Executive Summary
The Pennsylvania Patient Safety Reporting System (PA-PSRS), a statewide adverse event and near miss reporting system of the Pennsylvania Patient Safety Authority, received 277 reports related to alarm response during medical telemetry monitoring between June 2004 and October 2006. All the reports described events in which patients were not consistently monitored for physiologic condition, and three events resulted in patient death.
Telemetry physiologic monitoring systems generate visual and audible alarm signals based on changes in patient physiologic conditions that violate established alarm criteria for a specific patient or a particular patient population. A key function of monitoring systems is to alert appropriate staff to the change in patient condition so that staff can promptly intervene with the appropriate care.
Prompted by the reports—especially because three involved patient death—PA-PSRS analysts conducted a failure mode and effects analysis (FMEA) to help healthcare facilities better understand the FMEA process and use the lessons learned and our remediation results as guidance in developing facility-specific process remediation strategies for similar alarm response events. FMEA is a proactive risk assessment method used to evaluate a system or process in order to identify potential failures and develop and implement mitigation strategies to reduce or eliminate failures before they occur.
Our FMEA focused on the stage in the telemetry monitoring process specific to alarm intervention in response to a change in patient physiologic condition. The high-priority failure modes that we targeted for mitigation include the following:
- Patient misidentification
- Human/equipment error (i.e., telemetry transceiver not connected to patient, signal drop out)
- Alarm condition not detected
- Alarm condition not detected by electrocardiography (ECG)-qualified staff
- ECG-qualified staff not available
- Detection of alarm condition delayed
- Verification of alarm condition delayed
- Locating patient delayed
- Intervention for alarm condition delayed
The high-priority failure modes listed above represent the core failure modes for the 29-step telemetry monitoring process we reviewed. Many of the failure modes were duplicated for the various process steps.
The common mitigation strategies that we developed, which can be implemented for several of the different failure modes we analyzed, include the following:
- Placing slave displays and alarm enunciators in strategic locations throughout a telemetry care area
- Developing a protocol for setting the volume level of an alarm to higher than the minimum audible level that can be heard in a typical environmental noise level for given care area (The volume level setting will be specific to the noise level for each healthcare facility’s care area environment.)
- Developing standardized practices for periodic ECG-electrode and lead-set inspection and replacement and proper electrode-site skin preparation
- Developing a protocol that requires prompt response for all alarm conditions (low-, medium-, high-priority alarms)
- Developing a protocol that establishes alarm limit default settings based on a particular patient population in a given care area
- Developing protocols that establish criteria for when and how to adjust alarm default limits per patient condition
- Developing protocols to delineate responsibility for primary alarm response and to establish tiers of backup alarm coverage
The results we obtained from our FMEA process can be used by healthcare facilities to understand their respective telemetry monitoring alarm response processes and similar process failures and as guidance in developing facility-specific risk reduction strategies.
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