Defining the Hand Hygiene and Garbing Competency
I can’t tell you how many times I’ve read the 2021 proposed version of the chapter. But every time I read it, I pick up on another change that I somehow missed before.
We all know that the frequency of the hand hygiene and garbing competency will increase. Those compounding Category 1 and 2 CSPs will need to be assessed at least every six months and those compounding Category 3 CSPs will need to be assessed at least every 3 months. What I missed is how the garbing competency is being defined. The garbing competency includes two components: a visual observation of the hand hygiene and garbing process AND gloved fingertip sampling.
This means that after the initial competency that must be successfully performed three times, every subsequent hand hygiene and garbing evaluation must end with gloved fingertip sampling, demonstrating the staff member’s ability to don sterile gloves properly. This is in addition to the gloved fingertip and surface sampling that is required as part of the media-fill test.
This table breaks down the chapter defined competency testing requirements.
Although we don’t know what the final chapter will look like, there will most certainly be changes. However, with USP <797> moving towards a more quality-driven mindset, I would expect these competency requirements to stand. Plan now for increased media needs and more space in the incubators.
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