What evidence is the Care Quality Commission (CQC) looking for?
When inspecting your clinic, the CQC wants to ensure you meet the fundamental standards and key lines of enquiry (KLOE) as set out in their guidance. Five questions are asked, which guide their decisions in their enquiries: are you safe, caring, responsive, effective and well-led.
Evidence is crucial
Gathering evidence must not be seen as a tick-box exercise, but rather as an ongoing audit to ensure that due process is being followed. When things go wrong, you will be glad to have an audit trail. Many clinics prefer to just get on with the treatment. While that is commendable, it is also important to have processes set in place that are appropriate to the size of the clinic and the complexity of the treatments given.
A good way of knowing where forms are needed in place, is to do a process-mapping exercise, looking at all the contact points of the clients and documents. This can highlight areas where there are gaps or bottlenecks in your process. Conduct this exercise with the different staff roles.
Quite often, it is clear that clinics are doing things right; they are merely not evidencing it. In terms of an inspection, if the inspector cannot see evidence then it never happened. When I was inspected by the European inspector for the Joint Accreditation Committee—ISCT and EBMT (JACIE) standard, in the field of clinical bone marrow transplantation and cellular therapy, I had to ensure the evidence gathered by the consultants during each interaction met the criteria of the standards. The inspector gave me a commendation for the best evidence presented during inspection. There were many moving parts and different stakeholders to consider.
Why the right evidence is important
Too many forms can overwhelm staff. Think about the purpose of the form and which regulation it can help you evidence? How many of the KLOE are in the first consultation form evidence? Can you add a question to gain more clarity or give better evidence?
Caring is an intangible key line of inquiry to evidence that your staff show compassion, know how to treat people with dignity and kindness, as well as how to preserve privacy. You need to create client feedback forms to elicit this information. While asking if the treatment went well, you should also ask questions around dignity and privacy, for example, so you are directly getting feedback and it is therefore good evidence. Explain to your clients why you are asking these questions. This shows you take compliance seriously.
Plan to gather the right evidence
Look at what documents you already have in place. Look at the requirements of the standards set by CQC, Healthcare Infection Society, Care Inspectorate Wales, Regulation and Quality Improvement, or the Health Information and Quality Authority. Ascertain where the gaps are and plan on how best to fill them.
Assess this against both the seven pillars of governance and the fundamental standards (Table 1). This way, you know you are covering most of the evidence areas required.
Table 1. Care Quality Commission's fundamental standards
| 1 | Person-centred care Regulation 9 | Care or treatment that is tailored to the needs of the client and meets their preferences | The treatment meets the needs of the patient and they are involved in decisions |
| 2 | Dignity and respect Regulation 10 | Clients must be treated with dignity and respect at all times while they are receiving care and treatment This includes making sure: They have privacy when they need it Everybody is treated as equal | All staff should be aware of the Equality Act 2010 and about treating people with compassion and kindness. |
| 3 | Consent Regulation 11 | Clients (or anybody legally acting on their behalf) must give consent before any care or treatment is given to a client | Staff should be aware of the different types of consent. Specific consent for media use of their photos |
| 4 | Safety Regulation 12 | Clients must not be given unsafe care or treatment or be put at risk of harm that could be avoided. Providers must assess the risks to your health and safety during any care or treatment and make sure their staff have the qualifications, competence, skills and experience to keep you safe | Make sure all aspects of this regulation is covered |
| 5 | Safeguarding from abuse Regulation 13 | This includes: Neglect Degrading treatment | You need to know the contact details of your local safeguarding Board and staff must have appropriate level of training, depending on their role |
| 6 | Food and drink Regulation 14 | You must have enough to eat and drink to keep you in good health while you receive care and treatment | Not applicable if you do not provide food. For those who do, they need to have a food hygiene certificate and staff need appropriate training |
| 7 | Premises and equipment Regulation 15 | The places where a client receives care and treatment and the equipment used in it must be clean, suitable and looked after properly | Ensure staff have appropriate training and remain competent |
| 8 | Complaints Regulation 16 | Clients must be able to complain about their care and treatment. The provider must have a system in place so they can handle and respond to complaints. They must investigate it thoroughly and take action if problems are identified | It is a good idea to mention this on your website and at reception |
