s many people know by now, from April 5, 2015, the CQC will be adopting a new approach to regulation. From that date its remit will be to assess whether dental practices are meeting the requirements of the new Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, which include the new fundamental standards.
However, the structure of inspections will change. Instead of inspectors looking at a selection of outcomes as has happened to date, the CQC will now be inspecting and making judgements against five key questions, namely:
- Is the service safe?
- Is the service effective?
- Is the service caring?
- Is the service responsive to people’s needs?
- Is the service well-led?
These are known as key lines of enquiry, or KLOEs, and inspections will be structured in a way that addresses these five key questions. This means that we need to respond by adjusting our approach to the evidence we offer and thinking laterally about how we demonstrate that we can answer ‘yes’ to each of these five questions. This article is the first of a series of five focusing on each question and what it means for us.
Is the service safe?
The CQC tells us that by ‘safe’ they mean that people are protected from abuse and avoidable harm. This clearly covers a wide range of activities that are currently regulated and inspected, and CQC inspections will rely on a number of ‘prompts’. These are not checklists, nor are they an exhaustive list but they act as a useful guide to practices in preparing for new style inspection this year.
It is worth also bearing in mind that the CQC has stated that good practice means doing more than what the regulations require. They will therefore be looking not just for evidence that the practice is compliant with the regulations or meets the fundamental standards. It will also be looking for – and will ask you if you want to highlight – evidence of good practice, which will be included in the inspection report.
Do remember that the CQC will also be gathering people’s views in advance of their inspections through organisations such as Healthwatch, NHS area teams and local overview and scrutiny committees.
Currently under the essential standards an inspector may look at the following regulations related to safety to draw a conclusion about how well the practice complies with them:
- Records Regulation 20
- Safeguarding Regulation 11
- Cleanliness and infection control Regulation 12
- Medicines Regulation 13
- Safety and suitability of premises Regulation 15
- Safety and suitability of equipment Regulation 16
- Requirements related to workers Regulation 21
- Supporting workers Regulation 23
- Staffing Regulation 22
- Quality of service provision Regulation 10
However, as we move to the new Fundamental Standards from April, in order to answer the question ‘Is the service safe?’ an inspector will be considering how the practice meets the following new regulations:
- Safe care and treatment Regulation 12
- Safeguarding service users from abuse and improper treatment Regulation 13
- Fit and proper persons employed Regulation 19
- Staffing Regulation 18
- Premises and equipment Regulation 15
- Duty of candour Regulation 20
It is worth noting that this list includes the new Duty of Candour, which will be introduced for dental practices from April this year. CODE members can download the duty of candour procedure and policy templates from the CODE website.
Questions that may be asked
However, rather than look at these outcomes individually, the inspector will be following their key line of enquiry or theme ‘Is the service safe?’ To determine this they may ask these types of questions:
- What systems, processes and practices are in place to ensure all care and treatment is carried out safely?
- How is care assessed to prevent unsafe care and treatment?
- What systems, processes and practices are in place to protect people from unsafe use of equipment, materials and medication?
- What systems, processes and practices are in place to prevent healthcare-associated infections?
- How are potential risks to the service and individuals assessed/identified and managed/minimised?
- How are lessons learned and improvements made when things go wrong?
- What systems, processes and practices are in place to keep people safe and safeguard them from abuse?
These questions have some quite complex answers as they cover a range of regulations and outcomes so they need some careful thought. They could usefully be brought to a practice meeting so that people understand how what they are currently doing to comply with the essential standards meets the new fundamental standards and KLOEs. The CQC points out that these questions are examples only and an inspector may choose to ask other or further questions to ascertain the safety of the service.
Of course, the sort of evidence that an inspector would be looking for in answer to this question would include the more obvious things such as the fact that premises and equipment are clean and kept in accordance with current legislation and guidance, equipment is used, cleaned and/or decontaminated according to manufacturers’ instructions, and that there are sufficient quantities of instruments/equipment to cater for each clinical session and takes into account the decontamination process. Staff also need to know how to use equipment safely, health and safety risk assessments need to be regularly carried out, and the practice should also identify and analyse events,
incidents, errors and near misses to establish what caused them. Arrangements should also be in place to ensure that the provider can take appropriate action in the event of a clinical/medical emergency.
Under this KLOE the CQC also lists a number of other areas of evidence, such as that care and treatment takes account of published research and guidance. As you might anticipate, this KLOE would also expect to see that there is a zero tolerance approach to abuse, that staff know what to do in response to suspected or actual abuse, and that everyone works within the ethos of the Mental Capacity Act 2005.
In addition, this KLOE would explore whether staff understand the reporting system for raising concerns and feel confident to use it, and if there is openness and transparency when things go wrong.
The example questions relating to this KLOE take a rather lateral approach. For example, I would expect that the answer to the questions ‘How are potential risks to the service and individuals assessed/identified and managed/minimised?’ would also include a reference to your practice’s business continuity plan, which is after all a plan of how the risk to the service through fire, flood or other disaster would be managed.