- F314
(Rev.4, Issued 11-12-04, Effective: 11-12-04, Implementation: 11-12-04)
§483.25© 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©
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).1 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.2
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.3
• “Colonized/Infected” Wound 4, 5
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. 6, 7, 8
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.9
• “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.10 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.