| 9 | Good governance Regulation 17 | The provider must have plans that ensure they can meet these standards. They must have effective governance and systems to check on the quality and safety of care. These must help the service improve and reduce any risks to client's health, safety and welfare | Appropriate processes need to be in place and the Board/owner must have reports on a regular basis on this |
| 10 | Staffing Regulation 18 | The provider must have enough suitably qualified, competent and experienced staff to make sure they can meet these standards. The staff must be given the support, training and supervision they need to help them do their job | If you have self-employed people using your premises you still need to do your due diligence |
| 11 | Fit and proper staff Regulation 19 | The provider must only employ people who can provide care and treatment appropriate to their role. They must have strong recruitment procedures in place and carry out relevant checks such as on applicants’ criminal records and work history | Having a good recruitment process is crucial |
| 12 | Duty of Candour Regulation 20 | The care provider must be open and transparent with the client about their care and treatment. Should something go wrong, they must tell the client what has happened, provide support and apologise | You must know which notifications need to be made to the CQC; the list can be found on their website: https://www.cqc.org.uk/guidanceproviders/notifications |
| 13 | Displaying of ratings Regulation 20A | The provider must display their CQC rating in a place where clients can see it. They must also include this information on their website and make the latest report on their service available to clients |
Seven pillars of governance
The seven pillars of governance help organisations support and improve the quality of services being provided. These seven pillars are:
- ►Patient involvement
- ►Audit
- ►Risk management
- ►Training and education
- ►Information
- ►Effectiveness
- ►Staff management
Patient involvement
Considering that research has shown better health outcomes when patients participate in decision-making, can you provide evidence for the same in your clinic? When you give information to your patients, are you ensuring that they understand what you are telling them? As asking questions can be overwhelming for patients, do they have an accessible way of making any enquiries/having discussions after the consultation? I have seen instances where information is sent in advance and at consultation, the information is covered again. This is good practice. Remember to evidence this in the patient notes. Records must be kept of all assessments, care and treatment plans, and decisions made by people who use the service and/or those acting on their behalf.
Audit
This is an essential part of showing compliance. Audits are important as you are checking if the processes you have developed are being followed; where this is not the case, updates need to be made. Audits must be carried out to monitor the quality of clinical care being carried out to make sure it meets national guidance or policy.
Some audits might focus on what controls need to be put in place to minimise risk. For instance, a common audit asked for is hand hygiene, as this is clearly important in a clinic. There are some common audits like sharp-object bins, record-keeping, recruitment and accessibility, that all clinics should adopt and follow, as well as others, such as those undertaken to decontaminate the equipment. The frequency of an audit will depend on each task being audited. For example, a fire alarm needs to be checked every week. Whereas, hand hygiene could be looked into once a month.
CQC are looking for audits of all regulations that apply to the clinic. Therefore at a minimum, audits must cover the fundamental standards.
Risk management
Management of risk is a key area that inspectors will look at. They will ask for the risk assessments for Control of Substances Hazardous to Health Regulations and your treatments, for example. Risk management does not mean you can eliminate every risk; it means looking at what controls may need to be put in place. A clinic should be looking at identifying problem areas in treatments, improvement through learning, and the reduction in risks by implementing risk systems through risk assessment and incident reporting.
Training and education
Staff must have appropriate continual training for their role. There are different ways to enhance staff development; for example, events, webinars, courses and journals. Consider each person's needs for development. Keep the mandatory training matrix up-to-date. I have known inspectors mark down a clinic for infection training being out-of-date by a month.
Information
Patient and staff information must be up-to-date and secure. Information governance is important as many clinics are now paperless or working towards it. Cybersecurity is essential. Your staff need to understand the importance of passwords, online safety and phishing. Evidence any training you do around this. Make sure you are registered with the Information Commissioner’s Office (ICO). A good source is the National Cyber Security Centre. You can look at their website to create an action plan: https://www.ncsc.gov.uk/cyberaware/actionplan
Ensure all your General Data Protection Regulation (GDPR) documents are up to date and that your staff have training in GDPR.
