Centralized Sterile Product Preparation Workflow for

Anywhere Health System (AHS)

Centralized Sterile Product Preparation Workflow

Purchasing Preparing Testing Storage DistributionCost

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

Sterility Testing

• Send USP Chapter <71> 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

Delivery• Medical courier picks

up totes at designated time

• Delivers them to hubnext 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 <797> 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.