Rooting Out Errors in
Your Pharmacy
Donna Horn, RPh, DPh
Karen Ryle MS., RPh
2
Supporter
Disclosures
• Donna Horn and Karen Ryle declare no conflicts of
• Cosponsored by the American Society for Pharmacy Law.
interest, real or apparent, and no financial interests in
any company, product, or service mentioned in this
program, including grants, employment, gifts, stock
holdings, and honoraria.
Supported by the Pharmacy Technician Certification
Board.
The American Pharmacists Association is accredited by the Accreditation
Council for Pharmacy Education as a provider of continuing pharmacy
education.
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Learning Objectives
• Describe how to analyze a medication error using a
• Target Audience: Pharmacists and Pharmacy Technicians
• ACPE#: 0202-9999-16-051-L05-P
•
0202-9999-16-051-L05-T
•
• Activity Type: Knowledge-based
•
•
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© 2016 by the American Pharmacists Association. All rights reserved.
specific set of steps and associated tools to identify the
contributing factors and root causes of the event.
Specify how to use information gathered during a Root
Cause Analysis (RCA) to minimize the reoccurrence of
medication errors.
Prepare an action plan from the RCA which includes riskreduction strategies, communication, and implementation
strategies as well as ways to measure effectiveness.
Identify common pitfalls that may occur during an RCA.
Explain how the use of technology can help prevent
medication errors from occurring.
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Self-Assessment Question 1
Self-Assessment Question 2
What is the first step for conducting a Root Cause Analysis?
a)
b)
c)
d)
Create a flow chart
Formulate a team
Develop an Action Plan
Identify root-reduction strategies
All adverse events that occur at the pharmacy must be
investigated using the RCA method
a) True
b) False
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Self-Assessment Question 3
Self-Assessment Question 4
Which statement is false in regards to a successful RCA?
a) Continuously asks ‘why’ until all root causes have been identified
b) Focuses primarily on individual performance
c) Identifies changes to reduce the risk of reoccurrences or close
calls
d) The RCA team includes organization’s leadership and individuals
closely involved in the incident
All of the following basic questions must be asked during the
RCA process but which is the most critical to answer?
a)
b)
c)
d)
What happened?
What normally happens?
What do the policies and procures require?
Why did it happen?
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Self-Assessment Question 5
Case Study
When an event involves staff who cut corners, breech a
policy, or did not follow a procedure, the RCA process can be
stopped since the root cause leading to the error event has
been discovered.
a) True
b) False
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© 2016 by the American Pharmacists Association. All rights reserved.
•
•
•
•
•
•
It is a Friday afternoon
Pharmacist–in-charge had a stroke
Pharmacist covering is from a temporary agency
The technician has left for the day (from out of state)
One pharmacist on duty
This is his first full week working in the pharmacy
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Case Study
•
•
•
•
•
•
•
Meet the Patient
“Martin” went to the pharmacy to refill his prescription
Ziprasidone 20 mg #120
Take one cap in the morning and 3 caps in the evening
Total dose = 80 mg
The pharmacist told Martin that he did not have enough of
the medication but would give him some to “hold him over”
Martin received #30 Olanzapine in the bottle labeled
Ziprasidone
Martin took the wrong medication following the directions
on the label for approximately 1 week
•
•
•
•
•
•
•
•
“Martin” is a 48 year old male
Diagnosed with Schizophrenia
Currently working nights delivering luggage
Loved by his family, friends and co-workers
Lived with his parents, saving up for an apartment to live
on his own
Enjoyed his nieces and nephews and Kentucky Fried
Chicken
Stable on Ziprasidone 80 mg for over 6 months
Extremely compliant with his meds
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Meet the Pharmacist
•
•
•
•
•
•
•
Case Study
“Richard”
10 years experience in a chain pharmacy
“Worst mistake I have ever made in my life”
Had minimal knowledge of the pharmacy operating system
He did not know how to perform a prospective drug
utilization review (DUR) on the operating system
Admits to not checking the NDC, his normal process
Felt rushed and distracted while trying to perform a DUR
override on another patient’s prescription
• “Martin” received 80 mg/day of Olanzapine for
approximately 1 week, 4 times the maximum dose
• He was aware that the pills looked different but thought
•
•
•
because the pharmacy didn’t have enough pills, the
pharmacist was giving him a different generic
He is not “feeling well”
Calls in sick for 2 days, can’t move off the couch
Mother is concerned
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Case Study
Case Study
• Mother returns to the pharmacy with a few tabs left in the
•
•
•
•
•
• Olanzapine has a dose-dependent risk of thrombotic
bottle
Pharmacist didn’t warn her of the dangers of her son taking
the wrong medication for 7 days
She leaves the pharmacy with the correct medication and
an apology
Medication was not quarantined
“Duty to preserve evidence”
Nurse Practitioner was notified and didn’t seem concerned
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© 2016 by the American Pharmacists Association. All rights reserved.
