CQC quality statement — Safe
Medicines optimisation
"We make sure that medicines and treatments are safe and meet people's needs, capacities and preferences by enabling them to be involved in planning, including when changing or stopping medicines." In MyCareCompliance, 16 mapped checks across 11 audit templates map to this quality statement.
Last reviewed: September 2026. This guidance reflects CQC information available at the date above — always refer to cqc.org.uk for current regulatory requirements.
How we check it
Each check below is a real question from a MyCareCompliance audit template. It names the regulation it evidences, describes what an auditor looks for in good and poor practice, and lists the evidence an inspector would expect you to produce.
- 16 mapped checks under the "Medicines optimisation" quality statement
- Evidences 1 regulation: Regulation 12 — Safe care and treatment
- Failed checks become tracked improvement actions with an owner, due date and evidence
The 16 checks
- Regulation 12 — Safe care and treatmentCare Plan Audit
If the service provides medication support, is there a clear, accurate medication care plan specifying the level of support required?
What we look for: Check if the plan states exactly what staff must do (e.g., administer, prompt, assist). Good looks like clear instructions on times, routes, and specific PRN protocols. Fails if the level of support is ambiguous or contradicts the MAR chart.
Evidence: Medication care plan, PRN protocols, MAR charts, pharmacy letters
- Regulation 12 — Safe care and treatmentCompetency Audit
Is there a robust system for annual and post-incident medication administration competency assessments?
What we look for: Review the competency tracking matrix and sample 3 individual staff files. Good looks like annual observational sign-offs in the community, plus ad-hoc checks following any medication errors. A fail is relying solely on Q&A without practical observation, or expired assessments.
Evidence: Medication competency assessment forms, MAR chart audit follow-ups, staff training matrix
- Regulation 12 — Safe care and treatmentDaily Care Records Audit
Where care plans specify medication support, are daily logs aligned with MAR charts to confirm completion or refusal?
What we look for: Check logs for service users receiving medication support. Good looks like daily notes explicitly mentioning medication administration/prompts, matching the signatures on the MAR. A fail is discrepancies between the daily log narrative and the MAR chart.
Evidence: Daily logs, MAR charts, medication care plans
- Regulation 12 — Safe care and treatmentHospital Transitions
Is a full medicines reconciliation completed immediately following hospital discharge to ensure safe administration of new or altered prescriptions?
What we look for: Review the MAR charts and discharge notes for recently discharged people. Check that new medications are accurately transcribed, stopped meds are removed, and staff are clear on changes. A fail is an active MAR that contradicts the hospital discharge prescription.
Evidence: Hospital discharge summaries (TTOs), New MAR charts, Pharmacy correspondence, Medicine risk assessments
- Regulation 12 — Safe care and treatmentLate / Shortened Visits Audit
Have late or shortened visits impacted the safe administration of time-critical medicines (e.g., insulin, Parkinson's medication)?
What we look for: Identify clients on time-critical medicines. Compare their prescribed medication times with actual arrival/departure times on the ECM system. A fail is medication given outside the safe window due to poor timekeeping without clinical consultation.
Evidence: MAR charts, ECM logs cross-referenced with medication times, Incident reports
- Regulation 12 — Safe care and treatmentMedication / MAR Audit
Are medication administration records (MARs or eMARs) fully completed without unexplained gaps, showing correct codes where medication was not given?
What we look for: Sample at least 10% of active MAR charts from the previous cycle. Good looks like zero blanks; every entry must have a signature or an appropriate non-administration code (e.g., refused) with a corresponding note. A fail is any unexplained gap or use of Tipp-Ex.
Evidence: Paper MAR charts, eMAR records, daily care notes, communication logs
- Regulation 12 — Safe care and treatmentMedication / MAR Audit
Do all 'as required' (PRN) medications have a clear, person-centred protocol, and are reasons and outcomes recorded when administered?
What we look for: Check files of people prescribed PRN medication (e.g., pain relief, inhalers). Good looks like a detailed protocol stating what the medication is for, signs of need, max dose, and when to call GP. Fails include missing protocols or staff not recording the outcome of giving the PRN.
