hey baby 4d southend · hey baby 4d southend is operated by hey baby 4d south east group limited....

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? Good –––

Are services effective? Not sufficient evidence to rate –––

Are services caring? Good –––

Are services responsive? Good –––

Are services well-led? Requires improvement –––

Overall summary

Hey Baby 4D Southend is operated by Hey Baby 4D SouthEast Group Limited. The service provides diagnosticimaging for self-referring women through a range ofultrasound scan examinations during pregnancy.Ultrasound scan packages include early reassurancescans (from seven – 24 weeks), gender scans (from 16weeks), growth and wellbeing scans (from 24 – 38 weeks)and 4D scan packages (from 24 -34 weeks). The servicealso offers non-invasive prenatal testing (NIPTS, a blood

test taken during pregnancy to identify foetalchromosomal anomalies). Facilities include oneultrasound room, a waiting area, reception, staff area anda disabled toilet.

We inspected this service using our comprehensiveinspection methodology. We carried an initial shortnotice announced inspection on 26 February 2019, alongwith an unannounced visit to the service on 7 March 2019.

HeHeyy BabyBaby 4D4D SouthendSouthendQuality Report

6a Warrior House,Southchurch Street,Southend-on-Sea,EssexSS1 2LZTel: 01702 690285Website: www.southend.heybaby4d.co.uk

Date of inspection visit: 26 February 2019 and 7March 2019Date of publication: 07/06/2019

1 Hey Baby 4D Southend Quality Report 07/06/2019

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 was diagnostic and screeningprocedures.

Services we rate

This was the first time we have rated this service. Werated the service as Good overall.

We found good practice in relation to diagnostic imaging:

• The service used well maintained equipment andpremises.

• Feedback was positive.

• Staff were seen to be kind, caring andcompassionate.

• The service was located close to public transportand accessible to women and visitors.

• The service was responsive to the needs of the localpopulation offering flexibility in choice forappointment times.

However, we also found areas of practice that requireimprovement in diagnostic imaging:

• The registered manager had a lack of oversight ofmandatory training compliance and staffcompetencies for sonographers working at theservice.

• Cleaning records for clinical and non-clinical areashad not been regularly completed.

• There was a lack of audit programme in place.Therefore, we could not gain assurances that theservice was routinely monitored to ensureimprovements were made.

• The safeguarding lead for the service had notcompleted level three safeguarding children trainingdespite the service seeing women aged 16 to 17years of age. There was no child safeguarding policyin place and the service was not registered to seewomen of this age.

• Patient confidential information was not alwaysstored in a secure manner.

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 fourrequirement notice(s) that affected diagnostic imaging.Details are at the end of the report.

Amanda Stanford

Deputy Chief Inspector of Hospitals

Summary of findings


Our judgements about each of the main services

Service Rating Summary of each main service

Diagnosticimaging

Good –––

Hey Baby 4D Southend is operated by Hey Baby 4DSouth East Group Limited. The service providesdiagnostic imaging for self-referring women through arange of ultrasound scan examinations duringpregnancy. Ultrasound scan packages include earlyreassurance scans (from seven – 24 weeks), genderscans (from 16 weeks), growth and wellbeing scans(from 24 – 38 weeks) and 4D scan packages (from 24-34 weeks). The service also offers non-invasiveprenatal testing (NIPTS, a blood test taken duringpregnancy to identify foetal chromosomal anomalies).Facilities include one ultrasound room, a waiting area,reception, staff area and a disabled toilet.In diagnostic imaging, we found areas of good practiceincluding:

• The service had suitable premises and lookedafter them well.

• The service had adequate staffing in place.• Staff understood how and when to assess

whether a woman had capacity to make decisionsabout their care.

• Staff cared for women with compassion.Feedback was positive.

• The service mostly took account of individualwomen’s need.

• People could access the service when theyneeded it.

However, we found the following areas forimprovement:

• There were no processes in place to ensure staffwere up to date with mandatory training.

• The safeguarding lead had not completed levelthree safeguarding adults and children training.There was no specific child safeguarding policy inplace.

• There were limited processes in place to ensurestaff had the appropriate competencies to carryout their role.

• The registered manager had not identified severalrisks the service faced.

Summary of findings


• There was a lack of managerial oversight inrelation to infection prevention and controlprocesses.

• There was a lack of effective processes in place toensure that all staff had received a disclosure andbarring service check.

• Confidential patient information was not alwaysstored in a secure manner.

Summary of findings


Contents

PageSummary of this inspectionBackground to Hey Baby 4D Southend 7

Our inspection team 7

Information about Hey Baby 4D Southend 7

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

Detailed findings from this inspectionOverview of ratings 11

Outstanding practice 25

Areas for improvement 25

Action we have told the provider to take 26

Summary of findings


Hey Baby 4d Southend

Services we looked atDiagnostic imaging

HeyBaby4dSouthend

Good –––


Background to Hey Baby 4D Southend

Hey Baby 4D Southend is operated by Hey Baby 4D SouthEast Group Limited. The service was newly registered withthe Care Quality Commission and opened in September2018. It is a private ultrasound scanning service inSouthend-on-Sea, Essex. The service primarily serves thecommunities of Southend-on-Sea and surrounding areasfor women on a self-referral basis only.

The service offers:

• Early reassurance scanning (from seven – 24 weeks)

• Gender scan (from 16 weeks)

• Growth and wellbeing scan (from 24 – 28 weeks)

• Four-dimensional (4D) scan package (from 24 – 34weeks)

• Non-invasive prenatal testing blood testing (a bloodtest to identify various conditions such as Down’sSyndrome, Edward’s and Patau’s Syndromes andgender of the baby).

Appointments include scan findings and images forkeepsake purposes. In the event of possible anomalydetection, women are referred to the local NHS earlypregnancy assessment unit or maternity service,depending on the stage/gestation of pregnancy. Theclinic was open between the hours of 9am to 2pm onSundays, 4pm to 8pm on Tuesdays, 5pm to 8pmThursdays and 9am to 2pm on Sundays.

The service has had a registered manager in post sinceSeptember 2018.

