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This report describes our judgement of the quality of care at this location. It is based on a combination of what we found when we inspected and a review of all information available to CQC including information given to us from patients, the public and other organisations Ratings Overall rating for this location Inadequate ––– Are services safe? Inadequate ––– Are services effective? Are services caring? Good ––– Are services responsive? Requires improvement ––– Are services well-led? Inadequate ––– Overall summary Precious Glimpse is operated by Precious Glimpse Limited. Precious Glimpse provides pregnancy reassurance and keepsake scans to self-paying members of the public. The service carries out trans abdominal ultrasound scans, including 2D, 3D and 4D baby keepsake scans and gender scans. The clinic does not provide diagnostic scans. The service is based in Burnley and in addition to the manager employs two ultrasound assistants; and one part time receptionist. The clinic is situated in Burnley Town Centre, close to public transport and nearby parking. The premises have a waiting room reception area; a scanning room; a storage room, office and toilet facilities. We inspected this service using our comprehensive inspection methodology. We carried out an unannounced inspection on 15 August 2019. To get to the heart of patients’ experiences of care and treatment, we ask the same five questions of all services: are they safe, effective, caring, responsive to people's Pr Precious ecious Glimpse Glimpse Quality Report 11 Hammerton Street Burnley BB1 1NA Tel: 01282 411112 Website: www.preciousglimpse.co.uk Date of inspection visit: 15 August 2019 Date of publication: 20/11/2019 1 Precious Glimpse Quality Report 20/11/2019

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Page 1: Precious Glimpse NewApproachComprehensive Report ...Background to Precious Glimpse Precious Glimpse is operated by Precious Glimpse Limited. The service has been registered at a previous

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 Inadequate –––

Are services safe? Inadequate –––

Are services effective?

Are services caring? Good –––

Are services responsive? Requires improvement –––

Are services well-led? Inadequate –––

Overall summary

Precious Glimpse is operated by Precious GlimpseLimited.

Precious Glimpse provides pregnancy reassurance andkeepsake scans to self-paying members of the public.The service carries out trans abdominal ultrasound scans,including 2D, 3D and 4D baby keepsake scans and genderscans. The clinic does not provide diagnostic scans.

The service is based in Burnley and in addition to themanager employs two ultrasound assistants; and onepart time receptionist.

The clinic is situated in Burnley Town Centre, close topublic transport and nearby parking. The premises have awaiting room reception area; a scanning room; a storageroom, office and toilet facilities.

We inspected this service using our comprehensiveinspection methodology. We carried out anunannounced inspection on 15 August 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's

PrPreciousecious GlimpseGlimpseQuality Report

11 Hammerton StreetBurnleyBB1 1NATel: 01282 411112Website: www.preciousglimpse.co.uk

Date of inspection visit: 15 August 2019Date of publication: 20/11/2019

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needs, 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 Precious Glimpse was babykeepsake scanning.

Services we rate

We rated this service as Inadequate overall because.

• The service did not provide mandatory training in keyskills for all staff and did not ensure everyonecompleted it

• Staff did not always understand how to protectpatients from abuse and had not completedsafeguarding training in line with nationalsafeguarding guidance.

• Staff did not identify risks for service users or followsystems to minimise risk.

• The service did not have any policies or procedures forescalating abnormal findings and did not provideevidence for how staff had been trained to identifythese.

• The service did not use appropriate control measuresto manage the risk of infection.

• The service did not provide care and treatment basedon national guidance and evidence-based practice.Managers did not check to make sure staff followedguidance.

• The service did not ensure staff were competent fortheir roles.

• The service did not have a formal induction process forstaff and records for disclosure and barring serviceenhanced checks were not completed for staff.

• Leaders did not operate effective governanceprocesses throughout the service and there was a lackof systematic performance management whichincluded the failure to identify and manage risk.

Following this inspection, we undertook due processregarding the significant safety concerns and told theprovider to suspend the regulated activities at thelocation. The provider gave us assurances of immediateimprovement actions taken and the suspension wasremoved at the end of the four week period.

We will continue to monitor the location and carry out afuture inspection to ensure the provider has continued tomake sustained improvements and that these areembedded.

We also issued the provider with two requirement noticeswith actions they must complete that affected PreciousGlimpse Limited.

