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Preparing for the New QAPI and Adverse Event Requirements

Posted by QA Reader on March 3, 2016 at 5:15 PM

change_ahead.jpgThis coming fall, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) will issue the long-awaited updated requirements that long term care facilities must meet to participate in the Medicare and Medicaid programs. At just over 112,000 words, the proposed rules and their implications to LTPAC providers are overwhelming.

After reading the entire document, we suggest three actions that every skilled nursing facility (SNF) or other licensed long term care facilities take in preparation for the QAPI and adverse event tracking requirements in the document (See: §483.75(c)(4)).

  • Track and trend adverse events and near-misses
  • Document the relationship of antipsychotics to adverse events
  • Select as many adverse event risks as you can on the transfer form

Tracking Adverse Event Trends and Near-Misses

The proposed rules for participation in Medicare and Medicaid require that providers track and trend adverse events and near-misses related to those events. Per the CMS document, “examples of situations that would qualify as an adverse event for a facility include, but are not limited to, medication errors, resident injury due to falls, resident injury due to abuse or neglect by caregivers or other residents, failure to identify acute change in condition, pressure ulcers due to inappropriate care and the spread of disease due to errors in infection prevention and control. Near misses in any of these situations would be considered potential adverse events.”

It’s a bit confusing, but the proposed rules also require tracking and trending of “near-misses” or “close calls.”

The rules refer to a World Health Organization (WHO) study on adverse event reporting learning systems, which defines a near-miss as “a serious error or mishap that has the potential to cause an incident, but fails to do so by chance or because it was intercepted.”

According to the WHO, “A key advantage of a near miss reporting system is that because there has been no harm the reporter is not at risk of blame or litigation. On the contrary, he or she may be deserving of praise for having intercepted an error and prevented an injury.”

The revised State Operations Manual (42 CFR 483.25(H) (1) AND (2)) (SOM) also includes a requirement to track near-misses. The SOM states that “an episode where a resident lost his/her balance and would have fallen, if not for staff intervention, is considered a fall.” You can see the inconsistency here, but the reality is that you need to track near-misses.

F323 tags are typically issued related to the following adverse events:

  • Injuries sustained from falls and/or unsafe wandering/elopement
  • Resident-to-resident altercations
  • Thermal burns from spills/immersion of hot water/liquids
  • Falls due to environmental hazards
  • Ingestion of chemical substances
  • Burns related to smoking materials
  • Medication errors
  • Resident injury due to falls
  • Resident injury due to abuse or neglect by caregivers or other residents
  • Failure to identify acute change in condition
  • Pressure ulcers due to inappropriate care
  • The spread of disease due to errors in infection prevention and control

The proposed QAPI rules identify the following adverse event types specifically:

  • Medication errors;
  • Resident injury due to falls; 
  • Resident injury due to abuse or neglect by caregivers or other residents;
  • Failure to identify acute change in condition; 
  • Pressure ulcers due to inappropriate care; and 
  • The spread of disease due to errors in infection prevention and control.

You can track and trend these events manually or use a cloud-hosted risk management solution like QA Reader that provides a comprehensive QA solution for the tracking and trending of all adverse events and near-misses.

Documenting Antipsychotics and Adverse Events

CMS is keen on reducing the use of antipsychotics in the SNF population - so much so that this metric has now been added to the five-star quality rating algorithm. According to the document, “evidence suggests that antipsychotics have … the potential to lead to adverse consequences such as the risk of movement disorders, falls, hip fractures, cerebrovascular accidents, and death.”

For QAPI, it’s important to identify the relationship between antipsychotic usage and adverse events. Applications like QA Reader allow you to identify trends in adverse events and help you conduct analysis into root causes into the event, like the use of antipsychotics. At a minimum, you should identify antipsychotic medication as a contributing factor in the incident report. Remember – don’t attach the incident report to the chart.

Selecting Adverse Event Risks on Transfer Forms

We’re not entirely sure whether a transfer form will be required in the final rules, but it is listed as a requirement in the draft document. Per the proposed regulations, you’ll need to complete a transfer form like this one for all residents transferring out of your facility. Although the content of the form is not clearly described in the rules, the example requires that you select the appropriate “at risk alerts” for the resident related to all adverse events like falls, elopements, wanders, harm to self, and harm to others. You also need to identify whether the resident is at-risk for the ubiquitous “other” type of event.

The risk manager in me suggests that long term care providers select every “at risk” area they can for every single resident they transfer, simply to avoid possible liability for failing to select an area that's subsequently triggered at the hospital. For instance, let’s say you don’t select fall risk because the resident hasn’t fallen and has no clinical fall risk factors, and then the resident falls at the hospital and breaks a hip. The hospital may accuse the SNF of failing to properly identify fall risk on the transfer form.

You still have time to implement changes to your Quality Assessment and Assurance (QAA) committee and QAPI process. We’ll keep you informed along the way to the final rule, and its implementation.

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