Cobalt Health NewApproachComprehensive Report ... · The service provides diagnostic imaging...

This report describes our judgement of the quality of care at this location. It is based on a combination of what wefound when we inspected and a review of all information available to CQC including information given to us frompatients, the public and other organisations

Ratings

Overall rating for this location Good –––

Are services safe? Requires improvement –––

Are services effective?

Are services caring? Good –––

Are services responsive? Outstanding –

Are services well-led? Good –––

CobCobaltalt HeHealthalthQuality Report

Cheltenham Imaging Centre,Linton House Clinic,Thirlestaine Road,Cheltenham,Gloucestershire.GL53 7ASTel: 01242 535910Website: https://www.cobalthealth.co.uk

Date of inspection visit: 9, 10 and 17 July 2019Date of publication: 18/09/2019

1 Cobalt Health Quality Report 18/09/2019

Letter from the Chief Inspector of Hospitals

Cobalt Health is operated by Cobalt Health and provides services to patients across Gloucester, Hereford and Worcester.The Cobalt Imaging Centre in Cheltenham opened in 2006. The centre provides Positron emissiontomography–computed tomography (PET/CT) (a nuclear medicine technique), Computed Tomography (CT), Cone BeamComputed Tomography (Cone beam computed tomography is a medical imaging technique consisting of X-raycomputed tomography where the X-rays are divergent, forming a cone), 3.0T Magnetic Resonance Imaging (MRI)(medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of thebody), high field open MRI, ultrasound and digital radiography. The service also provides a fleet of six mobile MRIscanners and one mobile CT scanner which are located in various regions across the UK. Cobalt Health also providesconsultation rooms for orthopaedic surgeons to facilitate a one-stop service for outpatients, with diagnostic imagingcarried out during the consultation.

The service provides diagnostic imaging services for children under the age of 18 years of age and adults.

We visited the clinical imaging centre in Cheltenham and six mobile units. Cobalt Health also provides a satellite serviceat The Institute of Translational Medicine Imaging Centre at the Queen Elizabeth Hospital (QEH) in Birmingham. This is asatellite MRI facility supporting a wide range of research and clinical service for the QEH. However, this location was notinspected during this inspection as it was recently inspected in January 2019 and rated good.

We inspected this service using our comprehensive inspection methodology. We carried out the announced part of theinspection on 9, 10 and 17 July 2019.

To get to the heart of patients’ experiences of care and treatment, we ask the same five questions of all services: are theysafe, effective, caring, responsive to people's needs, and well-led? Where we have a legal duty to do so we rate services’performance against each key question as outstanding, good, requires improvement or inadequate.

Throughout the inspection, we took account of what people told us and how the provider understood and compliedwith the Mental Capacity Act 2005.

Services we rate

We rated it as Good overall.

• The service provided mandatory training in key skills. Staff understood how to protect patients from abuse and theservice worked well with other agencies to do so

• The risk of infection was managed well. Staff used equipment and control measures to protect patients, themselvesand others from infection. They kept equipment and the premises visibly clean. The design, maintenance and use offacilities and premises kept people safe.

• Staff completed and updated risk assessments for each patient and removed or minimised risks.• There were sufficient numbers of staff with the necessary skills, experience and qualifications to meet patients’

needs. The service made sure staff were competent for their roles. Managers appraised staff’s work performance.• The service managed patient safety incidents well. Staff recognised and reported incidents and near misses.

Managers investigated incidents and shared lessons learned with the whole team and the wider service.• The service provided care and treatment based on national guidance and evidence-based practice. Managers

checked to make sure staff followed guidance.• Staff monitored the effectiveness of care and treatment in line with contractual arrangements with commissioners.

The service had been accredited under relevant clinical accreditation schemes.• Staff treated patients with compassion and kindness, respected their privacy and dignity, provided emotional

support to patients, and supported and involved patients, families and carers to understand their condition andmake decisions about their care and treatment.

Summary of findings


• The service planned and provided care in a way that was tailored to the needs of local people and the communitiesserved. It also worked with others in the wider system and local organisations to plan care. People could access theservice when they needed it and received the right care promptly. Waiting times from referral to treatment andarrangements to admit, treat and discharge patients were exceeding national standards.

• Leaders had the integrity, skills and abilities to run the service. They understood and managed the priorities andissues the service faced. They supported staff to develop their skills and take on more senior roles.

• Staff felt respected, supported and valued. They were focused on the needs of patients receiving care.• All staff were committed to continually learning and improving services. They had a good understanding of quality

improvement methods and the skills to use them. Leaders encouraged innovation and participation in research.

However, we found the following issues that the service provider needs to improve:

• Patient group directions used by the service did not have the required authorisation as recommended by nationalguidance.

• Risk assessments were not always documented to provide an audit trail behind the rational for the decision.• Daily cleaning records were not maintained to demonstrate cleaning had taken place.• There was limited documentation regarding additional patient care carried out by the service.• Further work around audit was required as there was not always a formal process to identify the actions required to

make the necessary improvements where audits had not met required targets.• There were limited risks associated with children attending the service on the risk register.• We were not assured that risks were being regularly reviewed and discussed and that mitigating actions were being

acted on. It was unclear whether actions associated with risk mitigation had been completed and implemented.• Meeting minutes did not always identify the depth and detail behind discussions held.• There was no evidence to demonstrate that recommendations from the staff survey had been acted on or

implemented.

We also found areas of outstanding practice:

• Staff worked closely with the referring NHS trust to carry out additional scans when significant findings wereidentified. This prevented patients from having to return to the service for additional scans which could lead to adelay in accessing treatment.

• The provider offered 800 free scans to support the local NHS trust to meet demand and ensure timely diagnosticscans for patients.

• Cobalt Health provided facilities free of charge for the local NHS trust to carry out ‘one stop’ clinic for patients referredfor musculoskeletal complaints. Patients could receive scans and advice or treatment without the need for furtherwaiting to attend for scans.

• Cobalt Health provided facilities free of charge to accommodate a breast screening service provided by the local NHStrust to help them meet demand.

• Following this inspection, we told the provider that it must take some actions to comply with the regulations and thatit should make other improvements, even though a regulation had not been breached, to help the service improve.We also issued the provider with two requirement notices. Details are at the end of the report.

Nigel Acheson

Deputy Chief Inspector of Hospitals (South Region)

Overall summary

Cobalt Health is operated by Cobalt Health and providesservices to patients across Gloucester, Hereford and

Worcester. The Cobalt Imaging Centre in Cheltenhamopened in 2006. The centre provides Positron emission

Summary of findings


tomography–computed tomography (PET/CT) (a nuclearmedicine technique), Computed Tomography (CT), ConeBeam Computed Tomography (Cone beam computedtomography is a medical imaging technique consisting ofX-ray computed tomography where the X-rays aredivergent, forming a cone), 3.0T Magnetic ResonanceImaging (MRI) (medical imaging technique used inradiology to form pictures of the anatomy and thephysiological processes of the body), high field open MRI,ultrasound and digital radiography. The service alsoprovides a fleet of six mobile MRI scanners and onemobile CT scanner which are located in various regionsacross the UK. Cobalt Health also provides consultationrooms for orthopaedic surgeons to facilitate a one-stopservice for outpatients, with diagnostic imaging carriedout during the consultation.

The service provides diagnostic imaging services forpatients over the age of 18.

We visited the clinical imaging centre in Cheltenham andsix mobile units. Cobalt Health also provides a satelliteservice at The Institute of Translational Medicine ImagingCentre at the Queen Elizabeth Hospital (QEH) inBirmingham. This is a satellite MRI facility supporting awide range of research and clinical service for the QEH.However, this location was not inspected during thisinspection as it was recently inspected in January 2019and rated good.

We inspected this service using our comprehensiveinspection methodology. We carried out the announcedpart of the inspection on 9, 10 and 17 July 2019.

To get to the heart of patients’ experiences of care andtreatment, we ask the same five questions of all services:are they safe, effective, caring, responsive to people'sneeds, and well-led? Where we have a legal duty to do sowe rate services’ performance against each key questionas outstanding, good, requires improvement orinadequate.

Throughout the inspection, we took account of whatpeople told us and how the provider understood andcomplied with the Mental Capacity Act 2005.

Services we rate

We rated it as Good overall.

• The service provided mandatory training in key skills.Staff understood how to protect patients from abuseand the service worked well with other agencies to doso.

• The risk of infection was managed well. Staff usedequipment and control measures to protect patients,themselves and others from infection. They keptequipment and the premises visibly clean. The design,maintenance and use of facilities and premises keptpeople safe.

• Staff completed and updated risk assessments foreach patient and removed or minimised risks.

• There were sufficient numbers of staff with thenecessary skills, experience and qualifications to meetpatients’ needs. The service made sure staff werecompetent for their roles. Managers appraised staff’swork performance.

• The service managed patient safety incidents well.Staff recognised and reported incidents and nearmisses. Managers investigated incidents and sharedlessons learned with the whole team and the widerservice.

• The service provided care and treatment based onnational guidance and evidence-based practice.Managers checked to make sure staff followedguidance.

• Staff monitored the effectiveness of care andtreatment in line with contractual arrangements withcommissioners. The service had been accreditedunder relevant clinical accreditation schemes.

• Staff treated patients with compassion and kindness,respected their privacy and dignity, providedemotional support to patients, and supported andinvolved patients, families and carers to understandtheir condition and make decisions about their careand treatment.

• The service planned and provided care in a way thatmet the needs of local people and the communitiesserved. It also worked with others in the wider systemand local organisations to plan care. People couldaccess the service when they needed it and receivedthe right care promptly. Waiting times from referral totreatment and arrangements to admit, treat anddischarge patients were exceeding national standards.

• Leaders had the integrity, skills and abilities to run theservice. They understood and managed the prioritiesand issues the service faced. They supported staff todevelop their skills and take on more senior roles.

Summary of findings


• Staff felt respected, supported and valued. They werefocused on the needs of patients receiving care.

• All staff were committed to continually learning andimproving services. They had a good understanding ofquality improvement methods and the skills to usethem. Leaders encouraged innovation andparticipation in research.

However, we found the following issues that the serviceprovider needs to improve:

• Patient group directions used by the service did nothave the required authorisation as recommended bynational guidance.

• Risk assessments were not always documented toprovide an audit trail behind the rational for thedecision.

• Daily cleaning records were not maintained todemonstrate cleaning had taken place.

• There was limited documentation regarding additionalpatient care carried out by the service.

• Further work around audit was required as there wasnot always a formal process to identify the actionsrequired to make the necessary improvements whereaudits had not met required targets.

• There were limited risks associated with childrenattending the service on the risk register.

• We were not assured that risks were being regularlyreviewed and discussed and that mitigating actionswere being acted on. It was unclear whether actionsassociated with risk mitigation had been completedand implemented.

• Meeting minutes did not always identify the depth anddetail behind discussions held.

• There was no evidence to demonstrate thatrecommendations from the staff survey had beenacted on or implemented.

We also found areas of outstanding practice:

• Staff worked closely with the referring NHS trust tocarry out additional scans when significant findingswere identified. This prevented patients from having toreturn to the service for additional scans which couldlead to a delay in accessing treatment.

• The provider offered 800 free scans to support thelocal NHS trust to meet demand and ensure timelydiagnostic scans for patients.

• Cobalt Health provided facilities free of charge for thelocal NHS trust to carry out ‘one stop’ clinic forpatients referred for musculoskeletal complaints.Patients could receive scans and advice or treatmentwithout the need for further waiting to attend forscans.

• Cobalt Health provided facilities free of charge toaccommodate a breast screening service provided bythe local NHS trust to help them meet demand.

Following this inspection, we told the provider that itmust take some actions to comply with the regulationsand that it should make other improvements, eventhough a regulation had not been breached, to help theservice improve. We also issued the provider with tworequirement notices. Details are at the end of the report.

Summary of findings


Our judgements about each of the main services

Service Rating Summary of each main service

Diagnosticimaging

Good –––

The service provided diagnostic and imagingservices through the provision of a number ofdiagnostic imaging modalities for both NHS andprivate patients.We rated this service as good because caring and wellled were good. Responsive was outstanding, howeversafe required improvement.

