July 24, 2012_NH"Dear Administrator" Letters

July 24, 2012

ADSA: NH #2012-009    
S&C 12-35: safe use of single dose/single use medications to prevent healthcare-associated infections (NH)

Dear Nursing Facility/Home Administrator:

The purpose of this letter is to let you know that the Centers for Medicare & Medicaid Services (CMS) has issued a survey and certification (S&C) memorandum on the use  of single dose/single use medications to prevent healthcare-associated infections.

CMS has recently received requests to relax its policies regarding the use of single dose vials (SDVs) for multiple residents. While there has been concern about resident access to critical medications that are in short supply, CMS remains equally concerned about healthcare-associated infections caused by unsafe medication preparation and injection practices, including using SDVs for multiple residents in the same manner as vials labeled as "multi-dose".

Highlights from the CMS memorandum:

  • The United States Pharmacopeia (USP) has established standards for compounded sterile preparations.
  • Under certain conditions, it is permissible to repackage single-dose vials or single use vials (SDVs) into smaller doses, each intended for a single resident.
    • Facility doing repackaging must use qualified, trained personnel under International Organization for Standardization (ISO) Class 5 air quality conditions within an ISO Class 7 buffer area and repackaging must be completed within 6 hours of the initial needle puncture.
    • All repackaged doses prepared under these conditions must be assigned and labeled with a beyond use date based on appropriate determination of contamination risk level.
  • Administering drugs from one SDV to multiple residents without adhering to specific standards is not acceptable.

To read the details of the memorandum online, please visit:  https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-12-35

Please contact your local RCS Field Manager if you have any questions.


Joyce Pashley Stockwell, Director
Residential Care Services