CMS Manual System

Department of Health &

Human Services (DHHS)

Pub. 100-07 State Operations

Provider Certification

Centers for Medicare &

Medicaid Services (CMS)

Transmittal 4 Date: NOVEMBER 12, 2004

SUBJECT: Guidance to Surveyors for Long Term Care Facilities

I. SUMMARY OF CHANGES: Appendix PP, Tag F314, current Guidance to

Surveyors, is entirely replaced by this revision which is to be inserted in the Appendix

immediately after the regulatory text for F314. To complement the revision of F314, new

language is being added to Tag F309 to include certain definitions of non-pressure related

ulcers. Hypertext links are added for all Web sites listed in the Overview,

(www.ahrq.gov, www.npuap.org, www.amda.org, www.medqic.org, www.wocn.org, and

www.healthinaging.org ). Hypertext link is added in the Endnotes section to link to a

CMS site (www.cms.hhs.gov/medicaid/survey-cert/siqhome.asp) for further information.

NEW/REVISED MATERIAL - EFFECTIVE DATE*: November 12, 2004

IMPLEMENTATION DATE: November 12, 2004

Disclaimer for manual changes only: The revision date and transmittal number apply

to the red italicized material only. Any other material was previously published and

remains unchanged. However, if this revision contains a table of contents, you will

receive the new/revised information only, and not the entire table of contents.

II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual not updated.)

(R = REVISED, N = NEW, D = DELETED) – (Only One Per Row.)

R/N/D CHAPTER/SECTION/SUBSECTION/TITLE

R Appendix PP/483.25/Quality of Care/Tag F309

R Appendix PP/483.25(c)/Pressure Sores/Tag F314

III. FUNDING: Medicare contractors shall implement these instructions within

their current operating budgets.

IV. ATTACHMENTS:

Business Requirements

x Manual Instruction

Confidential Requirements

One-Time Notification

Recurring Update Notification

*Unless otherwise specified, the effective date is the date of service.

F309

(Rev.4, Issued 11-12-04, Effective: 11-12-04, Implementation: 11-12-04)

§483.25 Quality of Care

Each resident must receive and the facility must provide the necessary care and

services to attain or maintain the highest practicable physical, mental, and

psychosocial well-being, in accordance with the comprehensive assessment and plan

of care.

Use F309 for quality of care deficiencies not covered by §483.25(a)-(m).

Intent: §483.25

The facility must ensure that the resident obtains optimal improvement or does not

deteriorate within the limits of a resident’s right to refuse treatment, and within the limits

of recognized pathology and the normal aging process.

Definitions: §483.25

• “Highest practicable” is defined as the highest level of functioning and well-being

possible, limited only by the individual’s presenting functional status and

potential for improvement or reduced rate of functional decline. Highest

practicable is determined through the comprehensive resident assessment by

competently and thoroughly addressing the physical, mental or psychosocial

needs of the individual.

• “Skin Ulcer/Wound”

NOTE: Skin ulcer definitions are included to clarify clinical terms related to

skin ulcers. At the time of the assessment and diagnosis, the

clinician is expected to document the clinical basis (e.g., underlying

condition contributing to the ulceration, ulcer edges and wound bed,

location, shape, condition of surrounding tissues) which permit

differentiating the ulcer type, especially if the ulcer has

characteristics consistent with a pressure ulcer, but is determined

not to be one.

o “Arterial Ulcer” is 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.

Inadequate blood supply to the extremity may initially present as

intermittent claudication. Arterial/Ischemic ulcers may be present in

individuals with moderate to severe peripheral vascular disease,

generalized arteriosclerosis, inflammatory or autoimmune disorders (such

as arteritis), or significant vascular disease elsewhere (e.g., stroke or

heart attack). 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 (e.g., 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, toenail thickening.

o “Diabetic neuropathic ulcer” requires that the resident be diagnosed with

diabetes mellitus and have peripheral neuropathy. The diabetic ulcer

characteristically occurs on the foot, e.g., at mid-foot, at the ball of the

foot over the metatarsal heads, or on the top of toes with Charcot

deformity.

o “Pressure ulcer”. See Guidance at 42 CFR 483.25(c)-F314.

o “Venous insufficiency ulcer” (previously known as “stasis ulcer”) is 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.

Recent literature implicates venous hypertension as a causative factor.

Earlier, the ulceration was believed to be due to the pooling of blood in

the veins.

Venous hypertension may be caused by one (or a combination of) factor(s)

including: loss of (or compromised) valve function in the vein, partial or

complete obstruction of the vein (e.g., deep vein thrombosis, obesity,

malignancy), and/or failure of the calf muscle to pump the blood (e.g.,

paralysis, decreased activity). Venous insufficiency may result in edema

and induration, dilated superficial veins, cellulitis in the lower third of the

leg or dermatitis (typically characterized by change in skin pigmentation).

The pigmentation may appear as darkening skin, tan or purple areas in

light skinned residents and dark purple, black or dark brown in dark

skinned residents.

F314

(Rev.4, Issued 11-12-04, Effective: 11-12-04, Implementation: 11-12-04)

§483.25(c) Pressure Sores

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

Intent: (F314) 42 CFR 483.25(c)

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

clinically unavoidable and that the facility provides care and services to:

• Promote the prevention of pressure ulcer development;

• Promote the healing of pressure ulcers that are present (including prevention of

infection to the extent possible); and

• Prevent development of additional pressure ulcers.

NOTE: Although the regulatory language refers to pressure sores, the nomenclature

widely accepted presently refers to pressure ulcers, and the guidance

provided in this document will refer to pressure ulcers.

DEFINITIONS

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

evaluation and treatment.

