New CMS Requirement for 1 hour BUD in OR

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Tue, 03/08/2016 - 16:37
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Rich S Darryl
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Joined: 04/30/2014 - 15:12
New CMS Requirement for 1 hour BUD in OR
Per the CMS Survey and Certification Memo 16-01 Hospital dated October 30, 2015, the Interpretive Guidelines for the Pharmaceutical Services section of the Medicare Conditions of Participation for Hospitals, has been revised. Compliance to USP <797> is now mandated in all areas of the hospital, including the OR and procedural areas.  Two of the requirements cited in the S&C memo specify that all compounded sterile products prepared in the OR are considered “immediate use” and must be administered within 1 hour of preparation.  Compounded sterile products, per USP’s definition, include not only IV admixtures and irrigations, but also medications drawn up into syringes for use during the procedure.
 
I have heard from a number of hospitals that they are having trouble in their OR and procedural areas in complying with this new requirement.  I would appreciate hearing if anyone has experienced a similar issue and what you have done to comply with this new requirement?
 
Darryl S. Rich, PharmD, MBA, FASHP
Medication Safety Specialist, ISMP
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