An article for physicians by physicians
Originally published June 2011
While physicians and hospitals have generally established an appropriate process for disclosing harm or potential harm to individual patients, they may not have established a system for communicating with a large number of patients affected by the same adverse event. As well, at times physicians and hospital administration may have divergent views regarding how best to proceed. This article examines how advanced planning, properly structured reviews, and timely coordination can support effective multi-patient disclosure.
Patient safety experts recognize that adverse events are usually due to failures in the system or processes of care. An adverse event that affects a large number of patients can be the result of a single or repeated occurrence over a period of time. Examples of such large-scale adverse events include harm from the delayed delivery of diagnostic imaging reports due to computer programing problems, the improper disinfection of surgical instruments, malfunctioning or inaccurately calibrated equipment, or incorrectly conducted laboratory tests. Physicians, like all health professionals, often rely on these systems and processes.
An adverse event refers to unintended harm to a patient from healthcare delivery. A multi-patient or large-scale adverse event involves many patients.
It is also recognized that an individual healthcare provider's performance may result in, or contribute to, multi-patient adverse events. For example, a delay in the diagnosis of a serious medical condition may trigger a retrospective review of the quality of care of a physician's practice. This retrospective review may sometimes identify problems in the care provided to many other patients, each requiring individual disclosure.
Disclosing such events to patients is a significant challenge for healthcare organizations and providers and is stressful for patients. The potential for harm is not always easily quantified. Indeed, the risk and extent of harm, as well as the number and identity of the potentially affected patients, may initially be unknown.
Disclosure is the process of communicating the reasons for an adverse event to a patient.
Comprehensive planning is required. This ensures that a timely, properly structured, and fair review of the adverse event is initiated, that effective disclosure to patients takes place, and that patients' needs are addressed.
Organizations are encouraged to have a consistent approach for these events, including a prepared toolkit with a general plan and steps to be taken. Consulting with experts experienced in multi-patient adverse events may help establish what is needed. The plan should include emotional support for patients during the disclosure process, and include any necessary follow-up diagnostic testing and treatment.
Learning that an adverse event has or might have occurred
Learning that an adverse event has occurred can happen in a variety of ways.
Healthcare leaders may identify problems in care through clinical performance indicators, peer comparisons, or other benchmarks. Healthcare providers, workers, and patients may also raise concerns about care, including patterns of clinical outcomes and real or perceived issues in a healthcare facility.
Physicians, whether in leadership roles or in practice, should communicate patient safety concerns to the person responsible for validating the concern, initiating a proper review and, if warranted, taking corrective action. In a supportive and just culture of patient safety, reporting patient safety concerns is encouraged. It is important for the leaders of healthcare organizations to listen to concerns and to provide timely feedback on whether the concerns are valid and how they will be fairly addressed.
In a just culture of safety, the leaders and all staff of a healthcare organization are committed to providing the safest possible care to patients. There is a shared commitment to learn from adverse events and near misses and to make improvements. The interests of both patients and providers are protected.
Protection from ongoing safety risks
If there is an imminent safety risk, steps should be taken immediately to protect patients, healthcare providers and others by correcting any ongoing safety issues (e.g. correcting any existing biohazard or equipment problem).
As with any adverse event, the next priority is to take care of the clinical needs of affected patients and to reassure patients that their needs are being met. Any necessary follow-up diagnostic testing and treatment should be provided promptly.
Understanding what happened and assessing the risk
The next step is to identify which patients have been harmed or possibly been harmed (e.g. exposed to the risk of an infection).
An appropriate analysis of the event and an assessment of the relative risk of harm should take place as soon as reasonably possible so as to minimize, to the extent possible, any further harm to patients and others and minimize the loss of treatment opportunities for individual patients. This analysis will determine if there is a need for further care or if disclosure is required.
While it may be challenging to determine which patients may be at risk of harm, the threshold for notifying patients should be the existence of a realistic possibility of harm, as opposed to a theoretical risk of harm. Early consultation with experts, including legal counsel, can help determine the potential for harm and which patients require notification for a multi-patient adverse event.
Even if the occurrence of harm to patients is obvious, proper analysis is needed. All of the reasons for what happened will seldom be understood at this early stage.
Examining a sample of medical records or administrative data may help estimate the resources required to accomplish the entire review and achieve disclosure as soon as reasonably possible.
