Inquests are investigations carried out by a Coroner (in rare cases with a jury) to answer four questions:  who the deceased was, when they died, where they died and how they came by their death.  Inquests are required whenever a coroner has a reason to believe that the death was violent or unnatural, the cause of death is unknown, or the deceased died while in custody or otherwise in state detention (the latter no longer applies in respect of detention under DoLS).

 

The hearing

 

The Coroner will start the hearing by explaining the purpose of an inquest as set out above. They will usually say that the coroner’s court is not a court of blame and that they are not permitted to make determinations of civil liability or criminal liability in respect of any named individual.

 

The Coroner finds answers to the questions by calling evidence.  Some of that may be documents read by the coroner into the record without calling the witnesses. In some cases, all of the evidence is read and there are no live witnesses.

 

If the Coroner calls witnesses, they are first sworn in either by making an oath on a holy book or by affirming – making a promise to tell the truth but not on a religious book. It makes no difference which option the witness takes and in both cases the witness will be told what to say.

 

As an inquest is part of the Coroner’s investigation rather than a trial, the Coroner will ask questions first.  If the witness has made a statement, they will usually be permitted to refresh their memory from it if they need to.  After the Coroner asks questions, interested persons or their representatives may ask questions.  Interested Persons (often abbreviated to IPs) are people or organisations that have an interest in the case.  This can include family members and organisations that may have been involved in caring for the person such as GPs and hospitals.  CQC is sometimes made an IP by the Coroner, usually where the Coroner has concerns about the case though CQC tends not to take an active role in the case.  The Coroner has a duty to exclude any questions that are not relevant to the inquest.

 

The Conclusion

 

At the end of the hearing, the Coroner will answer the four questions and give a conclusion.  Conclusions can be ‘short form’ such as natural causes or accidental death, or a narrative explaining what happened.  If the Coroner considers that the death was contributed to by a gross failure to provide treatment to a person in a dependent person, the coroner can add that the death was contributed to by neglect.

 

If anything revealed by the Coroner’s  investigation gives rise to a concern that circumstances creating a risk of other deaths will occur, or will continue to exist, in the future, and in the coroner’s opinion, action should be taken to prevent the occurrence or continuation of such circumstances, or to eliminate or reduce the risk of death created by such circumstances, the Coroner must report the matter to a person who the coroner believes may have power to take such action.  Such reports are often referred to as reports to prevent future deaths (often PFD for short) or regulation 28 reports.  They are routinely published on the publicly available judiciary website and sent to interested persons.

 

When to seek advice.

 

Applying the criteria above, a wide range of cases require inquests.  They can include unpredictable falls where there are no criticisms of the care provided to cases where there have been obvious failures in care, and there is a risk of enforcement by the CQC or other regulatory bodies.  Representation is certainly not indicated for every inquest.  Where the provider is clearly not at fault, and no one has any concerns with the provider, representation may not be required.

 

Consideration should be given at the earliest stage as to the risk of the particular case, and that should be kept under review.  Each case will turn on its own facts but the following are risk factors that suggest that legal representation should be considered:

 

1. The provider is given Interested Person status by the coroner. That suggests the coroner considers that the death may be due to an act or omission of the provider, or the coroner thinks the provider has sufficient interest in the case to be granted IP status, for example because others are critical of the provider.
2. The family have expressed concern about the care.
3. The family or other IPs are legally represented.
4. Press interest.
5. There is an ongoing investigation by the police, HSE, Local Authority and/or CQC.
6. The coroner has raised concerns about the provider previously.
7. Conflicts of evidence.
8. Internal and/or external investigations identify shortfalls in the care provided.
9. Jury cases.

 

Statements

 

Coroner’s officers will usually ask for statements early on in the investigation.  If specific information is required, that should be included in the statement.  If statements are sufficiently detailed about the key issues and remedial action, that will reduce the chance that the witnesses will be called to give live evidence, and so reduce the risks and costs to the provider.  However, the Coroner has a wide discretion as to calling witnesses.  Whilst witnesses are often called despite having made detailed statements, the statements will help them when they give evidence.

