Dr Julia Sevi provides her top tips for successfully registering your clinic with the Care Quality Commission
Engaging in the registration, inspection and rating process of the UK’s independent regulator of health and social care in England, the Care Quality Commission (CQC), is like scaling a mountain. It can be strenuous, painful, sometimes tedious, yet hopefully culminating in a triumphant summit. Wales, Scotland and Northern Ireland have their own individual regulatory systems, but like the CQC share the aim of providing people with safe, effective, high-quality care, with emphasis on continued improvement.1
Our clinic was graded ‘outstanding’ at our recent CQC inspection, the first doctor-led aesthetic clinic to achieve this grade,2 but the true reward has been the training and commitment required to succeed, and its positive impact on every aspect of our organisation. This article aims to dispel anxieties and reframe CQC registration as an opportunity for a positive and formative experience.
Unlike general practice and dental clinics, aesthetic clinics are not automatically required to register with CQC, so why would some of us voluntarily take on this challenge? For many clinics, it is mandatory by virtue of the services they offer, while for others, registration is a voluntary choice to set aspirational standards that improve quality of care and promote patient confidence.
CQC registration and inspection is a requirement when a healthcare professional (doctor, nurse or dentist) working within a provider (individual, partnership or company) performs or supervises any ‘regulated activities’.3 The ‘regulated activities’ most relevant to aesthetic clinics are:
Indeed, in this situation, it is a prosecutable offence to carry out a regulated activity without CQC registration.4 In a non-surgical aesthetic clinic a ‘regulated activity’ might be ‘treatment of disease, disorder or injury’. The common diagnoses we as aesthetic practitioners may make while performing this regulated activity might include:
Essential registration is subject to some exceptions e.g. botulinum toxin for cosmetic purposes rather than medical concerns. Hence, there is a perception that many aesthetic clinics fall outside the jurisdiction of CQC, which indeed they could, if they choose to provide their services in a manner that does not include the regulated services above. For these clinics, registration is therefore voluntary.
Simply put, if an aesthetic clinic chose NOT to make a medical diagnosis and NOT to treat disease i.e. only treat cosmetically not medically, then it would not need to CQC register, but would need to pay VAT over the threshold. Alternatively, the same clinic could register with the CQC, perform the same treatments with diagnoses, write treatment plans, record therapeutic purpose and then potentially not charge VAT on those treatments now deemed as medical.5
Although CQC registration is not an easy process, when embraced, I find that it facilitates and supports delivery of optimal patient care, through a clear framework to drive continuous improvement and quality. Aesthetic clinics wishing to pursue registration can design their services to fall within the CQC’s remit, but will only be inspected on their regulated services.6 I believe the requirements that need to be fulfilled in order to become registered with the CQC do make for better practice; consequently, many clinics opt to apply the same rigorous standards to all their services, not only the regulated ones.
For example, a medical aesthetic clinic could choose to underpin its skin services by medical diagnosis, and therefore treat diseases such as acne and rosacea, in which case some treatments could be considered ‘regulated activities’ and be managed according to CQC standards. This is because if you make the diagnosis and are therefore treating the disease, then the use of the laser for example would be CQC regulated. If you are using the laser without having diagnosed a disease, it is not necessary to regulate its use.
In addition to increasing quality, the regulatory improvements to process, policy and procedure that accompany CQC registration are certainly valuable. Also notable are the benefits to confidence and cohesion within the team, measurable improvements to services and the opportunity to focus on refining the culture and leadership of the organisation. For example, following the CQC process, feedback from staff in our clinic demonstrated that uniting around the CQC challenge improved team morale and unity.
In addition, following this intense period, the team instinctively embraced the aims, visions and values of the clinic. Some clinics would willingly pay a business consultant who claimed to be able to deliver all of this, and yet colleagues often cite the cost of registration and maintenance of standards as a detractor for CQC. In our clinic, when we estimate the positive financial impact of being CQC registered, let alone the other benefits, we believe it to be a worthwhile investment.
Furthermore, the new grading system introduced in aesthetic clinics this year, which evaluates evidence for regulated activities as ‘outstanding, good, requires improvement or inadequate’, helps to establish quality benchmarking, which could promote greater patient confidence.7
Whilst initial CQC registration involves copious P-words (paperwork, processes, policies, procedures, pain and panic), the essence of it is more focused on creating a learning organisation that uses the CQC assessment framework to drive continuous improvement and quality.
