SAFE Roll Out v12

UNCMC Patient Safety Reporting System:

S afety A wareness f or E veryone¶

March 2019¶

Table of Contents¶

1. Safety Culture¶

a. Why report?
b. Fair and Just Culture
c. Plan, Do, Study, Act

2. New Reporting Portal: SAFE - Safety Awareness for Everyone¶

a. Purpose of SAFE system
b. Standards for Reporting and Documentation
c. How to submit a SAFE report
d. How to review a SAFE report
e. How to assign a Safety Assessment Code Matrix Score
f. Understanding data from your SAFE reports

3. Understanding data from your SAFE reports¶

Multi-disciplinary/multi-team committees
a. What happens to my SAFE report after it's submitted? (framework)
b. Feedback to submitter

5. Appendix¶

a. Learning from Defects tool
b. Root Cause Analysis tools
c. References

Safety Culture¶

Why report?¶

Why should we report Patient Safety concerns, near misses and errors?¶

When errors, near misses and safety concerns are reported, the information can help to:

o understand what happened;
o identify the combination of factors that caused the error/near miss to occur;
o determine its frequency;
o analyze and identify root causes of near misses and events that could result in patient harm so that appropriate and patient safety improvement activities can be initiated;
o collect data for trending and analysis; and
o Improve patient safety.

UNC Hospitals Compared to the National Database Teaching Hospitals Scores¶

What are our staff saying about our safety culture?¶

Patient Safety Culture Survey Composites	UNC Hospitals Avg % Positive 2015	UNC Hospitals Avg % Positive 2017	Database Teaching Hospitals Avg % Positive 2016
Teamwork Within	86	86	80
Supervisor Expectations	78	81	77
Organizational Learning	72	75	71
Hospital Management Support	69	72	70
Communication Openness	66	69	62
Feedback about Error	65	69	66
Overall Perception of Safety	64	65	63
Teamwork Across Units	62	63	59
Event Reporting	59	62	64
Staffing	55	54	51
Non-punitive Response	53	55	43
Handoff and Transitions	47	49	45
Resilience	56	55	No comparison

Promoting Safety Culture¶

Fair and Just Culture¶

Accountability¶

Staff are expected to adhere to standards¶

Psychological Safety¶

Staff feel free to express thoughts and feelings. The work environment promotes trust and mutual respect.

Fair and Just Culture¶

Systems and personal accountability are balanced. It is not a 'punitive' or 'blame-free' environment.

Fair and Just Culture¶

Human Error Inadvertent action, slip, lapse or mistake.

Console them Behavior that increases risk where risk is not recognized.

At-Risk Behavior¶

Coach them back Conscious disregard for a substantial risk.

Reckless Behavior¶

Corrective Action¶

Patient Safety Reporting System Conceptual Model for Improvement¶

Patient Safety Reporting System Model for Improvement¶

The PDSA cycle is shorthand for testing a change in the real work setting - by planning it, trying it, observing the results, and acting on what is learned.

What are we trying to accomplish?

How will we know that a change is an improvement?

What change can we make that will result in improvement?

SAFE Reporting Portal¶

SAFE - Reporting Portal¶

Bea SafetyStar!¶

Formerly: Patient Occurrence Reporting System

PORS¶

SAFE Program¶

Safety Awareness for Everyone (SAFE) is a patient safety learning system, which aims to

1) develop sustainable infrastructure for responding to safety concerns, and
2) create an environment of continuous quality improvement (CQI) to improve the care we provide to our patients

To do this, we need to:

Create a culture of safety in which all employees feel safe and empowered to speak up and report near misses, errors or safety concerns
Create a system that:
learns from near misses, errors and mishaps
works to improve the system through CQI efforts
is responsive and accountable to staff concerns
Develop effective and efficient organizational infrastructure to support CQI efforts

SAFE - Reporting Portal - What's NEW?¶

SAFE - Safety Awareness for Everyone¶

Improvements made:¶

Shorter submission forms
Reorganized order of fields
Suggestions to prevent error from happening again
Addition of Safety Assessment Code Matrix to prioritize events for further review (Learning from Defects or Root Cause Analysis)
Customizable dashboards
Improved appearance of reports within SAFE

What to report¶

Hazardous/Safety Conditions or Concerns
Near miss/Good Catch
Unanticipated Adverse Patient Outcome (whether error occurred or not)
Medical Error - Regardless of Harm Status
Sentinel Event

Sentinel Events¶

Sentinel events - Unanticipated death, permanent harm or severe temporary harm, not related to the natural course of the patient's illness or underlying condition - not always caused by a medical error.