complications
• Martin died as a result of pulmonary thromboembolism
from phlebothrombosis of the left leg
• Found by his parents on the floor of the bathroom
• Contributing factors: Obesity and Olanzapine
Supratherapeutic levels of 230 ng/mL detected in
postmortem blood
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Human Performance Factors
What type of Behavior?
• Human Error: mistakes, slips, lapses, and unintentional
deviations from accuracy and correctness
– Most errors are in this category
– Action: Console
• At-Risk Behavior: Behavioral choices that increase risk where
risk is not recognized, or is mistakenly believed to be justified
– Increase situational awareness
– Action: Coach
• Reckless Behavior: Conscious disregard of a risk of causing
harm
– Remedial and punitive action
– Action: Punish
The original source for the Swiss Cheese illustration is: “Swiss Cheese” Model – James Reason,
1990. The book reference is: Reason, J. (1990) Human Error. Cambridge: University
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Human Error
Patient Safety and the “Just Culture” David Marx JD
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At Risk Behavior
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Reckless Behavior
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What is RCA?
• A systematic process to identify the causal factors
contributed to the occurrence of a sentinel event
• Goal - find out what happened, why it happened & what to
do to prevent it from happening again
• Focus on pharmacy systems & processes - not individuals,
does not assign blame
• Conducted by team of interdisciplinary individuals
• Recognizes the underlying and fundamental conditions
that increase the risk of adverse events
• Implements effective strategies that target root causes
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© 2016 by the American Pharmacists Association. All rights reserved.
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When is RCA Necessary?
Harm Scores
• Not every adverse event
• Organizations should specify/define “require RCA?” or
“investigate through case reviews or investigative
techniques?”*
• NOTE: If the event is thought to be the result of a criminal
or purposefully unsafe act or related to alcohol or
substance abuse, stop the RCA process and report
individual(s) to organization leader
*http://www.ismp.org/Tools/Community_AssessERR/default.asp
©2001 National Coordinating Council for Medication Error Reporting and Prevention. All Rights Reserved. Permission is hereby
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granted to reproduce information contained herein provided that such reproduction shall not modify the text and shall include the
copyright notice appearing on the pages from which it was copied.
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Harm Scores from NCCMERP
Harm Scores (cont.), an error
occurred that…
A: Circumstances or events that have the capacity to cause
error
B: An error occurred but the error did not reach the patient
(An "error of omission" does reach the patient)
C:An error occurred that reached the patient but did not
cause patient harm
D: An error occurred that reached the patient and required
monitoring to confirm that it resulted in no harm to the
patient and/or required intervention to preclude harm
E: May have contributed to or resulted in temporary harm to
the patient and required intervention
F: May have contributed to or resulted in temporary harm to
the patient and required initial or prolonged hospitalization
G: May have contributed to or resulted in permanent patient
harm
H: Required intervention necessary to sustain life
I: May have contributed to or resulted in the patient’s death
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Purpose of ISMP RCA Workbook and
Associated Tools
7 steps of RCA
• Describe the root cause analysis (RCA) process
• Prompt users to create an action plan from the RCA,
including implementation strategies
• Describe common pitfalls when conducting RCA
• Provide examples of RCA with actual errors
• Incorporate RCA template and tools
• Adaptable for community, mail order or other ambulatory
pharmacy practice settings
• Describes the RCA process to help identify the primary
cause of a sentinel event
• Prompts users to create an action plan
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© 2016 by the American Pharmacists Association. All rights reserved.
