September 4, 2018

CQC

What is the CQC?

The Care Quality Commission is an Independent Regulator that is responsible for the Registration, Inspection and Enforcement of the standards of Health & Social Care in England.

What do they do?

The CQC Register and Inspect a wide variety of Health and Social Care Providers throughout England to ensure Patient Care standards are being met and maintained, this is done through regular visits and service monitoring. Where a service is failing to meet the standards, the CQC have the powers to restrict and even close a service depending on the level of failure.

As a Healthcare Provider, does Priority One Medical Services need to be registered?

The short answer is no, Priority One Medical Services is exempt from registration as our activities fall outside of scope.

How does Priority One Medical Services fall outside of scope?

Priority One Medical Services is an Event Medical Company that provides a variety of differently medically qualified staff to a wide variety of publicly attended events throughout the Northwest, we also provide staffed vehicles such as Ambulances and Responder Vehicles.

The 3 areas of the Scope of Registration that CQC would normally apply to a medical service of our type,

Transport services, triage and medical advice provided remotely.
Treatment of disease, disorder or injury.
Diagnostic and screening procedures.

The 3 sections are broken down below including our exemption

Transport services, triage and medical advice provided remotely, as taken from the Scope of Registration 2015

Regulated activity covers two main service types:

  • Transport (ambulance) services
  • Remote medical advice.

Transport Services are captured by this regulated activity where they involve a vehicle that was designed for the primary purpose of transporting people who require treatment. Transport services provided in vehicles that have a different primary purpose (such as taxis, volunteers using their private cars, or mortuary vehicles and Dial-A-Ride vehicles) are not captured in this regulated activity, even though they may be registered with the Driver and Vehicle Licensing Agency as ambulances. Search and rescue transport services are also currently exempt because the service is provided under arrangements made on people’s behalf by a government department.

Because it is the nature of the vehicles used that determines the need to register, transport services provided in ambulances operated by hospital providers will require registration, as well as transport services provided by ambulance only providers. The term ‘designed for’ will apply to vehicles used to transport people who require treatment not only where this was the manufacturer’s original design, but where a vehicle has been made suitable for this purpose (e.g. modification, livery, etc). Air ambulances and water ambulances are also included in this regulated activity. However, providers of air ambulances services are exempt from the activity where the aircraft used is registered with the Civil Aviation Authority and that same provider is not carrying out treatment to a patient. Air ambulance providers are also exempt if the transport is not carried out in England or if it is carried out under travel insurance arrangements. Refer back to ‘third party exemptions’ for further detail.   This regulated activity relates to transport but will not cover other activities that may be provided in or from a vehicle, such as ‘treatment of disease, disorder or injury’ or ‘diagnostic and screening procedures’.

Our view is that this regulated activity will normally cover routine, planned patient transport related to treatment.

The transport activity will not apply where a provider only uses a vehicle to transport a person within the confines of an event site. As an example, if a person attending or participating in a sporting event requires treatment, and as such, is carried in a vehicle from one part of the event ground to another, then registration for that transport is exempt. However, if the same situation arose and the person was carried from the event ground to hospital, then registration will be required.

We will take a proportionate and reasonable approach if emergency, unplanned treatment in this context includes some aspects of other regulated activities on an exceptional basis (such as ‘diagnostic and screening procedures’, ‘surgical procedures’ or ‘maternity and midwifery services’). We will also take a proportionate and reasonable approach if, in exceptional circumstances, a provider transports a patient outside an event ground and ordinarily would not consider or plan to do this.

Some ambulance providers may also need to register for the regulated activity of ‘treatment of disease, disorder or injury’. For example, where they employ health care professionals and ordinarily carry out treatment.

Where procedures are carried out, such as emergency tracheotomy, insertion of a chest drain or intubation, for the purpose of registration these would be considered as treatment for disease, disorder or injury, not as the regulated activity of ‘surgical procedures’.

