This outcome is about the management, monitoring systems, and decision making processes you have in place to ensure consistent and guaranteed quality assurance.

Outcome in plain English

16A Monitoring the quality of your services

  • You must have proper quality monitoring systems.
  • Examples of sources of your quality information:-
    • Patient feedback
    • Observations
    • Audits
    • Adverse events
    • Incidents
    • Errors and near misses
    • Investigations into the misconduct of a person employed
    • Comments and complaints
    • Claims
    • Professional bodies
  • You must submit data where required by law
  • Utilise findings from clinical audits both internal and by external bodies
  • Identify non-compliance and risks of non-compliance and put it right
  • Reduce risks of non-compliance

16B Ensure safe care by:

  • Gathering information about risk to patients' safety
  • Make changes to their plan of care if necessary
  • Continuously identify risks, incidents, and errors
  • Analyse adverse events
  • Allow staff to raise concerns without being penalised
  • Involve patients and staff in decisions"
  • Practice informed consent about safety and self-responsibility

16C Reporting on risks to quality and improvement plans

  • You should make your findings above available to patients and plan quality improvements

16D Decision making arrangements

  • Involve the patient in decisions about their care with written descriptions of :-
    • Names and roles of decision makers
    • People who must be consulted
    • Types of decisions requiring consultation
    • What happens people are not available for consultation
    • Record how each decision was reached

16E You must have the following in place:-

  • Continuous quality improvement
  • Up to date description of your quality management system
  • CQC can ask for a full description of your system


What the BMA says

Your practice is likely to be compliant if your practice does the following:

Collects and reviews information about its services for the purpose of quality improvement through:

  • having a mechanism for patient feedback/comments;
  • having a publicised and robust complaints procedure for handling complaints from patients, which complies with the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009;
  • conducting clinical audits (such as those required for the Quality and Outcomes Framework- see the BMA/NHSE QOF guidance). The RCGP has extensive guidance on conducting clinical audits.
  • conducting regular significant event reviews and analyses. The National Patient Safety Agency has guidance on conducting significant event audits and analyses. There is also guidance on significant event reviews in the BMA/NHSE QOF guidance.
  • conducting risk assessments as and when appropriate.
  • collecting information related to misconduct investigations of its staff.

  • Creates an environment where staff feel able, on a confidential basis if necessary, to raise concerns about risks to patients or staff.

  • Circulates and acts on clinical guidance, medical alerts and safety alerts and any other relevant local or national reports so that staff change their working practices, if necessary, for the benefit of patients


Primary Care Networks (PCNs)

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