the gynaecology ultrasound centre

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 Requires improvement –––

Are services safe? Requires improvement –––

Are services effective?

Are services caring? Good –––

Are services responsive? Good –––

Are services well-led? Inadequate –––

Mental Health Act responsibilities and Mental Capacity Act and Deprivation of LibertySafeguardsWe include our assessment of the provider’s compliance with the Mental Capacity Act and, where relevant, MentalHealth Act in our overall inspection of the service.

We do not give a rating for Mental Capacity Act or Mental Health Act, however we do use our findings to determine theoverall rating for the service.

TheThe GynaecGynaecologyology UltrUltrasoundasoundCentrCentreeQuality Report

137 Harley StreetLondonW1G 6BFTel:0207 7250521Website: www.ultragyn.co.uk

Date of inspection visit: 22 January 2019Date of publication: 08/04/2019

1 The Gynaecology Ultrasound Centre Quality Report 08/04/2019

Further information about findings in relation to the Mental Capacity Act and Mental Health Act can be found later inthis report.

Overall summary

The Gynaecology Ultrasound Centre is operated by TheGynaecology Ultrasound Centre Limited. Facilities includetwo clinical rooms for examinations and ultrasoundscanning. There is a changing cubicle and a clinicalstorage area in each room.

The Gynaecology Ultrasound Centre is a standaloneservice and provides a private clinical and diagnosticservice for women with concerns about theirgynaecological health, including early pregnancy. It doesnot provide a service to NHS patients. The centre offerstransvaginal and transabdominal scanning as well as twoand three-dimensional scans where appropriate. Mostwomen are referred by their consultant or GP. It providesgynaecological diagnostic services to women andchildren under 18 years of age.

We inspected this service using our comprehensiveinspection methodology. We carried out theunannounced part of the inspection on 22 January 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.

The main service provided by this hospital was diagnosticimaging.

Services we rate

We rated this service as Requires improvement overall.

We found areas of practice that were inadequate in thisservice:

• Systems for the management and referral ofsafeguarding concerns did not reflect current bestpractice in relation to safeguarding adults.

• The providers statement of purpose did not reflectits services for patients under 18 years of age.

• At the time of inspection, the provider did not have asafeguarding children policy in place, despitetreating patients under the age of 18.

• At the time of inspection, the service had no processin place to audit infection control measures,including hand hygiene and regular cleaning.

• The service did not follow best practice when storingmedicines.

• At the time of inspection, the provider did not have aformal incident reporting mechanism in place which

• Policies, procedures and guidelines did not alwaysreference current legislation, evidence-based careand treatment or best practice.

• The service did not always make sure staff werecompetent for their roles.

• Staff had not completed dementia or learningdisability awareness training. The service plannedand provided services in a way that met the needs oflocal people.

• Risk and audit were not embedded within themanagement of the service and there was a lack ofoverarching governance.

• The service did not have systems to identify risks,plan to eliminate or reduce them, and cope withboth the expected and unexpected.

However, we found the following areas of good practice:

• The clinical environment was visibly clean and tidyand staff decontaminated ultrasound equipmentafter use.

• The service had sufficient staff to provide the rightcare and treatment.

• Recent audits demonstrated effective and safepractice.

Summary of findings


• Staff were aware of the importance of gainingconsent from patients before conducting anyprocedures.

• Staff worked well together to place the patients atthe centre of service and ensure their comfort andsatisfaction.

• Staff were supportive, caring and ensured patient’sprivacy and dignity was maintained.

• The service planned and provided services in a waythat met the needs of those who used the service.

• The manager promoted a positive culture thatsupported staff and created a sense of commonpurpose based on shared values.

• The service engaged well with patients and staff.

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 that affected this service. Details areat the end of the report.

Prior to the publication of this report the providerprovided evidence that it was in the process ofaddressing the concerns we had raised with them.

Dr Nigel Acheson

Deputy Chief Inspector of Hospitals (London andSouth)

Summary of findings


Our judgements about each of the main services

Service Rating Summary of each main service

Diagnosticimaging

Requires improvement –––

Ultrasound scanning was the only core serviceprovided. We rated this service as requiresimprovement overall. We rated well-led asinadequate and safe as requires improvement. Werated caring and responsive as good. Effective wasnot rated. Systems for the management andreferral of safeguarding concerns did not reflectcurrent best practice. There was no safeguardingchildren policy in place and staff did not have theappropriate level of safeguarding training. Theservice did not have an incident reportingmechanism in place. Policies, procedures andguidelines did not always reference currentlegislation, evidence-based care and treatment orbest practice. The providers statement of purposedid not reflect its services for patients under 18years of age. The service did not systematicallyimprove service quality and there was a lack ofoverarching governance. The service did not havesystems to identify risks, plan to eliminate orreduce them.However, we also found the service had enoughstaff to provide the right care and treatment. Staffcared for patients with compassion. Feedbackfrom patients confirmed that staff treated themwell and with kindness. Managers promoted apositive culture that supported and valued staff.The service engaged well with patients and staff.