Our inspection team

The team that inspected the service comprised a CQClead inspector, and a CQC assistant inspector. Theinspection team was overseen by Fiona Allinson, Head ofHospital Inspection.

Information about Hey Baby 4D Southend

The service has one ultrasound scanning room and isregistered to provide the following regulated activities:

• Diagnostic and screening procedures

During the inspection, we visited the service’s location inSouthend-on-Sea, Essex. We spoke with four members ofstaff including the registered manager, two sonographersand sonography assistant. We spoke with two women.During our inspection, we reviewed 23 sets of medicalrecords.

There were no special reviews or investigations of theservice ongoing by the CQC at any time during the 12months before this inspection. This was the services firstinspection since registration with CQC.

Activity (22 September 2018 – 26 February 2019)

• In the reporting period 22 September 2018 to 26February 2019, the service saw 518 women forultrasounds examination and 15 women for non-invasiveprenatal testing.

• All attendances at the service were on a private,self-funding basis.

Two sonographers, one sonography assistant and theregistered manager worked at the service. There was noaccountable officer for controlled drugs (CDs) in post asthe service did not supply or administer medicines.

Track record on safety

- Zero Never events

- Zero clinical incidents

- No serious injuries

Summaryofthisinspection

Summary of this inspection


- No incidences of hospital acquired Methicillin-resistantStaphylococcus aureus (MRSA),

- No incidences of hospital acquired Methicillin-sensitivestaphylococcus aureus (MSSA)

- No incidences of hospital acquired Clostridium difficile(c.diff)

- No incidences of hospital acquired E-Coli

- Five complaints

Services provided at the hospital under service levelagreement:

• Non-invasive prenatal testing (NIPTS).




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 Good because:

• The service had suitable premises and looked after them well.• Staff completed and updated risk assessment for each woman.

They kept clear records and referred anomalies to other NHSservices where required.

• The service had adequate staffing in place.• Staff kept detailed records of women’s care and treatment.

Records were clear, up-to-date and easily available to staff.

However:

• There were no systems or processes in place to ensure that staff(not directly employed by the service) had completedmandatory training at recommended intervals.

• There were limited systems in place for staff to seek guidance inthe event of identifying or escalating a safeguarding concern.

• Cleaning check sheets were not regularly completed.

Good –––

Are services effective?We do not currently rate effective, however we found:

• The service did not have effective systems and processes inplace to ensure that staff were competent for their roles as theregistered manager did not maintain oversight of trainingcompliance and competencies for sonographers who worked atthe service.

• There was a lack of clinical audit in place to allow the service tomake improvements based on findings.

However, we also found:

• Policies and guidance were reviewed on a regular basis. Policieswere well organised and accessible to staff within the service.

• Staff understood how and when to assess whether a womanhad the capacity to make decisions about their care.

Not sufficient evidence to rate –––

Are services caring?We rated caring as Good because:

• Staff told us they cared for women with compassion. Feedbackfrom women confirmed that staff treated them well and withkindness.

• Staff provided emotional support to women to minimise theirdistress.

Good –––




• Staff involved women and those close to them in examinationsand decisions about their care.

Are services responsive?We rated responsive as Good because:

• The service mostly took account of women’s individual needs.• The service planned and provided services in a way that met

the needs of local people.• People could access the service when they needed it. Due to

the nature of service provided, there were no nationalrecommended waiting times.

• The service treated concerns and complaints seriously,investigated them and learned lessons from the results, andshared these with staff.

Good –––

Are services well-led?We rated well-led as Requires improvement because:

• There was limited processes and oversight in place to ensurestaff had the appropriate competencies to carry out their role.

• The registered manager had not identified several risks theservice faced.

• There was a lack of managerial oversight in relation to infectionprevention and control processes.

• Confidential patient information was not always stored in asecure manner.

However, we also found:

• Staff described an open culture.• The service provided a variety of methods to engage with

women and visitors.

Requires improvement –––




Overview of ratings

Our ratings for this location are:

Safe Effective Caring Responsive Well-led Overall

Diagnostic imaging Good N/A Good Good Requiresimprovement Good

Overall Good Not rated Good Good Requiresimprovement Good

Detailed findings from this inspection


Safe Good –––

Effective

Caring Good –––

Responsive Good –––

Well-led Requires improvement –––

Are diagnostic imaging services safe?

Good –––

We rated safe as good.

Mandatory training

• There were no systems or processes in place toensure that staff had completed mandatorytraining at recommended intervals.

• Both sonographers working at the service held postswithin NHS trusts. At the time of our inspection, theregistered manager was unable to providedocumentation to evidence sonographers compliancewith mandatory training. Therefore, we were unable togain assurances that staff had received the necessarytraining to safely and effectively carry out their role.

• Sonographers received basic life support training aspart of their role at external NHS organisations.However, we were unable to verify dates of trainingcompletion as the service did not hold thisinformation at the time of our inspection.

• After our inspection, the registered managerforwarded evidence that both sonographers hadpreviously completed a variety of mandatory trainingcourses including but not limited to; adults and childsafeguarding, infection prevention and control andinformation governance. However, we could not gainassurances that there were effective systems andprocesses in place to maintain oversight of staffs’mandatory training outside of the service.

• For staff directly employed by the service, mandatorytraining was provided through an online system. Theservice relied on sonographers to completemandatory training in their NHS roles.

• We reviewed training records for the sonographyassistant and registered manager (the only staffdirectly employed by the service) and saw that theyhad completed mandatory training in several subjectsincluding but not limited to; hand hygiene, infectioncontrol, recording information, person centred careand safeguarding adults within the last 12 months.

Safeguarding

• There were limited systems in place for staff toseek guidance in the event of identifying orescalating a safeguarding concern. However, staffunderstood how to protect women from abuseand the service had systems and processes inplace to work with other agencies if required.

• We saw evidence that staff directly employed by theservice had completed safeguarding adults level twotraining. However, there were no systems, processes oroversight in place to ensure that sonographers whoworked at the service had received safeguardingtraining in their posts within the NHS.

