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Tools to Identify and Control Patient Safety Risks Dr. Mohamed Mosaad Hasan CQI/ PS Specialist

2 tools to identify and control patient safety risks

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Page 1: 2 tools to identify and control patient safety risks

Tools to Identify and Control Patient Safety Risks

Dr. Mohamed Mosaad Hasan

CQI/ PS Specialist

Page 2: 2 tools to identify and control patient safety risks

Risk Identification.

•Training video

Page 3: 2 tools to identify and control patient safety risks

Risk Identification • Risk identification is the process through which

we become aware of risks in the health care environment that constitute potential loss exposures for the institution.

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Systems for Risk IdentificationInformal Risk Identification Systems– Claims data– Medical record reviews– Patient complaints – Standardized surveys and questionnaires– Personal inspections– Committee minutes– Survey or regulatory reports– Recall notices– Experts

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Systems for Risk Identification

Formal Risk Identification Systems– Incident reporting– Occurrence reporting and screening– Sentinel event tracking– Failure mode and effect analysis– Device reporting and tracking logs– Security reports

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Risk Identification

• Identification of risks is important but early identification is our goal

• Early identification is important because :

1- A prompt investigation can be initiated while information is still fresh and available.

2- An early intervention can be considered.

3- A high potentiality of eliminating or reducing the cost of the claim.

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Risk Identification

2 main methods to identify risks :

1- Incident reporting

2- Generic / Occurrence screening

Both aim at early identification of risks and take appropriate measures to eliminate or limit liability exposures.

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Incident / occurrence Reporting

• Definition of incident: any happening that is not consistent with the routine care of a particular patient or an event that is not consistent with the normal operations of a particular organization.

• Considered as early warning system.

• The analysis result should be revised by process owners and who have the authority to make changes in protocols ,policies and procedures

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Content of the Incident Report

• vary in content and structure and vary from organization to organization

• emphasis has been placed on making forms “user friendly,”

Incident report

Socioeconomic data

Facility-related information

Demographic information

Description of the incident,

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Content of the Incident Report

Demographic information :• including name, home address, and telephone number of the

patient, visitor, or employee involved in the incident. (For patients, medical record numbers also may be recorded as part of the identifying information.)

• This information is used to identify the potential claimant and witnesses in case of litigation.

Facility-related information : such as admission or visit date, patient identification number, patient room number, and admitting diagnosis or presenting complaint.

This is used as aggregate data to determine whether certain units of the system are more incident prone.

Trending this information promotes risk management intervention and actions plan to react to frequency or severity in incidents reported.

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Content of the Incident Report

Socioeconomic data : on the individual involved in the occurrence, such as age, gender, marital status, employment, and insurance status.

This information aids in assessing potential loss. For example, collecting employment status assists the risk manager and counsel in determining the potential for wage loss or economic (loss of salary) damage.

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Categories according to type of event

• Medication error• Adverse drug reaction• Fall• Equipment problem• Complication related to procedure , treatment , or

test• Transfusion event• Behavioral problem( e.g. , assault , elopement ,etc.)• Visitors events• Unsafe conditions with potential for harm

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Categories according to harm to patient

• Category A: circumstances or events that have the capacity to cause error but no error occurred.

• Category B: An error occurred but the error did not reach the patient i.e. no harm occurred ( near miss )

• Category C: an error occurred that reached the patient, but did not cause patient harm.

• Category D: An error occurred that may have to or resulted in harm to the patient and required intervention

• Category E: an error occurred that may have to or resulted in the patient’s death ( sentinel event )

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Staff Participation in Incident Reporting

• Incident reporting should be the responsibility of all staff , responsibility for completing an incident report rests with any facility staff members who witnesses, discovers, or has direct knowledge with the incident.

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Staff Participation in Incident Reporting

Barriers How to remove

staff view reporting as a routine task or low-priority paperwork.

1. By providing feedback on the results of investigation and problem resolution

2. Trending and analysis reports that lead to changes in protocol, procedures, or equipment based on these findings

fear the report is an admission of negligence that exposes them to liability and could be used against them in court or for a punitive measure

1. incident report is not used as either a punitive measure in disciplining employees or a vehicle for airing interpersonal disagreements.

