All organisations experience change, whether macroenvironmental or microenvironmental. In fact, change is ever present; it is inevitable. In primary care, there is no escaping change, be it changes to clinical processes, changes to clinical IT systems, changes to the structure of primary care, or changes to regulations.

Of course, we have responded to many changes over time, but perhaps most significantly, we have responded to multiple changes from one specific organisation within the healthcare sector: the CQC – the independent regulator of health and adult social care in England.

In recent times, such changes began when the COVID-19 pandemic gripped the country and, just like the rest of us, the CQC were forced by macroenvironmental factors (namely, government-issued safety regulations) to change their strategy. This, in turn, impacted all providers in England.

One quick way to list all the changes would be to use TLAs (three-letter abbreviations), but fear not, I’ll explain (briefly)! So, there was the Emergency Support Framework (ESF), the Transitional Regulatory Approach (TRA), Transitional Monitoring Approach (TMA), and let’s not forget the Annual Regulatory Review (ARR). However, this wasn’t enough change and the CQC aspired to adopt a less invasive approach, resulting in the current direct monitoring approach.

Monthly monitoring, it would appear, is here to stay – as is the current inspection process; this consists of the two-week notification, a request for policies, protocols and other documentation, remote interviews with the practice team, and a short on-site inspection which primarily focuses on HR, premises, and infection prevention and control.

Throughout all the changes, you’ve been kept up to date by the many blogs I’ve written and you’ve had access to a plethora of useful resources including the CQC Handbook (second edition, Sept 2022). Yet, as I’ve already mentioned, change is omnipresent! And it should come as no surprise that further changes are imminent.

Let me start with quality statements. This is a fundamental change that sees Key Lines of Enquiry (KLOEs) being replaced by ‘quality statements’, of which there are 34 in total. Currently being rolled out with what the CQC are calling ‘early adopters’, quality statements will come into effect for all service providers in January 2023. You can learn more about this change in the For CQC, it’s quality that matters, not quantity blog.

In conjunction with the above, the CQC are also introducing a single assessment framework. This framework covers all service types and all providers in England, including local authorities and integrated care systems, and comprises four key components:

1. Registration – the first element of assessment activity for providers
2. Quality statements – referred to as ‘we statements’, they explain what is required to deliver high-quality, person-centred care
3. Five key questions and six new evidence categories
4. Ratings – outstanding, good, requires improvement, and inadequate

Another noteworthy change is the introduction of six new evidence categories, the aim of which is to ensure the consistency of assessments. These categories can be referred to as ‘required evidence’ and this is what the CQC will use to assess the quality of care being delivered against the quality statements. So, what are they? The evidence categories are:

• People’s experience of health and care services
• Feedback from staff and leaders
• Feedback from partners
• Observation
• Process
• Outcomes

Determining which evidence categories will be considered during an inspection is dependent on the type of service being provided, the level of assessment (service, provider, authority, ICS), and whether the assessment is being undertaken for registration or for an existing service that is being delivered.

This strategic change will enable the CQC to adopt a more flexible approach to regulation, an approach not determined by dates or previous ratings, but an approach driven by continued monitoring and a response to risk. Such strategic change impacts all providers of regulated activity in England.

As these changes are going to impact everyone, a question that must be answered is ‘what do these changes mean for me?’ Well, for now, you don’t need to do anything differently, but in January 2023, you’ll need to align your evidence to the quality statements for each key question and not to the KLOEs.

Collating your evidence in an order that’s aligned to the key questions and quality statements is essential. Why? It ensures you know what’s required and you can adopt a methodical approach to preparing for an inspection. The next question is ‘how can this be achieved?’

Either now or in 2023, you can use CQC Manager, which gives you one central, secure place to collate all the evidence for the CQC effectively. Currently, CQC Manager is aligned to the KLOEs; however, in 2023, it will be aligned to the quality statements. Furthermore, any evidence you’ve added will still be accessible and easily re-mapped in a matter of clicks.

We all know we must meet not only our patients’ expectations but those of the CQC, and it’s therefore essential that we have evidence to demonstrate our commitment, as providers, to delivering high-quality, person-centred care.

Change is coming; compliance is essential. Change often leads to frustration, but by using the tools available, you can turn your frustration into focus. Focus your aim on the future and achieving CQC compliance.

For information on CQC Manager, find out more about the Compliance Package here.