Originally published March 2010 / revised November 2017
Could the following occur in your hospital or institution? Would it be reported and what would happen?
A 45-year-old male, being followed for difficult-to-control asthma, presented with cough and fever to his respirologist in a hospital outpatient clinic. The clinical findings were sufficient that a chest X-ray was ordered. Antibiotics were prescribed for a presumptive early pneumonia. The patient was discharged with instructions on symptoms to watch for that would prompt him to seek further medical care. As for the X-ray, the patient was told that "no news is good news," but if the report was positive then the patient would be telephoned. The encounter was well documented in the medical record. Months later, the patient returned because of worsening symptoms. At that visit, the report of the chest X-ray was discovered in the medical record. An important finding suspicious for lung cancer had not been followed up.
Improving patient safety
Patient safety experts have recognized that more patient safety incidents can be prevented over time by strengthening system protections, which will benefit future patients. Blaming an individual provider most often does not change the factors that contributed to the patient safety incident. The same problem may recur for another patient and provider unless a real attempt is made to understand the circumstances and context for action and decision-making at the time of the event.
The challenge is to find the right balance between improving systems of care to help prevent similar events in the future, while fairly addressing any issues of individual provider performance and accountability. Many healthcare experts have identified the shift to a more balanced approach as establishing a "fair and just" culture of patient safety.
Advice on incident/occurrence reports
Most hospitals have policies and a system for reporting patient safety incidents and near misses.
These reports are usually not considered quality improvement information and are unlikely to benefit from legislative protection from disclosure in legal, regulatory or other proceedings. Incident/occurrence reports should not be kept in the patient's medical record, except in Ontario and Québec, where the law requires a copy be placed in the hospital's medical record for a patient.1
Reports should contain only facts from the medical record. In a just culture of safety, the reasons for clinical outcomes and events are not prejudged, and any rush to blame individuals is avoided. Reports should, therefore, not contain statements of blame, speculation, opinion or other commentary as to the reasons for what happened, or any recommendations.
While it is important to report patient safety incidents and near misses, what is done with these reports is equally significant.
What is a just culture of safety?
In a just culture of safety, the leaders and all staff are committed to providing the safest possible care to patients. There is a shared commitment to learn from patient safety incidents and near misses and make improvements. The interests of both patients and providers are protected.
Types of reviews
Broadly speaking, there are two types of reviews of patient safety incidents that should be used by leadership/management in Canadian hospitals. If asked to participate in a review, physicians should first determine what type it is. A quality improvement (QI) review examines system issues, whereas an accountability review looks at the specific care by an individual provider (for example, the respirologist in the case involving the failure to follow-up on the chest X-ray).
Generally, the preferred approach is to start the process with a QI review. Accountability reviews should only occur in response to a concern that an individual provider’s performance may have caused a patient safety incident. If serious concerns regarding a provider's performance or conduct are discovered in the course of a QI review, the QI review should be halted or accountability issues segregated in a separate process so that these issues may be appropriately considered.
Quality improvement reviews
Reviews by quality improvement committees2 are designed to identify the reasons for patient safety incidents or near misses by looking at the system in which healthcare is provided.
To encourage the full participation of providers, the legislation in each province/territory generally protects the work of a QI committee. Unless specifically exempt from protection, the opinions and documents prepared for or generated by a QI committee cannot be used in subsequent legal, regulatory or other proceedings. Following the analysis, the patient should be informed of new facts identified in the analysis of the event and the conclusions (but not the opinions leading to the conclusion) describing the reasons for the clinical outcome. It is also appropriate to share recommendations for improvement, but not the deliberations, opinions and speculations that led to them. An apology may be considered when appropriate. Legislation in some jurisdictions imposes requirements on hospitals and health authorities regarding the specific information that must be disclosed to affected patients.
The CMPA supports learning from properly structured and conducted QI reviews and encourages its members to participate. Participation by providers in reviews of patient safety incidents may be mandated by law in some provinces/territories or by hospital bylaws.
In the case with the respirologist, the event was used as an opportunity to look at the existing administrative systems of several hospital departments for their follow-up of test and diagnostic imaging reports. The QI review identified several potential failure points in the system, and allowed these vulnerabilities to be corrected.
The role of hindsight bias
In reviewing a patient's clinical outcome, all involved should help gather the facts but avoid blaming themselves or others. Knowing an undesirable outcome has occurred increases the belief that it was predictable and therefore preventable. This "hindsight bias" contributes to the belief that the unexpected outcome was due to carelessness or poor clinical care, rather than the context or specific conditions in which the individual provider was working.
At times the hospital/departmental chiefs or other leadership may decide to conduct an accountability review to focus on a specific provider's role in a patient safety incident. In a just culture of safety, when a deficiency in a provider's performance is identified, education and support are the preferred approaches. Sometimes discipline and other sanctions may be necessary.
Healthcare providers are generally obligated to take part in reviews of their own professional work, if asked to do so. Members should contact the CMPA for advice.
Building a just culture of safety
Identifying and reporting patient safety incidents and near misses is a cornerstone of patient safety and is vital to improving the quality of care. Properly structured QI reviews are an important way to encourage healthcare providers to assess and improve the healthcare system.
General advice about patient safety incidents
Communicating with your patient
Following a patient safety incident, patients have clinical, emotional and information needs.
Reporting to the hospital/institution
- Physicians should be familiar with, and follow the policies and procedures regarding, the reporting of patient safety incidents
- Physicians should provide only factual information in incident/occurrence reports and refrain from statements of blame, speculation, opinion or other commentary as to the reasons for what happened.
Participating in QI reviews of patient safety incidents
- Inquire as to whether the QI committee is properly constituted under the relevant legislation and seek assurances that QI reviews will be conducted in a confidential manner. Physicians are encouraged to fully participate in systems-oriented QI reviews.
Participating in an accountability review about your professional work
- Participate, as it is generally an obligation to take part.
- Contact the CMPA for advice.
- Remain factual and do not speculate.
Contact the CMPA for advice if…
- You are generally uncertain how to proceed.
- You are obliged to participate in a QI review structured outside the parameters of the relevant provincial/territorial legislation.
- Your privileges are threatened.
- A coroner/medical examiner is requesting information from a review or a regulatory authority (College) disciplinary proceeding in which you are involved.
- You have been threatened with litigation or named in litigation that has already begun.
CMPA members are encouraged to understand the difference between a quality improvement review and an accountability review, in terms of their different purposes, procedures, the likely approach to analysis, information protections and consequences.
- Under Québec law, a near miss is termed an "incident" and a patient safety incident is an "accident"; both are specifically defined in legislation. The law requires the completion of a report for both incidents and accidents in government-run institutions such as hospitals. A copy of the report is kept in the patient's hospital medical record. In Ontario, the Public Hospitals Act regulations require that an incident report be filed in a patient’s hospital medical record when the patient experiences a “critical incident,” defined as any unintended event that occurs when a patient receives treatment in hospital that results in death, or serious disability, or serious injury or serious harm, and does not result primarily from the patient’s underlying medical condition or from a known risk inherent in providing the treatment.
- Quality improvement committees, depending on the province or territory, may have different titles, for example: Quality of Care, Critical Incident Review, Risk Management.