to main content Medication - Sterile Compounding - Preparation of Allergens | Hospital and Hospital Clinics | Medication Management MM | The Joint Commission
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.
Manual: Hospital and Hospital Clinics
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 October 28, 2021
Was this response helpful?

If no, please comment on how we could improve this response.

If you have additional standards-related questions regarding this topic, please use the Standards Online Submission Form

Get Extra Help with Books and E-books

Browse our gallery of books and e-books to find trusted prep and readiness resources, practical checklists and toolkits, and resources on specialized health care topics.

Stay Informed with Online Education

Online education is the most convenient and cost-effective way to educate your staff and minimize expenses without the need to leave your organization.

Reach Your Safety Goals with eProducts

Assessing and sustaining compliance with accreditation standards or CMS CoPs can be a challenge, but it doesn’t have to be. Rely on our proven software solutions developed by our team of industry experts.

Can't Find What You're Looking For?

If you do not find an answer to your question, please contact the Standards Interpretation Group (SIG).

Note: To provide adequate support to those organizations that are either accredited/certified or seeking accreditation/certification, we will only answer those questions submitted by those organizations seeking accreditation/certification or currently accredited/certified by the Joint Commission. The Joint Commission no longer answers questions submitted by students or vendors. Thank you for your understanding.