Summary of findings


Contents

PageSummary of this inspectionBackground to Cobalt Health 9

Our inspection team 9

Information about Cobalt Health 9

The five questions we ask about services and what we found 11

Detailed findings from this inspectionOverview of ratings 15

Outstanding practice 39

Areas for improvement 39

Action we have told the provider to take 40

Summary of findings


Cobalt Health

Services we looked atDiagnostic imaging

CobaltHealth

Good –––


Background to Cobalt Health

Cobalt Health is operated by Cobalt Health. The CobaltImaging Centre opened in Cheltenham in 2006. Theservice also has a fleet of mobile units which are locatedin different regions around the UK.

The service has had a registered manager in post since2011.

Cobalt Health is registered to provide the regulatedactivity:

• Diagnostic and screening procedures

• Treatment of disease, disorder and injury

Our inspection team

The team that inspected the service comprised a CQClead inspector, one other CQC inspector, and a specialistadvisor with expertise in diagnostic imaging. Theinspection team was overseen by Mary Cridge, Head ofHospital Inspections.

Information about Cobalt Health

Cobalt Health provides diagnostic imaging services at itsimaging centre in Cheltenham providing services acrossGloucestershire, Hereford and Worcestershire. The servicealso has a fleet of mobile units, including six MRI scannersand one CT scanner which are located across differentregions in the UK. The service is commissioned through alocal NHS hospital trust, NHS specialised commissioning,a local Clinical Commissioning Group and the NHSSupply Chain Framework Agreement. The service also hasa service level agreement with a London mental healthtrust to provide open scanning for claustrophobicpatients. Just over 60% of the work carried out by CobaltHealth across all modalities was for NHS patients. Theremaining 40% was carried out on privately fundedpatients or funded via research.

During the inspection, we visited the imaging centre inCheltenham and six the mobile units. We spoke with 28staff including radiographers, administration staff, andsenior managers. We spoke with eight patients and onerelative.

There were no special reviews or investigations of theservice ongoing by the CQC at any time during the 12

months before this inspection. The service has beeninspected once previously in 2013. The inspection foundthe service was meeting all standards of quality andsafety it was inspected against.

Activity (June 2018 to June 2019)

• 10,727 patients were seen at the imaging centre forMRI. Of these patients, 162 patients were under 18years of age which equated to 1.5% of the number ofpatients who had attended the centre for MRI over theyear.

• 3,105 patients were seen in PET/CT at the imagingcentre. Of these, five patients were under 18 years ofage. This equated to 0.2% of the patients seen acrossthe year.

• It is estimated that about 39,000 scans were carriedout on the mobile units between this time period. Thenumber is not definitive because Cobalt do not keep arecord of activity when the mobile unit is booked by anNHS trust as the data is held on their computersystems. This data belongs to the trust and is reportedon nationally.

Track record on safety between April 2018 and April 2019:

• 0 Never events

Summaryofthisinspection

Summary of this inspection


• 0 serious incidents• 31 Complaints

Services accredited by a national body:

• Quality Standard for Imaging (QSI) (October 2018)formally Imaging Services Accreditation Scheme (ISAS)

• ISO 9001:2015 quality management standard (October2018)




The five questions we ask about services and what we found

We always ask the following five questions of services.

Are services safe?We rated it as Requires improvement because:

We found the following issues that the service provider needs toimprove:

• Patient Group Direction (PGDs) were in use without therequired authorisation to enable their use.

• Daily cleaning records were not maintained to demonstratecleaning had taken place.

• Individual risk assessments for people attending the servicewere not always documented, therefore there was no record ofthe rationale behind decisions made and actions taken.

• There was limited documentation regarding additional patientcare carried out by the service.

However, we found the following areas of good practice:

• Staff received effective mandatory training in the safetysystems, processes and practices.

• There were systems, processes and practices essential to keeppatients safe from abuse, and staff understood theirresponsibilities to report safeguarding incidents.

• Infection risks were controlled.• The design, maintenance and use of facilitates prevented

patients from avoidable harm.• Comprehensive risk assessments were carried out for patients

using the service.• There were sufficient numbers of staff with the necessary skills,

experience and qualifications to meet patients’ needs.• Arrangements for managing radioactive medicines protected

patients from avoidable harm.• There was an effective system in place for reporting incidents.

Staff understood their responsibilities to raise concerns, torecord safety incidents, concerns and near misses.

Requires improvement –––

Are services effective?We do not currently rate effective for diagnostic services due toinsufficient data being available to rate these services’ effectivenessnationally.

We found the following areas of good practice:

• Relevant and current evidence-based guidance, standards, bestpractice and legislation were used to identify and develop howservices and care were delivered.




• Patients had access to food and drink at the imaging centre inCheltenham.

• The effectiveness of care and treatment was in line withcontractual arrangements with commissioners.

• Staff had the right qualifications, skills, knowledge andexperience to do their job.

• Staff worked as a team to benefit patients.• Staff understood the relevant consent and decision-making

requirements of legislation and guidance, including the MentalCapacity Act 2005.

Are services caring?We rated it as Good because:


• Patients were treated with kindness, dignity and respect. Thiswas reflected in feedback we received from patients and fromthe way staff interacted with patients.

• Patients received information in a way they understood and feltinvolved in their care. Patients were always given theopportunity to ask staff questions, and patients felt comfortabledoing so.

• Staff were aware of the needs of patients attending the serviceand how scan-related anxiety could impact on patientsreceiving their diagnosis and a treatment delay. Staff weresupportive of anxious or distressed patients.

Good –––

Are services responsive?We rated it as Outstanding because:


• The service planned and provided care in a way which wastailored to meet the needs of local people and the communitiesserved.

• The involvement of other organisations and the localcommunity was integral to how services were planned. Theservice worked with local partners to increase their capacity toimprove patient experience and support system-wide working.

• Patients individual needs were central to the planning anddelivery of tailored services. Patients could access serviceseasily, appointments were flexible and waiting times short.

• The services provided reflected the individual needs of thepopulation served and ensured flexibility, choice and continuityof care.

Outstanding –




• The service was performing highly with waiting times fromreferral to treatment and data demonstrated the serviceexceeding national standards.

• Staff worked closely with the referring NHS trust to carry outadditional scans when significant findings were identified. Thisprevented patients from having to return to the service foradditional scans which could lead to a delay in accessingtreatment.

• The provider offered 800 free scans to support the local NHStrust to meet demand and ensure timely diagnostic scans forpatients.

• Cobalt Health provided facilities free of charge for the local NHStrust to carry out ‘one stop’ clinic for patients referred formusculoskeletal complaints. Patients could receive scans andadvice or treatment without the need for further waiting toattend for scans.

• Cobalt Health provided facilities free of charge toaccommodate a breast screening service provided by the localNHS trust to help them meet demand.

• Patients we spoke with told us they knew how to make acomplaint or raise concerns about the service. Complaints wereresponded to in a timely way.

Are services well-led?We rated it as Good because:


• Leaders had the skills, knowledge, experience and integrity tomanage the service and understood the challenges toproviding high quality sustainable care.

• There was a clear vision with quality and safety as the toppriorities.

• Staff felt respected, supported and valued and were focused onthe needs of patients receiving care.

• Electronic patient records were kept secure to preventunauthorised access to data.

• The service gathered patients’ views and experiences

However, we found the following issues that the service providerneeds to improve:

• Not all staff were clear about the values of the service.• There was not always a formal process to identify the actions

required to make the necessary improvements where auditshad not met required targets.

• Meeting minutes did not always provide detail around thediscussions held.

Good –––




• It was unclear whether actions associated with risk mitigationhad been completed and implemented and we were not assurerisks were regularly reviewed and discussed.

• There was no evidence to demonstrate that recommendationsfrom the staff survey had been acted on or implemented.




Overview of ratings

Our ratings for this location are:

Safe Effective Caring Responsive Well-led Overall

Diagnostic imaging Requiresimprovement N/A Good Good Good

Overall Requiresimprovement N/A Good Good Good

Detailed findings from this inspection


Safe Requires improvement –––

Effective

Caring Good –––

Responsive Outstanding –

Well-led Good –––

Are diagnostic imaging services safe?

Requires improvement –––

Safe means the services protect you from abuse andavoidable harm.

We rated safe as requires improvement.

Mandatory training

• The service provided mandatory training in keyskills. Staff completed mandatory training in safetysystems, processes and practices. Mandatory trainingwas completed in a number of subject areas including,but not limited to, basic life support, immediate lifesupport, equality and diversity training, consent, mentalcapacity and information governance. In addition, staffreceived training on radiation risks where this waspertinent to their role.

• Mandatory training records for staff were heldelectronically by the central team and each member ofstaff also had access to the mandatory training record.The training matrix identified when each staff memberhad completed and were due to refresh their mandatorytraining. The service did not keep records of compliancewith mandatory training for radiologists working underpracticing privileges. Documentation stated radiologistswere up-to-date with their mandatory training andregular updates at the time of the appraisal but did notinclude the date training was completed.

• Mandatory training was completed mostly electronicallyvia e-learning. There was also one face-to-face daywhich staff had to attend on a yearly basis. The agendafor this day was adapted each year according to thetraining needs of the staff. Mandatory training was

reviewed over a fixed year period. For the year fromJanuary to December 2018 there was 86% compliancewith face-to-face mandatory training against a 100%target. E-learning training records showed the largemajority of the 87 staff had completed their e-learningtraining. Only four staff were out of date with equalityand diversity training, three with health, safety andwelfare and two with patient consent training. Staffspoke positively of the content and quality of themandatory training available to them.

• The service had come to an agreement with staff toensure e-learning training was completed in a timelyway. Due to the demand for the service, staff did notusually have time in their working day to completetraining. Recognising this, the senior team now allowedstaff to complete mandatory training at home and paidstaff to do this. This ensured staff remained compliantwith mandatory training.

• There were processes to ensure relevant safety checkswere carried out when agency staff were called in to fillrota gaps. The service checked references andqualifications, professional registration, enhanceddisclosure and barring service (DBS), originalidentification documentation and mandatory trainingcertification.

Safeguarding

• Staff understood how to protect patients fromabuse and the service worked well with otheragencies to do so. Staff had training on how torecognise and report abuse, and they knew how toapply it. There were systems and processes reflectingrelevant safeguarding legislation to safeguard adults.The service had a protection of vulnerable adults’ policyand safeguarding children policy available for staff. Thepolicy outlined the responsibilities of the staff in

Diagnosticimaging

Diagnostic imaging

Good –––


reporting concerns and how to do this. The policy alsocontained contact details for the local authority inGloucestershire and the action which should be takenby staff operating in the mobile units when they hadsafeguarding concerns about a patient.

• There was a system to ensure there were always staffmembers on duty with the correct level of safeguardingtraining. Most staff were up-to-date with their regularsafeguarding training. Two members of staff needed torefresh their safeguarding children level one and twotraining. Three members of staff were due training torefresh safeguarding adults’ level one, and twomembers of staff were due safeguarding adults’ leveltwo training. Only one member of staff was out of datewith level one training but was in date with their leveltwo safeguarding training. Seven members of staff hadalso received training in safeguarding level three andwere all in date with this training. This metintercollegiate guidance ‘Safeguarding Children andYoung People: Roles and competencies for Health CareStaff’ (January 2019) and would enable staff torecognise any safeguarding concerns.

• Staff understood their responsibilities to reportsafeguarding incidents. Staff were able to tell us theaction they would take if they had safeguardingconcerns in accordance with the service’s safeguardingpolicies and procedures. For example, if non-accidentalinjuries were detected during scans or on reporting thescan results.

• Processes to ensure the right patient received the rightscan were embedded. We observed staff pause andcheck with patients identify, the correct procedure theywere attending for and the anatomical part they wereexpecting to be scanned. This formed part of standardprocesses to ensure the right scans were carried out forall patients and risks were assessed to safeguardpatients.

Cleanliness, infection control and hygiene

• The service controlled infection risk well. Staffused equipment and control measures to protectpatients, themselves and others from infection.They kept equipment and the premises visiblyclean. However, the service did not maintainrecords to demonstrate daily cleaning had beencarried out. Standards of cleanliness and hygiene weremaintained. The unit in Cheltenham and the mobileunits looked visibly clean. There was an infection control

lead for the service and there had been no healthcareacquired infections one year prior to our inspection. Theservice had infection prevention and control (IPC)policies and procedures

• Precautions were taken when patients were due tocome to the service with suspected communicablediseases. Patients were scheduled for appointments atthe end of the day, when a deep clean of the area couldbe completed.

