Functions, Role and Regulations of Care Quality Commission (CQC)

CQC is England’s health and social care services regulator. They make sure health and social care services provide people with safe, effective, compassionate, high-quality care and we encourage them to improve.

CQC’s principles are to:

• Put people who use services at the heart of its work


• Have an open and accessible culture


• Be independent, rigorous, fair and consistent


• Work in partnership across the health and social care system


• Commit to being a high-performing organisation


• Promote equality, diversity and human rights

What does the CQC do?

CQC carries out its role in the following ways:

• Setting national standards of quality and safety that people can expect whenever they receive care.


• Registering care services that meet national standards.


• Monitoring, inspecting and regulating care services to make sure they continue to meet the standards.


• Protecting the rights of vulnerable people, including those whose rights are restricted under the Mental Health Act.


• Listening to and acting on patient concerns and experiences.


• Working in partnership with other organisations and local groups.


• Challenging all providers, with the worst performers getting the most attention.


• Making fair and authoritative judgements supported by the best information and evidence.


• Taking appropriate action if care services are failing to meet the standards.


• Carrying out in-depth investigations to look at care across the system.


• Reporting on the quality of care services, publishing clear and comprehensive information, including performance ratings to help people choose care.

Who do CQC regulate?

CQC regulate:

• Treatment, care and support provided by hospitals, GPs dentists, ambulances and mental health services.


• Treatment, care and support services for adults in care homes and in people’s own homes (both personal and nursing care).


• Services for people whose rights are restricted under the Mental Health Act.

How are bodies regulated?

In accordance with ‘The Scope of Regulation – August 2013’ CQC Guidance Leaflet, the CQC say that all health and social care services in England need to register with them. In practice however, this is confined to those who carry out any of the CQC’s fifteen regulated activities.

These regulated activities are listed in Schedule 1 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2012. These include:

1. Personal care (which is provided to them in the place where those people are living at the time when the care is provided)


2. Accommodation for person who require nursing or personal care


3. Accommodation for persons who require treatment for substance misuse


4. Accommodation and nursing or personal care in the further education sector


5. Treatment of disease, disorder or injury (if provided by a listed health care professional, social worker or multi-disciplinary team)


6. Assessment or medical treatment for persons detained under the Mental Health Act 1983 (only in hospitals)


7. Surgical procedures (carried out by a healthcare professional, some exceptions for minor procedures, eg foot and nail treatment, tattooing, piercing, removal of hair and blemishes, etc)


8. Diagnostic and screening procedures (radiation, ultrasound and MRI etc)


9. Management of supply of blood and blood-derived products (includes NHS Blood and Transplant)


10. Services in slimming clinics (that include giving medicines AND are led by a registered medical practitioner)


11. Transport services (where the vehicles primary purpose is for transporting people who require treatment), triage and medical advice provided remotely (where the advice is medical AND responsive i.e. for immediate attention or action OR it constitutes triage AND is provided by a body responsible for that service)


12. Maternity and midwifery services


13. Termination of pregnancies (does not include the ‘morning after pill’ when used as an emergency contraceptive)


14. Nursing care (where not under another regulated activity)


15. Family planning services (services for the insertion or removal of an intrauterine contraceptive device by, or under the supervision of, a health care professional)

Any organisation that carries out these regulated activities in England must register with CQC. Separate provisions are available in the rest of the UK.

For any bodies that carry out these services in England from neighbouring countries for short periods of time (eg. Ambulance services) the CQC have said that they will take a ‘proportionate’ and ‘reasonable’ approach to registration.

Registration takes many forms and varies slightly for different practice groups (eg. Corporate groups, franchises, partnerships). This includes the fact that a GP surgery is normally registered under their partner’s (lead doctor’s) name, rather than the surgery itself.

Failure to register

Any service that provides one or any of the fifteen regulated activities who fails to register will be liable for a criminal offence and may face prosecution.

Section 10 of the Health and Social Care Act 2008 states:

(1) Any person who carries on a regulated activity without being registered under this Chapter in respect of the carrying on of that activity is guilty of an offence.

(4) A person guilty of an offence under this section is liable—

• on summary conviction, to a fine not exceeding £50,000, or to imprisonment for a term not exceeding 12 months, or to both;


• on conviction on indictment, to a fine, or to imprisonment for a term not exceeding 12 months, or to both.

Exemptions to regulation

The following bodies aren’t covered currently, even though they provide regulated activities:

• Scottish, Irish, Welsh and non-Mainland UK services


• Non-NHS primary pharmaceutical services – eg. Boots, Superdrug, Lloyds


• Non-NHS primary ophthalmic services – eg. Specsavers, Vision Express


• Some mobile treatment units – eg. Blood donation, breast scanning. Often broader registration is kept with the CQC.


• Some fertility clinics after 01 October 2013


• Independent practitioners – acting as a ‘designated body’ providing services in a surgery or consulting room, treatment does not include anaesthesia or intravenous sedation, childbirth services and termination of pregnancy, certain cosmetic surgery, haemodialysis etc.


• Independent midwives - exemption if midwife is self-employed AND providing non-NHS care AND providing services to their patient ONLY in their home.


• Third party exemptions - Occupational health schemes; defence medical/dental teams for the armed services; forensic medical service (eg in police custody); medical assessment or treatment linked to insurance schemes (does not exclude services through private medical insurance schemes); medical services organised by a government department that do not involve treatment requiring admission to hospital (eg. medical assessments to determine eligibility for social security benefits).


• Individual budgets, individual user trusts and self-funded personal care or nursing care - Where a person, or a related third party on their behalf, makes their own arrangement for nursing care or personal care, and the nurse or carer works directly for them and under their control without an agency or employer involved in managing or directing the care provided, the nurse or carer does not need to register for that regulated activity.