Suicide within 72 hours of discharge
Unanticipated death of a full-term infant
Discharge of infant to the wrong person
Rape, assault homicide of a patient
Hemolytic reaction after receiving the wrong blood
Wrong site, wrong procedure, wrong patient (surgery/invasive procedure)
Severe neonatal hyperbilirubinemia
Radiation Overdose
Fire
Maternal Death
Patient Elopement resulting in harm

EMR Documentation for Medical Errors¶

Do:¶

Describe the situation in a factual manner.
Describe discussions held with patient and/or family.

Don't:¶

Document conversations with legal or risk management departments in the EMR unless you are instructed to do so.
Document that a SAFE report was submitted
Speculate
Draw conclusions, assign fault, blame others, or include personal feelings

Maintain Communication¶

Submitting a SAFE report is not a substitute for:¶

Addressing an immediate safety concern.

Having a conversation with a coworker or supervisor that needs to know about the situation.

How to Report?¶

Submit a SAFE report for Inpatient and Outpatient concerns through the SAFE portal on the Intranet.
For any patient injury or harm event during business hours, you should also notify Risk Management @ 984-974-3041
Any serious incident that causes actual physical injury to patient that occurs during nights, weekends or a holiday should immediately be reported to the Attorney on Call (pager 216-0813).

Submitting a SAFE Report¶

How to Complete a SAFE Report¶

SAFE¶

How to Complete a SAFE Report¶

Log into SAFE¶

Procedure:¶

Username and Password are the same as your computer/EPIC sign on.

In the Username field, type in your username.
In the Password field, type in your password.
Click Login.
To sign in Anonymously , click the Submit Anonymously button underneath Login button.

How to Complete a SAFE Report¶

Initiate a File¶

Procedure:¶

Click the Icon for the type of report you wish to submit.
Option: You can also search for the type of form in the Find a Form field.

How to Choose a Form¶

Examples:¶

Wrong Drug
Wrong Dose
Dose Omitted
Missing Medication / Delayed Delivery
Unusable Medication

Examples:¶

Collection Issue
Labeling Issue
Results Delayed
Ordering Issue
Testing Issue
Specimen Processing Issue

Examples:¶

Delayed Treatment
Delayed Diagnosis
Inappropriate Treatment
Failure to assess patient
Delay / Lack of response to patient condition
Missed Diagnosis
Rapid Response Team

How to Choose a Form¶

Examples:¶

Unsafe Environment
Elopement
Destruction of Property
Abandonment
Left AMA
Unauthorized Drugs

Examples:¶

Cancelled / Delayed
Count Discrepancy
Delayed Start / Completion
Wrong Procedure
Wrong Side/Site
Complications

Examples:¶

Alarm Failure
Bed Malfunction
Equipment Malfunction
Inadequate Supplies
Computer Issue
Disconnected
Electrical Issue

How to Complete a SAFE Report¶

Fill in the Form¶

Procedure:¶

At a minimum, complete all of the fields marked with a green asterisk.
The File Status section shows how many fields have been completed and are remaining.

Use the scroll bar on the right to view additional fields.

