# Record how long tissue waited before fixation in every pathology report

Source: https://onco.cc/ideas/idea-tr2-preanalytics-in-report/  
OnCo record `idea-tr2-preanalytics-in-report` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

How a tissue sample is handled before it reaches the lab changes the results of biomarker tests. That handling time is almost never recorded, so nobody can tell a true negative from a spoiled sample.

## Summary

Cold ischaemia time and fixation duration affect phosphoprotein, RNA and even some IHC markers (including HER2 and ER), yet pre-analytical variables are rarely recorded in structured form. Guidelines (ASCO/CAP for HER2) specify limits but compliance is unmeasured. Adding mandatory structured fields for time to fixation and fixation duration to pathology reporting standards and laboratory information systems would let biomarker results be interpreted, audited and used in research.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Once recorded, pre-analytical time will explain a measurable share of the between-hospital variation in biomarker positivity rates, and hospitals with out-of-range times will improve within a year of feedback.
- Rationale: Clinical chemistry rejects samples with documented pre-analytical faults; anatomic pathology has no equivalent because the data are not captured.
- Proposed test: Implement the fields in five hospitals; correlate recorded times with HER2 and ER positivity rates and with repeat-test rates.
- Maturity: speculative
- Actor: clinic

## Sources

- Bottleneck evidence (Biomarkers are not validated or standardised): Fernandez et al., Examination of low ERBB2 protein expression in breast cancer tissue (JAMA Oncology 2022): https://doi.org/10.1001/jamaoncol.2021.7239

## Connected records

- ideas: [Publish each laboratory's biomarker proficiency results](https://onco.cc/ideas/idea-tr2-eqa-public-results/)
- technologies: [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/)
- terms: [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/)
- bottlenecks: [Biomarkers are not validated or standardised](https://onco.cc/bottlenecks/b-biomarker-validation/)
- key papers: [Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue](https://onco.cc/key-papers/paper-fernandez-jama-oncol/)

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