Sample policy · Dental

Dental decontamination policy: HTM 01-05 template

Statutory anchor: Regulation 12 (safe care and treatment), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). The real primary technical standard for this policy is the Health Technical Memorandum 01-05 (Decontamination in primary care dental practices); the engaged CQC regulation quoted below is Regulation 12, in particular the premises, equipment and infection-control duties. · primary source

1. What the regulation says

Care and treatment must be provided in a safe way for service users. (Reg 12(1) (the headline duty))

assessing the risks to the health and safety of service users of receiving the care or treatment, (Reg 12(2)(a) (risk assessment))

doing all that is reasonably practicable to mitigate any such risks, (Reg 12(2)(b) (risk mitigation))

ensuring that the premises used by the service provider are safe to use for their intended purpose and are used in a safe way, (Reg 12(2)(d) (premises safety))

ensuring that the equipment used by the service provider for providing care or treatment to a service user is safe for such use and is used in a safe way, (Reg 12(2)(e) (equipment safety))

assessing the risk of, and preventing, detecting and controlling the spread of, infections, including those that are health care associated, (Reg 12(2)(h) (infection control))

The full text of the regulation is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

Care and treatment must be provided in a safe way. The regulation lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning. Regulation 12 is central to CQC's safety expectations.

3. Purpose

This policy sets out how the Practice decontaminates reusable dental instruments, records traceability, checks equipment and audits the process. It is written for primary-care dental services that use local decontamination arrangements.

This policy is a starting template. The Practice must verify the detail against the current Health Technical Memorandum 01-05 source before adoption.

4. Sources to verify before adoption

5. Scope

This policy applies to:

Single-use instruments are not reprocessed. Staff dispose of them according to the Practice waste policy.

6. Step-by-step decontamination procedure

The Practice follows a documented decontamination cycle for each reusable instrument batch.

6.1 Acquisition and intake

6.2 Transport from surgery to decontamination area

6.3 Cleaning

6.4 Inspection

6.5 Sterilisation

6.6 Storage

6.7 Traceability

6.8 Failed cycle, contamination or traceability gap

  1. Stop release and separate the batch. Mark affected instruments as not for use and keep them outside the clean flow.
  2. Record the failure. Capture the equipment, cycle or batch reference, time, operator, failed check and instruments affected.
  3. Assess whether anything was already used. Identify any patient, surgery or procedure linked to the affected batch and obtain clinical and infection-prevention advice where required.
  4. Identify and correct the cause. Check loading, cleaning, packaging, equipment, process and staff factors. Do not return faulty equipment to use without the required checks or competent advice.
  5. Reprocess only when safe. Start the full approved cycle again where the instrument and manufacturer's instructions permit it, then record the successful release decision.
  6. Escalate and learn. Open an incident for a used, lost or potentially contaminated batch, consider the risk register and track corrective action through governance.

7. Essential-quality and best-practice-quality position

HTM 01-05 distinguishes between essential-quality requirements and best-practice-quality improvements. The Practice records its current position against both levels.

The Practice must verify the current wording and test requirements in HTM 01-05 before adopting this section.

8. Autoclave validation and equipment checks

The Practice keeps an equipment file for each steriliser. The file includes:

Staff do not restate test frequencies from memory. They use the current HTM 01-05 source and the manufacturer's instructions when setting the local test schedule.

9. Responsibilities

10. Recording requirements

The decontamination record should include:

Records are kept in the Practice's governance records and are available for internal audit, CQC review and external review where required.

11. Audit cadence

The Practice uses the following Verivius default audit rhythm unless the current HTM 01-05 source, commissioning requirement or local risk assessment requires more frequent review:

Any audit finding is recorded as an improvement action with an owner and review date.

12. Version control and review date

The Practice keeps a controlled copy of this policy. The footer or document-control table records:

13. Related records

Review cadence: annual or on regulatory change, whichever sooner. Owner: Registered Manager.

14. Related policies in this pack

15. Sources and further reading

This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.

16. When to seek further advice

Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.

17. Document control

Version Date Author Changes
v1.1 2026-07-18 Verivius (sample) Added the failed-cycle quarantine procedure, detailed evidence fields and linked policy controls.
v1 2026-06-10 Verivius (sample) Initial sample template, conformed to the Verivius policy standard.

This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the provider's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.

What good looks like here

Written from an ex-CQC inspector's chair, but the point is safe, well-led care your team can stand behind. Each row shows what strong evidence looks like, what thin evidence looks like, and where the expectation comes from.

A patient in the chair has no way of knowing whether the instrument about to go into their mouth was sterilised properly or only looks clean, and the harm that decontamination guards against, transmission of a blood-borne virus or another infection from one patient to the next, may not surface for months or years. That is why the evidence trail matters more here than almost anywhere in a dental practice. Cycle records, periodic test logs and instrument traceability are not paperwork for its own sake: when a steriliser is later found to have failed, or a contamination alert is raised, they are the only way the practice can work out which instruments were affected and which patients were treated with them, so those people can be identified and told rather than left unaware. A practice that decontaminates well but cannot trace what it processed still cannot answer the one question that protects the person when something goes wrong.