• “Pressure Ulcer”- A pressure ulcer is 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.

• “Avoidable/Unavoidable” Pressure Ulcers

o “Avoidable” means that the resident developed a pressure ulcer and that

the facility did not do one or more of the following: evaluate the resident’s

clinical condition and pressure ulcer risk factors; define and implement

interventions that are consistent with resident needs, resident goals, and

recognized standards of practice; monitor and evaluate the impact of the

interventions; or revise the interventions as appropriate.

o “Unavoidable” means that the resident developed a pressure ulcer even

though the facility had evaluated the resident’s clinical condition and

pressure ulcer risk factors; defined and implemented interventions that

are consistent with resident needs, goals, and recognized standards of

practice; monitored and evaluated the impact of the interventions; and

revised the approaches as appropriate.

• “Cleansing/Irrigation”

o “Cleansing” refers to 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.

o “Irrigation” refers to 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.

• “Colonized/Infected” Wound

o “Colonized” refers to the presence of bacteria on the surface or in the

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

o “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.

Various debridement methods include:

o “Autolytic debridement” refers to 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.

o “Enzymatic (chemical) debridement” refers to the topical application of

substances e.g., enzymes to break down devitalized tissue.

o “Mechanical debridement” refers to the removal of foreign material and

devitalized or contaminated tissue from a wound by physical rather than

by chemical or autolytic means.

o “Sharp or surgical debridement” refers to removal of foreign material or

devitalized tissue by a surgical instrument.

o “Maggot debridement therapy (MDT)” or medicinal maggots refers to 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.

• “Eschar/Slough”

o “Eschar” is described as 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.

o “Slough” is 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).

• “Exudate”

o “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.

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

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

o “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”

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

any surface.

o “Shearing” is the interaction of both gravity and friction against the

surface of the skin. Friction is always present when shear force is

present.

Shear 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”

o “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”-Tunnel and sinus tract are often used

interchangeably.

o “Tunneling” is a passageway of tissue destruction under the skin surface

that has an opening at the skin level from the edge of the wound.

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

area larger than the visible surface of the wound.

o “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 in undermining and the absence of a channel or tract extending

from the pressure ulcer under the adjacent intact skin.

OVERVIEW

A pressure ulcer can occur wherever pressure has impaired circulation to the tissue.

Critical steps in pressure ulcer prevention and healing include: identifying the individual

resident at risk for developing pressure ulcers, identifying and evaluating the risk factors

and changes in the resident’s condition, identifying and evaluating factors that can be

removed or modified, implementing individualized interventions to attempt to stabilize,

reduce or remove underlying risk factors, monitoring the impact of the interventions, and

modifying the interventions as appropriate. It is important to recognize and evaluate

each resident’s risk factors and to identify and evaluate all areas at risk of constant

pressure.

A complete assessment is essential to an effective pressure ulcer prevention and

treatment program. A comprehensive individual evaluation helps the facility to:

• Identify the resident at risk of developing pressure ulcers, the level and nature of

risk(s); and

• Identify the presence of pressure ulcers.

This information allows the facility to develop and implement a comprehensive care plan

that reflects each resident’s identified needs.

The care process should include efforts to stabilize, reduce or remove underlying risk

factors; to monitor the impact of the interventions; and to modify the interventions as

appropriate.

The facility should have a system/procedure to assure: assessments are timely and

appropriate; interventions are implemented, monitored, and revised as appropriate; and

changes in condition are recognized, evaluated, reported to the practitioner, and

addressed. The quality assessment and assurance committee may help the facility

evaluate existing strategies to reduce the development and progression of pressure

ulcers, monitor the incidence and prevalence of pressure ulcers within the facility, and

ensure that facility policies and procedures are consistent with current standards of

practice.

Research into appropriate practices for the prevention, management and treatment of

pressure ulcers, continues to evolve. As such, there are many recognized clinical

resources regarding the prevention and management of pressure ulcers (including wound

care, and complications such as infections and pain). Some of these resources include:

• The Clinical Practice Guidelines from the Agency for Healthcare Research and

Quality (AHRQ) www.ahrq.gov (Guideline No. 15: Treatment of Pressure Ulcers

and Guideline No.3: Pressure Ulcers in Adults: Prediction and

Prevention)(AHRQ was previously known as the Agency for Health Care Policy

and Research [AHCPR]);

• The National Pressure Ulcer Advisory Panel (NPUAP) www.npuap.org;

• The American Medical Directors Association (AMDA) www.amda.com (Clinical

Practice Guidelines: Pressure Ulcers, 1996 and Pressure Ulcer Therapy

Companion, 1999);

• The Quality Improvement Organizations, Medicare Quality Improvement

Community Initiatives site at www.medqic.org;

• The Wound, Ostomy, and Continence Nurses Society (WOCN) www.wocn.org;

and

• The American Geriatrics Society guideline “The Management of Persistent Pain

in Older Persons”, www.healthinaging.org

NOTE: References to non-CMS sources or sites on the Internet 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 as of the date of this publication.

PREVENTION OF PRESSURE ULCERS

42 CFR 483.25 (c) requires that a resident who is admitted without a pressure ulcer

doesn’t develop a pressure ulcer unless clinically unavoidable, and that a resident who

has an ulcer receives care and services to promote healing and to prevent additional

ulcers.

The first step in prevention is the identification of the resident at risk of developing

pressure ulcers. This is followed by implementation of appropriate individualized

interventions and monitoring for the effectiveness of the interventions.