Summary of findings


Contents

PageSummary of this inspectionBackground to The Gynaecology Ultrasound Centre 7

Our inspection team 7

Information about The Gynaecology Ultrasound Centre 7

The five questions we ask about services and what we found 9

Detailed findings from this inspectionOverview of ratings 12

Outstanding practice 22

Areas for improvement 22

Action we have told the provider to take 23

Summary of findings


The GynaecologyUltrasound Centre

Services we looked atDiagnostic imaging

TheGynaecologyUltrasoundCentre



Background to The Gynaecology Ultrasound Centre

The Gynaecology Ultrasound Centre is a standaloneindependent private service in central London andaccepts self-referrals as well as referrals from consultantsand general practitioners. The service opened in 2003and registered with CQC in 2013.

The service is registered for diagnostic and screeningprocedures. During our inspection the provider informedus they were also providing scans for children under 18years of age, this was not recorded on their statement ofpurpose.

The service has had a registered manager in post sinceFebruary 2013. This person is also the nominatedindividual.

Our inspection team

The team that inspected the service comprised a CQClead inspector, and a specialist advisor with expertise inradiological services. The inspection team was overseenby Terri Salt, Head of Hospital Inspection.

Information about The Gynaecology Ultrasound Centre

The registered location was registered to provide:

• Diagnostic and screening procedures

• Family planning

We inspected the registered location in Harley Street,London. We spoke with eight staff including thenominated individual/registered manager and clinicmanager. We also spoke with health care assistants,secretarial staff and medical staff.

We spoke with two patients and reviewed two patientrecords.

There were no special reviews or investigations of theservice ongoing by the CQC at any time during the 12months before this inspection. The service was notpreviously inspected since registration with CQC in 2013.

Activity (1 January 2018 to 31 December 2018)

• The service performed ultrasound scans on 10,671adults and 218 on patients under 18 years of age.

• All activity within the service was privately fundedand no NHS patients were treated.

• There was a combined reception and waiting roomon the ground floor. The two clinic rooms were onthe first floor, which was accessible by stairs or lift.

The clinic manager, deputy clinic manager, secretary andhealthcare assistants worked full time at the service. Theregistered manager was a consultant and worked parttime at the service. Eight consultants worked at theservice under practising privileges.

The service did not use any medicines and therefore theydid not have an accountable officer for controlled drugs(CDs).

Track record on safety between 1 January and 31December 2018:

• There were no Never Events

• No serious injuries

• No incidences of healthcare acquiredMeticillin-resistant Staphylococcus aureus (MRSA).

• No incidences of healthcare acquiredMeticillin-sensitive staphylococcus aureus (MSSA).

Summaryofthisinspection

Summary of this inspection


• No incidences of healthcare acquired Clostridiumdifficile (C.diff).

• No incidences of healthcare acquired E-Coli.

• Three formal complaints which were upheld.

Services accredited by a national body:

• The service had no accreditation by a national body.

Services provided at the centre under service levelagreement:

• Clinical and or non-clinical waste removal.

• Laundry.

• Maintenance of medical equipment.

• Oxygen supply.

• Pathology.

• Information technology support.




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 safe as Requires improvement because:

• Systems for the management and referral of safeguardingconcerns did not reflect current best practice in relation tosafeguarding adults.

• At the time of inspection, the provider did not have asafeguarding children policy in place, despite treating patientsunder the age of 18. They submitted one following inspection.

• At the time of our inspection, the provider had no access to stafftrained at level three safeguarding children. However, followinginspection we were informed that the designated safeguardinglead completed level three safeguarding training.

• All other members of staff had level one safeguarding adultsand children training despite the fact that they acted aschaperones.

• At the time of inspection, the service had no process in place toaudit infection control measures, including hand hygiene andregular cleaning. The provider submitted a clinical audit toolfollowing inspection which identified areas for regular audit.

• Resuscitation equipment was in three different places and wasnot readily accessible.

• The service did not follow best practice when storingmedicines.

• The provider did not have a formal incident reportingmechanism and told us they dealt with incidents as they arosebut were unable to provide evidence of any such incidents.

However, we also found:

• All consultants with practising privileges had current level 2safeguarding adults and level 2 safeguarding children trainingas part of their employment within the NHS.

• Staff we spoke with knew how to identify and escalate adultand child safeguarding issues if they arose.

• The provider had systems in place which ensured patientidentification was confirmed against three points of patientidentity including full name, date of birth and address.

• The clinical environment we visited during our inspection wasvisibly clean and tidy and staff decontaminated ultrasoundequipment after use.

• The service had sufficient staff to provide the right care andtreatment.