 

Coroners do not have a duty to issue PFDs if they are satisfied that sufficient remedial action has already been taken by the provider.  It follows that provides should always consider including remedial action in evidence provided to the coroner.  Setting out such evidence can be a comfort to families and reassure regulators that lessons have been learnt.  However, in some cases, particularly when there are open regulatory investigations, the risks of including such information must be balanced against the risk of a PFD.

 

The Coroner may also ask for other documents such as care plans.  Deadlines should be met wherever possible.  Where deadlines are not achievable, extensions should be sought well in advance of their expiry.

 

The Coroners and Justice Act 2009 includes offences for altering or distorting evidence, and intentionally supressing, concealing, altering or destroying a relevant document (defined as a document the Coroner would want to see if they were aware of its existence).

 

Preparing for the hearing.

 

Witnesses may often be giving evidence for the first time and may not have previously attended an inquest.  They will need support to explain the process and reassure them.  If they are particularly nervous, applications can be made to the Court for special measures for example permitting them to give evidence behind a screen or remotely.  Staff are usually reassured by someone explaining the process, though caring employers will of course wish to ensure that they are offered any support.

 

Staff should be given copies of their statements.  Hearings are often months, and sometimes years, after the death, and staff will usually benefit from reminding themselves of the content of their statements and other key documents such as care plans.

 

Lawyers can help them prepare and explain the process though must not coach them or rehearse their evidence.

 

If there is or may be media interest, operators should also consider reputational risk and seek advice about a responsive statement should there be an approach from the press or broadcasters.

 

Finally, operators should consider any new learning identified by the inquest so that further remedial action can be taken if necessary.

 

 

Healthcare Counsel regularly helps health and social care providers in relation to inquests.  If you would like to discuss a particular case to help you consider whether representation would be useful, we are always happy to have an informal initial discussion.

 

Telephone: 0207 406 7532

Mobile: 07980 897 429

Email: [email protected]

 

Our blog posts are not legal advice.

The Court of Appeal has given a firm view on whether the CQC’s FAC process is procedurally fair.

 

R (on the application of Hexpress Healthcare Ltd) v Care Quality Commission[1] was an appeal against the refusal of permission for judicial review on two grounds including that the factual accuracy check (“FAC”) process was unlawful on the grounds of unfairness.

 

The CQC sent a draft report to the Claimant, an online pharmacy upon which it submitted a response in line with the CQC’s FAC process.  In accordance with the CQC’s current practice, the lead inspector completed a response which was reviewed by an inspector independent of the inspection.  The report was subsequently published (though, in fact, it was subject to further changes following the FAC process through dialogue after the judicial review claim was issued).

 

The Claimant remained dissatisfied with the report and argued that fairness required that the CQC consider its response to the CQC’s reply to its FAC submission, relying on the case of SSP[2] which appeared to require such a step.

 

At first instance, Mostyn argued that the ground of challenge was unarguable as it would be “elaborate, and time-consuming”, and “a work of supererogation”.

 

Usually, judgments relating to whether a ground is arguable may not be cited in courts in England and Wales.  In the present case, the Court of Appeal expressly stated that its judgment may be cited as it clarifies conflicting authorities on the issue.

 

The Court of Appeal noted that the declaration made by the court in SSP differed from the grounds of challenge made.  Likely as a consequence of that, none of the leading authorities on procedural fairness were cited.  Having analysed those authorities, the Court of Appeal came to the firm view that:

 

“the process adopted by the CQC of: sending Hexpress the draft report; permitting Hexpress to comment on the draft report through the FAC process; considering those comments through the lead inspector and another inspector independent of the inspection of Hexpress and making the modifications considered appropriate in the light of the FAC comments; before producing the final report; was procedurally fair.”

