Risk Assessment Index

Risk Assessment Index — RAI

Introduction

In a healthy organization, many events will be detected; however, not all should receive the same amount of attention. The selection process ensures that an organization will target the events with the greatest potential risk, thus making the best use of time and resources. MERS-TM provides a tool for establishing the level of patient risk for each event. That guide is the Risk Assessment Index or RAI.

As part of the event management process, all events receive at least a routine investigation; however, approximately 10% of all events should receive an expanded investigation. Fewer than this will result in less than optimal information when considering system changes. The major difference between the two investigation types is that an expanded investigation requires a root cause analysis.

To determine whether an expanded investigation is recommended, the consequent event’s risk index must be assessed. MERS-TM recommends that a root cause analysis be conducted if the final risk index calculated using the RAI is greater than or equal to .5.

In addition to assessing patient risk using the RAI, organizational risk should also be considered when selecting events for an expanded investigation.

Assessing Patient Risk

In first assessing the patient risk related to a single event, the following factors must be considered:

estimate of severity – either actual or potential
estimate of the probability of recurrence (likelihood that it will happen again)
whether or not a product was issued
type of recovery from the event, if any

The RAI examines patient risk based on the following formula:

RISK = SEVERITY X PROBABILITY OF RECURRENCE

SEVERITY is the Quantified Estimate of Severity of patient harm or QES.
PROBABILITY is the Quantified Estimate of Probability of recurrence or QEP

Both parameters are estimated using a six-level scale. The scale goes from Very Low to Extremely High, and each of the six levels has been assigned a numerical value.

To determine the QES for a misadventure (an event that directly affected the patient), use the six levels to rate the actual level of harm experienced by the patient. To determine the QES for a near miss or no-harm event, the potential for that event to have caused harm is considered. One way to estimate this potential is to consider if the event were to occur ten times, how many times would the event actually pass through all the barriers, reach to the patient, and cause patient harm?" The QA SysOp, based on expert knowledge of their organization, will be able to estimate this probability.

To determine probability of recurrence, a time frame should be incorporated. The RAI tool uses a 12 month time period. Therefore, to determine QEP, the question to be asked is, "What is the probability of this event occurring again within the next twelve months?" Again, based on QA SysOp expert knowledge of their organization, this probability can be estimated.

On the RAI form, the estimated QES and QEP levels have been multiplied (Severity X Probability of Recurrence) and the resulting risk values are presented in a table. This value is the initial risk value.

The final risk index is determined by considering two additional parameters and making the appropriate adjustments to the initial risk value:

If the product was issued – add .2 to the initial risk value (this data element is found in Part B of the Event Discovery Report form)
If an unplanned recovery occurred – add .1 to the initial risk value (this data element is the leading digit of consequent event code on QA SysOp Investigation Report form)
NOTE
A recovery is referred to as "unplanned" when there was no planned barrier, such as a checkpoint in the work process, to "catch" the error.

Example: A driver and passenger approach a washed out road. There is no roadblock, but an observant passenger sees the washed out road and yells, "Look out!"

The recovery resulted from an accidental catch, not a planned barrier, such as a roadblock; therefore, the recovery was unplanned.

If the Final RAI is greater than or equal to 0.5, then an expanded investigation is recommended.

Assessing Organizational Risk

If an event is shown to present risk to the patient, this presupposes risk of harm to the organization. However, even in the absence of significant patient risk, the event may still represent a significant risk to the organization in terms of financial loss or damaged reputation. As a result, even if the Final RAI is less than .5 – indicating that an expanded investigation is unnecessary based on patient risk – organizational risk should be considered.

For each event, organizational risk will be rated as High, Low, or None. If the risk to the organization is high, the QA SysOp may opt to do an expanded investigation.

Recording the Risk Level

For each reported event, the estimated values for the QES and QEP will be entered online into the QA SysOp Investigation Report (located in the Database Functions section of the MERS-TM web site). The Final RAI will be automatically calculated in the database using the information entered.

When gathering information, you may use the worksheet version of the QA SysOp Investigation Report to record the QES and QEP. The final index can also be calculated by hand and recorded on that worksheet.

Both the online QA SysOp Investigation Report form and the worksheet provide an area to indicate the level of organizational risk.

Conclusion

Using the following criteria – severity, recurrence, product issue status, and type of recovery – the Risk Assessment Index provides an essential tool in the MERS-TM process for meeting the following goals:

guiding the QA SysOp in determining what level of investigation to conduct for the individual event
maximizing an organization’s event management resources by targeting selected events for an expanded investigation
providing an important outcome measure for the event reporting system, which is that the risk index for all events should decrease