Are services effective?We do not rate effective.

We found:

• Policies, procedures and guidelines did not always referencecurrent legislation, evidence-based care and treatment or bestpractice. They were not routinely updated or version controlled.

• Managers did not consistently monitor the effectiveness of careand treatment and use the findings to improve them.

• The service did not always make sure staff were competent fortheir roles.

• Staff told us they had not completed any dementia or alearning disability awareness training.

• The provider did not have a Mental Capacity Act 2005 (MCA)policy in place and non-clinical staff did not Mental Capacity Acttraining included in their mandatory training.

However, we also found:

• Recent audits of early scan safety and hysterosalpingo contrastdemonstrated effective and safe practice.

• Staff were aware of the importance of gaining consent frompatients before conducting any procedures. We observed staffgaining consent from patients prior to starting their ultrasoundscan.

Are services caring?We rated caring as Good because:

• Staff were supportive, caring and ensured patient’s privacy anddignity was maintained.

• Staff had sufficient time to support patients.• Staff provided emotional support to patients to minimise their

distress.• Staff involved patients and those close to them in decisions

about their care and treatment.

Good –––

Are services responsive?We rated it as Good because:

• The service planned and provided services in a way that metthe needs of people receiving the service.

• People could access the service when they needed it.• The service treated concerns and complaints seriously and

investigated them in accordance with the provider’s complaintspolicy.

Good –––

Are services well-led?We rated well-led as Inadequate because:

Inadequate –––




• The provider’s statement of purpose did not reflect its servicesfor patients under 18 years of age.

• Risk and audit were not embedded within the leadership of theservice.

• The service did not systematically improve service quality andthere was a lack of overarching governance.

• The service did not have systems to identify risks, plan toeliminate or reduce them, and cope with both the expectedand unexpected.

• The service did not have an incident reporting mechanism andso it was not possible to detect incident themes and patternsand learn from them.

However, we also found:• The manager promoted a positive culture that supported staff

and created a sense of common purpose based on sharedvalues.

• The service engaged well with patients and staff.




Overview of ratings

Our ratings for this location are:

Safe Effective Caring Responsive Well-led Overall

Diagnostic imaging Requiresimprovement N/A Good Good Inadequate Requires

improvement

Overall Requiresimprovement N/A Good Good Inadequate Requires

improvement

Detailed findings from this inspection


Safe Requires improvement –––

Effective

Caring Good –––

Responsive Good –––

Well-led Inadequate –––

Are diagnostic imaging services safe?


We previously did not have the authority to rate thisservice. However, on this inspection we did haveauthority to rate and we rated safe as requiresimprovement.

Mandatory training

• The service provided mandatory training incertain areas to staff all of whom had completedit.

• The provider did not have a policy for mandatorytraining and mandatory training comprised of first aid;safeguarding adults and safeguarding children level 1;equality and diversity and General Data ProtectionRegulation(GDPR). Staff told us this training was viae-learning and they could complete this during thecourse of the working day.

• Data submitted following inspection showed thatthere were six staff eligible to complete this training. Ofthese, three had completed first aid and five hadcompleted equality and diversity and GDPR training.

• The providers statement of purpose did notspecifically relate to staff training in order to meet theneeds of patients under the age of 18 years. We didnot see any additional training for directly employedstaff to support this activity. Consultants withpractising privileges had completed relevant trainingin their substantive employment.

Safeguarding

• Staff we spoke with understood how to protectpatients from abuse, however systems for themanagement and referral of safeguardingconcerns did not reflect current best practice inrelation to safeguarding adults and the providerhad no safeguarding children policy in place.

• The service did not have a formal system in placewhere alerts for known safeguarding concerns couldbe activated and the provider had no links to externaladvice or guidance in relation to safeguardingchildren.

• At the time of inspection, the provider did not have adedicated safeguarding children policy or protocol inplace. There was brief reference made to safeguardingchildren in the incident reporting policy but theguidance referred to [Department for Children Schoolsand Families 2006] was out of date.

• Following inspection, the provider submitted theirsafeguarding children policy. This identified thesafeguarding lead and gave guidance to staff aboutthe different types of abuse. However, the policy alsoidentified a deputy safeguarding lead despite themonly having level 1 safeguarding children training.

• The policy did not include any reference to femalegenital mutilation (FGM). The FGM mandatoryreporting duty is a legal duty provided for in the FGMAct 2003 (as amended by the Serious Crime Act 2015).The legislation requires regulated health and socialcare professionals and teachers in England and Walesto make a report to the police where there are reportsor concerns about FGM having taken place.

• The provider had a safeguarding adults protocolwhich was not dated and had no version control. The

Diagnosticimaging

Diagnostic imaging



protocol did not relate to key areas in relation to thesafeguarding of adults, including female genitalmutilation (FGM), forced marriage, domestic violence,modern slavery or on-line protection. Five out of sixpermanent staff had level I safeguarding adultstraining and one (designated safeguarding lead) waslevel 2 trained.

