Statutory notifications Guidance for registered providers and managers of − adult social care − independent healthcare − primary dental care − independent ambulances March 2011 Update note We have updated this guidance document from version 2 to version 3 to incorporate dental and private ambulance providers who need to be registered from April 2011. We have also updated information about personal data coding and infection control guidance. Statutory notifications: Guidance for providers 2 Introduction This guidance tells you: • About incidents and events that adult social care, independent healthcare, primary dental care and independent ambulance providers must notify us about. • How to notify us (submit a notification). • How to find out more about the requirements to make notifications. Main points 1. All registered providers have a statutory duty to notify us in writing about certain important events that affect people who use their service or the service itself. Some of these events are unlikely to happen in certain services, but where they do we must be notified. 2. The regulations about notifications are in the Care Quality Commission (Registration) Regulations 2009. You can read them on our website at www.cqc.org.uk. You can use the search function to find a continuously updated version of the regulations. You can also find them in other publications and at other websites, but they may not be completely up to date. This includes appendix D of the Guidance about compliance: Essential standards of quality and safety, which you can find on our website (www.cqc.org.uk/standards). 3. Different types of notifications have different timescales. Providers must tell us about a notifiable event within the timescale set by the law, otherwise we may take enforcement action. 4. We use the information in notifications to: • Help us build up a picture of each service and the regulated activities it provides. • Identify risks to people. • Continuously monitor that services are complying with the law. • Keep our information about services up to date. • Monitor whether applications for registration are needed. • Help us work in a proportionate way and use our resources wisely. 5. Some notifications may be about routine events that require no further action. However, where a reported incident or pattern of reports is significant and affects the safety of people using the service, we will assess what action the provider has taken and respond accordingly. 6. Requirements to make notifications under the Health and Social Care Act 2008 are broadly similar for all the different kinds of regulated activities and providers, but there are significant differences between some processes for: • Regulated healthcare activities carried on by NHS bodies, and • All other regulated activities carried on by any provider, including adult social care activities carried on by NHS bodies (covered in this guidance). It is important that you know about and understand these differences, so that you can submit notifications properly and lawfully. Statutory notifications: Guidance for providers 3 7. We have published separate guidance on notifications required by the Health and Social Care Act 2008 in relation to regulated healthcare activities carried on by NHS bodies. What notifications are required under the Health and Social Care Act? 8. You should familiarise yourself with the Guidance about compliance outcome sections that include detailed information about notifications requirements. These outcomes are: • Outcome 15 (Regulation 12) Changes to the statement of purpose • Outcome 27 (Regulation 14) Notice of absence • Outcome 28 (Regulation 15) Notice of changes − A person other than the registered person carries on or manages the regulated activity − A registered person ceases to carry on or manage the regulated activity − The name of the registered person changes (where the person is an individual) − Where the service provider is a partnership, any change in the membership of the partnership − Where the service provider is a body other than a partnership: (i) a change in the name or address of the body (ii) a change of director, secretary or other similar officer of the body (iii) a change of nominated individual − Where the service provider is: (i) an individual, the appointment of a trustee in bankruptcy in relation to that individual, or (ii) a company or partnership, the appointment of a receiver, manager, liquidator or provisional liquidator in relation to that company or partnership (The law does not require NHS bodies to notify us about changes of director, secretary or other similar officers, but we ask them to provide details of changes of chief executives using the changes form). • Outcome 18 (Regulation 16) Deaths of people who use the service • Outcome 19 (Regulation17) Deaths and unauthorised absences of people who are detained or liable to be detained under the Mental Health Act 1983 Statutory notifications: Guidance for providers 4 • 9. Outcome 20 (Regulation 18) Other incidents: − Serious injuries − Applications to deprive a person of their liberty − Abuse − Events that prevent or threaten to prevent the registered person from carrying on an activity safely and to an appropriate standard In addition, there are three notifications requirements not included in the Essential standards: • Regulation 20 Death of a woman after termination of pregnancy • Regulation 21 Death of a service provider • Regulation 22 The appointment of liquidators 10. We have developed forms that providers can use to submit notifications. See annexe 1 for more information about how to use these forms and about the required timescales for submitting notifications. What’s different from Care Standards Act (CSA) notifications? 11. Primary dental care and independent ambulance providers were not required to register under the CSA and so did not have to submit statutory notifications. 12. The requirement to notify us of “any event adversely affecting the safety and welfare of a person using the service” has been replaced with a number of more specific incident notification requirements. Please see Regulation 18 notifications in annexe 1. 13. Domiciliary care agencies and nursing agencies are now required to notify us about certain deaths and other incidents involving people who use their service. 14. There are new notifications requirements about: • Unauthorised absences of people detained or liable to be detained under the Mental Health Act 1983. • Abuse and allegations of abuse. • Applications to deprive people of their liberty under the Mental Capacity Act 2005. • Events that stop an activity from being carried on safely and properly. 