2. The event itself may require disciplinary action but not through the incident reporting process

3. Training must stress that the report should be a factual account of what happened; no finger-pointing . Incident reports are meant to collect “just the facts,” .

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Staff Participation in Incident Reporting

Why incident reports may not be filed when policy directs staff to do so ?

• Observer is too busy to complete the report when a narrative section is required.

• Staff believe that reporting is of little value due to lack of feedback.

• Staff fear disciplinary action based on the report.

• Non-physicians are reluctant to report incident involving physicians.

• Staff are concerned that the report may lead to a lawsuit leading to personal responsibility.

• Staff failed to recognize that an incident occurred.

• Staff do not understand the definition of an incident.

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Occurrence Screening

• This system, utilizes a clearly defined list of patient occurrences with which patient medical records are screened.

• It’s an example of 100% review system , • The screeners are looking for deviations from practice, policy,

and procedures. • Criteria for the screens are established in areas that are

considered to be either :

1. high risk.

2. have a high number of incidents that have been reported as quality of care “red flags” to be further evaluated.

3. areas where the effects of an untoward event occurring can have disastrous results from an injury standpoint.

As an example :inappropriate informed consent documentation

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Occurrence Screening

• In an inpatient setting, all patient records are reviewed against the criteria within forty-eight to seventy-two hours of admission and every three or four days thereafter until the patient is discharged.

• The patient chart also is reviewed approximately two weeks after discharge to ensure that compliance with all criteria has been assessed.

• Results of this screening process are prepared for each admission by trained data retrieval personnel (screeners).

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Occurrence Screening

• The abstract is then forwarded to the quality improvement office for follow-up.

• When identified, serious occurrences are reported immediately by the patient care reviewers to the appropriate person for action.

• All occurrences are aggregated to aid in identifying any trends that reflect patient care problems requiring remedial action.

• It’s concurrent (may be retrospective review).

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Sentinel event

• an unexpected occurrence involving death or serious physical or psychological injury.

• Serious injury includes loss of limb or function.• Death or major permanent loss of function (sensory,

motor, physiologic, or intellectual), suicide, rape, hemolytic transfusion reaction, Surgery/procedure on the wrong patient or wrong body part, infant abduction or infant discharge to the wrong family.

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Response to sentinel event

Root cause analysis

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Sentinel Events

• Rosie King’s video

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Root Cause Analysis

• Is a process done in response to occurrence of sentinel event or near miss.

• The aim of root cause analysis is to conduct intensive analysis to reach the embedded problems in the system and solve it.

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RCA- Sequential steps1- Define the problem • Ask what is wrong, what is involved: conditions, activities,

materials.• Ask when: day ,date, time, shift, time pattern, schedule.• Ask where: site, area department, physical environment,

step in process.• Ask how the what or who is affected, how much, how many,

work practice, omission / commission. • Ask who is involved: patients, caregivers, other staff,

vendors, visitors.• Review relevant documents.• Consider other data collection options: surveys,

observations, interviews.

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RCA- Sequential steps2- perform task / process analysis• divide a process into steps by sequencing

actions, instructions, conditions ,tools , and materials associated with the performance of the task (flowchart).

• learn exactly what was supposed to happen.

• contrast the baseline with what actually happened (based on initial data collection).

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RCA- Sequential steps

3- perform change /different analysis: • compare the task /steps successfully

performed to the same task /steps when unsuccessful.

• analyze the difference.• describe for each difference its effect on

the situation.

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RCA- Sequential steps

4- perform control barriers/ safe guard analysis:• analyze safeguards needed to prevent the event.• analyze missing or ineffective safeguards.

Safeguards may be : physical: safety equipment and devices; locks, walls. Natural: distance and time (limited exposure). information: caution such as labels , alarms. knowledge: making information constantly available. administrative: safety policies and procedures, regulations,

supervisory practices, training, education, communication process.

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RCA- Sequential steps

5- Begin cause and effect analysis• List each undesirable step of the occurrence • considering each a primary effect • using data collected to date , determine what

causes allowed or forced each effect to occur• show the relationship between each cause

and effect

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RCA- Sequential steps

• continue the cause and effect analysis until : Cause is outside the organization control

to correct. Primary effect is fully explained. No other causes can be found to explain

the effect. Further analysis will yield no additional

benefit in correcting the problem.• List all validated causes.

