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Guide

The POCT SOP assessors expect

In short

A good POCT SOP tells a trained operator exactly what to do, covers the whole result lifecycle including QC failure and result handling, and is controlled: versioned, authorised, reviewed and withdrawn when superseded. The classic findings are SOPs that describe the device but not the service, uncontrolled local copies, and procedures that do not match observed practice.

What the SOP is for

The SOP is the contract between your governance and the person holding the device at 3am. If it only paraphrases the manufacturer's manual, it governs nothing. The manual tells anyone how to use the device; your SOP tells your people how this service uses it, on your patients, with your records and your escalation routes.

A structure that works

  1. Purpose and scope: which device, which analytes, which locations, which patient groups.
  2. Responsibilities: who may test, who trains, who signs off competency, who owns the SOP.
  3. Before testing: patient identification, sample requirements, device readiness, consumable checks and storage.
  4. Quality control: what to run and when, acceptance rules, and precisely what to do on failure, including who to tell and what stops.
  5. Testing: the procedure, written for a trained operator rather than a novice.
  6. After the result: reference ranges and flags, results requiring repeat or escalation, how results reach the record, what to do when they cannot.
  7. Troubleshooting and errors: common device errors and the incident route.
  8. Maintenance: daily to periodic tasks and where they are recorded.
  9. References and control: version, author, authoriser, review date, change history.

The classic findings

  • The photocopy problem. Uncontrolled copies taped inside cupboards, three versions old. Control the copies or point everyone at one live location.
  • The fiction problem. The SOP says two levels of QC daily; the log shows one level on weekdays. Assessors read documents and then watch practice. The two must match, whichever direction you fix.
  • The missing middle. Beautiful testing steps, nothing about QC failure or unreportable results. The middle of the lifecycle is where harm happens.
  • The novel. Fifteen pages nobody has read. Length is not compliance; a tight SOP plus a one-page quick reference beats a comprehensive doorstop.

Our free POCT SOP starter template carries this structure with guidance notes in every section, and the Fundamentals course teaches the service around it.

Questions, answered

Can we just use the manufacturer's manual as our SOP?

No. The manual describes the device; the SOP describes your service: your responsibilities, QC rules, escalation and records. Reference the manual rather than replacing it.

How often should a POCT SOP be reviewed?

At a defined interval, commonly every one to two years, and immediately on any change to device, method, QC design or workflow. The review must be recorded even when nothing changes.

One SOP per device or one master SOP?

Both patterns pass assessment. A common approach is a master POCT policy for the service wide rules plus a concise device level SOP per platform. What matters is coverage without contradiction.