Standard 11: Procedure Units, Endoscopy and Interventional Care

Why this criterion matters. A procedure given to someone who should not have it can cause serious harm. A short assessment before each procedure, recorded, is the step that catches the reason not to proceed.

Sample. Review the pre-procedure assessment records for 30 procedures in the last 3 months, across all practitioners.

1. Each patient is assessed before the procedure.

Method. Check each sampled procedure for an assessment dated before the procedure.

Evidence to show. Pre-procedure assessment record (PRO-FRM-001).

Pass when. At least 98% of procedures have an assessment before the procedure.

2. The assessment covers history, medicines, allergies and suitability.

Method. Check each assessment for the four items.

Evidence to show. Pre-procedure assessment record.

Pass when. Every assessment covers all four items.

3. The assessment is recorded and signed.

Method. Check each assessment for a signature and time.

Evidence to show. Pre-procedure assessment record.

Pass when. Every assessment is signed.

4. Contraindications are resolved before the procedure.

Method. Check each recorded contraindication for its resolution before the procedure date.

Evidence to show. Pre-procedure assessment record (PRO-FRM-001).

Pass when. Every recorded contraindication is resolved and recorded before the procedure.

Immediate fail (any one means the criterion is not met)

• A procedure is given with no pre-procedure assessment.

Why this criterion matters. Products used in injection and procedure work must be real, in date and stored as the manufacturer requires. An unlicensed or expired product can cause harm that is hard to trace.

Sample. Review the product batch register and the verification records for 30 products used in the last 3 months, and the quarantine log.

1. Each product is verified for source, expiry and batch before use.

Method. Check each sampled product for its verification before use.

Evidence to show. Product verification record (PRO-FRM-002).

Pass when. Every sampled product has source, expiry and batch verified before use.

2. Unlicensed or unverified products are never used.

Method. Check the stock and the use records for any unlicensed product.

Evidence to show. Product batch register (PRO-REG-001).

Pass when. No unlicensed or unverified product is recorded as used.

3. Products are stored as the manufacturer requires.

Method. Check storage temperature and conditions against the manufacturer requirement.

Evidence to show. Medicine storage and temperature record (PHM-SOP-001).

Pass when. Storage is within the manufacturer requirement at every check.

Immediate fail (any one means the criterion is not met)

• An unlicensed or unverified product is used.
• A product past expiry is used.

Why this criterion matters. Each procedure needs its own training. A practitioner trained for one procedure is not competent for another, and the centre must know who can do what.

Sample. Review the procedure competence register for every practitioner who performs a procedure, with the training record for each procedure.

1. Each practitioner is trained for each procedure they perform.

Method. Check the register for a training record for each procedure per practitioner.

Evidence to show. Procedure competence register (PRO-REG-002).

Pass when. Every procedure performed has a training record for that practitioner.

2. Credentials are verified against the issuing body.

Method. Check each credential for verification with the issuing body.

Evidence to show. Procedure competence register.

Pass when. Every credential is marked as verified with its date.

3. Competence is assessed each year.

Method. Check the competence assessment for each practitioner.

Evidence to show. Annual competency assessment procedure (WRK-SOP-001).

Pass when. Every practitioner has an assessment in the last 12 months.

Immediate fail (any one means the criterion is not met)

• A practitioner performs a procedure they are not trained for.

Why this criterion matters. Consent for a procedure must cover what can go wrong, not only what is expected. A patient who did not hear about the risks cannot make a real decision.

Sample. Review the consent records for 30 procedures in the last 3 months, across all procedure types.

1. Consent is informed and recorded.

Method. Check each sampled record for a signed consent.

Evidence to show. Procedure consent and reconsideration record (PRO-FRM-003).

Pass when. Every sampled procedure has a signed consent before the procedure.

2. Consent covers the expected outcome, the risks, the complications and their treatment.

Method. Check each record for the four items.

Evidence to show. Procedure consent and reconsideration record.

Pass when. Every record covers all four items.

3. Consent covers the alternatives.

Method. Check each record for the alternatives explained.

Evidence to show. Procedure consent and reconsideration record.

Pass when. Every record covers the alternatives.

4. Elective patients are given a defined time to reconsider.

Method. Check each elective consent for the reconsideration time and the consent date.

Evidence to show. Procedure consent and reconsideration record (PRO-FRM-003).

Pass when. No elective consent is taken before the reconsideration time ends.

Immediate fail (any one means the criterion is not met)

• A procedure starts without consent that covers the risks and complications.

Why this criterion matters. Complications happen even in a safe centre. A defined pathway, with a named contact available at the time, means the patient is treated quickly and the team learns from it.

Sample. Review the complication records for the last 12 months, and test the named contact by calling on 3 days chosen at random.

