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    Coronavirus and the regulatory burden of care home management


    David Edwards highlights the importance for care homes to continue their compliance with the Care Quality Commission’s regulatory system during the coronavirus pandemic and outlines the principle areas for consideration.

    The COVID-19 pandemic and the government’s response continue to have a huge impact on the care sector. As has been well-documented in the media, care homes were largely ignored in the government’s initial response to the pandemic.

    It is now apparent the real impact that COVID-19 is having on the care sector. Estimates suggest that deaths in care homes may account for over a third if not more, of all coronavirus-related deaths.

    Despite the huge impact COVID-19 is having on the care sector, the government has only provided a slight reduction in the regulatory burden upon care homes and stakeholders in this sector.

    Obligations under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014

    The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (2014 Regulations) set out a number of obligations for care homes and their registered managers.

    The care sector’s huge regulatory burden is overseen by the sector’s regulator, the Care Quality Commission (CQC). Despite the ever-changing circumstances for the sector during the current crisis it is important that care providers continue to adhere to the regulatory burden that remains applicable during the COVID-19 pandemic.

    Below is an outline of the obligations from the 2014 Regulations that I believe will be most affected by the COVID-19 pandemic. The CQC provides further guidance on each of these obligations.

    Regulation 12: Safe care and treatment

    Providers must assess the risks to people’s health and safety during any care or treatment and make sure that staff have the qualifications, competence, skills and experience to keep people safe.

    Providers must make sure that the premises and any equipment used is safe and where applicable, available in sufficient quantities. Medicines must be supplied in sufficient quantities, managed safely and administered appropriately to make sure people are safe.

    Providers must prevent and control the spread of infection. Where the responsibility for care and treatment is shared, care planning must be timely to maintain people’s health, safety and welfare.

    Regulation 15: Premises and equipment

    Care providers must make sure that the premises where care and treatment are delivered are clean, suitable for the intended purpose, maintained and where required, appropriately located, and that equipment used to deliver care and treatment is clean, suitable for the intended purpose, maintained, stored securely and used properly.

    Providers retain legal responsibility under these regulations when they delegate responsibility through contracts or legal agreements to a third party, independent suppliers, professionals, supply chains or contractors. They must therefore make sure that they meet the regulation, as responsibility for any shortfall rests with the provider.

    Where the person using the service owns the equipment needed to deliver their care and treatment, or the provider does not provide it, the provider should make every effort to make sure that it is clean, safe and suitable for use.

    Regulation 16: Receiving and acting on complaints

    To meet this regulation providers must have an effective and accessible system for identifying, receiving, handling and responding to complaints from people using the service, people acting on their behalf or other stakeholders.

    All complaints must be thoroughly investigated, and any necessary action taken where failures have been identified.

    When requested to do so, providers must provide CQC with a summary of complaints, responses and other related correspondence or information.

    Regulation 17: Good governance

    To meet this regulation providers must have effective governance, including assurance and auditing systems or processes.

    These systems must assess, monitor and drive improvement in the quality and safety of the services provided, including the quality of the experience for people using the service. The systems and processes must also assess, monitor and mitigate any risks relating the health, safety and welfare of people using services and others. Providers must continually evaluate and seek to improve their governance and auditing practice.

    In addition, providers must securely maintain accurate, complete and detailed records in respect of each person using the service and records relating the employment of staff and the overall management of the regulated activity.

    As part of their governance, providers must seek and act on feedback from people using the service, those acting on their behalf, staff and other stakeholders, so that they can continually evaluate the service and drive improvement.

    Regulation 18: Staffing

    Providers must have sufficient numbers of suitably qualified, competent, skilled and experienced staff to meet the needs of the people using the service at all times and the other regulatory requirements set out in this part of the above regulations. Staff must receive the support, training, professional development, supervision and appraisals that are necessary for them to carry out their role and responsibilities.

    They should be supported to obtain further qualifications and provide evidence, where required, to the appropriate regulator to show that they meet the professional standards needed to continue to practise.

    Regulation 19: Fit and proper persons employed

    This regulation is designed to ensure providers only employ ‘fit and proper’ staff who are able to provide care and treatment appropriate to their role and to enable them to provide the regulated activity.

    Providers must operate robust recruitment procedures, including undertaking any relevant checks. They must have a procedure for ongoing monitoring of staff to make sure they remain able to meet the requirements, and they must have appropriate arrangements in place to deal with staff who are no longer fit to carry out the duties required of them.

    Employing unfit people or continuing to allow unfit people to stay in a role, may lead CQC to question the fitness of a provider.

    Regulation 20: Duty of candour

    Providers must be open and transparent with people who use services and other ‘relevant persons’ for example people acting lawfully on their behalf, in general in relation to care and treatment.