ASSESSMENT

An admission evaluation helps identify the resident at risk of developing a pressure ulcer,

and the resident with existing pressure ulcer(s) or areas of skin that are at risk for

breakdown. Because a resident at risk can develop a pressure ulcer within 2 to 6 hours

of the onset of pressure,

the at-risk resident needs to be identified and have

interventions implemented promptly to attempt to prevent pressure ulcers. The

admission evaluation helps define those initial care approaches.

In addition, the admission evaluation may identify pre-existing signs (such as a purple or

very dark area that is surrounded by profound redness, edema, or induration)

suggesting that deep tissue damage has already occurred and additional deep tissue loss

may occur. This deep tissue damage could lead to the appearance of an unavoidable

Stage III or IV pressure ulcer or progression of a Stage I pressure ulcer to an ulcer with

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

contributed to this tissue damage, include pressure resulting from immobility during

hospitalization or surgical procedures, during prolonged ambulance transport, or while

waiting to be discovered or assisted after a debilitating event, such as a fall or a cerebral

vascular accident.

Some evidence suggests that because it may be harder to identify erythema in an older

adult with darkly pigmented skin, older individuals with darkly pigmented skin may be

more at risk for developing pressure ulcers.

13, 14, 15, 16

It may be necessary, therefore, in a

darker skinned individual to focus more on other evidence of pressure ulcer development,

such as bogginess, induration, coolness, or increased warmth as well as signs of skin

discoloration.

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

significantly affect the potential for the development and healing of pressure ulcers. An

individual may also have various intrinsic risks due to aging, for example: decreased

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

circulation or innervation.

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.

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.

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

having an impact on the development, treatment and/or healing of pressure ulcers,

including, at a minimum: risk factors, pressure points, under-nutrition and hydration

deficits, and moisture and the impact of moisture on skin. Each of these factors is

discussed in additional detail in the following sections.

Risk Factors

Many studies and professional documents identify risk factors that increase a resident’s

susceptibility to develop or to not heal pressure ulcers.

17,

18,

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 wound 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

• A healed ulcer. The history of a healed pressure ulcer and its stage [if

known] is important, since areas of healed Stage III or IV pressure ulcers are

more likely to have recurrent breakdown.

Some residents have many risk factors for developing pressure ulcers, such as diabetic

neuropathy, frailty, cognitive impairment, and under nutrition. Not all factors are fully

modifiable and some potentially modifiable factors (e.g., under-nutrition) may not be

corrected immediately, despite prompt intervention, while other factors such as pressure

may be modified promptly. It may be necessary to stabilize, when possible, the

underlying causes (e.g., control blood sugars or ensure adequate food and fluid intake).

Although the requirements do not mandate any specific assessment tool, other than the

RAI, validated instruments are available to assess risk for developing pressure ulcers.

Research has shown that a significant number of pressure ulcers develop within the first

four weeks after admission to a long term care facility.

Therefore, many clinicians

recommend using a standardized pressure ulcer risk assessment tool to assess a

resident’s pressure ulcer risks upon admission, weekly for the first four weeks after

admission for each resident at risk, then quarterly, or whenever there is a change in

cognition or functional ability.

21,

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.

Regardless of any resident’s total risk score, the clinicians responsible for the resident’s

care should review each risk factor and potential cause(s) individually

to: a)Identify

those that increase the potential for the resident to develop pressure ulcers; b) Decide

whether and to what extent the factor(s) can be modified, stabilized, removed, etc., and c)

Determine whether targeted management protocols need to be implemented. In other

words, an overall risk score indicating the resident is not at high risk of developing

pressure ulcers does not mean that existing risk factors or causes should be considered

less important or addressed less vigorously than those factors or causes in the resident

whose overall score indicates he or she is at a higher risk of developing a pressure ulcer.

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 and tissue tolerance (ability

of the skin and its supporting structures to endure the effects of pressure without adverse

effects) after pressure to that area has been reduced or redistributed.

Tissue closest to the bone may be the first tissue to undergo necrosis. Pressure ulcers 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 on a static surface may be more prone to get ischial

ulceration. Slouching in a chair may predispose an at-risk resident to pressure ulcers of

the spine, scapula, or elbow (elbow ulceration is often related to arm rests or lap

boards). Friction and shearing are also important factors in tissue ischemia, necrosis

and pressure ulcer formation.

Pressure ulcers may develop at other sites where pressure has impaired the circulation to

the tissue, such as pressure from positioning or use of medical devices. For example,

pressure ulcers may develop from pressure on an ear lobe related to positioning of the

head; pressure or friction on areas (e.g., nares, urinary meatus, extremities) caused by

tubes, casts, orthoses, braces, cervical collars, or other medical devices; pressure on the

labia or scrotum related to positioning (e.g., against a pommel type cushion); pressure

on the foot related to ill-fitting shoes causing blistering; or pressure on legs, arms and

fingers due to contractures or deformity resulting from rheumatoid arthritis, etc.

While pressure ulcers on the sacrum remain the most common location, pressure ulcers

on the heel are occurring more frequently,

are difficult to assess and heal, and require

early identification of skin compromise over the heel.

It is, therefore, important for clinical staff to regularly conduct thorough skin

assessments on each resident who is at risk for developing pressure ulcers.

Under-Nutrition and Hydration Deficits

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; skin breakdown may be the most visible evidence of a general catabolic state.

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 pressure ulcer 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 pressure

ulcer 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. 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 protein intake of approximately 1.2-1.5 gm/kg body weight daily (higher end of

the range 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.

NOTE: Although some laboratory tests may help clinicians evaluate nutritional

issues in a resident with pressure ulcers, no laboratory test is specific or

sensitive enough to warrant serial/repeated testing. Serum albumin, pre-

albumin and cholesterol may be useful to help establish overall prognosis;

however, they may not correlate well with clinical observation of

nutritional status.

