MOH

RCA
General Directorate of Health
Methodology for Investigation and
Affairs in Riyadh Region development of action plan following
Quality Management & Patient
Safety (QM&PS)
Sentinel Events and high risk events
Definitions
o Sentinel Event: is any event leading to serious patient harm or death and is caused by
healthcare rather than the patient’s underlying illness.

o Adverse drug reaction: Response to a drug which is noxious and unintended which occurs at
doses normally used in human prophylaxis, diagnosis, or therapy of disease or for the
modification of physiologic function

o Disclosure: To inform the patient, or the patient’s representative, of any adverse event or
error in his treatment

o Root Cause Analysis (RCA): is a process for identifying the basic or causal factors of an adverse
event. A root cause analysis focuses primarily on systems and processes, not on individual
performance. It progresses from special causes in clinical processes to common causes in
organizational processes and systems and identifies potential improvements in processes or
systems that would tend to decrease the likelihood of such events in the future
o Consequence: is the outcome of an event and has an effect on objectives. A single event can
generate a range of consequences which can have both positive and negative effects on
objectives
Definitions
o Contributory Factor: Is a condition that influences the effect by increasing its
likelihood, accelerating the effect in time, affecting severity of the
consequences

o Care Delivery Problems CDPs: CDPs are problems that arise in the process of
care, usually actions or omissions by members of staff

o Action Plan: The product of the root because analysis is an action plan that
identifies the strategies that the organization intends to implement to reduce
the risk of similar events occurring in the future. The plan should address
responsibility for implementation, oversight, pilot testing as appropriate, time
lines, and strategies for measuring the effectiveness of the actions
Sentinel event

o Sentinel Event: is any event leading to serious patient harm or death and is
caused by healthcare rather than the patient’s underlying illness.

o The appropriate response to sentinel event must include conducting a thorough

RCA (root cause analysis) and developing an action plan made up of
recommendations with responsibilities and timeline within thirty 30 working
days, upon becoming aware of the event

o A RCA focuses primarily on systems and processes, not on individual

performance

o Any intentional unsafe act must be handled through administrative lines of

authority, for appropriate disciplinary action.
Sentinel event
oSentinel Event include any of the following criteria, but is not limited to:
• Wrong patient
• Medication Error Leading to Death or Major Morbidity
• Wrong Site Surgery
• Maternal Death
• Hemolytic Blood Transfusion Reaction
• Infant Discharged to Wrong Family
• Suicide in an Inpatient Unit
• Infant Abduction
• Retained Instruments or a Sponge
• Unexpected Death
• Intravascular Gas Embolism
• Unexpected Loss of a Limb or a Function
• Medical equipment or device related error/dysfunction leading to
death or permanent harm
•
 RCA

• RCA is a process for identifying basic or contributing causes of an Adverse Event or any
unexpected occurrence.

• A systematic process for identifying the most basic or causal factors underlying variation
in performance, including the occurrence or possible occurrence of adverse events that
might be precursors to a sentinel event (special cause) or broader system and process
issues ( common cause )

• The intensive, in-depth analysis of a problem event , e.g, sentinel event , to learn the most
basic reason(s) for the problem, which, if corrected, will minimize recurrence of that event

• This process focuses on systems and processes rather than individuals and identifies
proposed changes and preventive strategies.
 RCA

• Evidence based , in depth analysis, structured investigation process

which utilizes tools and techniques to identify true causes of an incident or
a problem by understanding what, how and why a system failed

• Unsafe act • Human • Contributing

behavior factors

What How Why

 RCA

• The hospital leaders should appoint a team who will conduct a root cause analysis
especially in response to a sentinel event occurrence.

