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: jlandau@healthcarecounsel.co.uk

 

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

 

Since discussing CQC’s transitional framework on Wednesday’s Zoom, CQC published further information about it on Thursday, available here: https://www.cqc.org.uk/guidance-providers/how-we-inspect-regulate/transitional-monitoring-approach-what-expect

The process will be:

  1. CQC will review information from a variety of sources.
  2. CQC will hold a conversation with providers either by phone or using Microsoft Teams typically lasting 1-2 hours.
  3. CQC may ask providers to share your screen during the call to share information, or may ask providers to send encrypted documents within 24 hours.
  4. Based on the discussion and evidence, CQC will decide whether to take further action including an inspection.
  5. It will also produce, but not publish, a record of the discussion.

CQC has published the questions that will be asked during the monitoring call.  They are targeted questions drawn from the existing KLOEs and key questions. They are available here: https://www.cqc.org.uk/guidance-providers/how-we-inspect-regulate/monitoring-questions-adult-social-care-providers.  Providers would be well-advised to make sure that all managers have prepared answers to the questions and have collated supporting evidence.

We also discussed the government’s Adult Social Care Covid-19 Winter Plan.  It sets out expectations for providers as well as national and local bodies.  Providers should therefore take note of the content.  It’s available here:  https://www.gov.uk/government/publications/adult-social-care-coronavirus-covid-19-winter-plan-2020-to-2021/adult-social-care-our-covid-19-winter-plan-2020-to-2021

We also discussed the Test and Trace App. Of note, the supporting guidance states that the app should be paused when:

  1. When PPE is worn
  2. When employees are behind a Perspex or similar screen
  3. When phone are kept in a locker or communal area.

The next zoom will be on 21 October.  Email me if you’d like the dial in details: jlandau@healthcarecounsel.co.uk

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: jlandau@healthcarecounsel.co.uk

 

 

28 July 2020

On 26 and 27 of February 2020, the Supreme Court heard the case of R (on the application of Maughan) v Her Majesty’s Senior Coroner for Oxfordshire.  The issue was whether the standard of proof for suicide in inquests is beyond reasonable doubt, as had been thought since at least 1984, or on the balance of probabilities, as held by the High Court and Court of Appeal in this case.

The judgement is still awaited.  Are we in for a surprise though?  Might the Supreme Court rule that not only does the civil standard apply to suicide but also to unlawful killing?

The Chief Coroner in the case to advocate against that result.  There are a number of arguments in favour of this outcome though:

  1. Inquests are civil cases. The civil standard of proof is on the balance of probabilities (more likely than not) rather than the criminal standard (beyond reasonable doubt).
  2. The legislation makes no provision that the criminal standard applies to findings of unlawful killing.
  3. The argument that findings of unlawful killing (on a balance of probabilities) would prejudice criminal trials is not tenable. It is settled law that the findings of one court do not bind another.  Moreover, as Lord Reed pointed out at the hearing, the potential for difference outcomes exists in any event.  Currently, an inquest reaches a conclusion of unlawful killing, the case could still lead to an acquittal following a criminal trial.
  4. Even if there was such inconsistency, that at best is undesirable. It does not point to what the standard is one way or the other.
  5. There are currently some occasions when a civil court has to apply the civil standard in relation to criminal offences. For example, the Criminal Injuries Compensation scheme (and its associated Tribunal) must apply the civil standard to determine whether a crime has been committed which is a precondition for an award under the scheme.
  6. Incontrovertibly, the standard of proof for narrative conclusions is the civil standard. Such conclusions could in principle include findings on all elements of a criminal offence.   It is accordingly difficult to see why there should be a higher standard for a short form conclusion of unlawful killing.

The consequence of such an outcome would undoubtedly be far reaching.  Unlawful killing will be a the appropriate conclusion in more cases.  Interested Persons, particularly the bereaved, will more frequently make submissions in favour of that conclusion.  The risk to those whose actions or omission may have contributed to the death will accordingly increase.  Those risks include risk to reputation, an increased risk of prosecution and of claims.  It is likely that there will be more representatives at hearings, as insurers routinely take an active role in inquests.   Inquests would be even more stressful for employees than they are now. More staff will wish to be separately represented, especially where staff have concerns about their involvement in the death was affected poor management, training, or lack of resources.

There are also resource implications for the Coronial system, already under strain in many areas due to cuts in local authority areas.

It’s not the outcome anyone is expecting, but watch this space…..

Healthcare Counsel’s Weekly Zoom

15 July 2020

 

This week we were delighted to be joined Jodie Sinclair, head of employment, pensions and immigration at Bevan Brittan.  Jodie answered questions on some thorny issues regarding Covid and employment law.  The following is a summary of the discussion setting out general principles.  Providers should, however, seek legal advice in specific cases especially if considering disciplinary action.