Ann Ford

Deputy Chief Inspector of Hospitals (North Region)

Summary of findings

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Our judgements about each of the main services

Service Rating Summary of each main service

Diagnosticimaging

Inadequate –––

The service provided at this location was diagnosticand screening procedures. We rated this core serviceas inadequate overall.We saw no evidence to confirm staff were sufficientlyskilled or qualified to deliver effective care andtreatment to individuals using the service.There were insufficient systems to safeguard adultsand children who may be using the service.Appropriate, policies and guidelines referencingnational evidence-based practice were not developedby the provider.Risk, governance and operational performancearrangements were not robust and there wasineffective monitoring of quality improvements.

Summary of findings

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Contents

PageSummary of this inspectionBackground to Precious Glimpse 6

Our inspection team 6

Information about Precious Glimpse 6

The five questions we ask about services and what we found 7

Detailed findings from this inspectionOverview of ratings 9

Outstanding practice 20

Areas for improvement 20

Action we have told the provider to take 21

Summary of findings

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Precious Glimpse

Services we looked atDiagnostic imaging;

PreciousGlimpse

Inadequate –––

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Background to Precious Glimpse

Precious Glimpse is operated by Precious GlimpseLimited. The service has been registered at a previouslocation in Burnley from 2016 and has been registered atthe current location since December 2018. The serviceoffers pregnancy reassurance scans, 2D, 3D and 4D scans

to fee paying members of the public. It is a private clinicin Burnley England, primarily serving the communities ofBurnley and the surrounding area. It also accepts serviceusers on a self-referral basis from outside this area.

The service has had a registered manager in post sinceMay 2016.

Our inspection team

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

Information about Precious Glimpse

The clinic had one ultrasound scanning machine and isregistered to provide the following regulated activities:

• Diagnostic and Screening services.

During the inspection, we inspected all areas at the clinicand observed three ultrasound scans. We spoke withthree staff, the manager, a director and receptionist. Wespoke with patients and reviewed service user feedback.

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

Activity (July 2018 to July 2019)

In the reporting period 30 July 2018 to 30 July 2019 therewere 2,914 scans performed.

Track record on safety

• Zero never events (never events are serious patientsafety incidents that should not happen if healthcare

providers follow national guidance on how toprevent them. Each never event type has thepotential to cause serious patient harm or death butneither need have happened for an incident to be anever event), or serious incidents.

• Zero duty of candour notifications (the duty ofcandour is a regulatory duty that relates to opennessand transparency and requires providers of healthand social care services to notify people who use theservices (or other relevant persons) of certain‘notifiable safety incidents’ and provide reasonablesupport to that person).

• Zero safeguarding referrals.

• Zero incidences of healthcare acquired infections.

• Zero unplanned urgent transfers of a patient toanother health care provider.

• Zero number of cancelled appointments for anon-clinical reason.

Summaryofthisinspection

Summary of this inspection

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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 this service as Inadequate because:

• The provider did not identify or provide mandatory training inkey skills to staff.

• Staff did not have the right qualifications, skills, training andexperience to keep patients safe from avoidable harm and toprovide the right care.Staff did not always understand how to protect service usersfrom abuse, but staff knew how to contact other agencies incase of any safeguarding concern.

• Staff had only completed safeguarding vulnerable adults’ levelone training in the month before the inspection and had notcompleted safeguarding children training, although the servicewas offered to under 18-year olds.

• The service did not always control infection risk well and didnot always use control measures to prevent the spread ofinfection.

• There was not always a member of staff trained in first aid onthe premises.

• Staff did not assess risks to service users.• The service did not have any policies or procedures for

escalating abnormal findings and did not provide evidence forhow staff had been trained to identify these.

• The provider did not ensure staff had completed necessaryemployment checks for new staff, including Disclosure andBarring Service checks.

Inadequate –––

Are services effective?We inspected but do not rate effective because we do not haveenough information to make a judgment. We found:

• The provider did not develop policies or procedures to ensurecare and treatment was delivered in line with national guidanceand best practice.

• The provider did not monitor the effectiveness of care andtreatment delivered or use audit to monitor outcomes anddrive improvement.

• There was no induction process for new staff.• The service did not have a policy and staff had not completed

training regarding the Mental Capacity Act.

Are services caring?We rated this service as Good because:

Good –––

Summaryofthisinspection

Summary of this inspection

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• Staff cared for service users with compassion and respect.• Staff ensured women were comfortable during their

appointments and protected their privacy and dignity.• Staff were aware of women’s emotional needs and supported

them professionally when they needed to communicate anyconcerns identified.

• Staff involved women and those close to them in decisionsabout their care.

