Medication - Sterile Compounding - Preparation of Allergens (USP 797 2008 Version Only)
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:
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.
Manual:
Ambulatory
Chapter:
Medication Management MM
First published date: September 28, 2018
This Standards FAQ was first published on this date.
This page was last updated on November 05, 2024
with update notes of: Editorial changes only
Types of changes and an explanation of change type:
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