Incident Report System - RCA - CAPA

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INCIDENT REPORTING SYSTEM

Ms. Susmi Alphonsa Kurian


Assistant Quality Co-ordinator
Quality Control dept.
It is defined as written or verbal reporting of any event in the process of
INCIDENT patient care ,that is inconsistent with the deserved patient outcome or

REPORTING routine operations of the healthcare facility.

SYSTEM Any event that has caused harm, or has the potential to harm a patient,
visitor, or staff, for any event which involves malfunction or loss of
equipment or property, and any vent which might lead to a complaint
Why is it so
To improve patient safety and quality of care
important to To identify safety hazards
report
incidents?
To guide the development of interventions to
mitigate risks, thereby reducing harm.
◆ Near miss
◆ No-harm

4 Categories ◆ Adverse event

◆ Sentinel event
Category - 1 A near-miss is an unplanned event that did not result in
Near-miss injury, illness, or damage--but had the potential to do so.
Errors that did not result in patient harm, but could have, can
be categorised as near-misses.
A No-harm is an event is a patient safety event that
reaches the patient, but does not cause harm.
The most common type of no-harm incident was “fall
without harm,” which was considered preventable to
Category -2 a lesser extent than most other types of no-harm
No -harm incidents. The second most common type,
“deficiencies in medication management,” resulted in
patients not receiving the correct prescribed dose of
their medication
Other examples
A blood transfusion being given to the wrong patient but the patient was
unharmed because the blood was compatible
An injury related to medical management, in
Category -3 contrast to complications of disease. Medical
Adverse management includes all aspects of care,
Event including diagnosis and treatment, failure to
including diagnose or treat, and the systems and
ADR9 equipment used to deliver care. Adverse events
Adverse may be preventable or non-preventable
Drug
Reaction) Examples :
Care management issues - medication errors, mismatched blood transfusion, fall
with harm
.
The wrong unit of blood was transfused, and the patient died from a haemolytic
reaction
A relatively infrequent, unexpected incident, related to system
or process deficiencies, which leads to death or major and
enduring loss of function for a recipient of healthcare services.
Major and enduring loss of function refers to sensory, motor,
physiological, or psychological impairment not present at the
time services were sought or begun.
Category -4
The impairment lasts for a minimum period of two weeksand is
Sentinel not related to an underlying condition.
Event

Eg:
Surgery performed on the wrong body part.
Surgery performed on the wrong patient.
The Role of Incident and Event
Reporting in Risk Reduction and
Error Prevention
Preventing Future
Early Identification
Harm through Near
of Risk
Miss Reporting

Learning from Errors


through Incident Data-Driven Decision
Making

Safety Culture and Cost Optimization


Employee through Incident and
Engagement Event Reporting
Incident Reporting
mechanism in OneAmala
Step 1: Open One Amala and open iApps

EVENT
REPORTING
SYSTEM
Step 2: Login with your username and password

EVENT
REPORT
SYSTEM
Step 3: Click on the Register New Event under Quality

EVENT
REPORT
SYSTEM
Step 4: Click on the “New” option

EVENT
REPORT
SYSTEM
Step 5: Click on the “New” option and enter the data and submit

EVENT
REPORT
SYSTEM
EVENT MATRIX
SYSTEM
Reporting of an event (near miss/ incident/ adverse event/ sentinel event) to the quality department
via iApps
Identification and division of event

Quality department Nursing administration HIC Biomedical


department Operations
Blood Bank
Root cause analysis Radiology
Laboratory
RCA Event review by concerned department OT
Pharmacy
Classification of event MRD

Reporting Impact on safety Repeat Occurrence Financial impact to


Category of patient/ staff/ public of the same staff patient/ institution

Incorporate into the scoring matrix

Implementing CAPA and remedial measures.


Impacts (I) Score
Negligible/ Insufficient 1
Physical impact on the patient—No Injury or no effect on patient.
Examples: Documentation error.
Minor Harm 2
Minor patient injury or increased patient monitoring or change in treatment plan (with or without injury), but no increase in
the length of stay.