• The service met National Institute for Health and CareExcellence (NICE) QS61 statement three (2014): Peoplereceive healthcare from healthcare workers whodecontaminated their hands immediately before andafter every episode of direct contact or care. Weobserved staff consistently adhering to the World HealthOrganisation: five moments for hand hygiene whenproviding diagnostic screening.

• Staff followed national guidance (NICE) QS61 statementfive (2014) for the insertion of cannulas (thin tubeinserted into the vein) for administration of contrast, tominimise the risk of blood stream infection. Staffwashed their hands and used aseptic techniques as setout in the guidance. Once the diagnostic scan had beencompleted, staff removed the cannula promptly.

• There were no daily checklists or cleaning records todemonstrated that equipment was cleaned daily. Weobserved staff clean scanning equipment between eachscan with antibacterial wipes. The deep cleaning auditfor the imaging centre identified that discussions wereongoing about providing radiographers with protectedtime to clean the unit at the end of the working day. Atthe time of our inspection we did not know the outcomefrom these discussions.

• Deep cleaning records for the imaging centre inCheltenham showed 100% compliance with deepcleaning between January to March 2019 and 98%compliance between April to June 2019.

Environment and equipment

• The design, maintenance and use of facilities andpremises kept people safe. The building housingthe diagnostic suites were purpose built and metsafety requirements. However, staff did not haveaccess to paediatric resuscitation equipment incase of an emergency.

Diagnosticimaging

Diagnostic imaging

Good –––


• Equipment was serviced and maintained in line withmanufacturers’ guidance. Records showed thatservicing and maintenance was up to date for allequipment located at the imaging centre and on themobile units.

• Equipment on the mobile units was mostly checkeddaily to ensure safety. A test referred to as ‘the waterbottle test’, was carried out in the MRI scanner to ensureto ensure they were in working order, along with checksof other equipment vital to ensure the smooth runningof the day. This included the resuscitation equipment,oxygen, lift and telephone lines. Weekly tests were alsocarried out as required by the manufacturers of thescanning equipment, where the results were reviewedby the manufacturers to enable the early identificationof faults. These tests also occurred at the imagingcentre. However, we were not always able to findcomprehensive records that these tests had beencompleted.

• The arrangements for managing waste and clinicalspecimens kept people safe. There were facilities toseparate waste into clinical and non-clinical waste.Waste from the PET/CT suite was monitored beforebeing disposed of securely and the service held thecorrect license to remove this waste. Sharps bins wereclosed when not in use and were not overfilled.

• The service had completed risk assessments for all newor modified use of radiation. The risk assessmentsaddressed occupational safety as well as consideringrisks to people who used services and the public.

• The service had arrangements to control access to areaswhere there was non-ionising and ionising radiation.Where there was ionising radiation, these areas wereclearly signposted with warning lights. For example, inthe PET/CT scanning suite, safety standards were metfor the safe administration of nuclear pharmaceuticals(radioactive medicine enabling this specificcomputerised tomography scan). This includedrestricted access by key pad only and specifically to thelaboratory where the radioactive medicines wereprepared. There were designated single waiting roomsfor patients who had received the radioactive medicineand were waiting for their scan. The rooms were referredto as ‘hot rooms’ and included access to toilet facilities.Staff wore ‘dose meters’ to monitor exposure toradioactivity and these were audited to ensure theirsafety.

• All relevant MRI equipment was labelled in line withMedicines and Healthcare Products Regulatory Agency(MHRA) recommendations. Equipment displayed MRIsafe, MRI conditional or MRI unsafe stickers. This madestaff aware what equipment could be used around theMRI machines at both the imaging centre and on themobile units, for example trolleys and fire extinguishers.There was also a list of equipment available to staffidentifying the equipment available on the mobile unitsand on posters on the wall at the imaging centre.However, we found one fire extinguisher in one mobileunit which was not labelled as MRI safe in line withMHRA recommendations.

• There were systems and processes to make surespecialised personal protective equipment wasavailable and used by staff. There were systems to checkthat lead aprons, lead screens and syringe shielding forPET/CT scans was not damaged.

• The service carried out assessments and reviews of theiractivities under the Control of Substances Hazardous toHealth (COSHH) Regulations 2002 (COSHH). Wereviewed COSHH risk assessments for the use ofcleaning solutions for the cleaning of water dispensers,skin preparation for the insertion of intravenous devicesand equipment cleaning wipes. The risk assessmentswere carried out in 2011. Following the inspection, wewere provided with further evidence to demonstratethat COSHH assessments were carried out regularly

• Resuscitation equipment for adults was readilyavailable. Records demonstrated the resuscitationequipment was checked monthly between January andJuly 2019. Staff recorded on the checklist whenequipment was due to expire to ensure it was replaced.We checked randomly selected consumables whichwere all in date. Emergency medicines kept on theresuscitation trolley were in tamper evident packaging,intact and in date. However, we were not assured theservice had taken account of all relevant sources ofadvice in assessing risks and managing paediatricpatients safely. Staff did not have access to paediatriclife support equipment in the event of a clinicalemergency involving a child.

• There was an equipment replacement programme. Theservice had recently bought a new mobile scanner andall staff were aware that one of the MRI scanners was oldand needed replacing. Senior leaders were exploringdifferent scanner options as this particular scanner wasused for patients who were afraid of confined spaces.

Diagnosticimaging

Diagnostic imaging

Good –––


• The service had technical support for the electronicprogrammes it used. We saw the contract with anexternal company who provided the technical support.There was also a member of staff with a designated ITsupport role based at the imaging centre, who wasavailable to manage problems. Staff on the mobile unitscould call this member of staff for help and advice.

Assessing and responding to patient risk

• Staff completed and updated risk assessments foreach patient and removed or minimised risks,however these were not documented to provide anaudit trail behind the rational for the decision.

• Thorough and comprehensive generic risk assessmentswere carried out for people who used services, andthese were documented. The service carried out riskassessments multiple times to ensure patient safety. Weobserved risk assessments being carried outconsistently for all patients at three different stages ofthe process: initially when the patient was booked in fortheir appointment, again on arriving at the unit andfinally just prior to their scan, when the radiographerwould go through the risk assessment to confirm theanswers the patient had given. This ensured there werenumerous opportunities to identify risk and ensurepatient safety.

• Staff at both the imaging centre and on the mobile unitswere confident in carrying out additional on the spot,individualised risk assessments to ensure patient safety,but these were not always formally documented. Forexample, if patients arrived for an MRI scan with metaljewellery which could not be removed or tattoos, theyrisk assessed the individual to identify whether it wassafe to continue with the scan. We observed staff weighup and discuss the risks and benefits of going aheadversus not going ahead and explaining the rationale tothe patient. Staff were clearly able to verbalise theirrationale. However, despite carrying out these riskassessments, they were not documented and thereforethere was no record these risk assessments occurred.

• There were processes to ensure the right personreceived the right imaging procedure or radiologicalscan at the right time which was routinely completed byall radiographers working for the service. The Societyand College of Radiographers (SCoR) “Paused andChecked” guidance system was used to reduce the riskof errors occurring. “Pause and check” consisted of thethree-point demographic checks to correctly identify the

patient. This also included checks with the patientregarding the site to be imaged, the existence ofprevious imaging and for the operator to ensure that thecorrect imaging modality was used.

• There was a procedure which staff followed if a persondeteriorated whilst visiting the service. The medicalemergency (cardiac arrest) policy outlined theprocedure staff must take if they were involved inresuscitation. There were local protocols for the imagingcentre and posters available on the walls of the controlrooms to provide guidance for staff in an emergency.Staff at the mobile units we visited were clear on theemergency procedure for their particular mobile unit.We were given an example of when staff on a mobileunit had followed their emergency procedure tomanage a deteriorating patent. Between April 2018 andApril 2019, there were three unplanned transfers fromthe service due to patients suddenly deteriorating whilstvisiting the service for their investigation.

• Authorisation was sought prior to children attending theunit to receive a PET/CT scan. The service did not acceptreferrals for children and young people under the age of14 years for PET/CT scans. Prior to children attending theservice, authorisation had to be sought from a numberof people and professional bodies. These included NHSEngland, the local clinical commissioning group, themedical director and lead radiologist holding theAdministration of Radioactive Substances AdvisoryCommittee (ARSAC) license. We saw evidence of theaudit trail demonstrating approved authorisation fromthe required people.

• There was a radiation protection advisor accessible forproviding radiation advice. The service had a namedmember of staff fulfilling this essential role who wasbased on site at the imaging centre. There were alsoradiation protection supervisors in each clinical area.The medical physics expert (MPE) was readily accessibleon the telephone for providing radiation advice whenrequired. This support was provided by a member ofstaff employed by an NHS hospital trust.

• There were signs or information in the radiationdepartment waiting area informing people about areasor rooms where radiation exposure took place. Signswere located throughout the unit in both words andpictures highlighting the dangers and contraindicationswith scanning procedures.

• The service made sure women (including patients andstaff) who were or may have been pregnant always

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informed a member of staff before they were exposed toany radiation in accordance with Ionising Radiation(Medical Exposure) Regulations 2018 (IR(ME)R). Theservice had a set of local rules to follow regardingpregnancy for both staff and patients. These providedclear advice and protocols about the different stageswhen pregnant women could or could not be scanned.Risk assessments were also completed at three differentstages of the process, which covered pregnancy. Thelocal rules around pregnancy were based on nationaland evidence-based guidance to ensure the safety ofboth staff and patients.

• There were local rules and policies available for the riskassessment and prevention of contrast-inducednephropathy. These were in keeping with NICE acutekidney injury guidelines and the Royal College ofRadiologists’ standards for intravascular contrast agentadministration. There was a policy and guidanceavailable for staff at the imaging centre and on themobile units. The contrast media checklist formrequired staff to complete the nephrogenic systemicfibrosis (NSF) (a rare disease that occurs mainly inpeople with advanced kidney failure, which can betriggered by exposure to contrast agents used in MRIscanning) risks section which included a review of thepatient’s blood test results. The form also providedguidance regarding parameters for safe treatment.

• At the imaging unit in Cheltenham, we observed staffcheck when kidney function tests were last obtained,and these were repeated prior to scanning if required.The service used a small device specifically designed totest kidney function, where the result was availableimmediately.

• We observed contrast being used for scans at one of themobile units we visited. A contrast prescription wasdrawn up by the host trust, who also carried out therequired renal function testing in line with their protocoland a risk assessment to determine whether it was safeto use contrast media with the patient. Radiographerson the unit were made aware of the outcome of therenal function tests on the contrast prescription. Afurther risk assessment was carried out around the useof contrast media with the patient.

• Staff ensured the safety of patients when there was arequirement to administer contrast media.Radiographers used a contrast media and drug safetychecklist on patients who required the used of contrastmedia for their scan.

• A record of the medicine given to the patient wasmaintained along with the time it was administered. Thepatient was also provided with this information onleaving the mobile unit. If for any reason the patient hadto seek medical assistance once they had left the unit, incase of any adverse reaction, healthcare professionalswould be aware of the medicine they had received.

• There was a process to support staff when referring apatient to a drug allergy specialist where contrastreactions were identified, or when staff needed adviceand support

• There were clear processes to escalate significantfindings. Staff were clear on the procedure they wouldfollow if there were significant findings and mark therecord as urgent and call the radiologists to alert them.Staff also told us that if there was anything unexpectedidentified, they could call the radiologists to view thescan whilst on the telephone to see if they could doanything additional. For example, additional scans oruse a contrast media to save the patient having toreturn for further scans. This would reduce thelikelihood of delays for the patient to access treatment.Staff were able to provide examples of when thisscenario had occurred and the actions they had taken.