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Healthcare FMEA Definitions

Healthcare Failure Mode & Effect Analysis (HFMEA):

(1) A prospective assessment that identifies and improves steps in a process thereby reasonably ensuring a safe and clinically desirable outcome.

(2) A systematic approach to identify and prevent product and process problems before they occur.

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Healthcare FMEA Definitions

Effective Control Measure:

A barrier that eliminates or substantially reduces the likelihood of a hazardous event occurring.

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Healthcare FMEA Definitions

Hazard Analysis:

The process of collecting and evaluating information on hazards associated with the selected process. The purpose of the hazard analysis is to develop a list of hazards that are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled.

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Healthcare FMEA Definitions

Failure Mode:

Different ways that a process or sub-process can fail to provide the anticipated result.

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HFMEA Points Out System/Process Vulnerabilities

A B C

Identified process

issue;

focus for intervention

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The Healthcare Failure Modes and Effects Process

Step 2 - Assemble the Team

Step 3 - Graphically Describe the Process

Step 4 - Conduct the Analysis

Step 5 - Identify Actions and Outcome Measures

Step 1- Define the Topic

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Healthcare FMEA Process

STEP 1

 Define the Scope of the HFMEA along

with a clear definition of the process to be studied.

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Healthcare FMEA Process

STEP 2

 Assemble the Team – Multidisciplinary

team with Subject Matter Expert(s) plus advisor

 

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Healthcare FMEA Process

STEP 3 - Graphically Describe the Process

A. Develop and Verify the Flow Diagram (this is a process vs. chronological diagram)

B. Consecutively number each process step identified in the process flow diagram.

C. If the process is complex identify the area of the process to focus on (manageable bite)

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Healthcare FMEA Process

STEP 3 - Graphically Describe the Process

D. Identify all sub processes under each block of this flow diagram. Consecutively letter these sub-steps.

E. Create a flow diagram composed of the sub processes.

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Healthcare FMEA Process

STEP 4 - Conduct a Hazard Analysis

A. List Failure Modes

B. Determine Severity & Probability

C. Use the Decision Tree

D. List all Failure Mode Causes

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Healthcare FMEA Process

STEP 5 - Actions and Outcome Measures

A. Decide to “Eliminate,” “Control,” or “Accept” the failure mode cause.

B. Describe an action for each failure mode cause that will eliminate or control it.

C. Identify outcome measures that will be used to analyze and test the re-designed process.

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Healthcare FMEA Process

STEP 5 - Actions and Outcome Measures

D. Identify a single, responsible individual by title to complete the recommended action.

E. Indicate whether top management has concurred with the recommended actions.

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Forms & Tools

Worksheets

Hazard Scoring Matrix

Decision Tree

Forms

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Step 1. Select the process you want to examine. Define the scope (Be specific and include a clear definition of the process or product to be studied). This HFMEA is focused on__________________________________________ _________________________________________________________________ _________________________________________________________________ __________________________________________________________________________________________________________________________________ _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ 

 

   

 

Healthcare FMEA Process

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Step 2. Assemble the Team FMEA Number_____________ Date Started ______________ Date Completed_____________ Team Members 1.__________________ 4.______________________ 

2.__________________ 5.______________________ 

3.__________________ 6.______________________ Team Leader ____________________________________  Are all affected areas represented? YES / NO Are different levels and types of knowledge represented on the team? YES / NO Who will take minutes and maintain records?____________________________

 

   

 

Healthcare FMEA Process

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HFMEA Worksheet

Step 4

1 Process Step

2 Failure Mode

3 Cause

4 Severity

5 Probability

6 Hazard Score

7 Decision

Step 5

8 Action (E,C,A)

9 Description of Action

10 Outcome Measure

11 Person Responsible

12 Management Concurrence (Y/N)

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HFMEA Decision Tree

The HFMEA Decision Tree… 

Does this hazard involve a sufficientlikelihood of occurrence and severity to

warrant that it be controlled?(e.g. Hazard Score of 8 or higher)

Is the hazard so obvious and readilyapparent that a control measure is not

warranted?(Detectability)

STOP

NO

YES

YES

PROCEED TO HFMEASTEP 5

NO

Does an Effective Control Measure exist for theidentified hazard?