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Basic Questions
Definitions
• Root Cause: Most fundamental reason an event has
Basic Questions to Answer During RCA
1. What happened?
2. What normally happens?
3. What do policies/procedures require?
4. Why did it happen?
5. How was the organization managing the risk
before the event?
occurred
• Contributing Factor: Additional reasons, not necessarily
the most basic reason that an event has occurred
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Characteristics of a Thorough and
Successful RCA
Purpose of RCA Action Plan
• Creates means to:
• Focuses primarily on systems and processes, not
•
•
•
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– Develop risk-reduction strategies
– Communicate and implement strategies
– Measure effectiveness of strategies
individual performance
Continuously asks ‘why’ until all root causes have been
identified
Identifies changes to reduce the risk of reoccurrences
Participation:
– Leadership of organization
– Individuals closely involved
• Internally consistent
• Consideration of relevant literature
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Case Study: the Error
Definitions
• Sentinel Event: an unexpected occurrence involving death
• Patient received 20 mg of olanzapine tablets instead of
•
or serious physical or psychological injury or risk thereof
the 20 mg ziprasidone capsules
The patient ingested the incorrect medication and within
7 days, died as a result of pulmonary thromboembolism
from phlebothrombosis of the left leg
• Medication Error: any preventable event that may cause
or lead to inappropriate medication use or patient harm
while the medication is in the control of the health care
professional, patient, or consumer
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© 2016 by the American Pharmacists Association. All rights reserved.
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Sentinel Event?
Steps in Conducting RCA
a. Yes
b. No
1. Form a team and complete STEP 1 on RCA template
•
•
•
•
•
Event Expert
Front-line worker
Personnel from an unrelated area
Optional: Technical RCA expert
Elect a leader to guide the process
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Step 1: Formulate a Team
Steps in Conducting RCA
Step 1 ‐ RCA Name: olanzapine 20 mg dispensed in error
2. Determine what happened, then complete step 2 on RCA
template
Date of Event: 7‐19‐15
•
•
•
•
Problem Statement: Patient ingested the incorrect medication and died as a result of pulmonary thromboembolism from phlebothrombosis of the left leg
Team Members
Review documentation
Assess the physical environment
Review labeling and packaging product
Interview pharmacy staff involved in incident
Team Leader: Ross Geller, DM
Event expert (person involved in event): Chandler Bing, CPhT
Front line worker familiar with process: Rachel Green, RPh
Non‐pharmacy personnel: Joseph Tribianni
Technical RCA expert (optional): Phoebe Buffay
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Review Documentation
Review Labeling and Packaging
• Pharmacy system documentation: refill number entered
•
•
•
•
•
•
•
•
•
by pharmacist and product verified by pharmacist
Patient counseling log: no documentation of counseling
Staffing logs: temporary staff pharmacist on duty; one
technician but left before her shift was over and not
replaced
Current policy and procedure manual
Olanzapine vs. Ziprasidone
Not located on the same shelf
Not sound alike/ look alike
Packaged differently (bottle of #30, bottle of #60)
Ziprasidone 20 mg NDC 64679-0991-02
Olanzapine 20 mg NDC 00378-5713-93
Ziprasidone 20mg
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© 2016 by the American Pharmacists Association. All rights reserved.
Olanzapine 20mg
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Assess Physical Environment
•
•
•
•
•
•
Interview Staff
• Important to interview all staff on duty at time of incident
• Use proper interviewing techniques without assessing
Pharmacy is located within a psychiatric practice
50 Rx’s per day
No bar code scanning
No pill imaging
No prescription scanning
No local staff support
blame
• Use interview to create timeline of events
• Create workflow chart
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Step 2- Details of Event
Interview Staff
• “Stressful” Friday afternoon; technician just left because lived
out of state
• Patient brought in empty Rx vial for refill of Ziprasidone
• Pharmacist processed refill on one terminal while working on
DUR for a different patient on a different terminal
• Pharmacist unfamiliar with operating system; flustered
• Label printed and pharmacist filled the order of “Ziprasidone”
• Pharmacist counted capsules, noticed short of stock and
•
•
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informed patient, labeled vial and gave to patient
Pharmacist ignored/missed NDC check
Pharmacist realized error when issuing owed quantity to Mom
Step 2 ‐ What Happened
Question
Finding
What are the Patient went pharmacy to obtain a refill of his medication. His medication
details of the that was filled inadvertently with Olanzapine instead of Ziprasidone.