15. Some Care Standards Act notification requirements have not been carried over to the Health and Social Care Act. These are: • Outbreaks of infectious disease. • Serious illnesses (non-nursing care homes only). • Accidents. • Allegations of misconduct. Statutory notifications: Guidance for providers 5 Guidance 1 Why do I have to submit notifications to CQC? The law says that registered persons must notify CQC of certain events. This includes notifications from NHS trusts in relation to adult social care activities for which they are registered to carry on. These activities are: 2 • Personal care. • Accommodation for people who require nursing or personal care. • Accommodation for people who require treatment for substance misuse. • Accommodation and nursing or personal care in the further education sector. How do I submit a notification? We will introduce electronic forms on our website for providers to use to submit notifications online in due course. Until this new system is ready, you can download Word forms from our website to fill in electronically on a computer. You can download the Word forms and read more information about submitting notifications from the relevant sections of our website (www.cqc.org.uk): adult social care independent healthcare primary dental care independent ambulances You don’t have to use our forms, but using them helps to ensure that you submit all the information required by the law. Notifications of deaths and unauthorised absences of people liable to be detained under the Mental Health Act are dealt with under a different process to the other notifications. This is because they are part of our Mental Health Act monitoring functions. You can download these notification forms and find out how to submit them here. You should assign a reference number or code to the space provided at the top of each form. You should record this number in an appropriate place so that if we need more information about the incident, event or change you have told us about you can look it up more easily. Statutory notifications: Guidance for providers 6 The forms show which information you must submit. They also ask for additional information that helps us to understand what has happened and how you have responded to it. If you submit this additional information it will often mean that we don’t have to contact or visit you to gather more information. When completed, you should send the forms (except those about unauthorised absences and deaths of people liable to be detained under the Mental Health Act) as an email attachment to: [email protected]. If you submit this additional information it will often mean that we do not have to contact or visit you to gather more information. If you are unable to return the form by email you should print them, fill them in by hand if necessary, and send them to: CQC Notifications [Region] (please add your region here – for example ‘North West Region’ – on the first line of the address) Citygate Gallowgate Newcastle upon Tyne NE1 4PA If you don’t have access to the internet you should contact us on 03000 616161 and ask for printed copies of each form to duplicate and have ready for use when needed. These forms should also be sent to the above address. 3 Who should fill in and submit CQC notification forms? The regulations say that the ‘registered person’ must submit notifications. This can be either the provider or a registered manager. In practice, larger providers will probably need to delegate this task to appropriate members of staff. You need to ensure that your delegation arrangements clearly show which staff are responsible for submitting notifications. Schemes of delegation together with other policies and procedures and staff training arrangements must ensure that CQC is told about notifiable events properly and within required timescales. In all cases, we need to know the name of the person who submits a notification. It is the registered person’s responsibility to ensure notifications are made, and you will be committing an offence if you fail to do so. Any arrangements for delegation of this task must therefore be very clear. Statutory notifications: Guidance for providers 7 4 What if I need to give CQC more information about the incident or event after I have submitted a notification? You may need to tell us more about some incidents after you have submitted a notification. For example, after telling us about a safeguarding alert. If you quote the notification’s reference number when you submit additional information and explain that you are telling us more about a notified incident or event we will be able to link the information to the original notification quickly. Some CQC notifications forms are used to give required follow-on information to previously submitted forms. Where this is the case there is a space to provide the reference number for the original notification. This helps us to link the two notifications. 5 What does CQC do with notifications? Notifications add to our knowledge of each provider and health and social care services across local areas and the country. This will help us to plan our work, target our resources, write our reports, and contribute to improving services for people at provider, regional and national levels. If a notification is about changes to your registered details we will bring our register and records up to date. If a new application is needed, we will check to make sure one is made. If a notification is about a serious event that affects a person or people using the service we will ensure we have all the information we need and assess the incident and what has been done about it. We will make a judgement about whether the law has been complied with using our ‘judgement framework’. Where necessary we will use our ‘setting the bar’ tool and relevant enforcement processes. You can read more about these on our website. When resolving problems, we will try to avoid duplication and avoidable burden by working with partner agencies and regulators. These include local authorities and primary care trusts acting as service commissioners, the Heath and Safety Executive and the Health Protection Agency. Statutory notifications: Guidance for providers 8 6 How can I protect people’s privacy when making a notification? The Data Protection Act makes important requirements about how information about people is stored, ‘processed’ and shared, and requires appropriate measures to be taken to protect personal data. Notifications about people must not include their names or other details that a third party could use to identify them. You must therefore use codes instead of names. You should carefully record the codes used in notifications in a secure place, in case we need to know more about the incident or event that you have told us about. We suggest that you allocate a code to each person who uses your service, and use this code in statutory notifications. Some providers use codes like this for a variety of purposes. You must keep information about who the codes refer to safely and securely, in case we need to know more about the event. It is up to you to decide the format of the codes. Even where codes are used, they must not easily identify the person, such as a room number or date of birth. 