What a procedure has to say, and where it can borrow from

Organize procedure content around decisions that prevent unsafe or invalid work: specimen path prevents use of an unsuitable specimen; test performance prevents an invalid method step; quality and limits prevent use or release outside approved controls; result reporting prevents an incorrect or uncontrolled report; downtime and failure actions prevent improvised work when the normal system is unavailable.

Use current manufacturer material where it applies, and add laboratory-controlled content where it does not. The procedure must make the method actually in use clear and route a modified method through the applicable performance process.

An actionable step names the action, the applicable acceptance criterion, the responsible role, and what happens when the criterion is not met. Criteria and header fields are controlled by the laboratory or applicable accreditor; do not present a local example as a universal federal field list.

CLIA does not require an annual review cycle. What it requires is that the laboratory keep the manual current with the tests, reagents, and instruments actually in use, on whatever review schedule the laboratory sets and documents. A manufacturer package-insert revision, a new instrument, a failed proficiency-testing event, or an internal audit finding are all legitimate triggers for revision outside a fixed calendar. Retention has a federal floor, not a ceiling: the laboratory must keep a copy of each procedure showing its dates of initial use and discontinuance, and retain it for at least two years after it is discontinued. State law, accreditation requirements, or local policy commonly extend that floor; check current organizational policy (QMS02 and local policy) for the actual retention period your laboratory applies.

When you write or revise a step, ask whether a colleague who has never seen the analyte could follow it to a defensible action without asking you a follow-up question; if not, the step is not finished.