV

pressure ulcer(s).

Examples of Severity Level 3 Noncompliance Actual Harm that is not Immediate

Jeopardy include, but are not limited to:

• The facility failed to provide necessary equipment, interventions, monitoring, and

care, for a resident who was identified to be at risk for developing PU/PIs due to

the presence of contractures and had no PU/PIs upon admission. The facility’s

occupational therapist (OT) assessed the resident and provided a pressure

relieving device for use on the resident’s left hand, which was to be in place at all

times except when daily hygiene was being provided. The interventions were not

recorded on the resident’s care plan. During observation and interviews with staff,

the assistive device was unable to be located and was not in use. This resulted in

the resident developing a Stage III pressure injury.

• The development of recurrent or multiple avoidable Stage II pressure ulcer(s): As

a result of the facility’s non-compliance, the resident developed multiple and/or

recurrent avoidable Stage II ulcers.

• Failure to implement the comprehensive care plan for a resident who has a

pressure ulcer: As a result of a facility’s failure to implement a portion of an

existing plan related to pressure ulcer care, such as failure to provide for pressure

redistribution, or inappropriate treatment/dressing changes, a wound increased in

size or failed to progress towards healing as anticipated, or the resident

experienced untreated pain.

Examples of Severity Level 2 Noncompliance No Actual Harm with Potential for

More Than Minimal Harm that is Not Immediate Jeopardy include, but are not

limited to:

• The facility failed to assure that a resident with a healed Stage I PI in the coccyx

area received care to prevent the development of another PU/PI. The resident’s

care plan identified the use of a pressure-relieving device while up in the chair

and repositioning every 30 minutes. During observations, the pressure relieving

device was not present on the seat of the wheelchair but staff did reposition

resident every 30 minutes. The device was available, but the staff person

interviewed stated that although it was usually on his wheelchair, it had not been

placed that day. The resident’s skin was intact and did not indicate the presence of

a stage I PI based on observation, but the likelihood existed of a PU/PI developing

as a result of not implementing care as identified in the plan of care.

• The facility failed to assess the skin condition of a resident who used continual

oxygen for management of a chronic respiratory disease. The resident’s oxygen

was provided via nasal cannula and the resident voiced discomfort and irritation

with the tubing on his nares. There was a small reddened area where the tubing

contacted the nares. The resident had mentioned this to the staff, but was not

addressed, and the resident continued to experience discomfort and irritation.

• Failure to implement an element of the care plan for a resident who has a pressure

ulcer however, there has been no evidence of decline or failure to heal.

• Failure to recognize or address the potential for developing a pressure ulcer: As a

result of the facility’s non-compliance, staff failed to identify the risks, develop a

plan of care and/or consistently implement a plan that has been developed to

prevent pressure ulcers.

Severity Level 1: No Actual Harm with Potential for Minimal Harm

The failure of the facility to provide appropriate care and services to prevent pressure

ulcers/injuries or heal existing pressure ulcers/injuries is more than minimal harm.

Therefore, Severity Level 1 does not apply for this regulatory requirement.

POTENTIAL TAGS FOR ADDITIONAL INVESTIGATION

During the investigation of F686, the surveyor may have determined that concerns may

also be present with related outcome, process and/or structure requirements. The surveyor

is cautioned to investigate these related requirements before determining whether non-compliance may be present. Some examples of related requirements that should be

considered include §483.20 Resident Assessment, §483.21 Comprehensive Person-Centered Care Planning, §483.24 Quality of Life, §483.30 Physician Services, §483.35

Nursing Services, §483.70 Administration, and §483.75 QAPI.