A lawyers’ perspective on health and social care regulation – where we have come from and where we need to go
When I started out as a regulatory lawyer in health and social care over 25 years ago, the operative legislation was the Registered Homes Act 1984. Regulation of nursing homes and mental nursing homes was discharged by the old district health authorities while local authorities did the same in relation to residential care homes. Each registration authority had its own quality standards so, on the face of it, there was little consistency across the country. This was one of the main justifications for the creation of a national inspectorate which finally came to fruition with the establishment of the National Care Standards Commission in April 2002.
This article considers whether the goal of greater consistency has been achieved over the last 16 years in the context of changes to legislation, standards and regulatory methodologies over that period. It also puts forward a number of recommendations to improve regulation. Inspectors carry out an essential public function and do not get the credit they deserve. My real concern about regulation stems from what I see as systemic weaknesses at CQC which then adversely impact on the ability of inspectors to do their work as effectively and efficiently as possible.
The historical background
One of the features of regulation up to 2002 was that the underpinning regulations (or secondary legislation) had changed very little since the 1960s. Even the overarching legislation was largely consistent over the period with the Registered Homes Act being a consolidating piece of legislation i.e. bringing together the various Acts of Parliament that had applied to the regulation of nursing homes and residential care homes up to that time into a single piece of legislation.
There was further continuity in that regulation had always been conducted at a local level. There was no home working in those days. Inspectors worked together in offices as teams, sharing intelligence and best practice. As a result they knew their patches intimately, often working with providers on a pragmatic basis to resolve issues: a negotiation model of regulation as opposed to top down control and command. However, it was not soft touch regulation. With the expansion of the private care home sector through the 1970s and 1980s, there was an increasing amount of enforcement activity.
The one significant new power in the Registered Homes Act was the introduction of urgent enforcement powers. For the first time, registration authorities could apply to a single Justice of the Peace for an Order to cancel the registration of service provider immediately, or impose conditions urgently, on the basis of alleged serious risk. After 1985, the Registered Homes Tribunal dealt with appeals from providers and a large caseload ensued with many cases proceeding to hearing. Certainly the Registered Homes Tribunal was far busier than the Care Standards Tribunal that replaced it in 2002. A bank of case law developed which provided guidance to the sector. There was also the emergence of specialist lawyers of which Paul Ridout was the first with others following, including myself.
One weakness of the old regulatory system was that inspection reports were not published until 1998. When publication of inspection reports was introduced in that year, providers could have any objections published as part of the inspection report, a practice which was abandoned by the first national inspectorate. Furthermore, reports named the inspectors so that there was openness and transparency as far as the authors of reports was concerned. It was therefore easier to track inconsistency linked to identified inspectors. In contrast, the Care Quality Commission (CQC) refuses to name inspectors on reports.
It is worth remembering that the sector was subject to repeated regulatory upheaval between 2002 and 2009.
The National Care Standards Commission came into existence in April 2002 operating under the new Care Standards Act 2000 and applied national minimum standards. One significant change was the development of more detailed sets of regulations, most notably the Care Homes Regulations 2002. However, the organisation was abolished within two years, being replaced by two bodies: the Commission for Social Care Inspection and the Healthcare Commission. These bodies operated quite differently with their own distinct methodologies. Notably, the Commission for Social Care Inspection moved from a compliance based model of regulation to an improvement model, introducing star ratings of services for the first time. However, within five years both organisations were merged into CQC as part of the “bonfire of the quangos.”
Turmoil at the regulator, 2009-2012
With the creation of CQC in April 2009, there was the opportunity to create a consistent model of regulation across the NHS and independent sector. New legislation was introduced in the form of the Health and Social Care Act 2008 which provided for a single registration system, allowing providers with more than one site to register each one as location conditions, rather than the old one system of each individual service being separately registered as an establishment or agency. New generic regulations were introduced to apply to all sectors, but at least they were reasonably detailed. However, consistency was undermined by a policy of requiring inspectors to inspect and report on all types of services irrespective of their skill base. This lack of differentiation was bound to fail, and fail it did.