• We could not gain assurances that all staff hadreceived and were up to date with safeguarding adultsand children training (sonographers) in line withnational guidance. This was not in line with thenational guidance which states that staff should havecompleted level two safeguarding children training.The service saw children aged 16 to 17 years aspatients and adult women using the service didsometimes bring children with them to appointments.

Diagnosticimaging

Diagnostic imaging

Good –––


• After our inspection, the registered managerforwarded evidence that one sonographer hadcompleted safeguarding adults level two andsafeguarding children level two within recommendedtimeframes. For the additional sonographer, we sawevidence they had completed safeguarding adultslevel one and children level two within recommendedtimeframes. The registered manager acknowledgedthat he did not have evidence of safeguarding adultslevel two training for this member of staff and advisedthey would send this once received. However, after ourinspection, he advised that the sonographer did notrequire safeguarding level two training in their otherplace of work. The registered manager advised theywould send evidence of completed level twosafeguarding adults training however at the time ofpublication we had not received this.

• The registered manager was the service’s safeguardinglead and had been trained to level two safeguardingadults. There was no access to a level threesafeguarding trained person within the service. Weraised our concerns with the registered manager whoadvised they were due to complete a designatedsafeguarding officer (Level three Safeguarding) course.After our inspection, we saw evidence that theregistered manager had completed a designatedsafeguarding officer (level three) training course on 14March 2019.

• The service had accepted women aged 16 to 17 years.From 22 September 2018 to 26 February 2019, fourwomen under 18 years of age had visited the service.There was no child safeguarding policy in place andthe service’s statement of purpose outlined the agesof patients eligible for examination and stated womenaged 18 years of age and over. We raised our concernsat the time of inspection and the registered managerimmediately suspended the service for those aged 16to 17.

• The service had an adult safeguarding policy in placewhich had been reviewed in July 2018. The policyoutlined various types of abuse including but notlimited to; female genital mutilation (FGM), domesticviolence and neglect. The policy provided clearguidance to staff on how to report and escalate anyidentified adult safeguarding concerns.

• The policy also referenced the local authoritysafeguarding adults guidelines (Southend, Essex andThurrock (SET) Safeguarding Adults Guidelines,Version 4.3), and links to further information on how toraise safeguarding concerns relating to children (thoseunder 18 years of age).

• Whilst the service’s policy referred to safeguardingchildren, details were limited and focused morearound children who may visit the service withrelatives rather than as a patient aged 16 to 17 years.

• We spoke with two members of staff about theirknowledge of safeguarding processes. Staff were clearon the potential signs of safeguarding concerns andhow to appropriately escalate concerns whennecessary.

• The service had a chaperone policy in place.Chaperone signage was displayed in the waiting roomoffering this service to women upon request.

• We reviewed the employee files and were unable togain assurances that all staff had received a disclosureand barring service (DBS) check prior tocommencement in post.

• We raised our concerns with the registered managerwho advised he had carried out a DBS for thesonography assistant who was directly employed bythe service. However, the service did not holdevidence of DBS checks for sonographers who workedat the service as they relied upon sonographers otherroles within the NHS as assurance of DBS checks inplace. In addition, one sonographer had beenprovided through an agency. The registered managerrelied on this as assurance of DBS in place.

• After our inspection, the registered managerforwarded evidence of recent DBS checks for bothsonographers and the sonography assistant whoworked at the service. Both sonographers had newDBS checks carried out following our inspection andthe registered manager also forward a previous DBS(2016) for one member of staff. However, at the time ofour short notice announced inspection, there was alack of systems and processes in place to maintaineffective oversight of staff DBS records.

Cleanliness, infection control and hygiene

Diagnosticimaging

Diagnostic imaging

Good –––


• The service had limited systems and processes inplace to monitor compliance for infectionprevention and control policy and practices.

• All areas we inspected were visibly clean and free fromclutter.

• Staff kept themselves, equipment and the premisesclean. There were some control measures to preventthe spread of infection.

• The service had an infection prevention and control(IPC) policy in place. This provided guidance to staff onseveral IPC related processes including but not limitedto; hand washing, equipment cleaning, blood takingprocedures and needle stick injuries.

• Staff told us they completed daily, weekly andmonthly cleaning tasks as per checklists. Our review ofcleaning checklists showed that paperwork had notbeen completed on a regular basis.

• From December 2018 to 24 February 2019, there weresix documented daily checks and four weekly checksfor the scanning room area. We raised our concernswith the registered manager who advised thatcleaning was carried out regularly, and this was a lackof documentation and oversight on their part.

• At our return unannounced visit on 7 March 2019, werequested to see completed cleaning checks for theprevious week. Staff advised that all documentationrelating to cleaning had been removed after our initialinspection on 26 February 2019. We raised ourconcerns with the registered manager who adviseddocumentation had been removed to revisedocumentation. Whilst clinical and non-clinical areasappeared clean, there was no documentary evidenceavailable to demonstrate that regular cleaning hadtaken place.

• There were no infection prevention and control auditsin use such as clinical waste disposal or hand hygieneaudits. Therefore, we could not gain assurances thatthere were effective systems and processes in place tooversee and monitor compliance with IPC bestpractice and policy.

• Alcohol hand gel was available at regular intervalsthroughout the service. Staff had access to personalprotective equipment when carrying out ultrasoundexaminations or taking blood samples fornon-invasive prenatal testing purposes.

• Staff told us that the ultrasound examination couch,probe and other equipment was cleaned after eachwoman in between scans using antibacterial wipes.We saw staff cleaning equipment during ourinspection.

• Hand washing facilities were available in theultrasound examination room. We saw staff washingtheir hands at regular intervals prior to and afterpatient examination.

• During our initial announced inspection, we saw thatwaste was generally handled and disposed of in a safemanner to help prevent and control the spread ofinfection.

• However, on our return unannounced visit on 7 March2019, we found that the cupboard containing cleaningfluids and mop heads was locked. Staff could notaccess this equipment as they did not have keys heldon site. Therefore, we were unable to gain assurancesthat effective cleaning could take place as staff couldnot access the necessary equipment.

• We also found used gloves and couch roll (used tocover the ultrasound bed) in a black domestic binliner. We raised our concerns with the registeredmanager who advised with immediate effect, all usedgloves would be placed within clinical waste bins.