YES

NO

Is this a single point weakness in theprocess?

(e.g. failure will result in system failure)(Criticality)

YES

NO

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HFMEA Decision Tree

1. Does this hazard involve a sufficient likelihood of occurrence and severity to warrant that it be controlled?(e.g. Hazard Score of 8 or higher)

YES NO

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HFMEA Decision Tree

2. Is this a single point weakness in the process?(e.g. failure will result in system failure)(Criticality)

YES

NO

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HFMEA Decision Tree

3. Does an Effective Control Measure exist for the identified hazard?

NOSTOP

YES

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HFMEA Decision Tree

4. Is the hazard so obvious and readily apparent that a control measure is not warranted?(Detectability)

NOSTOP

YES

PROCEED

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SEVERITY RATING:  

 

   

 

Hazard Analysis

Catastrophic Event(Traditional FMEA Rating of 10 - Failure could cause death or injury)

Major Event(Traditional FMEA Rating of 7 – Failure causes a high degree of customer dissatisfaction.)

Patient Outcome:Death or major permanent loss of function (sensory, motor, physiologic, or intellectual), suicide, rape, hemolytic transfusion reaction, Surgery/procedure on the wrong patient or wrong body part, infant abduction or infant discharge to the wrong family Visitor Outcome: Death; or hospitalization of 3 or more. Staff Outcome: * A death or hospitalization of 3 or more staff Equipment or facility: **Damage equal to or more than $250,000 Fire: Any fire that grows larger than an incipient

Patient Outcome:Permanent lessening of bodily functioning (sensory, motor, physiologic, or intellectual), disfigurement, surgical intervention required, increased length of stay for 3 or more patients, increased level of care for 3 or more patientsVisitor Outcome: Hospitalization of 1 or 2 visitorsStaff Outcome: Hospitalization of 1 or 2 staff or 3 or more staff experiencing lost time or restricted duty injuries or illnesses Equipment or facility: **Damage equal to or more than $100,000Fire: Not Applicable – See Moderate and Catastrophic

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SEVERITY RATING:  

 

   

 

Hazard Analysis

Moderate Event (Traditional FMEA Rating of “4” – Failure can be overcome with modifications to the process or product, but there is minor performance loss.)

Minor Event(Traditional FMEA Rating of “1”– Failure would not be noticeable to the customer and would not affect delivery of the service or product.)

Patient Outcome: Increased length of stay or increased level of care for 1 or 2 patientsVisitor Outcome: Evaluation and treatment for 1 or 2 visitors (less than hospitalization)Staff Outcome: Medical expenses, lost time or restricted duty injuries or illness for 1 or 2 staffEquipment or facility: **Damage more than $10,000 but less than $100,000Fire: Incipient stage‡ or smaller

Patients Outcome: No injury, nor increased length of stay nor increased level of careVisitor Outcome: Evaluated and no treatment required or refused treatmentStaff Outcome: First aid treatment only with no lost time, nor restricted duty injuries nor illnessesEquipment or facility: **Damage less than $10,000 or loss of any utility♦ without adverse patient outcome (e.g. power, natural gas, electricity, water, communications, transport, heat/air conditioning). Fire: Not Applicable – See Moderate and Catastrophic

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Hazard Analysis

PROBABILITY RATING:

Frequent - Likely to occur immediately or within a short period (may happen several times in one year)

Occasional - Probably will occur (may happen several times in 1 to 2 years)

Uncommon - Possible to occur (may happen sometime in 2 to 5 years)

Remote - Unlikely to occur (may happen sometime in 5 to 30 years)

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HFMEA Hazard Scoring Matrix

Pro

bability

Severity

Catastrophic Major Moderate Minor

Frequent 16 12 8 4

Occasional 12 9 6 3

Uncommon 8 6 4 2

Remote 4 3 2 1

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Example - Driving to Work

Decided to perform FMEA on driving to work.

Want to include the processes associated with this activity.