Pharmacist processed the prescription in the pharmacy system, obtained
event? the wrong drug off the shelf, labeled the wrong medication and
completed the final verification of the medication while trying to resolve a
(i.e., event DUR alert for someone else. Patient took the medication as prescribed
description)
When did the event occur? (e.g., date, day of week, time)
on the label, which led him take the wrong medication at 4 times the
dose. The label stated Ziprasidone 20 mg but the bottle contained
Olanzapine 20mg. Patient's mother brought back wrong caps but
pharmacist did not warn her Olanzapine at a dose that could be lethal
and require immediate medical care.
The patient picked up the Olanzapine on 7-19-15 and died on 7-26-15 as
a result of pulmonary thromboembolism from phlebothrombosis of the left
leg representing a complication of morbid obesity. A contributory cause of
death was determined to be an inadvertent administration of Olanzapine
with supratherapeutic levels of 230ng/ml detected in postmortem blood.
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Step 3- Flow Chart
Steps in Conducting RCA
Step 3 – Flowchart Steps in the Process
In this step, describe how the event happened using a flowchart to illustrate.
Tip: When developing the flow chart of events, don’t jump to conclusions. It is essential to stay focused on what actually happened – not what the team thinks happened; construct a basic “time series” of the facts leading up to and including the adverse outcome.
Question
Finding
What are the steps in the process? (complete a flowchart)
Why did it happen?
What events were involved in (contributed to) the event?
Attach process flow chart to template
3. Identify root causes
•
Diagram the flow of events
• Describe how the event happened using a flowchart to
illustrate
• Attach flow chart to RCA
Remember: When developing the flow chart of events,
don’t jump to conclusions. It is essential to stay focused
on what actually happened – not what the team thinks
happened; construct a basic “time series” of the facts
leading up to and including the adverse outcome
RPh attempting to resolve DUR at the time of verification; working alone; did not understand operating system
RPh did not follow verification procedures
Mother not counselled as to severity of error
http://www.ismp.org/communityRx/aroc/
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© 2016 by the American Pharmacists Association. All rights reserved.
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Step 3 – Flowchart Steps in the
Process
Order
entry
Rx
received
Label
Stock
selection
Order received
Filling
Pharmacist
verification/
DUR
Transfer to
will-call area
Dispensing
Review of the Event: Process
flow/steps (from interviews)
Order entered
Patient shows
up at
pharmacy with
empty Rx vial
for refill
Refill number
entered and
processed by
Pharmacist
The patient
intends to wait
for
prescription
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Ask “Why”?
Label Print
Ask “Why”?
Label
applied
Stock
RPh
Verification
Pharmacist did not check
drug name and strength
on the bottle against the
drug name and strength
prescribed per policy
Pharmacist retrieves
Olanzapine instead of
Ziprasidone
Pharmacist flustered
Trying to resolve
DUR for patient #2
Working alone
Tech left; lived
out of state and
wanted to get
home
Patient #2 needed
medication for weekend
Both medications
are second
generation
(Atypical) Antipsychotic and 20
mg
Pharmacist not
familiar with
pharmacy
layout
Pharmacy is
located within
a psychiatric
practice
Pharmacist
first week on
site
Pharmacist does not
know the policy
Pharmacist from
temp agency
Organization did not have
staff in state; staff PIC on
medical leave
No local staff
available
Pharmacist did
not use
barcode
scanning
Pharmacist did not
check NDC per his
college training
Organization
did not provide
training to
agency staff
No technology
in pharmacy
Working on
two patients at
one time
Tech went
home because
lived out of
state
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Ask “Why”?
Delivery
Sort
Systems of Medication Use
1. Patient information
2. Drug information
3. Communication of drug
Prescription
Pick-Up and
Patient
Counseling
information
The pharmacist
bagged
prescription
The offer to
counsel was
not given
The
prescription
was a refill
4. Labeling, packaging, and
Error discovered when
owed quantity issued
but no counseling on
severity of error
5.
Pharmacist was afraid of
losing his job
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© 2016 by the American Pharmacists Association. All rights reserved.
nomenclature
Drug storage, stock,
standardization, and
distribution
6. Device acquisition, use,
and monitoring
7. Environmental factors
8. Staff competency and
education
9. Patient education
10. Quality and risk
management issues
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Steps in Conducting RCA
Which Key Elements ?
4. Identify Root Causes
a.
b.
c.
d.
•
Drug information (2) and Environmental factors(7)
Staff competency (8) and Patient education (9)
Patient information (1) and Patient Education (9)
Staff competency (8), Environmental factors (7), and
Patient Education (9)
Study the problem
• Identify which elements/systems are involved from
flow chart (7 & 8)
• Review key element and contributing factors
charts (AROC)
Common Contributing Factors Involving Staff
Competency and Education
Insufficient competency validation
New or unfamiliar drugs/devices
And more…..