The inspection framework sets out five ‘domains’, assessing providers on whether they are: safe, effective, caring, responsive to patient needs, and well-led, outlined in more detail in ‘the five domains of CQC assessment’ section.8
Registering with CQC and preparing to be inspected on the five domains can be a lengthy, challenging and expensive process.
Every clinic procedure, policy and process must be created or updated, and in addition to the extra staff costs incurred, there is the added expense of CQC fees, as well as external consultancy advice if you choose to use it. The registration and preparation phase can take between three to 12 months depending on the standards already in place and, once registered, a clinic is then subject to regular inspections, which can range from six months to five years.9 Clinics should have at least 48 hours’ notice of an inspection, but the CQC does have the right to make unannounced inspections (usually if they have concerns).9
1. Familiarise yourself with CQC hot topics
Inspectors must see evidence that a clinic fulfils ‘The Fundamental Standards’ which include the presence of person-centred care, treating patients with dignity and respect, informed consent, safety for patients and staff, safeguarding from abuse, a good standard of premises and equipment, good governance, duty of candour and an adequate number of fit and proper staff.10
In our experience, there are certain areas that you can expect CQC inspectors to concentrate on. These include health and safety for patients and staff, infection control, safeguarding and other mandatory training. We would also recommend that HR and staff qualifications, patient engagement, clinical records, confidentiality and GDPR, information provided for patients, participation in care, respect, dignity and chaperones, are also be considered.
Each year there are particular topics of current focus, so in addition to speaking with your inspector prior to the visit to ascertain the domains they will be inspecting, it can be helpful to gather local intelligence by speaking to other clinics who have recently been inspected. Reading the reports of other clinics on the CQC website can also be a further source of useful information, demonstrating what clinics are doing to achieve high ratings or what might require improvement.11
2. Prepare the evidence
The onus is on the clinic to use evidence to demonstrate that it is meeting each essential standard;12 if it is not evidenced then the CQC cannot report on it, for example showing documentation in patient notes of a patient’s involvement in decisions about care. The evidence does not all have to pertain to perfect situations. One key factor is to identify areas for potential improvement and develop an action plan for change to achieve the desired improvements. For example, if a mistake in care has occurred, demonstrate how you have used duty of candour to disclose this openly and honestly to the patient, as well as evidencing how the clinic has learnt from the mistake and put a process in place to prevent a recurrence.
3. Train your staff
All staff should understand the essence of CQC, as well as knowing about CQC essential standards and what the clinic is doing to meet them. Inspectors may speak with anyone in the clinic, so you need to prepare the staff to be confident and informative when interviewed.
We usually do this by holding a whole clinic meeting where we cover the following:
All the managers and directors are involved in delivering the training using powerpoint presentations, quizzes, role play and discussions.
Our external CQC advisors also provide an invaluable ‘mock CQC visit’, which highlights areas requiring attention.
4. Organise paperwork and clinical records
Inspectors may request a sample of clinical records, so prepare for this by regularly screening to check they are up to date and correctly filed. Ensure your paperwork is current and reflects any new changes, including statement of purpose, visions values and culture, policies and procedures, emergency numbers e.g. local social services contact.
5. Inform patients
Inform the patients who will be in-clinic on the day of the inspection that the CQC might ask to interview them, although they are entitled to decline to speak to the inspectors. Involving regular patients in the CQC process usually supports a good outcome for the clinic as these patients are likely to be ‘clinic fans’ and happy to be advocates of your services.
6. Be authentic
Be confident to permit the inspectors to see a real day in the life of the clinic, remembering we have no need to hide. Recently, the CQC process has become more akin to peer review13 and, as such, we stand to gain from any issues raised as they signpost routes to improved care. Last year our inspectors highlighted the absence of a portable defibrillator, something that had been pricking our consciences for a while. We were grateful for this nudge and felt it was just what we needed to help us dive in, purchase one and train the whole team.
