Improving Patient Safety
In its 2023 Report on Transforming Patient Safety, The President’s Council of Advisors on Technology and Science (PCAST) underscored the urgent need to upgrade public reporting of serious, avoidable harm events as a national priority for patient safety improvement. NQF’s Serious Reportable Events (SRE), or “Never Events,” first introduced in 2002 and maintained through periodic updates, defines serious, largely preventable, and harmful clinical events. It is used by national and state-based event reporting systems to increase accountability and improve patient safety. NQF: Focus on HARM (Harmonizing Accountability in Reporting and Monitoring) - Description.
We define patient harm as any undesirable clinical outcome—not caused by underlying disease—that was the result of medical care or that occurred in a health care setting, including the failure to provide needed care. Our definition of patient harm does not include near misses that had the potential to cause harm. For each harm event, we identify (1) a clinical cause (commission or omission) demonstrating that the event is not the result of underlying disease, (2) signs and symptoms of harm to the patient, and (3) a medical intervention to treat the harm. For further discussion refer to: Adverse Events Toolkit: Medical Record Review Methodology and Adverse Events Toolkit: Clinical Guidance for Identifying Harm
Michigan Meridian utilizes the following grid to determine the Severity Level of Adverse Events:
Severity Level | Definitions | Example |
Level 0- None | Investigation indicates acceptable quality of care has been rendered. | The member experienced an adverse outcome due to an unavoidable complication or progression of disease process. |
Level 1- Low | Investigation indicated that a particular case was without significant potential for serious adverse effects, but could become a problem if a pattern developed. | Cases in which there was inadequate documentation, over or under-utilization without severe member impact, poor communication, or delay in obtaining a needed referral of consultation without severe member impact. Or a complication that was discussed in the informed consent process. |
Level 1b | No medical records received | After 60 days of medical record requests and records were not received. |
Level 2- Medium | Investigation indicates that a particular case demonstrated a moderate potential for adverse effects. | Unnecessary delay in treatment, preventable drug toxicity, failure to obtain referral or consultation, preventable non- life or limb threatening complication, inappropriate case management or preventable readmission. |
Level 3- High | Investigation indicates that a particular case has demonstrated a significant potential for serious adverse effects. | Preventable impairment or other serious preventable complications. |
Level 4- Critical | Investigation indicates that a particular case demonstrated a serious significant adverse outcome. | Any of the above situations that may have resulted in the death of a member or other serious, irreversible harm including loss of limb |