Meant as an illustrative example by walking through the steps.

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Step 1. Select the process you want to examine. Define the scope (Be specific and include a clear definition of the process or product to be studied). This HFMEA is focused on__________________________________________ _________________________________________________________________ _________________________________________________________________ __________________________________________________________________________________________________________________________________ _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ 

 

   

 

Healthcare FMEA Process

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Step 2. Assemble the Team FMEA Number_____________ Date Started ______________ Date Completed_____________ Team Members 1.__________________ 4.______________________ 

2.__________________ 5.______________________ 

3.__________________ 6.______________________ Team Leader ____________________________________  Are all affected areas represented? YES / NO Are different levels and types of knowledge represented on the team? YES / NO Who will take minutes and maintain records?____________________________

 

   

 

Healthcare FMEA Process

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Step 3A. Gather information about how the process works – describe it graphically.  

 

   

Teaching Example

Wake Up Get dressed

Start the car

Drive the car

Walk into work

Park the car

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Step 3B. Consecutively number each process

  

Teaching Example

Wake Up Get dressed

Start the car

Drive the car

Walk into work

Park the car

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Step 3C. If process is complex, choose area to focus on.

  

Teaching Example

Wake Up Get dressed

Start the car

Drive the car

Walk into work

Park the car

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Step 3D. If necessary, list sub-process steps and consecutively number.

 

 

Teaching Example

Wake Up Get dressed

Start the car

Drive the car

Walk into work

Park the car

1A. Hit snooze on alarm

1B. Again, hit snooze on alarm

1C. Get out of bed

1D. Find fuzzy slippers

2A. Get coffee

2B. Take shower

2C. Find clean clothes

2D. Find shoes

3A. Find keys

3B. Find wallet

3C. Look for bag

3D. Look for coffee

3E. Shovel out car

4A. Coffee in cupholder

4B. Bagel on seat

4C. Listen to traffic report

4D. Choose route

5A. Notice and take exit

5B.Negotiate turn

5C. Find spot

5D. Get car to turn off

6A. Collect bag, coffee, bagel

6B. Close and lock doors

6C. Begin walking

6D. Return for keys

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Step 3D. Wake up (Sub-process flow diagram) 

 

   

 

Teaching Example

1A. Hit snooze button

1C. Get out of bed

1D. Look for fuzzy slippers

1B. Again, hit snooze button

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Step 4A. List all failure modes.

 

   

 

Teaching Example

1A. Hit snooze button

1C. Get out of bed

1D. Look for fuzzy slippers

1B. Again, hit snooze button

Failure Modes

1A(1) Turn off alarm

1A(2) Unplug Alarm

1A(3) Break alarm clock

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HFMEA Worksheet, Step 4A

Step 4

1 Process Step 1A. Hit snooze button

2 Failure Mode 1A(1). Turn off alarm

3 Cause

4 Severity

5 Probability

6 Hazard Score

7 Decision

Step 5

8 Action

9 Description of Action

10 Outcome Measure

11 Person Responsible

12 Management Concurrence

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HFMEA Worksheet

Step 4

1 Process Step 1A. Hit snooze button

2 Failure Mode 1A(1) Turn off alarm

3 Cause

4 Severity

5 Probability

6 Hazard Score

7 Decision

Step 5

8 Action (E,C,A)

9 Description of Action

10 Outcome Measure

11 Person Responsible

12 Management Concurrence (Y/N)

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Step 4B. Determine the Severity and Probability of each potential cause. This will lead you to the Hazard Matrix Score.

SEVERITY RATING:  

 

   

 

Step 4: Hazard Analysis

Catastrophic Event(Traditional FMEA Rating of 10 - Failure could cause death or injury)

Major Event(Traditional FMEA Rating of 7 – Failure causes a high degree of customer dissatisfaction.)