25,

At his or her discretion, a practitioner may order

test(s) that provide useful additional information or help with management

of treatable conditions.

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 with a pressure ulcer or at risk of developing

an ulcer, be identified and that hydration needs be addressed.

(The surveyor should refer to the Guidance at 42 CFR 483.25 (i), F325, Nutrition, and

483.25(j), F327 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 sufficient to cite a pressure ulcer deficiency.)

Moisture and Its Impact

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

the skin more susceptible to breakdown. Some studies have found that fecal incontinence

may pose a greater threat to skin integrity,

most likely 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 skin loss (pressure ulcer). This differentiation should be based on the clinical

evidence and review of presenting risk factors. A Stage I pressure ulcer usually presents

as a localized area of erythema or skin discoloration, while perineal dermatitis may

appear as a more diffuse area of erythema or discoloration where the urine or stool has

come into contact with the skin. The dermatitis may occur in the area where the

incontinence brief or underpad has been used. Also, the dermatitis/rash more typically

presents as intense erythema, scaling, itching, papules, weeping and eruptions.

INTERVENTIONS

The comprehensive assessment should provide the basis for defining approaches to

address residents at risk of developing or already having a pressure ulcer. A

determination that a resident is at high risk to develop a pressure ulcer has significant

implications for preventive and treatment strategies, but does not by itself indicate that

development of a pressure ulcer was unavoidable. Effective prevention and treatment

are based upon consistently providing routine and individualized interventions.

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

resident’s plan of care 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 pressure ulcers. Alternatively, facility staff and practitioners should document

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

Repeated hospitalizations or emergency room visits within a 6-month period may

indicate overall decline or instability.

Resident Choice

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

choices about care and treatment or to refuse treatment, the facility and the resident (or

the resident's legal 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 refused specific treatments. (See Resident Rights at 42 CFR 483.10(b)(3) and (4),

F154 and F155.)

Advance Directive

A resident 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 surrogate or representative, in accordance with state law).

If a resident has a valid Advance Directive, the facility’s care must reflect a resident’s

wishes as expressed in the Directive, 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 Advance Directive. If the facility

has implemented individualized approaches for end-of-life care in 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 to provide care to prevent or treat the pressure ulcer (including pertinent, routine,

lesser aggressive approaches, such as, cleaning, turning, repositioning), then the

development, continuation, or progression of a pressure ulcer may be consistent with

regulatory requirements.

NOTE: The presence of a "Do Not Resuscitate" (DNR) order is not sufficient to

indicate the resident is declining other appropriate treatment and services.

It only indicates that the resident should not be resuscitated if respirations

and/or cardiac function cease.

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

needs, basic or routine care should include interventions to: a) Redistribute pressure

(such as repositioning, protecting heels, etc); b) Minimize exposure to moisture and keep

skin clean, especially of fecal contamination; c) Provide appropriate, pressure-

redistributing, support surfaces; d) Provide non-irritating surfaces; and e) 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 pressure ulcers

or for non-healing pressure ulcers (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.

Repositioning

Repositioning is a common, effective intervention for an individual with a pressure ulcer

or who is at risk of developing one.

29,

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 plan of care consistent with the resident’s need and goals. Repositioning

is critical for a resident who is immobile or dependent upon staff for repositioning. 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

pressure ulcer should be avoided since it puts additional pressure on tissue that is

already compromised and may impede healing.

Surveyors should consider the following repositioning issues:

• 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.

• 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 tolerance of the tissue load

(pressure). Depending on the individualized assessment, more frequent

repositioning may be warranted for individuals who are at higher risk for

pressure ulcer development or who show evidence (e.g., Stage I pressure ulcers)

that repositioning at 2-hour intervals is inadequate. With rare exception (e.g.,

both sacral and ischial pressure ulcers 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.

• 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.

Based upon

an assessment including evidence of tissue tolerance while sitting (checking for

Stage I ulcers as noted above), the resident may not tolerate sitting in a chair in

the same position for1 hour at a time and may require a more frequent position

change.

• Postural alignment, weight distribution, sitting balance and stability, and

pressure redistribution should all be considered when positioning a resident in a

chair.

A teachable resident should be taught to shift his/her weight

approximately every 15 minutes while sitting in a chair.

• Wheelchairs are often used for transporting residents, but they may severely limit

repositioning options and increase the risk of pressure ulcer 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.

• There isn’t evidence that momentary pressure relief followed by return to the

same position (that is a “microshift” of five or 10 degrees or a 10-15 second lift

from a seated position) is beneficial. This approach does not allow sufficient

capillary refill and tissue perfusion for a resident at risk of developing pressure

ulcers. Ongoing monitoring of the resident’s skin integrity and tissue tolerance is

critical to prevent development or deterioration of pressure ulcers.

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 (reduction of interface pressure, not necessarily

below capillary closure pressure) and pressure relief (reduction of interface pressure

below capillary closure pressure).

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

potential therapeutic benefit with the resident’s specific situation; for example, multiple

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

pressure redistribution devices (e.g., 4-inch convoluted foam pads, gels, 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” (completely compressing the overlay, when, for example, the caregiver

can feel 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 (e.g., solid foam, convoluted foam, gel

mattress) may be indicated when a resident is at risk for pressure ulcer

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.

• 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.

• 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.

MONITORING

At least daily, staff should remain alert to potential changes in the skin condition and

should evaluate and document identified changes. For example, a resident’s complaint

about pain or burning at a site where there has been pressure or a nursing assistant’s

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 to including prevention and management interventions with

measurable goals. Many clinicians recommend evaluating skin condition (e.g., 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.

