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Nursing Staff Preparing CSPs

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Question:

Is there an update from CMS addressing nursing staff and preparing CSPs?

Answer:

Yes. CMS issued, Revised Hospital Guidance for Pharmaceutical Services and Expanded Guidance Related to Compounding of Medications on October 30, 2015

CMS updated guidance for the nursing service regulatory requirements [§482.23(c)(1), (c)(1)(i) & (c)(2)], concerning medication administration to clarify that hospitals must ensure staff adherence to accepted standards of practice in those limited instances when Compounded Sterile Preparations (CSPs) may be prepared outside of the pharmacy.  CMS also included discussion regarding medication beyond-use-dates (BUD).

CMS provides the following as part of the Interpretive Guidelines:

  • Hospital policies and procedures for the preparation and administration of all drugs and biologicals must not only comply with all applicable Federal and State laws, but also must be consistent with accepted standards of practice based on guidelines or recommendations issued by nationally recognized organizations with expertise in medication preparation and administration. Examples of such organizations include, but are not limited to:
  • Compounded sterile preparations (CSPs) may be a source of healthcare-associated infection if proper precautions are not followed. The applicable standards of practice for safe sterile compounding are, at a minimum, the standards published in The United States Pharmacopeia National Formulary Chapter (“Pharmaceutical Compounding – Sterile Preparations”) and other relevant USP/NF Chapters (USP). (See the guidance for §482.25(b) (1) for more information on the role of USP/NF standards and for discussion of the term “compounding.”)
  • Hospitals must ensure that they meet all currently accepted standards for safe preparation and administration for CSPs, whether they are the type of CSP that must be compounded in an aseptic pharmacy location that meets USP standards for low, medium or high-level risk CSPs or are “immediate-use CSPs” prepared outside of the pharmacy.
  • Nurses commonly prepare sterile medications that are categorized by USP as “immediate-use CSPs,” which are needed for immediate or emergency use for a particular patient and are not to be stored for anticipated needs. The following USP standards apply when preparing an immediate-use CSP:
    • Preparation of an immediate-use CSP must only involve “simple transfer of not more than three commercially manufactured…sterile nonhazardous products from the manufacturer’s original containers and not more than two entries into any one container or package (e.g. bag, vial) of sterile infusion solution or administration container/device;”
    • “Administration begins not later than one hour following the start of the preparation of the CSP (if not, the CSP must be appropriately discarded);”
    • Meticulous aseptic technique must be followed during all phases of preparation. If the CSP is not administered to the patient as soon as it is ready, “the finished CSP is under continuous supervision to minimize the potential for contact with non-sterile surfaces…,” contamination and/or confusion with other CSPs; and
    • “Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer…,” the CSP must be labeled with at least:
      • Patient identification information;
      • The names and amounts of all ingredients;
      • The name or initials of the person who prepared it; and
      • The exact one hour “beyond use date”

Related Products from MCN:

Compounded Sterile Preparation – USP 797 Compliance Manual

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