Determining the Probability and Severity of Harm

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The page below is a sample from the LabCE course Concept and Construction of a Laboratory Individualized Quality Control Plan. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Determining the Probability and Severity of Harm

The probability of the failure and the severity of the consequences, if the failure does occur, can be estimated. Estimates then point to specific risks that may require mitigation. Specific steps to mitigate each risk to prevent negative patient outcomes are built into the IQCP. The Safety Assessment Code (SAC) is a useful tool to help with this evaluation. The SAC Matrix is provided by the VA National Center for Patient Safety and is available at: http://www.patientsafety.va.gov/professionals/publications/matrix.asp. Accessed May 18, 2022.
The table on this page is based on the VA's SAC matrix. We have added the colors, using a stoplight color scheme. In this table, the frequency and level of risk determine the color to be applied to the steps on the process map for easy, swift visualization of areas for focused action. This table and provided definitions are included to serve as an example for adaptation to a specific laboratory's test menu and operating procedures. However, your laboratory team may decide to use different terms on the risk matrix and define those terms differently.
Definitions of severity terms
  • Catastrophic-- Failure that could lead to patient death or permanent loss of function not related to the natural course of the patient's illness or underlying condition.
  • Major-- Permanent lessening of bodily functioning not related to the natural course of the patient's illness or underlying condition.
  • Moderate-- Increased length of patient hospitalization or increased level of care.
  • Minor-- No injury, increased length of hospitalization, or increased level of care.
Definitions of probability terms
  • Frequent-- Likely to occur immediately or within a short period of time (may happen several times in one year).
  • Occasional -- Probably will occur in time (may happen several times in 1 to 2 years).
  • Uncommon --Possible to occur in time (may happen sometime in 2 to 5 years).
  • Remote - Unlikely to occur (may happen sometime in 5 to 30 years).