• At the time of inspection, five members of staff, all ofwhom acted as chaperones, had level 1 safeguardingchildren training.

• However, according to the ‘Safeguarding children andyoung people: roles and competences for health carestaff Intercollegiate document: Third edition: March2014’ which sets out minimum training requirements,all non-clinical and clinical staff who have any contactwith children, young people and/or parents/carersshould have level 2 safeguarding children training.

• The designated safeguarding lead had level twosafeguarding children training and was unaware thatthe designated lead must have level 3 safeguardingchildren training for the role.

• Following inspection, we were informed they hadcompleted their level three safeguarding childrentraining.

• Staff could describe some examples of what mayconstitute a vulnerable person including those at riskof domestic violence and abuse. However, most wereunable to describe to us female genital mutilation andsigns to be aware of.

• We confirmed that all consultants with practisingprivileges had current level 2 safeguarding adults andlevel 2 safeguarding children training as part of theiremployment within the NHS.

• The provider had systems which ensured patientsidentification was confirmed against three points ofpatient identity including full name, date of birth andaddress. Patient details were also matched against theoriginal referral form. These processes ensured theright person received the right type of scan.

Cleanliness, infection control and hygiene

• The service did not control infection riskconsistently well.

• At the time of inspection, the service had no process inplace to audit infection control measures, includinghand hygiene and regular cleaning.

• The provider submitted a clinical audit tool followingthis inspection. This included audit of areas such asclinical environment; equipment waste and sharps.

• We observed how staff in clinical areas were notalways ‘bare below the elbows’ and there were noinfection control audits in place.

• Staff used paper towel to cover the examination couchduring a scanning procedure. We observed staffchanged this in between each patient. However, theydid not clean the examining couch in betweenpatients. We were told couches were cleaned at theend of each day but there was no checklist maintainedto confirm this was done.

• We saw staff used disposable gloves duringprocedures but there was no evidence of aprons beingworn.

• The clinical environment we visited during ourinspection was visibly clean and tidy. However, therewas no cleaning schedule in place.

• We observed staff decontaminating equipment afteruse. They used an automated machine to steriliseprobes. Each probe serial number was recorded onthe patient’s record in order to provide a trackingsystem in case of infection.

• The clinical area had dedicated hand washing facilitiesand staff and patients had access to hand sanitiser.

• There were no reported incidents ofhealthcare-associated infections reported for thisservice in the preceding twelve months.

Environment and equipment

• There were appropriate arrangements forensuring clinical equipment was maintained andserviced in line with manufacturer guidelines.

• The provider had resuscitation equipment whichincluded a defibrillator, oxygen and resuscitationdrugs. However, these were all kept in separate places;the oxygen was kept in a cupboard on the groundfloor; the resuscitation drugs were kept in one clinical

Diagnosticimaging

Diagnostic imaging



room and the defibrillator was kept in a cupboard inthe office along with general files. One member of staffwe spoke with was unclear where the defibrillator waskept.

• We pointed this out to the provider who told us thiswould be remedied by siting a resuscitation trolley inthe office for immediate access.

• We were told that all electrical equipment waschecked as per safety recommendations. However, thelabels to confirm this were not visible on theequipment. A member of staff subsequently showedus these labels which were kept separately in a file.This meant that proof of testing was not readilyavailable for assurance.

• There was a sharps bin in each of the clinical rooms,both of which were undated. These contained sharpsand single use equipment. Staff told us the bins werereplaced on a regular basis by a private contractor.

• Staff told us they had sufficient amounts of equipmentto provide the service and said the equipment theyused was of a good standard.

Assessing and responding to patient risk

• Staff completed and updated medicalquestionnaires for each patient. They kept clearrecords and asked for support when necessary.

• All staff were trained in basic life support and told usthey would put their training into use until anambulance arrived. Since the service started, staffreported no incidences of having to call for anambulance.

• All patients who underwent a transvaginal ultrasoundscan were asked on two separate occasions if they hadany allergies to latex. The service had both latex andnon-latex covers for the transvaginal ultrasound probeand would select the cover according to the responsefrom the patient.

• The service had clear procedures in place to guidestaff on what actions to take if any suspicious findings(whether expected or unexpected) were found on theultrasound scan performed.

• The provider did not have eligibility criteria for theservice; however, a medical questionnaire was used toscreen patients and if there were any concerns theprovider would refuse treatment and give a fullexplanation why.

• We observed two scans with patient permission andsaw that the patient identification was verified prior tothe start of the procedure.

Staffing

• The service had enough staff to provide the rightcare and treatment.

• This was a privately-owned service that offeredultrasound services to self-funding patients. Thenominated individual/registered manager workedbetween one and two days per week. In addition,there were seven consultant obstetricians andgynaecologists who worked on a regular basis at theservice under practising privileges.