• Chairs within the waiting area were wipe clean toensure effective cleaning processes could take place.

• There was a set NIPT procedure in place outlining thesteps to take when obtaining blood samples. Theguidance cross referred to the service’s IPC policy,outlining hand hygiene steps and the safe disposal ofsharps and clinical waste to prevent and control thespread of infection.

Environment and equipment

• The service had suitable premises and lookedafter them well.

Diagnosticimaging

Diagnostic imaging

Good –––


• The service was accessible to those with additionalmobility needs. All clinical and non-clinical areas werelocated on the ground floor.

• The service consisted of a waiting area, ultrasoundroom, administrative area and toilet.

• All waiting areas had oversight from the receptiondesk meaning women and visitors were not leftunattended at any time.

• The premises were well lit and clearly signed toindicate clinical and non-clinical areas.

• Both fire extinguishers had been recently serviced. Fireexit routes were clearly marked.

• There were effective systems in place to ensure thatsonography equipment was maintained on a regularbasis. We saw that equipment contracts were in dateto cover equipment maintenance and failure.

• Clinical waste and sharps (needles) were storedcorrectly in colour coded bags. Sharps boxes werewithin safe fill limits to prevent and control the spreadof infection and minimise the risk of needlestick injury.However, we noted one box had been assembled andwas lacking an assembly date and signature. Weraised our concerns to the registered manager on theday of our inspection.

• During our second inspection on 7 March 2019,despite raising this on the initial inspection, we sawthat sharps box still lacked an assembly date andsignature. We raised our concerns again with theregistered manager who forwarded emailconfirmation that this had been completed after ourreturn unannounced inspection.

• Equipment in the service had been safety tested andserviced in line with manufacturers recommendations,with future testing due in August 2019. Equipmentmaintenance and safety testing was carried out undera contract currently in place.

• Non-invasive prenatal testing (NIPT) kits came inindividual packs, one per woman. The kit containedindividual needles, a tourniquet (used to obtain bloodsamples through applying pressure on the arm) andvials for blood samples.

• The non-invasive prenatal test (NIPT) procedureprovided clear instructions on the labelling, packagingand method of postage. In addition, the package wassent via recorded delivery to enable tracking.

Assessing and responding to patient risk

• Staff completed and updated risk assessment foreach woman. They kept clear records andreferred anomalies to other NHS services whererequired.

• Due to the nature of services provided, the service didnot have an emergency resuscitation trolley.

• A first aid kit was in an accessible area within theservice. Supplies were in date and well organised. Theaccident book was kept with the first aid kit to ensureaccidents and injuries were recorded.

• The service had a document named ‘emergency andsignificant event policy’. This document outlined keyguidance for staff in the event of major emergencies(such as accident, fire) and action staff should take.Staff we spoke with were clear to call 999 in anemergency in the event of medical collapse of apatient.

• Informed consent documentation placed emphasis onthe fact that 4D scans were elective andnon-diagnostic. Wellbeing checks during the scanprocesses included the gestational age of the babyand various biometric measurements. Documentationclearly stated that any measurements taking duringscanning did not supersede those made at NHSappointments. This information was also given towomen verbally, prior to scanning taking place toensure that women continued to attend regular carewithin the NHS which was provided for diagnosticpurposes.

• There were clear systems and processes in place torefer women with any identified ultrasound anomaliesor concerns (maternal or foetal) to the local NHStrust’s early pregnancy assessment unit (EPAU) ormaternity service.

• There was a referral policy to EPAU or the localmaternity service in place. The policy placed emphasison the importance of a plan of where the woman wasto go and what to do next in the event of unexpectedfindings.

Diagnosticimaging

Diagnostic imaging

Good –––


• Referring clinicians completed a referral form forwomen to take to the local NHS trust EPAU ormaternity service. We reviewed one medical recordwhere onward referral was required. Referral hadtaken place in a timely manner, with a copy of thereferral form held securely on the computer systemwithin the service.

• Staff we spoke with were clear on referral processes toNHS services.

• The service’s website made clear that all scanningprocedures were for souvenir purposes only and notdiagnostic.The service made clear to women the scansoffered, should not be considered as a replacementfor NHS care during pregnancy and encouragedwomen to attend NHS appointments to ensuremedical needs during pregnancy were identified andmet.

• Length of scan times were monitored to ensure thatno scan exceeded 20 minutes. This was in line tomaintain ultrasound exposure to the principle ofALARA (as low as reasonably achievable). The ALARAprinciple is used to ensure that excessive tissueheating does not occur during ultrasoundexamination. Doppler recordings of heartbeat soundswere limited to 20 seconds duration.

Sonographer and sonography assistant staffing

• The service had adequate staffing in place.

• The service was staffed by one full time sonographyassistant (non-clinical) and two sonographers. Bothsonographers worked for NHS trusts, one of which wasemployed for 16 hours a week, the other sonographerwas self-employed and worked three hours per weekat the service.

• In the event of staff illness, the registered managertold us that access to agency sonographers would besought. In addition, there was also access to othersonographers within the Hey Baby 4D group. Sinceclinic opening, the service used an agencysonographer for two Saturday shifts when the clinicfirst opened in September 2018.

Records

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

• Medical records were well organised, securely storedand accessible. Scan images were held electronically,informed consent documentation was stored for allwomen in a locked cabinet.

• We reviewed 23 medical records and saw thatinformed consent had been sought in all cases.Medical records detailed pertinent informationincluding but not limited to; name, date of birth,estimated due date or date of last menstrual period.

• We reviewed a medical record with referral to the localNHS maternity service. We saw that adequate detailson the concern were noted, and a copy of the referralhad been stored electronically within the individualmedical record.

• Wellbeing forms were given to all women where foetalmeasurements and other observations had takenplace. The service did not hold a copy of wellbeingforms as ultrasound only produces a ‘snapshot’ attime of scanning. Any anomalies were documented atthe bottom of consent documentation.

• The service’s data protection policy, reviewed in July2018 provided clear information and guidance onretention periods of medical records and scan images.

