NOTE: Physicians seeking guidance about disclosing harm from healthcare delivery are advised to read the CMPA handbook Disclosing harm from healthcare delivery: Open and honest communication with patients. The following article describes processes and responsibilities for the handling of large-scale harmful incidents (i.e. incidents in which more than one patient has been affected). These responsibilities may be shared among leaders of healthcare organizations and individual physicians.
What are large-scale harmful incidents?
A harmful incident refers to an event or circumstance that results in harm to the patient. When a harmful incident affects more than one patient, it is considered a large-scale harmful incident. Examples of large-scale harmful incidents include:
- harm from the delayed delivery of diagnostic imaging reports due to computer issues
- improper disinfection of surgical instruments
- malfunctioning or inaccurately calibrated equipment
- incorrectly conducted diagnostic or laboratory tests
- multiple incidents resulting from the acts of a single healthcare worker, discovered after a retrospective review triggered by one incident
Roles and responsibilities
With any harmful incident, affected patients should be notified to ensure that their clinical, emotional, and information needs are met. Patients may also need to be notified when there is potential harm, such as patients having been exposed to poorly sterilized equipment—though not all potentially harmful incidents necessarily require disclosure.
When harmful incidents take place on a large scale, there are unique considerations, such as who is responsible for disclosure and what role treating physicians have in these situations.
Healthcare organizations will often have protocols that outline a general plan and steps to be taken in relation to large-scale harmful incidents. While physicians in leadership roles will likely have greater involvement in managing, reporting and disclosing these incidents, treating physicians are generally responsible for providing clinical and emotional support to their patients.
Initial actions following a large-scale harmful incident
Once a large-scale harmful incident has been discovered, the healthcare organization should assess the potential of an imminent safety risk. If there is a risk, the organization should take immediate steps to protect patients, healthcare workers, and others by correcting any ongoing safety issues (e.g. correcting biohazard risks or equipment problems). Treating physicians should provide any necessary follow-up diagnostic testing and treatment as soon as possible to prevent any further harm.
Once safety risks have been addressed, the healthcare organization will typically conduct a critical incident review. Even if the harm to patients is obvious, proper analysis is needed. Examining a sample of medical records or administrative data may help to estimate the resources required to conduct the review and provide appropriate disclosure as soon as reasonably possible. The CMPA encourages physicians, especially those in leadership positions, to participate in large-scale harmful incident reviews when requested.
Providing disclosure to patients
The CMPA handbook Disclosing harm from healthcare delivery: Open and honest communication with patients provides suggestions on how to meet the needs of patients affected by harmful incidents.
Following a large-scale harmful incident, it can be challenging to determine to which patients to disclose the incident. The threshold for notifying patients should be whether there is a realistic possibility of harm, as opposed to a theoretical risk of harm. If a review indicates that the incident did not reach the patient and that no harm occurred (a “near miss”), then disclosure to patients is generally not required. Early consultation with experts, including legal counsel, can be helpful in determining which patients require notification.
Generally, the more urgent or serious the risk of harm, the stronger the case for in-person initial disclosure. Where the risk is less urgent or less serious, or where in-person initial disclosure is not practical, written communication might be more appropriate.
The decision as to who will provide disclosure will vary depending on the circumstances. Individual physicians working in a clinic or institutional setting should not act on their own but rather do so in accordance with the organization’s plan.
All meetings and written communications should take place in the same short time period. These communications should include emotional support for patients and families and, if applicable, should mention any new measures that are being taken to minimize the risk of similar incidents in future. Treating physicians can also be a valuable source of information and support for patients, though it is important that physicians providing such support take into account the overall response plan.
As large-scale harmful incidents can lead to class action lawsuits, physician leaders should ensure their organization has procedures in place for documenting every step of disclosure: how affected patients are identified, which patients were notified and how they were informed, efforts to provide emotional support, and documentation of related clinical care for individual patients.
Communicating with other healthcare workers
It is generally appropriate for leadership to brief the healthcare professionals involved in a large-scale harmful incident and subsequent patient care. Briefings should include a reminder about the importance of maintaining patient confidentiality in any discussions. Where appropriate, support should be offered to the professionals involved.
Leaders may also consider providing information to other healthcare workers within the organization. While these individuals may not have been directly involved in the incident, they may still benefit from guidance on how to respond to any inquiries they receive.
As information disclosed to multiple patients will potentially trigger media interest, it is important for healthcare organizations to have a plan for a coordinated response.
Individual physicians should be guided by the media relations procedures in their hospital, clinic, institution, or regional health authority. If a healthcare organization prefers to alert the media before the review of the large-scale harmful incident is complete, it should avoid making premature, unsubstantiated, or inappropriate statements, including comments about professional competency.
Leaders should also determine whether information needs to be provided to other stakeholders to limit the likelihood of similar occurrences (e.g. other healthcare organizations, equipment or pharmaceutical manufacturers, computer software vendors).