Severity Levels¶

0 = Safety Concern 1A = Near Miss/Good Catch 1B = Reached Patient, No Harm 1C = Reached Patient, No Harm, Monitoring 2 = Temporary Harm 3 = Permanent Harm 4 = Death

Severity Levels¶

0 = Safety Concern¶

Not necessarily patient involvement or patient identified
No actual error
Unsafe condition
Circumstances that increase the probability of a patient safety harm event occurring
Circumstances or events that have the capacity to cause an error

Examples:¶

Department has been stocked out of Sage Oral Care kits (Lawson 382492) since yesterday. We currently have 13 patients who need a kit to provide routine oral care as a part of the VAP bundle policy (along with dependent patient oral care expectations)....
Unsecured meds in syringes found in dirty utility room
Tylenol tables found in pyxis drawer designated for Benadryl

Severity Levels¶

1A = Near Miss/Good Catch¶

Patient Identified
Near Miss / Good Catch
Error or condition occurred BUT did not reach the patient
Error or condition was caught by an error detection barrier (the 'system' worked)

Examples:¶

The wrong patient's consent was scanned into another patient's chart. This was caught and medical records removed the incorrect consent.
Medication incorrectly mixed in dextrose instead of normal saline. Noted prior to administration
Cart fill medication had two patient medication labels attached to one bag. This medication made it to the patient floor. Unit tech discovered and brought back to the pharmacy to correct
Ear wax present upon opening myringotomy pan. Document and notified manager. Contacted CPD for another pan.

Severity Levels¶

1B = Reached Patient, No Harm¶

Reached the patient
No Monitoring - no observations or recording of physical or psychological data or testing done
No Intervention - no change in therapy or change in the medical/surgical treatment
Note: Error or condition of 'omission' - does reach the patient

Examples:¶

Medication ordered for the wrong patient, and the patient received this medication no harm
Patient given moderate sedation during procedure without an updated airway assessment and the patient had not been NPO for 6 hours prior
0400 labs drawn at 0900 - physician and phlebotomy notified
Patient was transported to OR - as scheduled for a procedure. Shortly after patient returned to the floor- the procedure was being cancelled due to the unavailability of the appropriate equipment. The patient had been NPO, started on IVF the night before and underwent blood sampling for pre-operative labs.

Severity Levels¶

1C = Reached Patient, No Harm, Monitoring¶

Reached the patient AND monitoring occurred
No Harm - sufficient information available to determine that no harm occurred ('got lucky')
Monitoring required to confirm there was no harm (may include increased observations, radiology testing or lab work, additional monitoring of condition or vital signs)

Examples:¶

Admitting nurse administered 10mg oxycodone and nurse accepting also administered oxycodone. No hard stop by computer. Physician informed - patient monitored
Patient had orders for dialysis fluid 2K if Potassium >5.4 and 4K if Potassium <5.6 for CRRT. Based on patients 0338 and 1239 labs patient should have had 2K running, however 4K was running.

Severity Levels¶

2 = Temporary Harm¶

Reached the patient AND resulted in harm
o Monitoring may occur - but not required
o Transfer to higher level of care - but not required
Detectable Harm (physical, emotional, psychological) lasting for a limited time, resulting in no permanent injury, yet causing discomfort, injury and/or distress
Tingling, change in sensation, pain, redness, bruising, swelling, break in the skin - skin tear or abrasion or cut, suturing, application of a dressing/steri-strips or skin glue, splinting of a limb, muscle or joint strain, fracture, bleeding, internal injury, intervention required to preclude harm (limb elevation, medication, blood transfusion, invasive procedure or surgery), initial or prolonged hospitalization

Examples:¶

Patient maintained on nifedipine XL 60mg PO BID and the addition of voriconazole. The following day, the patient experienced confusion, severe hypotension, and required transfer to the ICU and initiation of vasopressors. This was likely due to the drug interaction
Patient found on floor. Returned to bed. Noted bruising and redness to left leg
Returned to OR for post-operative bleeding

Severity Levels¶

3 = Permanent Harm¶

Reached the patient AND resulted in harm
Permanent Harm - sensory, motor, physiologic, or intellectual impairment not present on admission requiring continued treatment or life-style change

Examples:¶

Post-surgery - patient with facial droop and left sided weakness. No improvement planning on discharge to acute inpatient rehabilitation
Loss of left pedal pulse after heart catheterization - resulted in below the knee amputation
IV infiltration - required surgical repair and extensive physical therapy - patient did not regain full us of the hand

Severity Levels¶

4 = Death¶

Unexplained OR Unexpected patient death - error may or may not have occurred
Complication(s) occurred AND reached the patient AND resulted in death
Death attributed to deviation in care

How to Complete a SAFE Report¶

Fill in the Form¶

Procedure:¶

Continue to complete the green asterisk fields.
To complete the Person Affected Details , click on the search icon in the MRN field.
Use the MRN, first or last name to search for patient Once you've found the patient, click Accept . The rest of the demo info will be filled into the section.

