Cabinet for Health and Family Services Office of the ... Presentation Guidelines... · –Serious harm, injury, impairment, or death does not have to occur before considering IJ

Cabinet for Health and Family Services

Office of the Inspector General

Division of Health Care

Presents

Guidelines for Determining Immediate Jeopardy-Appendix Q

By

Connie Payne, RN, Director

Immediate Jeopardy Definition

42 CFR 489.3

“…a situation in which the provider’s

noncompliance with one or more

requirements of participation has caused, or

is likely to cause, serious injury, harm,

impairment, or death to a resident.”


Immediate Jeopardy Principles

Goal:

• To ensure the provision of quality care to all

residents receiving care or services from a

certified Medicare/Medicaid facility.

• The identification and removal of Immediate

Jeopardy, either psychological or physical,

are essential to prevent serious harm, injury,

impairment or death for individuals.


Immediate Jeopardy Principles (cont.)

• Actual vs. potential harm

– Harm does not have to occur before considering IJ

• Actual-Was there an outcome of harm? Does the

harm meet the definition of IJ? Has the provider’s

noncompliance caused serious injury, harm,

impairment or death to a resident?

– High potential for harm also constitutes immediate

jeopardy

• Potential-Is there a likelihood of potential harm? Does

the potential harm meet the definition of IJ? Is the

provider’s noncompliance likely to cause serious injury,

harm, impairment or death to a resident?



– Only one individual needs to be at risk

• Identification for one individual will prevent risk to other

individuals in similar situations

– Serious harm, injury, impairment, or death does not have to

occur before considering IJ. The high potential for these

outcomes to occur in the very near future also constitutes IJ.

– Individuals must not be subjected to abuse by anyone

including, but not limited to, entity staff, consultants or

volunteers, family members or visitors.



– Serious harm can result from both abuse and neglect.

– Psychological harm is as serious as physical harm.

– When a surveyor has established through investigation that

a cognitively impaired individual harmed an individual

receiving care and services from the entity due to the entity’s

failure to provide care and services to avoid physical harm,

mental anguish, or mental illness, this should be considered

neglect.

– Any time a team cites abuse or neglect, it should consider IJ.



Investigation

• Must proceed until IJ is:

– Confirmed

or

– Ruled out



Investigation cont.

• Timing of serious harm, injury, impairment or

death:

– Past

– Present

– Likely to occur in the very near future


Noncompliance

• Immediate jeopardy includes

determining whether the facility

created a situation or allowed a

situation to continue in which serious

harm or potential for serious harm,

injury impairment or death to an

individual resulted.


Failure to Implement Corrective Measures

• Did the facility have an

opportunity to implement

corrective or preventive

measures?


Immediate Jeopardy Issues

– The guide in Appendix Q includes situations that

are most likely to create jeopardy to an individual’s

psychological and/or physical health & safety.

• Failure to:

– Protect from abuse

– Prevent neglect

– Protect from psychological harm

– Protect from undue adverse medication

consequences or provide medications as

prescribed

– Provide adequate nutrition or hydration


Immediate Jeopardy Issues (cont.)

• Failure to:

– Protect from widespread nosocomial

infections

– Identify individuals correctly

– Provide safety from fire, smoke &

environmental hazards & educate staff in

handling emergency situations

– Provide medical services


Immediate Jeopardy Triggers

• They describe situations that will cause the

surveyor to consider if further investigation is

needed to determine the presence of

Immediate Jeopardy.

• They are general examples and are not all

inclusive and may apply to more than one

issue.

• Both potential and actual harm is considered

when reviewing the triggers.


Immediate Jeopardy Issues and Triggers


Issue Triggers

Failure to Prevent Abuse • Serious injuries (head trauma or fractures)

• Suspicious injuries (black eye, cigarette burns on skin)

• Bruises around breast or genital area

• Unexplained serious injuries not investigated

• Staff striking or roughly handling residents

• Staff yelling, swearing, gesturing or calling residents names

• Nonconsensual sexual interactions

Failure to Prevent

Neglect

• Failure to adequately monitor & intervene for serious medical

or surgical conditions

• Lack of supervision for individual with known special needs

• Lack of timely assessment after injury

• Failure to follow doctor’s orders

• Repeated occurrences (falls) without interventions

• Access to chemicals & physical hazards

• Hot water temperature too high

• Broken call system without alternatives

• Unsupervised smoking

• Failure to adequately monitor individuals with known severe

self injurious behavior

Immediate Jeopardy Issues and Triggers (cont.)

