The Laboratory Manual Is the Protocol

Part of Clinical Laboratory (LAB) Training: Processing to the Laboratory Manual.

About 2 minutes. Free, in your language, no account needed.

One document governs your bench

For a given study, the laboratory manual tells you the tube type, the processing steps, the centrifuge settings, the aliquot volumes, the storage temperature and the shipping conditions.

It is not guidance. For that study it is the requirement, and departures from it are deviations.

Your own procedures still apply

Your laboratory's safety procedures, equipment maintenance and quality controls do not disappear. They run alongside.

The conflict to watch for is in study-specific handling. When your standard practice and the study manual differ on how this sample is treated, the manual wins.

Read it per study, every study

The most common honest error in a trial laboratory is doing the right thing for the last study.

Two oncology protocols can require different spin speeds for the same analyte. One may want plasma within thirty minutes and another within two hours. Neither is wrong. They are different studies.

Check the manual at the start of each run, not from memory.

Versions matter

Manuals are amended. Working to a superseded version is a deviation even when you follow it exactly.

Check the version number and the effective date on the copy you are holding. If you cannot confirm it is current, find out before you process.

Training on the new version must be documented too.

Where the manual is silent

Sometimes the manual does not cover what is in front of you.

Do not improvise and move on. Ask the central laboratory or the sponsor, and record the answer you were given, including who gave it and when.

An undocumented decision made at the bench becomes an unexplained inconsistency later.

Why the settings are exact

A centrifuge speed is not a preference. It is validated to separate the fraction the assay needs without damaging cells.

Spin too slowly and platelets carry over. Spin too fast and hemolysis releases intracellular contents. Either can shift a result enough to matter, and neither is always visible.

You cannot tell by looking that a sample was spun wrong. That is why the setting is specified, and why it is recorded.