How to Complete a SAFE Report¶

How to Check Status of Your SAFE Report¶

Check Status of Your Report¶

Procedure:¶

Click Clipboard.
Click on My Submitted Files to view File State, Risk Status or date last updated.
You can also open files you haven't yet completed and submitted.

Note: You will not be able to see all activity that has been completed for the event as risk manager analysis is private and protected.

How to Check Status of Your SAFE Report¶

Check Status of Your Report¶

Procedure:¶

Click Document icon.
Click on the file on the left for which you want to see status.
General File Information and File updates will appear.

Note: You will not be able to see all activity that has been completed for the event as risk manager analysis is private and protected.

File Submission Tracker¶

Last3months¶

Open(1)

File42291（Fall)¶

Event date:02-26-2019

Submitted date:02-26-2019

-Closed(o)

GeneralFileInformation¶

File¶

42291-Fall

State¶

New InProgress¶

General Event Type¶

Fall¶

Specific EventType¶

FromExam Stool¶

BriefFactual Description¶

GynOncNurse Clinician(Shamekia Wilson）hearda¶

Examroom 2.Shewent in examand p.ShowMore¶

loudnoisewhilesittingintheconsultroomnexto

Severity Level(Reported)¶

Injury Incurred?

Equipment/Device Contributed to Event?

No Closed FileUpdates¶

02-26-2019

Kinley Reeves¶

1new follow-up(s)

1fle update(s),

Kinley Reeves File opened1 time(s）.

File submitted on 02-26-2019.

Newest toOldest¶

Reviewing SAFE Reports¶

How to Review a SAFE Report¶

Review a File¶

Procedure:¶

Access SAFE portal via email alert of event, or by logging in as previously described.

You can also see all of your area reports by clicking on the Clipboard.
Read the report, and enter Follow-up by clicking on the Add Follow-up icon on the left of the screen.
Select type of Follow-up
Only choose Sign-off if all review and action items have been identified and feedback has been provided to the report submitter.

How to Review a SAFE Report¶

Review a File¶

Procedure:¶

You can also see all of your area reports by clicking on the Clock for Alert Notification Management.
Click on the Notification ID to open the alert.
Alert Notification Details box will pop up. Scroll through information to the bottom of alert and click Open File to access the report.
Click Acknowledge at the bottom to remove the alert notification from your list.

New

How to Review a SAFE Report¶

Send a Task¶

Procedure:¶

Click on Tasks .
Click Create Task

How to Review a SAFE Report¶

Send a Task¶

Procedure:¶

Task Box appears. Click Type to choose type of Task Complete the green asterisk sections.
The Re-Assign To box will initially appear with your name. Delete your name (if not sending task to self) and start typing the name of the person you wish to assign the task.
Insert Task Deadline .
Send your message or instruction to the recipient.
Click Ok.

How to Review a SAFE Report¶

Send a Task¶

Procedure:¶

You can also send a task from the Task Management section.

Click on the Flag icon to get to the Task Management page.
Click Add Task at the top. And follow instructions from previous slide.
You can also manage all tasks from this page.

How to Review a SAFE Report¶

When to use which Follow-up type:

Referral Sent¶

: Sent a task

Reply Received : Add content of a Response received from a referral/task

Physician Comment : Add a physician comment

Review : Reviewed file (also place to refer to local committee)

Sign-off : Use ONLY when file can be closed as action items have been completed or no work to be done. (Signals risk to close file.)

How to Review a SAFE Report¶

Refer to Local Committee¶

If Safety Assessment Code Score is 2 or 3, refer to Local Committee for review.

Procedure:¶

From report, click Add Follow-up icon on the left of the screen.
Select Review .
Review screen pops up. Click Sub-type down arrow. Choose Local Committee Review . You can also leave comment in the free text box.

