In order to achieve the best possible quality ratings and outcomes, primary healthcare providers must prepare adequately for Care Quality Commission (CQC) inspections. One way of doing so, is to conduct a self-audit, working through the relevant guidance published by the CQC and including a “mock” inspection. This toolkit provides you with some tips for improving your preparation.
When do I start?
The earlier you start the better. It doesn’t matter:
The aim is always to be continuously learning, developing and improving, and to always be prepared for regulatory activity.
If you currently have a “Good” or “Outstanding” rating you can expect formal inspections less often than if you have a “Requires Improvement” or “Inadequate” rating. However, you still might receive focused inspections and if the CQC has information suggesting a drop of standards, it could bring a scheduled inspection forward.
Inspections are usually announced, although they may be unannounced if inspectors are responding to a particular issue or concern.
The CQC state that they will telephone providers on an annual basis to gather information. CQC stress that the call is not an inspection. Instead, it is a conversation with you about any changes at the practice.
If your practice has an overall rating of “Requires Improvement” or “Inadequate” the inspectors will usually ask you for additional information before they inspect. This will typically include pre-inspection information about how you have monitored the quality of treatment and services, including details of completed clinical audit cycles with evidence of actions taken as a result and outcomes achieved. Inspectors may also ask for various policies, procedures and other documentation.
To adequately prepare for an inspection or a phone call, it is important for registered primary care providers to understand exactly what the inspection process involves, what inspectors might look for when they visit and what information they should have ready at hand.
The inspection may take many hours and involve interviews of staff and patients, and reviews of documents such as operational policies and care records. It is therefore important that preparation for the inspection process is fully integrated into the practice’s quality assurance and internal audit processes and procedures.
Practice managers should prepare by asking a number of questions.
Do you understand or need to refresh your understanding of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and the Fundamental Standards that all adult social care and healthcare providers in England must demonstrate compliance with during an inspection? The application of the standards in specific areas are covered in many of the individual topics in this product. For instance, the Medicines and Medication topic covers the application of Regulation 12: Safe Care and Treatment, which includes a requirement for the “proper and safe” management of medicines.
Do you understand the current inspection model used by CQC? Since the publication of the Fundamental Standards the CQC have set out guidance in handbooks produced for each sector they regulate. These have been regularly updated so you should always look at the latest one. The most recent publication covering inspection in primary care is How CQC Monitors, Inspects and Regulates NHS GP Practices, published in April 2019 and available on the CQC website. See also the CQC Inspections topic in this product which summarises the main points.
Do you understand how inspectors use what are called “Key Lines of Enquiry” (KLOE) to address the five “key questions” test (Is the service safe? Is it effective? Is it caring? Is it responsive? Is it well-led?) and determine a quality rating for each provider? As well as the current handbook, the CQC website also includes a full list of KLOEs for healthcare providers. Alongside the KLOEs are a series of “ratings characteristics” which describe to inspectors what an Outstanding, Good, Requires Improvement or Inadequate Service looks like.
Have you made yourself aware of any changes made to inspection during the Covid-19 coronavirus pandemic? In March 2020, at the start of the pandemic, the CQC paused its routine inspection programme as a safety measure to protect both inspectors and primary care staff and services. In October 2020, the CQC moved to a flexible and risk based “transitional” approach of targeted regulatory enforcement. In February 2021, the approach was extended and a consultation launched on future changes to inspections.
Have all the staff in the practice been prepared for the inspection? Practice managers must make sure that staff understand the importance of inspection and the significance of the ratings awarded. Key elements of the training will include informing staff about what will happen on the day of inspection.
Auditing the practice against the regulations and standards
The CQC carry out their regulation of primary care by ensuring that all practices are registered and made subject to regular inspection. In between inspections, the CQC monitor registered providers remotely by gathering information from a variety of sources, including from complaints, from annual monitoring calls, from performance monitoring data and from statutory notices, etc.
Actual on-site inspections are carried out according to a set programme. Practices with higher ratings will be inspected less often than those with lower ratings. Practices graded as “Inadequate” may be subject to an improvement plan and a follow-up inspection organised within six months to ensure that the practice has made sufficient progress in improving.
During their visits, the inspection team will review a service with reference to the five “key questions” using compliance with the Fundamental Standards and the relevant KLOEs as guidance. Effective preparation should include carrying out a “self-audit” against the same guidelines.
Inspections are carried out in just one or two days, but your “internal inspecting” should be an ongoing and continuous process. You cannot do everything at once, so you may need a schedule of activities to cover all the key standards and KLOEs systematically.
This product includes “worked examples” of audits into overall compliance with the five key questions:
You can use these examples to complete your own audits and measure and record your compliance against each of the CQC's KLOEs and relevant key indicators. The frequency with which the audits should be completed may vary from practice to practice. Annual updates are recommended but audits may be required more often if there are weaknesses to be addressed, such as when a practice is required to make improvements following a previous inspection. The audits should be carried out frequently enough to ensure that the practice remains compliant and is ready for any inspection.