• Objectives of the root cause analysis are: to identify those causative issues, systems or
processes that represent core reasons for occurrence of the event; to develop an action
plan that will prevent future recurrence of the event; and to implement the plan
 RCA
The Joint Commission Concept of Root Cause Analysis :
• Primary focus is on systems and processes
• Progression is from special cause to common cause variation
• Approach : Why? Why? Why? Why? Why? ( Five Whys)
• Goal : Redesign for risk reduction
• Thorough and credible analysis
• Action plan identifying changes to reduce risk of recurrence
• Measurement strategy
 RCA
Thoroughness of root cause analysis includes inquiry into at least these areas , as applicable to the
specific event:

• Processes ( related to behavioral assessment, physical assessment, patient identification, care

planning, competency assessment/credentialing and patient observation

• Staffing levels of communication, staff orientation/training and supervision

• Availability of information and communication with patient / family

• Adequacy of technological support, physical environment , and equipment maintenance /

management

• Medication control : storage , access, control

 RCA
• To conduct RCA, the hospital should assign a team, which ideally should be between 3- 5
individuals. The team should have an appointed lead investigator. This team will perform
the following tasks:
• Describe event( sequence of the event and steps of process can be described by
flowchart )
• Identify immediate (proximate) cause(s) - human factors (CDPs)
• Identify contributing factors– latent errors – systems and processes
• Analyze the causal factors.
• Complete the root cause matrix.
• Provide a complete report and create action plan for the SYSTEM to prevent future
occurrence ( please see conducting RCA policy for more details)
 Root Cause Analysis Process
( determining what happened, how it happened, and why it happened )

• Significant / sentinel event occurs/notification

• Define problem / collect initial data
• Conduct interviews
• Perform task / process analysis
• Perform change / difference analysis
• Perform control barriers / safeguared analysis
• Begin cause and effect analysis
• Determine root causes
• Develop / recommend changes / actions specific to the root causes
• Develop an action plan to implement the changes
• Report conclusions
• Evaluate effectiveness and efficiency of RCA
• Analyze RCA database for common cause analysis opportunities
 Tools ( event mapping and clarifying the process)

flowchart ( graphical representation of step by step of the process)

 Tools ( Understanding the causes )

FISH BONE
Team Organizational &
Task Management

CDP
Patient Individual Environment

Identify any possible subcauses of main causes by using the "Five-Why" technique

Cause and effect diagram( fishbone diagram) (ischekawa diagram) : diagram that display the root cause of problem/
situation in several related categories of causes
Tools

• The following may be considered when identification of possible causes and contributing
factors:

Identification of contributing factors:

• Human resource issues
• Information management issues
• Environmental issues
• Leadership and organizational culture
• Communication
RCA Steps
A - Identification and Decision to Investigation

B - Select People for Investigation Team

C - Organization and Data Gathering

D - Determine Incident Chronology

E - Identify CDPs (care deliver problems)

F - Identify Contributing Factors

G - Making Recommendations and Developing an action Plan

Reporting of sentinel event
Reporting Steps
NO. STEP RESPONSIBILITY TOOL/FORM TIME
Event discovered: Staff reports the event using OVR (Paper/
1 Staff (discoverer) Immediate
the OVR form. Electronic)
Staff submits the OVR report to the person in Person in charge/ direct OVR (Paper/
2 Immediate
charge. manager Electronic)
Send the report to the Quality and Patient Person in charge/ direct OVR (Paper/
3 Immediate
Safety director. manager Electronic)
Conduct initial review to determine if it meets OVR (Paper/
4 Risk Manager 48 hours
the sentinel event criteria. Electronic)
If a sentinel event is confirmed, secure the Medical Record Director Email Immediate
5 medical record and a copy of the medical
record will be made for investigation.
The incident must be reported to the MOH Risk Manager Electronic Form Immediate
6 sentinel event reporting website.
https://hsp.moh.gov.sa/Login.aspx.
Notify the facility medical director, the director, Risk Manager Email/SMS Immediate
nursing director, the regional directorate
7 director, and the regional directorate. QPS
director must be notified using email and/or
short message SMS.
Reporting Steps

Submits the OVR Send the report to Conduct initial

Event discovered
report the Q&PS review

Notify MD, NR-D,

Secure MR & a copy The incident
regional directorate,
of MR will be made reported to MOH SE
and QPS director
for investigation reporting website
“email and/or SMS”
Investigation of sentinel event
RCA
 Investigation steps

Activation of core investigation team (3 - 5) Individuals.