• There were three healthcare assistants who supportedthe consultants during each procedure. provideremployed a full-time receptionist and two othersessional

• All clinics had at least one healthcare assistant presentand a receptionist to greet patients and complete allthe necessary records for treatment.

• The service used bank staff infrequently. These wereprevious employees or staff known to the providerfrom their NHS clinics. There were 27 healthcareassistant shifts filled by bank staff between 01September 2018 and 31 December 2018.

The provider told us there was low usage of agencystaff. During inspection, we were told there was noinduction handbook or checklist specific to agencystaff and they were given a ‘tutorial’ on the differentaspects of the clinic and referred to an ‘administrationand clinic handbook’ which was not updated since2012.

Records

• Staff kept detailed records of patients’ care andtreatment. Records were clear, up-to-date andeasily available to all staff providing care.

Diagnosticimaging

Diagnostic imaging



• All patients were given a unique identifying numberand a file was created on the provider’s database. Thiscontained all clinical records, correspondence andreports, results of investigations and signed consentforms.

• Consultants recorded their findings onto the IT systemduring the ultrasound scan. They explained to patientsthat the scan would be sent to the referring doctorthat same day. Patients who self-referred weree-mailed their report. If there were concerns raised bythe scan then the consultant would spend time withthe patient on the day going through the findings. Wewere told that where there were findings of concernthe patient was requested to go to their GP and thiswas followed up with the patient to ensure they didthis.

• Passwords were in place and the user was required toenter a password to gain access to this information. Inaddition to this step there was a ‘firewall’ in place toprevent unauthorised external access to the system.

• We reviewed two patient records during the inspectionwhich had been transferred to the providers secure ITsystem.We found staff recorded all the specifiedinformation in a clear and accurate way.

• The provider told us systems were backed up on adaily basis to ensure that data was secure in the eventof system failure. A disaster recovery system was inplace to ensure that in a disaster situation all criticalsystems and data remain available.

• All patient records were stored on the clinic databasewhich was remotely backed up. Patient records wererequired to be stored for a period of 30 years from thepoint of the last entry into the clinic as a patient.

• All paper patient data that was no longer required wasshredded on-site.

Medicines

• The service did not follow best practice whenstoring medicines.

• Local anaesthetic and resuscitation medicines werestored out of their boxes on a shelf in an unlockablecupboard, alongside cleaning materials. There was no

temperature control indicator in the cupboard androom temperatures were not checked to ensure theyremained at the ambient temperature for safemedicines storage.

• There were no stock control checks done on themedicines and staff confirmed that they would beunable to confirm if any medicine was missing.

• The provider submitted an action plan following thisinspection, with actions to be completed by February2019. This specified that a lockable cupboard to storedrugs and medications will be installed. Athermometer will be purchased and temperatureschecked regularly to ensure the correct storage ofmedicines according to the manufacturer’sinstructions. In addition, there would be a regularstock take and date check of all medicines.

Incidents

• The service did not always manage patient safetyincidents well, staff recognised incidents but didnot have any means by which to report themappropriately.

• At the time of inspection, the provider had an incidentreporting policy which outlined the types of reportableincidents, but not the mechanism by which theincidents should be reported.They told us they did nothave a formal incident reporting system and said theywould deal with incidents as they arose but wereunable to provide evidence of any such incidents.

• Following this inspection, the provider submitted anincident report form to document and describeincidents.

• There were no never events reported for the servicebetween 01 January 2018 and 31 December 2018.Never events are serious incidents that are entirelypreventable as guidance, or safety recommendationsproviding strong systemic protective barriers, areavailable at a national level, and should have beenimplemented by all healthcare providers.

• There were no serious incidents reported for theservice between 01 January and 31 December 2018.

Diagnosticimaging

Diagnostic imaging



Serious incidents are events in health care where thereis potential for learning or the consequences are sosignificant that they warrant using additionalresources to mount a comprehensive response.

• The provider did not apply the Duty of Candourregulation between 01 January and 31 December2018. The duty of candour is a regulatory duty thatrelates to openness and transparency and requiresproviders of health and social care services to notifypatients (or other relevant persons) of certain‘notifiable safety incidents’ and provide reasonablesupport to that person.

Are diagnostic imaging serviceseffective?

We do not rate effective for diagnostic imaging services.

Evidence-based care and treatment

• We reviewed policies, procedures and guidelinesproduced for the service to implement locally.The manager did not have a system in place tocheck to make sure staff followed guidance.

• All staff had access to a policy folder which containedpaper copies of the providers policies. We found thatsome policies and procedures were not routinelyupdated or version controlled.

• The provider had a clinical audit programme in place,some of which had been completed. For example, wesaw results of early scan safety and hysterosalpingocontrast sonography (HyCoSy).