The resident should be monitored for condition changes that might increase the risk for

breakdown and the defined interventions should be implemented and monitored for

effectiveness.

ASSESSMENT AND TREATMENT OF PRESSURE ULCER(S)

It is important that each existing pressure ulcer be identified, whether present on

admission or developed after admission, and that factors that influenced its development,

the potential for development of additional ulcers or for the deterioration of the pressure

ulcer(s) be recognized, assessed and addressed (see discussion under Prevention

regarding overall assessment and interventions). Any new pressure ulcer suggests a

need to reevaluate the adequacy of the plan for preventing pressure ulcers.

When assessing the ulcer itself, it is important to:

• Differentiate the type of ulcer (pressure-related versus non-pressure-related)

because interventions may vary depending on the specific type of ulcer;

• 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.

TYPES OF ULCERS

Three of the more common types of ulcers are pressure, vascular insufficiency/ischemia

(venous stasis and arterial ischemic ulcers) and neuropathic. See Guidance to Surveyors

at 42 CFR 483.25 (F309) for definition and description of ulcer types other than pressure

ulcers.

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/ulcer, location, shape, ulcer edges and wound bed,

condition of surrounding tissues) for any determination that an ulcer is not pressure-

related, especially if the injury/ulcer has characteristics consistent with a pressure ulcer,

but is determined not to be one.

ULCER 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 pressure ulcer is present, daily monitoring, (with accompanying documentation,

when a complication or change is identified), should include:

• An evaluation of the ulcer, 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 ulcer (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 pressure ulcer

wound 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

ulceration), 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 accepted standards

(e.g., frequency, consistent distance from

the wound, type of equipment used, means to assure digital images are accurate and not

modified, inclusion of the resident identification/ulcer location/dates/etc. within the

photographic image, and parameters for comparison).

STAGES OF PRESSURE ULCERS

The staging system is one method of summarizing certain characteristics of pressure

ulcers, including the extent of tissue damage. This is the system used within the RAI.

Stage I pressure ulcers may be difficult to identify because they are not readily visible

and they present with greater variability. Advanced technology (not commonly available

in nursing homes) has shown that a Stage I pressure ulcer may have minimal to

substantial tissue damage in layers beneath the skin's surface, even when there is no

visible surface penetration. The Stage I indicators identified below will generally persist

or be evident after the pressure on the area has been removed for 30-45 minutes.

The definitions for the stages of pressure ulcers identified below, are from the NPUAP

and used with permission.

• “Stage I” - An observable, pressure-related alteration of intact skin, whose

indicators as compared to an adjacent or opposite area on the body may include

changes in one or more of the following parameters:

o Skin temperature (warmth or coolness);

o Tissue consistency (firm or boggy);

o Sensation (pain, itching); and/or

o A defined area of persistent redness in lightly pigmented skin, whereas in

darker skin tones, the ulcer may appear with persistent red, blue, or

purple hues.

• “Stage II” - Partial thickness skin loss involving epidermis, dermis, or both. The

ulcer is superficial and presents clinically as an abrasion, blister, or shallow

crater.

• “Stage III” - Full thickness skin loss involving damage to, or necrosis of,

subcutaneous tissue that may extend down to, but not through, underlying fascia.

The ulcer presents clinically as a deep crater with or without undermining of

adjacent tissue.

• "Stage IV” - Full thickness skin loss with extensive destruction, tissue necrosis,

or damage to muscle, bone, or supporting structures (e.g., tendon, joint capsule).

Undermining and sinus tracts also may be associated with Stage IV pressure

ulcers.

NOTE: If eschar and necrotic tissue are covering and preventing adequate

staging of a pressure ulcer, the RAI User’s Manual Version 2

instructs the assessor to code the pressure ulcer as a Stage IV.

These instructions must be followed for MDS coding purposes until

they are revised. Although the AHCPR 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 HEALING PRESSURE ULCER

Ongoing evaluation and research have indicated that pressure ulcers do not heal in a

reverse sequence, that is, the body does not replace the types and layers of tissue (e.g.,

muscle, fat and dermis) that were lost during the pressure ulcer development.

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

healing pressure ulcer(s). The regulation at 42 CFR 483.20(b)(1), F272, requires that

facilities use the Resident Assessment Instrument (RAI), which includes direction to

describe the healing of the pressure ulcer(s)for coding purposes for the MDS: The RAI

User’s Manual Version 2.0, instructs staff to identify the stages of pressure ulcer(s) by

describing depth in reverse order from deepest to lesser stages to describe the healing or

improvement of a pressure ulcer (e.g., a Stage IV becomes a Stage III and so forth. This

has been referred to as “reverse staging” or “back staging”).

Some clinicians utilize validated instruments to describe the healing of a pressure ulcer.

Although such instruments are appropriate for making treatment decisions, they may not

be utilized for coding the MDS. Until the MDS is revised, the present coding system

(reverse staging) must be used for completion of the RAI.

Clinicians may use the National Pressure Ulcer Advisory Panel - Pressure Ulcer Scale

for Healing (NPUAP-PUSH) tool. The NPUAP always refers to a healed pressure ulcer

as a healed ulcer at the deepest stage of its development (e.g., a healed Stage IV or a

healing Stage IV). The NPUAP cautions that the tool does not represent a

comprehensive pressure ulcer assessment, and other factors may need to be considered

when selecting pressure ulcer treatment options.