 

Corridor countries and quarantine

At the time of writing, there are over 70 countries and territories on the UK’s exemption list.  People arriving into the UK from those places do not need to isolate for 14 days if they have not travelled to any non-corridor countries within the last 14 days.  The current list is available here.

Providers’ concerns include:

  • Covid is a rapidly changing crisis. Countries currently on the list may soon be found to be unsafe, by which time residents and staff may be exposed risk.
  • There remains uncertainty about how safe air travel is, especially as there is growing suspicion that Covid may be an airborne transmitted disease.
  • Government guidance to care homes throughout the crisis has later proved to be misguided.

Employment law risks associated with requiring staff to quarantine when returning from corridor countries include:

  • Employment law is not trumped by Covid considerations.
  • Restrictions that go beyond government guidance – including requiring staff to take leave to cover a quarantine period for corridor countries – may not be regarded as reasonable management instructions and may be in breach of an employer’s duty to provide work, and the implied duty of trust and confidence.
  • Refusing requests of staff to travel to non-corridor countries may constitute indirect discrimination as such requirements are more likely to affect those of a particular race or religion both of which are protected characteristics.
  • Failure to pay for periods of quarantine may amount to unlawful deductions of wages.

 

Key considerations include:

  • Staff are not entitled to SSP if they are fit to work and are returning from a corridor country.
  • As with all difficult issues, engagement and communication is key.
  • There are range of measures that could work if the employee agrees including unpaid leave and banking leave.
  • Other practical solutions can include arranging rotas following leave that facilitates a quarantine period without reducing the number of hours staff work. Staff can also be asked to use the time after leave abroad to catch up on training.
  • Depending on the needs of the business, providers may take the view that it is not currently practicable to grant leave requests due to the additional demands of Covid and the risk of using agency staff for cover.
  • Providers may decide to impose a quarantine period for corridor countries and pay staff for special leave for that period.
  • Providers making decisions based on health and safety obligations in respect of risk to residents and staff must be able to evidence an audit trail that includes engagement with staff, risk assessments and guidance at the time.
  • Providers are advised to date stamp any government and other guidance relied on as it is changing at pace.

 

Testing

Providers concerns include:

  • Some staff are resisting testing, possibly because staff are concerned that they will not be able to work following a positive result.
  • Some providers have been told by employment law advisors provided by their indemnifiers that they cannot enforce testing.
  • There are practical and legal practicalities about enforcing testing.

 

Key points include:

  • Providers owe health and safety duties in respect of residents and staff, as well as further regulatory duties under the CQC regime and duties of care to staff and residents.
  • Testing and PPE is a significant part of that equation. Whilst WHO guidance does not recommend employers test employees, the UK government has rolled out weekly testing for care home staff, based on the latest scientific evidence.
  • There is unlikely to be any contractual provision about testing in current contracts.
  • Asking staff to undergo testing is likely to be a reasonable management instruction.
  • Speak with any individuals who decline testing to seek to understand their anxieties and explore if and how they can be managed.
  • Advice should be sought if staff still refuse testing, as imposing a policy that staff are not allowed on site without testing could be regarded as a suspension. There may also be claims if it is alleged that the reason for a refusal is due to a disability (for example anxiety).
  • Again, communication and engagement is important. Explain the health and safety obligations that underpin the request to test.
  • A negotiated period of unpaid leave may be an option if the employee agrees.
  • Care should be taken that policies are not applied selectively, as that could lead to discrimination claims.
  • Test results are special category personal data. Accordingly, providers must consider the GDPR implications.  See my earlier post on this here.
  • Future contracts can include a requirement to follow instructions relating to infection control measures.

 

Staff, including shielding staff, who are nervous about returning to work.

 

Key considerations:

  • Shielding staff will be entitled to SSP until 1/8.
  • For staff with a disability, there is a duty to provide reasonable adjustments.
  • Accordingly, providers need to consider whether a staff member has a disability, and if so, what adjustments can be made.
  • Medical suspension may be an option, but advice should be sought. There are special provisions in respect of pregnancies.
  • As above, consideration should be given to any work that can be done from home (or that is not hands on) such as training or paperwork.
  • In principle, an employee who is fit to work but refuses to work could be subject to disciplinary action.
  • However, again there is a risk of a discrimination claim.
  • As always, engagement and communication is key.
  • That includes consulting on risk assessments in respect of returnees.
  • Providers considering disciplinary action should seek advice.

 

Please let me know if there are any other topics you’d like covered in future Zooms – jlandau@healthcarecounsel.co.uk

Healthcare Counsel’s Weekly Zoom last Wednesday concentrated on mental capacity and Covid.

Liberty Protection Safeguards

There was no way the LPS can be implemented by October as initially planned as the regulations and Code of Practice have still not been issued. Indeed, a draft of the Code of Practice has not yet been issued, and following that, there will be a period of consultation before it is finalised. In short, it does not look like the LPS will be implement soon. A new timetable will be announced in due course.