Are services responsive?We rated this service as Requires improvement because:

• The service did not always identify people’s individual needsprior to their appointment.

• Information was in English and translation facilities were notroutinely provided for.

• Accessible toilet facilities were not available, but the servicedirected service users to appropriate local retail facilities if thiswas needed.

• Staff had not completed any training in Equality and Diversity.

However

• Women could access the service when they needed to.• Appointments were planned to allow sufficient time for any

discussion.

Requires improvement –––

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

• Although there was an overall aim to develop the service, therewas no strategy or plan documented to progress this.

• There was not an effective governance process in place. Theservice did not review its practice in line with nationalguidelines or review staff training or competencies.

• The service had few policies and procedures and those it hadwere very limited.

• The service did not have arrangements in place for identifying,recording and managing risks. Leaders were not always awareof key risks, issues and challenges in the service.

• The service did not have effective recruitment processes andrecords of Disclosure and Barring Service checks for staff hadnot been completed.

Inadequate –––

Summaryofthisinspection

Summary of this inspection

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Overview of ratings

Our ratings for this location are:

Safe Effective Caring Responsive Well-led Overall

Diagnostic imaging Inadequate N/A Good Requiresimprovement Inadequate Inadequate

Overall Inadequate N/A Good Requiresimprovement Inadequate Inadequate

Detailed findings from this inspection

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Safe Inadequate –––

Effective

Caring Good –––

Responsive Requires improvement –––

Well-led Inadequate –––

Are diagnostic imaging services safe?

Inadequate –––

We rated this service as inadequate.

Mandatory training

The service did not provide mandatory training inkey skills to all staff and did not ensure everyonecompleted it. Staff had only completed safeguardingadults training in the month prior to the inspection,otherwise no other formal mandatory training wasidentified for staff to complete.

• The service did not have a clear mandatory trainingpolicy and staff had not received any training in coresubjects such as health and safety, infectionprevention and control, and information governance.Prior to inspection, information provided by theservice stated, ‘all of our staff have the relevanttraining to carry out their roles to a high standard’.During inspection we did not see any records whichconfirmed this, and we found a lack of evidence tosupport this.

• Information provided by the service stated staff wouldcomplete training at the start of their employment.However, we did not see any records that were kept bythe manager to confirm this and staff did not tell us ofany mandatory training apart from safeguardingtraining.

• The manager had recently introduced a training matrixwhich documented staff knowledge of differentprocedures relating to the service. Included in thetraining matrix were various topics such as: confidence

in use of booking and payment systems; stock control;awareness of gestation for different types of scanoffered; awareness of escalation process. A score wasrecorded for each member of staff to indicate thestandard of attainment; these were high standard,requiring improvement, or not trained.

• Information recorded on the training matrix indicatedthe two ultrasound assistants in the service weredeemed to be at a high standard for their ability tocarry out abdominal reassurance scans, accurategender scans, and accurate 3D/4D scans safely.However, there was no other supportingdocumentation to indicate the criteria and standardsthat had been applied, in order to assess that staffwere competent in their use of ultrasound equipment.

• The manager described how they used their ownjudgement and observation to supervise staff whilsttraining, until they had reached a level where theywere deemed to be competent. The manager said thaton occasion scans were offered free of charge toservice users, when these were undertaken by traineestaff.

• During inspection we saw certificates of completedsafeguarding vulnerable adults’ level one training andfire safety training that were held in staff files. All staffat Precious Glimpse Burnley had been completedthese training courses in July 2019.

Safeguarding

Staff did not always understand how to protectservice users from abuse, but they knew how tocontact other agencies to share concerns. Staff hadlimited understanding of potential safeguardingissues which may arise in the service.

Diagnosticimaging

Diagnostic imaging

Inadequate –––

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• All staff in the service had completed safeguardingvulnerable adults’ level one training. Staff in theservice had not completed any safeguarding childrentraining. The service did not have a clear safeguardingpolicy for adults of children which referenced currentnational safeguarding guidance.

• Information provided by the service prior to theinspection indicated ultrasound scans, including 3D/4D keepsake and diagnostic screening services wereprovided to 16-17-year olds and over 17-year olds. Theservice did not ask for service users’ date of birth onappointment booking or client waiver form andtherefore were not able to identify if an under18-year-old woman attended for a scan or if someoneunder the age of 16 years old had attended for a scan.

