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Thawed Plasma Expiration Joint Commission Standards. TAC October 2011. Joint Commission Standards. Federal regulation 21 CFR 606.122 (m) Requires the infusion of thawed plasma within six hours of thawing
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Thawed Plasma ExpirationJoint Commission Standards TAC October 2011
Joint Commission Standards • Federal regulation 21 CFR 606.122 (m) • Requires the infusion of thawed plasma within six hours of thawing • Review regulation at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=606.122
Joint Commission Standards • File for variance from FDA for extension of plasma infusion time from 6 hours to 24 hours • Sample variance form included in packet • Joint Commission will recognize the FDA variance as evidence for extending the expiration date