Team composition: Incident investigation team and analysis experts.

• External expert(s)
• Senior management expertise (e.g. medical director, director of nursing).
• Senior clinical expertise (medical director or senior consultant).
• It is also valuable to have someone who knows the relevant unit or
department well, though they should not have been directly involved in the
incident.
 Investigation steps
Information Gathering:
All facts, knowledge and physical items related to the incident should be
collected as soon as possible. This may include:
• The medical records.
• Documentation and forms related to the incident (e.g. protocols and
procedures).
• Immediate statements and observations.
• Interviews with those involved in the incident.
• Physical evidence (e.g. ward layout schematics, etc.).
• Secure equipment involved in incident (e.g. CTG machine).
• Information about relevant conditions affecting the event (e.g. staff Rota,
availability of trained staff, etc.).
 Investigation steps
Analysis (identify care delivery problems (CDPs) and contributory factors):
Gathered information will be organized in a chronological order using one of the following tools:
• Narrative chronology
• Time Person Grid
• Flow chart

• Variation from appropriate practice will be determined by comparing actual events sequence with
what should have occurred (according to the relevant policy and procedures).

• The investigation team will identify active failures - unsafe acts or omissions committed by those at the
`sharp end' of the system (anesthetists, surgeons, nurses, etc.) whose actions can have immediate
adverse consequences
 Investigation steps

•The investigation team should now identify the care delivery problems (CDPs). All CDPs are
specific actions or omissions on the part of the staff, rather than more general observations on
the quality of care.

•The investigation team then considers the conditions in which errors occur and the wider
organizational context, which are known as contributory factors.

•With many CDPs, it is best to select a small number of these regarded as most important.
Nominal group technique and multi-voting can be used to agree on the top CDPs, contributory
factors and causes.

•The team can use fishbone diagram to organize the information and analyze the causes.
 Recommendations and action plan
Making Recommendations and Developing an Action Plan:
The action plan should include the following information:

•Prioritize the contributory factors in terms of their importance for the safety of future healthcare
delivery.
•List of actions needed to address these contributory factors as determined by the investigation team.
•Identify:
- Who is responsible for implementing the actions.
- The timeframe for implementation.
- Any resource requirements
- Evidence of completion (such as training record, approved forms/policy).
- Formal sign-off of actions as they are completed.
- The date to evaluate the effectiveness of the Action Plan.
Investigation Steps

Making
Activation of core
Information Analysis (identify Recommendations
investigation team
Gathering CDPs & CFs) and Developing an
(3 - 5) Individuals
Action Plan

Present the
Submit the Submit the recommendations
Investigation Report Investigation Report and action plan to
to MD, QPS director to GDOHA and MOH the quality council
for approval
Monitoring of action plan
 Monitoring of action plan

•Review of all RCAs action plans monthly

•Review measures of success monthly.

•The organization will use measures of success (MOS) to follow up of the RCA action plan.
•The planned action element of performance (EP) compliance will be determined according to the
following:
•If the action EP is associated with a standard or Essential Safety Requirement (ESR) the level of
the compliance will be level "A" which is equivalent to 100%.
•If the action is not associated with ESR equivalent to an EP that is identified as a “B” EP, the
minimum required level of compliance for the SE MOS for that action will be 90%.

