Case Review: A Winnipeg Lab Cut Specimen Rejections After a Packaging Audit

Specimen rejection is expensive, because the sample has to be recollected and the patient brought back. When a Winnipeg laboratory noticed rejections edging up, the cause turned out to be packaging and labelling rather than the collection itself. This case review walks through the audit and the changes that brought the rate back down.

What triggered the packaging audit?

The lab reviews rejections monthly by reason code. Over several weeks the share attributed to packaging faults, including leaks and unsuitable containers, crept up enough to be noticeable. Rather than treat it as a courier problem, the quality lead pulled the rejection logs and worked backwards through the transport chain.

Two patterns stood out. Bags were being used past their intended purpose, and secondary containment was inconsistent between collection sites and the main lab.

What did the audit actually find?

Finding Effect
Mixed bag types across sites Inconsistent leak protection
Missing absorbent material Spill risk on rupture
Incomplete labelling Unidentifiable samples
Overfilled primary containers Leaks at the seal
No consistent UN3373 marking Transport non-conformance

How did packaging choices address the findings?

The lab standardised on tape-sealed transport bags with a documented specification. A 6x9 inch three-wall specimen transport bag gives primary containment plus an absorbent layer and a separate documentation pocket, which covers the leak and paperwork gaps in one item.

Where pressure changes were a factor, the lab moved to a 6x9 inch 95 kPa certified specimen bag that holds its seal under pressure differentials. Choosing one specification and sticking to it removed the site-to-site variation that had been driving rejections.

95 kPa specimen transport bag with absorbent layer and documentation pocket for diagnostic specimens

What did the lab change in its process?

Packaging alone does not fix a process. The lab rewrote the collection SOP to require the correct fill volume, the transport bag with absorbent, a completed label, and the UN3373 marking before a sample left the site. Staff at each collection point were retrained against the SOP and given a one-page visual guide in the room.

They also added a quick pre-transport check: seal intact, absorbent present, label complete, bag within its pressure rating. That thirty-second check caught most of the faults the audit had found.

What were the results and lessons?

Rejections tied to packaging fell sharply once the specification and the SOP matched. The lesson was that packaging is a system, not a stocked item: container, absorbent, bag and label have to work together, and the same specification has to be used everywhere.

The lab now reviews rejection codes monthly and treats any upward trend as a trigger for a small audit rather than a large crisis. The diagnostic labs hub collects the deeper background on transport packaging. The audit also reinforced a simple point: one bag specification is easier to train and to audit than a shelf of near-identical options, and that clarity is what kept the improvement in place after the project ended.

CliniEco Medical Class 4 dual-indicator sterilization pouches, 200-pack, used for packaging and integrity control in a sterile processing suite

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Frequently Asked Questions

What causes most specimen rejections?

Rejections commonly stem from labelling gaps, leaks, incorrect fill volume and unsuitable packaging, so audits usually start with the transport chain.

Do specimen transport bags need to be pressure rated?

Where transport involves pressure changes, a bag certified to 95 kPa helps hold the seal, which reduces leaks and packaging-related rejections.

How can a lab reduce specimen rejections?

Standardising on one bag specification, adding absorbent material, checking labels and running a short pre-transport check cut packaging-related rejections.

CliniEco Medical is a licensed medical device establishment (MDEL #35334).

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