However, there is every reason to think that the LPS will be implemented eventually. The LPS were proposed following a project by the Law Commission, the body responsible for reviewing law in England and Wales and making recommendations for legal reform. A protocol agreed between the Law Commission and Government in 2010 included a requirement for a relevant minister to give an undertaking that there is a ‘serious intention to take forward law reform’ in the proposed area before the Lord Chancellor approves inclusion of a project in the Law Commission’s program. Moreover, there is both a practical and legal need for reform. Currently, DoLS only applies to care homes and hospitals and of course people can be detained in other places. Currently, the only way to do that lawfully is to apply to the Court of Protection which is costly and burdensome to all involved. There is also need for a regime that includes children aged 16 and 17 who are not covered by DoLS.

In short LPS is delayed but is likely to be implemented eventually. Without the regulations and Code of Practice, we only have the skeleton of the regime so it would make sense to wait before investing in training.

Assessments during Covid

DHSC issued helpful guidance on DoLS and Covid available here.  It includes the following:

“To carry out DoLS assessments and reviews, remote techniques should be used as far as possible, such as telephone or video calls where appropriate to do so, and the person’s communication needs should be taken into consideration.”

In some cases, for example for people who find direct face to face communication distressing, remote assessments can be more effective than on-site assessments.

Providers facing requests by local authorities to visit homes to conduct assessments should draw their attention to the guidance and explain their concerns about the risk of Covid transmission. If local authorities persist, providers should in the first instance seek their reasons as to why they do not consider that assessments can be conducted remotely. In some cases, the local authority may have valid concerns in respect of certain individuals and their particular needs. The starting point should be an attempt to work in collaboration to facilitate a high-quality assessment without requiring risky visits.   Each case must be carefully considered in a person-centred way. A position by a local authority that face to face assessments are its usual practice, as reported by one contributor on the call, is not adequate.  Nor would a blanket refusal by a provider to permit visits by assessors under any circumstances.

The guidance also suggests being pragmatic by taking into account evidence taken from previous assessments of the person.

Covid Testing and Mental Capacity

39 Essex Street’s Court of Protection team published a guide to this topic available here. It is a clear and useful guide that I recommend as a first port of call.

For those who may lack capacity in relation to the decision as to testing, the process should be as with all decisions:

1.     Assess whether the person has capacity to make the decision for themselves (with support if needed). That includes understanding the information relevant to the decision. which in turn includes, among other things, understanding the consequences of a positive test such as isolation. This is not a simple issue because of the complexity of the government guidance: a person may be required to isolate if they do not have a test at all but have symptoms, or if they live with others who have had Covid, regardless of whether they are tested.

2.     If the person lacks capacity, determine whether anyone is lawfully authorised to make the decision on their behalf (either a health and welfare LPA or a Deputy). Check the documents to ensure that the authority covers this decision.

3.     If there is no one who has authority to make the decision on their behalf, make the decision in their best interest. The 39 Essex Street guide is particularly useful here. A test can be in a person’s best interests even if it is intended to protect people other than the resident  The resident’s previous wishes to be a good citizen come into play here. Even in cases where it is clear that the person would not have wished to be tested, it may be possible to argue that testing is lawful as other factors are also important in determining best interests. The MCA requires consideration of all relevant circumstances and that includes, in this case, risk of harm to others. As with all best interests decisions, there should be appropriate consultation as set out in section 4 of the MCA and the Code of Practice.

Particular care needs to be taken for anyone who may need to be restrained in any way. If it is likely that the person will resist, force may be used if it is necessary and proportionate. Providers should draft an assessment in advance setting out why restraint is necessary to protect harm to the resident, and how the restraint used will be the minimum necessary to conduct the test. The assessment should also consider whether restraint is in the person’s best interests (this is separate to whether the test itself is in the person’s best interests: conducting a test, and using restraint for the purposes of the test, are two different things).

I would urge providers to seek advice if:

1.     Restraint is needed and the purpose of the test is to prevent harm to others rather than to the person being tested: and/or

2.     The test itself would cause serious distress to the individual.

Again, blanket decisions are inadequate. Decisions should be made on a case by case basis.

Deprivation of Liberty and DoLS

Almost all residents who live in a care home who lack capacity should already be subject to DoLS. The additional restrictions put in place as a result of Covid are unlikely to require any further authorisation in the vast majority of cases if they are therapeutically necessary for the resident in question. In cases where restrictions are necessary only to protect others, the DHSC guidance recommends seeking advice from your local health protection team.

Minimising Impact of Restriction – Quality of Life Considerations

From a risk perspective, providers are unlikely to face negative consequences for following government guidance to protect residents and others if they act in a proportionate way. But that includes giving careful consideration to minimising the adverse impact of restrictions on residents. Again, this should be done on a case by case basis.  It will include maximising contact with families and friends (such as through the use of technology) and maintaining meaningful activities. Care must be taken to monitor the mental wellbeing of residents and changes acted upon quickly. Providers should also seek external advice on best practice.