  1. Every reusable instrument used in a patient's mouth has passed a full decontamination cycle that was released as safe, and the practice can trace back from the patient to the cycle that processed the instruments, not just give a general assurance that it decontaminates its instruments.

    Strong evidence: The instrument traceability record connecting the instrument set or batch, the sterilisation cycle reference and, where the local process requires it, the patient or procedure, held in the decontamination log or approved digital record, with the release decision recorded for each cycle.

    Weak evidence: A decontamination log that shows cycles ran but cannot connect any instrument set to the cycle that processed it, so a steriliser later found to have failed, or a contamination alert, leaves no way to identify which patients were treated with the affected instruments. Or release entries in a suspiciously even daily rhythm with no operator named and no failed cycle ever recorded.

    What the regulator expects to see. Not a law in itself, but CQC judges you against it, so an inspector will look for it and expect a reason where you depart from it.

  2. The steriliser and washer-disinfector run to the manufacturer's validated cycle and the local decontamination procedure, each machine validated on installation, maintained on plan and periodically tested, with the test and cycle records retained, not equipment assumed to be working because it switches on and completes.

    Strong evidence: The equipment file for each steriliser and washer-disinfector: asset and model detail, the installation validation record, planned preventive-maintenance and service-engineer reports, and the periodic test and cycle records kept at the frequencies set by the manufacturer's instructions and the current HTM 01-05 source rather than a schedule restated from memory.

    Weak evidence: An autoclave in daily use carrying a validation certificate from installation and nothing since, periodic tests missing or back-filled in one pen after the fact, and a fault report closed with no record of what the engineer did or whether the machine was retested before returning to use. Test frequencies restated from a staff member's memory rather than taken from the manufacturer's instructions and the current HTM 01-05 source.

    The instructions from the maker of a product, device, or medicine. Following them is how the item is used safely, and for medical devices it is effectively expected.

  3. When a cycle fails, an instrument is found contaminated, or traceability cannot be confirmed, the affected instruments are quarantined out of the clean flow and the practice first works out whether any of them had already been used on a patient, rather than quietly reprocessing the batch and moving on.

    Strong evidence: A worked example in the decontamination log or incident record: the failed cycle or batch marked not for use and separated, the equipment, cycle and instruments captured, the assessment of whether any affected instrument had already been used and on whom, the cause identified and corrected, and the release decision recorded only once reprocessing was safe.

    Weak evidence: A failed-cycle entry with no follow-through: the batch marked failed but nothing on whether those instruments had already reached a patient, faulty equipment back in use the same day with no repair or retest recorded, and no incident opened where a potentially contaminated set had been used. A quarantine step written into the policy that no log entry ever shows actually happening.

    What the regulator expects to see. Not a law in itself, but CQC judges you against it, so an inspector will look for it and expect a reason where you depart from it.

  4. Sterilised instruments are stored so they stay fit to use, and used and clean instruments never share the same route, so the instrument taken to the chair is one that has not been recontaminated on the way there.

    Strong evidence: The clean-storage arrangement and local procedure showing separated dirty and clean routes, instruments not used where packaging is damaged, wet, unsealed or past the practice's locally verified storage period, and storage kept to the current HTM 01-05 source.

    Weak evidence: Used and processed instruments handled in the same space or carried together, packaged sets stored loose with no way to tell how long they have been there, or a local storage period no one can point to a source for. Wet or unsealed pouches still sitting in the clean stock.

    What the regulator expects to see. Not a law in itself, but CQC judges you against it, so an inspector will look for it and expect a reason where you depart from it.

  5. The decontamination cycle is run only by staff trained and signed off as competent for it, so the person cleaning, inspecting and releasing instruments knows what a rejected instrument looks like and when to stop, not just whoever happened to be free.

    Strong evidence: The training and competency file for each member of staff who handles decontamination: role-specific decontamination training, the competency sign-off, and any recorded restriction where sign-off is not yet complete, tracked on the training matrix.

    Weak evidence: A staff member recorded as running cycles with no decontamination competency sign-off on file, a training matrix that reads green because leavers were removed and new starters never added, or an induction that put someone on the decontamination bench before their competency was assessed.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, reg 18(2)(a) (training and professional development), supported by reg 12(2)(c) (persons with the necessary competence). The detailed content of that competence comes from the current HTM 01-05 and the equipment manufacturer instructions.

  6. The practice knows and records where it stands against the HTM 01-05 essential-quality and best-practice-quality requirements, and its decontamination audits produce improvement actions that close, not a checklist scored high and filed.

    Strong evidence: The recorded essential-quality and best-practice-quality position with a written improvement plan for anything not yet in place, plus the log reviews, the periodic instrument-journey sample and the annual decontamination audit against HTM 01-05, each finding carried as an owned improvement action with a review date.

    Weak evidence: An annual audit that is a downloaded HTM 01-05 checklist scored highly with no actions, no re-audit and nothing to show findings changed practice. A best-practice-quality element long outstanding with no improvement plan behind it, or a decontamination lead's log review that no record shows ever taking place.

    Our recommended baseline. Not a legal or regulatory requirement, but a sensible standard we suggest where the rules leave the detail to you. Adapt it to your service.

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Last verified 20 July 2026

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Last reviewed 10 June 2026