Since surveyors may encounter clinician’s notes in which the NPUAP-PUSH tool is used

as part of the facility’s documentation protocol, the following description of the tool is

provided. The NPUAP-PUSH tool documents pressure ulcer healing consistent with the

healing process, describes a healing pressure ulcer in terms of three ulcer

characteristics, and assigns a numeric value to the characteristics: length (cm) x width

(cm), exudate amount, and type of tissue (closed with epithelium; new pink, shiny

epithelial tissue; clean, pink or beefy red, shiny, moist granulation tissue; slough tissue;

or necrotic, eschar tissue).

The 1994 AHCPR Guidelines and current literature

indicate that a clean pressure ulcer

with adequate blood supply and innervation should show evidence of stabilization or

some healing within 2-4 weeks. Evidence accumulating since 1962 indicates that

management of wound exudate coupled with a clean, moist wound environment allows a

chronic wound (e.g., pressure ulcer) to lay down healthy granulating tissue more

efficiently.

36,

If a pressure ulcer fails to show some evidence of progress toward healing within 2-4

weeks, the pressure ulcer (including potential complications) and the resident’s overall

clinical condition should be reassessed. Re-evaluation of the treatment plan including

determining whether to continue or modify the current interventions is also indicated.

Results may vary depending on the resident’s 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 (for

example, why some, or all, of the plan’s interventions remain relevant despite little or no

apparent healing).

Pressure ulcers 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 pressure ulcer itself.

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

wound or overall resident condition are identified.

INFECTIONS RELATED TO PRESSURE ULCERS

Current literature reports that all Stage II, III, and IV pressure ulcers are colonized with

bacteria but may not be infected. Identification, diagnosis and treatment of infection,

when present, are critical to healing a pressure ulcer.

The infection occurs when the

bacteria have invaded the tissue surrounding or within the pressure ulcer.

As with any infection, classic signs and symptoms of infection may include purulent

exudate, peri-wound warmth, swelling, induration or erythema (erythema may not be

readily determined in individuals with dark skin pigmentation), increasing pain or

tenderness around the site or delayed wound healing. These classic signs may not be as

evident in someone with a granulating, chronic wound or an immuno-compromised or

aged resident. Some infections may present primarily with pain or delayed healing

without other typical clinical signs of infection.

Clinicians have developed some tools,

which may facilitate identifying and assessing an infection

40,

and documenting

progress toward healing.

Wounds may be classified as infected if the signs and symptoms of infection are present

and/or a wound culture (obtained in accord with accepted standards, such as sterile

tissue aspirate, a “quantitative surface swab” using the Levine technique or semi-

quantitative swab) contains 100,000 (10

)

or greater micro-organisms per gram of tissue.

A superficial swab may show the presence of bacteria, but is not a reliable method to

identify infection.

Findings such as an elevated white blood cell count, bacteremia, sepsis, or fever may

signal an infection related to a pressure ulcer area or a co-existing infection from a

different source.

PAIN

The assessment and treatment of a resident’s pain are integral components of pressure

ulcer prevention and management. “The goal of pain management in the pressure ulcer

patient is to eliminate the cause of pain, to provide analgesia, or both.”

Pain that

interferes with movement and/or affects mood may contribute to immobility and

contribute to the potential for developing a pressure ulcer or for delayed healing or non-

healing of an already existing ulcer.

It may be difficult to assess the degree of pain in a resident who is cognitively impaired.

Some strategies and tools exist to help determine the presence and characteristics of pain

(e.g., nature, intensity and frequency).

43,

Recent research suggests that a resident with

a Stage IV pressure ulcer can feel as much pain as those with a Stage I or II ulcer.

The

relationship of pain to the pressure ulcer healing process is not yet clear. Pain is an

individual perception and response and an individual’s report of pain is a generally valid

indicator of pain. One resident may experience pain of varying intensity and frequency

(e.g., continually or periodically) or episodically in association with treatments (e.g.,

debridement, dressing changes) or movement or infection, while another resident may

not have or report pain.

DRESSINGS AND TREATMENTS

Research has found that chronic wounds such as pressure ulcers heal differently from

acute wounds, primarily because of differing biochemical and cellular characteristics.

Current clinical practice indicates that 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. No particular dressing promotes healing of all pressure

ulcers within an ulcer classification.

For those pressure ulcers with significant exudate, management of the exudate is critical

for healing. A balance is needed to assure that the wound is moist enough to support

healing but not too moist to interfere with healing.

Since excess wound exudate

generally impairs wound healing, selecting an appropriate absorptive dressing is an

important part of managing chronic wound exudate.

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

identified pressure ulcer(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 pressure ulcers. 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.

Present literature suggests that pressure ulcer 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.

Debridement of non-viable tissue is frequently performed to reduce the amount of wound

debris or non-viable tissue and to reduce the risk of sepsis. A variety of debridement

methods (e.g., mechanical, sharp or surgical, enzymatic, autolytic, MDT) are available.

Removal of necrotic tissue should enhance wound healing. Ongoing monitoring (and

timely intervention in case of change in the character of the wound) is critical for areas

with eschar and those areas that have been debrided.

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.

ENDNOTES

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INVESTIGATIVE PROTOCOL

PRESSURE ULCER

Objectives

• To determine if the identified pressure ulcer(s) is avoidable or unavoidable; and

• To determine the adequacy of the facility’s interventions and efforts to prevent

and treat pressure ulcers.

Use

Use this protocol for a sampled resident having--or at risk of developing-- a pressure

ulcer.

If the resident has an ulcer, determine if it was identified as non-pressure related, e.g.,

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 pressure related, 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.

Procedures

Briefly review the assessment, care plan and orders to identify facility interventions and

to guide observations to be made. For a newly admitted resident either at risk or with a

pressure ulcer, the staff is expected to assess and provide appropriate care from the day

of admission. Corroborate observations by interview and record review.

