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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
4
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
9
• 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
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