• At return unannounced visit on 7 March 2019, wefound a black domestic bin liner on the floor in thestaff room. The bag contained a printed list ofwomen’s names (confidential identifiable information)and reason for attendance/time slots (first name, lastname). These findings were not in line with the HeyBaby 4D ‘Data Protection’ Policy which states: ‘allsensitive/confidential information in the buildingrelating to staff and customers should be filed away inlockable cabinets. Access to cabinets should berestricted to contracted employees only’.

• After our return unannounced visit, we raised ourconcerns with the registered manager (not on site attime of inspection). They advised that the lock hadbroken on the filing cabinet, and that a replacement

Diagnosticimaging

Diagnostic imaging

Good –––


was now in place. In addition, a paper shredder hadbeen purchased to ensure all patient identifiable andconfidential information was shredded prior todisposal.

Medicines

• The service did not stock or administer medicines orcontrast media for any scanning procedures. Thesewere not required for the type of service offered.

Incidents

• The service had systems and processes in place tomanage patient safety incidents well.

• The service had no reported clinical or non-clinicalincidents from September 2018 to February 2019.

• The service had a policy named ‘emergency andsignificant events’ policy. The policy providedguidance for staff of the actions to take in the event ofseveral situations including, but not limited to majoremergencies, significant events, near misses andaccidents.

• The policy stated that all significant events and nearmisses were to be entered on the ‘quality assurancefeedback monitoring form’. We reviewed thisdocument on the day of inspection and saw that sinceclinic opening, only complaints were documented asthere had been no clinical incidents reporting duringthis time frame.

• As there had been no clinical incidents at the time ofour inspection, we were unable to see documentaryevidence that patient safety incidents had beenrecorded, however, the quality assurance feedbackmonitoring form had specific areas to documentactions taken, by who and mitigating steps taken toavoid reoccurrence of potential incidents.

• All staff we spoke with could describe examples of apotential incident and the subsequent action to betaken; staff told us they would report all incidents tothe service’s registered manager.

• The service had a duty of candour policy in place. Theduty 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 safety

incidents’ and provide reasonable support to thatperson. The policy provided guidance for staff onprocesses to follow in the event of notifying womenabout any mistakes in care.

• The registered manager described the meaning of theduty of candour and action they would take in event ofthe duty of candour being required.

• The registered manager advised that if further externalinvestigation was required, for example in the event ofa conflict of interest, incident investigation wasreferred to another director within the Hey Baby 4Dfranchise.

Are diagnostic imaging serviceseffective?

We do not currently rate effective in diagnostic imaging.

Evidence-based care and treatment

• The service had systems and processes in place toensure policies and guidelines were reviewed,current and up-to-date.

• Policies and guidance were reviewed on a regularbasis. Policies were well organised and accessible tostaff within the service.

• The service worked in accordance with the ‘as low asreasonably achievable’ (ALARA) principle. The ALARAprinciple is used to ensure that excessive tissueheating does not occur during ultrasoundexamination.

• The service’s health and safety policy containedreference to ALARA and highlighted the risk of tissueheating with the use of doppler devices. A dopplerdevice uses high-frequency sound waves to measurethe amount of blood flow through arteries and veinsand hence produces an audible ‘heartbeat’.

• There were no audits carried out in relation toultrasound scanning. This would have enabled theservice to assess if image quality, anomalyidentification and report quality were withinacceptable limits and to seek service improvements.Image quality was overseen by the registered managerto ensure patient satisfaction of images which wereprovided for souvenir purposes only.

Diagnosticimaging

Diagnostic imaging

Good –––


Nutrition and hydration

• Due to the nature of service provided, food and drinkwere not required or provided in the service. However,women and visitors had access to fresh drinking water.

Pain relief

• Sonographers and the sonography assistant wouldcheck the woman’s comfort during examination.

• Due to the nature of service provided, pain relief wasnot required.

Patient outcomes

• There were some systems and processes in placeto monitor patient outcomes.

• The registered manager monitored the rate ofdetection of anomalies. Due to the nature of serviceprovided, the service did not routinely monitor orlearn of patient outcomes.

• The service did not participate in national audits dueto the size of the service.

• The service sought feedback through a variety ofmethods including social media platforms andfeedback through the service’s website.

Competent staff

• There was a lack of systems and processes inplace to ensure that staff were competent in theirrole.

• The service did not have effective systems andprocesses in place to ensure that staff were competentfor their roles as the registered manager did notmaintain oversight of training compliance andcompetencies for sonographers who worked at theservice.

• Due to recent establishment of the service, staff wereyet to complete an appraisal.

• We reviewed staff files for both sonographersemployed to work at the service. Both staff membersalso worked at NHS organisations. We saw that staffhad completed relevant qualifications in sonography.

Of note, sonography is not recognised as a professionby the Health and Care Professions Council (HCPC)and therefore professional registration is not arequirement.

• Staff completed an induction which includedfamiliarisation with the service and premise and areview of all policies in use. We saw from staff recordsthat both sonographers had completed the policychecklist.

• We could not gain assurances that sonographersworking at the service had completed relevant trainingin phlebotomy/venepuncture to enable them to takeblood samples for non-invasive prenatal tests.

• We requested assurances after our inspectionhowever, the registered manager was unable toprovide assurances for one sonographer. In responseto this, the registered manager arranged re-trainingand advised that they would not carry outnon-invasive prenatal blood tests (NIPTs) until trainingwas complete. In the interim, the other sonographer (aregistered midwife) was instructed to carry out NIPTs.

• Staff were provided with non-invasive prenatal testingprocedure guidance. This ensured that women weretold the associated benefits and limitations of thisscreening method. This service (blood testing) wasprovided by a third party.

• The registered manager told us that in the future,there were developmental opportunities for thesonography assistant employed by the service.Development opportunities included a phlebotomy(blood taking) course and training to become asonographer.

Multidisciplinary working

• We found limited evidence of multidisciplinaryworking.

• The registered manager and sonography staff hadestablished a link with the local NHS early pregnancyassessment unit (EPAU) and maternity services toensure referral in a timely manner.