Examples: Missed medicine/ insulin dose requiring change in dosing for next administration.
Moderate Harm 3
Injury that affects basic functions of daily living.
Examples: Fracture, Burns, Omission of antibiotics/ high risk medicines, Increased length of stay (up to 72hrs), but recovery
without complication.
Severe Harm 4
Extended length of stay 73hrs to 1 week
Recovery with significant complication
Examples: Ortho surgeries
Extreme Harm 5
Extended length of stay more than 1 week leading to significant permanent disability/ death
Examples: Brain damage, severe paralysis
Reporting Category ( RC) Score
Self reporting -1
Reporting of incident by the concerned staff himself/ herself

In charge reporting 1
Reporting of incident by the In charge of the concerned department/ unit

Doctor /Supervisor/ Secondary reporting 2


Reporting of incident by Doctors/Supervisors (Quality Control staff ,
HICN, Nursing Coordinators) / any other departments

Patient/ Patient relatives/ any others 4


Reporting of incident by Patient/ Patient relatives
RCA Score =(Impact x Occurrence)
+Reporting Category
FORMULA
Formula
RCA Score = (Impact x Occurrence) +Reporting Category

Impact Negligible Minor harm Moderate Harm Severe Harm Extreme harm Reporting Category
Occurrence 1 2 3 4 5
Self reporting
1 1 2 3 4 5 -1
2 2 4 6 8 10
+ In-charge
1
3 3 6 9 12 15
Supervisor/Dr/
Secondary 2
4 4 8 12 16 20
Patient/Patient
5 5 10 15 20 25 relatives 4
Reporting Hierarchy
Nursing Staffs General Staff Doctors
HS/PG JR/SR
Link Nurse Link Person Link Doctor Link Doctor
In charge In charge Consultant Consultant
Nursing Coordinator HOD HOD HOD
CNO HR Department Principal Medical Superintendent
Priest In charge Priest In charge Priest In charge Priest In charge
Director Director Director
Director
RCA Score Action
0-2 Verbal warning by Link Nurse/Link person/ Link Doctor
3- 8 Verbal warning/ Disciplinary action by In charge
9 - 13 Apology letter to Nursing Coordinator/ HOD
14 - 19 Apology letter to CNO/ HR/ MS/Principal
20 - 23 Apology letter to Priest In charge
Disciplinary actions by Management
24 & above Apology letter to Director
Disciplinary actions by Management
Disciplinary action can be
1. Compensation/ Punishment
2. Memo
3. Show cause notice ( 3 memos or within 3 months any severe/ extreme incident
happened)
4. Suspension
5. Termination

Disciplinary action can vary up to case to case; Decision is based on the discretion of the
Management.
Tips for Performing an
Effective Root Cause
Analysis in Healthcare
Just culture is a concept related to systems thinking which emphasizes that
mistakes are generally a product of faulty organizational cultures, rather than
Foster a solely brought about by the person or persons directly involved.

Just In a just culture, after an incident, the question asked is, "What went wrong?"

Culture for rather than "Who caused the problem?"

Incident A just culture is the opposite of a blame culture.[1]

Reporting A just culture is not the same as a no-blame culture as individuals may still be
held accountable for their misconduct or negligence.

A just culture helps create an environment where individuals feel free to report
errors and help the organization to learn from mistakes
Focus on
High-Impact  Prioritize issues that have the most significant impact on patient
safety and care quality
Areas
5 Why Diagram

2. Engage in
Effective
Questioning
Fish bone diagram

FACILITY PATIENT
MAN POWER

INCIDENT

SYSTEM ENVIRONMENT BYSTANDER


Implement  Monitoring phase to assess the effectiveness of these changes in
Changes and improving patient safety and care quality.
 Continue to assess success by monitoring trends over time, and
Monitor making sure the prevalence of related events and incidents
Outcomes decreases.
Involve a
Multidisciplinary  Include a diverse team in your RCA process. This team
should include clinicians, nurses, support staff, and even
Team patients or their families where appropriate.
CAPA
Corrective Action & Preventive Action
 Corrective action is reactive and is intended to fix the situation in
question.

Corrective  If a fall happens due to absence of broken tiles, repair it with new
action tile.
 Spot training
 A preventive action is proactive, to ensure the incident, and those
like it, don’t happen in the future.
Preventive
action  E.g.: Developing an SOP
 Departmental training
 Elimination consists of physically removing the hazard.
 Substitution replaces something that produces a hazard with
something that does not.
 Engineering controls isolate people from hazards but do not
Hierarchy of eliminate the hazards themselves, such as adding guard rails
rather than investing in fall arrest systems.
hazard  Administrative controls change how people work in order to limit
controls exposure to hazards. This ranges from installing warning signs to
implementing procedural changes.
 Personal protective equipment (PPE) reduces exposure to
hazards when engineering and administrative controls are not
feasible or effective. PPE is needed whenever there are hazards
present.
Summary
A healthcare incident refers to an unintended or unexpected event that harms a
patient or caregiver or has the potential to harm them.

Incidents or errors occur for various reasons or root causes, such as system design
flaws, lack of administrative oversight, poor training, digression from protocols,
miscommunication, and more.

Some incidents are preventable, which means there are a multitude of examples of
incidents in healthcare that, when properly evaluated, can ultimately contribute to
better quality care and help reduce harm.

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