Centralized Sterile Product Preparation Workflow for Anywhere Health System (AHS)

Centralized Sterile Product Preparation Workflow PurchasingPreparingTestingStorageDistribution Cost Transfers, Audits

Purchasing Ordering Bulk Product Technician places order Receive product, set aside for Central IV technician (CIV) to take to storage space CIV Technician unloads- inventories into appropriate area/safe

Preparation Preparing Products Technician gathers supplies based on composite sheet Technician prints the necessary amount of “IV BATCH” labels from designated computer to label printer Technician copies down NDC bulk, manufacturer, lot# and expiration date on composite sheet Transfer to ARCOS system for controlled substances Technician takes composite sheet and medications into high risk room to prepare Pharmacist checks repeater pump (if applicable), products, labels Run initial product with pharmacist in IV room to validate run/weight of product When complete, technician puts initials on the composite sheet Sequester date- mark date when passed Record time to prepare batch Technician notifies pharmacist when complete Pharmacist verifies products Pharmacist checks the accuracy of filled medication and puts initials on composite sheet

Sterility Testing Send USP Chapter required amount to external lab for testing Sequester Products Quarantine for 14 days Confirmation of Sterility Document when complete on composite Filed for audits & recalls

Distribution Package for distribution Technician verifies LOT to be released to site Sell to (CII safe) for controlled substances Distribution Record keeping- internally and ARCOS Cost transfer Monthly Spreadsheet sent to finance

Delivery Medical courier picks up totes at designated time Delivers them to hub  next day delivery to site; TPN sites likely same day

Reporting & Auditing Auditing Develop & follow audit procedures- count with each movement of the product for controlled substances Reporting DEA: Quarterly ARCOS- all purchases, preparation, and distribution DEA: Year-end reporting Compounding: monitor batches- sterility documentation

Inventory/Production Inventory: Surplus supply, site must notify preparation site ~3 weeks before shipment would have been received to adjust quantity. In the event of a shortage of supply… Borrow from another site Make their own (USP Chapter dating) Purchase from wholesaler In the event of a recall…. Manufacturer Recall: Sites will be notified if NDC product was used, which LOT to look for/remove CIV Recall: same as above, site notified for internal LOT to remove Sites need to purchase adequate supply for 14 days minimum Expiring Products: If products will be expiring soon, sites should re-allocate to Main Pharmacy or other AHS site that can use the volume.