• There were procedures for the collapse of a patientwhen in an MRI scanner. Practice drills took place at theimaging centre. Staff from the mobile units would alsoattend the unit to carry out the practice drills. Drills tookplace twice a year. Following each drill, a report waswritten up detailing the observation, outcomes andrecommended actions. This was circulated to all staff tosupport their knowledge and learning. We saw evidencethe outcome of a drill was discussed at a staff meetingin June 2019. Staff stated these drills were valuable andaddressed different scenarios, such as the safeevacuation of a deteriorating patient from an MRIscanner or mobile unit. Staff were knowledgeable aboutthe correct procedures to take to ensure the safety ofthe patient and staff, including additional staff from thehost trust of mobile scanning units.

• There were local rules (IRR) and employers’ procedures(IR(ME)R) which protected staff and patients fromionising radiation. The local rules were available at theimaging centre and on the mobile units in paper form.Staff also had access to these electronically.

• There were effective arrangements in case of a radiationor radioactive incident occurring, such as radioactivespillage while carrying out a PET/CT scan. There was

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guidance available and a designated spillage kit. Stafftold us of how they had safely managed an incident of asmall spillage of radioactive medicine. The room wherethe incident occurred was taken out of action until theradiation exposure was within safe limits.

Radiographer staffing

• There were sufficient numbers of staff with thenecessary skills, experience and qualifications tomeet patients’ needs. Actual staffing levels and skillmix compared well with the planned and requiredlevels. The staffing protocol ensured the serviceoperated safely, with the appropriate number of staffand correct skill mix levels required to facilitate safecare.

• The service had a procedure to identify safe staffingrequirements. There was no national guidance aboutsafe staffing for diagnostic imaging services. However,the service had developed its own minimumradiographic staffing level protocol.

• The protocol identified the PET/CT scanner must beoperated by two PET/CT trained radiographerscompetent in PET/CT scanning procedures. The MRIscanners required one fully trained radiographer,supported by a second radiographer, MRI trainedassistant practitioner or radiographic assistant. Whenlocated offsite, the minimum staffing requirement forthe mobile MRI scanners was two members of staff at alltimes. This included one fully qualified MRI trainedradiographer and either a second qualified MRI trainedradiographer, MRI trainee radiographer, MRI trainedassistant practitioner or radiographic assistant. Therewere also specific requirements for minimum staffing forthe CT scanner, X-ray and core beam computerisedtomography (CBCT).

• As of May 2019, there were a small number of staffvacancies within the service. There were 6.5 full timeequivalent (FTE) vacancies for radiographers, a 0.8 FTEvacancy for radiographer assistants and 1.8 FTEvacancies for administrative support. Senior staffidentified staffing as a challenge. Senior leaders told usrecruitment was an ongoing challenge. Work wasongoing to explore what was needed to attractradiographers to work for the service. This includedproviding bursaries to students.

• Agency staff were used to cover unfilled shifts. BetweenFebruary and April 2019, agency radiographers hadcovered 252 shifts and agency administration staff had

covered 172 shifts. During these three months, agencystaff had covered shifts for the 2.9% average sicknessrate of radiographers and 0.9% average sickness rate foradministration staff. Agency staff completed aninduction checklist which was kept by the provider.

• There was clear guidance for staff regarding lone/unaccompanied working mainly for staff working offsiteon the mobile MRI/CT units. Staff working on the mobileunits were very clear about this policy and theinformation it contained. The minimum staffing protocolset out action staff needed to take when faced withdifferent scenarios. All staff on the mobile units wereaware of the risks involved with the work they carriedout and would not see patients alone. They were able toclearly discuss the risks with lone working on the mobileunits. This ensured the safety of both staff and patients.

Medical staffing - Radiologists

• The service had enough medical staff with the rightqualifications, skills, training and experience tokeep patients safe from avoidable harm and toprovide the right care and treatment. Medicalstaffing was provided by a local NHS trust. The servicepurchased 10 consultant radiologist programmedactivities, each providing four-hour sessional cover on aweekly basis. This made sure there was a radiologist onsite for a large proportion of the week to provide expertmedical advice. Additional radiology sessions were alsosecured from another external company to provideadditional radiology reporting on site to meet demand.

• Medical staff worked at the imaging centre underpractising privileges. Practising privileges are whenmedical practitioners are granted permission to work inan independent hospital, clinic, or service. A system hadbeen implemented to ensure medical staff only carriedout work they were skilled and insured to carry out.Information requested and held by the service includedindemnity insurance, information about appraisals,revalidation and registration with the General MedicalCouncil.

Records

• Staff kept electronic records of patients’ care andtreatment. Staff entered relevant information intopatients’ electronic records and scanned in paperdocuments to ensure all information was available tostaff. Scanned records were destroyed to ensure patientconfidentiality.

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• Patients’ personal data and information was kept secureand only staff had access to the information. Staffreceived training on information governance as part oftheir mandatory training programme.

• The service used the radiology information system (RIS)and picture archiving and communication system(PACS). These were secure, and password protected.Each staff member had their own personally identifiablelog in.

• Information needed to deliver safe care was available torelevant staff in a timely and accessible way at theimaging centre and on the mobile units. This includedreferral information, previous imaging results and testresults if required.

• Staff recorded any additional comments or informationwhich may be of use or required by the radiologistreading the images on the electronic system. Additionalrisk assessments or consent forms which were paperbased were scanned onto the electronic system andheld with the patient’s electronic record following theirappointment. Staff completing the scan updated theelectronic records and submitted the scan images forreporting by the relevant organisation.

• There was limited documentation of additionalinformation regarding patient care. For example, staffdid not record when patients left the unit followingadministration of contrast media, that cannulaswereremoved,and that post scan care information hadbeen given to patients and their next of kin. Patientsreceiving contrast were advised to stay in the waitingroom for 30 minutes following the scan. However, thiswas not recorded unless patients declined and leftstraight away following their scan.

Medicines

• The service used systems and processes to safelyprescribe, administer, record and store medicines.However, the Patient Group Directions (PGDs) usedby the service did not have the requiredauthorisation as recommended by nationalguidance.

• A record of the medicine given to the patient wasmaintained along with the time it was administered. Iffor any reason the patient had to seek medicalassistance once they had left the unit, in case of any

adverse reaction, healthcare professionals would beaware of the medicine they had received. The patientwas also provided with this written information onleaving the mobile unit.

• Contrast media and other medicines were storedsecurely. Contrast media was stored in lockedcupboards to which only radiologists had access. Wereviewed the expiry dates for some of these and foundthem all to be in date and in intact packaging. Therewere processes to log each contrast media given topatients. This ensured the patient could be traced ifrequired.

• Patient Group Directions (PGDs) were not used inaccordance with The Human Medicine Regulations 2012regulation. This meant these were given without aprescription or authorisation. A Patient Group Direction(PGD) is defined by the National Prescribing Centre(2004) as 'a written instruction for the sale, supply andor administration of named medicines in an identifiedclinical situation’. The service used five PGDs formedicines. However, none of these had been signed offby a pharmacist and two were not signed by theadditional authorised people as recommended. Also,there was no PGD for the use of saline when givingmedicines or radioactive tracers intravenously.Following the inspection, the senior team informed usthe medical director was engaging with a pharmacist toensure the right authorisation was sought to meet thelegislation.

• Emergency medicines were available in the event of ananaphylactic reaction. The local NHS trust providedpharmacist support and supplied anaphylaxis and othermedicines as required following signed requests fromthe medical director. No controlled drugs were stored oradministered by the service.

• Radioactive tracers were ordered from an externalsource daily and prepared overnight before beingdispatched and delivered each morning by designatedcouriers. The radioactive tracers were stored within leadlined containers and locked into a designated crate,which was protected by a safety code. The code wasshared with the service via email each day. There wereprocesses for signing radioactive tracers in and recordsmaintained to identify all unused tracers.

• Contrast and radioactive medicines were prescribed byradiologists. Contrast medicines were prepared andchecked by two radiographers before they were

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administered as part of the scans for which they wererequired. Radioactive tracers were administeredthrough a designated pump designed to administer thecorrect dosage to patients.

• The service ensured the Medicines (Administration ofRadioactive Substances) Regulations 1978 (MARS), weretaken account of. PET scanning was performed withaccess available by telephone to either anadministration of radioactive substances committee(ARSAC) license holder or their delegates. We sawevidence of the licence which was held by the leadconsultant and the imaging centre also maintained acopy. We also saw evidence of the environmentalagency permit which supported the safe removal ofradioactive clinical waste.

Incidents

• The service managed patient safety incidents well.Staff recognised and reported incidents and nearmisses. Managers investigated incidents andshared lessons learned with the whole team andthe wider service.

• Staff were aware of their responsibilities to raiseconcerns, record safety incidents and near misses andreport them internally. There was an incident reportingpolicy and pathway to enable staff to report incidents ornear misses. The policy outlined the responsibilities ofthe staff in reporting incidents and provided informationabout the procedure to report incidents. Staff explainedthe procedure of reporting incidents electronically atthe imaging centre, and the paper incident reportingprocess in use on the mobile units.

• There had been no never events between April 2018 andApril 2019. Never Eventsare serious, largely preventablesafety incidents that should not occur if the availablepreventative measures are implemented.

• There had been no serious incidents or IR(ME)R/IRRreportable incidents at the service between April 2018and April 2019. Serious incidents can be identified as anincident where one or more patients, staff members,visitors or member of the public experience serious orpermanent harm, alleged abuse or a service provision isthreatened.

• Staff received feedback about incidents which hadoccurred. Staff were able to give examples of incidentsand the actions they now took as part of their practiceas a result of the incident. Staff at the imaging centreand out on the mobile units told us incidents were

discussed at staff meetings and information was alsoprovided to them by email to ensure staff working in thefield on the mobile units remained up to date withimportant information about incidents. We reviewed theminutes form the staff meeting in June 2019 whichincluded a list of incidents which were discussed.

• There was a process to make sure radiation incidentswere fed into risk management. For accidental andunintended exposures, processes included notificationto CQC under IR(ME)R or to HSE under IRR requirements.We saw an example of an incident involving radiation inJuly 2019, prior to our inspection. We saw evidence theincident was promptly discussed with the radiationprotection advisor (RPA) from the NHS trust whichsupported the service to determine whether it wasinternally or externally reportable. Once this had beenclarified, the service said they would notify the correctprofessional bodies.

• The duty of candour is a regulatory duty that relates toopenness and transparency and requires providers ofhealth and social care services to notify patients (orother relevant persons) of ‘certain notifiable safetyincidents’ and provide reasonable support to thatperson. There was a duty of candour policy whichprovided guidance and examples of incident eventswhich would be recognised as a duty of candour trigger.The policy also provided information for staff regardingthe duty of candour pathway. There had been norequirement to implement the duty of candour betweenApril 2018 and April 2019.

Are diagnostic imaging serviceseffective?

Effective means that your care, treatment and supportachieve good outcomes, helps you to maintain quality oflife and is based on the best available evidence.

We do not currently rate effective for diagnostic servicesdue to insufficient data being available to rate theseservices’ effectiveness nationally.

Evidence-based care and treatment

• The service provided care and treatment based onnational guidance and evidence-based practice.Managers checked to make sure staff followedguidance.

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• There were processes to ensure ‘local’ rules werereviewed and updated regularly. The service made sureit identified and implemented relevant best practice andguidance, such as National Institute for Health and CareExcellence (NICE) guidance. We reviewed a set ofprotocols known as ‘local rules’ for different processes/scans carried out by the service. The local rules wereevidence-based, version controlled and reviewedregularly. For example, there was an implant and devicepolicy which was written in April 2019 and due a furtherreview in April 2020. The local rules included a referencelist to support the evidence and guidance which hadbeen used to develop the local rules.

• The service ensured guidance from the Faculty ofClinical Radiology (FCR) for the communication ofradiological reports was followed. There was a standardoperating procedure which stated the reporting time forscans carried out at the imaging centre in Cheltenham.Radiologists reviewed and reported on scans daily andsome reports were reviewed and signed off by tworadiologists. There were processes for radiographers torefer scan results for immediate interpretation wherethere were unexpected scan results, in line withstandards one to three of the guidance. Scans carriedout on the mobile scanning units were sentelectronically to the host hospital. Staff were advised toinform patients when they could expect the results ofthe scan.

• The service ensured the Ionising Radiation (MedicalExposure) Regulations 2018 (IR(ME)R) were adhered to.There was an administration of radioactive substancescommittee (ARSAC) certificate holder (the medicaldirector for the service).