Those with Capacity

We did not discuss this on the call but I have had queries about this subsequently. What do you do in respect of residents who have capacity and wish to leave the home contrary to shielding guidance or your home’s lockdown policy?

In a nutshell:

1.     Try to explain the reasons for the restrictions.

2.     Explore whether there is anything you can do to reduce the impact on them, for example by shopping on their behalf.

3.     If they still wish to leave, explain that you may need to end the placement in order to protect other residents and/or contact public health who may use powers to enforce the restrictions.

A similar approach would apply if someone with capacity refuses to be tested.

In practice, I would urge providers to seek legal advice if residents cannot be persuaded to agree restrictions (and/or testing).

This Week’s Zoom

The series will continue this Wednesday at 10.30. This week we will be discussing communication – how do you communicate:

–        with relatives who are becoming increasing concerned about your lockdown policy?

–       with stakeholders if you have any Covid cases?

–       with the press if they contact you for comment?

We will be joined by crisis communications expert Chris Gilmour from Beattie Communications who will be on hand to answer any questions.

We will also cover providers’ experiences of accessing Infection Control funding. The government grant is ring-fenced and worth around £1000 / bed but are providers able to access it and how are they overcoming red tape put in place by local authorities?

The login details remain the same. If you’d like to join for the first time, please message me or email me: jlandau@healthcarecounsel.co.uk

Introduction

It was great to see so many people on the Weekly Zoom on Wednesday.

I wanted to give my take on some of the data protection points. 

These views are entirely my own.  I stress that all of this is to give what I hope is a useful steer.  Those who wish to rely on this should seek legal advice as I cannot accept liability other than to clients who have engaged me to provide advice.

As a general comment, I think anything that you are doing to genuinely protect people’s health is likely to be lawful if you are complying with the notice requirements and have given consideration to the risks.   

Even if there are any inadvertent breaches, it is likely that these will be dealt with an a proportionate manner.  The Information Commissioner’s Office (‘ICO’) has published its regulatory approach during the Covid  which recognises the challenges organisations are facing.  The ICO states it is ‘committed to a an empathetic and pragmatic approach’ as a result.  So I wouldn’t worry to much about anything you do which is intended to protect people’s health.

 However, if you are sharing information about Covid status for any other purpose, that is clearly risky.  ICO’s regulatory approach above states:

               “We will take firm action against those looking to exploit the public health emergency through nuisance calls or by misusing personal information.”

And

               “We will take a strong regulatory approach against any organisation breaching data protection laws to take advantage of the current crisis.”

Data Protection Law in a Nutshell

Personal data is information about a person from which they can be identified.

To process any personal data, you need to be able to meet at least one condition from Article 6 of GDPR.

To process special category personal data (which includes data concerning health), you also need to be able to meet at least one condition from Article 9 of GDPR (and in some cases you also need an appropriate policy document in place).

Here is a summary of the conditions that are most likely to apply to the issues we discussed:

Article 6
(c) Legal obligation: processing is necessary for compliance with a legal obligation to which the controller is subject; Providers have legal duties in respect of infection control and health and safety of staff, and safety of visitors to their premises.  They also have a duty of candour to residents (if they have capacity or otherwise to people lawfully acting on their behalf) to be  open and transparent in relation to care and treatment provided to service users in carrying on a regulated activity.

 

 

Article 9
(b) Employment, social security and social protection law.

 

This includes ensuring the health, safety and welfare of employees.

You would need an appropriate policy document in place.  A template with guidance is available here.

 

(h) Health or Social Care Applies if the processing is necessary for the purposes of the provision of health or social care.

You must be able to justify why processing of the specific data is ‘necessary’.  It must be a reasonable and proportionate way of achieving the purpose of providing health or social care.  

This condition applies where there is a duty of confidentiality owed to the individual concerned, as is of course the case in respect of care homes and their residents.

You don’t need to have an appropriate policy document in place.

(i)  Public interest in the area of public health

 

This includes responding to new threats to public health such as epidemics.

You don’t need to have an appropriate policy document in place.

 

As to particular issues:

 

Testing temperatures of visitors as a precondition for visiting.

Whether or not a high temperature is a good indicator of Covid, the current guidance is that people who have high temperatures should self-isolate for seven days.  Accordingly, I think it perfectly reasonable to assure yourselves that visitors do not have high temperatures.  Indeed, I think providers are at risk if they don’t do so.  Whilst you could simply ask visitors to test before they come, staff performing a test is more reliable for a number of reasons (less likelihood for error due to staff familiarly with taking temperatures and better equipment, the test being done immediately before admission and no opportunity for visitors to give the wrong information whether unintentionally or not).  The visitor would of course need to consent to the test, but the lawful basis for processing the data would be 6(c) together with (most obviously) 9(h) and also possibly 9(b) and 9(j).  You would need to document how the data is being used and for what purpose in your privacy notice.   If you relied on 9(b) you would also need a policy document.