• The early scan audit was carried out in April 2018 on44 early pregnancy ultrasound examination scans.

• Results of this audit showed there was 100%compliance with safety standards.

• There were 197 HyCoSy procedures carried outbetween January and December 2017, of which arandom sample of 20 cases was audited. The outcomeshowed 100% completion of the procedure and lowcomplication rates. Antibiotics were given to allpatients in accordance with the guideline.

• Eighty per cent of cases had a documented negativepregnancy test. The recommendation was that

• The provider submitted their audit programme whichwas planned to commence between March andDecember 2019. This included early scan quality;endometrial thickness measurement; HyCoSy -pregnancy test; early scan safety; diagnosis ofmiscarriage; quality of reporting.

Nutrition and hydration

• Staff had access to a selection of refreshments (tea,coffee and water) which they provided patients insome circumstances if it was safe to do so.

Pain relief

• Patients were asked by staff if they were comfortableduring their ultrasound scans and they were offeredadditional pillows or assisted to alter positions to aidpatient comfort.

• No formal pain level monitoring was undertaken asthese procedures are usually pain free. Patients wererequested to take in their own pain-relievingmedication as a precautionary measure.

Patient outcomes

• Managers did not consistently monitor theeffectiveness of care and treatment and use thefindings to improve them.

• The nominated individual/registered manager told usthere was an informal process of audit. They told usthey sampled random scans on a regular basis butacknowledged that this was not formally recorded.Where there were any discrepancies, they wouldverbally address this with the clinician.

• There were no regular audit meetings for consultantsto learn from each other or give feedback.

Competent staff

• The service did not always make sure staff werecompetent for their roles.

• The provider appointed staff within the organisationto lead on safeguarding adults and children, infectionprevention and control and medicines management.At the time of inspection, none of these members ofstaff had done any additional training or support todevelop their knowledge and skills for thesesignificant roles.

Diagnosticimaging

Diagnostic imaging



• The registered manager told us they appraised staff’swork performance to provide them with support andto monitor the effectiveness of the service. However,since staff were appraised annually, we were notassured this was a robust way in which to measure theeffectiveness of the service.

• Staff told us they were regularly appraised andinformation provided by the service showed 100% ofstaff had received an appraisal within the last 12months.

Multidisciplinary working

• Staff with different roles worked together as ateam to benefit patients.

• This was a small service, however we observed thatworking relationships between clinical andnon-clinical staff were positive and professional. Staffworked well together to place the patients at thecentre of service and ensure their comfort andsatisfaction.

Seven-day services

• The service had taken into consideration therequirement for having a range of appointmentsavailable to patients and therefore appointments werescheduled to ensure patients could attend a clinicdaytime, evenings and Saturdays.

Consent and Mental Capacity Act

• The provider did not have a Mental Capacity Act 2005(MCA) policy in place and non-clinical staff did notMental Capacity Act training included in theirmandatory training.

• We saw no reference made to a child being ‘GillickCompetent’ in any documentation. Children under theage of 16 can consent to their own treatment if theyare believed tohave enough intelligence, competenceand understanding to fully appreciate what's involvedin their treatment. This is known as being Gillickcompetent.

• We saw that all consultants with practising privilegeshad completed mandatory training within their NHSrole.

• Staff were aware of the importance of gaining consentfrom patients before conducting any procedures. Weobserved staff gaining consent from patients prior tostarting their ultrasound scan.

Are diagnostic imaging services caring?

Good –––

We previously did not have the authority to rate thisservice. However, on this inspection we did haveauthority to rate and we rated caring as good.

Compassionate care

• Staff cared for patients with compassion.Feedback from patients confirmed that stafftreated them well and with kindness.

• During our inspection, we spoke with two patientsfollowing their treatment at the clinic. Feedback aboutthe service was positive with comments including“This was slick; the whole process dovetailed nicelyand I only had to take one day off work” and “I woulddefinitely recommend to a friend”.

• The environment had been adapted to ensurepatients privacy and dignity was maintained.

• The service recently initiated an independent patientfeedback survey tool in January 2019 to gatherfeedback. There were no results available at the timeof this inspection.

• We observed how staff did not rush patients whoappeared nervous prior to or during the procedure.They provided care that was patient centred andpatients clearly appreciated this.

• There was a chaperoning protocol which ensuredhealth care assistant staff were present for all patientexaminations. Staff could describe their role and anyactions they would take should they have anyconcerns regarding the conduct of individualclinicians. However, they told us they did not completeany formal chaperoning training.

Emotional support

• Staff provided emotional support to patients tominimise their distress.

Diagnosticimaging

Diagnostic imaging



• Staff supported people through their scans, ensuringthey were kept well informed and knew what toexpect.