Patient Outcome : Death or major permanent loss of function (sensory, motor, physiologic, or intellectual), suicide, rape, hemolytic transfusion reaction, Surgery/procedure on the wrong patient or wrong body part, infant abduction or infant discharge to the wrong family Visitor Outcome: Death; or hospitalization of 3 or more. Staff Outcome: * A death or hospitalization of 3 or more staff Equipment or facility: **Damage equal to or more than $250,000 Fire: Any fire that grows larger than an incipient

Patient Outcome:Permanent lessening of bodily functioning (sensory, motor, physiologic, or intellectual), disfigurement, surgical intervention required, increased length of stay for 3 or more patients, increased level of care for 3 or more patientsVisitor Outcome: Hospitalization of 1 or 2 visitorsStaff Outcome: Hospitalizationof 1 or 2 staff or 3 or more staff experiencing lost time or restricted duty injuries or illnesses Equipment or facility: **Damage equal to or more than $100,000Fire: Not Applicable – See Moderate and Catastrophic

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Step 4. Determine the Severity and Probability of each potential cause. This will lead you to the Hazard Matrix Score.  

 

   

 

Step 4: Hazard Analysis

PROBABILITY RATING:

Occasional - Probably will occur (may happen several times in 1 to 2 years)

Uncommon - Possible to occur (may happen sometime in 2 to 5 years)

Remote - Unlikely to occur (may happen sometime in 5 to 30 years)

Frequent - Likely to occur immediately or within a short period (may happen several times in one year)

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HFMEA Hazard Scoring Matrix

Probability

Severity

Catastrophic Major Moderate Minor

Frequent 16 12 8 4

Occasional 12 9 6 3

Uncommon 8 6 4 2

Remote 4 3 2 1

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Step 4: HFMEA Decision Tree

1. Does this hazard involve a sufficient likelihood of occurrence and severity to warrant that it be controlled?(e.g. Hazard Score of 8 or higher)

YES NO

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Step 4: HFMEA Decision Tree

2. Is this a single point weakness in the process?(e.g. failure will result in system failure)(Criticality)

YES

NO

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Step 4: HFMEA Decision Tree

3. Does an Effective Control Measure exist for the identified hazard?

NOSTOP

YES

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Step 4: HFMEA Decision Tree

4. Is the hazard so obvious and readily apparent that a control measure is not warranted?(Detectability)

NOSTOP

YES

PROCEED

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HFMEA Worksheet, Steps 4B & 4C

Step 4

1 Process Step 1A. Hit snooze button

2 Failure Mode 1aA(1). Turn off alarm

3 Cause

4 Severity Major

5 Probability Occasional

6 Hazard Score 9

7 Decision Proceed (start listing Causes)

Step 5

8 Action (E,C,A)

9 Description of Action

10 Outcome Measure

11 Person Responsible

12 Management Concurrence (Y/N)

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HFMEA Worksheet, Step 5Step 4

1 Process Step 1A. Hit snooze button

2 Failure Mode 1A(1). Turn off alarm

3 Cause 1A(1)a. Missed snooze button

4 Severity Major Major

5 Probability Occasional Occasional

6 Hazard Score 9 9

7 Decision Proceed (start listing causes

Proceed

Step 5

8 Action (E,C,A) Continue Analysis Eliminate

9 Description of Action Purchase new clock

10 Outcome Measure Purchase by x/xx/xx

11 Person Responsible YOU

12 Management Concurrence (Y/N)

Yes

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Step 3A. Gather information about how the process works – describe it graphically.  

 

   

 

HFMEA PSA Example

Process Step Process Step Process Step Process Step Process Step

PSA test ordered

Draw sample

Analyze sample

Report to physician

Result filed (CPRS)

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Step 3B. Consecutively number each process step.

 

   

 

HFMEA PSA Example

PSA test ordered

Draw sample

Analyze sample

Report to physician

Result filed (CPRS)

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Step 3C. If process is complex, choose area to focus on.  

 

   

 

HFMEA PSA Example

PSA test ordered

Draw sample

Analyze sample

Report to physician

Result filed (CPRS)

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Step 3D. If necessary, list sub-process steps and consecutively number.

 

   

 

HFMEA PSA Example

Sub-processes:

A. Order writtenB. Entered in CPRSC. Received in lab

Sub-processes:

A. ID patientB. Select propertube/equip.C. Draw bloodD. Label blood

Sub-processes:

A. Review orderB. CentrifugeSpecimenC. VerifyCalibrationD. Run QCE. Run sampleF. Report resultG. Enter in CPRS

Sub-processes:

A. Report received

Sub-processes:

A. TelephoneB. Visit set upC. Result given

PSA test ordered

Draw sample

Analyze sample

Report to physician

Result filed (CPRS)

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Step 3E. Analyze Sample (Sub-process flow diagram) 

 

   

 

HFMEA PSA Example

3A.

