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adverse event
An unexpected outcome negatively affects patient care
It results in:
Prolonged hospitalization
Injury
Death
Often caused by complications in managing patient care
Also called:
Adverse event
Critical incident
When an Adverse Event Occurs…
Key people must be informed:
Patient
Substitute decision maker (if applicable)
Healthcare administrators
Nurses should:
Follow workplace policies
Understand reporting and disclosure procedures
Know their role in the process
Reporting vs Disclosure
Reporting
Information shared with healthcare administrators
Done by staff involved in or discovering the event
Used for investigation and prevention
Disclosure
Information shared with patient or family
Explains what happened
Focuses on patient communication
Reporting: Key Points
Reporting usually involves:
Following employer policies
Completing incident reports
Triggering an investigation
Helping reduce future risks
Examples:
Reporting adverse drug reactions
Reporting medical device incidents
Serious incidents reported to Health Canada
Disclosure: Key Points
Disclosure involves:
Informing patient or family about the event
Explaining known facts
Expressing sympathy or regret
Explaining investigation steps
Important notes:
Minor incidents may not require disclosure
More serious events require full communication
Some provinces require disclosure by law
Which Comes First?
Order depends on:
Severity of the event
Workplace policies
Legal requirements
Typical process:
Initial disclosure to patient
Reporting to administration
Investigation
Follow-up disclosure
Follow-up may include:
Findings
Changes to prevent future events
Who Discloses to the Patient?
A trained healthcare professional
Someone with strong communication skills
Possibly:
Physician
Surgeon
Healthcare administrator
Not always the nurse involved.
What Is Disclosed to Patients?
Known facts about the event
Effects on care or treatment
Expression of sympathy or regret
Explanation of investigation process
After investigation:
Responsibility may be acknowledged
A formal apology may be given
All information must be documented.
Do Apologies Prevent Lawsuits?
Proper reporting
Timely disclosure
Appropriate apology
A lawsuit may still occur.
Important note:
Some provinces have apology legislation
Apologies cannot always be used as proof of negligence.
Patient safety
reduction and mitigation of unsafe acts within the healthcare system
using best practices that are proven to lead to optimal patient outcomes
unsafe act
any action or inaction that has the potential to cause harm to a patient
errors in judgment, lapses in communication, failures in following established protocols
usually not intentional —> system, flaws, human error, or risky shortcuts taken under pressure
what is patient safety about
Keeping patients free from harm
Providing high quality healthcare
Decreasing risks to patients
Implementing evidence-based interventions
Why is Patient Safety Important?
1 in 17 hospital stays (about 150,000 out of 2.5 million) involved at least one harmful event
These events are categorized as:
47% related to health care and medications (e.g., bed sores, medication errors)
31% related to infections (e.g., surgical site infections)
18% procedure-related (e.g., bleeding after surgery)
4% patient accidents (e.g., falls)
***Note: These figures exclude data from Quebec and patients with mental health or substance use diagnoses.
inequity in healthcare
quality of healthcare varies significantly across populations influenced by age, gender, race and ethnicity, geography, and socio-eoconomic status
indigenous people, black communities, LGBTQ2S+, immigrants + newcomers, radicalized groups
is patient safety improving
following covid patient safety was displaced by recovery efforts, workforce burnout, climate change, and heightened political and economic uncertainty
infection control took precedence
lack of family presence decreased safety, less experienced staff hired and orientation efforts reduced
What are some of the barriers to patient safety?
Safety goes beyond just physical
Emerging technologies: AI and EHR can create gaps if not user friendly or replaces rather then supports clinical judgment
Resistance to change: staff may resist new protocols or safety initiatives due to fear of lame, lack of trust in leadership, burnout. creating a culture of safety requires buy in, transparency, psychological safety
Communication failures: one of leading causes, unclear handovers, language barriers, and assumptions made
Workload issues: high patient to nurse ratios, overtime, and staff shortages
Training issues: inconsistent or outdated training can leave staff unprepared for emergencies or new procedures. ongoing education, simulation training, and interprofessional learning
How do we Improve patient safety?
Invest in staff education, teamwork, and leadership development.
Engage with Patients and Families
Strengthening Safety Culture —> promote non-punitive environments
Use Data and Technology Wisely —> user-friendly + integrated
Support the workforce (work-life balance)
Promote Equity and Inclusion
What is Safety Culture?
“Culture refers to shared values (what is important) and beliefs (what is held to be true) that interact with a system’s structures and control mechanisms to produce behavioural norms.”
“It influences patient safety directly by determining accepted practices and indirectly by acting as a barrier or enabler to the adoption of behaviours that promote patient safety.” Healthcare excellence Canada, 2025.
combo of values, beliefs, and structures to promote pt safety
Components of Patient Safety Culture (FIVE DIMENSIONS)
Informed culture – relevant safety information is collected, analyzed and actively disseminated —> staff aware of risk/trends + evidence-based decisions
Reporting culture – an atmosphere where people have the confidence and feel safe to report safety concerns without fear of blame, and they trust that concerns will be acted upon
Learning culture – preventable patient safety incidents are seen as opportunities for learning and changes are made as a result
Just culture – the importance of fairly balancing an understanding system failure with professional accountability —> systemic issues
wrong med (nurse is at fault) —> also pharm labelling, understaffed, computer glitching
Flexible culture – people are capable of adapting effectively to changing demands
Key Contributors to culture of safety
Leadership (Board, Directors, Managers): sets the tone, reflected in policies, resource allocation, and accountability structures. leaders empower staff to prioritize safety
Teamwork and communication: interprofessional collaboration, handover reports + shared decision making
Openness to report and learn from problems and incidents: organizations must ensure reporting leads to action + feedback (encourages ppl to come forward)
Proactive organizational learning: identifying risks before harm occurs + anticipating problems and evolving practices
Organizational resources for patient safety: financial investment. safe staffing levels, training programs, and technology
Priority of safety versus production: safety should not be compromised for speed/cost
organizational culture
beliefs, values, norms, shared by health care staff
determines behaviours that are rewarded, supported, expected, and accepted
exists at multiple levels: system, organization, department, unit
just culture
A framework that promotes fairness, accountability, and learning by recognizing human fallibility and responding to errors in a non punitive way.