Where procedures that require specialist surgical training and equipment are an expected part of the service, for example, thoracotomy or amputation, we regard these as constituting the regulated activity of ‘surgical procedures’. Therefore, providers that are equipped, and expect to carry out such procedures must register for that activity. However, if a provider carries out emergency procedures unexpectedly, we would be proportionate and would not regard this as committing an offence where they are not separately registered for ‘surgical procedures’.

Providers registering for this activity will not have to additionally register for the regulated activity of ‘diagnostics and screening procedures’ if they only carry out the following diagnostic procedures along with transport:

  • 12-lead ECG.
  • Use of an AED.
  • Pulse Oximetry.
  • Use of a Sphygmomanometer.
  • The analysis of urine or stool samples by means of dip stick or another reagent.
  • Taking blood, urine samples or swab specimens.

Remote advice is a regulated activity when:

  • The advice is medical, and
  • It is responsive, i.e. for immediate attention or action (as opposed to, for example, a service in which a person electronically submits questions to a provider who provides responses at some later time, or when a person seeks general health care or lifestyle advice), or
  • It constitutes triage (see glossary), and
  • It is provided over the telephone or by electronic mail, and
  • It is provided by a body established for that purpose (as opposed to, for example, the occasional provision of advice by a body such as a hospital or university on an informal basis). The second consideration above means that:
  • NHS Direct and any other organisation established for the purpose of providing telephone or internet-based medical advice where immediate action or attention is needed, or triage provided will be covered.
  • Ambulance control centres will be covered where they provide triage by means of telephony service

 

Priority One Medical Services falls out of scope as under Paragraph 5 and 6 we do not offer or maintain a conventional ambulance service and we do not transport casualties off site or conduct planned Patient Transport operations.

Should a casualty need emergency and immediate medical care or transport off site, our default action will be to enlist the services of county NHS ambulance services.

In the unlikely event that this service is unavailable, and the casualty is time critical in nature, Priority One Medical may transport in a one off circumstance to an appropriate hospital with the agreement of the Duty Manager, the attending ambulance crew and NHS ambulance control.

This is not a normal service provided by Priority One Medical and transport would only be carried out in exceptional circumstances on a case-by-case basis.

Our vehicles are kitted to full A&E standards and crewed by NON-HPC fully qualified and experienced personnel, should the need arise to convey a casualty to hospital due to life threatening conditions or injuries, we have the capability to do so.

Treatment of disease, disorder or injury as taken from the Scope of Registration 2015

This activity covers a treatment service that is:

  1. a) provided by a health care professional (see list in glossary), or a social worker in the case of mental health treatment, or by a multi-disciplinary team that includes a listed health care professional, or social worker where the treatment is for a mental disorder, and is

 

  1. b) related to disease, disorder or injury. It includes a wide range of treatment, such as, but not limited to, emergency treatment, ongoing treatment for long-term conditions, treatment for a physical or mental health condition or learning disability, giving vaccinations/immunisations, and palliative care.

This regulated activity applies to the treatment of disease, disorder or injury in any setting, for example hospitals, clinics, hospices, ambulances, community services, and care homes.

What is included in this regulated activity?

  • Any treatment that is for the treatment of a disease disorder or injury.

What is excluded from this regulated activity?

  • Purely cosmetic interventions.
  • Most alternative and complementary therapy.
  • First aid where it is delivered by: – Health care professionals in unexpected or potentially dangerous situations requiring immediate action. –  Non-health care professionals who are trained to deliver such treatment.
  • Treatment provided in a sports ground or gymnasium (for people taking part in, or attending, sporting activities or events).
  • Treatment provided through temporary arrangements for sporting or cultural events (such as festivals, championship sporting events or motor sport events).
  • Hyperbaric oxygen therapy provided to workers in connection with their work or when governed by the Diving at Work or Work in Compressed Air regulations.
  • Activities authorised by a license granted by the Human Fertilisation and Embryology authority.