Diagnosticimaging

Diagnostic imaging

Good –––


• The registered manager maintained oversight of thenon-invasive prenatal testing service and processeswere in place to track samples, through to receipt inthe lab and subsequent results sent through anencrypted email.

Seven-day services

• The service did not open every day however, staffworked to provide appointment flexibility toaccommodate the needs of women.

• The service opened Saturday 9am to 5pm, Sunday9am to 2pm, Tuesday 4pm to 8pm and Thursday 5pmto 8pm. Opening times had recently been increased tomeet demand.

Consent and Mental Capacity Act

• Staff understood how and when to assesswhether a patient had the capacity to makedecisions about their care.

• All women were given a written consent form prior toexamination. The consent form provided informationincluding but not limited to; details on 4D scanning,information around wellbeing checks, what to expectduring the scan and what factors could affect if thescan was successful.

• We reviewed 23 medical records and saw thatinformed consent had been sought and documentedin all cases.

• Staff had access to a policy named ‘informed consentand Mental Capacity Act (MCA) policy’. The policy wasin date and had been regularly reviewed. The policydescribed capacity assessment, and action to take if awoman lacked capacity. In addition, it providedguidance for staff on the action to take in the event ofany safeguarding concerns relating to the woman andtheir representative.

• After our inspection, the registered managerforwarded evidence that both sonographers hadcompleted MCA training in their other places of work.

Are diagnostic imaging services caring?

Good –––

We rated caring as good.

Compassionate care

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

• Throughout the duration of our first day of inspection,we saw that staff greeted women and relatives in awarm and friendly manner, introducing themselves byname.

• A review of feedback showed women were positiveabout their experience at the service. Many reviewsindicated that women had returned to the service forfurther scans at later stages in pregnancy.

• Feedback described staff as ‘wonderful, friendly,helpful and nice’.

• We reviewed online feedback and saw that all reviews,since service opening were positive and described thestaff as kind and caring.

• We spoke with one woman who described staff as kindand caring, polite and that they felt well informedabout the scanning process.

• Another woman we spoke with described staff as‘kind’ and that they had received enough informationabout the appointment/scanning process.

• The privacy and dignity of women was respected; allscanning took place in a private room. In addition, thewaiting area had music playing to ensureconversations could not be overheard. All sensitivediscussions took place in the private consultationroom.

• Women recalled for non-invasive prenatal test results,or those who had received bad news were supportedin the privacy of the examination room and staff toldus they gave women as much time as possible tounderstand what they had been told.

• The service’s website offered early reassurancescanning from seven weeks of pregnancy.

Diagnosticimaging

Diagnostic imaging

Good –––


Emotional support

• Staff provided emotional support to patients tominimise their distress.

• The service openly welcomed up to three additionalpeople to accompany the woman for their scan. Thisenabled relatives and loved ones to provide supportto the woman emotionally, if required.

• The service provided means of contact for womenwho had any queries relating to their scan or generalscanning processes. Details were provided at theinitial point of contact or through the service’s publicwebsite and social media platforms.

• The service did not offer counselling services. Allwomen who had identified anomalies with scanresults were referred back to their local NHS trust earlypregnancy unit or maternity service.

• Genetic counselling was provided by a third party inthe event of receiving a positive non-invasive prenataltest result. The sonographer requested parentalpermission for their details to be passed to a geneticcounsellor, who could explain more about what theresults mean and advise them on the next steps totake.

Understanding and involvement of patients andthose close to them

• Staff involved women and those close to the inexaminations and decisions about their care.

• After initial consultations, the service held contactdetails for women requiring test results fromnon-invasive prenatal testing (NIPT) to enablefeedback of blood test results though arrangement ofa face to face consultation.

• Women were advised that they could contact theservice at any point for further advice, if required.

• The service’s website provided clear informationaround the costs of ultrasound scanning andnon-invasive prenatal testing. For ultrasound scans, a£20 deposit was taken and the point of booking (eitheron the telephone or online) with balances beingsettled after the ultrasound appointment had beenattended.

Are diagnostic imaging servicesresponsive?

Good –––

We rated responsive as good.

Service delivery to meet the needs of local people

• The service planned and provided services in away that met the needs of local people.

• The service offered a range of ultrasound scanningpackages and non-invasive prenatal testing to womenfrom seven weeks gestation (seven weeks ofpregnancy).

• The premises and facilities were appropriate for thedelivery of service.

• The service was located within a town centre andtherefore offered a choice of access by publictransport and car parking in the immediate vicinity.

• The service was bright, well lit, offered adequateseating and fresh drinking water to women and theirrelatives.

Meeting people’s individual needs

• The service mostly took account of patients’individual needs, however there was no access totranslation services for women whose firstlanguage was not English.

• The service provided private ultrasound scans andnon-invasive prenatal blood tests to self-referringwomen only. The service did not complete imaging onbehalf of the NHS.

• The service clearly advertised scanning package andnon-invasive prenatal testing costs on its publicwebsite. In addition, staff were available to discussvarious packages and costs at the point of booking, ifover the telephone.

• The service’s public website provided a range ofinformation around various scanning packages andNIPT services that were offered. Information explained

Diagnosticimaging

Diagnostic imaging

Good –––


that NIPT testing is not available through the NHS, andoutlined the process of testing and how the testidentifies various chromosomal abnormalities, as wellas the gender of the baby.

• The service offered flexibility in appointments,providing both weekend and evening appointments.Where possible, short notice appointments werefacilitated. The service recognised that pregnancy canbe a worrying time, hence offering short noticeappointments.

• The service did not have access to translation services.However, one member of staff described that theywould use the internet to translate if a woman’s firstlanguage was not English.

• During our return unannounced visit, we saw that afamily member translated on behalf of a relativewhose first language was not English. This is notconsidered best practice.

• Staff had access to a chaperone policy. The clinicdisplayed a poster offering chaperones, on request. Inaddition, all scans were carried out with an assistantsonographer present.

• Following feedback, appointment times had beenamended to provide more time for women andimprove the scanning experience therefore givingadequate time to ask any questions a woman mayhave.

• The premises were all located on ground floor level.There was appropriate access and disabled toiletfacilities available.