How to Review a SAFE Report¶

Safety Assessment Code Matrix¶

Safety Assessment CodeSeverity Score¶

HowtheSAcMatrixWorks:Whenaseveritycategoryispairedwithaprobability categoryforeitheranactualeventoraclosecall,arankedmatrixscore (3=highest,2=intermediaterisk,1=lowestrisk)results.theseranks,orSACs, canthenbeusedfordoingcomparativeanalysisandfordecidingwhoneedstobe notifiedoftheevent.

Potential Severity¶

Catastrophic:	Deathormajorpermanentlossof functionnotrelated tothenaturalcourseof thepatient illnessorunderlying condition
Major:	Permanentlesseningofbodllyfunctioningnotrelated tothenatural course of thepatient illness orunderlying condition. (i.e.Disfigurement,surgical interventionrequired, increasedlength of stay)
Moderate:	Increasedlengthofstayorincreased levelofcare
Minor:	No injury,norincreased lengthof stay,orincreased level ofcare

ProbabilityOf Occurrence¶

Frequent:	Likelytooccurimmediatelyorwithinashortperiod (mayhappenseveral times In 1year)
Occasional:	Probablywill occur(mayhappenseveral times In1-2 years)
Uncommon:	Possible to occur(mayhappen sometime in2-Syears)
Remote:	Unlikely tooccur(may happensometime in Sormore years)

How to Review a SAFE Report¶

Safety Assessment Code Matrix: Severity Score¶

Catastrophic	Major	Moderate	Minor
Death or major permanent loss of function (sensory, motor, physiologic, or intellectual) not related to the natural course of the patient's illness or underlying condition (i.e., acts of commission or omission). This includes outcomes that are a direct result of injuries sustained in a fall; or associated with an unauthorized departure from an around-the-clock treatment setting; or the result of an assault or other crime. Sentinel Events should also be considered in this category.	Permanent lessening of bodily functioning (sensory, motor, physiologic, or intellectual) not related to the natural course of the patient's illness or underlying conditions (i.e., acts of commission or omission) or any of the following: a. Disfigurement b. Surgical intervention required c. Increased length of stay for three or more patients d. Increased level of care for three or more patients	Increased length of stay or increased level of care for one or two patients	No injury, nor increased length of stay nor increased level of care

How to Review a SAFE Report¶

Safety Assessment Code Matrix - Severity Score¶

Key factors for the severity categories are extent of injury, length of stay, or level of care required for remedy. These categories apply to actual adverse events and near misses.

If the event is a near miss, assign severity based on a reasonable 'worst case' scenario. For examples, if you entered a patient's room before they were able to complete a suicide attempt, the event is catastrophic because the reasonable 'worst case' is suicide.

Example:¶

The nursing staff was providing the patient with routine a.m. care. This consisted of showering the patient in the shower room on the ward. The patient was seated in a chair being washed when he slid off the chair and hit his face, hip, and shoulder. The patient was examined by the doctor at 7:55 a.m. and transferred to the acute evaluation unit (AEU) for further evaluation. The AEU physician ordered x-rays. No fractures noted. The patient was returned to the ward where neuro checks were initiated as per policy and reported as normal.

Severity Score = Minor; Probability Score = Uncommon; SAC Score = 1

Example:¶

YXZ monitor did not trigger an alarm in the Surgical ICU. The problem was observed by the nurses while they cared for a DNR patient who developed cardiac arrhythmias, but the monitor failed to trigger the alarm. Since the patient had a DNR order he was not resuscitated.

Severity Score = Catastrophic; Probability Score = Uncommon; SAC Score = 3

How to Review a SAFE Report¶

Safety Assessment Code Matrix Score¶

Probability and Severity	Catastrophic	Major	Moderate	Minor
Frequent	m	3	2	1
Occasional	3	2	1	1
Uncommon	3	2	1	1
Remote	3	2	1	1

How to Review a SAFE Report¶

Report¶

Feedback Loop¶

Respond¶

Agenda item in staff meetings
Aggregate Data
Action Plans
Email notifications from SAFE
Service/Operational Leadership meetings
Direct feedback
Speak to supervisor that needs to know about the situation
Submit SAFE report in portal
Call Risk Management if harm event
Service Line Leadership review within 72 hours
SAC Score applied
SAC Score 1; managed in Unit
SAC Score 2 or 3 refer to Local Committee - action items implemented referral to Central Review Committee if necessary

Review¶

Understanding Data from SAFE Reports¶

How to view a SAFE Report¶

File Info Center¶

Access reports, search reports and identify reports as important.

