CQC Status:Inspection Ready (96% Compliant)
Health & Social Care Act 2008 & CQC Registration Regs 2009

CQC Fundamental Standards & Statutory Regulations Matrix

Comprehensive breakdown of the statutory fundamental standards and registration regulations governing dental providers in England. Clear mapping of direct prosecution offences, clinical requirements, and inspection evidence.

10 Direct Prosecution Offences (Can prosecute without Warning Notice)
100% Dental Compliance Coverage
Regulation 4 & 5

Fit and proper persons: Directors & Partners

Part 3: Fundamental Standards (2014)

Ensures directors, partners, and governing officers are of good character, have necessary competence, are physically/mentally fit, and have not been responsible for serious misconduct/bankruptcy.

Dental Practice Mandatory Requirements
  • Companies House director check & insolvency register check
  • Enhanced DBS check for all partner dentists/directors
  • Fit & Proper Person annual declaration adhering to Nolan principles of public life
Inspection Evidence Files in DentaComp
📄 Director DBS Certificates📄 Companies House Registry📄 Fit & Proper Person Audit
Regulation 6 & 7

Requirements relating to Registered Managers & Nominated Individuals

Part 3: Fundamental Standards (2014)

Requires an appropriate, competent, skilled Registered Manager in day-to-day charge with necessary dental qualifications and suitability documentation (Schedule 3).

Dental Practice Mandatory Requirements
  • GDC registration verification and dental practice management qualifications
  • Continuous CPD in leadership, CQC regulations, and clinical governance
  • Documented Nominated Individual supervision arrangements
Inspection Evidence Files in DentaComp
📄 GDC Certificate📄 Registered Manager Job Description📄 Management CPD Log
Regulation 9

Person-centred care

Part 3: Fundamental Standards (2014)

Care and treatment must be appropriate, meet needs, and reflect patient preferences. Requires collaborative assessment, clear treatment plans, and reasonable adjustments.

Dental Practice Mandatory Requirements
  • Personalised dental treatment plans (FP17DC / Private estimates) with agreed recall intervals
  • Full explanation of risks, benefits, and alternatives (including option of doing nothing)
  • Reasonable adjustments under Equality Act 2010 (wheelchair access, large print, translator support)
Inspection Evidence Files in DentaComp
📄 Treatment Planning SOP📄 Dental Record Keeping Audit📄 Disability Access Assessment
Regulation 10

Dignity and respect

Part 3: Fundamental Standards (2014)

Patients must be treated with dignity and respect at all times, ensuring privacy during clinical discussions/procedures and protection from discrimination.

Dental Practice Mandatory Requirements
  • Clinical consultations and fee discussions held in closed surgery rooms with sound privacy
  • Chaperone policy available for intimate/sensitive procedures
  • Non-discriminatory care respecting all protected characteristics under Equality Act 2010
Inspection Evidence Files in DentaComp
📄 Privacy & Dignity Policy📄 Chaperone Policy📄 CCTV Privacy Notice
Regulation 11

Need for consent

Part 3: Fundamental Standards (2014)
Direct Prosecution Offence

Care and treatment may ONLY be provided with valid consent. Mentally incapacitated patients must be protected under Mental Capacity Act 2005. Under-16s assessed under Gillick competence.

Dental Practice Mandatory Requirements
  • Montgomery-compliant informed consent discussing all material risks and aesthetic expectations
  • Two-stage Mental Capacity Act 2005 assessment & best interests documentation for vulnerable adults
  • Right to withhold or withdraw consent respected at any stage of treatment
Inspection Evidence Files in DentaComp
📄 Informed Consent Policy📄 Consent Form Templates📄 Mental Capacity Protocol
Regulation 12

Safe care and treatment

Part 3: Fundamental Standards (2014)
Direct Prosecution Offence

Must prevent unsafe care, mitigate health & safety risks, control infection spread (HTM 01-05), ensure equipment safety, and manage medicines safely.

