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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Process Map

A process map breaks down the total testing process into steps in order to determine points that are at risk for failure. These risks are then evaluated using a risk matrix, such as the one previously presented. It is not necessary to include every minute detail in the process, but enough detail should be included to identify areas of potential risks.
Software is available to assist with the creation of the process map. Software options can be found by performing a search on "process mapping software" or "process map template" using your preferred search engine. The symbols that are shown on the right are often used in flow diagrams, such as process maps, to identify what a step represents or relationships between procedural steps.
An example of a process map that details the flow of a blood specimen, from test order to report, is shown below.
The causes identified in your fishbone diagram(s) can be matched to steps on your process map to identify potential failures that could occur at that step in the process, leading to the effect of incorrect test results. The risk matrix is then employed to evaluate the probability and severity of the risk. Remember that not every instance of failure will lead to patient harm. However, it is important to be sensitive to events or trends that may alert you to risk potential. For example, although continually monitoring the number of phlebotomies that are performed in a day may not be a normally effective method for evaluating risk, if there is a sudden staff shortage of phlebotomists or a sudden increase in hospital census, it may be worth evaluating the number of phlebotomies that are done because the risk potential may increase if the phlebotomy staff is overworked.
As you assess risks and develop your IQCP, note the risks that have already been mitigated by the test system manufacturer within the system design.