Lack of orientation process; not trained for specific duties
Training on procedures and processes is insufficient
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http://www.ismp.org/communityRx/aroc
Steps in Conducting RCA
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Steps in Conducting RCA
4. Identify Root Causes
4(cont.) Identify Root Causes
• Read and apply the five rules of causation
• Complete Step 4 (I-X key elements)
• Indicate if “contributing factor” or “root cause”
and check “take action” if root cause
• Review key element and contributing factors charts
(AROC)
Common Contributing Factors Involving
Environmental Factors, Workflow, and Staffing
Patterns
Lack of staffing contingency plans to cover illnesses
and vacations, resulting in short staffing
Older technology not replaced
Managers not considerate of human factors when
scheduling
Interruptions
Workload inappropriate for staff
http://www.ismp.org/communityRx/aroc
http://www.ismp.org/communityRx/aroc
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Step 4 – Identify Proximate (Contributing) Factors and Root Causes
As an aid to avoiding “loose ends,” the last three columns on the right are provided to be checked off for later reference:
*
“Root cause?” should be answered “yes” or “No” for each finding Each finding that is identified as a root cause should be considered for an action and addressed in the action plan. Number each finding that is identified as a root cause.
*
“Contributing factor?” should be answered “yes” or “No” for each finding.
*
“Take action?” should be checked off for each finding that can reasonably be considered for a risk reduction strategy. Each item checked in this column should be addressed later in the action plan.
Tip: Contributing factor statements must clearly address why something has occurred and there must be a clear focus on process and system vulnerabilities, never on individuals.
Proximate Factor Questions Findings/Proximate Factors
Root Cause?
Contributing Take (If yes, assign Factor?
Action?
#)
I. Was critical patient information None
missing? (e.g., age; sex; weight, allergies; pregnancy; patient identity; address; indication for use or health conditions)
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© 2016 by the American Pharmacists Association. All rights reserved.
Proximate Factor Questions Findings/Proximate Factors
II. Was critical drug None
Take Root Cause?
Contributing Action
(If yes, Factor?
?
assign #)
information
missing?
(e.g., inadequate computer alerts; typical dose; maximum dose; route; contraindications; precautions; special warnings; drug interactions; cross allergies; outdated or absent references)
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Proximate Factor Questions Findings/Proximate Factors
III.
Miscommunication of drug order?
Root Cause?
Contributing Take (If yes, assign Factor?
Action?
#)
Root Cause?
(If yes, assign #)
Proximate Factor Questions Findings/Proximate Factors
None
IV. Drug name, label, packaging problem?
(e.g., look‐ and sound‐alike names; look‐alike packaging; no drug image; pharmacy labeling issue; label that obscures information; label not visible; warning labels missing or inconsistently applied; NDC or barcode not available or not used; faulty drug identification)
(e.g., illegible; ambiguous; incomplete; misheard or misunderstood spoken prescription; poor fax quality; unable to clarify with prescriber teamwork issues; warnings bypassed; error‐
prone abbreviations or dose expressions)
Both medications are second generation (Atypical) Anti‐psychotic and 20 mg
Contributing Take Factor?
Action?
Yes
No
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Proximate Factor Questions V. Drug storage or delivery problem?
Findings/Proximate Factors
Root Cause?
(If yes, assign #)
Contributing Factor?
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Take Action?
Proximate Factor Questions None
VI. Drug delivery device problem?
(e.g., automated dispensing devices not calibrated or maintained; oral measuring device not dispensed)
(e.g., drug stocked incorrectly; crowded shelves; look‐alike products stored next to each other; adult dosage forms for neonatal or pediatric Findings/Proximate Factors
Root Cause?
(If yes, assign #)
Contributing Factor?
Take Action?
None
patients)
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Proximate Factor Questions Findings/Proximate Factors
VII. Environmental, staffing or workflow problems?
Pharmacist not familiar with pharmacy layout
(e.g., poor lighting; excessive noise; clutter; foot traffic
interruptions; human factors; workload; inefficient workflow; breaks not scheduled; staffing levels and skills; work schedules; inadequate supervision)
Pharmacist working alone
Root Cause?