• The service used the diagnostic reference levels (DRLs)as an aid to optimisation in medical exposure. Data wascollected and audited to ensure radiation dosesremained as low as reasonably practicable inaccordance with IR(ME)R guidelines 2017. Data wassubmitted monthly to the radiology protection servicesprovided to by an NHS trust to monitor DRL. DRLs werebenchmarked against other services and a report wasproduced yearly following a review of the data providedby the unit. The report which covered January toDecember 2018 identified one area which needed to bereviewed. There was no corresponding action plan forthe management of this recommendation, nor wasthere documented evidence this recommendation hadbeen acted on.

Nutrition and hydration

• There were arrangements to provide access to foodand drink for patients at the imaging centre inCheltenham. Snacks and drinks were available in thereception area for patients at the imaging centre. Tea,coffee and chilled water was available and free ofcharge. There was also a fridge with a selection ofalternative drinks, which patients could buy. Snacks andfruit were also available for patients to purchase.

• The service took account of people living with diabeteswhen they were required to attend for fastingexaminations/scans. The booking staff spoke withpatients and asked for their preferred time to attend forscans if they were required to fast in preparation.

Patient outcomes

• Staff monitored the effectiveness of care andtreatment in line with contractual arrangementswith commissioners. They used the findings tomake improvements and achieved good outcomesfor patients. The service had been accredited underrelevant clinical accreditation schemes.

• The service participated in the Quality Standard forImaging (QSI), formerly the Imaging ServicesAccreditation Scheme (ISAS). The service was accreditedfor its imaging centres and its mobile units and receivedthis accreditation in September 2018. It was due forrenewal in October 2022. This enabled the service tobenchmark against national standards and constantlyreview and improve service provision.

• The service was also working towards Cyber EssentialsPlus (CE+) accreditation (technical controls to helporganisations protect themselves against commononlinesecuritythreats). Work was ongoing at the time ofthis inspection to meet the standards required tobecome accredited. The service aimed to becomeaccredited in September 2019. The service had alsoachieved the ISO 9001:2015 quality managementstandard. This was an accreditation of their qualitymanagement systems which demonstrated their abilityto consistently provide evidence to support compliancewith applicable statutory and regulatory requirements.

• The service collected data around their performance.The service worked towards monthly key performanceindicators (KPIs) for MRI and PET/CT. The KPIs includedcontacting patients within five days of acceptance to the

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service for MRI scans and sending reports for reviewwithin five days of a patient’s scan. See the access andflow section under responsive for further detail roundKPIs and performance.

• Information was collected for the commissioners toprovide oversight of how the service was performing inrelation to key performance indicators such as reportwriting times, patient waiting times and cancellation ofscans. Data was collected monthly from several internalaudits and a quarterly report was submitted to thecommissioners. This provided commissioners withinformation on activity and any issues impacting onservice provision such as staffing, equipment,operational issues and improvements.

• There were processes for peer feedback and QA ofreports. Radiologists reviewed and reported on scanresults and these were sampled by a second review byanother radiologist to ensure quality. All PET/CT scanswere reported on by two radiologists before the resultswere shared with the referring clinician.

Competent staff

• The service made sure staff were competent fortheir roles. Managers appraised staff’s workperformance. Staff who administered radiation wereappropriately trained. Staff who were not formallytrained in radiation administration were adequatelysupervised in accordance with legislation set out underIR(ME)R.

• Staff working with radiation had appropriate training inthe regulations, radiation risks, and use of radiation.Staff were able to provide evidence of training and wereaware of the Ionising Radiation Regulations 2017 (IRR17)and the Ionising Radiation (Medical Exposure)Regulations 2017 (IR(ME)R). Records identified all staffwho required this training had completed this. Staff hadalso completed competencies within the requirementsof their role and responsibilities on joining the service.

• All radiographers held immediate life supportqualifications, and these were renewed annually.

• Cannulation audits were completed yearly to ensurestaff remained competent to carry out this aspect oftheir role. Competencies were completed and signed offwhen radiographers started working for the service. Staffwere then required to do a yearly self-audit of 20cannulations to evidence their competence. This wasthen followed up every three years with an observedcompetency assessment, which was signed off by senior

staff. Staff were responsible to report any concerns theyhad regarding their competence in this area and seekadditional support and training as part of theirprofessional code of conduct and responsibilities.

• Staff received an induction on starting employment withthe service. New employees attended a corporate andlocal induction covering rules, processes andprocedures. This made sure new employees understoodhow the service worked and their expectations ofemployees. We spoke with staff who had recently beenemployed who stated their induction had beenthorough and informative.

• Agency staff working for the services underwent a seriesof check to ensure they were competent to work for theservice. Agency staff were also provided with corporateand local inductions. These inductions covered the localrules, processes, and procedures, which provided themember of staff with greater understanding of the role,service and expectations. Agency staff told us they hadfound the three-day induction informative. They feltsupported by having the opportunity to work alongsideestablished staff to ensure they worked in accordancewith Cobalt Health’s values and expectations.

• Staff were supported and encouraged to develop. AllMRI staff attended in-house Cobalt Health MRIradiographer training. This training had been recentlydeveloped by the training lead and broken down intomodules which staff completed, to make this moreaccessible. Competencies were signed off as staffbecame competent in their knowledge and skills in aspecific area. There were plans to develop this in-housetraining programme for PET/CT in the future.

• Staff had additional opportunities to attend training toenhance their knowledge and skills. Radiologists fromthe local NHS trust arranged evening training sessionswhere staff were invited to attend. For example, anorthopaedic consultant had presented a session on theshoulder joint. This had provided information to theradiographers as to what the consultant would look forfrom the scans and provided more information onconditions and disease processes.

• There were arrangements to make sure the service wasinformed if a staff member from an NHS trust wassuspended from duty. There were processes to ensurethe local NHS trust informed the service if any of theradiologists working under practicing privileges weresuspended from the usual place of working.

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• Most staff had received an annual appraisal. There was100% compliance with appraisals for superintendentradiographers (two staff), and 96% (24 of 25)radiographers had received their appraisal. Of theradiography assistants, 89% (eight out of nine staff) hadreceived their appraisal, along with 72% ofadministration staff (31 of 43). Staff told us appraisalswere useful and helped them to identify their trainingand development needs.

Multidisciplinary working

• All those responsible for delivering care workedtogether as a team to benefit patients. Theysupported each other to provide good care andcommunicated effectively with other services. Theservice hosted a team of multidisciplinary healthcareprofessionals from the local NHS trust to provideone-stop screening services for patients presenting withmusculoskeletal complaints. They supported the servicewith imaging or scans to ensure patients could receive adiagnosis and treatment during one appointment.

• Staff were appropriately involved in assessing, planningand delivering patients’ care. Staff worked closely withthe referring NHS trusts, to ensure a smooth pathway forpatients.

• Staff could access patients’ previous scans and images.Booking staff asked patients as part of the bookingprocess, if they had had previous scans. Radiographersand radiologists could access these scans to ensuresimilar protocols were used in order that scans/imagescould be compared.

• The service had good relationships with other externalpartners and undertook scans for local NHS providersand clinical commissioning groups (CCGs). We sawevidence of good communication between services andthere were opportunities for staff to contact referrers foradvice and support. Staff on the mobile units spokehighly of the support they received from the host NHStrusts. Staff from the host trusts also spoke of positiverelationships with the radiographers on the mobile unitsand with the staff at the imaging centre headquarters inCheltenham.

Seven-day services

• The imaging centre was operational from 8am to7.30pm Monday to Friday and operated a Saturdaymorning service. Additional services could be providedto manage an increase in demand on a Saturday

afternoon and a Sunday, if the service was able to findstaff to cover the shifts. The mobile units operatedbetween Monday and Friday. Services ran from 8am andfinished at either 6pm or 8pm depending on thecontract provision requirements for the NHS trust themobile unit was supporting.

Health promotion

• Information leaflets about the patient’s scan were sentalong with their appointment letters. Furtherinformation was also available in the reception area.These leaflets included information about what thescan would entail and what was expected of the patientbefore and after the scan appointment.

Consent and Mental Capacity Act

• Staff supported patients to make informeddecisions about their care and treatment. Theyfollowed national guidance to gain patients’consent. They knew how to support patients wholacked capacity to make their own decisions orwere experiencing mental ill health.

• Staff understood the relevant consent anddecision-making requirements of legislation andguidance, including the Mental Capacity Act 2005. Staffreceived training on mental capacity and there wereposters on the walls around the imaging centre toremind staff of the principles and their responsibilities.

• Some imaging was consented for using implied consent.The risk assessment which patients completed requiredthem to confirm whether they understood the reason fortheir scan and the risks associated with this. Consentwas implied, which meant that if a patient continued tomove forwards with the procedure as instructed by theradiographers then they would continue with the scan.Staff told patients they could request to stop the scan atany stage and we observed this happening. Staff alsoprovided us with examples where patients had not beenable to progress through the different stages to preparefor the scan due to fear and anxiety. On occasions likethis, it was deemed by the radiographers as not havingconsent to continue, which they respected.

• There were procedures to ensure imaging was properlyconsented for when required. Where contrast media wasrequired, patients were asked to provide writtenconsent. Information was sent to patients alongsidetheir appointment letter to ensure they had sufficientknowledge to give informed consent for scans.

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• Staff were aware of what to do if they had concernsabout a patient and their ability to consent to the scan.They were able to clearly tell us what they would do ifthey were faced with this situation and how they wouldmanage this for the patient. They would make thereferrer aware of their concerns, and it would then be fora radiologist to determine their suitability to receive theintervention.

• Staff demonstrated their understanding around mentalcapacity and decision-making processes. A patientattended the service who had fluctuating capacity. Thepatient attended with a relative who provided supportto the patient. Staff were able to demonstrate andverbalise how they had come to a decision that theywould continue to scan the patient. However, thisdecision-making process was not documented.

Are diagnostic imaging services caring?

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Caring means that staff involve and treat you withcompassion, kindness, dignity and respect.

We rated caring as good.

Compassionate care

• Staff treated patients with compassion andkindness, respected their privacy and dignity, andtook account of their individual needs.

• We observed staff to be kind and compassionate in theway they interacted with patients. Staff took time tointeract and answered questions in a kind mannerensuring patients understood the information theyshared. This met NICE QS15 Statement two: Patientsexperience effective interactions with staff who havedemonstrated competency in relevant communicationskills.

• Care observed met National Institute for Health andCare Excellence (NICE) QS15 Statement one: Patients aretreated with dignity, kindness, compassion, courtesy,respect, understanding and honesty. There were areaswhere the patient could get changed if necessary.Patients could also be provided with gowns to maintaintheir privacy and dignity. We observed staff always takecare to maintain patients’ privacy and dignity.

• Staff demonstrated a supportive attitude to patients atthe unit. Staff used appropriate humour to engage withpatients and thereby help to alleviate patients’ anxiety ifrequired. Staff ensured patients had a call bell, so theycould call for assistance if required. During scans, stafffrequently interacted with patients using an intercomsystem.

• Staff worked to maintain patient comfort during theirscan. Staff consistently checked patients were ascomfortable as they could be. Staff recognised whenpatients needed extra support. For example, a patientwho started to cough when laying down was given anadditional headrest to improve their comfort.

• All patients we spoke with talked positively about thecare provided by the unit staff. Patients told us staffwere kind and explained “all I needed to know about thescan” and spoke about staff “going the extra mile.”

• Staff introduced themselves to patients and explainedtheir role. This was in line with NICE QS15 Statementthree: Patients are introduced to all healthcareprofessionals involved in their care and are made awareof the roles and responsibilities of the members of thehealthcare team.

• Staff treated children, young people and their familieswith compassion and kindness, respected their privacyand dignity, and took account of their individual needs.We observed staff on one of the mobile units care forand provide a diagnostic scan to a young person. Theyoung person was treated with kindness and respect.Staff supported their next of kin to be present in thescanning room during the scan following appropriaterisk assessment in line with their policy. This helped theyoung person to feel less anxious about the scan.

Emotional support

• Staff provided emotional support to patients,families and carers to minimise their distress. Staffunderstood the impact that a patient’s care, treatmentor condition had on their wellbeing and on theirrelatives, both emotionally and socially. Staff spokeclearly and could empathise with patients who attendedthe service for a scan. They were understanding of theemotions, anxieties and fears patients faced whenattending the service and provided support.

