Adverse Event Management Framework

Introduction

The Canadian Patient Safety Institute (CPSI) defines an adverse event as an unexpected event in healthcare delivery that results in harm to the patient and is related to the care and/or services provided to the patient, rather than to the patient’s underlying medical condition. (Canadian Patient Safety Institute. Canadian Disclosure Guidelines, March 2008). While the health and community services system must strive to prevent the occurrence of adverse events, it is an unfortunate reality that such events do happen. Therefore, it is essential that the system is equipped with policies and procedures to quickly address adverse events when they occur. In this way, harm to patients and clients will be minimized and lessons from these events can be rapidly used to prevent future adverse events. Patients and the public understand that every adverse event cannot be prevented, but they expect a high standard for managing an adverse event once it has occurred.

The Task Force has been asked by government to examine how the health and community services system in Newfoundland and Labrador addresses adverse events. The Task Force will examine how the system identifies, assesses, discloses and takes action on adverse events, as well as how effective communication can facilitate these processes.

The Task Force will examine current practices within Newfoundland and Labrador, identify best practices across Canada, identify case studies, interview experts, consult closely with regional health authorities and stakeholders, and hold a forum to synthesize views and perspectives on the issues.

What will the Task Force be examining?

The terms of reference requires the Task Force to focus on the “health system”. For purposes of its workplan, the Task Force will define the health system to include publicly funded bodies such as regional health authorities (RHAs) and the Department of Health and Community Services. Most contact with patients occurs in facilities of RHAs, though some services of RHAs are provided directly to patients or clients in other private or domestic settings.

The Task Force, in general, will not examine patient-provider adverse events which occur in private practice settings unless they involve employees or agents of the RHAs or the Department of Health and Community Services. However, there may be issues in private settings which need special attention in this review, such as services provided under contract from, or regulated by, a RHA or the Department of Health and Community Services. Services provided by private fee-for-service professionals within the facilities of a RHA are within the scope of the Task Force.

RHAs provide both acute care and community services. The latter category contains such services as public health, home care, long term care, and child, youth and family services. While adverse events management is a concept rooted in acute health care settings, the Task Force will apply this concept to "community services" offered by RHAs and adapt it to unique circumstances.

The Task Force is interested in the full continuum from single patient/client events to large multi-patient events. In the case of multi-patient events, special attention will be given to coordination across multiple jurisdictions (e.g., multiple RHAs).

Managing adverse events after they occur is not a simple matter of patient-provider contact. It goes well beyond disclosure of information to the patient. Responding to adverse events involves care providers, quality officials, managers, and other people in support roles. It is a complex process that needs to be well-defined, adopted in policy, reinforced through training, and cultivated in the organizational culture.

RHAs currently expend much effort on patient safety activities, though not all such activities are of relevance to the Task Force. For example, a new online pharmaceutical prescribing system may avoid many adverse events each year. New procedures for placing children in care may avoid dangerous situations for children and health care providers. Such initiatives are patient/client safety improvements which prevent adverse events, and they must be supported, but they fall outside the purview of the Task Force because they are not part of the management of adverse events.

The Adverse Event Management Framework

A six part conceptual framework has been developed to describe the stages and processes of managing an adverse event. This framework will be modified and improved through the workplan of the Task Force and the input of partners and stakeholders.

“Identifying” Adverse Events

Identification of adverse events can include systems for management of patient complaints, provider self-reporting and team reporting, occurrence reporting, monitoring performance data, and indicator reporting.

“Assessing” Adverse Events

Assessment of adverse events may be a small or large task depending on the impact which the event has on the health or well-being of the patient/client and the number of clients and patients affected. In an event of minimal impact on a single person, assessment may be limited to an occurrence report which describes the event and the involvement of just a few people. In a more complex or significant event, the assessment process might take place in two or more stages, the first stage involving sufficient assessment to enable disclosure to the patient; and later stages to better understand how the event occurred and the lessons which can be learned. Formal techniques for investigating adverse events, such as root cause analysis and peer review, may be used in these instances.

“Disclosing” Adverse Events

Disclosure to affected patients and clients is a critical part of managing an adverse event and has been the focus of considerable attention in recent years. The recent publication of disclosure guidelines by the Canadian Patient Safety Institute is a significant aid to the work of the Task Force, and means that the Task Force, rather than duplicating this effort, can consider its applicability to a Newfoundland and Labrador setting. Special issues for consideration will include disclosure in multi-patient and multi-jurisdictional events. The symposium sponsored by the Commission of Inquiry on Hormone Receptor Testing on April 22 and 23, 2008 focused primarily on the disclosure process, and the papers and presentations at the symposium will be reviewed by the Task Force.

“Acting” on Adverse Events

Acting on adverse events includes the immediate types of diagnostic, treatment and supportive services that are provided to a patient or client, and activities that ensure the source of harm is removed. It also includes fixing the problems identified in an assessment, such as implementing capital repairs, new machinery, new information systems, training and reorganization or new policies. Capturing lessons learned so that other providers can be informed, and educational programs modified is equally important. The Task Force is not focused on which specific changes might occur after an adverse event, but rather that an action stage is included as a critical part of the overall response process. The response process is not completed unless the action stage is fully implemented.

"Communicating, Coordinating and Leading" on Adverse Events

Responding to adverse events will only be effective if there is good leadership and coordination. Communication, both internal and external, is a central feature of leadership and coordination. The Task Force will look at communication at every stage of the adverse event framework. In a small event, who writes a report, who informs management, who receives the report, and who else needs to know? In a larger event with the involvement of many players, there needs to be a protocol for a single leader, communication channels, data management, and reporting. Depending on the circumstances there may be a need to communicate with the board of directors, government, other external stakeholders and the public through the media. When do these requirements start and who is in charge?

Follow-up Evaluation

Managing adverse events includes evaluation to ensure that policies and procedures are implemented and followed as designed, and that recommendations arising from specific events are acted upon within a predetermined time frame.