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FUNDAMENTAL STANDARDS

The CQC’s new regulations introduce the new fundamental standards, detailed below.

*Regulations 4 to 8 relate to the requirements of the service provider and registered manager and so are not relevant here.

   
Regulation 9: Person-centred care
  • Enabling and supporting the patient to understand the care or treatment choices and helping them to make informed decisions
  • Ensure the patient has the capacity and ability to provide consent (work within the requirements of the Mental Capacity Act 2005)
  • Use nationally recognised evidence-based guidance, eg, NICE, clinical protocols.
Regulation 10: Dignity and respect 
  • Confidentiality
  • Chaperone policy
  • Equality and diversity
Regulation 11: Need for consent 
  • Providing information for the patient in order for them to provide consent, EG, information leaflets
  • Practice policies for obtaining consent for treatment
  • Ensure the patient has the capacity and ability to provide consent (work within the requirements of the Mental Capacity Act 2005)
  • Safeguarding vulnerable children and adults policies/procedures.
Regulation 12: Safe care and treatment 
  • Health and safety.
  • Risk management.
  • Ensuring staff have the qualifications, competence, skills and experience to do the job.
  • Safe management of medicines.
  • Safety of premises and equipment.
  • Infection control.
  • Incident reporting.
  • Being able to respond to a medical emergency, EG, availability of oxygen, emergency drugs, defib.
  • Supervision and training of new staff.
  • Responding to safety alerts.
  • Ensure that staff work within the scope of their qualifications, competence, skills and experience.
Regulation 13: Safeguarding service users from abuse and improper treatment
  • Safeguarding children and vulnerable adults policies and procedures.
  • Ensure that staff have been trained at a level that is suitable for their role.
  • DBS checks.
  • Ensure that clinical staff have an understanding of the Mental Capacity Act 2005.
  • Policies and procedures for reporting concerns.
  • Policies and procedures for dealing with allegations of discrimination (equality and diversity policy).
Regulation 14: Meeting nutritional and hydration needs   N/A
Regulation 15: Premises and equipment 
  • Cleaning of premises and equipment, eg, cleaning rota
  • Waste management
  • Security of the premises
  • Safety of staff
  • Maintenance of the premises
  • Ensuring adequate facilities, eg, toilets, storage, seating and waiting areas
  • Health and safety risk assessment of the premises.
  • Infection prevention and control, eg, Health and Social Care Act 2008: Code of Practice for health and adult social care on the prevention and control of infections and related guidance.
Regulation 16: Receiving and acting on complaints
  •  Procedure for identifying, receiving, recording, handling and responding to complaints.
Regulation 17: Good governance 
  • Systems and processes such as regular audits of the service provided.
  • Systems and processes enable the provider to identify where quality and/or safety are being compromised , eg, risk assessment.
  • Provide information for patients and seek feedback from patients.
  • Health and safety risk assessments.
  • Record keeping. Security of records.
  • Information governance.
  • Audit of records.
Regulation 18: Staffing 
  • Sufficient numbers of staff
  • Ensuring appropriate training, professional development, supervision and appraisal for staff
  • Ensuring that staff staff are able to meet the requirements of the relevant professional regulator.
Regulation 19: Fit and proper persons employed
  • Robust processes for the recruitment of staff ensuring suitability, eg, ensuring staff have the qualifications, competence, skills and experience necessary for the role
  • Ensuring pre-employment checks are undertaken, eg, GMC, NMC, DBS, verification of identity.
Regulation 20: Duty of candour 
  • Act in an open and transparent way in relation to care and treatment provided to patients. It requires practices to have systems in place to capture notifiable safety incidents and processes to inform the patient of the incident and provide support. (See guidance in more details below.)
Regulation 20A: Requirement as to display of performance assessments 
  • Practices are required to display the CQC ratings in the practice and on the website.
CQC may prosecute breaches of the following regulations without first issuing a Warning Notice.
   
Regulation 11  Need for consent: care and treatment may only be provided with consent. 
Regulation 16(3) 

Receiving and acting on complaints: a summary of complaints, responses, correspondence and other relevant information identified must be provided to CQC within 28 days of a request.

Regulation 17(3) 

Good governance: a report into how the registered person is complying with the good governance requirements and their plans for improvement of services delivered must be provided to CQC within 28 days of a request.

Regulation 20 (2)(a)

Regulation 20(3) 

Duty of candour: registered persons must as soon as reasonably practicable notify a service user (or person lawfully acting on their behalf) when an unintended or unexpected incident occurs. Notifiable safety incidents are explained further in Regulation 20(8) and 20(9).

Duty of candour: notifications given under Regulation 20(2)(a) must meet specific requirements.

Regulation 20A 

Requirement as to display of performance assessments: providers must display on their website details of CQC’s website, the most recent CQC rating and the date it was given. They must also display the most recent rating at each location where regulated activities are provided from and at the provider’s principal place of business. Signs must be legible, conspicuously displayed and show the date the rating was given.

Read the CQC’s guidance on meeting the regulations