When lab supplies arrive, check four things before they go on the shelf: the count, the item, the lot’s expiration date and the condition the shipment arrived in. A receiving check compares the order, the packing slip and what’s in the box. It’s your chance to catch a short, damaged or short-dated delivery and raise it with the supplier before anything goes into use.
What the label tells you
FDA labeling rules require a diagnostic reagent’s label to carry storage instructions, including temperature, light and humidity where they matter. The label also gives the user a way to tell the product still meets its standards when it’s used, such as an expiration date based on those storage instructions. 21 CFR 809.10. Dates on device labels are printed year first, such as 2027-03-31, with two exceptions. 21 CFR 801.18.
Read both at receipt. The expiration date tells you whether the lot meets your lab’s minimum, and the storage instructions tell you where the box goes next.
What CLIA expects of your lab
For nonwaived testing, CLIA bars using supplies that are past their expiration date, have deteriorated or are of substandard quality. It requires your lab to define the storage conditions its reagents need, then monitor and document them, including temperature. It also bars interchanging components of reagent kits with different lot numbers unless the manufacturer allows it. 42 CFR 493.1250 and 493.1252.
Some supplies need a second check when they’re opened. The same CLIA rules require labs to check each lot number and shipment of reagents, disks, stains, antisera and identification systems for positive and negative reactivity when they’re prepared or opened. 42 CFR 493.1256. Recording the lot number at receipt keeps each shipment easy to find when that check comes due.
Example: a short-dated lot
In this illustrative example, a lab orders ten reagent kits, and the order asks for at least six months of dating on arrival. The box holds ten kits, and the packing slip matches the order. The lot expires in four months.
Lab staff store the kits as the label says, set them apart from stock in use and tell the operations manager. The operations manager sends the supplier the packing slip, the lot number and a photo of the label, and asks for a longer-dated lot or a return. The kits stay unopened until the supplier answers. When a replacement arrives, staff check it the same way. If the delivery is short or the invoice doesn’t match what was kept, check the invoice against the receipt.
Receiving checklist
| Check | Owner | Evidence to keep | Status |
|---|---|---|---|
| Count against the packing slip and the order | Lab staff | Packing slip with the count marked | ______ |
| Item, manufacturer, catalog number and ordering unit | Lab staff | Packing slip and order line | ______ |
| Lot number and expiration date against your minimum | Lab staff | Lot and expiration date recorded | ______ |
| Storage condition on arrival, then store as labeled | Lab staff | Temperature indicator or note, storage location | ______ |
| Damage or leaks | Lab staff | Photo and a short note | ______ |
| Kit components kept together by lot | Lab staff | Lot recorded for each kit | ______ |
| Problems reported to the supplier | Operations manager | Supplier’s reply, return authorization or replacement | ______ |
| Invoice matched to what was kept | Operations manager, then accounting | Order, receipt and invoice | ______ |
Ask for dating before it ships
Put your minimum dating on the order or the quote request. The supplier can then choose a lot that meets it, or tell you it can’t, before anything ships. If the supplier can’t ship the item at all, our guide to clinical lab supply backorders covers finding the same item from another source. The quote comparison checklist covers the other terms to confirm before you order.
Where Manoa fits
Manoa follows up with the supplier when a delivery is short, damaged or short-dated, arranges the replacement or return you choose and matches the credit to your invoice. Your staff check what arrives and decide what goes into use. Our purchasing examples include a lab’s dating check at receipt.
