F Tag 314 309 Quality of Care Part 8 Compliance DeterminationDETERMINATION OF COMPLIANCE (Task 6, Appendix P) part 8
- 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 noncompliance
in either or both aspects of this requirement.
- Criteria for Compliance
– Compliance with 42 CFR 483.25©(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
– Revised the approaches as appropriate.
If not, the development of the pressure ulcer is avoidable, cite at F314.
– Compliance with 42 CFR 483.25©(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
– 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
– 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
– 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
– 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 noncompliance 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
– 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
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
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
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
– 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
– 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