WHAT IS YOUR BACKUP PLAN?
If the pandemic has taught us anything, it is to expect the unexpected and the time to plan for the unexpected is before it happens. You do not want to be trying to figure out how to handle an inoperable test system when you are in a crisis or close to a crisis due to unforeseen circumstances.
Would you know what to do if:
- One of your test systems went down?
- The freezer where you store fresh frozen plasma failed?
- The platelet rotator died?
- The CO2 incubator was at room temperature?
- You ran out of testing supplies?
- Your Laboratory Information System (LIS) was taken down by ransomware?
CLIA standard §493.1251(b)(14) requires that, within the laboratory’s procedure manuals, there is a description of the course of action to be taken if a test system becomes inoperable.
CLIA defines test system as all the instrumentation, equipment, reagents, and supplies need to perform an assay or examination.