Prosecution if breach results in avoidable harm or significant risk of harm
Dental Practice Mandatory Requirements
  • HTM 01-05 compliant decontamination with daily autoclave logs and 6-monthly IPS audits
  • Medical emergency kit & AED weekly checks complying with Resuscitation Council UK standards
  • Safer sharps systems and compliance with MHRA / CAS Patient Safety Alerts
  • Safe storage and dispensing of local anaesthetics, antibiotics, and prescription pads
Inspection Evidence Files in DentaComp
📄 Daily Autoclave Logbook📄 Emergency Drug Check Records📄 HTM 01-05 IPS Audit📄 Sharps Risk Assessment
Regulation 13

Safeguarding service users from abuse and improper treatment

Part 3: Fundamental Standards (2014)
Direct Prosecution Offence

Zero-tolerance to abuse, neglect, degrading treatment, or unlawful restraint. Requires robust safeguarding systems and immediate reporting.

Prosecution if breach results in avoidable harm or significant risk of harm
Dental Practice Mandatory Requirements
  • Lead Safeguarding Dentist appointed with Level 2/3 training (3-yearly)
  • Clear protocol for recognizing non-accidental dental injuries (NADI) and child neglect
  • Direct referral pathways to local Multi-Agency Safeguarding Hub (MASH)
Inspection Evidence Files in DentaComp
📄 Safeguarding Children & Adults Policy📄 Staff Safeguarding Certificates📄 MASH Contact Directory
Regulation 15

Premises and equipment

Part 3: Fundamental Standards (2014)

Premises and equipment must be clean, secure, suitable for purpose, properly maintained, and appropriately located with appropriate hygiene standards.

Dental Practice Mandatory Requirements
  • Annual servicing and Pressure Systems Safety Regulations (PSSR 2000) written scheme for autoclaves/compressors
  • Radiation safety critical examination and 3-yearly QA tests by Radiation Protection Adviser (RPA)
  • Legionella risk assessment and monthly sentinel tap temperature monitoring (HTM 04-01)
Inspection Evidence Files in DentaComp
📄 PSSR Written Scheme of Examination📄 RPA Radiation Safety Report📄 Legionella Risk Assessment
Regulation 16

Receiving and acting on complaints

Part 3: Fundamental Standards (2014)
Direct Prosecution Offence

Must operate an accessible complaints system. All complaints must be investigated without delay with statutory response timescales.

Regulation 16(3) summary of complaints must be provided to CQC within 28 days of request
Dental Practice Mandatory Requirements
  • Written complaints policy displayed in waiting area and website
  • Mandatory 3 working day acknowledgement and 10-20 day full investigation response
  • Signposting to Parliamentary Ombudsman (NHS) and Dental Complaints Service (Private)
Inspection Evidence Files in DentaComp
📄 Complaints Register📄 Patient Complaints Leaflet📄 Annual Complaints Audit
Regulation 17

Good governance

Part 3: Fundamental Standards (2014)
Direct Prosecution Offence

Must operate effective auditing and governance systems, maintain contemporaneous dental records, seek patient feedback, and continually improve quality.

Regulation 17(3) governance & improvement report must be provided to CQC within 28 days of request
Dental Practice Mandatory Requirements
  • Clinical audit programme (HTM 01-05, Radiography IRMER, Record keeping, Antibiotic prescribing)
  • Complete, contemporaneous, indelible dental records adhering to FGDP standards
  • Regular practice governance meetings and Friends and Family Test (FFT) patient surveys
Inspection Evidence Files in DentaComp
📄 Clinical Audit Portfolio📄 Practice Meeting Minutes📄 Patient Feedback Reports
Regulation 18

Staffing

Part 3: Fundamental Standards (2014)

Must deploy sufficient numbers of suitably qualified, competent, and skilled staff who receive appropriate induction, supervision, appraisal, and mandatory training.

Dental Practice Mandatory Requirements
  • Safe staffing levels with qualified dental nurses for four-handed dentistry
  • Structured induction programme covering safety, IPC, medical emergencies, and local rules
  • Annual staff appraisals and GDC Enhanced CPD portfolio maintenance
Inspection Evidence Files in DentaComp
📄 Staff Training Matrix📄 Annual Appraisal Records📄 Staff Induction Checklist
Regulation 19

Fit and proper persons employed

Part 3: Fundamental Standards (2014)

Robust recruitment checks (Schedule 3): ID, 2 written references, full employment history with gap analysis, Enhanced DBS, qualifications, and Hepatitis B immunity.