The role of physicians
Physicians, particularly those in leadership positions, may be asked to help conduct analyses of an event to determine if harm occurred and who might be affected.
The CMPA encourages physicians to take part in the review of multi-patient adverse events, and provide the disclosure, clinical assessment, follow-up, and emotional support to patients harmed or potentially harmed.
Deciding on multi-patient disclosure should be made on a situation-by-situation basis.
After the review analysis, answering the following questions will help to decide whether disclosure is appropriate:
- Has the review confirmed harm occurred to patients? If yes, disclosure and appropriate care and follow-up should occur.
- Has the review confirmed there are patients that have possibly been harmed? If so, disclosure and appropriate care and follow-up should occur.
- Does the review indicate what happened was a near miss1 (did not reach any patients) and therefore that no harm occurred? If so, disclosure to patients is generally not required.
1 Near miss: an adverse event which did not reach the patient (WHO ICPS 2009). Reached in this context means the event did not touch or enter the patient. Sometimes called a "close call" or "good catch."
Suggestions for providing disclosure
Planning and timing
Having determined that disclosure should occur, the importance of planning the disclosure cannot be overstated. The CMPA booklet, Disclosing harm from healthcare delivery: Open and honest communication with patients, provides suggestions on how to meet the clinical, information, and emotional needs of patients and families who have experienced unexpected clinical outcomes, including harm from healthcare delivery. Patients affected by large-scale adverse events have the same needs.
Adequate resources should be available to readily and consistently communicate information, and respond to any questions. The goal is to provide disclosure to patients as soon as reasonably possible to minimize the loss of treatment opportunities.
Emotional stress produced by the disclosure should be anticipated, and counselling and support be made available to patients and families.
Who provides disclosure and where
The decision as to who will provide disclosure will vary depending on the circumstances. The healthcare organization may have protocols for such notification.
The more urgent or serious the risk of harm, the stronger is 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 may be appropriate. Ideally, all of the required meetings should be held in the same short time period3.
What information is provided?
Speculation and blaming are not part of disclosure. Briefing sessions and an information package for those providing multi-patient disclosure are often useful. The package may include:
- A factual description of what has happened, including clinical advice relating to the harm or possibility of harm from the exposure to the event.
- A recommended care plan that includes any immediate testing requirements, treatment recommendations, and follow-up advice. In the case of contagious infectious diseases, testing may be required for those who may have been exposed to the risk of infection from the patient. Public health officials may also have to become involved.
- Answers to expected questions, supported by the clinical facts.
- Contact information if there are further questions.
- Recommended sources of information and supports for patients.
Printed or online information on the clinical condition may be appreciated by patients, but should not replace individual discussion and advice.
In complex cases, the perspective of the institution or hospital may differ from that of the physician, increasing the importance of seeking CMPA advice.
Patients may wish to learn about any safety improvements being made to the system that will minimize the risk of similar events occurring in the future. Although sometimes improvements are not possible, when changes are made to the processes of care based on quality improvement recommendations, these should be disclosed to patients. An organization's leadership or management must decide whether provincial or territorial law allows the release of quality improvement system recommendations that have not yet been implemented and whether it is appropriate for these to be discussed with patients4.
In appropriate circumstances, a sincere apology acknowledging responsibility may be made to individual patients. When a healthcare organization is involved, a consideration will be who should make the apology and what should be stated.
The CMPA recommends that those making apologies avoid using words that express or imply legal responsibility such as "negligence" or "fault," and avoid referring to "failure to meet the standard of care." Such legal determinations are complex. Generally, the courts are responsible for making these determinations based on the evidence, including independent expert peer opinion.
Documentation of disclosure
TThe review of any adverse event should be carefully documented, including the decision-making process used to identify harmed or potentially harmed patients. Should the disclosure and subsequent patient care be questioned later, appropriate documentation will confirm that the situation was approached in a well-thought-out manner that benefited patients.
3 Chafe, R., Levinson, W., Sullivan, T. "Disclosing errors that affect multiple patients." CMAJ, (May 26, 2009) Vol. 180 no. 11 p.1125-27.
4 Legislation across the provinces and territories can differ on whether the recommendations from a QI review can be disclosed to patients or released to the public. Generally speaking, factual statements about actual systemic improvements that have been implemented are appropriate for disclosure. CMPA members are encouraged to contact the Association prior to making any disclosure.