1. Observation

Observe whether staff consistently implements the care plan over time and across various

shifts. During observations of the interventions, note and/or follow up on deviations from

the care plan as well as potential negative outcomes, including but not limited to the

following:

• Erythema or color changes on areas such as the sacrum, buttocks, trochanters,

posterior thigh, popliteal area, or heels when moved off an area:

o If erythema or color change are noted, return approximately ½ - ¾ hours

later to determine if the changes or other Stage I characteristics persist;

o 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;

• Previously unidentified open areas;

• Whether the positioning avoids pressure on an existing pressure ulcer(s);

• Measures taken to prevent or reduce the potential for shearing or friction during

transfers, elevation, and repositioning; and

• Whether pressure-redistributing devices for the bed and/or chair, such as gel-

type surfaces or overlays are in place, working, and used according to the

manufacturer’s recommendations.

Observation of Existing Ulcer/Wound Care

If a dressing change is scheduled during the survey, observe the wound care to determine

if the record reflects the current status of the ulcer(s) and note:

• 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; and

• Based on location, steps taken to cleanse and protect the wound from likely

contamination by urine or fecal incontinence.

If unable to observe the dressing change due to the dressing protocol, observe the area

surrounding the ulcer(s). For ulcers with dressings that are not scheduled to be changed,

the surveyor may request that the dressing be removed to observe the wound and

surrounding area if other information suggests a possible treatment or assessment

problem.

If the resident expresses (or appears to be in) pain related to the ulcer or treatment,

determine if the facility:

• Assessed for pain related to the ulcer, addressed and monitored interventions for

effectiveness; and/or

• Assessed and took preemptive measures for pain related to dressing changes or

other treatments, such as debridement/irrigations, and monitored for

effectiveness.

2. Resident/Staff Interviews

Interview the resident, family or responsible party to the degree possible to identify:

• Involvement in care plan, choices, goals, and if 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; and

• 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 developing the ulcer.

Interview staff on various shifts to determine:

• Knowledge of prevention and treatment, including facility-specific

guidelines/protocols and specific interventions for the resident;

• If nursing assistants know what, when, and to whom to report changes in skin

condition; and

• 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.

3. Record Review

Assessment

Review the RAI and other documents such as physician orders, progress notes, nurses’

notes, pharmacy or dietary notes regarding the assessment of the resident’s overall

condition, risk factors and presence of a pressure ulcer(s) to determine if the facility

identified the resident at risk and evaluated the factors placing the resident at risk:

• For a resident who was admitted with an ulcer or who developed one within 1 to

2 days, review the admission documentation regarding the wound site and

characteristics at the time of admission, the possibility of underlying tissue

damage because of immobility or illness prior to admission, skin condition on or

within a day of admission, history of impaired nutrition; and history of previous

pressure ulcers; and

• For a resident who subsequently developed or has an existing pressure ulcer,

review documentation regarding the wound site, characteristics, progress and

complications including reassessment if there were no signs of progression

towards healing within 2 to 4 weeks.

In considering the appropriateness of a facility’s response to the presence, progression,

or deterioration of a pressure ulcer, take into account the resident’s condition,

complications, time needed to determine the effectiveness of a treatment, and the

facility’s efforts, where possible, to remove, modify, or stabilize the risk factors and

underlying causal factors.

Care Plan

For the resident at risk for developing or who has a pressure ulcer, determine if the

facility developed an individualized care plan that addresses prevention, care and

treatment of any existing pressure ulcers, including specific interventions, measurable

objectives and approximate time frames.

If the facility’s care of a specific resident refers to a treatment protocol that contains

details of the treatment regimen, the care plan should refer to that protocol. The care

plan should clarify any major deviations from, or revisions to, that protocol in a specific

resident.

A specific care plan intervention for risk of pressure ulcers is not needed if other

components of the care plan address related risks adequately. For example, the risk of

skin breakdown posed by fecal/urinary incontinence might be addressed in that part of

the care plan that deals with incontinence management.

If the resident refuses or resists staff interventions to reduce risk or treat existing

pressure ulcers, determine if the care plan reflects efforts to seek alternatives to address

the needs identified in the assessment.

Revision of the Care Plan

Determine if the staff have been monitoring the resident's response to interventions for

prevention and/or treatment and have evaluated and revised the care plan based on the

resident’s response, outcomes, and needs. Review the record and interview staff for

information and/or evidence that:

• Continuing the current approaches meets the resident’s needs, if the resident has

experienced recurring pressure ulcers or lack of progression toward healing and

staff did not revise the care plan; and

• The care plan was revised to modify the prevention strategies and to address the

presence and treatment of a newly developed pressure ulcer, for the resident who

acquired a new ulcer.

4. Interviews with Health Care Practitioners and Professionals

If the interventions defined or care provided appear not to be consistent with recognized

standards of practice, interview one or more health care practitioners and professionals

as necessary (e.g., physician, charge nurse, director of nursing) who, by virtue of

training and knowledge of the resident, should be able to provide information about the

causes, treatment and evaluation of the resident’s condition or problem. Depending on

the issue, ask about:

• 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; or

• How they validated the effectiveness of current interventions.

If the attending physician is unavailable, interview the medical director, as appropriate.

DETERMINATION OF COMPLIANCE (Task 6, Appendix P)

Synopsis of Regulation (F314)

The pressure ulcer requirement has two aspects. The first aspect requires the facility to

prevent the development of pressure ulcer(s) in a resident who is admitted without

pressure ulcer(s), unless the development is clinically unavoidable. The second aspect

requires the facility to provide necessary treatment and services to promote healing,

prevent infection and prevent new ulcers from developing. A facility may have non-

compliance in either or both aspects of this requirement.