• We spoke with staff who told us how providingemotional support to patients was an importantaspect of the work they did. There was a quiet room todiscuss difficult matters when the need arose.Theservice told us that patients could stay with ahealthcare assistant after receiving bad news. Theyensured the patient was in a fit state to travel homeand called a taxi for them if required.

• At the end of all procedures, patients were alwaysgiven advice of what to do if they had concerns aroundtheir health and wellbeing. This included advice tocontact their consultant or general practitioner if theyhad concerns following the scan.

Understanding and involvement of patients andthose close to them

• Staff communicated with patients to ensure theyunderstood the reasons for attending the centre. Allpatients were welcomed into the reception area andaccompanied to the clinical room by a healthcareassistant.

• Staff told us they encouraged patients to askquestions about their scan. Patients could also accessinformation on different types of scans and packagesfrom the Gynaecology Ultrasound Centre website.

• The provider’s website gave information about theconsultants who worked at the service; type of serviceoffered and a description of procedures and relatedcosts.

Are diagnostic imaging servicesresponsive?

Good –––

We previously did not have the authority to rate thisservice. However, on this inspection we did haveauthority to rate and we rated responsive as good.

Service delivery to meet the needs of peoplereceiving a service

• The service offered a range of appointment times anddays, including early evening and Saturday clinics tomeet the needs of the patients who used the service.The nominated individual told us there was varieddemand for appointment times and in most cases,they could accommodate patient requests.

• Appointments were booked by the secretary who rangeach patient and arranged a time which best suitedtheir requirements.

Meeting people’s individual needs

• The service did not always take account ofpatients’ individual needs.

• There was no translation service readily available ifrequired. Staff told us that where English was not thepatient’s first language, they were accompanied by apartner or relative who could translate for them. It isnot considered best practice to have a relative or careract as translator for a patient.

• The service rarely treated people living with dementiaor with a learning difficulty. Staff could not recall atime when a patient with these needs attended theirclinic for an ultrasound scan. They told us that whilstthey had not done any awareness training, they wouldbe able to meet the patient’s needs.

We were told the service ensured that appointmentsfor new patients were of sufficient length to allowthem time to ask questions.

Access and flow

• People could access the service when they neededit.

• We were told that no hard data on waiting times fromreferral to appointment was maintained since mostappointments were arranged within a timeframe toaccommodate the patient. They were booked to seethe consultant best suited to provide them withclinical assessment and advice.

• In the case of a requirement to conduct an urgent scanthe service told us that it would attempt to make anappointment as soon as possible. The service told us

Diagnosticimaging

Diagnostic imaging



that if there were no appointment slots available andthe patient felt they required urgent attention then theservice would request doctors to stay after normalopening hours to accommodate the patient.

• Reports were issued on the same day and were sent tothe referring doctors by facsimile and regular post.Reports were also sent by e-mail in PDF format,subject to patients’ explicit consent. We saw that thisconsent was clearly documented on the patient’snotes.

Learning from complaints and concerns

• The Gynaecology Ultrasound Centre registeredmanager managed and responded to all formalcomplaints.

• There was a complaints handling policy whichoutlined the procedure and how they would be dealtwith, depending on the type of complaint. We notedthat the provider’s complaint policy recommendedthat where complaints were not resolved to thesatisfaction of the complainant, they should contactthe Care Quality Commission (CQC). This is inaccurateadvice since the CQC does not address individualcomplaints.

• Complaints were investigated by the nominatedindividual. The policy stated that complaints wouldacknowledged within two working days and resolvedwithin 20 working days.

• The provider received a total of three writtencomplaints between 01 January and 31 December2018 of which there was no recurrent theme. Onecomplaint related to a letter being sent to a patient’sformer doctor rather than their current one. Staff toldus they now ensured that the current referring doctor’sname was prominently listed on all patient details.

Are diagnostic imaging services well-led?

Inadequate –––

We previously did not have the authority to rate thisservice. However, on this inspection we did haveauthority to rate and we rated well-led as inadequate.

Leadership

• The manager of the service did not have all of theskills and abilities to run a service providinghigh-quality sustainable care.

• There was one service director who was also thenominated individual and registered manager. Therewas also a clinic manager and deputy manager.

• The nominated individual/manager told us they tookfull responsibility for overseeing risk and audit. Theyacknowledged that they did this in an informal wayand did not record any actions they may have taken inthe past. They told us this was something which theyintended to rectify by sharing areas of responsibilitywith consultants with practising privileges in theservice.

• Staff spoke positively about the nominated individual,saying they were approachable and always willing tolisten, offer advice and guidance.

Vision and strategy

• The provider had a vision to continue to providequality care for patients. Staff we spoke with felt theycontributed to the provision of a high-quality service.

Culture

• Staff during our inspection spoke of a positiveplace to work where staff shared information andworked together well to meet the needs of thepatients.