    It also sets out some specific requirements that providers must follow when things go wrong with care and treatment, including informing people about the incident, providing reasonable support, providing truthful information and an apology when things go wrong.

    The regulation applies to registered persons when they are carrying on a regulated activity.

    Obligations under the Care Quality Commission (Registration) Regulations 2009

    The Care Quality Commission (Registration) Regulations 2009 (2009 Regulations) has set out further obligations for care homes and their registered managers.

    Highlighted below are the obligations from the 2009 Regulations which I believe will be most affected by the COVID-19 pandemic. The CQC provides guidance on each of these and a breach of any of the regulations listed below risks the CQC to lead to regulatory action which in some cases may lead to prosecution of culpable individuals.

    Regulation 13: Financial position

    Providers must make sure they take all reasonable steps to meet the financial demands of providing safe and appropriate services.

    To meet this regulation, providers must have the financial resources needed to provide and continue to provide the services as described in the statement of purpose to the required standards.

    Regulation 14: Notice of absence

    To meet the requirements of this regulation, the provider must inform CQC about any planned or unplanned absences from the service that are for a continuous period of 28 days or more, how the service will be run while they are away and when they return from a significant absence.

    Providers must use forms provided by CQC to make notifications under this regulation.

    Regulation 15: Notice of changes

    The provider must inform CQC when:

    • The person who manages or carries on the service changes
    • There is a change to the registered details of the service and any individual, partnership or organisation who manage or carry it on
    • The registered person becomes financially insolvent
    • The service closes.

    Providers must use forms provided by CQC to make notifications under this regulation.

    Regulation 16: Notification of death of service user

    This regulation is designed to ensure that CQC is notified of the deaths of people who use services so that where needed, CQC can take follow-up action.

    Notifications include those deaths that:

    • Occurred while services were being provided in the carrying on of a regulated activity or
    • Have, or may have, resulted from the carrying on of a regulated activity.

    Notifications about deaths must be sent to CQC without delay. All providers must send their notifications directly to CQC unless the provider is a health service body, local authority or provider of primary medical services and it has previously notified the NHS Commissioning Board Authority (now known as NHS England) of the death.

    Providers must use forms provided by CQC to make notifications under this regulation.

    Regulation 18: Notification of other incidents

    Care providers must notify CQC of all incidents that affect the health, safety and welfare of people who use their services. The full list of incidents is in the text of the regulation.

    All providers must send their notifications directly to CQC unless the provider is a health service body, local authority or provider of primary medical services and it has previously notified the NHS Commissioning Board Authority (now known as NHS England).

    Regulation 19: Fees

    Providers must give timely and accurate information about the cost of their care and treatment to people who use the services.

    To meet this regulation, providers must make written information available about any fees, contracts and terms and conditions, where people are paying either in full or in part for the cost of their care, treatment and support.

    CQC’s response to the COVID-19 pandemic

    In response to the COVID-19 pandemic, the CQC has announced a range of measures to reduce the regulatory burden on the care sector, however the effect of such measures is limited.

    They are:

    • CQC to stop routine inspections to focus on supporting providers to deliver safe care during COVID-19 pandemic. Remote methods of inspections will be explored to ensure the continued safety and quality of care.
    • Free and fast DBS checks with the option of staff starting work before enhanced DBS checks are still processed.
    • Notifications to the CQC to submitted through an online portal or by post.

    Beyond the above, there is no other reduction in the regulatory burden, which is of course concerning, considering the impact that the COVID-19 pandemic has, and will continue to have, on the care sector.

    A consideration of the risks to the care sector

    Each of the obligations highlighted above may potentially be impacted during the current crisis, whether that relates to adequate and appropriate staffing, supply of PPE, safety of residents and staff members, or the finances of care homes.

    Although the CQC will not be carrying out routine inspections for the foreseeable future, they will be looking to continue to monitor care homes through remote inspections, which of course increases the risk of care homes being found in breach of many of the obligations highlighted above.

    Care homes need to give thought to the following risks and legal implications with regards to meeting CQC requirements during the COVID-19 crisis:

    • Personal claims from employees as a result of employers failing to provide a safe workplace. Lack of PPE and the inability to implement social distancing measures will of course impact this.
    • Regulatory action by the CQC for breaches of obligations outlined above. There are numerous obligations above which care homes risk breaching during the COVID-19 pandemic, which the CQC can take regulatory action on, and even consider prosecution of culpable individuals.
    • Personal claims by residents for failure to provide a safe living environment during the COVID-19 pandemic. Of course, this would depend on the contractual arrangement in place between care homes and its residents.

    The above guidance is intended as an overview of the risks to the care sector should providers fail to follow their regulatory burden during the crisis. To discuss your specific concerns or requirements please contact David Edwards, head of our healthcare and regulatory teams, on 01772 258321.

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