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Nigel's surgery 21: Statutory notifications to CQC

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  • Organisations we regulate

GP 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.

For example, you do not need to notify us if a cancer patient with a terminal diagnosis died the week after an appointment for pain relieving medication. This is because the patient the disease took its predictive course, and the appointment for pain relief did not contribute to their death in any way.

Case studies

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

Example 1: prescribing error

Patient B is on a repeat prescription for morphine sulphate slow release tablets 10mg twice a day for chronic pain. B requests a prescription from his dispensing practice. In error, a prescription is issued for morphine sulphate slow release tablets 100mg twice a day. The practice dispenses the medication. Patient B’s wife, who looks after his medicines, gives her husband a 100mg tablet of morphine sulphate instead of a 10mg tablet. He takes 2 doses over the next day and his wife is unable to rouse him in the morning. He is admitted to hospital where he has a cardiac arrest and dies.

Is statutory notification to CQC required?

Yes.

  • Patient B died within a few days of receiving care from the practice when a prescribing error was made
  • the death was, or may have been, as a result of the care or how it was provided (the prescribing error). It could not be attributed to the course which his medical condition would naturally have taken if he had received appropriate care and treatment. (The patient’s chronic pain would not have led to his death had it not been for the prescribing error).

You must notify us as soon as possible.

Example 2: during a home visit

Patient C, a 65-year-old male, has mobility issues so is unable to attend the surgery for his annual flu vaccine. The practice arranges for a clinician to administer his vaccine on a home visit. The clinician checks that they have all the necessary equipment with them. Soon after the vaccine, C goes into anaphylactic shock. The clinician administers a dose of adrenaline (epinephrine) and calls for an ambulance, but C’s condition continues to deteriorate. The clinician gives a second dose of adrenaline, but the patient dies on scene after the paramedics arrive.

Is statutory notification to CQC required?

Yes. The clinician acted entirely appropriately and in line with guidance, yet the death:

  • occurred while the regulated activity was being provided (during the home visit), and
  • was the result of the regulated activity (the flu vaccine) being given.

You must notify us as soon as possible.

Example 3: myocardial infarction (heart attack)

Patient D has been diagnosed with ischaemic heart disease. D attends the GP surgery for a routine follow up appointment. Their review is satisfactory and no changes are made to D’s medication as a result of the appointment. 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 wouldn’t be necessary.

Example 4: serious injury

Patient E, an older gentleman, visits his surgery when the lift to the first-floor consultation room is out of order. He trips on an unsecured carpet edge while walking down the stairs and falls. E suffers a fractured hip.

Is statutory notification to CQC required?

Yes. The injury:

  • occurred in the surgery, while the services were being carried out in the delivery of the regulated activity, and
  • resulted in prolonged pain for the service user

You must notify us as soon as possible.

Example 5: injury outside the practice

Patient F, a frail, 89-year-old lady, falls in the road outside her GP practice. She has no obvious injuries, but a member of the public brings her into the surgery so a doctor can assess her.

Is statutory notification to CQC required?

No. The incident:

  • did not occur while the regulated activity was being provided, and
  • was not a result of the regulated activity
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, but they can delegate the task to an appropriate staff member.

You must still notify CQC of all applicable events even if you have informed your CCG.

Find out more

CQC notifications guidance for primary care providers

Nigel’s surgery 25: safeguarding adults at risk

Nigel’s surgery 33: safeguarding children

Last updated:
11 April 2019

 


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