The ICO has useful guidance on testing staff most of which is applicable to testing visitors too.  The ICO recommends completing a Data Protection Impact Assessment and  provides a link to a simple template available here.

Visitor Agreements

‘Contract’ is a lawful basis for processing data.  In this case, you would not replying on that basis because the agreement is probably not an enforceable contract.  However, that does not mean that such agreements are not useful in mitigating the risk of transmission.  The agreement will set out the expectations of visitors very clearly in respect of disclosing information about any Covid symptoms, possible exposure to others with Covid, agreement to temperature testing and infection control measures on the premises.    

If you think that having an agreement (or asking a visitor to sign a policy) will mean that it’s more likely that visiotrs will read the document carefully and will attach greater weight to their obligation to comply with the requirements, it seems like a good idea.  Some people may object in which case you would definitely need to check that they have read and understood the policy and seek their verbal agreement to comply with the requirements.  

It’s really a matter for your judgment – providers on the front line are better placed to judge what will work best.  If you consider that it won’t make a difference whether people sign the document or not in terms of compliance, it may be preferable to go through the policy with each person before they are admitted.  Whichever option you choose, you should send the agreement / policy in advance of the visit so that visitors have a chance to read it before they arrive, not least to ensure that they don’t arrive at the home when they have a high risk of transmission.

Whichever option you choose, you would again be relying on the lawful bases set out above.

Communicating Covid Status of Staff or Residents

The ICO has a useful summary in its Covid guidance to healthcare providers.

               “As a manager of a care home, can I tell a resident or their family if another resident or member of staff may have contracted coronavirus?

Yes. Data protection doesn’t prevent you exercising your duty to ensure the health and safety of your residents. But you shouldn’t disclose the identity of any individuals unless you really have to. For example, a simple notice that there is a virus case on the premises, with instructions about what isolation precautions should be followed, would usually suffice.”

A joint statement from the Residents and Relatives’ Association, the National Care Forum, Skills for Care, CQC and the Care Provider Alliance (though not the ICO) includes the following:

“Care providers should keep residents and their family members as informed as possible about the situation in relation to the COVID-19 status of the home. This includes whether there are any suspected or confirmed cases amongst residents and staff, what steps are being taking as a result of this, how the care home is working to keep residents and staff safe, and how they will keep residents and family members informed on an ongoing basis.

Whilst data protection rules must continue to be observed and personal details of individual cases may not be shared, providing a general update about the COVID-19 status of the care home, and the steps being taken to deal with any cases and mitigate the risk to others, will help to allay fears.  As stated above, this will also help to protect the resident’s and family member’s right to private and family life (protected by Article 8 of the Human Rights Act). As the care home is the resident’s home and its COVID-19 status is a factor which may put the resident at risk, keeping residents and family members informed allows them to weigh up any steps they may need to take to mitigate this risk, and to participate in care decisions.”

One of the case studies of good practice includes the statement:

              “We always notify the families of people living in our care homes where COVID-19 is suspected or confirmed.”

Both the ICO guidance and the joint statement accordingly state that you can share information about there being Covid cases in your home as long as it does not disclose information about individuals (unless ‘you really have to’).  Neither expressly discusses communicating when you have no cases. 

Saying you have no cases discloses health data about each resident which as set out above is special category personal data.

If the information is disclosed to residents, or those lawfully acting on their behalf if they lack capacity, I would argue that disclosure is covered by 6(c) and 9(h)  ‘necessary for the provision of health or social care’ given that there is a duty of candour owed to them and CQC, the social care regulator, has expressly required providers to be transparent with stakeholders about Covid.

The issue of disclosing information to families of those with capacity, or to families not acting on their behalf, is more difficult.

I would bear in the mind the following:

  1. The Joint Statement, though not a statement of the law, sets out the importance of being transparent.
  2. The ICO’s Covid statement above suggests that it would be sympathetic in the current climate.
  3. However, using a ‘no Covid’ message for marketing purposes, rather than for reassuring residents and relatives, would constitute ‘breaching data protection laws to take advantage of the current crisis’ which risks ICO enforcement even during the current crisis.

One way of handling this that we discussed on the call is to have a Covid policy that sets out what you would do if you had any cases including that you would be open and transparent about it as recommended by the Joint Statement.   Families will then of course be able to work out that there are no cases if you haven’t told them otherwise.

For all the above reasons, I think the risk of enforcement for communicating to families that there are no Covid cases is low, but the disclosure of that information more widely for marketing purposes is much riskier.

Outside or indoor visits?

