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This case study illustrates how 8folds expert team supported Express Medicine to successfully register with the CQC, enabling them to conduct regulated activities in England.
Supporting the CQC Registration of a small private clinic
Express Medicine, a provider of patient-centred bespoke medical services, sought to navigate the complex process of Care Quality Commission (CQC) registration to ensure compliance with regulatory standards and demonstrate their commitment to quality care. The CQC, established in 2009, is the independent regulator of health and social care services in England, responsible for ensuring that care providers meet essential quality and safety standards.
This case study illustrates how 8folds expert team supported Express Medicine to successfully register with the CQC, enabling them to conduct regulated activities in England.”
Express Medicine, founded by Rory Irwin and Leigh Rogers, is an independent healthcare provider that emerged to fill a gap in the market. The company initially focused on offering private minor cosmetic work, but through a loyal customer base, they were increasingly approached by patients seeking more medical assistance, and they recognised an opportunity to provide these much-needed services.
Express Medicine’s initial patient offering fell outside the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, meaning they did not need to register with the CQC.
As Express Medicine grew and sought to expand its service offerings, the founders recognised that CQC registration would become a necessary step. This realisation and commitment to take action is demonstrable of the values held by Rory and Leigh, two experienced NHS clinicians who knew they could do more for their patients by expanding the scope of Express Medicines services.
Express Medicine found itself at a critical juncture as it expanded its service offerings. The company recognised the need to register with the Care Quality Commission (CQC) to comply with UK regulations and ensure the quality and safety of their services. However, their initial attempts at registration encountered significant challenges.
Express Medicine’s primary obstacle was it could not clearly define and articulate the patient services it provided to the CQC. This lack of clarity had several implications:
Regulatory Ambiguity: It is important to be clear about what healthcare organisations do and don’t offer to patients. This ensures that:
Any ambiguity in the application process means the CQC can not be sure what they are assessing, which can hold up the process.
Recognising the complexity of the CQC registration process and the importance of getting it right, Express Medicine turned to 8foldGovernance for support.
Our strategy for supporting Express Medicine’s successful CQC registration focused on three key components:
Nick Pavard, Clinical Safety Officer and CQC Lead, initiated the process by consulting with the CQC and Express Medicine to identify the specific challenges hindering registration. This revealed a lack of clarity regarding the company’s service offerings.
To address this, Nick facilitated discussions to define the precise scope of practice and guided the decision to register under “treatment of disease and disorder” as the regulated activity. Importantly, Nick did not solve the issue; he created the environment for Express Medicine to explore their thoughts on what they wanted to offer and highlighted the consequences of each choice. This enabled Express Medicine to develop a business model that satisfied its commercial goals and made it easy to demonstrate how it would satisfy regulatory requirements.
With the scope clearly defined, we then:
The approach focused on producing concise, easy-to-understand policies that would streamline the CQC’s review process and minimise potential delays.
Throughout the engagement, we adopted an embedded support approach. As part of this, Nick integrated deeply with Express Medicine’s team and operations, allowing him to gain a comprehensive understanding of the company’s culture and objectives. As a result of this in-depth understanding, he was able to tailor all recommendations to align with Express Medicine’s values and long-term goals.
This strategy ensured that our guidance was not only technically accurate but also practically implementable within the organisation’s specific context.
Part of the registration process involves a meeting with the CQC registration team to discuss the documentation provided. Nick was able to join this meeting to support the Express Medicine team utilising his knowledge as a former CQC Specialist Advisor to pre-empt questions from the regulator This was especially important when certain decisions had been made that the registration team needed to explore.
By addressing these core areas, we were able to guide Express Medicine through the registration process, resulting in a successful outcome that positioned the company to begin serving patients under full regulatory compliance.
Part of our success in a stress-free registration process is early and open communication with the CQC. Each service we help register is unique—it responds to a market need and helps solve a problem. This usually means that on first appearance, the service offering does not neatly fit into one of the regulated activities, and/or it needs to be clarified how the organisation will satisfy its regulated requirements.
Engagement with the registration team enables exploring and resolving potential barriers before applying. In addition, it delivers a real-time understanding of the challenges the CQC are facing.
Our support was instrumental in helping Express Medicine clearly define the regulated activities they would be providing and how they would provide them, ensuring all necessary safety measures were implemented. This has also enabled them to operate safely, effectively, and in a caring, responsive, and well-led manner.
As a result of our assistance, Express Medicine experienced a swift and seamless application process with the CQC, which has subsequently allowed them to expand their business.
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