Dental Practice Mandatory Requirements
  • Complete recruitment files with verified ID and references before start of employment
  • Enhanced DBS check registered on DBS Update Service
  • Hepatitis B antibody titer check (>100 mIU/mL) confirming immunity for clinical workers
Inspection Evidence Files in DentaComp
📄 Staff Recruitment Checklist📄 Hep B Immunity Records📄 DBS Register
Regulation 20

Duty of candour

Part 3: Fundamental Standards (2014)
Direct Prosecution Offence

Open and honest communication when things go wrong. For any notifiable safety incident (moderate harm, severe harm, or prolonged pain >28 days), must provide in-person explanation and written apology within 10 days.

Dental Practice Mandatory Requirements
  • Significant Event Analysis protocol identifying notifiable safety incidents
  • In-person notification with truthful account of facts and offer of reasonable support
  • Formal written apology and copy of all correspondence securely archived
Inspection Evidence Files in DentaComp
📄 Duty of Candour Policy📄 Significant Event Log📄 Written Apology Templates
Regulation 20A

Requirement as to display of performance assessments (CQC Rating)

Part 3: Fundamental Standards (2014)
Direct Prosecution Offence

Providers must conspicuously and legibly display their CQC performance assessment and rating at each practice premises and on their website.

Dental Practice Mandatory Requirements
  • CQC inspection certificate/rating displayed in patient waiting room
  • CQC digital widget and link to CQC inspection report on practice homepage
Inspection Evidence Files in DentaComp
📄 Waiting Room Display📄 Website CQC Widget
Part 4 Reg 12

Statement of purpose

Part 4: Registration Regulations (2009)
Direct Prosecution Offence

Must maintain a clear Statement of Purpose containing Schedule 3 details (aims, registered manager, locations, regulated activities). Must notify CQC within 28 days of any revision.

Dental Practice Mandatory Requirements
  • Complete Parts 1-4 Statement of Purpose detailing primary dental care activities
  • Annual review and written notification to CQC of any managerial or location change
Inspection Evidence Files in DentaComp
📄 Statement of Purpose (Parts 1-4)📄 CQC Registration Certificate
Part 4 Reg 14 & 15

Notice of absence & Notice of changes

Part 4: Registration Regulations (2009)
Direct Prosecution Offence

Mandatory written notice to CQC 28 days before a continuous absence of 28+ days of the Registered Manager, and notice of return within 7 days. Notice of change in partners, directors, or provider status.

Dental Practice Mandatory Requirements
  • Registered Manager absence notification procedure with designated acting manager
  • Formal notification to CQC of any change in partnership or ownership structure
Inspection Evidence Files in DentaComp
📄 Absence Contingency SOP📄 CQC Notification Records
Part 4 Reg 18

Notification of other incidents (CQC Reg 18)

Part 4: Registration Regulations (2009)
Direct Prosecution Offence

Must notify CQC without delay of: serious injuries lasting >28 days, abuse allegations, incidents reported to police, service disruptions/utility outages >24 hours, fire alarm failures >24 hours.

Dental Practice Mandatory Requirements
  • Immediate CQC notification for any dental patient hospital admission or permanent injury
  • Notification if practice closes due to flood, fire, power failure, or compressor breakdown >24h
  • Police incident reporting log for theft of prescription pads or physical threats
Inspection Evidence Files in DentaComp
📄 CQC Regulation 18 Incident Form📄 Business Continuity Log
Part 4 Reg 19

Fees & Written Cost Estimates

Part 4: Registration Regulations (2009)
Direct Prosecution Offence

Must provide a written statement of terms, conditions, payment methods, and written cost estimates prior to the commencement of treatment.

Dental Practice Mandatory Requirements
  • Itemised written treatment plan and fee estimate provided and signed before treatment commences
  • Price list clearly displayed in waiting area and on website (NHS Band 1/2/3 & Private fee guide)
  • Clear notice of payment terms and any deposit/cancellation policies
Inspection Evidence Files in DentaComp
📄 Practice Fee Guide📄 Written Estimate Form Template📄 Terms of Service