Communicating with others
Leaders involved in disclosing a large-scale adverse event should 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)
- public health individuals or organizations (e.g. medical officer of health), in accordance with a legal duty to report
- the general public, to alert and reassure (e.g. through the media or another means of mass communication).
Communicating within the healthcare organization
It is generally appropriate for leadership and management to brief the healthcare professionals involved in the adverse event, as well as those involved in subsequent patient care and follow-up. The briefings should include a reminder about the importance of maintaining patient confidentiality in any discussions. Where appropriate, support should be offered to the professionals involved5.
Consideration should also be given as to whether it is appropriate to provide information to other healthcare providers (e.g. healthcare providers in the organization, local family physicians, staff, etc.) who may not have been directly involved in the adverse event, but still may receive questions or inquiries from patients who were involved or potentially affected. These individuals require adequate information and guidance on how to respond.
The general public and the media
Recognizing that information being disclosed to multiple patients will likely trigger media interest, it is important to have a plan for a coordinated response to media or public inquiries.
Physicians should be guided by the media relations procedures in their hospital, institution, or regional health authority. Any public statements, including apologies or disclosure, should not include a claim to speak on behalf of another professional or the institution, unless advance authorization has been given. To the extent the media is advised about a large-scale adverse event, the privacy of patients and healthcare providers must be respected, unless these individuals have consented to the release of their personal information
A healthcare organization may prefer to alert the media before a review of a multi-patient adverse event is complete. In these circumstances, it is important to avoid premature, unsubstantiated, or inappropriate remarks, including comments about professional competency. Such comments can be misleading and have the potential to destroy careers and reputations.
The Canadian Patient Safety Institute provides further information in Guidelines for informing the media after an adverse event, available at http://www.patientsafetyinstitute.ca
5 Wu, Albert. "Medical error: the second victim. The doctor who makes the mistake needs help too." British Medical Journal (2000) Vol. 320 p. 726-727.
Litigation and documentation
Although disclosure is the right thing to do, any adverse event can lead to legal action.
The careful documentation of disclosure, related clinical care, and the efforts to emotionally support the patient will help establish later what was done. This is also important in large-scale adverse events, which can lead to class action lawsuits. A class action is a lawsuit brought by a group of plaintiffs with a similar interest in a particular issue in the litigation. (See "Class actions: On the increase?".)
Depending on the circumstances, patients may claim that they were harmed by the mental stress of simply learning about the possibility of potential harm, even if subsequent testing proves negative. While the courts have tended to decline to award damages in respect of such claims, these allegations reinforce the need for appropriate explanation and emotional support for patients during the disclosure process.
Reviews of large-scale adverse events
Reviews of large-scale adverse events will vary in type and scope.
CMPA members are encouraged to understand the difference between a quality improvement review, which focuses on systems and processes of care, and an accountability review, which focuses on individual providers. Each type of review is different in purpose, procedures, approach to analysis, information protections, and consequences. For more information read the CMPA booklet, Learning from adverse events: Fostering a just culture of safety in Canadian hospitals and healthcare institutions.
Participating in quality improvement reviews of adverse events
- Inquire as to whether the quality improvement committee is properly constituted under the relevant legislation and seek assurances that quality improvement reviews will be conducted in a confidential manner. Fully participate in systems-oriented quality improvement reviews.
Participating in an accountability review about your professional work
- Participate, as it is generally an obligation to take part.
- Remain factual and do not speculate.
Contact the CMPA for advice if...
- You are uncertain how to proceed or are uncomfortable with the process, your role in the process, or the advice being given to patients.
- You are obliged to participate in a quality improvement review structured outside the parameters of the relevant provincial or territorial legislation.
- You are involved in an accountability review about your professional work.
- Your privileges are threatened.
- A coroner or medical examiner is requesting information from a review or a medical regulatory authority (College) disciplinary proceeding in which you are involved.
- You have been threatened with litigation or named in litigation that has already begun.
No matter if one or many patients are involved, patients have clinical, emotional, and information needs following an adverse event or when exposed to the risk of harm. Multi-patient disclosure following a large-scale adverse event can add complexity. Meeting these patients' needs typically requires interdisciplinary planning, collaboration, and commitment of appropriate resources.