Posted on September 6, 2017
The table below depicts required personnel and environmental sampling as well as CriticalPoint’s recommended frequencies:?
At this time, Chapter <797> states that any growth (even one cfu) be sent out for identification to the genus level. The rationale for this was in case any of the growth was a “highly pathogenic organism” however any organism can be pathogenic when it is administered intravenously or intraspinally. By essentially requiring significant actions and cost for even 1 cfu (a level of growth that is to be expected), the current version of Chapter <797> has had unintended negative consequences which include:
CriticalPoint believes that once proper Action Levels are established (per the Action Levels detailed in the chapter or more strict levels determined by each pharmacy based on more frequent, trended results at their location), that specific actions should be required to investigate and remediate findings that exceed the Action Level.
Investigations need to evaluate the following:
When an excursion occurs, there must be evidence of an investigation and remediation. There must also be an indication if the remediation was successful and these actions must be documented.
In an effort to assist the field, we have attached a matrix for the initial actions that should occur when an excursion first occurs. The matrix details suggested actions by type of sampling and the ISO class environment in which the sampling occurred.
This article was published in CriticalPoint Pearls in June 2017.
To learn more about investigating and remediating environmental and personnel sampling excursions from Eric S. Kastango, RPh, MBA, FASHP and Abby Roth, BS, ASQ-CMQ , click the link below to watch our webinar replay.