A further problem for CQC in its early years was that it was focussed on getting new sectors such as the NHS and primary care fully registered, a huge undertaking whose impact was underestimated by the Centre. As a result, inspection targets were not met and scandals emerged which CQC had not foreseen. This was not surprising given that reporting in many cases became a desk top exercise with inspections only occurring where there were concerns, allowing poorly performing providers not to be visited for some time. Additionally, large numbers of redundancies occurred and there was an obvious concern that CQC would not be able to cope with so few staff which was proven correct.
The senior management at CQC was further wounded by the Mid Staffordshire Inquiry even though that scandal happened on the Healthcare Commission’s watch. The final nail was the Morecambe Bay maternity scandal. In 2012, David Behan replaced Cynthia Bower as Chief Executive and there was wholesale managerial change at the top.
An opportunity missed, 2012-2017
The first two years under David Behan’s stewardship led to a variety of positive changes aimed at improving regulation. There was the creation of Chief Inspectors for Adult Social Care, Hospitals and Primary Care with their own dedicated directorates. Inspectors were given portfolios based on their expertise and many more were recruited to deal with the backlog of inspections. There was a sense that the organisation was improving and had turned a corner.
There was a clear inspection methodology with services judged against what were called the Essential Standards. A service would be compliant or not with legal requirements. If non-compliant, that was set out in the inspection report with the severity of the breach graded as major, moderate or minor. As a consequence, there was a clear compliance focus. There was at least a basis for judging providers on a consistent basis.
What changed to undermine these early achievements? Firstly, the introduction of performance ratings at the end of 2014. Secondly, the passing of new regulations called the Fundamental Standards that came into force from April 2015.
CQC will no doubt try to argue that ratings have improved consistency but unfortunately that is not the case in my experience. Instead of having a clear compliance focus, the inspection methodology was changed to look beyond compliance. The starting point in terms of ratings was ‘good’ which was above compliance. Inspectors conducted inspections in accordance with the performance frameworks which were focussed on ratings. The problem was that until October 2017, services were rated against very general ratings characteristics which gave inspectors a wide discretion in how the ratings were applied. Compliance fell away to the point where CQC introduced a policy for determining breach of regulations linked to enforcement – only ever a minority of cases.
The second weakness was the introduction of the Fundamental Standards which are little more than headlines. The guidance for providers in complying with them is again general in nature and described as not being exhaustive. Annex B lists a large volume of guidance documents (currently 324) but this is not complete or regularly updated. For example, it does not contain the Building the Right support guidance which is so important to CQC decision-making on new Learning Disability services. CQC states in its guidance for providers:
“Links to guidance include guidance specific to the different types of activities and services provided and recognised quality standards. We expect registered providers and managers to take account of other nationally recognised guidance that might be specific to the services they deliver. This includes guidance produced by the Department of Health, National Institute for Health and Care Excellence, Public Health England, the former National Patient Safety Agency, NHS England, Skills for Health, Skills for Care and relevant clinical and professional bodies.”
The question arises as to whether CQC’s internal systems have sufficient resources to enable it to keep up-to-date.
As a consequence of the above, inspectors would regulate services in very different ways. Some would refuse to accept any new information after the inspection visit had finished, while others would give credit for things put right in the days after an inspection. In other cases, concerns would be described as improvement issues with no reference to a breach of regulation, while others would judge the same issue to be a breach. This distinction matters all the more now given that in Adult Social Care, a single breach of a regulation will lead to the overall rating being downgraded to no more than ‘requires improvement.” I suspect this is leading to a situation where inspectors will either not include concerns in reports in otherwise good homes or they will fudge it and describe the concerns but will not link them back to the regulations.
