What Should a Canadian Laboratory Put on a Specimen Rejection Policy?
A rejected specimen is a signal that something upstream broke, in collection, labelling, timing or transport. A written policy turns that signal into an audit trail. Here is what a Canadian laboratory should put on the page, and which fields a rejection record has to capture.
What does a specimen rejection policy have to do?
It has to do three jobs at once. Define what counts as a rejection, tell the receiving bench what to do the moment one occurs, and leave a record that survives a quality-system review. The version that gets used also states who notifies the collection site, how quickly, and what the site must change. ISO 15189, the standard for medical laboratories, treats specimen acceptance as a controlled pre-examination step rather than a judgement call.
What are the standard rejection criteria a policy should list?
Most Canadian laboratories build the list from five families and give a worked example under each. The reason code should be short enough to write at the bench.
| Rejection family | Typical reason | The record must show |
|---|---|---|
| Identification | Mislabelled or unlabelled tube | Who drew it, when, and the discrepancy |
| Container | Wrong tube type or additive | Test ordered versus container received |
| Volume | Short draw or wrong fill line | Measured fill against the requirement |
| Condition | Haemolysis, clotting or a leak | Observed condition and the time noted |
| Transport | Temperature or time breach | Transport mode and arrival time |
Which fields should every rejection record capture?
A rejection record needs the specimen identifier, the collection date and time, the receiving date and time, the reason code, the person who made the call, the notification sent to the collection site, and the corrective action requested. A short code list lets a laboratory show a falling rejection rate over a quarter.
How should packaging and transport failures be documented?
Canadian laboratories move diagnostic specimens under the transport rules for dangerous goods, so a policy should separate a clinical rejection from a transport breach. A leak, a missing absorbent pad or an unmarked package is recorded against the transport leg as well as the specimen, because the fix sits with the sender rather than the analyser. A sealed graduated leak-proof specimen cup removes one whole rejection family before it starts, and a 95 kPa specimen transport bag keeps the packaging step inside the rule.
How does a Canadian policy differ from a US one?
The two countries share the same science but run on different rule layers, and that changes the wording a policy needs.
| Item | Canadian laboratory | US laboratory |
|---|---|---|
| Governing frame | ISO 15189 and provincial rules | CLIA and CLSI documents |
| Transport wording | Dangerous goods requirements | Same family, different phrasing |
| Sign-off role | Quality manager and medical lead | Laboratory director |
How do you keep the policy usable at the bench?
Shorten it to one page of criteria, keep the codes beside the receiving bench, and review the three most common rejection reasons every quarter. Pairing the written rule with a container that seals properly, such as a 120 mL screw-cap specimen container, closes the loop where most rejections start.
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References
- Public Health Ontario - Infection Prevention and Control (checked 4 October 2026)
- IPAC Canada (checked 4 October 2026)
Printable companion: the free specimen rejection log template lays out the fields a rejection record should capture, so the bench logs as it works.
Want the record pre-structured for your laboratory? The lab quality self-check worksheet prints the columns a specimen acceptance audit asks for.
Related Reading
- Specimen Rejection Criteria: Ontario vs US Laboratory Standards
- Specimen Collection Containers for Canadian Labs: Urine Cups, Cary-Blair and 24-Hour Collection
- How Should Canadian Labs Store and Handle Sterile Specimen Containers?
Frequently Asked Questions
What should a specimen rejection policy contain?
At minimum it should define what counts as a rejection, name each rejection family with an example, state who notifies the collection site and how quickly, list the fields the rejection record must capture, and name the sign-off role.
What are the most common reasons a specimen is rejected?
Most rejections fall into five families: identification errors such as a mislabelled tube, the wrong container or additive, too little volume, a condition problem such as haemolysis or clotting, and a transport breach of time or temperature. Naming the family in the record is what lets a lab spot the pattern.
How do you document a rejected specimen?
Record the specimen identifier, the collection and receipt times, a short reason code, the person who made the call, the notification sent to the collection site, and the corrective action requested. A coded reason trends over time, so keep the code list short and next to the receiving bench.
Can a laboratory reject a specimen after testing has started?
Yes. A problem found mid-run, such as a clot that appeared after receipt or a result that does not fit the panel, can still make the specimen unacceptable. The same record and notification process applies so the collection site learns what to change.
Last updated: October 2026. CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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