(If yes, assign #)
Contributing Take Factor?
Action?
Yes
Yes
Yes
Yes
Proximate Factor Questions VIII. Lack of staff education?
(e.g., competency validation; new or unfamiliar drugs or devices; orientation process; feedback about errors and prevention;
inexperience; orientation; low compliance with mandatory education; required certification; support for advanced certification and education)
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© 2016 by the American Pharmacists Association. All rights reserved.
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Findings/Proximate Factors
Pharmacist had minimum knowledge of the operating pharmacy system Root Cause?
Contributing Take (If yes, assign Factor?
Action?
#)
Yes (1a)
Yes
Pharmacist did not know how to perform a prospective drug Yes (1b)
utilization review (DUR) Yes
NDC numbers were not used to verify product dispensed
Yes
Yes
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Proximate Factor Questions Findings/Proximate Factors
IX. Patient education problem?
(e.g., lack of information; non‐adherence; not encouraged to ask questions; lack of investigating patient inquiries; patient barriers; complex drug regimen; medication reconciliation problem; health literacy; language barrier or other communication problem; intimidated by staff; mental health issue)
Root Cause?
Contributing Take (If yes, assign Factor?
Action?
#)
Pharmacist knew that he Yes (2a)
had dispensed Olanzapine at a dose that could be lethal and he did not convey to the mother that this error could be an emergency and could require immediate medical care
Proximate Factor Questions X. Quality process and risk management?
Yes
(e.g., no culture of safety; fear of error reporting; system‐based causes not analyzed; lack of equipment quality control checks; focus on productivity and volume; financial resources or constraints; organizational structure and priorities conflict; technology workaround and/or malfunction; design flaw; technology user error; technology and devices not meeting needs)
(human factors issues: task and information complexity; ergonomics; time urgency; familiarity with task, product, or equipment; mental and physical health of staff; fatigue; fitness for duty; stress; motivation)
Findings/Proximate Factors
Pharmacist did not tell mother severity of error; fear of reporting
No safety and quality measures in place, such as bar code scanning, pill imaging or prescription scanning Root Cause?
(If yes, assign #)
Contributing Take Factor?
Action?
Yes (2b)
Yes
Yes
Yes
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Steps in Conducting RCA
5 Rules of Causation
• Rule 1 - Causal Statements must clearly show the
5. Write root cause statements
• Focus on system-level vulnerabilities
• Read and apply the five rules of causation
"cause and effect" relationship
– “pharmacist was flustered" is deficient without description of how
and why this led to a mistake
Wrong: RPh was flustered
Correct: Pharmacy organization did not have
locally trained pharmacy staff available; as a
result, the use of untrained agency staff increased
the likelihood of operational issues, which led to
trouble resolving DUR and subsequent incorrect
medication being dispensed
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5 Rules of Causation
5 Rules of Causation
• Rule 2 - Negative descriptors (e.g., poorly, inadequate)
are not used in causal statements
cause
–
–
–
–
– "carelessness" and "complacency" are bad choices; broad,
negative judgments that do little to describe the actual conditions
or behaviors that led to the error
Wrong: Policy and procedure manual was poorly written
Investigate to determine WHY the human error occurred
System-induced error (e.g., step not included in procedure)
At-risk behavior (doing task by memory, instead of a checklist)
Workarounds and violations are outcomes of human error- not
causes
Wrong: The RPh made a product selection error
Correct: The training manual was not indexed, used
a font that was difficult to read, and did not include
any technical illustrations; as a result, the manual
was rarely used and did not improve performance by
agency staff
Correct: Insufficient staffing levels led to the RPh working
around the procedural step to check the stock bottle against
the pharmacy generated prescription container label resulting
in the wrong medication being dispensed
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© 2016 by the American Pharmacists Association. All rights reserved.
