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Dental mythbuster 11: Statutory notifications to CQC

Categories:
  • Organisations we regulate

Dental practices are legally obliged to notify CQC about certain changes, events and incidents that affect their service or the people who use it.

We consider whether providers have the systems and processes in place to correctly notify us under the safe and well-led key questions. The relevant key lines of enquiry (KLOEs) are:

  • S6.1 Do staff understand their responsibilities to raise concerns, to record safety incidents, concerns and near misses, and to report them internally and externally, where appropriate?
  • W6.6 Are there effective arrangements to ensure that data or notifications are submitted to external bodies as required?

The CQC (Registration) Regulations 2009 define which specific incidents, events and changes that affect a service or the people using it, we must be notified of. Most are simple changes to a providers’ registration status, for example, changes to:

  • name and/or address
  • contact details
  • statement of purpose
  • the registered person and/or a partner (or long-term absence)

You must also notify us about events such as deaths and other incidents. These examples illustrate cases that you must notify us of.

Notification of deaths

You do not need to notify us about every death of a registered patient.

You must notify us if the death occurred while you were actually providing care. For example:

  • while a patient was in consultation with a healthcare professional
  • while at your health centre, practice or surgery
  • during a home visit

Also, you must also notify us of deaths that occurred within two weeks of a clinical interaction with practice staff if the death:

  • was, or may have been, as a result of the care or how it was provided, and
  • could not be attributed to the course which the illness or medical condition would naturally have taken if the deceased had been receiving appropriate care and treatment.

Case studies

Types of scenarios where dental practices should notify us of a death.

Example 1: anaphylactic shock

Patient B, who has a severe allergy to latex, attends their local dental practice for the first time. While waiting in reception, patient B completes a questionnaire on their medical history. After the dentist, they see the hygienist who speaks to them before making an initial assessment of their teeth and gums. The hygienist wears latex gloves. Patient B suffers a serious allergic reaction and quickly goes into anaphylactic shock. The dentist administers a dose of epinephrine (adrenaline) and the team calls an ambulance. Patient B’s condition continues to deteriorate. The dentist gives a second dose of adrenaline, but patient B dies shortly after paramedics arrive

Is statutory notification to CQC required?

Yes.

  • Patient B died at the practice while the regulated activity was being provided (in consultation with the hygienist)
  • the death was as a result of the care or how it was provided (the hygienist failing to check the medical history form and wearing latex gloves to examine the patient, prompting a severe allergic reaction).

You must notify us as soon as possible.

Example 2: conscious sedation

Patient C attends the dental practice for a tooth extraction. C is nervous so the dentist recommends conscious sedation. The dentist administers midazolam but does not double check the dosage. Patient C is given an overdose of the drug. Patient C’s heart rate decreases before stopping altogether. The team calls an ambulance and begins life support, but C later dies. 

Is statutory notification to CQC required?

Yes. The death:

  • occurred while the regulated activity was being provided (while the patient was at practice receiving treatment for a root canal), and
  • was the result of the way the regulated activity (the administration of midazolam for the purposes of conscious sedation) was given.

You must notify us as soon as possible.

Example 3: myocardial infarction (heart attack)

Patient D has been diagnosed with ischaemic heart disease. They attend for a routine check-up. This is satisfactory and patient D needs no major treatment. Three days later, patient D suffers a heart attack and dies.

Is statutory notification to CQC required?

No:

  • the death did not take place while the regulated activity was being provided
  • although the death occurred within 2 weeks of the patient’s appointment, it was not the result of the regulated activity or how it was provided.

Notifications of other incidents

Regulation 18 specifies events or occurrences that affect the health, safety and welfare of people who use services which must be notified to CQC. These include:

  • a serious injury to a service user
  • abuse or allegations of abuse
  • incidents that are reported to or investigated by the police
  • any event that stops or may stop the registered person from running the service safely and properly.

The full list is in the text of the regulation.

We only need to be informed of an applicable incident if it:

  • took place whilst a regulated activity was being provided
  • may have been the result of the regulated activity or how it was provided

Case studies

Examples when a notification would and would not be necessary.

Example 4: serious injury or harm

Patient E visits the dental practice for a tooth extraction. The dentist talks patient E through the procedure before treatment and quickly scans the notes to identify the correct tooth. It is only afterwards that the dental nurse sees that a different patient’s notes were consulted. The wrong tooth has been removed. The dentist must now refer patient E to another service for remedial treatment.

Is statutory notification to CQC required?

Yes. The injury:

  • occurred in the practice, while the services were being carried out in the delivery of the regulated activity, and
  • resulted in changes to the structure of the patient’s body

You must notify us as soon as possible.

Example 5: serious injury or harm

Patient Y needs root canal treatment. During the procedure there is a leak of sodium hypochlorite. Patient Y suffers irreversible nerve damage and a loss of sensation on one side of the face.

Is statutory notification to CQC required?

Yes. The incident:

  • occurred while the regulated activity (the root canal treatment) was being provided at the practice, and
  • resulted in an impairment of the sensory functions of the service user which is not likely to be temporary
Example 6: abuse or allegations of abuse

Patient G, an older patient with dementia, attends the practice and needs an injection. On seeing the needle, she becomes highly agitated. The nurse attempts to calm the patient, but when that fails, forcibly restrains her to allow the injection. Patient G’s arm is bruised. Her son makes a formal complaint to the practice manager.

Is statutory notification to CQC required?

Yes. It is alleged that the abuse was committed by a member of staff at the practice during the carrying on of a regulated activity. You should notify us even if the abuse is alleged and not yet proven to have taken place.

You must notify us as soon as possible.

Example 7: suspicion of abuse

A mother visits with her 7-year-old daughter (patient N). N appears unkempt and is very dirty. During the examination, the clinician identifies bruising on the child’s face and neck. When asked about the bruising, patient N’s mother's response does not explain the cause. The clinician makes a referral to the local authority safeguarding children’s team.

Is statutory notification to CQC required?

No. The abuse:

  • is not alleged to have occurred whilst the regulated activity was being provided (while at the surgery), and
  • was not a result of the regulated activity.

Although we would not require a notification in this instance, the clinician must make sure that they follow the practice’s normal processes for safeguarding children.

Example 8: event temporarily stops the practice operating normally

Staff find the electricity supply has been cut off and the practice cannot operate as normal for more than 24 hours. Administrative staff use their mobile phones to contact all non-urgent patients booked for that day to rearrange their appointments. They arrange for all urgent patients to be seen at another local practice.

Is statutory notification to CQC required?

Yes. The practice has been prevented from providing the regulated activities as usual due to an interruption to the supply of a utility for a period of more than 24 hours.

You must notify us as soon as possible.

Example 9: event stops the practice operating normally

Extreme weather has flooded the practice and there is extensive damage to premises and equipment. The premises have to close for five months for refurbishment works. Partners work with neighbouring practices to make sure patients can be seen at alternative premises during this period.

Is statutory notification to CQC required?

Yes. The practice has been prevented from providing the regulated activities as usual.

You must to notify us as soon as possible.

If you are unsure whether to notify us of an incident, contact your inspector for advice.

How to make a notification

See our full list of notification forms. For each type of notification, there is:

  • an online form, you must use this if you have a CQC online account
  • a paper form to submit if you do not have an online account.

The ‘registered person’ must submit notifications. This is often the registered manager in the case of a partnership or Limited Company, but this task can be delegated to an appropriate staff member.

You must still notify CQC of all applicable events even if you have informed your CCG (for practices with an NHS contract).

Find out more

CQC notifications guidance for primary care providers

Last updated:
13 June 2019

 


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