Criteria for Compliance

• Compliance with 42 CFR 483.25(c)(1), F314, Pressure Sore

o 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.

If not, the development of the pressure ulcer is avoidable, cite at F314.

• Compliance with 42 CFR 483.25(c)(2), F314, Pressure Sore

o 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.

If not, cite at F314.

Non-compliance for F314

After completing the Investigative Protocol, analyze the data in order to determine

whether or not noncompliance with the regulation exists. 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.

Potential Tags for Additional Investigation

During the investigation of F314, 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 the following:

• 42 CFR 483.10(b)(11)(i)(B)&(C), F157, Notification of Changes

o Determine if 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 483.20(b)(1), F272, Comprehensive Assessments

o Determine if 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 non-healing of the ulcer.

• 42 CFR 483.20(k)(1), F279, Comprehensive Care Plans

o Determine if 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 483.20(k)(2)(iii), F280, Comprehensive Care Plan Revision

o Determine if 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.

• 42 CFR 483.20(k)(3)(i), F281, Services Provided Meet Professional Standards

o Determine if pressure ulcer care was provided in accordance with

accepted professional standards.

• 42 CFR 483.25, F309, Quality of Care

o Determine if staff identified and implemented appropriate measures for

the management of pain as indicated as related to pressure ulcers and

pressure ulcer treatment.

• 42 CFR 482.30(a), F353, Sufficient Staff

o Determine if 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 483.40(a)(1), F385, Physician Supervision

o Determine if 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 483.75(i)(2), F501, Medical Director

o 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).

V. DEFICIENCY CATEGORIZATION (Part V, Appendix P)

Once the team has completed its investigation, analyzed the data, reviewed the regulatory

requirement, and identified the deficient practices that demonstrate that the facility failed

to provide care and treatment to prevent or treat pressure ulcers and that non-

compliance exists, the team must determine the severity of the deficient practice(s) and

the resultant harm or potential for harm to the resident. The key elements for severity

determination for F314 are as follows:

1. Presence of harm/negative outcome(s) or potential for negative outcomes because

of lack of appropriate treatment and care. Actual or potential harm/negative

outcome for F314 may include but is not limited to:

• Potential for development of, occurrence or recurrence of (an) avoidable

pressure ulcer(s);

• Complications such as sepsis or pain related to the presence of avoidable

pressure ulcer(s); and/or

• Pressure ulcers that fail to improve as anticipated or develop complications such

as sepsis or pain because of the lack of appropriate treatment and care.

2. Degree of harm (actual or potential) related to the non-compliance

Identify how the facility practices caused, resulted in, allowed or contributed to the

actual or potential for harm:

• If harm has occurred, determine if the harm is at the level of serious injury,

impairment, death, compromise or discomfort; and

• If harm has not yet occurred, determine how likely is the potential for serious

injury, impairment, death, compromise or discomfort to occur to the resident.

3. The immediacy of correction required

Determine whether the non-compliance requires immediate correction in order to

prevent serious injury, harm, impairment, or death to one or more residents.

The survey team must evaluate the harm or potential for harm based upon the following

levels of severity for tag F314. First, the team must rule out whether Severity Level 4,

Immediate Jeopardy to a resident’s health or safety exists by evaluating the deficient

practice in relation to immediacy, culpability and severity. (Follow the guidance in

Appendix Q.)

Severity Level 4 Considerations: Immediate Jeopardy to Resident Health or Safety

Immediate Jeopardy is a situation in which the facility’s non-compliance:

• With one or more requirements of participation has caused/resulted in, or is likely

to cause, serious injury, harm, impairment or death to a resident; and

• Requires immediate correction as the facility either created the situation or

allowed the situation to continue by failing to implement preventative or

corrective measures.

Examples of possible avoidable negative outcomes may include:

• 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. (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).

NOTE: If immediate jeopardy has been ruled out based upon the evidence, then

evaluate whether actual harm that is not immediate jeopardy exists at Severity

Level 3.

Severity Level 3 Considerations: Actual Harm that is not Immediate Jeopardy

Level 3 indicates noncompliance that results in actual harm, and can include but may not

be limited to clinical compromise, decline, or the resident’s ability to maintain and/or

reach his/her highest practicable well-being.

Examples of avoidable negative outcomes may include but are not limited to:

• The development of avoidable Stage III pressure ulcer(s): As a result of the

facility’s non-compliance, Stage III pressure ulcers occurred, which are open

wounds in which damage has occurred into the subcutaneous level and may be

painful.

• 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.

NOTE: If Severity Level 3 (actual harm that is not immediate jeopardy) has been

ruled out based upon the evidence, then evaluate as to whether Level 2 (no

actual harm with the potential for more than minimal harm) exists.

Severity Level 2 Considerations: No Actual Harm with Potential for More Than

Minimal Harm that is Not Immediate Jeopardy

Level 2 indicates noncompliance that results in a resident outcome of no more than

minimal discomfort and/or has the potential to compromise the resident's ability to

maintain or reach his or her highest practicable level of well being. The potential exists

for greater harm to occur if interventions are not provided.

Examples of avoidable negative outcomes may include but are not limited to:

• The development of a single avoidable Stage II pressure ulcer that is receiving

appropriate treatment: As a result of the facility’s non-compliance, a resident

developed an avoidable Stage II pressure ulcer.

• The development of an avoidable Stage I pressure ulcer: As a result of the

facility’s non-compliance, a resident developed an avoidable Stage I pressure

ulcer.

• 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 or heal existing pressure ulcers is more than minimal harm. Therefore, Severity

Level 1 doesn't apply for this regulatory requirement.