• Staff told us they would share any safeguardingconcerns initially with the manager for escalation. Wedid not hear of any examples of safeguarding concernsidentified in the service and the manager had notmade any safeguarding referrals.

• A safeguarding book was kept in a locked drawer atreception for staff to record any safeguarding concernswhere these had been identified. This also containedcontact details for the local safeguarding team, adultsocial care services and Lancashire police service. Wesaw there had been no details of safeguardingconcerns recorded in this book and the service hadnot made any safeguarding referrals in the last twelvemonths prior to inspection.

• The manager informed us they had a currentDisclosure and Barring Service certificate andevidence of this was provided following inspection. Amidwife who worked in the service had a Disclosureand Barring Service certificate relating to their NHSoccupation, but the service did not have evidence ofthis at the time of inspection. The two other staff andone of the directors in the service did not have acompleted Disclosure and Barring Service certificate.The service did not have ID of any of the staff orcharacter or professional references.

Cleanliness, infection control and hygiene

The service did not always control infection risk wellor use control measures to prevent the spread ofinfection. However, staff kept themselves and thepremises clean.

• The premises appeared visibly clean and were freefrom clutter. A checklist of cleaning duties identifieddifferent cleaning tasks for all areas. Staff managedcleaning duties on a daily basis, following the checklistand cleaning rota. We reviewed latest records of dailychecklists and saw these were all completed between20 May 2019 and 5 August 2019. We were informed aweekly deep clean was carried out of the premises,however we did not see any additional record toconfirm this.

• Staff wore uniforms with the company logo and werearms bare below the elbows. Staff did not have accessto hand washing facilities in the scanning room butused hand gel prior to scans. Aprons were notprovided but gloves were available for ultrasoundassistants to wear during scan procedures. However,we observed that staff did not always use these.

• The service did not have an infection prevention andcontrol policy, and staff had not completed anytraining for this.

• A paper towel covered the treatment couch duringclient scans and was replaced after each client’s use.During the scan, women were given a paper towel tohelp maintain their dignity. Following the scan, papertowels were used to wipe the gel from the ultrasoundtransducer head. We observed during one scan thepaper roll had fallen on the floor and was picked upand used again during the scan.

• Staff wiped down the treatment couch after eachappointment, using domestic cleaning wipes.Although this followed guidance in the cleaning tasksschedule, this was not in line with infection preventionand control guidance, which recommends use of anantibacterial cleaning product. Ultrasound assistantsmaintained the daily cleanliness of the ultrasoundmachine.

• Handwashing signs were not displayed in the toiletfacilities to prompt service users and staff.

• There had been no incidences of healthcare acquiredinfections at the service since it opened.

Environment and equipment

Diagnosticimaging

Diagnostic imaging

Inadequate –––

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The design, maintenance and use of facilities andpremises kept people safe although the service wasunable to provide records to show staff hadcompleted training for use of the equipment.

• The service had ground floor premises nearby toparking facilities, with main entrance at street level;this entrance was also the fire exit. External signagewas clear for people accessing the service.

• The clinic had a large waiting area with reception, ascan room, toilet facility, a store room and a separateoffice facility located to the rear of the unit. Thereception waiting area was light and spacious, withthree sofas providing comfortable seating for peopleusing the service. A large screen displayed familyfriendly images, in context of the service.

• The ultrasound scan equipment was serviced annuallyand maintained in accordance with themanufacturer’s guidance. Arrangements were in placefor supply of replacement equipment from thecontractor, in the event of any emergency breakdown.There were no reports of this having occurred.

• Records we reviewed showed the servicearrangements for electrical safety testing with anexternal contractor. All electrical equipment we sawdisplayed a current electrical safety testing sticker.

• The scan room contained seating, the treatmentcouch and ultrasound system, together with a largescreen for service users to view the scan. The furnitureand equipment appeared in good condition.

• The storage room contained a locked cupboard forstorage of substances hazardous to health, such ascleaning products. Various stock and items for salewere stored on shelves in an orderly manner.

• The storage room had two helium cylinders forinflating balloons, we saw these were freestandingand not secured. The storage room did not have a lockon the door but was visible from the reception deskand not immediately accessible from the waiting area.

Assessing and responding to patient risk

The service did not have systems in place to assessand manage risks to women and their babies. Therewas no policy or procedure for escalating abnormalfindings to keep women and their babies safe.

• The service did not offer medical diagnostic imagingscans. Website information stated scans werenon-medical, for baby bonding and souvenirpurposes, not intended to replace routine NHSmaternity scans and services.