Providers need to do deicide this on a case by case basis.  The obvious overall goal is to minimise the risk of transmission whilst facilitating visits that reduce the adverse affects of isolation on the resident.  Drive-through visits where everyone is outdoors, there is no risk of physical contact and distance can be easily regulated, seems a good option in many cases.  However, that will not always be possible.  Most obviously, those at the end of life may not be able to access outdoor spaces.  Where visits are indoors, the current guidance suggests that they should take place in residents’ rooms.  You should consider barriers such as full face shields, as well as other PPE.  Visitors will also need to wash hands before and after the visit, and assurances about their risk of Covid established through a questionnaire / agreement coupled with testing temperatures as above.  See my last blog for more thoughts on the risks and how to manage them.

Questions at daily briefing

The current guidance remains that visits should only be in exceptional cases, and only end of life is given as a concrete example of that.  That guidance dates back to 2 April.  Facilitating visits outside that guidance carries all the risks set out in my blog last week.  The sector is clearly in desperate need of updated guidance.  Anyone can submit a question to be asked at the daily government press briefing.  The questions are selected by an independent polling company.  You can have your question read out rather than recording a video if you prefer.  You can ask questions here.

Next session – Wednesday  10 June, 10.30

The dial in details are as before.  Please email me if you’d like to join for the first time (email below).  Alex Ruck Keene will be joining us to answer questions about Covid and Mental Capacity.  Alex is without a doubt one of the star lawyers in this field, but also has a passion in education and best practice.   If possible please email me in advance if there are any particular MCA / DoLS questions you have.  Please also let me know if there are any other topics you’d like covered.

I hope to see you then!

 

Jonathan

Please click on the links for the documents.

 

Applying ESF Guidance in ASC

ESF Escalation Flowchart supporting document – PMS

ESF escalation flowchart v5 ESF Guidance for Inspectors – Hospitals

ESF Guidance for Inspectors – PMS ESF Guidance for Inspectors

ESF Monitoring and Engagement Call Planning Template

ESF PPE Guidance – v latest

ESF Supporting Guidance for Inspector – Independent Health

ESF Supporting Guidance for Inspectors – Ambulance services

ESF Supporting Guidance for Inspectors – Childrens Homes

ESF Supporting Guidance for Inspectors – Dental

ESF Supporting Guidance for Inspectors – Dialysis services

ESF Supporting Guidance for Inspectors – Learning Disabilities and Autism Services

UPDATE – 30 May 2020

 

Since writing and posting the blog below, the government has updated its social distancing guidelines.  It includes the following:

If you have any of the following health conditions, you are clinically vulnerable, meaning you are at higher risk of severe illness from coronavirus. You are advised to stay at home as much as possible and, if you do go out, take particular care to minimise contact with others outside your household.

Clinically vulnerable people are those who are:

  • aged 70 or older (regardless of medical conditions)
  • under 70 with an underlying health condition listed below (that is, anyone instructed to get a flu jab each year on medical grounds):
  • chronic (long-term) mild to moderate respiratory diseases, such as asthma, chronic obstructive pulmonary disease (COPD), emphysema or bronchitis
  • chronic heart disease, such as heart failure
  • chronic kidney disease
  • chronic liver disease, such as hepatitis
  • chronic neurological conditions, such as Parkinson’s disease, motor neurone disease, multiple sclerosis (MS), or cerebral palsy
  • diabetes
  • a weakened immune system as the result of certain conditions, treatments like chemotherapy, or medicines such as steroid tablets
  • being seriously overweight (a body mass index (BMI) of 40 or above)
  • pregnant women

 

As above, there is a further category of people with serious underlying health conditions who are clinically extremely vulnerable, meaning they are at very high risk of severe illness from coronavirus. You, your family and carers should be aware of the guidance on shielding which provides information on how to protect yourself still further should you wish to.”

 

The points set out below are intended to help providers start to prepare for visitors when guidance changes. They may also assist those who are already facilitating visits despite visits being in breach of regulations and guidance.  There is no guidance permitting visits to care homes yet other than for end of life care.  Facilitating visits therefore exposes providers to a range risks that can be mitigated but not eliminated even with the greatest of care.

 

 

 

The context

Healthcare Counsel’s Weekly zoom session on Wednesday centred on planning to open homes to  visitors.  I commented that providers who are not currently facilitating visits nevertheless need to start preparing now because there has been a pattern of guidance and law changing without notice.  True to form, yesterday afternoon the Prime Minister announced that social distancing guidance would be eased as of Monday so that up to 6 people from different households could meet outdoors even on private premises.  There is no reason to think that will not include grounds of care homes. [UPDATE: Note the updated social distancing guidelines above regarding clinically vulnerable and extremely clinically vulnerable groups].