• Rule 3 - Each human error must have a preceding
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5 Rules of Causation
5 Rules of Causation
• Rule 4 - Each procedural deviation must have a
• Rule 5 - Failure to act is only causal when there was
preceding cause
a pre-existing duty to act
– Procedural violations are not directly manageable
– It is the cause of the procedural violation that we can manage
– If a technician is missing steps in a procedure because he is not
aware of the formal checklist, work on education
– Find out why this mishap occurred in our system as it is
designed today
– The duty to perform may arise from standards and guidelines for
practice; or other duties to provide patient care
Wrong: The pharmacist did not offer to counsel the patient
Wrong: RPh did not follow procedure for product verification
Correct: The absence of an established procedure insisting
on mandatory counseling for patients receiving high-alert
medications or for patients considered to be high-risk,
resulted in the patient not realizing the different looking
capsules were not merely a ‘different generic’
Correct: Uncertainty with the pharmacy operation system
and pressures to quickly complete dispensing increased
the probability of bypassing the verification protocol; this
resulted in the wrong drug being dispensed
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Steps in Conducting RCA
Root Cause Statements
6A. Develop Actions
Step 5 – Root Cause Statements
Using the findings identified as root causes in Step 4 above, write concise descriptions of the cause‐and‐effect relationship Ensure that the team has not focused on the actions of individuals or in any way placed blame.
•
Tip: To determine whether a statement is effective, ask, “If this is corrected, will it reduce the likelihood of another adverse event?” The answer should be yes.
•
Root Cause #
•
1 (a,b)
2 (a,b)
Formulate improvement actions for each identified root cause in
Step 5
Consider quality improvement actions for identified contributing
factors
Review key elements and suggested risk-reduction strategy charts
(AROC) http://www.ismp.org/communityRx/aroc/
Employ a mix of higher-and lower-leverage strategies that focus
on system issues and address human issues
•
Statement of Cause
Lack of knowledge of the pharmacy operation system and pressures to quickly complete
dispensing increased the probability of bypassing the verification protocol
The absence of a culture of safety resulted in the pharmacist not counseling the mother on
the severity of the error
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Rank Order of Error Reduction
Strategies
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Use Variety of Strategies
• Fail-safes and constraints true system changes
•
Forcing Functions and Constraints
•
Automation and Computerization
Standardization and Protocols
•
Checklists and Double Checks
Rules and Policies
•
Education and Information
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© 2016 by the American Pharmacists Association. All rights reserved.
Integrate pharmacy computer system and cash register;
prevents the clerk from "ringing up" the Rx unless RPh final
verification had occurred
Forcing functions are procedures that create a "hard stop”
•
Rx computer system prevents overriding selected high-alert
messages without a notation (e.g., patient-specific indication
must be entered if high-alert medication selected)
Automation and computerization reduce reliance on memory
•
True electronic systems receive eRx from a prescriber;
eliminate data entry misinterpretation at the pharmacy
•
Robotic dispensing devices
Standardization creates a uniform model to reduce the complexity
and variation of a specific process
•
Create standardized processes for receiving phone orders
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Brainstorming Action Plan, RCA Team
asks:
Use Variety of Strategies
• Redundancies incorporate duplicate steps to force additional checks
• Include use of both brand and generic names
• Patient counseling is an underutilized redundancy
• How can we decrease the chance of the event occurring
again?
• Reminders and checklists important information readily available
• Rx blanks that include prompts for important information
(e.g., medication indication, allergies, patient dob)
• How can we decrease the degree of harm if the event were
to occur again?
• When considering changing procedures or rules, ask: What
• Rules and policies guide staff toward an intended positive outcome
• Use relies on memory; used as a foundation to support other
strategies
• Education and information effectiveness relies on an individual’s
is best practice?
• How can devices, software, work processes, or workspace
be redesigned using a human factors approach?
• How can we reduce reliance on memory and vigilance by
improving processes in the workplace?
ability to remember what has been presented
• Read and review prescription verification policies and procedures
• Does the organization have resources for the proposals?
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80
Steps in Conducting RCA
Action Plan- Root Causes
Step 6 – Action Plan
6B. Establish Outcome Measures
•
•
Root Causes
Establish a way to measure effectiveness of action plan over
time
Record methods to measure effectiveness over time
For each of the root causes identified in Step 5 above as needing an action, complete the following table. Check to be sure the selected measure will provide data that will permit assessment of effectiveness over time. Tip: Discuss the proposed risk reduction strategies with the person who reported the incident to see if they believe that the RCA team is on the right track. Ask: If these recommendations were in place at the time of the incident, do you think it likely that the incident may have been prevented from occurring?