Issue Triggers

Failure to Protect from

Psychological Harm

• Use of chemical or physical restraints without clinical

indications

• Threatening or demeaning behaviors from staff resulting in

fearful residents

• Lack of interventions to prevent individuals from creating an

environment of fear

Failure to Protect from

Undue Adverse

Medication

Consequences

• Administration of medication to resident allergic to it

• Lack of monitoring to identify side effects

• Administration of contraindicated medications

• Lack of diabetic monitoring

• Lack of timely and appropriate monitoring for drug titration

Failure to Provide

Adequate Nutrition &

Hydration

• Inadequate food to meet nutritional needs

• Failure to provide adequate nutrition, resulting in malnutrition

• Withholding nutrition and hydration without advance directive

orders

• Lack of potable water supply


Immediate Jeopardy Issues and Triggers (cont.)

Issue Triggers

Failure to Provide

Safety from Fire,

Smoke &

Environmental

Hazards

• Fire in resident’s room

• Nonfunctioning or lack of emergency equipment &/or power source

• Widespread lack of knowledge of emergency procedures by staff

(tornado)

• Smoking in high-risk areas

• Widespread infestation by insects or rodents

• Lack of functioning ventilation system

• Improper disposal of hazardous material, chemicals or waste

• Lack of maintenance of fire alarm systems

• Unsafe dietary practices

Failure to Protect

from Widespread

Nosocomial

Infections

• Improper handling of body fluids

• High number of infections without appropriate reporting, intervention

and care

• Ineffective infection control precautions

• High number of nosocomial infections from cross-contamination

Failure to

Correctly Identify

Individuals

• Administration of medication or treatments to wrong resident


Immediate Jeopardy Survey Process

The survey process for IJ consists of:

• Investigation

• Decision making

• Implementation

• Documentation


Immediate Jeopardy Survey Process (cont.)

Investigation Process

– Conducted in an impartial, objective manner to

obtain accurate data to support reasonable

conclusion.

1. Observation is a key component of any

investigation. All observations need to be

thoroughly documented.

2. Interviews of staff & residents must be clear and

detailed.

3. Record review of documents is used to support

observations and interviews. Cabinet for Health and Family Services


Investigation Process cont.

4. If the case involves a potential criminal action, the

surveyor should be aware that any physical

evidence must be preserved for law enforcement

agencies.

5. Team Actions

a. Notify team leader immediately when an IJ situation is

suspected. The team leader will coordinate the

investigation and contact the Regional Program

Manager (RPM).

b. Gather information to address who, what, when, where

and why.



Investigation Process (cont.)

• Who was involved in the jeopardy situation: staff,

individuals receiving care and others?

– Does the individual(s) at risk have special

needs? Has this happened to other

individuals? If yes, how many? Are there

others to whom this is likely to occur? If so,

how many and who? Which facility staff knew

or should have known about the situation?




• What harm has occurred, is occurring, or

most likely will occur?

– How serious is the potential/actual harm? How

did the situation occur? What was the sequence

of events? What attempts did the facility make to

assess, plan, correct, and reevaluate regarding

the potential/actual harm? What did they do to

prevent any further occurrences of the same

nature?




• When did the situation first occur?

– How long has the situation existed? Has a

similar occurrence happened before? Has the

facility had an opportunity to correct the

situation? Did the facility thoroughly investigate

the event? Did the facility implement corrective

measures to prevent any further similar

situations? Did they follow up and evaluate the

effectiveness of their measures?




• Where did the potential/actual harm occur?

Is this an isolated incident or a facility wide

problem?

• Why did the potential/actual harm occur?



• Gather information:

– Was the immediate jeopardy preventable?

– Is there a system in place to prevent further

occurrences?

– Is this a repeat deficient practice?

– Is there a pattern of similar deficient practices?

• Validate the gathered information with facility

staff.



Components of Immediate Jeopardy

1. Harm

a. Actual- Was there an outcome of harm? Does

the harm meet the definition of IJ, e.g., has the

provider’s noncompliance caused serious injury,

harm, impairment, or death to a resident?

b. Potential- Is there a likelihood of potential harm?

Does the potential harm meet the definition of IJ,

e.g., is the provider’s noncompliance likely to

cause serious injury, harm, impairment, or death

to an individual?