Some providers  have already started to facilitate visits.   Some have held socially distanced garden tea parties.  Others have been arranging drive-through visits.  Until Monday, the visitors themselves would have been in breach of the regulations because visiting family is not covered by the regulations.  Moreover,  in both “Admission and Care of Residents during COVID-19 Incident in a Care Home”, published on 2 April  and “Covid-19: our action plan for adult social care” published on 15 April, the government recommended that visits should be limited to those who are at end of life.   CQC’s current guidance also reflects that.

It is easy to see why providers took a view, though.   Isolation from family is having a devastating impact on residents’ quality of life at at time when they may not have much life left.  Providers reported that some residents have become depressed and withdrawn without visits from their families, and some providers have even seen increases in physical frailty including pressure sores.

It is equally easy to why other providers have remained in complete lock-down.  As the guidance remains in force, it would be difficult to criticise a provider for following it, particularly given the nature and degree of the risks posed by Covid, set out below.  In contrast, the risks to residents and staff is real and grave.

Both those who have already opened up their homes to visits, and those who must now at least start planning to do so, need to consider the risks carefully and manage them effectively.

The Risks

For those planning to restart visits, the following risks must be considered:

  • Staff and residents contracting Covid from visitors.
  • Visitors contracting Covid from staff and residents.
  • Visitors contracting Covid from other visitors.
  • Heightened risks to clinically vulnerable residents.
  • Claims from staff, residents and/or visitors who contract Covid.
  • Regulatory enforcement in relation to resident safety.
  • Regulatory enforcement in relation to restricting visits.
  • Scrutiny from commissioners, public health, and safeguarding.
  • Embargos if there are new Covid cases or concerns about safety.
  • Insurers not covering any losses caused by Covid either because providers have not followed guidance and best practice or because they have withdrawn cover relating to Covid entirely when renewing insurance policies (several providers have reported this).
  • Data protection breaches in relation to handling information about Covid cases.
  • Staff concerns about being exposed to, and/or residents being exposed to, greater risk.

 

Managing the Risks

Points to consider include:

  • Compliance with the Health Protection (Coronavirus, Restrictions) (England) Regulations 2020. That will mean from Monday that visits can be in the grounds of care homes but must be outdoors.   Likewise, there should be no more than 6 people meeting together at a time, maintaining a minimum distance of 2 meters from those outside their own household.
  • Engaging with your local health protection team.
  • Discussing your plans with your insurance brokers and ensuring you have clarity as to the extent of your cover.
  • Consulting with staff and considering any concerns raised.
  • Drafting a policy and procedure regarding visits. This will include:
    • Preparing the environment, including cover for inclement weather.
    • How visit times will be staggered to ensure social distancing is maintained, and that there are sufficient staff available to facilitate meetings.
    • Duration of visits.
    • Cleaning the environment before and after each visit.
    • Deployment of staff.
    • Use of PPE by staff and visitors.
    • Obtaining resident consent (or LPA / Deputy / best interest decisions as appropriate for those lacking capacity).
    • Planning for each resident including risk assessments. Assessments should cover how the resident can safely access and meet visitors in the environment, and managing any particular challenges om ensuing that social distancing is maintained throughout the visits.
    • Consideration of how shielded residents will be protected from the risks of visitors.
    • How information about staff, residents and visitors relating to Covid will be processed
    • Maintaining contact through other means to supplement visits in person.
  • Drafting a visitors’ agreement in which visitors agree to comply with the visiting policy, including infection control and declaring any symptoms or exposure to anyone with symptoms in the preceding 14 days.

None of this will eliminate the risks set out above but  will help to mitigate that risk.  Providers should regularly keep up to date with government and CQC guidance.  SCIE usefully curates government guidance here: https://www.scie.org.uk/care-providers/coronavirus-covid-19

The next Healthcare Counsel Weekly Zoom will take place at 10.30 on Wednesday.  Please email me if you’d like the login details.  Please also let me know if there are any topics you’d like coveredjlandau@healthcarecounsel.co.uk.

These are my notes and reflections on this week’s Zoom.  As with last week’s session, it was clear that providers are often in novel and difficult situations without any clear guidance.  They are having to feel their own way through and find their own solutions.   This week, we discussed reusing medication, training, testing, and CQC’s Emergency Support Framework

Next week providers will be discussing financial support from Local Authorities.  Different LAs are offering differing levels of support.  What strategies have providers found most effective at accessing the funds? 

We will also be discussing planning to facilitate relatives’ visits.  Recent experience has shown that changes in the law and guidance about social distancing are changed very abruptly and without consultation.  This may affect guidance on visiting care homes.  Providers are also noticing how affected residents are by their increased isolation with many displaying low mood.  How can visits be arranged in a way that mitigates risk to residents, staff and visitors?  This is a crucially important topic and will no doubt prompt a thoughtful and informative discussion.  The Zooms take place on Wednesdays at 10.30am  Please email me if you’d like to join: jlandau@healthcarecounsel.co.uk

 

Reusing Medication

The Department of Health’s Standard Operating Procedure (‘the SOP’)  for reusing medicines in care homes is causing disquiet particularly in relation to end of life care medication.  Providers reported that a medicines training company is advising providers to treat reused medication as homely remedies.

