What information does ISO 15189 require in a reagent reception record?

For each reagent or consumable, clause 6.6.7 expects the identity of the item and its manufacturer, the lot or batch number, the date received, the date it went into service, its condition on receipt, its expiry date and, where applicable, the date it was withdrawn. The person who received it should be traceable from the record, and the record should connect to the lot's acceptance before use.

Does the reception record have to be electronic?

No. ISO 15189:2022 sets out what must be demonstrable, not the medium. A controlled spreadsheet or paper log is acceptable if the required fields are present and every entry is complete. Software helps most by making the fields mandatory and by connecting the receipt to the acceptance decision, not by replacing the log.

What does an assessor check first in a receiving log?

Usually completeness of a sample of recent rows: condition on receipt, receiver's initials, lot and expiry, and whether a new lot was verified before its first use. Blank condition columns and missing initials are the most common findings, followed by acceptance records that exist in a separate register and cannot be tied to the receipt.

What should happen when a delivery contains an expired reagent?

It should be identified at reception, kept apart from stock in use as clause 6.6.4 requires, recorded as not acceptable in the reception record, and actioned with the supplier. The record should show the quarantine decision and who made it, so the assessor can see the control worked rather than take it on trust.

ISO 15189:2022 reagent reception records: what assessors look for

Under ISO 15189:2022, every reagent, calibrator, control and consumable that enters the laboratory needs a reception record that shows what arrived, when, in what condition, and who received it, and that record has to connect to the lot's acceptance before use, its first use, and its removal. Clause 6.6 does not prescribe a form. It prescribes what must be demonstrable, and a NATA assessor will read your receiving log looking for exactly that chain.

What the clause asks for

Clause 6.6 covers reagents and consumables from reception to disposal. The parts that touch the receiving bench are these.

Reception and storage (6.6.2). Items are received and stored according to the manufacturer's instructions. In practice that means the condition on arrival is recorded, including whether cold-chain items were cold, and anything not acceptable is identified.
Acceptance before use (6.6.3). Each new formulation, and each new lot or shipment, is verified for performance before it goes into use. The record must show the lot was checked, and by whom.
Inventory management (6.6.4). Stock that has not yet been accepted, and stock that has expired or been withdrawn, is kept separate from stock in use and is identifiable as such.
Records (6.6.7). For each reagent and consumable: its identity, the manufacturer, lot or batch number, the date received, the date it went into service, its condition on receipt, expiry and, where relevant, the date it was withdrawn. The person who received it is part of the record.

Nothing in the clause says the record must be electronic. A controlled Excel workbook meets it, provided the fields are there and the entries are complete.

Where assessments usually find gaps

The reception record fails in the same four places, laboratory after laboratory.

1. The condition column is blank

The delivery was fine, so nobody wrote anything. An empty Condition column is not evidence that goods arrived intact; it is evidence that nobody looked. The fix is a mandatory entry per delivery, not per line: intact and cold chain acceptable, or not acceptable, with the exception described.

2. The receiver is missing

Clause 6.6.7 is about traceability to a person. A log row with a date and a lot number but no initials cannot answer the assessor's simplest question: who checked this? Make Received By a required field, and where a log has no such column, put the initials in Comments.

3. Acceptance is recorded somewhere else

In Chemistry the lot acceptance decision often lives in a separate pre-acceptance register, while the receipt lives in the reagent log. Both records may be correct and still fail, because nothing connects them. The receipt should say what the register said on the day the lot arrived: accepted, awaiting sign-off, testing in progress, rejected, or not on the register at all.

4. The docket number is not on the row

Without the delivery-note number, a receipt cannot be reconciled to the supplier's paperwork or to the order. When a recall arrives, that missing number is the difference between a two-minute trace and an afternoon in the filing cabinet.

The complete row

A reception record that survives an assessment has, on one row of the department's own log: date received, product identity and material number, lot, expiry, quantity, condition on receipt, the receiver's initials, the acceptance status at receipt, and the delivery-note number. Date in Use and the date withdrawn are added to the same row later, so the lot's whole life is readable in one place.

How LotWarden records it

LotWarden writes that row into the workbook the department already keeps, through Excel, so the log remains the laboratory's own controlled document. Reading a scanned docket fills the product, material number, lot, expiry and quantity; only clean, confident reads are pre-filled, and a person confirms every quantity before anything is written. The condition on receipt is one selector per delivery and is written to the Condition column, with failures highlighted and logged. Received By is required. In Chemistry every lot is cross-checked against the pre-acceptance register at the door and its verdict written into the comment, and every entry is stamped with the delivery-note number. Stock expired on arrival is flagged and placed first on an investigation worklist with a quarantine action. None of this changes the log's validation rules or macros, and the original workbook is never written to.