Procedure:¶

Click Clipboard icon.
All of your reports will appear to the right.
You can add a report to My Important Files list by clicking on the faded exclamation point icon.
That file will then also be able to be seen in the My Important Files section. To remove the file from the My Important Files list, just click on the exclamation point again.

How to run a Report¶

Run a Report¶

Procedure:¶

Click on Report icon on left side of page
Reports will appear in center of screen
Double-click on the report you would like to run.

How to run a Report¶

View and Drill Down¶

Procedure:¶

Report chosen will pop-up
To see additional details, place your curser which will turn into a 'drill' over the area you would like to drill down and click.

How to run a Report¶

View and Drill Down¶

Procedure:¶

Box will pop-up and click File List at bottom of box. Event details will then load for all of those events. If you then click on the event in the list, it will take you into the active report so you can add follow-up or otherwise review.

Theming Reports¶

You can pull your data by :¶

General event type
Specific event type
Severity / SAC score
Time range
Location / service
Role / team
How & where it was reviewed

…and more!

Tube/Drain¶

9%

Theming Reports¶

You can also:¶

Create and save customized reports
Set up recurring reports that run automatically
Customize your dashboard for viewing live data (coming soon)
Email submitters when reports are reviewed, sent to a committee, or closed (coming soon)

'Be safe with SAFE'¶

The data and reports within SAFE are legally protected from discovery in lawsuits if managed appropriately. If you want to display/review your area's SAFE graphs, reports, and events during a staff meeting or Local Review Committee, please access the SAFE portal live rather than exporting or printing the information. This helps keep our data protected.

If you want to present SAFE data outside of the SAFE portal or export SAFE data, please contact Stephenie Fenton-Wilhelm, AVP Risk Management, or Lori Nash, Director of Clinical Risk Management, to discuss what you would like to do and obtain the steps needed to keep that information protected.

All data presented outside of the SAFE portal must contain the following language: ' PSWP - Analysis within the PSES. ' This language should be prominently placed on all pages of printed out data, graphs or any document containing this data, including slides, word documents and excel spreadsheets. This identifies the information as being quality and safety improvement related and within the scope of legal protection through our Patient Safety Organization (PSO).

PSWP = Patient Safety Work Product; PSES = Patient Safety Evaluation System

Local Committees¶

UNCMC Patient Safety Local Review Committees - Draft Charter¶

Purpose Statement: Local review committees will be established at the service line or departmental levels as part of our patient safety learning community. The purpose of the local review committees is to provide opportunities for multidisciplinary review of patient safety reports.

Membership:¶

We recommend that the local review committee include the following representatives:

Clinical leader(s)
Provider leader(s)
Resident(s) as designated by provider leader
Risk management/PI/Quality (a representative from at least one of these groups)
Pharmacist (for inpatient units and outpatient clinics; highly recommended to consider for other units)

Ad hoc personnel should be considered based on local dynamics and patient populations, for example:

Radiology
PT/OT (for rehab units or areas with high fall rates)
CRNA or anesthesiology (for perioperative, PACU, ICUs)
Lab/phlebotomy (for outpatient clinics)
Frontline nursing staff, NAs, CNAs (for inpatient units)
Schedulers, patient transporters (for outpatient clinics)

UNCMC Patient Safety Local Review Committees - Draft Charter¶

Roles and Responsibilities of the local review committees include:¶

Meet on a regular basis (at least monthly, but preferably weekly or biweekly) to review all patient safety events referred by department leadership
Recognize and respond to patterns of safety concerns that affect service line or unit
Determine action plans in local area, as needed
Identify and deploy resources for implementing action plans, as needed
Document findings and action plans in SAFE report
Evaluate effectiveness of interventions
Report data and follow-up information with nurse managers and physician leaders within local area
Determine appropriate awards and recognition for staff
Coordinate with hospital-wide quality and safety committees to conduct reviews and share findings, as needed
Escalate reports of sentinel or high severity safety events, events that cross multiple disciplines and services, and events that might require changes to hospital policy to the central review committee, as needed
Prepare SBARs to central review committee, as needed