• Patients attending for PET/CT scans were given verbaland written information after their scan to ensure theyfully understood risks following the radioactive tracers

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given to them for their scan. Some patients wereanxious about this, but staff took time to reassure andexplain the risks and the precautions they were requiredto take.

• Staff were aware of the needs of the patients attendingthe service. They could tell if they were upset or anxiousand did their best to support and comfort them. Stafftold us they did what they could to overcome thepatient’s anxieties to make sure the patient could goahead with their scan during the appointment toprevent them having to return to the service. Staffrecognised scan-related anxiety could impact ondiagnosis for patients and cause possible delays infurther treatment.

• Staff provided support and reassurance to emotionalpatients. We observed staff tend to patients who wereemotional about undergoing their scan. In thesesituations, staff were calm and took their time toreassure the patient. They broke down what washappening, stage by stage, and maintainedcommunication with the patient throughout the scan.

• Staff provided ongoing reassurance to patientsthroughout the scan. They updated the patient on howlong they had left in the scanner and what they couldexpect with regards to the noise the scanner wouldmake.

• Staff understood and supported patients who sufferedfrom claustrophobia during scans. Staff took time toexplain the scan procedure and took time to ensurepatients were comfortable before leaving the scanroom. When possible, staff chose the leastclaustrophobic scanning process possible andreassured patients could call for help and that the scanwould be stopped immediately. During scans, weobserved staff talk with patients and providereassurance. They told patients how long the next scanwould take and so on. Staff offered patients theopportunity to listen to music during scan as a way oftaking the mind of the scanning process.

Understanding and involvement of patients andthose close to them

• Staff supported and involved patients, families andcarers to understand their condition and makedecisions about their care and treatment. Staffengaged with patients and provided support to ensurepatients understood what was going on before the scan,during the scan and when patients left the service.

• Staff communicated with patients to ensure theyunderstood their care and condition. They took the timeto explain the procedure and what would happenduring their appointment. Staff gave clear instructionsof when the results would be available and askedpatients to make an appointment with the referringpractitioner to discuss the result of their scan and anyongoing treatment if required.

• Staff understood the importance of involving familymembers and close relatives as partners in patients’care in line with NICE QS15 Statement 13: Patients’preferences for sharing information with their partner,family members and/or carers are established,respected and reviewed throughout their care. Theservice allowed for a parent, family member or carer toremain with the patient for their scan if this wasnecessary. This helped to calm some patients’ nervesand anxieties about their scan.

• Staff recognised when patients and their relativesneeded additional support to help them understandand be involved in their care and enable them to accessthis. Patients and those close to them were givenwritten information about scans and could askquestions about their scan. We observed staff givingpatients and their relatives time to ask questions, andwhen they did, they were answered clearly to ensureunderstanding.

Are diagnostic imaging servicesresponsive?

Outstanding –

Responsive services are organised so that they meet yourneeds.

We rated it as outstanding.

Service delivery to meet the needs of local people

• The service planned and provided care in a waywhich was tailored to meet the needs of localpeople and the communities served. The servicealso worked with others in the wider system andlocal organisations to plan care.

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• Patients individual needs were central to the planningand delivery of tailored services. The service workedwith NHS specialised commissioners to provide a PET/CT service for a population of two million patientsacross the south west and Midlands.

• The involvement of other organisations and the localcommunity was integral to how services were planned.The service was committed to ensuring timely access todiagnostic scans for patients to enable timely access tocare and treatment. This helped to improve patientexperience. The service provided 800 diagnosticprocedures for the local NHS trust as a charitabledonation to support them with waiting times andpatient experience.

• The service worked with local partners to increase theircapacity to improve patient experience and supportsystem-wide working. For example, the service providedfacilities to a local NHS trust to enable timely access forpatients to the breast screening programme. Also, theservice provided facilities for local consultants toprovide one-stop clinics for musculoskeletal patients toenable them to receive their scan and ongoing care andtreatment during the same appointments.

• The services provided reflected the individual needs ofthe population served and ensured flexibility, choiceand continuity of care. There were out of hours andweekend services provided for patients. Services wereprovided at the imaging unit and in the mobile units fivedays a week, and on a Saturday morning. Patients werealso able to access appointments outside of workinghours as the imaging centre and some mobile unitswere open 12 hours a day.

• In instances where demand increased, the serviceprovided extra capacity by offering additional services atthe weekend at the imaging centre in Cheltenham. Thiswas dependent on whether safe staff levels could besecured for the additional requirements of the service,because weekend working was voluntary for staff.However, we were told there was never a problem withstaff volunteering for additional shifts.

• Services were delivered from various locations to bringcare closer into the local community for patients.Patients could access the imaging centre in Cheltenhamand the mobile units. The mobile units moved betweenregions as required.

• There was involvement of other organisations, andsystem wide working to meet people’s individual needs.The service was able to support NHS trusts to manage

their capacity and demand challenges to improvewaiting times for patients. The week following ourinspection, the service was providing a mobile CTscanner to support an NHS trust to provide CT scans tohelp improve cancer waiting times for patients.

• Services were delivered in a way which promotedequality and supported patients with complex needs.The service had the facility to scan patients who wereless mobile, to make the process easier for them. Theservice provided a Cone Beam CT scanner. This machinewas easier to access for less mobile patients and themachine moved to accommodate the patient. Uptakefor this type of scanner was not as popular as othermodalities provided by the service. However, thescanner was due to be used to support a scaphoid study(one of the eight bones which makes up the bones ofthe wrist) as part of a research study. This was in theplanning stages at the time of our inspection.

• The environment was appropriate, and patient-centred.The imaging centre had facilities for ‘cold’ patients (whodid not receive radioactive tracers) and ‘hot’ patients(who received radio radioactive tracers). There was awaiting room for ‘cold’ patients, with a variety of seating,including chairs with arms. There were also three ‘hot’waiting rooms, one larger than the other two toaccommodate non-ambulant patients.

• Patients were provided with information prior to theirappointment so they knew what to expect whenattending the unit. Information included directions tothe imaging centre, information about the scan theywere having, how to prepare for this and what wouldhappen during the appointment. Written informationand explanations on aftercare were also given afterexamination. For example, cannulation sites andhydration, what to do in the event of feeling unwell andhow and where patients could get the results of theirscans.

• There was sufficient car parking available for patients. Atthe imaging centre, there were 31 spaces available forpatients, including three disabled spaces. Parking wasfree of charge for patients visiting the centre.

• The department was clearly signposted for patients.Once patients were called in for their appointments,they were always accompanied by staff.

Meeting people’s individual needs

• The service was inclusive and took account ofpatients’ individual needs and preferences. There

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was an innovative approach to providingintegrated patient-centred care. Staff madereasonable adjustments to help patients accessservices. They coordinated care with other servicesand providers.

• There was a proactive approach to understanding theneeds of different patient groups to enable service to bedelivered to meet their individual needs. Reasonableadjustments were made so disabled patients couldaccess and use services on an equal basis to others. Theimaging centre was spread over two floors. Patientscould either use the stairs or the lift to access the floorthey required. There were disabled toilet facilities,wheelchair availability and a variety of chairs in thewaiting room suitable for patients with differing physicalneeds.

• The needs of individual patients were also proactivelymanaged on the mobile units to ensure equality andequal access to local services. Disabled patients orpatients with mobility problems could also access themobile units via the lift mechanism on the vehicles. Weobserved this in use during out visit to one of the mobileunits.

• The service understood the needs of patients whoattended who were in vulnerable circumstances or whohad complex needs. There was a system for managingthe needs of patients living with dementia or a learningdisability. There was a system on the referrals process toidentify these patients. This meant additional timecould be added to the patient’s appointment to give thepatient time to understand and get used to theenvironment and what was required of them. Staff toldus in these situations they worked closely with thepatient and their relative/carer to get the best for thepatient and the appointment. Staff were able to give usexamples of when they had done this.

• The service met the needs of vulnerable service userssuch as patients with learning difficulties or dementia.These patients could bring a relative or carer to theirappointment as support. Patients and relatives could bepresent in the scanning room if required.

• We observed staff being responsive and supportive to apatient with mental health problems who had accessedthe service. This patient and their family member weregiven additional time to ensure all aspects of the

appointment were carried out. We saw how staff weresupportive of the patient, and also of their familymember who was visibly concerns and anxious as tohow the appointment would go for their loved one.

• Staff were very experienced in the management ofpatients who were anxious regarding the scanningprocess or who suffered with claustrophobia. Theservice provided an open MRI scanner for severelyclaustrophobic patients and received referrals fromacross the UK for this service. There was also a specificset of local rules providing guidance for staff to supportthem to manage patients who were claustrophobic. Weobserved staff being extremely responsive to thesepatients to ensure they had the best experience theycould despite their anxieties. We saw how staff tried tocall the patient and their anxieties and how theysupported them when emotionally the situationbecame too much for the patient. The service was ableto accommodate bariatric patients.

• Scanning areas and machines used advancedtechnology to help reduce patient anxieties. Equipmentincluded wide bore systems, ambient lighting andsoft-tone MRI gradient scanners for reduced noise foranxious patients and children. At the imaging centre,lighting in the scanning rooms could be chosen by thepatient. One of the scanners also had a facility forpatients to choose a video to watch for the duration ofthe scan to take their mind off the procedure. Patientswere also provided with headphones, so they could hearthe sound which accompanied the video. There was thefacility to provide ambient lighting on some of thenewer mobile scanners. On the mobile units, patientswere also given the option to listen to the radio todrown out the loud noises of the scanners.

• During scanning, staff made patients comfortable withpadding aids, ear plugs and ear defenders to reduce thenoise of the MRI. Patients were provided with anemergency call alarm in case of the patient experiencingany distress. Microphones were built into the scanner toenable two-way communication between the patientand staff. Staff also recognised when patients wereanxious and tried to liken the experience they weregoing to have with everyday events to try and keeppatients calm.

• The service took account of patients’ individual needs.Staff delivered care in a way which took account of theneeds of different patients on the grounds of age,disability, gender, race, religion or belief and sexual

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orientation. The service offered multilingualinterpreters, provided information for patients indifferent languages and in large print, and provided ahearing induction loop for patients.

• Refurbishment work was due to take place in thewaiting area of the imaging unit. A major part of thework included relocating the check in desk to improveprivacy and confidentiality for patients attending theimaging centre. The work was due to be completed byChristmas 2019. There would be no disruption toservices as a result of the refurbishment. Alternativecheck in and patient waiting areas had been identifiedto keep patients away from the renovation work until itscompletion.

Access and flow

• People could access the service when they neededit and received the right care promptly. Waitingtimes from referral to treatment and arrangementsto admit, treat and discharge patients wereexceeding national standards.

• In instances where demand increased, the serviceprovided extra capacity by extending the working dayand offering services at the weekend (seven-day access)at the imaging centre in Cheltenham and via theirmobile fleet of MRI and CT scanners.

• Same day and next day appointments were available forpatients as required. Referrals were received from avariety of referrers via email, fax or post. Referrals werecategorised as either routine or urgent. There was avetting process where all referrals were prioritisedaccording to clinical need. Flexible urgent / high priorityappointments were available, allowing access for urgentpatients when required. The vetting was carried out bythe radiographers within 24/48 hours. They woulddetermine the scanner and the amount of time requiredto carry out the appointment.

• There was a process to book patients in for theirappointments. Patients were telephoned by theadministration team to be offered a choice of days andtimes for their appointments. If the patient did notrespond to the telephone call within 24 hours, a letterwas sent to the patient. Patients would then be giventhree months to respond to make their appointment.

• The administration staff carried out initial screening ofpatients to ensure a seamless service could be providedfor patients to support access and flow through theservice. This made sure patients who were attending for

an MRI scan or PET/CT had no risk factors that mighthave meant they were not able to receive their scan onthe day of their appointment. If patients answered yesto questions which were categorised as a risk toreceiving their scan, the administrator called theradiographer for support and advice. The administrationstaff were provided with training, so they werecompetent to ask the safety questions. They were alsoprovided with additional paperwork to provide moredetail and rationale for the questions they were asking.

