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“CORRECT" Classification and Reporting of a Patient Safety Event

Patient safety in Pennsylvania is largely directed by Pennsylvania’s Medical Care Availability and Reduction of Error (MCARE) Act, which requires some healthcare organizations to report incidents, serious events, and infrastructure failures (see MCARE for definitions) into the Pennsylvania Patient Safety Reporting System (PA-PSRS). Many variables, including the complexity of healthcare, impact reporting and create inconsistencies.


This is most evident in facility determination of serious events. Final Guidance developed by key stakeholders provides criteria for serious event classification, with the intent to create consistency in reporting among facilities. The PSA encourages the use of the Final Guidance, as well as the FAQs and Reporting Decision Tree, to help make determinations in reporting.


A recent review of PA-PSRS events related to returns to surgery uncovered opportunities for reinforcement related to two specific guidance principles, known complications and high risk.


The PSA found that many return to surgery events are reported as incidents. If you perform surgical procedures in your area, consider reviewing the Final Guidance, #3 and #4.

1. Known Complications (FG3)a

A known complication is not typically considered anticipated by the patient.

If a patient experiences a “known complication” and/or a situation that is “discussed during consent,” the event is likely still reportable as a serious event if no other exclusion criteria apply, such as the patient being at a higher-than-normal risk.

2. High Risk (FG4)b

If a patient is at “high risk” for a return to surgery, it would be considered anticipated and not reportable as a serious event or incident. There is no need to enter a report into PA-PSRS.

Two conditions must be met for a patient to meet high-risk criteria.

a.  Disclosure to the patient (of the high probability of complication)

b.   Documentation in the chart/consent (of the high probability of complication)

*This does NOT pertain to the “standard” consent discussion or document (see #1 above).

Disclose High Risk

Document High Risk

Event Classification



No report



Serious Event



Serious Event



Serious Event

Most return to surgery events should be reported into PA-PSRS as serious events. Nothing in healthcare is absolute and there are many nuances that make each situation unique which may impact the report classification. Please contact your facility’s patient safety liaison for additional support. 

Telemetry Monitoring: Improvement Strategies for Everyone

Anyone who has worked in the clinical setting with telemetry monitoring recognizes this constant sound representing a patient’s heartbeat. Just as a guard stands watch, it reassures us that a patient is safe and well. However, over time the sounds of telemetry can also become background noise. What happens when the noise stops? Do you notice?

Cancellations and Transfers Related to New-Onset Atrial Fibrillation: An Analysis of Survey and Patient Safety Reporting Data From Ambulatory Surgical Facilities

Atrial fibrillation (AF) is a cardiac arrhythmia characterized by an irregular rhythm and often rapid heart rate. People with AF can be symptomatic or asymptomatic and are at increased risk for stroke. In this study, we used two data sources—a survey and Pennsylvania Patient Safety Reporting System (PA-PSRS) reports—to examine new-onset AF in Pennsylvania ambulatory surgical facilities (ASFs).

A Brief Analysis of Telemetry–Related Events

Successful telemetry monitoring relies on timely clinician response to potentially life-threatening cardiac rhythm abnormalities. Breakdowns in the processes and procedures associated with telemetry monitoring, as well as improperly functioning telemetry monitoring equipment, may lead to events that compromise patient safety.

Slow Down: New-Onset Atrial Fibrillation Challenges for Ambulatory Surgical Facilities

As patient safety liaisons (PSLs), we are continually educating and collaborating with our Pennsylvania healthcare facilities. We often are asked questions about reportable events under the Medical Care Availability and Reduction of Error (MCARE) Act. One of the most common examples we discuss is cancellations and transfers out of an ambulatory surgical facility (ASF).

Patient Safety Alert: Air Embolism During Cardiac Ablation

During a cardiac ablation procedure, the catheter irrigation fluid bag emptied and was replaced by staff. While priming the tubing, air was noted in the tube, and the catheter was immediately removed from the patient. The patient experienced a decrease of heart rate and blood pressure requiring a code response.

We All Win When Patients Speak Up: A Conversation With Patient Advocate Lisa Rodebaugh; Executive Director of the Patient Safety Authority (PSA), Regina Hoffman; and PSA director of Engagement, Caitlyn Allen

The patient is always at the center of discussions about patient safety. But patients shouldn’t only be talked about—they also need to participate in the conversation. They and their families have opportunities to be engaged in their own care: to share information, ask questions, and express their opinions. And if there aren’t opportunities to have a voice, patients can and should make their own and keep pushing to play an active role in their treatment.

a. “The disclosure of a potential complication on a patient consent form does not, in itself, constitute anticipation of the complication by the patient.” 44 Pa. Bull. 6178 (Sept. 27, 2014). Final Guidance for Acute Healthcare Facility Determinations of Reporting Requirements Under the Medical Care Availability and Reduction of Error (MCARE) Act.


b. “Complications may be considered anticipated (and therefore not meeting the Serious Event definition) when they occur frequently or the risk of the complication is considered high for a particular patient and the high probability of this complication was disclosed to the patient in the informed consent discussion and documented either on the consent form or medical record.” 44 Pa. Bull. 6178 (Sept. 27, 2014). Final Guidance for Acute Healthcare Facility Determinations of Reporting Requirements Under the Medical Care Availability and Reduction of Error (MCARE) Act.

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