Quality & Safety Reporting System Information Flow¶

Ideal State Cross-Functional Process Map¶

Appendix: Additional Tools & Resources¶

Analysis¶

Learning from Defects Tool (LFD) and Root Cause Analysis (RCA) are methods of reactive systematic analysis of an adverse event, a sentinel event or a near miss. An RCA identifies failure modes and causal factors likely to cause errors and answers.

What happened? Why did it happen? How can the system or process be

redesigned so the event does not recur?

UNC

HEALTH¶

CARE¶

Learning from Defects Tool¶

Learning from Defects Tool: A learning tool that provides a structured approach to help health care providers identify contributing factors that lead to a defect, develop interventions for each important contributing factor identified, and how to reduce likelihood of same defect from happening again.

What is a defect? A harmful event or situation that occurred or had the potential to cause significant harm to the patient.

Process:¶

All staff involved in the delivery of care related to a defect should be present while evaluating and using the tool.
Take about one hour to discuss:
o What happened?
o Why did it happen?
o What can we do to reduce the risk of it recurring with different caregivers?
o How will we know the risk is reduced?
o With whom should we share learning?

Learning from Defects Tool¶

Team uses the form to review each contributing factor and evaluates whether that factor had a contribution to the incident:
Negative contribution: increased harm to patient
Positive contribution: reduced harm to patient

Why did it happen? (what factors contributed)¶

What prevented it from being worse?

What happened to cause the defect?

Learning from Defects Tool¶

To determine the most important areas to focus on, the team completes the following after reviewing the list of contributing factors:
Team decides the most important contributing factors and develops an intervention for each factor identified
Select the best interventions and create an action plan
o Include the specific interventions, who will lead this effort, and follow-up date
To help know if the risk has been reduced from the chosen implemented interventions, ask frontline staff involved to provide feedback on the effectiveness of the interventions on the following:
o Was the intervention effectively carried out?
o Did the intervention reduced the likelihood of recurrence?

Learning from Defects Tool¶

What can we do to reduce the risk of it happening with a different person?

Howwillweknow the risk is reduced?

With whom shall we share our learning?

Root Cause Analysis (RCA)¶

A systems approach to identify and analyze a serious adverse event by identifying root causes and actions to prevent reoccurrence.

Root Cause Analysis - Step 3: Analysis¶

Fishbone Diagram¶

The Fishbone diagram is also known as the Cause and Effect Diagram or Ishikawa Diagram
It's a tool used to visually display all potential or real causes that result in a single defect or failure
Begin with defining the problem
Identify major areas or categories that contribute to the problem (i.e. people, procedures, policies, technology)
From there, brainstorm possible causes of the problem related to each area/category
Analyze diagram
Can then use the '5 Whys' Technique to drill down to root causes for each listed cause

Root Cause Analysis - Step 3: Analysis¶

Fishbone Diagram¶

Root Cause Analysis - Step 3: Analysis¶

5 Whys¶

The 5 Whys technique is used to identify the root cause of a problem and can show the relationship of causes
It begins with specific problem and asks why the problem happens, continues to ask why until the problems root cause is identified
It may get to the root of the problem before asking 'why' five times or it may need to ask more than five times

Root Cause Analysis - Step 3: Analysis¶

Causal Analysis¶

Barrier Analysis: Identify administrative and physical controls to prevent or inhibit an undesirable event from reach patient
Change Analysis:
Identify what happened
What should have happened?
What are the gaps?
Determine the ideal practice or situation
Effect and Causal Factor Chart: Written or graphical description for the time sequence of causal factors associated with the event.