Components of Immediate Jeopardy cont.

2. Immediacy- Is the harm or potential

harm likely to occur in the very near future

to this resident or others in the facility, if

Immediate action is not taken?



Components of Immediate Jeopardy cont.

3. Culpability

a. Did the facility know about the situation? If so when

did the facility first become aware?

b. Should the facility have known about the situation?

c. Did the facility thoroughly investigate the

circumstances?

d. Did the facility implement corrective measures?

e. Has the facility re-evaluated the measures to ensure

the situation was corrected?



Team Actions

• Meet as a team;

• Follow Appendix Q;

• Share collected data;

• Identify the 3 components of IJ;

• Decide if there is enough evidence to make a decision. If not

continue the investigation;

• Identify & clarify inconsistencies or contradictions among

interviews, observations and record reviews;

• Determine the specific Federal regulation(s) for the situation; and

• Consult with the supervisor as necessary.



Decision Making

• Has actual harm occurred?

• Does the actual harm that occurred meet the

definition of IJ?

• Is there a likelihood of potential serious harm?

• Does the potential harm meet the definition of IJ?

• Is the harm likely to recur in the near future, if

immediate action is not taken?

• Did the facility have knowledge of the situation?

– If so, when did they first become aware? Before

admission when notified of history?



Decision Making cont.

• Did the facility thoroughly investigate the

circumstances?

• Did the facility implement corrective measures?

• Does this meet the definition of IJ?

• Which is the most appropriate tag to define the

failed practice?



Outcome

• The team identifies the most appropriate

regulation that applies to the situation.

• The team proceeds with documentation of the

IJ deficient practice.



Implementation

• Team will notify the facility administrator of the

identified circumstances immediately

– Verbal notice

– Specific details

– At-risk individuals

• Encourage the facility to provide evidence of

corrective measures

• The Regional Program Manager (RPM) will notify

Central Office (CO) of the IJ



Confirmation of removal of immediate jeopardy:

• Only onsite confirmation of corrective action

justifies determination that immediate

jeopardy has been corrected



Past immediate jeopardy:

• Documented at the actual deficiency tag where past

noncompliance is identified

• A plan of correction (POC) is not provided by the

facility; however, the team documents the facility’s

corrective actions



Immediate jeopardy removed; but deficient practice

still exists at a lesser severity and scope:

• Cite immediate jeopardy at immediate jeopardy severity &

scope

• Include documentation to support remaining deficient

practice

• Document the level of harm and the identified individuals in

the Statement of Deficiencies (SOD)

• Attach the corrective measures submitted by the facility as

an immediate Plan of Correction (POC)



Immediate jeopardy removed; deficient practice

corrected:

• Cite immediate jeopardy at immediate

jeopardy severity & scope (J, K or L)

• Document evidence of facility actions

• Include dates & times facility removed

immediate jeopardy & corrected deficient

practice Cabinet for Health and Family Services


Immediate jeopardy not removed; deficient

practice present (ongoing):

• Inform administrator that the CMS Regional

Office will be notified of the immediate

jeopardy and termination procedures will be

initiated



Immediate jeopardy not removed:

• Inform administration that termination

procedures will be initiated

– 23-day termination (SOM, Chapter 7,

Section 3010)



Extended Survey

• Conducted after substandard quality of care (SQC) is

determined during a standard survey.

– SQC is one or more deficiencies related to participation requirements

under 42 CFR 483.13, Resident Behavior & Facility Practices; 42

CFR 483.15, Quality of Life; & 42 CFR 483.25, Quality of Care, which

constitute either IJ, patterns or widespread deficiencies at severity

level 3, or widespread deficiencies at severity level 2.

• If not possible before exit conference, may be conducted

later (no later than 2 weeks after conclusion of the survey

and advise facility that extended survey will occur at later

date)



Notification to the Facility

Initial notice includes:

• The nature of the IJ, including regulatory cites;

• Request an allegation of removal of IJ, including

evidence of steps taken to remove the IJ. The POC

will be deferred until IJ has been determined to be

removed;



Notification to the Facility (cont.)

• Opportunity for informal dispute resolution (IDR) and

independent informal dispute resolution (IIDR);

• Disapproval of nurse aide training & competency evaluation

program & competency evaluation program & appeal rights if

the program loss is based on a finding of substandard quality

of care (SQC); and

• When SQC is determined, the facility must provide the State

with a list of the physicians of the residents. The State must

notify each attending physician and refer the administrator to

the State’s licensing board.