• Patients could request a text message to remind themabout their appointment 24 hours in advance. Thisreduced the likelihood of patients not attending orforgetting their appointments.

• The service was exceeding the six-week diagnostic testnational standard. The service was meeting its 95%standard ensuring patients underwent their MRI and CTscans within four weeks of referral. The current year todate figure for 2018/2019 was 98%.

• The service was almost achieving its local keyperformance indicator for contacting patients within fivedays of acceptance to the service for MRI scans. In bothApril and May 2019, 98% of patients were contactedwithin five working days of acceptance to the clinicagainst a target of 99%. In April and May 2019, thereason for the small number of patients not beingcontacted within five days included four patients beingsubject to a delay in booking appointments.

• The service was almost achieving its aspirational targetfor MRI reports being sent within five working days of thepatient’s scan. In both April and May 2019, 97% ofreports were sent within five days of the patient’s scan,against a target of 99%.

• Between April 2018 and April 2019, 466 appointmentshad been cancelled due to a non-clinical reason. Themain reasons for these cancellations included delays intracer delivery, scanner breakdown or mobile vehiclebreakdown. This equated to just 0.7% of the totalnumber of patients booked annually. Of these 466appointments, 290 were due to equipment failure,however, appointments were moved to either later inthat day or to another appointment that best suited theneeds of the patient. Vehicle breakdown attributed to 17of the cancelled appointments.

• Between January and May 2019, between 198 and 225patients were attending the PET/CT services eachmonth. In these months, referral to report turnaroundtime ranged between 5.2 and 5.91 days. A small number

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of patients experienced a referral to report turnaroundtime of over seven days. This ranged between six and 15patients between January and May 2019. The mainreason for this was due to scanner breakdown, capacityissues due to increase in referral demand and failure ordelay of the radioactive tracer.

• The service had very few patients who did not attend(DNA) their appointment. In April 2019, out of 1,695patients, 28 (1.7%) did not attend their appointments. InMay 2019, out of 1,888 patients, 31 (1.6%) did not attendtheir appointments. The main three reasons for DNAswere; the patient was unwell, they forgot about theirappointment or they cancelled too late.

Learning from complaints and concerns

• It was easy for people to give feedback and raiseconcerns about care received. The service treatedconcerns and complaints seriously, investigatedthem and shared lessons learned with all staff.People using the service knew how to make a complaintand felt they could raise any concerns with the clinicalstaff. The complaints procedure was made available topatients. This was available and on display in thereception area at the imaging centre.

• There was a comprehensive complaints procedure toensure all complaints were handled effectively. Therewas a complaint policy available for staff. The policyoutlined there was to be an acknowledgement of acomplaint within one to three days, followed by a fullwritten explanation and response to a complaint within20 working days. Between April 2018 and April 2019, theservice received 31 complaints. Of these, 15 were dealtwith under the formal complaints procedure and sixwere upheld.

• The service maintained an electronic record of allcomplaints received. Trends and themes of complaintsincluded the quality of the images taken,communication and care and treatment by the service.

• Complaints were handled effectively to ensureopenness and transparency, confidentiality, regularupdates for the complainant, and a timely response andexplanation of the outcome. We reviewed tworesponses to complaints. Complainants received a fullwritten response which contained an apology, findingsagainst each issue raised by the complainant, and anyactions which may have been taken following theinvestigation of the complaint.

Are diagnostic imaging services well-led?

Good –––

Well-led means that the leadership, management andgovernance of the organisation make sure it provideshigh-quality care based on your individual needs, that itencourages learning and innovation, and that it promotesan open and fair culture.

We rated it as good.

Leadership

• Leaders had the integrity, skills and abilities to runthe service. They understood and managed thepriorities and issues the service faced. Theysupported staff to develop their skills and take onmore senior roles. However, they were not alwaysvisible on the mobile units for patients and staff.

• There was a clear leadership structure whichdemonstrated communication pathways from board todepartment and vice versa. Information was cascadedto staff in twice-yearly newsletters and throughdepartmental meetings. All staff were aware of whomthey reported to and of their role in the organisation.

• Senior leaders working in the service wereradiographers by background and had experience fromholding a number of posts within the field throughouttheir careers. During discussions with the seniorleadership team, they demonstrated an enthusiasm andpassion for their role, their department and the serviceas a whole.

• Staff spoke highly of their managers and the seniorteam. Staff told us leaders were approachable andsupportive. Staff working on the mobile units feltsupported by leaders and stated they were alwaysavailable to provide guidance and support if required.

• Leaders were visible and approachable at the imagingcentre, but not always at the mobile units. Staff at theimaging centre told us they often saw the seniorleadership team and described them as personable,friendly and approachable. However, staff on the mobileunits did not see the senior leadership team as they didnot come to visit the mobile units. They did, however,speak highly of one of the superintendent radiographerswhose role was working across the mobile units andacted as the link between staff in the field and the

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imaging centre. Despite the senior team based at theimaging centre not being visible on the mobile units,staff told us there was always support available on thetelephone if they needed it. One of the senior leaderscarried out one clinical shift a month when there was amobile unit based in Hereford.

• Leaders of all levels understood the challenges to goodquality care and were able to identify actions to addressthem. For example, we were told that bringing inradiographers from the field was challenging due tothem being geographically spread and keeping them upto date. However, there were several ways staff could bebrought back into the imaging centre headquarters inCheltenham. Most staff worked on rotations betweenmobile units and the service delivered from the mainsite. All staff attended the main site for training purposesor to attend meetings. This also provided them with theopportunity to be brought up to date with changes atthe imaging centre, opportunities to maintain their skillsusing different equipment located at the imaging centreand to take information back out to the mobile units asrequired. Other challenges included staffing,recruitment and space, which the senior team were ableto clearly discuss and explain how they were managingthese.

Vision and strategy

• The service had a vision for what it wanted toachieve and a strategy to turn it into action,developed with all relevant stakeholders. Thevision and strategy were focused on sustainabilityof services and aligned to local plans within thewider health economy. Leaders and staffunderstood and knew how to apply them andmonitor progress.

• There was a clear set of values for the service, althoughnot all staff were able to recall these. The values for theservice included being caring and friendly, professional,innovative, accessible and patient focussed. We spokewith a small number of staff who were not able toremember the values and referred to a quality policy asan aide memoir. We did not notice the values displayedin the imaging centre but noted they were on display inthe mobile units. However, throughout the inspection,staff continually demonstrated the values of theorganisation, in the way in which they spoke about andengaged with patients.

• There was a future vision for the service. There was aclear focus of maintaining and expanding currenthigh-quality services including further health screeninginitiatives. The vision was also to continue to contributeand expand on education and participation in ongoingresearch. Staff spoke with knowledge of the variousresearch programmes the service recruited patients for.There was an enthusiasm to help research projects andthe service had exceed the anticipated number ofpatient scans. The service was developing a ‘school ofimaging’ and working with a national equipmentprovider and a local university to develop an academyand to support post-graduate students with learningopportunities. The service was also working withanother local university to contribute towards thetraining programme for radiographer students.

• There was a realistic strategy. We spoke with leaders atvarious levels and all displayed awareness of andcommitment to plans to expand services. This alsoincluded the development of their role in research anddevelopment programmes to extend educationopportunities for their own staff and staff from the localNHS trust. The service worked with a local university toexplore opportunities to deliver teaching and facilitatestudent radiographer placements.

• The service had plans for the replacement of high costequipment and it was evident that this was reviewedregularly to ensure ongoing services could bemaintained.

Culture

• Staff felt respected, supported and valued. Theywere focused on the needs of patients receivingcare. The service promoted equality and diversityin daily work and provided opportunities for careerdevelopment. The service had an open culturewhere patients, their families and staff could raiseconcerns without fear.

• Staff at the imaging centre and in the mobile units feltsupported, valued and respected. Staff told us they hadsupportive relationships with their managers and feltcomfortable to approach them with any concerns orissues they may have. They felt the environment wassupportive and the culture was “friendly”, “kind”, “open”and “transparent”. Staff told us “it is a lovely place towork” and discussed the flexibility to achieve a goodwork/life balance.

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• The service was centred around the needs of thepatients. It was clear from observing care and the waystaff interacted with patients that staff were committedto providing high quality care for patients. Staffdemonstrated pride in their work and the service theydelivered to patients and their service partners.

• Senior leaders were proud of the service they gave topatients and in supporting the NHS to achievediagnostics for patients. Staff spoke positively aboutsenior leaders and the chief executive. They highlightedgood team work and good communication as positiveaspects of working for the service.

• Equality and diversity was promoted. It was part ofmandatory training, and non-discriminatory practiceswere part of usual working practice.

• The provider had a whistleblowing policy and a freedomto speak up policy which supported staff to be open andhonest. The service had also appointed a freedom tospeak up guardian and a deputy for staff to access andraise concerns if required. Staff were aware of who thefreedom to speak up guardian was and the name of thedeputy for the service. The senior management teamtold us they were looking to recruit to this post;however, there was no advert out for this at the time ofour inspection. Staff told us they would have noconcerns in approaching the deputy if required.

• All independent healthcare organisations with NHScontracts worth £200,000 or more are contractuallyobliged to take part in the Workforce Race EqualityStandard (WRES). Providers must collect, report,monitor and publish their WRES data and act whereneeded to improve their workforce race equality.Although the provider collected this information, seniorstaff told us publishing it may lead to the identificationof individuals due to the service being small. We weretold the service was seeking support with how topublish this information whilst maintaining theanonymity of individuals.

Governance

• There were governance frameworks to support thedelivery of good quality care. However, furtherwork around audit was required to strengthen thegovernance of the service. Staff at all levels wereclear about their roles and accountabilities and hadregular opportunities to meet, discuss and learnfrom the performance of the service.

• The service had local governance processes, which wereachieved through team meetings and local analysis ofperformance and discussions around other aspects ofthe service, including incidents and complaints. This fedinto processes at a corporate level.

• Performance measures were reported and reviewed.Key performance indicators (KPIs) were maintained forMRI and PET/CT and reviewed at the clinical committeemeeting. KPIs were also sent to the commissioners toprovide feedback about how the service wasperforming.

• Governance processes and oversight was achievedthrough committee meetings and analysis ofperformance. The clinical governance committee metevery six months, with the sub-committees meetingmore frequently. There had been a recent change in thesub-committees, with some committees being replacedwith others. This was due to some of the meetingsduplicating the conversations. The service had servicelevel agreements for the provision of services such asradiation protection advisor, medical physics supportand support for nuclear medicine which was providedby an NHS trust.

• Local governance processes were achieved throughregional clinical governance meetings, but these werenot always held as often as they were meant to be. Themeetings were due to be held bi-monthly but hadrecently slipped to being held every six months. Seniorleaders acknowledged this and were planning to getback to holding meetings bi-monthly. We reviewedminutes from the clinical governance committeemeetings held in September 2018 and March 2019.These had a rolling agenda which included discussionsaround adverse reactions, incidents and near misses,new policies, risk, the report from the informationgovernance committee and a review of the risk register.Feedback and actions from performance discussion oflocal incidents at subcommittee level were fed into theclinical governance committee. We saw evidence of thisprocess through reviewing minutes of meetings. Minutesprovided depth and detail of discussion held undereach agenda item.

• The clinical committee had been established in May2019 to replace the senior management committeemeeting. Incidents, complaints, KPIs and training wereincluded as items for discussion at this meeting. We

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reviewed the minutes from the first meeting in May 2019.The minutes contained limited information as to thedepth of the discussions held and level of scrutinyaround the issues.

• There were radiation protection committee meetingswhich were held yearly. Issues from this meeting werethen fed into the clinical governance meetings. Thissub-committee could hold additional meetings if therewas a requirement throughout the year. Minutesdemonstrated in-depth discussions around each areaon the agenda.

• There were processes to monitor the quality and reportturnaround times. The quality of images was peerreviewed and quality assured. Deficiencies in imageswere highlighted to the member of staff for theirlearning. The service told us that due to demand andcapacity, they had been unable to meet their internaltarget of reviewing 10% of images for each modality on amonthly basis. Due to this, they had hired an externalcompany to carry out this work to ensure targets weremet. We reviewed audits which had been carried out onimages from X-ray, MRI and MRI on the mobile units. Theyear to date results for all three areas demonstrated thequality of the images and the reporting was of highquality with no action required.

