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Independent Healthcare

Diagnostic imaging inspection

programme

Scope of the inspection programme

Modalities

• Magnetic Resonance Imaging (MRI)

• Computed Tomography (CT)

• Positron emission tomography computed tomography (PET-CT)

• Plain Film/ General/ Trauma & Acute

• Symptomatic breast imaging / mammography

• Fluoroscopy

• Nuclear Medicine (NM)

• Duel Energy X-ray Absorptiometry (DEXA/ DXA)

• Ultrasound (US)

• Mobile services

• Teleradiology services

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Scope of the inspection programme

• Total services approx. 380

• Approx 250 main modalities

• Baby scan services, diagnostic and keepsake/souvenir- approx. 85

• Endoscopy services – approx. 10

• To date we have completed 190 inspections

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Programme approach

• Project team with Head of Inspection, IH manager, regional link managers, designated inspectors in each team, policy team, IR(ME)R team, Academy, Pharmacy, Enforcement

• ED learning modules – 12 modalities mandatory for inspectors

• Advice on planning mobile and teleradiology services

• Face to face training and webinars for over 100 inspectors

• Query log

• Programme oversight

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Inspection approach

• Provider receives PIR which is designed for diagnostic imaging/endoscopy services.

• PIR letter explains the ‘ three month ‘window’ for inspection

• PIR returned and inspection planned

• Unannounced site visit unless fits criteria for short notice

• Site visit may include an inspector plus a specialist advisor

• Service specific frameworks for imaging and endoscopy services

• Feedback on the day followed by a feedback letter within two days

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Quality assurance and rating process

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1. Corroboration on site

2. Management review meetings to assess evidence for breaches

3. Review of draft report

4. Subsidiary Quality Assurance Group

5. Ratings characteristics as guidance

6. Outstanding and inadequate ratings to National Quality

Assurance Group

7. FAC to provider

8. FAC review response

9. If required, back to Quality group

10. Final report

11. Publication

https://www.cqc.org.uk/guidance-providers/independent-healthcare/your-

ratings-independent-healthcare-services

Our 5 key questions

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8

Outstanding

The service is performing exceptionally well.

Good

The service is performing well and meeting our

expectations.

Requires improvement

The service isn't performing as well as it should

and we have told the service how it must improve.

Inadequate

The service is performing badly and we've taken

action against the person or organisation that runs it.

What do the overall ratings mean?

Ratings

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• We have not rated Effective in any diagnostic imaging

services in line with our approach in NHS. We will review this

position.

• Caring has not been rated where services have no patient

contact such as teleradiology

• The majority of services have been rated as good

• Caring and responsive have been rated outstanding for some

services

• Level two QA panel for outstanding or inadequate ratings

chaired by Deputy Chief Inspector

Themes from inspections so far

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• Where we have found concerns these have resulted in

enforcement action through suspension and warning notices

• Some smaller services have lacked robust governance

systems either by the provider or local leadership

• Lack of appropriate safeguarding training and support

• Lack of assurance for recruitment and staff competence

• Lack of or limited risk assessments

Themes from inspections so far

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• We have seen much evidence of good standards and several

example of outstanding ratings in caring and responsive.

• Staff going the extra mile and exceeding expectations

• Adjusting to meet peoples needs e.g. MH, LD, claustrophobia,

area for prayer, adapting language and terminology

• Access to a registered midwife who specialised in bereavement

• Involving carers and external agencies such as care homes

when planning and preparing the scan

What has your experience of the inspections been

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Ionising Radiation -Regulations

IHPN

June 2019

Ionising Radiation

The use of ionising radiation in modern healthcare remains at the forefront of medicine in the diagnosis, monitoring and treatment of a wide variety of health conditions

40 million diagnostic imaging and nuclear medicine examinations were carried out on NHS patients in England

Growth of more than 8% in the last five years

NHS and independent sector

• Examples of medical exposures using ionising radiation:

Primary care: x-rays, dental, breast screening;

Hospital: X-ray, CT scans, nuclear medicine, radiotherapy treatment

Regulation of Ionising Radiation

A number of regulations to protect people against the dangers from exposure to ionising radiation

Ionising Radiation Regulations 2017

Occupational and Public Exposures

Ionising Radiation (Medical Exposure) Regulations 2017

Patient exposures

Radioactive Substances Regulation

Use of nuclear/radioactive materials in the environment

The Ionising Radiation Regulations 2017

Protection of staff and members of the public

Under IRR17 employers need to:

• ‘Register or consent’ prior to use (re-register under new regulations)

• Appoint a Radiation Protection Advisor

• Keep an up to date set of Local Rules

• Have suitable personal protective equipment available

• Monitor staff doses when advised

• Appoint Radiation Protection Supervisors

Ionising Radiation (Medical Exposure) Regulations 2017

Protection of patients

Under IR(ME)R17 employers need to:

• Appoint a Medical Physics Expert

• Notify the CQC of ‘significant accidental or unintended exposures’

• Keep an update set of Employer’s Procedures

• Have a routine programme of quality assurance of equipment

• Ensure referrers and practitioners are registered healthcare professionals

• Ensure staff are adequately trained

• Have licenses in place for the administration of radio-pharmeuticals

• Entitlement of duty holders

The IR(ME)R Team

• Group of clinical specialists, radiographers and clinical scientists

• Small team of 5 inspectors and 1 inspection manager

• Investigate notifications of ‘significant accidental or unintended exposures’

• Inspect providers to measure compliance with IR(ME)R

• Assist the CQC with policy and expert advice

• Maintain strong relationships with the radiology/therapy communities

• International work with IAEA and HERCA

IRMER@cqc.org.uk

IR(ME)R activity

Statutory Notifications -

• Previously investigated around 1000 a year

• New guidance released 3rd June which will reduce the number of low dose/low risk notifications by up to 50%

Inspections –

• Previously carried out around 15 a year

• Less notifications mean more inspections

• Not published

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IR(ME)R activity

Enforcement –

• Improvement Notices

• Prohibition Notices

• Published on our enforcement registry

Reports –

• Annual report

• Thematic report following inspection programmes

• Radiology review (not specifically IR(ME)R)

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Themes from IR(ME)R inspections

Areas of poor practice

• Unclear governance structure for radiation protection committees

• Insufficient MPE provision for high dose exams

• Failure to renew ARSAC licenses on time

• Not having full set of required procedures in place

• Poor oversight of radiation regulatory requirements in departments outside of the radiology/therapy settings

• Failure to maintain an equipment QA programme

Areas of good practice

• Approach to providing information on benefits and risks to pts

• Imbedding of Pause and check

• Detailed training records for equipment

• Hard work from staff in implementing two new sets of regulations in early 2018