ROOT CAUSE ANALYSIS

Mohammad Shah Rizal bin Ahmad Shahari Budin

Pegawai Farmasi UF41
Klinik Kesihatan Nabawan
 Definition

• A structured investigation that aims

to identify the true root cause of a
problem and the action necessary to
eliminate it
 Why do we perform RCA?
• To allow health professionals to learn and work together
as a team to improve quality in healthcare
• To promote patient safety through inter-professional
learning on root cause analysis
• As a tool to identify prevention strategies
 Outcome Expected from RCA
• Discovering all the contributing factors
• Identify changes that can be made to improve pre-existing
system & processes
• Construct and evaluate an action plan to prevent
recurrence
• Promote the safe use of medications as part of an
interdisciplinary health team
It focus more on systems
and processes, not on
individual performances..

hence..

no BLAMING CULTURE
 A flow of “WHY”
First question: Ask What happen?
then continue asking WHY? until...there's no more

Barred for Final Show up late Alarm didn't

WHY WHY Woke up late WHY
Exam to exam hall ring

WHY
Roomate left Phone used as
Door lock is
Fix the lock SOLUTION broken WHY early but didn't WHY alarm got stolen
lock door while asleep

- some events may not have such linear “WHY” - use fish scale diagram
 When to stop asking why?
arrived to a cause in which if an intervention were to be
done, it is:
• Reproducible
• Easily monitored
• Optimized the resources to be allocated (staff, fund,
time...)
• Recordable
 Who should we include in RCA team?
• Multi-disciplinary teams of 3-
5 people within the area of
expertise but not involved in
the incident

• Must have skills, knowledge

and experience to conduct an
RCA of the event
 When to conduct an RCA?
Please refer to:
Incident Reporting & Learning System: From Information to
Action Manual, MOH 2013

Health Clinic
Code 36
Medication error Category C,D, E, F, G, H & I
 Basic Process of an RCA
Identify
Evaluate
Issues
effectivenss
Select
Team
Implement
the plan
Plan and
conduct
investigation

Report
an action
plan Determine
sequence
of events

Develop
strategies Determine Identify
root contributing
causes factors
 Case Simulation
• 70-year old patient with u/l epilepsy & HTN was admitted to medical ward for
bronchopneumonia. During her stay at the ward, medication was ordered
manually by MO/HO using medication charts. No record of what medication
were given to patient during ward stay in PHiS
• After a one week stay, she was ready to be discharged. A new HO attend her,
doing all the discharge clerking alone. The time is 12.30 noon. HO wrote in
her case note, discharge patient with her anti-HTN, antibiotic and anti-
epileptic.
• HO was supposed to order the patient discharge medication using PHiS.
Patient was discharged with antibiotics and her anti-HTN only. The HO forgot
to key in her anti-epileptic into PHiS
 Case Simulation
• Patient and her caretaker went to pharmacy to collect the
medications.
• Pharmacist received her RN number and screen her RX in PHiS
• After screening the RX, they filled and dispensed only the
medications ordered by the HO.
• Patient caretaker took all the medications in a rush and they went
home.
• Patient was admitted to ICU a week later due to Status Epilepticus
 Identify
Issues

MEDICATION ERROR
CATEGORY H
(near death event)
 Select
Team

Form can be downloaded at:

http://patientsafety.moh.gov.my/v2/?page_id=56
 Plan and
conduct
investigation

• Responsibilities of The Investigation Team

 get detail information on:
“what happen, who are involved, where it happen, why it happen, when it happen and
how it happen” (5 Ws + 1 H)
 patient record, SOP, pictures, schedule

• Analysis is then conducted after relevant information has been gathered

• Analysis should be able to :

1. Identify weakness of the system
2. What can be done to prevent it from happening again?
3. Provide useful recommendations which is doable and impactful.
 Determine
sequence
6. SEQUENCE OF EVENTS: of events
Please state only the important information/events/steps that lead to the
incident:

Key person Comments- please add in

Date Time(24 h) Location Event description involved (initial) & what went wrong in
designation every sequence

Patient is to be discharged from the HO working alone, no

xx/xx/17 1230 Ward X HO XYZ
ward supervision

Discharge medications ordered in HO forgot to order

xx/xx/17 1245 Ward X HO XYZ
PHiS patient anti-epileptic

PF at satellite wouldn't
Satellite Rx in PHiS is being screened at the know what medication
xx/xx/17 1310 PF 4444
Pharmacy pharmacy were given to patient in
ward

Patient caretaker took

Satellite Rx was filled and dispensed to PF 4444 & PPF medications without
xx/xx/17 1320
Pharmacy patient caretaker ZXR question because in a
hurry
 Identify
contributing
factors

• Systematically categorize the contributing factors of the

incident.
• Action plan for each category may be similar or related.
• To prioritize the action based on the risk, resources and
capacity available.
• Based on the London Protocol, the contributing factors
can be divided into seven(7) categories:
 Identify
Contributing Factors Using London Protocol contributing
factors

Patient Factor Individual/ Staff Factor Work and Care Environment

• Co-morbidity • Competency • Building, design layout
• Difficulty in diagnosis • Fatigue, stress, lapse in • Physical environment
• Physical factor concentration • Structural, surrounding
• Personality • Domestic Issues safety
• Staff-patient relationship

Team Factor Task/ Technology Factor Management &

• Communication • Availability of guideline, Organization
• Supervision policy, protocols, SOP etc • Leadership, governance External Factor
• Leadership in the team • Availability of equipment of hospital • Political
• Clarity of responsibilities • LASA medication • Hospital policy & • Economic
• Support by staff, by standard • Laws
superior • Resource, constrain
• Work dynamic • Safety culture
• Work schedule
 Determine
root
causes

• Root cause is the original cause for the failure or inefficiency of a process
• It can be one of the contributing factors that have been identified

• Sometimes, it is not easy to find the root cause(s) that lead to an incident as
the incident may not due to a singular or linear cause.
• The incident is due to many contributing factors which must be controlled in
order to reduce the risk in future.

• To determine the Root Cause, few methods can be used:

Method 1: Fish Bone Diagram (Ishikawa Diagram) Determine
root
MANAGEMENT & TEAM FACTORS TASK & TECHNOLOGY causes
ORGANISATIONAL FACTORS
1. Poor supervision
FACTORS 1. Poor protocol when
2. Lack of support from screening and dispensing
1. Lack of training for
other colleague during discharge medication in
newly appointed HO
peak hour PHiS involving ward
regarding PHiS
  using manual med chart
 
 
INCIDENT/ ISSUE

Patient admitted to ICU

due to Status Epilepticus

 
EXTERNAL WORK/CARE INDIVIDUAL STAFF PATIENT FACTORS
FACTORS ENVIROMENT FACTORS FACTORS
1. Patient caretaker's
1. NONE 1. Peak time in ward, 12-
1. Fatigue always in a hurry
2 pm ward is filled
 
with family members 2. Poor alertness  
eager to bring patient
home  

 
Method 2: “Five Whys” Approach Determine
root
causes
What caused the situation?: Patient having Status Epilepticus at home

Why?
Patient was not prescribed her anti-epileptics

Why?
HO in charge didn't order it in her PHiS Rx during discharge
Why?
HO was busy and working alone, didn't have time to double check
Method 2: “Five Whys” Approach Determine
root
causes
Why wasn't it detected?: Pharmacist did not notice Dr didn't continue her
anti-epileptic

Why?
He did not call the ward to confirm about the Dr's discharge plan

Why?
PF was too busy attending to other patients
Why?
He need to screen and dispense all the Rx of discharge patients

Why?