Effectiveness
Are you using evidence-based approaches when deciding treatment? Are you checking the claims of the manufacturers? Are all staff adhering to guidelines? Is there a national benchmark you can follow? Are you using the experience of treatments and outcomes to make improvements in your procedures? Do you undertake research to enhance future care and treatment? How well do your processes work?
Staff management
Staff must have the appropriate skills and knowledge for their role; this is true even for those who are at your premises with practising privileges.
Staff development should be in line with the values of the organisation, and there should exist a culture within the clinic that exudes the values and ethos of the company. Staff must know what is expected of them, and there should be clear guidance on outcomes for each role. Some examples of evidence are listed below:
- ►Client records
- ►Safeguarding policy and processes
- ►Process for dealing with adverse events and lessons learnt
- ►Robust staff recruitment and records
- ►Appropriate skill mix of staff and workforce management
- ►Training matrix
- ►Cleaning regime
- ►Waste management
- ►Governance framework/policies
- ►Legionella test certificate
- ►Feedback from clients on treatment and also things like dignity/privacy, compassion
- ►Working with other stakeholders; for example, referrals.
When gathering evidence, think about the key lines of enquiry
The KLOE are used by inspectors to guide the five questions asked during inspections—are they safe, caring, responsive, effective and well-led.
Safe
People should be protected from abuse and avoidable harm. How are you keeping both patients and staff safe and meeting regulation 12 (safe care and treatment)? This is the area most clinics are marked down on because they are not showing enough evidence, or processes are not clear. It is also one of the largest regulations and covers many areas.
It is also important that all staff receive safeguarding training at the appropriate level.
Clinics must comply with relevant Patient Safety Alerts, recalls and rapid response reports issued from the Medicines and Healthcare products Regulatory Agency (MHRA), and the Central Alerting System (CAS). A policy needs to be set for this. It is not enough to say you look at updates; you need evidence that an appropriate member of staff is reviewing these when they come in.
Medications management is part of regulation 12 and clinics must ensure they are following good practice and have evidence of this.
Clinics must make sure that equipment is suitable for its purpose, properly maintained and used correctly and safely. This includes making sure that staff using equipment have the training, competency and skills needed to do so.
Caring
The service involves treating people with compassion, kindness, dignity and respect. Are staff recruited with these traits? Do you include information about this in your induction? Are you asking for feedback about this from all stakeholders?
All communication with people using services must be respectful. This includes using or facilitating the most suitable means of communication and respecting a person’s right to engage or not to engage in communication.
All reasonable efforts should be made to ensure that discussions about care, treatment and support only take place where they cannot be overheard.
Responsive
Services must meet people’s needs. Can you demonstrate that you are being responsive to the needs of your patients? How do you respond to complaints and concerns? Do you take into account cultural needs? Examples of evidence include staff training and induction; training matrix; complaints and concerns; accessibility of service online and on the premises; audits; information provided for people's needs.
Effective
People’s care, treatment and support achieve good outcomes, promote a good quality of life and are based on the best available evidence. You should have effective processes in place to ensure staff are following procedure and that they know what outcomes are expected. Examples of evidence include clinical supervision; validation; General Medical Council/Nursing and Midwifery Council checks; use of technology; cyber awareness; follow National Cyber Security Centre's 10 steps; registered with the ICO; up-to-date GDPR documents; consent policy and forms; chaperone policy and records of this in patient's notes; monitoring of effective care.
Well-led
The leadership, management and governance of the organisation assures the delivery of high-quality and person-centred care, supports learning and innovation, and promotes an open and fair culture. Examples of evidence include: management structures and governance framework being set-up to ensure that risk management meets their regulatory responsibilities; risk management; staff competency; governance culture; good staff culture.
Key points
- ■ The Care Quality Commission, during their inspections, wants to ensure that clinics meet the fundamental standards and key lines of enquiry (KLOE)
- ■ It is crucial that clinics have forms and processes in place to evidence the work being conducted; such evidence is vital during inspections
- ■ A plan must be set in place to gather such evidence, based on the seven pillars of governance and the fundamental standards
- ■ Evidence must also be gathered keeping in mind the KLOE, which inspectors use to guide the five questions asked during inspections—are they safe, caring, responsive, effective and well-led?