Root Cause Analysis - Step 3: Analysis¶

Causal Analysis¶

EventsandCausalFactorChart¶

Risk Reduction Actions¶

	Action Category	Example
Stronger Actions (these tasks require less reli- ance on humans to remember to perform the task correctly)	Architectural/physical plant changes	Replace revolving doors at the main patient entrance into the building with powered sliding or swinging doors to reduce patient falls.
Stronger Actions (these tasks require less reli- ance on humans to remember to perform the task correctly)	New devices with usability testing	Perform heuristic tests of outpatient blood glucose meters and test strips and select the most appropriate for the patient population being served.
Stronger Actions (these tasks require less reli- ance on humans to remember to perform the task correctly)	Engineering control (forcing function)	Eliminate the use of universal adaptors and peripheral devices for medical equip- ment and use tubing/fittings that can only be connected the correct way (e.g. IV tubing and connectors that cannot physically be connected to sequential compression devices or SCDs).
Stronger Actions (these tasks require less reli- ance on humans to remember to perform the task correctly)	Simplify process	Remove unnecessary steps in a process.
Stronger Actions (these tasks require less reli- ance on humans to remember to perform the task correctly)	Standardize on equipment or process	Standardize on the make and model of medication pumps used throughout the institution. Use bar coding for medication administration.
Stronger Actions (these tasks require less reli- ance on humans to remember to perform the task correctly)	Tangible involvement by leadership	Participate in unit patient safety evaluations and interact with staff; support the RCA2 process; purchase needed equipment; ensure staffing and workload are balanced.

Risk Reduction Actions¶

Intermediate	Redundancy	Use two RNs to independently calculate high-risk medication dosages.
Actions	Increase in staffing/decrease in workload	Make float staff available to assist when workloads peak during the day.
Actions	Software enhancements, modifications	Use computer alerts for drug-drug interactions.
Actions	Eliminate/reduce distractions	Provide quiet rooms for programming PCA pumps; remove distractions for nurses when programming medication pumps.
Actions	Education using simulation- based training, with periodic refresher sessions and observations	Conduct patient handoffs in a simulation lab/environment, with after action critiques and debriefing.
Actions	Checklist/cognitive aids	Use pre-induction and pre-incision checklists in operating rooms. Use a checklist when reprocessing flexible fiber optic endoscopes.
Actions	Eliminate look- and sound-alikes	Do not store look-alikes next to one another in the unit medication room.
Actions	Standardized communica- tion tools	Use read-back for all critical lab values. Use read-back or repeat-back for all ver- bal medication orders. Use a standardized patient handoff format.
Actions	Enhanced documentation, communication	Highlight medication name and dose on IV bags.

Risk Reduction Actions¶

Weaker	Double checks	One person calculates dosage, another person reviews their calculation.
Actions	Warnings	Add audible alarms or caution labels.
(these tasks require more reliance on humanstoremem- ber to perform the task correctly)	New procedure/ memorandum/policy	Remember to check IV sites every 2 hours.
	Training	Demonstrate correct usage of hard-to-use medical equipment.

References¶

5 Whys. Getting to the Root of a Problem Quickly. MindTools.com. Available from: https://www.mindtools.com/pages/article/newTMC_5W.htm.

Determine the Root Cause: 5 Whys. ISixSigma. Available from: https://www.isixsigma.com/toolstemplates/cause-effect/determine-root-cause-5-whys/

Learn from Defects Tool. Agency for Healthcare Research and Quality. (2012). Available from: http://www.ahrq.gov/professionals/education/curriculum-tools/cusptoolkit/toolkit/learndefects.html

Patient Safety Primer Root Cause Analysis. Agency for Healthcare Research and Quality. (2018). Available from: https://psnet.ahrq.gov/primers/primer/10/Root-Cause-Analysis

Root Cause Analysis: An Enterprise Approach. American Society for Healthcare Risk Management. (2015).

Root Cause Analysis. Washington State Department of Enterprise Services. Available from:

https://des.wa.gov/services/risk-management/about-risk-management/enterprise-riskmanagement/root-cause-analysis

The Cause and Effect (A.K.A. Fishbone Diagram). Simon, Kerri. ISixSigma. Available from: https://www.isixsigma.com/tools-templates/cause-effect/cause-and-effect-aka-fishbone-diagram/