Safe care and treatment policy template

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 persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely, (Reg 12(2)(c) (staff competence))

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))

where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs, (Reg 12(2)(f) (sufficient equipment + medicines supply))

the proper and safe management of medicines, (Reg 12(2)(g) (medicines management))

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))

where responsibility for the care and treatment of service users is shared with, or transferred to, other persons, working with such other persons, service users and other appropriate persons to ensure that timely care planning takes place to ensure the health, safety and welfare of the service users. (Reg 12(2)(i) (shared / transferred responsibility))

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. Scope

This policy applies to all employees, contractors, and external parties who deliver, support, or oversee regulated care or treatment at any location operated by . It covers every regulated activity the provider is registered for, every patient pathway from first contact to discharge, and every clinical and clinical-adjacent environment (consulting rooms, theatres, wards, recovery, mobile and home-based delivery, telephone and video consultations).

(Tenant updates the angle-bracket placeholder and confirms the location and activity coverage.)

4. Roles and responsibilities

• Registered Manager: accountable for Reg 12 compliance across every site. Reviews the risk register monthly, signs off the assurance calendar against the Reg 12 elements (medication audits, equipment checks, infection prevention audits), and reviews every incident involving significant actual or potential harm, using the service's local incident severity taxonomy, for the Reg 12 sub-causes.
• Nominated Individual: holds provider-side accountability for Reg 12 across all locations. Reads the quarterly Reg 12 dashboard at the governance meeting.
• Clinical Lead: accountable for the clinical-care component of Reg 12: assessing risks at the patient level, ensuring the team uses the equipment safely, ensuring medicines are managed per the medicines policy. Signs off any clinical-pathway change for Reg 12 implications.
• Infection Prevention and Control Lead (named individual): accountable for the infection-control element of Reg 12 per the IPC Code of Practice. Coordinates the annual IPC audit and surfaces any outbreak to the Registered Manager within 24 hours.
• Medicines Lead (where applicable): accountable for the safe-management-of-medicines element, including controlled-drugs governance where in scope.
• All staff: apply the procedure below, log any near miss or incident affecting safety the same working day, and escalate concerns immediately where harm has occurred or is likely.

(Tenant updates the named role-holders to fit their organisation.)

5. Procedure

The Reg 12 procedure operationalises the nine elements of Reg 12(2) across the patient pathway.

1. Per-patient risk assessment. At first contact, the clinician completes a risk assessment proportionate to the service. The assessment records foreseeable risks (clinical, equipment, medicines, infection, environment), the mitigation in place, and any handover points where additional risk may arise.
2. Mitigation in the care plan. The mitigations identified at assessment are recorded in the care plan and shared with every team member involved in the patient's care.
3. Equipment safety. Every piece of clinical equipment used in regulated activity is on the equipment register, has a current service or calibration record, and a daily or per-use check is logged where required (resuscitation equipment, anaesthetic machines, point-of-care testing devices, sterilisation equipment, controlled-drugs cabinets).
4. Medicines management. Medicines are obtained, stored, prepared, administered, recorded, and disposed of per the medicines policy. Controlled drugs follow the additional governance routine (named accountable officer, two-signature handling, register reconciliation, expiry checks). Medicines-related incidents are logged the same day.
5. Infection prevention. Hand hygiene, PPE, decontamination, environmental cleaning, sharps handling, and waste segregation operate per the IPC policy. The IPC Lead surfaces any breach pattern at the monthly governance meeting.
6. Incident recording. Every patient-safety event (incident, near miss, no-harm event) is logged the same working day. The lifecycle then runs through investigation to closure with action, per the incident reporting policy.
7. Shared-care handover. Where care is shared with another provider (a GP, a community team, a private referrer, an NHS trust), handover communication is documented and the receiving party's acceptance is recorded.
8. Duty of candour trigger. Any patient-safety incident that meets the notifiable-safety-incident threshold opens a duty-of-candour record per the Reg 20 policy. A notifiable safety incident is a specific legal term and the threshold differs by provider type, so the service applies the correct Regulation 20 definition for its provider type. The verbal-then-written notification trail is preserved on the source incident.
9. Statutory notification trigger. Any patient-safety event meeting a notification trigger under the Care Quality Commission (Registration) Regulations 2009 spawns a notification record per the CQC statutory notifications policy. The notification is filed within the operational SLA.
10. Periodic learning review. Aggregate patterns across incidents and near misses are reviewed quarterly at the clinical governance meeting. Learning that warrants a change to practice produces improvement actions; the actions are tracked to completion with evidence.

6. Training requirement

All clinical staff in scope complete the following at induction and on the cadence noted:

• Mandatory infection prevention and control training, annually.
• Resuscitation training (BLS, ILS, or ALS depending on role), annually for BLS, at the professional-regulator cadence for ILS or ALS.
• Medicines management training where the role involves administration, annually.
• Sepsis recognition (where in scope), annually.
• Safeguarding (adults and children), at the level the role requires, every three years minimum.
• Mental Capacity Act awareness, every three years for clinical roles.

Non-clinical staff complete the basic Reg 12 awareness module at induction.

Training records are held in the tenant's training matrix register and surfaced on the assurance calendar as renewals fall due. (Tenant adjusts the topic list to match the service shape.)

7. Audit

Compliance with this policy is monitored by the Registered Manager and the Clinical Lead jointly, on the following cadence:

• Quarterly file audit: random sample of 5 to 10 patient records reviewed against the per-patient risk assessment and care-plan-mitigation requirements.
• Monthly equipment register review: every entry's service or calibration date checked against the next-due date.
• Quarterly medicines audit: stock reconciliation, controlled-drugs register check, expiry audit.
• Annual infection prevention and control audit: against the IPC Code of Practice criteria, using the IPC audit tool the IPC Lead nominates.
• Quarterly incident-pattern review: aggregate incident themes against the Reg 12 elements.

Audit findings are recorded in the tenant's audit register, presented at the monthly clinical governance meeting, and any actions are logged in the improvement-actions register.

8. Record-keeping

Records this policy generates (per-patient risk assessments, equipment service records, medicines audits, infection-prevention audits, incident records, duty-of-candour records, statutory notifications, improvement actions) are held in the tenant's clinical and governance systems for a minimum of 8 years from the date of the last entry in the record (per the NHS Code of Practice on Records Management for adult records; longer for children's records, mental health records, and certain other categories per the same Code).

For controlled-drugs registers, the statutory minimum retention is 2 years from the date of the last entry per the Misuse of Drugs (Safe Custody) Regulations; most providers retain for 7 years aligned with clinical-record retention.

The Verivius platform records the per-record audit trail indefinitely while the workspace is active; on cancellation, the export pathway preserves the record set.

9. Related policies in this pack

• Person-Centred Care Policy
• Consent Policy
• Infection Prevention and Control Policy
• Medicines and Controlled Drugs Policy
• Duty of Candour Policy

10. 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.

• CQC Regulation 12: Safe care and treatment
• CQC Fundamental Standards
• Relevant NICE guidance
• MHRA safety alerts
• NHS Patient Safety Alerts / CAS alerts
• Misuse of Drugs (Safe Custody) Regulations 1973 (https://www.legislation.gov.uk/uksi/1973/798)
• NHS Records Management Code of Practice
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)

11. 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.

12. Document control

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