7. Consider your inspector
Imagine a day in the life of the inspector; look through their eyes at your clinic and try to make their day go more smoothly by being well prepared. They are not trying to find fault, are certainly willing to celebrate quality, and are simply trying to do their job. Plan carefully so that they have access to key people in order to gauge your organisation and ensure the evidence required for them to perform the assessment is readily accessible.
8. Go the extra mile
Our experience taught us that to achieve a ‘good’ clinic grading you should fulfill ALL mandatory CQC requirements and all five domains. However, to be considered ‘outstanding’ you need to provide evidence for regulated activities that you are really going the extra mile. Find innovative solutions to inequalities, problems, or unmet patient needs. While examples do not have to be original, many examples of ‘outstanding’ practice show innovative approaches to solving a problem or delivering a service.
9. Focus on regulated activates
Focus only on regulated activities during an inspection. As an aesthetic clinic, you may exceed in other areas, but these are not considered in inspection. It will not help your case if you evidence exceptional outcomes and patient satisfaction from purely cosmetic botulinum toxin treatments because the CQC cannot take these into consideration, they will only be looking for audit data from medical treatments such as bruxism or hyperhidrosis.
10. Seek external help with CQC registration
Unless somebody in your organisation has experience with CQC registration, I find it is helpful to consider the use of medical and healthcare regulatory compliance consultants. There are several such organisations, ranging in price from £1,500-£3,500. In general, companies can help with:
CQC registration can be a difficult and lengthy process. However, I have found that it builds confidence, morale and quality in your business. It also provides a continuous process of growth that nurtures an organisational culture focused on learning and the delivery of high quality compassionate care. When embraced and managed positively, the CQC process is formative for the clinic and the individuals within it, affording self-reflection and growth, with net consolidation of clinic culture, team cohesion and confidence, and measurable improvements to services.
1. Regulatory Systems for Healthcare Quality across the United Kingdom, British Medical Association <https://www.bma.org.uk/collectivevoice/policy-and-research/nhs-structure-and-delivery/monitoring-quality-in-the-nhs/regulatory-systems-for-healthcare-quality>
2. Aesthetics journal, CQC rates first aesthetic clinic as ‘Outstanding’, 2019. <https://aestheticsjournal.com/news/cqc-rates-first-aesthetic-clinicas-outstanding>
3. CQC, Regulated Activities, July 2019. <https://www.cqc.org.uk/guidance-providers/registration/regulated-activities>
4. Enforcement Policy, Care Quality Commission <https://www.cqc.org.uk/sites/default/files/20150209_enforcement_policy_v1-1.pdf > p27
5. Should you be paying VAT, Aesthetic Medicine <https://aestheticmed.co.uk/site/industrynewsdetails/should-you-be-paying-vat>
6. CQC, Treatment of disease, disorder or injury, February 2019. <https://www.cqc.org.uk/guidance-providers/registration/treatment-diseasedisorder-or-injury>
7. CQC, Ratings, June 2018. <https://www.cqc.org.uk/what-we-do/how-we-do-our-job/ratings>
8. CQC, The five key questions we ask, July 2018. <https://www.cqc.org.uk/what-we-do/how-we-do-our-job/five-key-questions-we-ask>
9. CQC, When we will inspect independent doctors and clinics, March 2019. <https://www.cqc.org.uk/guidance-providers/independentprimary-medical/when-we-will-inspect-independent-doctors-clinics >
10. CQC, The fundamental standards, May 2017. <https://www.cqc.org.uk/what-we-do/how-we-do-our-job/fundamental-standards>
11. CQC, Inspection Reports, June 2017. <https://www.cqc.org.uk/what-we-do/how-we-do-our-job/inspection-reports>
12. CQC, Key lines of enquiry for healthcare services, June 2018. <https://www.cqc.org.uk/guidance-providers/healthcare/key-lines-enquiryhealthcare-services>
13. The King’s Fund Consultation Response. A New start – Consultation on changes to the way the CQC regulates, inspects and monitors care <https://www.kingsfund.org.uk/sites/default/files/field/field_publication_file/consultation-cqc-regulate-inspect-monitor-care-aug13.pdf>
14. CQC, Regulation 7: Requirements relating to registered managers, 2017. <https://www.cqc.org.uk/guidance-providers/regulationsenforcement/regulation-7-requirements-relating-registered-managers#guidance>