Review order

3B.Centrifuge specimen

3C.Verify calibration

3D.Run QC

3F.Report result

3E.Run sample

3G.Enter in CPRS

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Step 4A. Hazard Analysis: List potential failuremodes for each process step.  

 

   

 

HFMEA PSA Example

Failure Mode:

1.Wrong testordered2.Order notreceived

Failure Mode:

1.Equip. broken2.Wrong speed3.Specimen notclotted4.No power5.Wrong test tube

Failure Mode:

1.Instr not calibrated2.Bad calibrationstored

Failure Mode:

1.QC results unacceptable

Failure Mode:

1.Mechanicalerror2.Tech error

Failure Mode:

1.Computer crash2.Result entered for wrong pt.3.Computertranscription error4.Result notentered5.Result mis-read by tech

Review order

Centrifuge specimen

Verify calibra-tion

Run QC Report result

Run Sample

Enter result (CPRS)

Page 82: 2 tools to identify and control patient safety risks

Step 4B,C, D. Determine hazard score and list all the potential causes for each potential failure mode.

 

   

 

HFMEA PSA Example

Process Step

(3F) Report result        

Failure Mode

(3F1) Computer crash

       

Potential Cause    

(3F1a ) Virus (3F1b) Old equipment

(3F1c) Software license expired

 

Severity Major Major Moderate Moderate  

Probability Occasional Occasional Remote Occasional  

HazardScore

9 9 2 6  

Decision Proceed Proceed Stop Stop  

Action          

Description of Action

         

Outcome Measure

         

Page 83: 2 tools to identify and control patient safety risks

 

   

Step 4: HFMEA Decision Tree

1. Does this hazard involve a sufficient likelihood of occurrence and severity to warrant that it be controlled?(e.g. Hazard Score of 8 or higher)

YES NO

Page 84: 2 tools to identify and control patient safety risks

 

   

Step 4: HFMEA Decision Tree

2. Is this a single point weakness in the process?(e.g. failure will result in system failure)(Criticality)

YES

NO

Page 85: 2 tools to identify and control patient safety risks

 

Step 4: HFMEA Decision Tree

3. Does an Effective Control Measure exist for the identified hazard?

NOSTOP

YES

Page 86: 2 tools to identify and control patient safety risks

 

Step 4: HFMEA Decision Tree

4. Is the hazard so obvious and readily apparent that a control measure is not warranted?(Detectability)

NOSTOP

YES

PROCEED

Page 87: 2 tools to identify and control patient safety risks

Step 4B,C, D. Determine hazard score and list all the potential causes for each potential failure mode.

 

   

 

HFMEA PSA Example

Process Step

(3F) Report result        

Failure Mode

(3F1) Computer crash

       

Potential Cause    

(3F1a ) Virus (3F1b) Old equipment

(3F1c) Software license expired

 

Severity Major Major Moderate Moderate  

Probability Occasional Occasional Remote Occasional  

HazardScore

9 9 2 6  

Decision Proceed Proceed Stop Stop  

Action          

Description of Action

         

Outcome Measure

         

Page 88: 2 tools to identify and control patient safety risks

 

   

 

HFMEA PSA Example

Process Step

(3F) Report result        

Failure Mode

(3F5) Tech mis-reads result

       

Potential Cause    

(3F5a) Tech fatigue

(3F5b) Too busy (3F5c) Poor lighting

(3F5d) Confusing readout on PSA instr.

Severity Moderate Moderate Moderate Moderate Moderate

Probability Frequent Frequent Frequent Remote Frequent

Haz Score 8 8 8 2 8

Decision Proceed Stop Proceed Stop Proceed

Action     C   E

Description of Action

    Hire tech   New equipment

Outcome Measure

    Staff increased   New equip. on site

Person Responsible

    Chief, PALMS   Chief, PALMS

Mgt Concur (y/n)

    Y   Y