7 Why do you ask about people’s ethnicity, religion, and so on? It is important that you take account of people’s diverse needs when carrying on or managing activities, and also that you monitor how well you are meeting the diverse needs of people. CQC has a duty as a public body to monitor and report on how well both individual providers and the health and social care sector as a whole are promoting equality and meeting people’s diverse needs. We ask that you tell us about people’s individual backgrounds in our notifications forms using the ‘equality strands’ widely used across government and the economy. You will already have collected this information when accepting or admitting people to your service under Outcomes 1 and 4 of the Guidance about compliance (‘respecting and involving’ and ‘care and welfare’ of people who use services). Statutory notifications: Guidance for providers 9 8 Do I have to notify CQC about outbreaks and individual cases of infection? You do not have to notify CQC about outbreaks and individual cases of infection. We are developing information sharing agreements with relevant organisations so that we have the information we need to assess compliance with infection control requirements. New laws about notifying infectious diseases were introduced in 2010. The Health Protection Agency and Department of Health have published guidance explaining the new laws and how they should be implemented. The guidance is called the Health Protection Legislation (England) Guidance 2010, and registered persons should read it so that they understand what needs to be notified. These laws do not affect the existing requirements of the Health and Social Care Act 2008 code of practice for the prevention and control of infections. The code requires that NHS providers report cases and outbreaks of certain infections. These infections are: • Clostridium difficile. • Blood stream infections caused by meticillin resistant Staphylococcus aureus (MRSA) and glycopeptide resistant enterococci (GRE). • Surgical site infections (SSI) following orthopaedic surgery. The code of practice also requires that registered providers report significant outbreaks of infection to the Health Protection Agency (HPA) if advised to do so by a suitably informed medical practitioner. Certain infections or conditions are notifiable to the Office of National Statistics by law. They must be reported by any doctor in clinical practice. Submitting reports Registered medical practitioners (RMPs) are required to notify the ‘proper officer of their local authority’ (in practice usually the consultant in health protection employed by the HPA) through locally agreed arrangements. RMPs must also report relevant deaths to the proper officer. The proper officer will then inform relevant primary care trust(s), local authorities, port health authorities, and the HPA. Diagnostic laboratories that test human samples must notify cases of infection to the HPA. NHS trust chief executives must report cases of MRSA bacteraemia and clostridium difficile infection to the HPA. NHS organisations should also report relevant outbreaks as ‘serious untoward incidents’ to their strategic health authority and the National Patient Safety Agency. Statutory notifications: Guidance for providers 10 Voluntary reporting Most pathology laboratories report confirmed human infections to the HPA electronically on a weekly basis. 9 Where can I find out more about the changes, events and incidents that have to be notified to CQC? You can find out more in the relevant outcome sections in the Guidance about compliance: Essential standards of quality and safety. Each outcome includes detailed information about notifications requirements. You can read the Essential standards here. Statutory notifications: Guidance for providers 11 Annexe 1: Guidance about timescales and using the standard CQC notification forms This annexe describes how you should use the standard CQC forms when making a notification, and follow the timescales for making the different kinds of notifications. Our notifications forms are ‘protected’ Word documents. You can navigate from field to field when filling them in on a computer by pressing the arrow or ‘tab’ keys, or clicking with a mouse. Regulation 12 (Outcome 15): Changes to statement of purpose Regulation 14 (Outcome 27): Absences and returns from an absence of 28 days or more You must notify CQC about changes to your statement of purpose for a regulated activity within 28 days. You can do this by completing our standard form and attaching it and the amended statement to an email. You should make sure that the new or changed parts of the statement can be easily identified. There is a standard form for notifying relevant absences of registered individuals (and arrangements for managing the activity during the absence) and another that you can use to tell us about returns from absences. You must complete all the relevant sections of the forms. Timescales: • Notifications about planned absences of 28 days or more must be submitted 28 days before they begin. • Shorter timescales can be agreed with CQC where appropriate – please contact us to discuss this. • Where an absence is caused by an emergency, you must submit the notification within five working days of the start of the absence. • Where a required absence notification has not already been submitted, you must send it to us within seven working days. • Returns to work from an absence must be notified within seven days. When an absence will clearly be lengthy but you are not sure how long it will last, there