1-2 pm are peak hour for patients discharging from all ward
Method 3: Event and Causal Factors Charting Determine
root
causes

Event 1 Event 2 Event 3 Event 4/ Conclusion

[event] → [event] → [event] → [event]

[date&time] [date&time] [date&time] [date&time]

Describe issue Describe issue Describe issue

Caused by Caused by Caused by

Explaination Explaination Explaination

Caused by Caused by Caused by

Explaination Explaination Explaination

Caused by Caused by Caused by

Explaination Explaination Explaination

Method 3: Event and Causal Factors Charting Determine
root
Patient with epilepsy being discharge causes

Dr did not prescribe No anti-epileptic Event 3 Patient having

anti-epileptic were dispensed to status epilepticus at
→ patient caretaker → [event] → home
[date&time] [date&time] [date&time] [date&time]

Omission Error Rx in PHiS not Describe issue

checked for accuracy

Caused by Caused by Caused by

forgot to order in PF only check Rx Explaination

PHis ordered in PHiS

Caused by Caused by Caused by

busy attending other No double checking Explaination

patients done by calling the
ward
Caused by Caused by Caused by

working alone with Busy & assumption Explaination

no supervision
 Develop
strategies

• Most important step of an RCA

• Identify actions that prevent the incident from recurring. If not possible,
reduce the severity if it recur

Consider the following when developing an action plan

 who will be affected by action(s)
 likelihood of success
 is it within the organization’s capabilities? (cost, HR...)
 the likelihood of causing other adverse events
 barriers to implementation
 implementation time
 measurability
Use HIERARCHY OF RISK CONTROL Develop
strategies
Use HIERARCHY OF RISK CONTROL Develop
strategies

Actions can be divided into 3 categories:

• 1. Stronger Actions - Which is “most effective”
• 2. Intermediate Actions - Which is “moderately effective”
• 3. Weaker Actions - Which is “less effective”

• An effective Action plan, contain at least ONE (1) “STRONGER” or

“INTERMEDIATE” action(s)
• At times, “weaker actions” need to be used while waiting for more effective or
“stronger actions” to be implemented (as a temporary measure)
Outcome Measures Develop
strategies

Outcome measures are designed to show whether or not

the actions have actually prevented or minimized
additional adverse events or near miss

• Specific and quantifiable as possible.

• Use numerators, denominators, thresholds and timeframes
whenever possible
Action Plan Table Develop
strategies

Action
Hierarchy Person
Evidence of
No Contributing (strong/ responsible Expected
Description of Action Plan completion/
. Factors/ Root Causes intermediate/ (Name & Completion Date
Progress
weak) designation)

Houseman working alone To make sure there's always another

during peak time in ward - no Dr (HO/MO) to assist in doing Strong Name list of
1 HOD xx.xx.17
supervision and counter- discharge during peak hour, to act as designated staff
checker counter-checker

Pharmacist at satellite
pharmacy unable to confirm
For clinical pharmacist/PRP in every
with Dr's discharge plan
ward to do bedside dispensing for
because the record is only
every patient discharged from their Name list of
2 available in ward. Didn't have KPF xx.xx.17
ward. They can easily counter-check Strong designated staff
time to call ward and assumed
with patient case note in the ward
the Rx is correct due to busy
and intervene right away.
handling patient discharging
on peak hour
 Report an
action plan
Report should be produced as soon as the investigation finishes.
The content of the report should include the following:
i. Details of the incident
ii. Details of patient
iii. Details of Investigation team
iv. Person produced the report
v. Summary of the incident
vi. Chronology of event
vii. Contributing factors, root cause(s)
viii. Action plan
ix. Lessons learnt
x. Attachment (if any)

• RCA2 report need to be submitted to State Health Department and Ministry within 60 days following
the incident.
• Present the report to top leaders/relevant officers in charge to get approval of the action plan and also
for learning purposes
Implement Recommended action plan should be implemented accordingly
the plan

Evaluate
Actions Implemented need to be monitored and evaluated for
effectivens
s effectiveness and problems that may occur
 THANK YOU

Full guideline in PDF form can be downloaded at:

http://patientsafety.moh.gov.my/v2/?page_id=56