I would caution providers against that.  CQC’s guidance on homely remedies suggests that providers should take advice from a healthcare professional, such as a GP or pharmacist on the use of such medication.

In contrast, paragraph 5 of the SOP states:

 

“Unless the product is being supplied under a PGD or a patient specific direction, a new prescription must be obtained prior to supply to the new patient.” 

 

The medicines training company is therefore wrong to suggest that end of life medication, or any medication that normally requires a prescription, may be treated as a homely remedy.  That advice implies that consulting a healthcare professional is sufficient, when in fact, a prescription is still required.

 

Furthermore, the usual requirements regarding controlled drugs remain firmly in place.  Obviously, those do not apply to homely remedies.

 

In short, I would only consider reusing medication as a last resort if there is a real supply issue.  I would in all cases ensure the medication is prescribed to the new patient before reusing it, and follow the permission and information provisions set out in the SOP.

 

Training

The regulatory requirement, and the duty of care, to ensure that staff are properly trained remains in force.  Providers are finding new ways of delivering the training – but they introduce their own risks.

Microsoft teams is proving a useful resource.  It enables training sessions to be delivered remotely across multiple sites.  Some providers with cinemas are using them effectively to deliver such sessions.  However, some staff have raised the point that they should continue to socially distance as far as possible and spending two hours in a room to receive training is not necessary.

Given the nature of Microsoft Teams and similar products, training could potentially be delivered in people’s homes, mitigating that risk.  Teams’ sessions can also be recorded so can be delivered when needed, and when staff are available.

As to effectiveness of training, that is a question that arises in respect of all training at all times, but it is particularly important to consider it in respect of online and remote training, which CQC inspectors are often sceptical about, and which may be new to some providers and/or staff.

Points to consider include:

  • Testing knowledge at the end of training
  • Seeking detailed feedback on training, and acting on it
  • Observing practice is in line with training
  • Considering training needs in response to incidents, in particular identifying any trends in incidents that might identify training needs across staff and services
  • Reflecting on training, and training needs, during supervisions
  • Providing refresher training at appropriate intervals.

Providers may also wish to see the Skills for Care page on training during Covid.  Skills for Care have developed 3 programs of training during Covid:  a rapid induction program; refresher training (8 topics for staff who urgently need refresher training because training has expired or will expire soon) and volunteer training.     All are delivered digitally by a number of accredited training providers.  Of note, there are no limits to the number of staff who can receive the rapid induction training without charge.

The page includes the following from Kate Terroni (Chief Inspector of Adult Social Care):

“We welcome the new guidance from Skills for Care on training staff during the COVID-19 crisis. We recognise that at this time providers will be prioritising providing care to people and that this may mean that training will be delayed. However, providers should make every effort to ensure that staff are competent, confident and skilled in providing safe care to the people using their service.

We understand the pressures that providers are facing and the difficult choices it may require them to make. We want to support providers in whatever way we can during this crisis period. We are on your side: we are here to work with you, to listen to you, and to support you with the inevitable tough decisions you will face.”

 

Incidentally, Skills for Care’s Guidance from other agencies page is a useful and well updated list of current guidance.

Testing

Providers are questioning whether frequent testing is helpful if it is taking up to three weeks for results to come back.  Testing at three week intervals may therefore be appropriate.  However, some providers are finding it difficult to find couriers to collect the samples before they expire, and many samples are still coming back with inconclusive results.

Testing residents with dementia is particularly difficult and there was discussion around needing to balance the quality of life with any benefits of testing.  Some older residents with capacity have declined tests on the reasonable ground that if they are asymptomatic, a positive test is unlikely to benefit them.

This is an area we will no doubt return to in coming weeks.  It would be interesting to hear from providers who have successfully overcome some of these issues.

 

CQC’s Emergency Support Framework (‘ESF’)

CQC’s records of the ESF calls are not an accurate account of what was discussed.  Some CQC inspectors are recording the calls which providers welcome as it ensures there is an accurate record.  However, practice in this regard seems to vary.

Providers have experienced inspectors objecting to managers having other people in with them during the call such as regional managers.   I commented that I found that very disappointing.  The calls are not inspections, let alone exams or tests.  The practice is not consistent with Kate Terrroni’s comments above.  I am contacting CQC to seek clarity on these points and meanwhile suggest that providers push back on any such objections, and take an accurate note of calls which they share with CQC and other stakeholders after the call.

Healthcare Counsel’s Weekly Zooms take place on Wednesdays st 10.30.  Contact jlandau@healthcarecounsel.co.uk for details.