• Any health or social care activity carried out by a carer for a member of their family or someone in a personal relationship – where there is no commercial consideration.


• School nurses - who are employed and managed by the school and who provide services to the school"s pupils. In general, this will exempt school nurses in independent schools, but not in public sector schools where the school nursing service will be included in the registration of the relevant provider.


• Aircraft operators – that only carry out the activity of transport services and do not carry out other regulated activities (such as treatment of disease, disorder or injury)


• Aircraft operators or air ambulance providers within the confines of event grounds - may fall out of regulation if their transport is confined to the event ground.

Archived services

Beyond these exempted services, the CQC have also removed a number of healthcare providers from their website.

These services include those where:

• The provider has voluntarily closed it – for example, a service closed because it is no longer profitable.


• The CQC has taken enforcement action to close it – for example, a service whose registration is cancelled after CQC inspectors found evidence of poor care or abuse.


• The legal entity providing the service has changed – for example, a service where a sole trader has been replaced by a partnership as the provider.


• The service has changed address - for example, a service that has moved to a new building to take advantage of better facilities.


• The provider is no longer required to be registered with the CQC - for example, some fertility clinics that have no longer been regulated by the CQC since 01 October 2013.

This means that it is very important to record the correct name of the healthcare provider when taking feedback from a helpline caller. Common mistakes may include recording a trust under a generic name (eg ‘Manchester Hospital’) or failing to specify which trust is being discussed.

What are the potential risks for service users?

When services are exempted by CQC, service users cannot feedback their experiences. This means that if poor care is experienced, or members of the public know that poor care is being provided, the information cannot be collected and acted upon by the CQC, these cases are not included in the CQC pilot.

CQC continues to expand in the services it regulates and covers. Changes to the CQC regulations were made following a consultation by the Department of Health in 2011. These amendments were then approved by Parliament in 2012. These changes mostly address technical points in the regulations that make them clearer in order to provide greater clarity.

Further changes in October 2013 meant that some further healthcare providers were no longer required to be registered with the CQC. The CQC have responded by saying that many of these services were already exempted by the regulations by another means.

With input from AVMA

 

Functions, Role and Regulations of Care Quality Commission (CQC)

What are Never Events?

The term ‘never event’ was first introduced in 2001 by Ken Kizer, former chief executive of the National Quality Forum in the United States, in reference to particularly shocking medical errors that should never occur.

Over time, the term has been expanded to signify adverse events that are unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability), and usually preventable if the available measures have been implemented by healthcare providers.

The information from the United States indicates that the use of the term and its associated focus has improved safety.

In the UK the term was introduced in April 2009, following Lord Darzi’s proposal in High Quality Care for All. The original list consisted of the following:

1. Wrong site surgery 


2. Retained instrument post-operation (includes swabs and throat packs)


3. Wrong route administration of chemotherapy


4. Misplaced naso or orogastric tube not detected prior to use


5. In-hospital maternal death from post-partum haemorrhage after caesarean section


6. Inpatient suicide using non-collapsible rails


7. Escape from within the secure perimeter of medium or high secure mental health services by patients who are transferred prisoners


8. Intravenous administration of mis-selected concentrated potassium chloride.

To be a never event, an incident must fulfil the following criteria:

• It has clear potential for, or has caused severe harm or death.


• There is evidence that it has occurred in the past (ie, it is a known source of risk).


• There is existing national guidance or safety recommendations on how it can be prevented and there is support for implementing these.


• It can be easily defined, identified and continually measured.

Serious events (including never events) are assessed and categorised as grade 1 or 2, depending on the seriousness of the event. They should all be reported to the primary care trust (or clinical commissioning group), as well as the National Reporting and Learning Service (NRLS – at Imperial College), with never events being specified in the free text field. Since the summer, reports should also be made to the Strategic Executive Information System.

Although such events are reported to CQC and Monitor through the NRLS, it is much better if they are reported directly to CQC (and Monitor for foundation trusts and the NHS Trust Development Authority for non-foundation trusts). Serious events are investigated and shared with the PCT and an action plan shared widely to improve the service.

CQC may use information on never events to inform our regulatory processes, alongside other indicators, and we may take enforcement action.

In the first year of reporting, there were 111 never events. Of these, 57 were due to wrong site surgery, and 41 due to misplaced nasogastric tubes. There were no events due to wrong route administration of chemotherapy, in-hospital maternal death from post-partum haemorrhage after elective caesarean section, and inpatient suicide using non-collapsible rails. The remainder were under 10 events.

We would all agree that the national reporting system is in dire need of revision to ensure that it becomes a true national learning experience.

There has been a recent review of never events and the list extended to the following:

1. Wrong site surgery


2. Wrong implant/prosthesis


3. Retained foreign object post-operation


4. Wrongly prepared high-risk injectable medication


5. Maladministration of potassium-containing solutions


6. Wrong route administration of chemotherapy


7. Wrong route administration of oral/enteral treatment


8. Intravenous administration of epidural medication


9. Maladministration of insulin


10. Overdose of midazolam during conscious sedation


11. Opioid overdose of an opioid-naïve patient


12. Inappropriate administration of daily oral methotrexate


13. Suicide using non-collapsible rails


14. Escape of a transferred prisoner


15. Falls from unrestricted windows


16. Entrapment in bedrails


17. Transfusion of ABO-incompatible blood components


18. Transplantation of ABO-incompatible organs as a result of error


19. Misplaced naso- or oro-gastric tubes


20. Wrong gas administered


21. Failure to monitor and respond to oxygen saturation


22. Air embolism


23. Misidentification of patients


24. Severe scalding of patients


25. Maternal death due to post partum haemorrhage after elective Caesarean section.

The bolded ones would be more appropriate for the Emergency Department.

Input from CQC

What are Never Events?