Adverse event reporting

Patient safety is a fundamental part of providing quality healthcare and practice managers and their practice staff play an integral role. Although practices take great care to ensure the safety of their patients, adverse, or sentinel* events do occur. When they do, as a practice manager it is important that you have a thorough system in place to manage these outcomes effectively and to identify and analyse the cause and effect of these events. The fundamental purpose of having a robust system in place is to reduce the risk of a similar incident occurring again.

* A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.

An adverse event, or incident, is any event or circumstance arising during care that could have or did lead to unexpected actual harm, loss or damage. Incidents include near misses, sentinel events and unsafe acts. For example:

An event that inappropriately places a patient, clinician, visitor, staff member, individual or practice property at risk.

• An event that puts the staff and/or the organisation in a position where there is a potential for legal action.
• An event that would not generally be expected in the routine patient episode.
• An unexpected or unusual occurrence, which is not consistent with accepted standards for providing care.
• Violent or threatening behaviour of any sort (including bullying/harassment).

A near miss is any event or circumstance arising during care that could have, but did not lead to unexpected actual harm, loss or damage.

As a practice manager you have a responsibility to promote and implement risk management strategies in your practice and to ensure all staff are involved actively in risk management. It is important to create a positive 'quality improvement' culture within the practice, and avoid a culture of 'blame' when things go wrong. The goal is to establish a practice culture that promotes event notification and provides staff with a comprehensive and effective system to ensure that all adverse events/incidents (including near misses) are reported, to enable the evaluation of their cause and effect, and the implementation of effective corrective action. This approach has been proven to assist in minimising the frequency and severity of adverse events, thereby improving healthcare delivery, and the provision of a safe environment for patients and staff. Avant has developed the Adverse Event Form. Practices may significantly reduce both their short- and long-term risks by repeating cycles of quality improvement review. This process can guide system improvement and process redesign.

The process that is often used to analyse an adverse event or near miss is called root cause analysis (RCA). RCA is a process used to investigate and categorise the root causes of adverse events and near misses – what and how an event occurred (or nearly occurred), and why? RCA avoids laying the blame with one or two persons, but instead reveals the distinct errors leading up to an adverse event/near miss. It looks beyond individual actions and identifies the underlying causes in the context in which the adverse event occurred.

• An event is considered outside of the RCA scope if it appears to be the result of:
• a criminal act
• a purposefully unsafe act.
• an act related to substance abuse by health provider or staff
• an event involving suspected patient abuse of any kind.

In your role as a practice manager you should familiarise yourself with Reason's ‘Swiss cheese’ model which has become the accepted method for analysing medical errors and patient safety incidents. Below is an example of how this might be used in analysing an adverse event involving a delay in follow-up of pathology results:

1. Identification
2. Notification (e.g. in an incident information management system)
3. Prioritisation
4. Investigation
5. Analysis and action
6. Classification
7. Feedback

To effectively manage adverse events in your practice, you will need to establish a culture for patient safety. You can start this process by looking at education and training in your practice.

This education and training starts at the induction of all staff when they join the practice – both clinical and administrative staff need to know their role in providing safe care to patients and require education on patient safety, practice-specific initiatives and lessons learned internally and externally: this should form part of the practice’s clinical governance policy. Practice risk strategies can include:

• an escalation hierarchy for the reporting of critical and other abnormal pathology results
• a system for checking that test results have been reviewed and acted upon appropriately. Including a central register to monitor all results have been received for all tests ordered including use of an outstanding audit trail. Perhaps put our sample test tracker as resource and advise to research capabilities within your computer software to identify the easy use of an outstanding audit trail. See the Tracking tests topic
• regular practice team (clinical governance) meetings to discuss any adverse events, near misses or other incidents. This will encourage an open communication culture and avoid any fear of blame among practice staff.
• policies and procedures which are informative and updated/reviewed at regular intervals to ensure that all staff understand their role in managing adverse events.

In accordance with your risk management responsibilities as a practice manager, it is important to act immediately following an adverse event and as soon as practicable following a near miss.

When an adverse event or near miss is recognised as having occurred, the staff member involved or the witness to the event should:

1. notify the practice manager or a senior member of the practice team note the facts of the situation on the patient record – staff should refrain from making any judgments as to the causation of the event and simply state what was observed and the actions taken at the time
2. document the incident on the practice adverse event reporting form or incident report as soon as practicable.
3. develop a procedure to be followed which includes the action, who is responsible for the action and a timeframe.
4. Follow up and review of the issues should take place as soon as possible by the person in the practice designated with risk management responsibilities.

If an adverse event occurs in your practice, it is critical to involve patients and their family in the discussion of the adverse event. ‘Open disclosure’ is the open discussion of incidents that result in harm to a patient while receiving healthcare. It is important to acknowledge that expressions of regret such as, “I’m sorry this has happened to you”, are not an admission of liability. Discussing adverse outcomes is frequently associated with highly charged emotions, therefore any discussions with patients and their families should be carefully planned, with an agenda to facilitate this process. It may be prudent to discuss with a legal expert, for instance from Avant, the circumstances of the event and what sorts of things may be safely said without risk of legal liability being assumed.

For information to guide this process, see Avant resources on open disclosure – ‘How to say sorry’.

With regard to a near miss, there may not be a need to involve patients and their family if no detrimental outcome has resulted.