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Environmental and Personnel Sampling are very important activities as this testing provides direct feedback about quality of sterile compounding facilities; sanitizing procedures and personnel work practices in terms of their cumulative ability to achieve and maintain the desired state of microbial state of control that is suitable for sterile compounding activities. At this time, Chapter <797> requires viable air sampling (VAS) only one to two times per year; surface sampling (SS) is required “periodically” and gloved fingertip sampling (GFS) is required initially to verify personnel’s’ ability to don sterile gloves without contaminating them and ongoing GFS only in association with aseptic media fills performed at least annually or semi-annually, again depending on risk level. CriticalPoint strongly recommends that sampling be conducted more frequently to ensure that the state of control has been achieved and to facilitate the detection away from a state of microbial control early so that actions can be taken before patient safety is compromised. The table below summarizes required and suggested frequencies of environmental and personnel sampling.
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 developed 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. You can download matrix here.