• There was a comprehensive programme of audit,however from the small sample of audits we reviewed itwas not always clear whether there was comprehensiveoversight of the audit programme. The servicemaintained an audit matrix which identified the auditsrequired and the timeframe in which they had to becompleted. These included monthly, annual orbi-annual audits consisting of clinical, infection control,information governance, finance and corporate. Fromthe few we reviewed, we found there was not always aformal process to identify the actions required to makethe necessary improvements and no record of who wasresponsible for overseeing these actions wereimplemented and embedded. There was also noindication when actions had been completed. Followingthe inspection, the service told us they had completed areview of their audits and had developed action planswhere they identified an audit had not met its set target.

• We discussed the service’s recent Quality Standard forImaging (QSI) (formerly ISAS) accreditation. There weretwo actions required before accreditation could beissued. However, there was no action plan to

demonstrate these actions had been achieved,although we were told evidence of completed actionshad to be sent to QSI before accreditation could beissued.

• In another example, we discussed an audit which wasdesigned to audit compliance with asking womenbetween the ages of 12 and 55 about their pregnancystatus. The audit result showed 85% compliance againstan internal target of 100%. There was no action plan tosupport improvement and no plan to re-audit againuntil 2020.

• Staff were clear about their roles and understood whatthey were accountable for. Staff were supported inincident reporting, and championing and implementinglocal policies and protocols. All clinical staff wereprofessionally accountable for the service and care thatwas delivered within the unit.

• The hospital had a paediatric management policy,however some responsibilities outlined in the policywere not being followed. The policy stated, ‘Cobaltclinical staff had immediate life support (ILS) training foradults and limited training in paediatric resuscitationprocedures.’ We saw evidence staff had ILS training butno training in paediatric life support.

• Senior leaders sought assurance about the ongoingwork carried out by the mobile units. The service hadgood working relationships with the hosting NHShospitals, and met with one NHS trust regularly todiscuss the work carried out by the service. Each mobileunit provided a daily report of scans carried out whichhighlighted any issues they had. The service had adesignated radiographer who travelled between mobileunits to provide support and act as the link between themobile units and the imaging centre headquarters inCheltenham.

• The service made sure all staff underwent appropriatechecks as required by Schedule three of the Health andSocial Care Act 2008 (Regulated Activities) Regulations2014. We reviewed two randomly selected staff fileswhich held all the required information in accordancewith legislation.

Managing risks, issues and performance

• Leaders and teams used systems to manageperformance. However, there were limited risksassociated with children attending the service on

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the risk register. We were not assured risks werebeing regularly reviewed and that actions werebeing acted on. The service had plans to cope withunexpected events.

• There were systems and processes to identify andmanage risks and mitigating actions and a corporaterisk register was maintained. Risks were assessed usinga risk matrix to identify the level of risk. The risk registeridentified controls and actions which had been taken tomitigate the risks. Each risk had a named responsibleperson associated assigned as the ‘risk owner’ meaningthey were responsible for ensuing actions were carriedout to lower or remove risks. Risks included operationaland information governance risks.

• However, we were not assured risks were being regularlyreviewed as we found limited evidence to demonstraterisks were discussed. Risks for the service were reviewedyearly by the board of trustees. We saw evidence of thisin meeting minutes from September 2018, althoughthere was no detail behind the discussions and the levelof scrutiny regarding the issues. A discussion around riskand the risk register was part of the agenda for thebi-annual clinical governance committee meetings. Theminutes from the September 2018 meeting requestedstaff to ‘consider the risks allocated to this committeeand remove / add any they feel are appropriate so thatthis can be reviewed at the next meeting.’ We reviewedthe minutes from the March 2019 meeting. These state‘no risks were tabled for review at this meeting.’ We onlyfound evidence of two other discussions around risksfrom June 2018, which requested staff to feedback riskswhich needed to be taken to the board but did notinclude any documented information to demonstrate adiscussion had taken place. We saw onefurther discussion around new risks in the financecommittee meeting minutes from March 2019.

• We had no assurance the due date for mitigating actionshad been achieved or implemented. The risk registeridentified mitigating actions along with a responsibleperson and a due date for completion. The risk registeridentified review dates for different risks to becompleted by January, September, and December 2018,and March 2019. It was unclear whether these had beencompleted, whether they were ongoing, how often theywere being reviewed or what discussion had been heldaround each of the actions.

• There were limited entries on the risk register relating tothe service provided for children. The only risk identified

was around children’s safeguarding. We were notassured risks to children were clearly identified andmanaged. The risk assessment for children attendingPET/CT did not identify the recommendations made bythe Royal College of Radiologists: ‘Guidelines for the useof PET/CT in children.’

• Risk assessments were completed for various aspects ofoperational activity across the services. We reviewedsome risk assessments which had been completed. Thedocuments contained a good description of the risk andits consequences, along with the control measures andactions taken to mitigate the risks. The risk was alsorated and identified a responsible owner and atimeframe for review.

• All eligible staff had had their professional registrationchecked in the last 12 months. All radiographers wereHealth and Care Professions Council (HCPC) registeredand met the standards to ensure delivery of safe andeffective services to patients.

• There was a major incident policy and businesscontinuity plans if the service was to experience a majorincident. The policy covered the roles andresponsibilities of the staff in major incidents andprovided action cards for staff to follow for variousmajor incidents. These included failure of the MRI andPET/CT scanners, a PET radiopharmaceutical major spill,IT system failure, flood, or catastrophic power failure.The business continuity plan provided a risk score forincidents which were likely to affect and impact on theservice. An impact analysis had been carried out foreach incident, along with the resource requirements forrecovery along with associated timeframes.

Managing information

• The service collected reliable data and analysed it.Staff could find the data they needed, in easilyaccessible formats, to understand performance,make decisions and improvements. Theinformation systems were integrated and secure.Data or notifications were consistently submittedto external organisations as required.

• Information was shared between the service and thelocal NHS trusts they provided services for as part oftheir contracted work. This enabled images to bereported on by local radiologists and helped to maintain

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the flow of patients through the system. Informationfrom scans could also be reviewed remotely by referrersto give timely advice and interpretation of results todetermine onward patient care.

• Staff at the imaging centre and on the mobile units hadaccess to provider policies and resource materialthrough the internal computer system. Staff couldlocate and access relevant key records electronically.Information was also available at the imaging centreand the mobile units in paper form. This enabled staff tocarry out their day to day roles. All staff were familiarwith the local rules for the service and how they couldaccess these.

• There were enough computers at the imaging centreand on the mobile units for staff to be able to access thesystem when they needed to. Staff used radiologyspecific software systems to ensure relevant people hadaccess to scans. All IT systems were password protectedto ensure only authorised persons could gain access. Inthe mobile scanner units, staff were provided withlaptops belonging to the hosting trust to enable them toaccess relevant information about patients such aswhen they had arrived. This also allowed staff tocommunicate directly with referring clinicians by email ifthey needed specific clarification.

• The service was aware of the requirements of managinga patient’s personal information in accordance withrelevant legislation and regulations. Electronic patientrecords were kept secure to prevent unauthorisedaccess to data. Authorised staff demonstrated theycould be easily accessed when required.

Engagement

• Leaders and staff actively and openly engaged withpatients, staff, the public and local organisations toplan and manage services, but there was notalways evidence to demonstrate recommendationshad been acted on. They collaborated with partnerorganisations to help improve services for patients.

• Patients’ views and experiences were gathered and usedto shape and improve the services and culture.Following their visit to the unit, patients were sent asatisfaction questionnaire. In April 2019, out of 1,172questionnaires sent out, 107 patients responded (9.1%).Data showed 84.8% of respondents rated the service asvery good, 9.4% rated it as good and 5.5% felt it wasneither good nor poor. Only 0.3% of patients rated theunit as poor. In May 2019, out of 1,227 questionnaires

sent out, 280 (22.8%) were returned. The generalanalysis of the survey demonstrated 85.6% ofrespondents rated the unit as very good, 10.2% rated itas good and 3.5% felt it was neither good nor poor. Lessthan 1% of respondents rated the unit as poor or verypoor.

• There was regular engagement with commissioners tounderstand the services they required and how theycould be improved. This produced an effective pathwayfor patients. The service had a good relationship withthe host hospital NHS trusts and staff told us seniorsfrom the trusts were supportive and reported good linesof communication.

• The service received feedback from staff. A staff surveywas carried out on a yearly basis, with 62 staffcompleting the survey in 2018. The survey identified alist of recommendations, including clarification aboutthe line management structure, action to improvehealth and wellbeing, ensuring appraisals were carriedout in a timely way, improving communication betweenmanagement and staff and creating more careeropportunities for staff. The recommendations had adate next to them indicating when they needed to becompleted, however there was no formaldocumentation or audit trail to show that the actionshad been implemented. Following the inspection wewere sent additional evidence to demonstrate that therecommendations form the survey had been acted onand implemented.

Learning, continuous improvement and innovation

• All staff were committed to continually learningand improving services. They had a goodunderstanding of quality improvement methodsand the skills to use them. Leaders encouragedinnovation and participation in research.

• The service was committed to improving services bypromoting training, research and innovation. Theservice had been part of 33 different national andinternational research studies. These included anoncology project such as lymphoma, oesophagealcancer and myeloma. The service funded two researchnurses to help research projects into diagnosis ofdementia using PET/CT scans and a research fellowworking at a local university to develop further research.

• In 2017, the service purchased a cone beam CT (CBCT)scanner. The clinical imaging site in Cheltenham was the

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first clinical site in the world for this new system. Thescanner enabled patients to have their joints scanned ina weightbearing position, enhancing optimal diagnosisfor patients.

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Outstanding practice

• Staff worked closely with the referring NHS trust tocarry out additional scans when significant findingswere identified. This prevented patients from having toreturn to the service for additional scans which couldlead to a delay in accessing treatment.

• The provider offered 800 free scans to support thelocal NHS trust to meet demand and ensure timelydiagnostic scans for patients.

• Cobalt Health provided facilities free of charge for thelocal NHS trust to carry out ‘one stop’ clinic forpatients referred for musculoskeletal complaints.Patients could receive scans and advice or treatmentwithout the need for further waiting to attend forscans.

• Cobalt Health provided facilities free of charge toaccommodate a breast screening service provided bythe local NHS trust to help them meet demand.

Areas for improvement

Action the provider MUST take to improve

• Ensure Patient Group Directions have the necessaryauthorisation to enable approved use.

• Ensure there is an active Patient Group Direction forthe use of saline when giving medicines or radioactivetracers intravenously.

Action the provider SHOULD take to improve

• Consider ways to demonstrate compliance with thedaily cleaning of scanning rooms and keep these up todate.

• Review risk assessments regularly to make sure theyremain in line with national guidance.

• Take account of all relevant sources of advice inassessing risks and managing paediatrics safely.

• Document the outcomes of risk assessments whichare carried out on an individual patient basis,including those around mental capacity, to ensurethere is an audit trail with the rationale behind thedecisions taken.

• Consider documenting when patients have receivedpost-care information and patient presentation onleaving the unit to ensure a clear record of the careprovided is in the patient record.

• Look at ways to provide assurance thatrecommendations from audits have been acted onand implemented.

• Monitor compliance with all aspects of policies.• Improve the quality of meeting minutes to provide

detail around the discussions held.• Identify, mitigate, review and discuss all risks

associated with the service and maintain records ofeach activity.

• Act on recommendations from the staff survey.

Outstandingpracticeandareasforimprovement

Outstanding practice and areasfor improvement


Action we have told the provider to takeThe table below shows the legal requirements that were not being met. The provider must send CQC a report that sayswhat action they are going to take to meet these requirements.

Regulated activity

Diagnostic and screening procedures

Treatment of disease, disorder or injury

Regulation 12 HSCA (RA) Regulations 2014 Safe care andtreatment

Regulation 12(1) – Care and treatment must be providedin a safe way for service users.

Patient group directions (PGDs) were not used inaccordance with The Human Medicine Regulations 2012regulation.

There were no PGDs for the use of saline, which meantthese were given without a prescription or authorisation.

Regulation

This section is primarily information for the provider

Requirement noticesRequirementnotices


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