• The service did not have a risk policy or guidance forrisk assessing women using the service. The servicedid not have any criteria for excluding women fromhaving a scan. Service users booking in were asked tocomplete their initials on a client waiver form prior tohaving a scan. The client waiver form asked women toconfirm they were currently in good health and had nonew or ongoing health concerns they needed to makePrecious Glimpse aware of. Between January andAugust 2019, the service had scanned four womenwho were bleeding and therefore may possibly havebeen having a miscarriage at the time of their scan.

• The service did not have any policies or procedures forescalating abnormal findings and did not provideevidence for how staff had been trained to identifythese. However, the service kept records of referral forcases where they had detected a possible anomalyfollowing a scan, or advised the woman to seek furtheradvice. We reviewed 25 referral records completedduring January – August 2019. In each case, staffdocumented whether they had contacted NHSservices on behalf at the woman’s request, or whetherthe woman had been directed to seek further advice.Six records indicated staff had followed up the contactwith NHS services; 13 records noted no further contacthad been received. While the service stated that it wasa non-medical service it had identified anomalies in 25cases, However, staff did not have guidance to followand staff, including the registered manager, had onlyreceived training on how to operate the equipment.This also meant the service was carrying out regulatedactivities beyond the scope of their registration.

• The client waiver form also stated, “Precious GlimpseLimited follows NICE guidance for frequency (soundwaves) and length of scan which has found nodetrimental effects in 40 years of case studies, but theBritish Medical Ultrasound Society do not recommendultrasound for non-medical purposes.” The providerdid not have any record to demonstrate how theyfollowed the NICE guidance referenced.

Diagnosticimaging

Diagnostic imaging

Inadequate –––

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• Women were not routinely asked to bring theirmaternity notes and for early pregnancy reassurancescans medical records would not generally beavailable. We observed pregnancy reassurance scanswhere ultrasound assistant advised service users onthe possible gestation term of the pregnancy. Thismeant the service was providing a diagnostic scanwhich was acting beyond the scope of registration.

• The service had a safety policy which stated, ‘theregistered manager is first aid trained & all employeeswill complete a health and safety at work course at thestart of their employment’. We did not see any recordsto confirm this and staff informed us they had notcompleted this.

• The manager stated they had completed first aidtraining and that a member of staff trained in first aidwould always be present on site; however, themanager worked across different locations and wasnot always present. There were no records to confirmany other staff had completed first aid training and wewere not assured there was always a member of stafftrained in first aid on site at all times.

• The service did not undertake non-invasive prenatalblood tests for service users.

Staffing

There were sufficient staff to meet the needs of theservice, however we were not assured all staff hadthe right skills and experience to keep people safefrom avoidable harm and to provide the right careand treatment.

• There were two part time ultrasound assistants andone part time receptionist working in the service. Theregistered manager also carried out scans when thiswas needed; staff worked together in shifts to providereception cover. On occasion staff worked betweenother locations of Precious Glimpse limited if therewas a need.

• There were no vacancies in the service at the time ofinspection. Any sickness was covered between staff, asand when it occurred. The service did not employbank or agency staff.

Records

Staff kept appropriate records of service users’ careand treatment, using electronic systems and paperrecords. Records were clear, up-to-date andavailable to all staff providing care.

• Women accessing the service completed a clientwaiver form at the time of their appointment. Thisstated the basic terms and conditions and identifiedthe service user’s consent for the scan procedure.

• The service maintained a secure file containing copiesof referral report forms for service users, where anyconcerns or anomalies had been detected and serviceusers had been directed to NHS professionals.

Incidents

The service did not always manage patient safetyincidents. Staff did not recognise or reportedincidents and near misses. Managers did notinvestigate incidents or share lessons learned withthe whole team and the wider service.

• The provider had an incident policy dated 1 March2019, which said ‘All Incidents that happen whileinside any Precious Glimpse studio must be reportedusing the accident and incident book which is locatedat reception. All incidents will also be reportedimmediately to the Registered manager’.

• The incident policy did not define what may constitutean incident and we saw no incidents had beenrecorded in the incident book held at the receptiondesk. The service had created an accident / incidentform for staff to use, however we did not see anyrecords of incident investigations or discussion aboutincidents.

• Staff were not provided with training regardingincidents but had a general awareness of their rolesand responsibilities to raise any concerns and woulddiscuss these with the manager in the first instance.