• The service provided toys to visiting children for usewithin the waiting area.

Access and flow

• People could access the service when they neededit. Due to the nature of service provided, therewere no national recommended waiting times.

• Access to the service was on a self-referral basis only.Appointments for early reassurance, gender, growthand wellbeing and 4D scanning packages were offeredin a timely manner.

• The service performed carried out ultrasound scanson 518 women and 15 non-invasive prenatal testsfrom 22 September 2018 to 26 February 2019.

• Women were offered a variety of appointment times,providing flexibility to those who required anappointment outside of normal working hours and atweekends. Bookings were taken either through thewebsite or over the telephone.

• The registered manager monitored how women hadaccessed the service, for example, through word ofmouth, advertising, the internet or social media.

• Whilst the rate of women who ‘did not attend’ (DNA)were monitored, the service did not routinely call toascertain the reason for non-attendance. This wasbecause a pregnancy may have ended, and they didnot wish to cause additional emotional distress.

• On the day of our inspection, we saw that all womenwere seen in a timely manner, at intendedappointment times.

• We spoke with one woman who advised they wereoffered a next day appointment upon enquiring at theservice. They felt that appointments were offered in atimely manner, at a convenient time which includedevenings and weekends.

Learning from complaints and concerns

• The service treated concerns and complaintsseriously, investigated them and learned lessonsfrom the results, and shared these with staff.

• The service had a complaints policy in place whichhad been reviewed in July 2018 (prior to serviceopening). This provided guidance to staff on processesto be followed in the event of a woman wishing tomake a complaint.

• The service had received five complaints from 22September 2018 (opening) to 26 February 2019. Wereviewed all complaints and saw that the service hadresponded to complaints in a timely manner, andmade changes to practice as a result of complaints.For example, the laboratory provider for non-invasiveprenatal testing was changed to better meet the

Diagnosticimaging

Diagnostic imaging

Good –––


expectations of women (relating to the timeframe forresults delivery). Staff were aware of this complaintand could outline the change in service provider fornon-invasive prenatal testing.

• The service received 49 compliments detailing positivefeedback from 22 September 2018 to 19 November2018.

Are diagnostic imaging services well-led?

Requires improvement –––

We rated it well-led requires improvement.

Leadership

• The service had a clear leadership structure in place.

• The registered manager was also the companydirector. The registered manager had been in postsince service opening in September 2018.

• At the time of our inspection, the registered managerwas in the process of completing a qualifications andcredit framework level five in Health and Social Careand children and young people services.

• Sonographers and sonography assistant reporteddirectly to the registered manager.

• During our inspection, we saw the registered managermaintained a visibility within the service, engagingregularly with clinical and non-clinical staff.

• Regular communication took place between theregistered manager and staff. Due to the small numberof staff in post, staff saw each other on a regular basisto discuss pertinent topics and issues affecting theservice. In the event of the registered manager beingoff-site, staff could contact the registered manager bytelephone, however there was no formal deputy inplace.

• An example of poor communication was highlightedduring our return unannounced visit. Staff did nothave keys to the filing cabinet, were unaware it hadbroken, and experienced difficulties logging on tocomputer systems as passwords had been changed,without staff being informed.

Vision and strategy

• Whilst the service did not have a formal visionplace, staff demonstrated the service’s values.

• Staff were passionate about providing a positive andhappy scanning experience at the service.

• The service’s values were ‘fun, family, fair and friendly’.The values focused on creating a positive experiencefor women whilst treating all with fairness and respect.

• The service had a set of fundamental standards whichincluded person centred care, dignity and respect,consent and safety.

• On clinic opening in September 2018, the serviceinitially offered appointments three days a week. Tomeet increasing demand, and grow the businessslowly, a fourth day had been introduced in January2019. In the future, the service would like to offertransvaginal scanning for early pregnancy (from sixweeks gestation) and more opening hours, however atthe time of our inspection, no implementation dateshad been set.

Culture

• The registered manager promoted a positiveculture that supported and valued staff, creatinga sense of common purpose based on sharedvalues.

• The service had a whistleblowing policy in place. Wereviewed the policy and noted that it had beenreviewed in July 2018.

• We spoke with two members of staff. Both describedthe culture within the service as open and told us theregistered manager was supportive to staff.

Governance

• There were limited systems and processes inplace to maintain the overall governance of theservice.

• The service had a document named ‘governancepolicy’ in place. This document outlined the keyresponsibilities for various staff roles from agovernance perspective including, but not limited to;the director, registered manager, sonographer/ultrasound technician and receptionist. Clinical staffcarried out their roles in accordance with this policy

Diagnosticimaging

Diagnostic imaging

Good –––


however, the registered manager had limited systemsand processes in place to ensure that policies werebeing adhered to and the quality of service wasregularly monitored (lack of regular audit).

• An additional ‘clinical governance policy’ was in use.This policy detailed various processes in place tomaintain high standards, record errors and identifyways to improve service provision. Processes includedregular review of the clinical governance and qualityassurance audit form, which was used to documenterrors including but not limited to; complaints,incorrect results provided from a non-invasiveprenatal test or if the wrong gender of a baby wasrevealed.

• If required, franchise director support was provided atrequest of the registered manager/director.

• There was a lack of oversight and governance inrelation to the identification and management of risksthe service may face. For more information, please seethe ‘managing risks, issues and performance’ sectionbelow.

Managing risks, issues and performance

• The service had minimal systems in place toidentify risk, plan to eliminate or reduce them,and cope with both the expected and unexpected.

• The registered manager had not identified the need toensure staff working at the service had completed therequired mandatory training, skills (including bloodtaking) and competencies to carry out their role. Inaddition, there were no systems or processes in placeto ensure that all staff working within the service hadreceived disclosure and barring service (DBS) checks.

• There was a lack of oversight in relation to infectionprevention and control processes. Cleaning schedulecheck sheets (from December 2018 to February 2019)were not completed when indicated on daily, weeklyand monthly check sheets. In addition, there were noinfection prevention and control (IPC) audits in use toensure compliance with IPC standards outlined in theservice’s IPC policy.

