System Evaluation
of Reported Adverse Events
(SERAE)
Risk Mitigation and Quality Improvement
Patient Safety and Risk Management
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Patient Safety and Risk Management
“To Err is Human” – IOM Report - 1999
Injuries caused by medical management:
974,400 to 1,243,200 annually
- 53% to 58% preventable
44,000 (8th leading cause of death) to
98,000 (4th leading cause of death)
Americans die from preventable adverse
events
Cost: $17 to $29 billion US dollars
Vehicle accidents 43,458; breast cancer 42,297; AIDS 16,516
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Preventing Adverse Events
After the occurrence –
Root Cause Analysis
Sentinel events (SE)
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Patient Safety and Risk Management
Before the Occurrence – Failure
Modes & Effects Analysis (FMEA)
“FMEA is a team-based, systematic, proactive
technique that is used to prevent process and
product problems before they occur.”
Joint Commission
Can assess severity but not probability of occurrence
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Patient Safety and Risk Management
Similarities of FMEA and RCA
• Aim to reduce harm to patients
• Detail and labor intensive
Difference between FMEA and RCA
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Characteristics
Analysis
FMEA
Proactive
RCA
Reactive
Questions
Hypothetical
Actual
Approach
Prospective
retrospective
Patient Safety and Risk Management
An innovative approach
Between RCA and FMEA
System Evaluation of Reported Adverse Events
(SERAE)
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Patient Safety and Risk Management
System Evaluation
Reported Adverse Events (SERAE)
SERAE is analysis of adverse events
occurred and reported in other hospitals.
a systematic, proactive technique that is
used to prevent process and system
problems before they occur in OUR hospital
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Patient Safety and Risk Management
Why SERAE?
•Actual occurrence has transpired.
•Actual data on interaction of failures can
be obtained
•Actual reference point and not just purely
theoretical exercise
•As in RCA, a “learn and prevent” mindset
can prevail
The boss (CCE) likes to know anyway…..
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Patient Safety and Risk Management
Advantages of conducting SERAE
• Proactive
• Timely
• Less labor intensive
• Meet standard
• Less threatening to staff
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Patient Safety and Risk Management
Adverse event reported
in other
hospital/institution
Flowchart of
the SERAE
NO
Possible risk
Report no risk
YES
Contact Department Manager//Unit-incharge
Review existing system / policy
/compliance
ID problem/ risk for improvement
recommendation for
improvement
Refer CQI
Report to
Cluster Director (Q&RM)
Report to CCE
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Patient Safety and Risk Management
System Evaluation of Reported Adverse Events
(SERAE)
Would similar AE be happening in our hospital?
Why did it happen?
Underlying
causes
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proximate
causes
Why did that happen?
processes
Why did that happen?
systems
Patient Safety and Risk Management
8 Key Questions to Ask in SERAE
1. Would similar adverse event (AE) be happening in our hospital?
2. Is there any SOP in your department?
3. How are the processes done?
Written document
Direct review on-site
4. Are there non-compliance and failure modes?
 Evidence of similar AE
 Other failure modes
Review past record
AIRS
5. What are the severity ratings of possible AE?
6. Which are the failure modes to address?
7. What are the corrective actions?
8. What improvement is planned for corrective actions?
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Patient Safety and Risk Management
Stratification of RAE for different
approaches
• Inappropriate / inadequate resources
• Suboptimal system problem
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 SSPI
single party
 SSPII
multiple parties
Patient Safety and Risk Management
Stratification of RAE
• Inappropriate / inadequate resources
Usually need simple corrective action
Example
Retention of laryngoscope light bulb in
patient’s airway :
Cause – detachable light bulb on blade
Remedy – change to fiber-optic laryngoscope
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Patient Safety and Risk Management
Stratification of RAE
•Suboptimal system problem
SSPI - single party
Example : Sharing of mortuary compartment leading
to mixing up of dead body – involve mortuary
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Patient Safety and Risk Management
Suboptimal system problem
SSPII - multiple parties
Look Alike Drugs Dormicum Vs Magnesium Sulphate (MgSO4 )
Pitfalls:
Look alike drugs
Focus on clinical areas:
A&E
AICU
CCU
COD
DR
OTS
PAM
Involve doctors, pharmacy, nurses
Remove all ward stock of MgSO4
Reinforce constant vigilance
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Patient Safety and Risk Management
13 SERAE done in 2007
Over Utilization of Mortuary
Percutaneous Coronary Intervention
Mixing of Intrathecal/Intravenous Administration of
Cytotoxic Drug
Wrong site and dosing of Teletherapy
Look alike and sound alike medication error - Dormicum and
Magnesium Sulphate
Retained tip of Close-Suction Tubing
Overdose of Protamine (Verbal Order)
Retention of swab in a patient’s cavity
Mixing up of disinfectants - OPA/Cidex and rinse water
Resuscitation in private ward
Fatal Fall Incident
Double BCG Vaccination
Wrong Labeling of Blood Specimens
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Patient Safety and Risk Management
11 SERAE done in 2008
Adverse Transfusion Reaction
Flying object in MRI
Missed radioactive material (C-137) in lab
Wrong corpse to families
Mix-up of Biopsy Specimen
Retained Detachable Light Bulb of Laryngoscope in
patient
Lost of USP with patient data - Data Security
Post-PCI Death
Wrong Site Surgery
Wrong Radioactive Dye
Delayed resuscitation for a Collapsed Victim outside
hospital
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Patient Safety and Risk Management
8 SERAE done in 2009
Missing baby corpse in mortuary
An Eye nurse performed outside work without seeking
approval
Wrong identification of 2 newborns
Expired BCG Vaccine was administered to 5 newborns
Oral syrup Morphine was injected to a patient
Penicillin was administered to a wrong neonates
Shortage of specimen bottle in GOPCs
Double doses of Influenza vaccine was administered to an
elderly
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Patient Safety and Risk Management
10 System Improvement through SERAE
Increased 22 numbers of cold chambers and
share usage of mortuaries in HKWC
Removed all chemotherapy drugs ward stock
Reinforced ‘time-out’ for all operations and
procedures
Removed all laryngoscope sets with detachable
light bulbs
Provide individual insulated containers for
transportation of blood/blood components to
prevent condensation and mix-up
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Patient Safety and Risk Management
Ten key Changes - continued
Reinforced proper record and handling of
abortus / fetus / stillbirth
Revised the form on “Request for Human Tissue
Disposal”
Installed 16 small cold chambers for babies /
fetus
Reinforced newborn identification by
encouraging rooming-in
Minimize “ward dispensing practice” - limit
ward stock
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Patient Safety and Risk Management
To get things done … we must be innovative
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Patient Safety and Risk Management
but…we must
also be safe
Thank You
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Patient Safety and Risk Management