Medication - Sterile Compounding - Preparation of Allergens

What does Joint Commission require for the preparation of allergens for use in patient testing ?

Any examples are for illustrative purposes only.

Allergens may be prepared outside of an ISO 5 environment as long as they are prepared with the following conditions:
• The compounding process involves simple transfer via sterile needles and syringes of commercial sterile allergen products and appropriate sterile added substances
• All allergen extracts shall contain appropriate substances in effective concentrations to prevent the growth of microorganisms.
 • Staff Preparing Allergens must:
  • Perform thorough hand-cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by vigorous hand and arm washing to the elbows for at least 30 seconds with either non-antimicrobial or antimicrobial soap and water.
  • Garb with hair covers, facial hair covers, gowns, and face masks.
  • Perform antiseptic hand cleansing with an alcohol-based surgical hand scrub with persistent activity.
  • Don powder-free sterile gloves that are compatible with sterile 70% isopropyl alcohol (IPA) be- fore beginning compounding  manipulations.
  • Disinfect their gloves intermittently with sterile 70% IPA when preparing multiple allergen ex- tracts  as CSPs.
• Ampule necks and vial stoppers must be disinfected by careful wiping with sterile 70% IPA swabs to ensure that the critical sites are wet for at least 10 seconds and allowed to dry before they are used to compound allergen extracts as CSPs.

• The aseptic compounding manipulations minimize direct contact contamination (e.g., from glove fingertips, blood, nasal and oral secretions, shed skin and cosmetics, other non-sterile materials) of critical sites (e.g., needles, opened ampules, vial stoppers).

• The label of each multiple-dose vial (MDV) of allergen extracts as CSPs lists the name of one specific patient and a BUD and storage temperature range that is assigned based on manufacturers' recommendations or peer-reviewed publications.

• Single-dose allergen extracts may not be stored for subsequent additional use.
Last updated on May 11, 2020
Manual: Ambulatory
Chapter: Medication Management MM

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