Sometimes, ‘treatment of disease, disorder or injury’ is provided as a minor component of a service – for example, a large care home that has just a few intermediate care or specialist palliative care beds. ‘Treatment of disease, disorder or injury’ if carried out by or under supervision of a listed health care professional will still require registration in its own right and in addition to any other activities that the provider may need to register for that service.

First aid is:

  • The initial response to a sudden illness, condition or injury or exacerbation of an existing illness.
  • Restricted to the aim of either alleviating it immediately through simple procedures and/or preventing it worsening until professional medical help is available.

First aid may include simple non-invasive physiological monitoring techniques carried out as part of the overall first aid care and be provided by lay people or health care professionals.

In the case of health care professionals, they will not rely upon broader knowledge and skills developed through professional training but will use only skills and knowledge that are to be reasonably expected of a person having received recognised training in first aid.

Our view is that:

  • A first aid service may involve health care professionals, but only where they are acting only in their capacity as a first aider. For example, they are not prescribing, following a patient group directive, using specialist drug administration techniques, or using other specialist skills that reflect their professional training rather than their first aid training.
  • A first aid service may involve simple procedures for assessment that do not require a recognised professional diagnostic qualification (e.g. as a radiographer or sonographer) and that are limited in their purpose to assessing the need for onward referral for treatment. This includes use of a 2- or 12-lead ECG, automated non-invasive blood pressure measurement, pulse oximeter, use of a thermometer, sphygmomanometer or ophthalmoscope.

Priority One Medical Services falls out of scope as the majority of its staff are non-HCPs and are working within the “Treatment provided in a sports ground or gymnasium (for people taking part in, or attending, sporting activities or events)” or the “Treatment provided through temporary arrangements for sporting or cultural events (such as festivals, championship sporting events or motor sport events)” exclusions.  Any HCP who attends an event does so as a Non-HCP unless an unexpected and potentially dangerous situation occurs requiring immediate action as defined.

Diagnostic and screening procedures, as taken from the Scope of Registration 2015

This regulated activity includes a wide range of procedures related to diagnostics, screening and physiological measurement.

All diagnostic procedures involving the use of any form of radiation (including x-ray), ultrasound or magnetic resonance imaging to examine the body are included. This will include all main forms of diagnostic radiology, radiography and sonography (including antenatal ultrasound scans), but it will not include use of the same technology for therapeutic purposes such as radiotherapy or some forms of interventional radiology (those will require registration for the activity of ‘treatment of disease, disorder or injury’). The activity also includes the analysis and reporting of the examinations that are carried out.

If the provider using the x-ray, ultrasound or magnetic resonance imaging is the same provider who is carrying out the analysis and reporting, then this may be included within a single registration; if a remote contractor is used for diagnostic analysis, the analysis and reporting will require registration in its own right.

Where diagnostic images are reported remotely by a subcontracted provider who is outside England, the subcontractor will not be registerable as they fall outside of CQC’s remit. However, we will hold to account the registered provider who made the contract with the subcontractor for the way the service is delivered and to make sure that there are appropriate arrangements for the service to be delivered, including arrangements for quality assurance.

The activity includes many, if not all, forms of endoscopy because it captures procedures if they involve the use of:

  • Instruments or equipment, which are inserted into the body to:

– view inside of the body, or

– gather physiological data.

The activity includes instances of taking a sample or biopsy because it captures procedures if they involve removal of tissue, cells or fluids from the body, for the purpose of diagnosing disease, disorder or injury or monitoring its cause or extent. Therefore, anyone who ‘removes’ tissue, cells or fluids from the body for diagnostic reasons must register.

The activity also includes anyone who uses equipment to examine tissue, cells or fluids from the body to obtain information on the cause and extent of a disease, disorder or injury. If the provider removing the sample is the same provider who is carrying out the examination then this may be included within a single registration; if a remote contractor is used for diagnostic analysis, such as a laboratory company, the analysis will also require registration in its own right.

There are a number of exclusions that apply to this activity, which are set out further on in this section.

