CMS has issued a memorandum that states healthcare providers that do not comply with United States Pharmacopeia standards for single-dose vials are subject to federal citation, according to an AORN release.
USP standards 797 require that healthcare providers comply with strict rules for repackage and re-entering single dose. The standards include a requirement that healthcare providers use qualified, trained personnel to repackage single dose vials under International Organization for Standardization Class 5 air quality conditions within an ISO Class 7 buffer area. For a full overview of USP 797, click here.
Healthcare providers that fail to comply with these standards may be cited for deficiencies under applicable federal infection control standards.
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USP standards 797 require that healthcare providers comply with strict rules for repackage and re-entering single dose. The standards include a requirement that healthcare providers use qualified, trained personnel to repackage single dose vials under International Organization for Standardization Class 5 air quality conditions within an ISO Class 7 buffer area. For a full overview of USP 797, click here.
Healthcare providers that fail to comply with these standards may be cited for deficiencies under applicable federal infection control standards.
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CDC Releases Statement Reiterating Position on Single Dose, Single Use Vials