Key areas may need additional self-assessment as part of standard quality assurance processes. These can then be fed into the key-question audits. In addition, they will ensure that you are ready to produce relevant evidence and data to demonstrate high levels of compliance.
Many of the topics in this product contain specific information about CQC compliance and requirements. Some also contain useful self-assessment and risk-assessment tools.
Examples of key areas include the following.
Regulation 12: Safe Care and Treatment, requires practices to ensure patients are not given unsafe care or treatment, or put at risk of harm that could be avoided. Providers must assess the risks to people’s health and safety during any care or treatment, and make sure that staff have the qualifications, competence, skills and experience to keep people safe. The fundamental standard is a major element in Key Question 1.
Key tools that may prove useful include:
Emergency planning and business continuity planning are also key elements in compliance with Regulation 12. How to respond in emergencies to keep people safe, and returning the service to normal afterwards, are covered in the Emergency Planning topic. Resources include an Emergency Planning: Business Continuity Risk Assessment and Contingency Planning Framework.
Regulation 13: Safeguarding Service Users from Abuse and Improper Treatment requires you to ensure that patients do not suffer any form of abuse or improper treatment, including neglect, degrading treatment, or unnecessary or disproportionate restraint, etc. The Safeguarding Children and Young People topic identifies the KLOEs inspectors will look to answer in relation to safeguarding for this group of patients. It also includes a model policy.
Regulation 15: Premises and Equipment covers compliance with all regulations and requirements for the appropriate safety, maintenance, cleanliness and running of the practice premises. Key tools that may prove useful in the preparation for inspection in this area include the following:
Regulation 16: Receiving and Acting on Complaints requires providers to have effective systems in place which enable patients to complain, if they wish to, and to have their complaints listened to. Practices must handle and respond to complaints effectively, investigating the complaint thoroughly and taking appropriate action if problems are identified. To assist with the key-question audit you should check your systems in relation to any complaints using, for example, the tools and resources in the Complaints topic.
Additional information related to complaints can be found in other “customer care” activities such as Patient and Public Participation and Involvement and Patient Surveys. Here you should show that the practice is continually listening to, valuing and acting on what service users are telling you.
Regulation 17: Good Governance states that you must have effective governance in place, including systems to check on the quality and safety of care, and to help the service to improve and reduce any risks to health, safety and welfare. This is a vital standard which requires the practice to maintain high standards through effective quality assurance monitoring. It is particularly important in answering the “well-led” key-question. This product contains further guidance on carrying out practice audits which should support practices in carrying out quality assurance analysis.
A wide range of documents and data could be used as evidence of good practice during an inspection. Such documents must be produced for inspectors if asked for.
For key question 1: Is the service safe?
General safety records, including health and safety policies, health and safety risk assessments and quality assurance audits for safety, etc.
Premises and equipment records such as fire safety assessments and records, adaptations and equipment assessments, maintenance checks and servicing records, security policies, etc.
Infection control risk assessments, cleaning records, Covid-19 risk assessments and management plans, etc.
Safeguarding records, such as safeguarding risk assessments, safeguarding policies, whistleblowing policies, physical intervention and restraint policies, etc.
Staffing levels records, including rotas and safe staffing level assessments.
For key question 2: Is the service effective?
Patients’ needs assessments, consent forms and healthcare records.
Mental capacity records, including best interest decisions, mental capacity policies.
Staff training records, qualifications records, recruitment and personnel files.
For key question 3: Is the service caring?
Privacy policies, dignity and respect policies.
Bullying and harassment policies, autonomy policies, equal opportunities policies, confidentiality policies.
Training records for subjects such as Equality and Diversity, etc.
For key question 4: Is the service responsive?
Healthcare and treatment records.
Complaints records, including complaints record or log, complaints investigation records, complaints policies and procedures.
For key question 5: Is the service well-led?
Leadership and management evidence, including vision and strategy documents, mission statements, business plans, governance documents, registered manager records, Duty of Candour policy, CQC registration records, staff disciplinary and grievance policies and records, data protection policies and records, etc.
Business continuity plans and policies.
Patient/public involvement records, including minutes of meetings, questionnaires, surveys, complaints/suggestions, records of user groups, patients guide/information, leaflets.
Quality assurance audits, action plans, quality assurance policies, etc.
Practices who, from their last inspection, have been asked to make a number of improvements, or where they have been rated as inadequate, will need to have a clear strategy for any inspection and ensure that they can demonstrate the improvements required.
Mock inspection exercises are a useful way to enable staff to rehearse how they will manage the inspection process on the day. CQC inspections can be a stressful experience and it is importance to ensure that everyone involved has adequate support and knows what to expect.
After the inspection
Once the inspection has finished the practice should review how it went and listen to feedback from the inspection team in order to learn lessons for the future. Reviewing the inspection report, and in particular the way the CQC inspection team obtained its evidence and awarded its ratings, can help the practice to identify areas where it can improve in the future.
Last reviewed 31 May 2021