A chance to reflect, 2018
The appointment of a new Chief Executive, Ian Trenholm, at CQC is a time to reflect on regulatory practice. Furthermore, the timely publication of the report into 14 Colne Road in June 2018 also raises issues for CQC to take on board, principally the need to discharge its investigative powers in relation to alleged criminal matters diligently and consistently.
I believe that CQC should address the following issues urgently:
- Refocus on compliance, introducing a Compliant or Satisfactory rating at the front of reports which denotes compliance with regulations. The current rating of ‘requires improvements” covers compliance and non-compliance which is nonsensical and misleading to the public. It also presents a poor image of the industry as a whole;
- Give clear guidance to inspectors on when to describe something as a breach of regulation. A concern should only be described as a breach if there has been a full legal and evidential review which concludes there has been a breach and that there is robust evidence to prove it;
- Be clear how each key question is rated given that the ratings characteristics now apply to each Key Line of Enquiry (KLOE). How are the KLOE ratings aggregated for each key question? If there is no aggregation system, is it simply left to the subjective judgement of the inspector? The previous performance framework indicated that a provider rated good or outstanding might not be meeting all aspects of the guidance. Is that still the case? If that is still the position, what guidance is provided to inspectors to ensure consistency?
- Be clear to the public and providers that inspection does not stop at the end of the site visit but continues down to publication of the report which will be several months down the line by which time the service in question may have changed significantly in terms of quality and standards. If new matters arise, whether positive or negative, they should be included since otherwise the report may give a false positive or false negative. Inspection is a video of the service down to publication, not a snapshot of the service at the time of the visit only (see the recommendation in the 14 Colne Road report on this point which CQC says its accepts);
- Respond to the operational burdens faced by inspectors in addressing factual accuracy challenges from providers. This requires a renewed focus on the quality of inspections and report writing. From the 14 Colne Road inquiry report there is a real sense that inspectors feel under siege from what they describe as aggressive providers and lawyers putting in threatening challenges to draft inspection reports. Providers and their lawyers should never be aggressive but it is entirely reasonable for them to be assertive in putting forward their objections to reports. CQC needs to listen to what provides are saying to them about the quality of inspections and learn from why challenges are occurring in the numbers they are. Inspectors are having to do twice the work to review and rectify repots rather than spend time of inspections where it is needed most.
- Admit to failings early and disclose underlying inspection documentation to improve regulation rather than hide behind arguments that disclosure is too onerous and burdensome. There should be a presumption in favour of disclosure where a provider raises a prima facie case of regulatory failure on inspection. This will promote trust and feed into a positive cycle of learning and improvement;
- Publish the names of inspectors on inspection reports, as was the case previously, to promote accountability, openness and consistency;
- Carry out proper independent reviews of inspection reports after the factual accuracy stage if the provider can show on the basis of objective evidence that aspects of the report are demonstrably wrong or misleading, in line with the High Court case of SSP v CQC. In addition, CQC should reform the Rating Review process to make it a credible and effective means of challenging ratings. The old star rating review process allowed for challenges before publication of the report thus making it a meaningful process. Restricting ratings reviews until after publication of the report and then limiting them to no more than 500 words renders it worthless; and
- Improve training for inspectors particularly in relation to evidence gathering and consistency of decision-making. It should be remembered that inspectors are investigative officers for the purposes of the Police and Criminal Evidence Act 1984 which is all the more important given that CQC is now the lead investigator and prosecutor for health and safety incidents involving service users in registered services.
If the above matters are attended to urgently, there is a real prospect that regulation can really turn a corner and become world beating in terms of excellence and consistency. If not, there is a genuine risk that a spiral of decline will ensue with more and more legal and provider challenges diverting resources away from CQC’s essential regulatory functions. David Behan turned a corner in 2012-2013 in terms of CQC performance. It is hoped that Ian Trenholm will do the same over the next two years and I wish him every success in his new role.
I would like to thank the care consultancy D&D Howells Ltd for their assistance in preparing this article.
Gordons Partnership LLP
9 July 2018