Root Cause#
1 a,b
Risk‐reduction Strategy
Measure of Effectiveness
Provide practice site, competency-based orientation
regarding stocking, dispensing, preparation, verifying
and delivery procedures to all newly hired staff
Require staff scheduler to refer to
documented levels of training before
assigning tasks and shifts
2 a
Promote a culture of safety from top management
down to staff in pharmacies
2 b
Educate staff members that all patients, whether new
or refill prescriptions, need an “offer to counsel”
Pharmacists and technicians are
periodically and anonymously surveyed to
determine their level of anxiety and fear
with making and reporting errors
Use a log book to document
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Action Plan
Almost Done! Review Common
Errors in RCA
Contributing Factors
For each of the contributing factor identified in Step 4 above as needing an action, complete the following table. Contributing factor
Pharmacist not familiar with
pharmacy layout
Pharmacist working alone
NDC numbers were not used to
verify product dispensed
No safety and quality measures in
place, such as bar code
scanning, pill imaging or
prescription scanning
Risk‐reduction Strategy
Measure of Effectiveness
When creating the work schedule,
consideration is given to the use of
supportive dispensing technology and
prescription volume, use of consistent
agency staff familiar with operating system
and pharmacist/technician ratios are ideally
suited to minimize dispensing errors
Periodically examine
prescription volume data
to determine appropriate
staffing levels, even
during peak times when
demand is highest
Educate staff members on the importance
of checking NDC numbers against the
pharmacy label;
Implement safety technology when
resources permit
Pilot test to ensure that
technology meets the
needs of the organization
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© 2016 by the American Pharmacists Association. All rights reserved.
82
• Avoid Common Pitfalls
– Start with accurate sequence of events and timeline to help
uncover all gaps
– Don’t rely on policies and procedures; illustrate what actually
happens
– Investigate why staff skipped steps
– Uncover more deep-seated latent failures in the system
– Uncover how human errors get through the system
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Review Common Errors in RCA
(cont.)
Last Step in Conducting RCA
– Seek outside knowledge
• Professional literature, regulations, standards, professional guidelines
– Each intervention should be clearly linked to one or more
causative factors
– Effective risk-reduction strategies involve redesigning
systems; don’t rely on:
7. Communicate the results
• Provide leadership recommendations for improvement and
preventative action plan
• Share with the entire organization as a learning tool and to get buyin to changes
• Developing new rules, educating staff, double checks, “be more
careful”
– Have realistic plans and measure outcomes
– Punitive action-not be available to provide important details
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Key Points
Self-Assessment Question 1
• RCA framework should be broken down into manageable steps:
o
o
o
o
o
o
o
o
o
o
Form a team
Review all documentation
Review physical environment
Review product labeling and packaging
Interview those involved in the incident
Determine sequence of events through flow charting on the
medication use system
Ask ‘why?’
Determine contributing factors and root causes
Develop an Action Plan for each identified root cause
Measure effectiveness of Action Plan over time
What is the first step for conducting a Root Cause Analysis?
a)
b)
c)
d)
Create a flow chart
Formulate a team
Develop an Action Plan
Identify root-reduction strategies
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Self-Assessment Question 2
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Self-Assessment Question 3
Which statement is false in regards to a successful RCA?
a) Continuously asks ‘why’ until all root causes have been identified
b) Focuses primarily on individual performance
c) Identifies changes to reduce the risk of reoccurrences or close
calls
d) The RCA team includes organization’s leadership and individuals
closely involved in the incident
All adverse events that occur at the pharmacy must be
investigated using the RCA method
a) True
b) False
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© 2016 by the American Pharmacists Association. All rights reserved.
90
Self-Assessment Question 4
Self-Assessment Question 5
All of the following basic questions must be asked during the
RCA process but which is the most critical to answer?
When an event involves staff who cut corners, breech a
policy, or did not follow a procedure, the RCA process can be
stopped since the root cause leading to the error event has
been discovered.
a)
b)
c)
d)
What happened?
What normally happens?
What do the policies and procures require?
Why did it happen?
a) True
b) False
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References
• Aspden P, Wolcott JA, Bootman JL, et al, eds. Preventing
•
•
•
medication errors: Quality chasm series. Washington, DC:
The National Academies Press; 2006.
Institute of Safe Medication Practices. Improving
Medication Safety in Community Pharmacy: Assessing for
Risk and Opportunities for Change. 2009.
Institute of Safe Medication Practices. Root Cause
Analysis Workbook for Community/Ambulatory Pharmacy.
http://www.ismp.org/tools/rca/
“Sentinel Event”. JointCommission.com. 2012.
http://www.jointcommission.org/sentinel_event.aspx. (27
June 2012).
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