This is a ready-to-use controlled record for one microbial identification. It captures the raw result, the confidence, the library version, and any escalation, so the call is attributable, reproducible, and defensible. Replace every <<FILL: ...>> placeholder, attach it to the source sample or investigation, and route it through your normal review. Field definitions and a filled specimen follow. This content is educational reference, not legal or regulatory advice.
1. Purity and first read
2. Primary identification (MALDI-TOF)
3. Escalation (if required)
4. Final result
5. Records and review
Field definitions
- Pure culture confirmed: identification of a mixed culture is invalid; confirm purity first.
- Score: the MALDI confidence value; compare to the cutoffs defined in the governing SOP, not to a personal judgment.
- Library / database version: records which reference produced the call so it can be reproduced; the library is a controlled record changed under change control.
- Level required for this situation: from the risk-based rule (species for Grade A/B and investigations; genus often acceptable for routine lower-grade trending).
Retention
Retain with the source sample record or investigation for not less than <<FILL: retention period>>. Retain the physical isolate at least until any related investigation closes; you cannot strain-type a plate you threw away.
Filled specimen
The following shows the record completed for an example Grade B active-air recovery during an excursion. Numbers are illustrative.
Record: ID-2026-0771. Isolate: ISO-2026-0512. Source: EM excursion DEV-2026-0140. Area/grade: Grade B, active air. Sample type: active air, 1 m3. Recovered: 09 May 2026.
The species-level call on a Grade B excursion isolate let the investigation conclude it was a transient human-associated organism rather than a waterborne Gram-negative or a spore-former, which directed the root cause and disposition. The isolate was retained in case the trend later required strain comparison.
Common inspection findings this record prevents
- A call recorded with no score and no library version, so it cannot be reproduced.
- Genus recorded where the situation required species, with no escalation.
- Identification of a mixed culture with no purity confirmation.
- Isolate discarded before the related investigation closed.
- Set your record numbering and link it to the sample and investigation systems.
- Make the library-version and score fields mandatory in your electronic or paper form.
- Make the “level requirement met” answer a gate: a No must force escalation, not a sign-off.
- Confirm the retention period and isolate-retention rule against your schedule.