• The compliance will be determined by conducted an audit of appropriate sample

 Monitoring of action plan
• Data must be collected for a period of 4 months or until level of compliance
has been achieved.
• Aggregate all MOS results and Action Plans status
• Write Action Plans Status Report.
• Review and Approve the Status Report.
• Share the report with organization director, other stakeholders, and the
QPS committee.
• Review and approve the report.
• Submit the report to the regional directorate QPS director
Monitoring of Action Plan
The planned Data must be collected
Review of all RCAs Review measures
action EP for a period of 4 M /until
action plans of success
compliance will level of compliance has
monthly monthly
be determined been achieved

Aggregate all Share the report with

Write Action Review and
MOS results and organization director,
Plans Status Approve the
Action Plans other stakeholders, and
Report Status Report
status the QPS committee

Submit the report

Review and
to the regional
approve the
directorate QPS
report
director
 Contributing factors
FACTOR TYPES CONTRIBUTORY/ INFLUENCING FACTOR
Patient Factors Condition (complexity & seriousness)
Language and communication
Personality and social factors
Task and Technology Factors Task design and clarity of structure
Availability and use of protocols
Availability and accuracy of test results
Decision-making aids
Individual (staff) Factors Knowledge and skills
Competence
Physical and mental health
Team Factors Verbal communication
Written communication
Supervision and seeking help
Team structure (congruence, consistency, leadership, etc.)
 Contributing factors
FACTOR TYPES
Work Environmental Factors
Organizational & Management Factors
Institutional Context Factors
CONTRIBUTORY/ INFLUENCING FACTOR
Staffing levels and skills mix
Workload and shift patterns
Design, availability and maintenance of equipment
Administrative and managerial support
Environment
Physical
Financial resources & constraints
Organizational structure
Policy, standards and goals
Safety culture and priorities
Economic and regulatory context
 Action Level
Level Action Category Example

Stronger Actions Architectural/physical Replace revolving doors at the main patient entrance into the building with
(these tasks require less plant changes powered sliding or swinging doors to reduce patient falls.
reliance on humans to New devices with usability Perform heuristic tests of outpatient blood glucose meters and test strips and
remember to perform testing select the most appropriate for the patient population being served.
the task correctly)
Engineering control Eliminate the use of universal adaptors and peripheral devices for medical
(forcing function) equipment. Use tubing/fittings that can only be connected through the correct
way (e.g., IV tubing and connectors that cannot be physically connected to
sequential compression devices or SCDs).
Simplify process Remove unnecessary steps in a process.

Standardize on equipment Standardize on the maker and model of medication pumps used throughout
or process the institution. Use bar coding for medication administration.

Tangible involvement by Participate in unit patient safety evaluations and interact with staff; support the
leadership RCA process; purchase needed equipment; ensure staffing and workload are
balanced.
 Action Level
Level Action Category Example

Intermediate Actions Redundancy Use two RNs to independently calculate high-risk medication dosages.
↑in staffing/↓in workload Make float staff available to assist when workloads peak during the day.
Software enhancements, Use computer alerts for drug-drug interactions.
modifications

Eliminate/reduce Provide quiet rooms for programming PCA pumps; remove distractions for
distractions nurses when programming medication pumps.
Education using simulation Conduct patient handoffs in a simulation lab/environment, with after action
based training, with critiques and debriefing.
periodic refresher sessions
and observations
Checklist/ cognitive aids Use pre-induction and pre-incision checklists in operating rooms. Use a checklist
when reprocessing flexible fiber optic endoscopes.

Eliminate look- and sound- Do not store look-alikes next to one another in the unit medication room.
alikes
 Action Level
Level Action Category Example

Intermediate Actions Standardized Use read-back for all critical lab values. Use read-back or repeat-back for all
communication tools verbal medication orders. Use a standardized patient handoff format.

Enhanced documentation, Highlight medication name and dose on IV bags.

communication
Weaker Actions Double checks One person calculates dosage, another person reviews their calculation.

Warnings Add audible alarms or caution labels

New procedure/ Remember to check IV sites every 2 hours
memorandum/policy

Training Demonstrate correct usage of hard-to-use medical equipment

Any Question?
 Workshop
• Is it sentinel event or not ? Why?
• RCA team formation and reporting mechanism?
• Sources of data gathering and responsibilities?
• Event mapping / variations from normal
• CDPs
• Contributing factors
• Cause and effect diagram
• Recommendations and action plan