 

The Court of Appeal has therefore given a very clear view that the CQC does not have a duty to have a process to consider providers’ responses to CQC’s reply to providers’ FAC comments.  It held:

 

“It was for the CQC, as the statutory regulator, to decide what processes to undertake to discharge its duties of procedural fairness, and the CQC reviewed its processes in the light of the decision in SSP Health. The CQC has adopted a process of reviewing the FAC comments first by the lead inspector before having that review considered by an inspector independent of the inspection. That process should ensure that any demonstrably wrong or misleading statement is corrected. In my judgment the process undertaken by the CQC in this case was fair.”

 

What this means for providers

 

Clearly, there may still be cases where the CQC makes erroneous findings of fact, or findings of fact or judgments that are unreasonable (in the sense of being so unreasonable that no reasonable regulator could have made them).  In those cases, providers will need to respond with a pre-action protocol letter for judicial review followed by a claim for judicial review if the CQC does not agree the amendments.  All claims for judicial review must be filed promptly, and in any event not later than 3 months after the grounds to make the claim first arose, so swift action is essential.

 

As there is no automatic right to a second bite of the cherry, it is also essential that FAC comments are comprehensive, persuasive and supported by robust evidence.

 

Please get in touch with us if you need any help with draft inspection reports or any other matters relating to CQC inspections or enforcement: [email protected]

 

[1] [2023] EWCA Civ 238

[2] R (on the application of SSP Health Ltd) v Care Quality Commission [2016] EWHC 2086 (Admin)

My take on ‘Help’, the Channel 4 drama by Jack Thorne about a Covid outbreak in a care home (Spoiler alert).

It is incredibly welcome that the messages ‘care homes don’t count’ and ‘no one is coming’ were voiced through ‘Help’.  Just as important was showing how committed carers can be.  Almost without exception, the stories presented about care homes in the media are the horrors of poor care.  Why is that?  Why is the NHS always the hero, and social care the villain?  Four reasons make a significant contribution:

 

1. We don’t want to confront aging and the unhappy challenges that will face us, particularly as they can’t be fixed. In contrast, we tell ourselves that hospitals will restore us to good health.
2. We feel guilty for outsourcing the care of those we love. In reality, properly funded care by well-trained professionals is usually the best option for people needing care.  We think that hospital care is different as it requires doctors and other professionals.  However, caring also requires highly specialised skills deployed by staff who are called to the caring professions.
3. Social care provision is usually operated for profit. The public seem to be suspicious of this.  They generally don’t realise that GP practices are generally profit-making businesses.
4. Poor care makes a good story.

 

It was refreshing, then, to see a care home provider who seemed to care.  Well done, Mr Thorne, for showing how providers tried to do the right thing and help to free up beds by taking hospital discharges, only for them to bring Covid into the home.  Bravo for pointing out how they were provided with neither the tests nor the PPE that they needed to have any chance of controlling the virus.  Thank you for showing the initiative and hard work providers took in sourcing their own PPE.

 

As to the night when Sarah was alone in the care home, it is welcome that the public were given a glimpse into what the Covid crisis was really like on the ground; it was a battlefield.  In the film, Sarah had interactions with three residents that night.  The reality would have been far, far worse.  With staff shortages and no agency availability, carers may have been looking after far more residents on night shifts, many suffering or dying from Covid.

 

Thorne should be applauded, therefore, for calling out the preposterous claim that a protective ring was placed around care homes.

 

If he had wanted an appropriate final act, Thorne  may have been interested in some of my clients who, after facing the horror of outbreaks, sometimes caused by hospitals discharges, and often with no support from any other agencies (‘no one’s coming’), they then found themselves the subject of Safeguarding Adults Reviews as though it was the care homes’ fault.   You couldn’t make it up.  But then again, you don’t have to.

