Designing a Verification and Monitoring Program

Identify Your Sterile Compounding Activities

In addition to your IV Admixtures program, also consider compounded sterile preparation (CSP) activities conducted in other departments such as anesthesiology, radiology, and oncology. Include all CSP activities, such as aqueous bronchial and nasal inhalations, baths and soaks for live organs and tissues, injections, irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants.

Determine the Risk-Levels

For each area or compounding group, determine the appropriate USP <797> Risk Level for the CSPs. This will be based upon several considerations, including the complexity of the compounding procedure, storage time and conditions, and the number of patients who might be adversely impacted by a single error.

View guidelines for determining immediate use or risk level of CSPs.

Remember that compounding hazardous drugs has special training and skill-set verification requirements and is not the same as high-risk compounding.

Identify the Most Complex Processes and Equipment Encountered by each Group of Compounding Personnel

Media-fill exercises given in USP <797> are examples and are not prescriptive. Your verification procedures must match your processes and equipment. VALITEQ offers several kits that are designed to meet the needs of most institutions for various categories of compounding. We also provide sterile growth-medium in a variety of package forms to facilitate customized verification procedures.

Customize your verification procedures and instructions.

Low-Risk Demonstration Using the ATTACK II Kit

Medium-Risk Demonstration Using the RL-2 Kit

Hazardous Compounding Demonstration Using the ChemoTEQ Kit

Serial Dilution Demonstration Using the Allerteq Kit

Low-Risk Compounding

Personnel compounding ONLY low-risk CSPs should undergo annual testing using the ATTACK II Verification Kit. One kit per three personnel.

Medium-Risk Compounding

Your verification procedure should include the most complex procedures and tools encountered. Personnel compounding medium-risk CSPs should demonstrate skills annually using the RL-2 Kit. One kit per three personnel.

Customize your verification procedures and instructions.

Observe, grade, and document your verification activity with the Assessment of Aseptic Technique Form.

Compounding Hazardous Drugs

Only ChemoTEQ™ combines verification of containment technique with verification of aseptic technique— simultaneously. ChemoTEQ is an educational tool, as well as, a verification test because the operator is immediately aware of any mistakes made which lead to product release.

Monitoring Program