Clinical Safety ToolkitStaffordshire Training Hub

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    The process

    The clinical safety steps within the five stages of adopting a tool. A small change to an existing system can take minutes; a big new tool, a few weeks.

    Stage 1 of 5

    Prepare

    • Add the tool to your technology register
    • Get the supplier’s clinical safety documents (DCB0129)
    • Agree who is acting as your Clinical Safety Officer (CSO)
    Who
    CSO and practice manager
    You end up with
    The supplier’s clinical safety documents on file; a named CSO
    More on this stage →

    Stage 2 of 5

    Assess

    • Hold a hazard workshop with the staff who will use the tool
    • Write the hazard log: each cause, effect, hazard and harm, with controls and mitigations
    • Score each hazard before and after controls
    Who
    CSO leads, with the staff who will use it
    You end up with
    A hazard log
    More on this stage →

    Stage 3 of 5

    Approve

    • The CSO writes and signs a short clinical safety case report (CSCR)
    • The partners review the residual risk, and accept it or decline to go live with the tool
    Who
    CSO and partners
    You end up with
    A signed safety case report
    More on this stage →

    Stage 4 of 5

    Go live

    • Train everyone who will use it, and record who was trained
    • Start small if possible, and check early outcomes closely for incidents and recurring themes
    Who
    Practice manager
    You end up with
    A training record; early checks under way
    More on this stage →

    Stage 5 of 5

    Monitor and review

    • Log incidents and near misses, and review the hazard log when incidents happen and periodically
    • Reassess when the supplier changes the product, or if you start to use it differently in your workflow
    • Switch the tool off safely when the time comes
    Who
    Everyone reports; the CSO reviews
    You end up with
    A live hazard log and incident log
    More on this stage →

    Stage 1: Prepare

    Add it to your technology register, your list of every digital tool you use.1

    Agree who your CSO is. See help.

    Ask the supplier:2

    • Can you send your clinical safety case report and hazard log?
    • How do you inform us about changes to the product?
    • Is it a medical device? What class?
    • How do we report a clinical safety problem to you?

    If your ICB or PCN already has a DCB0160 hazard log for the same tool, start from it, but remember your documents need to be specific to how you use the tool locally.

    Stage 2: Assess

    Hold a hazard workshop. A meeting with the people who’ll use the tool, reception included. Walk through the workflow and ask at each step what could go wrong.

    A simple way to do this is the Structured What-If Technique (SWIFT), which NHS England teaches on its clinical safety course. At each step of the workflow, ask “what if…?”: what if the wrong information is entered, the system is down, someone leaves without saving, or two records are open at once? Write each answer down as cause, effect, hazard and harm.

    Write the hazard log. Start from the supplier’s, then add hazards from your own set-up. Each row reads left to right:

    One row of Oakfield's hazard log: the chain, then the scores and controls

    1. CauseWhat could make it happenThe form doesn’t flag red-flag symptoms
    2. EffectWhat goes wrong with the informationAn urgent request sits in the routine queue
    3. HazardThe situation that puts a patient at riskA patient with red-flag symptoms isn’t directed to an urgent assessment in time
    4. HarmWhat could happen to the patientDelayed treatment; at worst, death
    5. Score beforeLikelihood × severity, with evidence3Medium × Major
    6. ControlsWhat stops it, and what limits the harm, each with an owner and evidenceRed flags stop the form; two-hour clinician review; safety-netting message
    7. Score afterThe risk that remains, with evidence2Very low × Major
    The full log, with evidence for each score, is in the hazard log template. Scores come from the risk grid.

    Stage 3: Approve

    Write the clinical safety case report. Two to six pages is plenty; it doesn’t have to be a long essay:

    1. What the tool is and how you’ll use it
    2. How you assessed it
    3. The main hazards and controls
    4. The risk that remains, and why it’s acceptable
    5. When you’ll review it

    The CSO signs it, and the partners review the residual risk before agreeing to go live with the tool.

    Stage 4: Go live

    Train everyoneAnd keep a record.
    Tell patientsFor example, for AI scribes, tell patients and respect a no.
    Start smallOne team first, outcomes checked closely.
    Add it to inductionSo new staff and locums know which tools are approved.

    Stage 5: Monitor and review

    Keep an incident log and review the hazard log when anything changes. It isn’t a one-off: it carries on as the product and your practice’s ways of working change. See after go-live.

    References

    1. DCB0160: Clinical risk management in the deployment and use of health IT systems. NHS England standards directory
    2. DCB0129: Clinical risk management in the manufacture of health IT systems. NHS England standards directory

    Sources on this page last checked 3 November 2026.