 

Instead, Mr Thorne wrote a fanciful final act in which Sarah abducts Tony from the care home after he is prescribed tranquilisers to prevent him from absconding.   Thorne reverts to tired tropes of providers doing the easiest thing, rather than the best thing.  On a dramatic level, it doesn’t work at all and is inconsistent with the rest of the film, its core themes and the owner’s character as established to that point.

 

Why did Thorne do it then?  See point 4 above: Thorne chose narrative over authenticity and the vital themes he was trying to portray.  He thought it would make a good story.  As well as the final act falling flat and rightly being panned by some critics, it was a wasted opportunity to laud care homes as heroes as they should be.

 

So thank you, Jack Thorne, for ‘Help’, or at least for most of it.

CQC has sent me its internal guidance on its transitional inspection framework under the Freedom of Information Act.  It is essential reading for those concerned with regulatory compliance of health and social care services.  I attach them below.

There is a guidance document that applies to all services – ‘Inspection guidance for Transitional Monitoring Activity’ – supplemented by 6 service specific guidance documents, one each for, Independent Hospitals (Dialysis Services), Independent Services for those with Learning Disabilities and/or Autism, Independent Ambulance Services, Adult Social Care, Primary Medical Services and NHS Trust level (urgent and emergency care services).  CQC says others will follow.

Of great practical use, the documents set out not only the questions that CQC will be asking on TMA calls, but also the sources of evidence inspectors may wish to look at to obtain supporting evidence.  That will help managers to prepare for the calls.

The disclosed documents provide a far more detailed picture of the TMA (a term new to me).  Details include:

• Inspectors have a TMA app that includes all the services in their portfolio.
• The services are prioritised automatically based on previous ratings and other (unspecified) data held by CQC. This is a new feature.  Such automation of regulatory decisions raises questions about fairness as providers will not have access to the underlying data or the opportunity to comment on them.
• Inspectors may obtain evidence from a variety of sources before the TMA call. That includes:
  • Local Authority/other stakeholder feedback
  • Last inspection/registration report
  • Feedback from people using the service and/or people who support them
  • Feedback from staff
  • Evidence of how the provider gathers and acts upon the views and experiences of people using the service.
• There is a particular emphasis on obtaining people’s experience of care. If that cannot be obtained reliably, CQC will consider an inspection even if no risk has been identified.  Providers may, therefore, wish to consider what evidence about service users’ experience they can obtain and make available in the event of a call.
• Inspectors are also guided to consider closed cultures.
• The TMA call will be on Teams or by phone.
• The guidance discourages recording of calls but does not prohibit providers from doing so. Indeed, paragraph 14.3 of the Inspection Guidance provides a range of options to inspectors should providers wish to record the calls.
• As above, the questions the inspectors will ask are set out in the service specific documents.
• CQC expects requested evidence to be available by screen sharing during the call or otherwise within 24 hours. Inspectors have discretion to accept documents beyond that but no guidance is provided on how to exercise that power.
• The inspector will give a risk score between 1 and 5 for each KLOE. 1 is very high, and 5 is very low.
• Risk is based on level of harm (major, moderate, minor, disproportionate restrictions of liberty) and probability of harm (harm has occurred, probably, possible).
• Usually, further regulatory action will only be considered if a service is scored 1 or 2 in any KLOE.
• There is an exception in respect of cases where 3 is awarded but moderate harm or disproportionate restrictions of liberty or loss of human rights is possible. In such cases, inspectors will use their judgement as to whether to the TMA outcome is changed and a management review meeting (MRM) will be held to discuss a proportionate response.
• Adult Social Care and PMS services will receive a summary record if there is to be further regulatory action. Hospitals may do so in time.
• TMA calls are not inspections and will not result in a change of rating.
• This means that, as anticipated, services that were rated as requires improvement will not be inspected if CQC is content with the level of risk following the TMA call and so their ratings will not change.
• Scores of 1 require a MRM within 24 hours and/or alerting other stakeholders such as the police and safeguarding.
• Scores of 2 will require a MRM within 2 working days. Services where a 3 was awarded but CQC considers that regulatory action is needed will be subject to a MRM within 5 working days.
• The MRM will decide what regulatory action is required.
• TMA calls are by consent. Any refusal to engage will be considered at a MRM.  I think ordinarily that will result in an inspection, though it could lead to a statutory request for information.

