Chapter 4 · Laboratory environment

The laboratory environment must be appropriate for the work performed. Requirements include: temperature and humidity monitoring where relevant to method performance, adequate lighting, clean work surfaces, segregation of incompatible activities (e.g. PCR pre- and post-amplification), biosafety cabinet function verification, and controlled access. Environmental records must be retained.

Practical example

A clinical chemistry laboratory runs PCR assays and conventional chemistry on the same bench. Good practice: The QM maps the workflow, identifies the risk of amplicon contamination, and ensures PCR pre-amplification, amplification, and post-amplification steps are in separate, controlled zones with documented access controls. Poor practice: PCR and conventional chemistry share the same bench because the laboratory is small — until a contamination event produces false-positive results across multiple patients.

What this means for your practice: Environmental segregation is not optional for PCR. The cost of building a partition is always less than the cost of a contamination incident.