1. A written pathway for complications exists.

Method. Read the pathway and check it covers complications and the hospital route.

Evidence to show. Complications pathway and named contact (PRO-SOP-003).

Pass when. The pathway covers both and is current.

2. A named contact is available at the time of the procedure.

Method. Call the named contact at the time of a procedure session and record the response.

Evidence to show. Complications pathway and named contact.

Pass when. The named contact answers on each test call.

3. A serious reaction has a route to hospital.

Method. Check each serious reaction for a transfer record.

Evidence to show. Complication record (PRO-FRM-004).

Pass when. Every serious reaction has a route to hospital recorded.

Immediate fail (any one means the criterion is not met)

• A serious complication has no named contact or route to hospital.

Why this criterion matters. Anaphylaxis and other emergencies can happen minutes after an injection. The centre must have the equipment and the training to respond at once.

Sample. Review the emergency kit checks for the last 3 months and observe one emergency drill.

1. Anaphylaxis drugs are in a known place and ready.

Method. Check the kit location and the drug stock at the drill.

Evidence to show. Daily resuscitation check record (HOS-FRM-013).

Pass when. Adrenaline is in the known place and in date at every check.

2. The emergency response is practised.

Method. Check the drill record for the last 12 months.

Evidence to show. Emergency drill record (HOS-SOP-015).

Pass when. A drill is recorded in the last 12 months.

3. Anaphylaxis is treated as the protocol sets.

Method. Observe the drill against the anaphylaxis protocol (PRO-SOP-004).

Evidence to show. Drill observation record.

Pass when. The drill follows the protocol at each step.

4. Equipment and drugs are complete and in a known place.

Method. Check the kit at the drill for each item and its location.

Evidence to show. Equipment inventory and service log (EQP-REG-001).

Pass when. Every item is complete and in its known place.

Immediate fail (any one means the criterion is not met)

• A procedure starts without adrenaline ready and checked.

Why this criterion matters. Every injection breaks the skin, which is the body's main barrier to infection. Sterile technique for each one is the simplest way to prevent infection from the procedure itself.

Sample. Observe 10 injections or procedures, and review the sterile technique audit for the last 3 months.

1. Each injection uses sterile technique.

Method. Observe each sampled injection for hand hygiene, sterile field and single-use items.

Evidence to show. Sterile technique audit record (PRO-FRM-005).

Pass when. At least 95% of observed injections use all three.

2. Single-use items are never reused.

Method. Check the disposal records and observe reuse.

Evidence to show. Sterile technique audit record.

Pass when. No single-use item is reused.

3. Sterile technique is audited each month.

Method. Check the audit record for each month.

Evidence to show. Sterile technique audit record.

Pass when. Every month has an audit.

Immediate fail (any one means the criterion is not met)

• An injection is given without sterile technique.

Why this criterion matters. Some reactions appear after the patient has gone home. A scheduled follow-up, with a named person to review the result, catches them.

Sample. Review the follow-up records for 30 procedures in the last 3 months.

1. Each patient has a scheduled follow-up.

Method. Check each sampled procedure for a booked follow-up.

Evidence to show. Post-discharge follow-up register (HOS-REG-003).

Pass when. At least 95% of procedures have a follow-up booked.

2. A named person reviews results and problems.

Method. Check each follow-up for a named reviewer.

Evidence to show. Post-discharge follow-up procedure (HOS-SOP-011).

Pass when. Every follow-up has a named reviewer.

3. Follow-up is completed on the scheduled date.

Method. Check the completion date against the scheduled date.

Evidence to show. Post-discharge follow-up register.

Pass when. At least 90% are completed on the scheduled date.

Immediate fail (any one means the criterion is not met)

• A patient who reacts after going home has no follow-up contact.

Why this criterion matters. A product recall is only effective if the centre knows which patients received the product. Checking notices against stock and against patients makes the recall reach the people affected.

Sample. Review the recall log and the batch register for the last 12 months, and each recall notice received.

1. Each recall notice is checked against stock and against patients treated.

Method. Check each recall for the stock check and the patient trace.

Evidence to show. Product recall and adverse reaction procedure (PRO-SOP-006).

Pass when. Every recall is checked against stock and against patients.

2. Each adverse reaction is recorded.

Method. Check each adverse reaction for a record.

Evidence to show. Adverse reaction record (PRO-FRM-006).

Pass when. Every adverse reaction is recorded.

3. Patients who received a recalled batch are contacted within the set time.

Method. Check each recall for the contact date.

Evidence to show. Product batch register (PRO-REG-001).

Pass when. Every affected patient is contacted within the set time.

Immediate fail (any one means the criterion is not met)

• A recalled batch is still in use.