This regulated activity also includes physiological measurement; that is the use of equipment to measure or monitor physiological data in relation to the following systems:

  • audio-vestibular
  • vision
  • neurological
  • cardiovascular
  • respiratory
  • gastro-intestinal system, or
  • urinary system

for the purposes of obtaining information on the causes and extent of a disease, disorder or injury, or the response to a therapeutic intervention, where such information is needed for the purposes of the planning and delivery of care or treatment.

Physiological measurement diagnostic services provide a wide range of specialist investigations and procedures that are often an essential part of care and treatment for patients. Physiological measurement includes not only assessment of the function of major organ systems, but also measurement and tests that are part of normal clinical care when carrying out other regulated activities that a provider will already be registered for under the Health and Social Care Act 2008 (HSCA).

Exclusions The following physiological tests are not included within the definition of physiological measurement and so will not lead to registration for this regulated activity:

  • 12 lead electrocardiograph recording (ECG).
  • Pulse oximetry when used for ‘spot’ recording.
  • Peak expiratory flow measured by a peak flow meter.
  • Screening or non-diagnostic spirometry.
  • Non-ambulatory blood pressure recording.
  • Use of an auroscope.
  • Carrying out a hearing needs assessment or supply and fitting of a hearing aid carried out by a hearing aid dispenser or a person acting under the direction or supervision of a hearing aid dispenser, where:
  1. a) The person is aged 19 or over, or
  2. b) The person is under 19 and the procedure is carried out in, or arranged by, a school or 16-19 Academy.

The following procedures are also excluded from this activity:

  • Procedures carried out for research or analysing and reporting such procedures. However, this exemption only applies where those research procedures do not form part of a person’s care or treatment. As an example, a university that has an imaging department would only be required to register with us if they carry out a radiological examination as part of the care of a patient. This is because such procedures would be part of a person’s treatment pathway. They would not be required to register with us if they restricted their examinations to research exposures on subjects or for teaching purposes using ‘phantoms’.
  • The national cancer screening programmes are excluded. However, other national screening programmes are not excluded and must register if they are providing any aspect of the regulated activity.
  • The taking of x-rays by registered chiropractors or the use of ultrasound by registered physiotherapists.
  • Fitness screening procedures in a gymnasium, related to the use of fitness equipment or fitness activities, (treadmill tests for clinical purposes, however, are not exempt).
  • Blood tests carried out by means of a pin prick test or removing blood from a vein where the sample is not sent to a laboratory for analysis.
  • Taking urine samples where the sample is not sent to a laboratory to be analysed.
  • The sending of samples of body fluids to a place to be analysed, where the samples are not collected or taken by the provider. For example, when a person produces a urine sample and the provider sends it away to be tested.
  • Procedures carried out by a person in connection with any of the activities authorised by a licence granted by the Human Fertilisation and Embryology Authority.
  • The taking or analysing of samples of tissue, cells or fluids in order to determine the existence of a genetically inherited disease or disorder, or to determine the influence of an individual’s genetic variation on a drug response.

However, such tests are not exempt if carried out as part of:

  1. a) the planning or delivery of the individual’s treatment or care, or
  2. b) a national screening programme other than a national cancer screening programme.

Priority One Medical Services only uses physiological measurement tests as described under the Exclusions, such as ECG, Pulse Oximetry and blood pressure, no other regulated Diagnostic and screening procedures take place and is there for out of scope of registration.

We have confirmed with the CQC that we do not need to register as all our activities fall outside of scope.

 So, will Priority One Medical Services Register with the CQC?

We have spoken to the CQC several times and our activities are not within their scope of registration and we have been told that for the time being, we do not need to register. However Yes, there are plans in place to do the formal registration and will be acted upon as soon as possible within the business plan.

For further reference and the full scope of registration document by the CQC, please go to https://www.cqc.org.uk/sites/default/files/20151230_100001_Scope_of_registration_guidance_updated_March_2015_01.pdf