• The provider had a Duty of Candour policy and therewere no duty of candour notifications made between01 January 2018 and 31 December 2018. They told usapologies would always be offered to the patients andstaff would ensure steps were taken to rectify anyerrors.

• Staff understood their responsibility to be open andtransparent with patients when any incidents whichmet the criteria where formal duty of candour requiredimplementation occurred.

Governance

• The service did not systematically improveservice quality and there was a lack ofoverarching governance.

Diagnosticimaging

Diagnostic imaging



• We found areas of concern including the managementand referral of safeguarding concerns which did notreflect current best practice in relation to safeguardingadults and children. There was no formal incidentreporting system in place and best practice was notfollowed when storing medicines.

• The nominated individual/registered manageracknowledged that there was what they termed as an‘under-developed’ governance framework. Forexample, the registered manager cited staff appraisalsas a measure of the quality of the service.

• At the time of inspection, the provider had no systemfor maintaining policies and procedures to ensure theywere up to date, version controlled and met nationalguidance. We found a number of polices for example,safeguarding adults protocol, consent forms fordifferent procedures, World Health Organisationchecklist for interventional procedures and medicalrecords policy were not dated or version controlled.

• Following inspection, the provider submitted a policylog which included all the service polices with versioncontrol and review dates.

• The provider did not have a policy for the safeguardingof children, despite the service seeing patients under18 years of age.

Managing risks, issues and performance

• The service did not have systems to identify risks,plan to eliminate or reduce them.

• The provider had no risk register and when we askedstaff for risks within the service, they were unsure whatrisks there would be. Following inspection, theprovider submitted an environmental risk assessmentwhich identified staff and their areas of responsibility.

• The providers incident reporting policy wasinadequate for the service and did not reflect the levelof risks within the service.

• Between January 2018 and December 2018, theservice performed 218 ultrasound scans on patientsunder 18 years of age. However, this part of the servicewas not within the providers statement of purposeand no guidance to the public was available for thisservice.

• The provider did measure some areas of performance,for example, patient waiting time when they came fortheir appointments as well as patient feedback.

• Patients had access to the providers terms andconditions via the providers website when making abooking.

Managing information

• The provider used secure electronic systems withsafeguards to maintain confidential patientinformation.

Engagement

• The service engaged well with patients, staff, andthe public.

• The provider’s website gave information about theconsultants who worked at the service; type of serviceoffered and a description of procedures.

• The service recently engaged with an external companyto develop a patient feedback service.

Diagnosticimaging

Diagnostic imaging



Areas for improvement

Action the provider MUST take to improve

• The provider must ensure that its systems for themanagement and referral of safeguarding concernsreflect current best practice in relation tosafeguarding adults and that all staff understandhow to make an adult safeguarding referral.

• The provider must ensure that it implements asafeguarding children policy and all staff receivespecific guidance on the policy and how to make achildren’s safeguarding referral.

• The provider must ensure that any staff memberexpected to deputise for the safeguarding lead haslevel three safeguarding children training.

• The provider must ensure it updates its incidentreporting policy and procedures and report safetyincidents appropriately.

• The provider must ensure its statement of purposereflects all its service activity and how it meets theneeds of patients under 18 years of age.

• The provider must ensure it implements systems toidentify risks, plan to eliminate or reduce them, andcope with both the expected and unexpected.

• The provider must ensure it implements a system tosystematically improve service quality andgovernance.

Action the provider SHOULD take to improve

• The provider should improve staff compliance withsafe infection prevention and control practices.

• The provider should improve the safe and securestorage of medicines.

• The provider should consider the individual needs ofpatients living with dementia or with a learningdifficulty.

• The provider should not use relatives or carers to actas translator for the patient.

• The provider should improve the availability ofresources to support patients who may not useEnglish as a first language.

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 Regulation 13 HSCA (RA) Regulations 2014 Safeguardingservice users from abuse and improper treatment

Systems for the management and referral ofsafeguarding concerns did not reflect current bestpractice.

The registered person must ensure service users areprotected from abuse and improper treatment inaccordance with this regulation. Systems and processesmust be established and operated effectively to preventabuse of service users. Systems and processes must beestablished and operated effectively to investigate,immediately upon becoming aware of, any allegation orevidence of such abuse.

Regulation 13 (1) (2) (3)

Regulated activity

Diagnostic and screening procedures Regulation 17 HSCA (RA) Regulations 2014 Goodgovernance

The service did not systematically improve servicequality and there was a lack of an overarchinggovernance framework. The service did not havesystems to identify risks, plan to eliminate or reducethem.

The registered person must ensure systems or processesare established and operated effectively to assess,monitor and improve the quality of the service andassess, monitor and mitigate the risks relating to theservice.

Regulation 17 (1) (2) (a) (b)

Regulation

Regulation

This section is primarily information for the provider

Requirement noticesRequirementnotices


the gynaecology ultrasound centre

Documents