USP 797/800
This is the primary goal of USP 797.
What is patient safety?
The action level for ISO Class 5 air samples
What is >1 CFU?
This is the most common type of medication prepared for home infusion.
What are antibiotics?
This item is required to be used every time hand hygiene is performed.
What is a nail pick?
This is the term for reviewing a prescription to ensure it is clinically appropriate and safe.
What is drug utilization review (DUR)?
This is the required ISO Classification of a PEC.
What is ISO Class 5?
This general growth agar and these neutralizers are used for collecting surface samples.
What is TSA with Lecithin and polysorbate 80?
This is one of the biggest challenges patients face when transitioning to home infusion therapy.
What is being properly educated?
The hand hygiene and garbing competency culminates with this test.
What is the gloved fingertip test?
This technology verification technique can be used to ensure a CSP is prepared with proper ingredients.
What is barcode scanning?
The maximum BUD for a Category 2 CSP prepared in a cleanroom using sterile components and stored at controlled room temperature.
What is 4 days?
The second incubation temperature for air, surface, and gloved fingertip samples.
What is 20°C – 25°C?
This documentation must be included with every home infusion delivery.
What are instructions?
This type of needle is used to withdraw contents from an ampoule.
What is a filter needle/straw?
This organization serves as the leading voice and advocate for the home and specialty infusion community.
What is NHIA?
The number of air changes per hour (ACPH) required in the HD storage room.
What is 12 ACPH?
The type of air sampler used to collect viable air samples
What is impaction?
This is the biggest risk of extended stability CSPs used in home infusion.
What is contamination?
This type of agent is used to physically remove HDs from surfaces.
What is a decontamination agent?
This regulatory body oversees 503A pharmacy practice.
What is the Board of Pharmacy?
HD gowns are changed at this frequency if no permeability data is available for the gown used.
What is every 2-3 hours?
The minimum air changes per hour (ACPH) required in an ISO Class 7 cleanroom used for sterile compounding.
What is 30 ACPH?
A critical reason for maintaining cold chain integrity during delivery of refrigerated medications.
What is drug efficacy?
These two cleaning principles should be followed when cleaning a laminar airflow workbench.
What are cleanest to dirtiest and top to bottom?
Although not mentioned in the chapter, it is this type of improvement you hope to gain by performing GAP audit of your sterile compounding operation.
What is continuous improvement?