• Risk within the service was monitored and overseenthrough use of a document named ‘risk assessment’.We reviewed this document and saw it identifiedpotential hazards, including but not limited to;

infection, fire and ultrasound. The document clearlyoutlined the owner for each risk with action dates andarea to indicate when actions were complete.However, we could not gain assurances this documentwas effectively monitored or overseen due to theidentified issues with infection prevention control, lackof documentary evidence for disclosure and barringservice checks and the lack of audits in use. Theseassessments were reviewed as part of governanceprocesses within the service by the owner (and staffwhere applicable).

• There had been no reported clinical incidents sincethe service opened in September 2018. The registeredmanager had not received training in root causeanalysis investigation. Root cause analysis trainingenables an individualto use quality improvementapproaches to identify, understand and resolve anyroot causes of problems or incidents. In the event of aroot cause analysis being required, or if investigativesupport was required, the registered manager advisedthey would contact the group franchise’s director forsupport.

• At our return unannounced visit, we had still notreceived copies of DBS checks for all members of staff.The registered manager forwarded evidence of DBSchecks after this time. In addition, we were unable togain assurances that one sonographer working at theservice had received the necessary training to safelycarry out their role (blood taking, safeguarding adultslevel two, basic life support and mental capacity acttraining). In response to the highlighted concerns, theregistered manager advised they had put training inplace for blood taking, and that this member of staffwould not carry out non-invasive prenatal blood testsuntil this was complete.

• The service had not identified that a lack of formaltranslation service could pose a risk to patients. Thiscould have posed a risk to expectant mothers ifanomaly findings were not communicated andunderstood correctly.

Managing information

• The service collected, analysed, mostly managedand used information well to support all itsactivities, using secure electronic systems withsecurity safeguards.

Diagnosticimaging

Diagnostic imaging

Good –––


• There were clear systems and processes in place formanaging information. The service’s data protectionpolicy, reviewed in July 2018 provided information andguidance on retention periods of medical records andscan images.

• Medical records were held on file for up to three years.Any scan images taken during consultation wereretained for one year (with the exception of imageswhere permission had been given to use these inmarketing materials).

• At our initial short notice announced inspection, wesaw that written consent forms were stored securely inlocked drawers. However, at our return unannouncedvisit we found some patient identifiable information(patient first and last name and time/type ofappointment details) in a black domestic waste bag.We raised our concerns with the registered managerwho took steps to ensure this would not happenagain.

• Non-invasive prenatal testing results were sent to theregistered manager (from a third-party service) usingencryption codes to ensure confidentiality.

• The service had secure processes in place to shareinformation to women and other relevant healthcareprofessionals where required.

• The service had a public website in place to provideinformation for women on various scan packages andexaminations offered.

Engagement

• The service welcomed women’s and visitor feedbackthrough a variety of methods. The website had a‘review your experience’ option to submit feedback. Inaddition, social media enabled women to leavereviews of their experiences at the service.

• The registered manager explained that a lot of womenwere introduced to the service by either friends, familyor social media platforms.

• Informal staff meetings took place on a regular basis.These were not formally minuted but notes fromprevious meetings showed discussion had taken placearound topics including, but not limited to; infectionprevention and training.

Learning, continuous improvement and innovation

• The service improved services by learning fromwhen things went well or wrong.

• The service actively sought feedback and madechanges as a result of feedback. For example, clinicopening hours had been amended to provide moreappointment availability. In addition, the non-invasiveprenatal testing laboratory provider had beenamended following feedback regarding expectationfor results time frames.

• The service had implemented a lighting system toenhance the gender reveal scan experience. Thecolour of pink, or blue, was revealed once the genderof the baby had been identified by the sonographer.This service was a choice given to women and notcompulsory.

Diagnosticimaging

Diagnostic imaging

Good –––


Areas for improvement

Action the provider MUST take to improve

• The provider must ensure that they act in accordancewith the registered Statement of Purpose.

• The provider must ensure that there are systems andprocesses in place to maintain effective oversight ofrisk, mandatory training completion, rolecompetencies and disclosure and barring servicechecks.

• The service must ensure that clinical waste is storedin correct receptacles.

• The service must ensure that confidential personalinformation is stored in a secure manner.

• The service must ensure that there are establishedsystems and processes in place to safeguard serviceusers from abuse and improper treatment.

Action the provider SHOULD take to improve

• The provider should have systems and processes inplace to maintain effective oversight of cleaningschedules for all clinical and non-clinical areas.

• The provider should consider having systems andprocesses in place to provide support andtranslation services to women whose first languageis not English.

• The service should consider implementing systemsor processes to ensure that women are only scannedafter seven weeks of pregnancy.

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 12 HSCA (RA) Regulations 2014 Safe care andtreatment

There was a lack of oversight in relation to staff’scompletion of mandatory training.

The service was not effectively assessing, preventing anddetecting the risk of infection. There was a lack ofdocumented cleaning records, used gloves and tissueswere stored in domestic waste bins and a sharpscontainer lacked an assembly date and signature.

Regulated activity

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

The service had no access to a level three trainedsafeguarding individual for support.

The service had no dedicated safeguarding childrenpolicy in place.

We could not gain assurances that one member of staffhad received the recommended safeguarding adults andchildren training.

Regulated activity

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

Regulation

Regulation

Regulation

This section is primarily information for the provider

Requirement noticesRequirementnotices


The service had limited systems and processes in placeto oversee sonographers compliance with mandatorytraining and disclosure and barring service checks toensure competence and suitability in role.

Consent documentation containing patient identifiableinformation was not securely stored.

The service had not recognised a number of risks thatthe service faced.

Regulated activity

Diagnostic and screening procedures Regulation 12 CQC (Registration) Regulations 2009Statement of purpose

The service was seeing women aged 16 to 17 years ofage, which was outside of their conditions ofregistration.

12 - (2) The registered person must keep under reviewand where appropriate revise the statement of purpose.

(3) the registered person must provide written details ofany revision to the statement of purpose to theCommission within 28 days of any such revision.

Regulation

This section is primarily information for the provider

Requirement noticesRequirementnotices


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