is a space on the form for you to propose a date by when – if the absent person has not returned to work – a new manager will be appointed and will apply for registration. We will review the proposed date and discuss the matter with you where needed. Regulation 15 (Outcome 28): Changes The information fields and sections of the standard form allow you to submit notifications about the variety of changes that regulation 15 requires you to tell us about. Notification of these changes must be submitted as soon as reasonably practicable and in advance of the change, unless this is not possible. Statutory notifications: Guidance for providers 12 You can also use this form to tell us about important changes that are not covered by the notifications regulations. If you have previously told us that you are willing to receive notices from us by email, you can use the standard form to tell us about: • A change to the email address that we should use for this purpose. • Changes to your main contact telephone number. • Changes of chief executive (for NHS providers). You must fill in section 1 in all cases, and then use the following sections of the form as needed to notify us about: Section Change 2 Changes of provider for an activity 3 Changes of registered manager for an activity 4 Changes to a registered individual’s name 5 Changes to the membership of a partnership 6 Changes to an organisation’s name or address 7 To notify the appointment of a new nominated individual 8 Changes to an organisation’s officers or directors (NHS bodies should use this section to tell us about new chief executives) 9 Changes of main contact email address and telephone number 10 The appointment of a trustee in bankruptcy, receiver, or liquidator 11 The sequestration of a registered person’s estate You can use the additional section 12 to clarify anything, or to give us any additional relevant information. Regulation 16 (Outcome 18): Death notifications must be submitted without delay. There is a standard form for doing so. Death of a person who uses the service The form has sections that enable you to tell us about the circumstances of the death (as required by the regulation). Statutory notifications: Guidance for providers 13 Regulation 17 (Outcome 19): Deaths and unauthorised absences of people who are detained or liable to be detained under the Mental Health Act 1983. Regulation 18 (Outcome 20): ‘Other incidents’ These notifications are dealt with under a separate process from that used for most notifications. This is because they are part of our statutory Mental Health Act monitoring duties. You can get information about this and download our standard forms here. These notifications must be submitted without delay. The law says that you must notify us without delay about a variety of ‘other incidents’ that take place while an activity is being delivered, or as a consequence of an activity being delivered. There are separate standard forms for notifying us about each kind of incident or event. These incidents and events are: Injuries You must notify us of the injuries that are specified in the Guidance about compliance: Essential standards of quality and safety and shown on our form. Deprivation of liberty applications and their outcomes You must notify us without delay about applications to deprive a person of their liberty under the Mental Capacity Act 2005. Care home and hospital providers must also tell us about the outcome of applications to a supervisory body. A separate form is available for this purpose. You should add the original notification reference to the appropriate information box at the top of the first page of the outcome form. This will help us to link outcome notifications with the relevant application notification. Abuse and allegations of abuse You must notify us about abuse or alleged abuse involving a person(s) using your service, whether the person(s) are the victim(s), the abuser(s), or both. Please see Essential standards of quality and safety for more information about what must be notified in relation to abuse. You must also alert the relevant local safeguarding authority for children or adults when you notify us about abuse or alleged abuse, and the police where a crime has been or may have been committed. Statutory notifications: Guidance for providers 14 Incidents reported to or investigated by the police You must notify us about any incident related to your carrying on of a regulated activity that is reported to or investigated by the police. Events that stop or may stop the registered person from running the service safely and properly You must notify us about any relevant infrastructure, equipment, premises or other problems that prevent or are likely to prevent you from carrying on a regulated activity safely and in accordance with the Essential standards of quality and safety. Regulation 20 Death of a woman after a termination of pregnancy Regulation 21 Death of a provider You must notify us within 14 days if you hear about the death of a woman who has had a termination of pregnancy at your service, where: • The death took place within 12 months before you received the information, and • You have reason to believe that the death may be associated with the termination. You can use the standard form that is used for the death of a person who uses a service (regulation 16). Where a member of a partnership dies, the/a surviving partner must notify us of the death without delay. Where a provider who is an individual dies, their personal representative must notify us of: • The death without delay, and; • Their plans for the future of the regulated activities carried on by the service within 28 days. Partners and personal representatives can use standard forms to send us these notifications. There is a separate form for personal representatives to use to tell us about their intentions for the future. These notifications are always significant. Regulation 22 Appointment of liquidators Where a receiver, manager, liquidator, provisional liquidator or trustee in bankruptcy is appointed in relation to a registered provider, the former must notify us about: • Their appointment, and • The reasons for their appointment, and • Their plans for the future of the regulated activities carried on by the service within 28 days. There are standard forms with relevant sections for liquidators to use when sending in these notifications. Statutory notifications: Guidance for providers 15
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