Based on our experience, we have identified 6 steps that health care organizations generally need to work through when addressing errors that involve many patients (Box 1
). The timely identification of an error is one of the more difficult steps. Errors are repeated because they are not immediately apparent. Typically, concerns are first raised by a clinician, technician or patient. Based on an initial estimate of the number of people affected, an appropriate sample of records or procedures needs to be reviewed to determine the extent of any further investigation.
Proposed steps to addressing a medical error affecting multiple patients
- Identify the error in a timely fashion. Typically this step is taken because of concern raised by patients or medical personnel about the quality of care given to a group of patients.
- Conduct a review of an appropriate sample of records or procedures to determine the extent of the error.
- If a full review is necessary, identify a project team, establish the scope of the review and determine the resources needed for the review.
- Identify patients who may have been affected by the error and include their records in the review.
- Review clinical records. When an error in laboratory or diagnostic testing has occurred, determine whether the resulting diagnostic report affected the clinician’s decisions, the appropriateness of care provided and the outcomes of that care.
- Inform patients and other stakeholders (e.g., affected hospital personnel, external authorities, insurers, family physicians, other health care institutions and the public). Affected patients need to be followed up individually by the physician who has been most closely involved in managing their care.
If a full review is necessary, then the next challenge facing the institutional leadership is to establish the period of the adverse event and the scope of the review. This step involves identifying a project team and determining the resources needed to undertake a full review. A list of patients who may have been affected by the error needs to be developed and their records included in the review. Staff need to be assigned and trained to perform high-quality and painstaking audits. Reliability checks and quality controls need to be considered in the training phase if more than 1 staff member is assigned to this task.
When a laboratory or diagnostic testing error has occurred, the review process needs to introduce steps to determine whether the resulting diagnostic report affected the decision-making of the clinician, the appropriateness of the patient care that was delivered and the potential outcomes of that care. Any decisions related to patient care that were made by the clinician on the basis of such a report need to be reviewed by an expert clinician or health care team. Moreover, institutional leaders need to determine the levels of independence required for those who make such evaluations as well as those who evaluate the overall findings of a review. Finally, physicians need to follow up with affected patients who require changes in treatment or have questions about their care.
Another difficult step is determining how and when to inform patients, other affected hospital personnel, external authorities, insurers and other stakeholders such as family physicians, other health care institutions and the public. Often numerous hospital departments need to be involved. Given the workload of the task, conducting a timely review may even require assistance from other health care organizations. Depending on the number of patients involved, months may be needed to determine whether specific patients were affected. Locating and contacting a large number of former patients is not easy. We believe that a disclosure process on this scale should not be initiated or led by the physicians who were directly involved in the error, despite current recommendations to the contrary.2
A clear disclosure plan is a necessity. The plan needs to include a timeline with specific dates and a communication strategy for disclosure to all affected groups, including the public. The specific information to be provided and the names of those who will provide it need to be listed.
A strategy for the management of data is also imperative. The team responsible for carrying out the review process needs to be able to identify, in real time, when all successful and unsuccessful attempts have been made to contact each of the patients affected and other stakeholders. To ensure appropriate sensitivity to the families of affected patients who have since died, protocol needs to be developed outlining the timing and manner of disclosure in these cases. Patients who are incapacitated may need to be contacted through surrogate decision-makers, who will need to be identified.