F-314 42 CFR 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

(2) A resident having pressure sores receives necessary

treatment and services to promote healing, prevent infection

and prevent new sores from developing.


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

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

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;


Non-compliance with 42 CFR 483.25(c)(2), F314, Pressure Sore

• 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.


Regulatory Requirements

Potential Tags for Additional Investigation

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

Changes

• 42 CFR 483.20(b)(1), F272, Comprehensive Assessments

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

• 42 CFR 483.20(k)(2), F280, Comprehensive Care Plan

Revision


Regulatory Requirements

Potential Tags for Additional Investigation • 42 CFR 483.20(k)(3)(i), F281, Services Provided Meet

Professional Standards

• 42 CFR 483.25, F309, Quality of Care

• 42 CFR 483.30(a), F353, Sufficient Staff

• 42 CFR 483.40(a)(1), F385, Physician Supervision

• 42 CFR 483.75(i)(2), F501, Medical Director


Deficiency Categorization

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.


Deficiency Categorization cont.

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.


Deficiency Categorization cont.

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.


Severity Level 4 Considerations: IJ

• Facility’s noncompliance with one or more

requirements of participation:

– Has allowed, caused, or resulted in (or is likely to allow,

cause, or result in) 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 preventive 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).


Severity Level 3 Considerations: Actual Harm not IJ

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.


Severity Level 3 Considerations: Actual Harm not IJ

• 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. Cabinet for Health and Family Services

Severity Level 2 Considerations: No Actual Harm with

Potential for More Than Minimal Harm that is not IJ

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.


Severity Level 2 Considerations: No Actual Harm with

Potential for More Than Minimal Harm that is not IJ

• 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.


Enforcement Grid

REMEDY CATEGORIES

Category 1 Category 2 Category 3

Directed Plan of

Correction

State Monitor; and/or

Directed In-Service

Training

Denial of Payment for New

admissions

Denial of Payment for all

individuals imposed by

CMS; and/or CMS: $50-

$3,000/day

$1,000-$10,000/instance

Temp. Mgmt.

Termination

Optional:

CMP

$3,000-$10,000/day

$1,000-$10,000/instance

Denial of Payment for new admissions must be imposed when a facility is not in substantial

compliance within 3 months after being found out of compliance.

Denial of Payment and State monitoring must be imposed when a facility has been found to

have provided substandard quality of care on three consecutive standard surveys.

NOTE: Termination may be imposed by the State Medicaid Agency or CMS at any time.

*This is required only when a decision is made to impose alternative remedies instead of or in

addition to termination.


Enforcement Grid (cont.) Immediate Jeopardy to

health or safety

J PoC

Required: Cat. 3

Optional: Cat. 1 & 2

SQC

K PoC

Required: Cat. 3


SQC

L PoC

Required: Cat. 3


SQC

Actual harm that is not

IJ

G PoC

Required* Cat. 2

Optional: Cat. 1

H PoC

Required* Cat. 2

Optional: Cat. 1

SQC

I PoC

Required* Cat. 2

Optional: Cat. 1

Temporary Mgmt.

SQC

No actual harm with

potential for more than

minimal harm that is

not IJ

D PoC

Required* Cat. 1

Optional: Cat. 2

E PoC

Required* Cat. 1

Optional: Cat. 2

F PoC

Required* Cat. 2

Optional: Cat. 1

SQC

No actual harm with

potential for minimal

harm

A No PoC

No remedies

Commitment to Correct;

Not on CMS 2567;

Substantial compliance

B PoC


C PoC


Isolated Pattern Widespread


Immediate Jeopardy Analysis Form

Immediate Jeopardy Notification

Tips for Developing an Allegation of Compliance

CMS Survey & Certification Memorandum: Admin Info: 07-14

Worksheet Instructions for Initial CMP Imposition in a Survey Cycle







CMP Worksheet





CMP GRID

Questions?

Connie Payne, RN

Director

Office of Inspector General

Division of Health Care

275 East Main Street

Frankfort, KY 40621

Phone: 502.564.7963, ext. 3306

[email protected]


Documents

Cabinet for Health and Family Services Office of the ... Presentation Guidelines... · –Serious harm, injury, impairment, or death does not have to occur before considering IJ