Evidence: PRN protocols, MAR charts, daily care notes
- Regulation 12 — Safe care and treatmentMedication / MAR Audit
Are time-critical medications (e.g., for Parkinson's or diabetes) clearly identified and administered at the exact required times?
What we look for: Identify service users on time-critical medicines. Cross-reference the logged call times and administration times against the prescribed time. Good looks like administration within 30 minutes of the prescribed time. Late or missed doses without escalating represent a failure.
Evidence: MAR charts, medication care plans, call time logs vs administration times
- Regulation 12 — Safe care and treatmentMedication / MAR Audit
Are topical medicines and prescribed creams recorded accurately on a body map and Topical MAR (TMAR) by care staff?
What we look for: Sample records of people prescribed creams. Good looks like a clear body map indicating where each specific cream goes, matched with a TMAR signed by staff after application. Fails involve staff signing the main MAR but ignoring the TMAR, or applying cream without a body map instruction.
Evidence: TMARs, body maps, daily care notes, medication care plans
- Regulation 12 — Safe care and treatmentMedication Competency Audit
Do staff files contain documented evidence of a face-to-face practical medication competency assessment completed in the field?
What we look for: Check that competency was assessed by direct observation in a service user's home, not just via a quiz or roleplay in the office. Good looks like a detailed checklist covering preparation, administration, and recording.
Evidence: Practical competency assessment forms, Field observation notes, Assessor sign-offs
- Regulation 12 — Safe care and treatmentMedication Competency Audit
Does the competency assessment specifically evaluate staff understanding and practice regarding the safe administration of 'as required' (PRN) medicines?
What we look for: Review the standard competency template. It must include checks on whether staff check when PRN was last given, understand the gap between doses, and document the reason/outcome of administration.
Evidence: Competency assessment templates, PRN protocols, Completed assessment forms
- Regulation 12 — Safe care and treatmentMedication Competency Audit
Do spot checks on recent MAR charts confirm that staff who recently passed their competency assessment are practicing safely and accurately?
What we look for: Sample MAR charts filled in by staff who passed their competency in the last month. Look for missing signatures or incorrect coding to ensure the competency assessment accurately reflects real-world practice.
Evidence: Completed MAR charts, Audit action plans, Care worker daily notes
- Regulation 12 — Safe care and treatmentOnboarding New Service Users
Where medication support is required, are safe systems established immediately, including accurate MAR charts and clear instructions?
What we look for: For any new user requiring medication support, audit the medication setup. Check that MAR charts are populated accurately against a pharmacy list or prescription, and that specific instructions (e.g., PRN protocols) are active from day 1. Any ambiguity in medication instructions upon onboarding is a critical fail.
Evidence: Medication care plans, MAR (Medication Administration Record) charts, pharmacy printouts, PRN protocols.
- Regulation 12 — Safe care and treatmentProbation Audit
Is a documented medication competency assessment completed in the field before the staff member administers medication alone?
What we look for: Check if a manager or senior has directly observed the new starter administering medication in a person's home. Passing this check requires a signed, dated, and detailed competency form on file prior to them acting independently.
Evidence: Medication competency assessments, spot check forms, MAR chart signatures
- Regulation 12 — Safe care and treatmentSkin Integrity
Are topical medicines and barrier creams applied according to instructions and recorded accurately on topical MAR (TMAR) charts?
What we look for: Check TMARs and body maps. Good looks like staff signing TMARs correctly and following body maps that indicate where creams should be applied. A fail is missing TMARs or using prescribed creams for general moisturising without instruction.
Evidence: TMAR charts, MAR charts, Body maps
- Regulation 12 — Safe care and treatmentSpot Checks Audit
Are staff directly observed administering medicines, with supervisors checking MAR chart completion and adherence to the 6 Rs?
What we look for: Examine spot checks for visits involving medication support. The supervisor must observe the carer checking the MAR, preparing the medication, offering it, and signing correctly. Missing observations of these critical safety steps would be a fail.
Evidence: Spot check records, medication competency assessments, MAR charts
Other Safe quality statements
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