Please let me know your experiences of TMA calls.  Are they fair?  Are they a reliable way of assessing risk?

 

Jonathan Landau

Telephone: 0207 406 7532

Mobile: 07980 897 429

Email: [email protected]

 

06 20201005 Inspector guidance for Transitional Monitoring Activity CQC IAT 2021 0419 REDACTED

07 20201007 TRA NHS Trust level urgent and emergency care conversation CQC IAT 2021 0419

05 20200925 TMA PMS guidance and prompts QC IAT 2021 0419

01 20200909 ASC Inspector Guidance Transitional Monitoring Approach CQC IAT 2021 0419

04 20200921 TRA Guidance for Independent Ambulances CQC IAT 2021 0419

03 20200921 independent dialysis Applying TRA guidance Hospitals CQC IAT 2021 0419

02 20200921 IH LD and Autism Applying TRA Guidance Hospitals CQC IAT 2021 0419

 

Yesterday (16 September), CQC published a joint statement of Chief Inspections about the transitional inspection framework that is expected to run until next spring when the new inspection framework is due to launch.  Here are the key points, and the implications for providers.

Key points

• Launches on 6 October 2020 for adult social care and dental services.
• Initial focus on safety, access to services and leadership, but based on existing KLOEs.
• Use of information for all available sources including from Provider Collaboration Reviews.
• CQC promoting feedback using CQC’s ‘Give Feedback on Care Services’
• On-site inspections limited to obtaining evidence that cannot be obtained by other means.
• No return to inspections at fixed intervals.
• Focus on providers where CQC has concerns.
• If CQC is satisfied there is a low level of risk after conducting a desk top review of monitoring information, it will let providers know but this won’t change the rating. However, in time, CQC proposes including a short statement on the service’s page confirming the outcome.
• If the review suggests a risk, CQC will inspect and review any or all KLOEs. However, as inspections will be targeted based on risk, not all KLOEs may be inspected meaning there will be fewer changes of ratings.

 

Implications

• Services that are currently rated as Requires Improvement who have invested in improving quality are likely to be the big losers because the level of risk may now be too low to warrant an inspection, and so there may be long delays before the ratings are raised to Good.
• Similarly, those services that have worked hard to raise standards to Outstanding are likely to be disappointed as it seems unlikely that CQC will inspect them soon.
• Given that ratings are likely to be out of date in many cases, providers will need to consider novel ways of communicating improved quality to commissioners and prospective clients. Certainly the sector will need to educate commissioners that, frankly, dated ratings will not be a reliable indicator of quality.
• If occupancy fails to recover due to an outdated rating, that should be raised with CQC as a matter that could ultimately threaten the viability of the service. CQC should be invited to inspect on that basis.
• CQC will be leaning heavily on data from a variety of sources. It is vital for providers to identify and resolve concerns with stakeholders promptly to avoid falling into CQC’s sights.
• If providers received positive feedback, they should signpost the CQC feedback feature (link above).
• The sector will need to keep a close eye on whether elements of the system lead to unfairness. For example, will providers have access, and be given the opportunity to respond, to the information that CQC uses for its initial desktop review?  That information  will undoubtedly prime CQC’s view of the service, and consequently its final judgments (see my article on unconscious bias and CQC here).

The joint letter is available here. I will blog again when I receive CQC’s internal guidance.

 

If you need any help with CQC or any other healthcare regulatory matter, please get in touch:

Telephone: 0207 406 7532

Mobile: 07980 897 429

Email: [email protected]