Key Principles
Human Error ≠ Punishment: Mistakes are seen as learning opportunities.
Accountability with Compassion: Responses are based on the intent behind actions.
System Redesign: Focus on improving processes to prevent future errors.
Psychological Safety: Staff feel safe to report errors without fear.
The Role of Legislation - QCIPA
Quality of Care Information Protection Act (QCIPA)
Purpose to promote open, frank discussion about quality of care issues without the fear of reprisal (before critical incidents occured, but no one reported)
Includes learning from critical incidents related to patient care delivery
Applies to hospitals, independent health facilities,LTC homes, licensed medical laboratories and specimen collection centres
Information collected related to speculations, opinions, thoughts are considered quality of care information and cannot be used in legal or disciplinary proceedings nor disclosed to patient/family
Decision to use QCIPA is determined by the Quality of Care Committee of the Board
what occurs during a QCIPA meeting
critical incident happens, very little discussion abt why/how it happened + how to improve in the future
hospital administrators can go to the hospital board or QOC committee and ask for QCIPA meeting to be enacted
if committee agrees then facilitator appointed to ensure all case facts, documentation, and witness statements are analyzed + anyone involved in the situation is interviewed
at beginning of interview, facillitator will tell nurse (or whoever) that anything shared is covered under QCIPA + cannot be held accountable
e.g. “could’ve been better prepared, weren’t trained, physician didn’t do a good job and this is why”
information is confidential but used to make recommendations
***** if info is documented on pt chart it shared w others (pt + family), conversation during meeting is not shared
The Role of Legislation - QCIPA - implications
Cannot discuss the case outside of the review meeting.
Anything discussed prior to QCIPA being invoked is not protected
Cannot share information that is not factual for learning purposes (speculation or opinion-based content excluded from report)
“i think other nurse was distracted bc she has a lot going on at home” —> “we were short staffed that day and we each had 2 more pts)
Limited in what can be shared with patient/family
Only actions that have been implemented
Cannot link the implemented actions directly back to the case
explain what improvements were made but not necessarily that they were due to a particular incident
Role of Legislation - ECFAA
Excellent Care for All Act (ECFAA) – 2010
It helps define quality for the health care sector —> places obligation on hospitals and care facilities to always look at QOC
Reinforces shared responsibility for quality of care
Builds and supports boards’ capability to oversee the delivery of high quality of care —> encourages creation of quality improvement committees, looking at pt or employee satisfaction surveys etc.
performance compensation —> higher QOC more money from gov
Ensures health care organizations make information on their commitment to quality publicly available.
critical incidents to be reported to hospital adminstration, Medical Advisory Committee, patient + SDM to improve QOC
Patient Rights Disclosure
Right to know about adverse events and near misses concerning themselves
Open and honest communication with families
CPSI Canadian Disclosure Guidelines provides a comprehensive overview
Disclosure is the process by which a harmful patient safety incident is communicated to the patient (or SDM).
Patient Safety Incidents Definitions
Patient safety incident = an event or situation that could have or did result in unnecessary harm to the patient (all three under are examples)
Harmful incident = a patient safety incident that resulted in harm to the patient(aka “adverse event”) —> wrong med causing allergic reaction
No harm incident = a patient safety incident which reached the patient but no harm occurred —> wrong med no reaction
Near miss = a patient safety incident that did not reach the patient (aka “close call”) —> dispenses wrong med but not given
Disclosure Culture
Supports patients by:
Supporting patients clinically (e.g. monitor after wrong med)
Respecting patients
Informing patients
Supporting patients psychologically and emotionally (esp following traumatic experiences)
Supporting patients practically (able to seek second opinions, access support services, make lifestyle adjustments) —> not left in the dark
Apologies
Not an admission of guilt or wrong-doing.
Help to validate emotions and acknowledge their experience
Display empathy and compassion
Help to build and maintain trust
When to Disclose?
Analysis of event
harm from natural progression of med condition VS healthcare associated event (combination can occur)
harm resulted from recognized risk of procedure/treatment (would’ve been explained before) VS patient safety incident
harmful incident (ALWAYS disclose), no harm incident (GENERALLY disclose, follow organization) , near miss (GENERALLY NEED NO disclose unless ongoing safety risk—> can harm relationship / trust)
Key points for Disclosure
Identify the team (based on severity of harm and organizational policy)
harmful incident that results in death/disability may include hospital administrators, lawyers, doctors, etc.
no harm may be disclosed by nurse themselves
Meet to plan what and how the disclosure will take place
Disclosure should not be done alone
Always document the disclosure in the patient’s record
Follow up with the patient/family after the meeting to answer any additional
questions or provide more information