• Staff were aware of the principles of being open andhonest and the duty of candour. The duty of candouris a regulatory duty that relates to openness andtransparency and requires providers of health andsocial care services to notify patients (or other relevantpersons) of certain ‘notifiable safety incidents’ and

Diagnosticimaging

Diagnostic imaging

Inadequate –––

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provide reasonable support to that person. We weretold of occasions where staff had communicatedopenly to share information with service users, afteridentifying a possible abnormality on their scan.

Are diagnostic imaging serviceseffective?

The domain for effective was inspected but notrated

Evidence-based care and treatment

The service did not provide care and treatmentbased on national guidance and evidence-basedpractice.

• Protocols and pathways to support safe care andtreatment of people who use the services were notestablished and there were no documented standardoperating procedures for staff to follow for scanprocedures.

• The manager had completed a two-day private trainingcourse in ultrasound awareness in May 2016. Followinginspection, the manager provided a letter confirmingthis training had been completed. The letter stated thetraining included ‘hands on training on the ultrasoundequipment that you intend to use, including producttraining of the GE Voluson E8 Expert (ultrasoundmachine); how to start the machine, select functionsappropriate to the scanning in pregnancy and how toselect the correct settings to obtain an image in 2D, 3 /4D and HD live to obtain images for reassurance andbonding.’ The registered manager did not have anyevidence of continued professional development orupdated training on how to use the equipment.

• Staff were trained in use of the ultrasound equipment bythe registered manager. There were no records toconfirm the dates when staff had completed thistraining and records did not indicate the content of thistraining. Staff had not completed any other training inultrasound practice outside of the service. Theregistered manager had not received any training orprovide any evidence of competency to provide trainingon the equipment to others.

• The service had not participated in any audits or usedaudit information to plan where improvements could be

made. Audits, such as for infection control, bookingforms, image quality, principles and safety problems ofdiagnostic ultrasound guidelines (ALARA), were notidentified.

• Women were advised regarding the need to drink waterprior to their scan to enable a better image of their baby.Staff provided water to women at their appointment, ifthis was requested or needed.

Patient outcomes

Staff monitored feedback from service users but didnot monitor the effectiveness of care and treatmentor use the findings to improve them.

• Staff recorded information about the number and typeof scan appointments each month.

• The service maintained a secure file containing detailsof referrals where any concerns or anomalies hadbeen identified following a scan. This included detailsof whether the provider had been requested tocontact NHS services or not.

Competent staff

The service did not always ensure staff werecompetent for their role.

• The provider did not maintain records of appropriatestaff recruitment. In staff files we did not seecompleted application forms to work at the service, ahistory of employment, successful interview records,supply of professional references, or completion ofenhanced Disclosure and Barring Service checks,which were appropriate to the current staff job role.

• There were no completed peer reviews for ultrasoundassistants although the manager informed us of theywould carry out a process of informal supervision.

• Staff had not had an annual appraisal, although theservice had recently introduced documentation forconducting performance appraisals and the managerinformed us this was a new system in practice andintended for future development. Staff we spoke withsaid they had met with the manager to identify theirdevelopment needs.

• The service had recently introduced documentationfor an induction checklist, but this had not beenimplemented to date. There had been no formalinduction process for any new staff and no records

Diagnosticimaging

Diagnostic imaging

Inadequate –––

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kept for this, although new staff confirmed they wouldbe shown the different tasks required for their role asneeded. The manager confirmed they would bepresent during the fist week of a new member of staff’semployment to provide this direction.

Multidisciplinary working

Staff of different kinds worked together as a team tosupport women accessing the service.

• During our inspection we observed professionalcommunication and a positive working environmentbetween staff and towards service users. Theatmosphere was calm and friendly, allowing womento feel at ease.

• The service linked with local NHS maternity serviceswith consent of women, where there was an identifiedneed. Staff reported there could be difficulty onoccasions in making this communication.

Seven-day services

• The service was open on Thursday, Friday, Saturdayand Sunday between 8.30am and 4.30pm at thelocation. Should women wish to have an appointmentoutside of the clinic opening hours, appointmentscould be offered at other locations operated byPrecious Glimpse Limited.

Consent and Mental Capacity Act

Staff did not always support service users to makeinformed decisions about their care and treatment.They did not follow national guidance to gainpatients’ consent. They did not know how to supportpatients who lacked capacity to make their owndecisions or were experiencing mental ill health.

• The provider told us that people self-referred to theservice and consent was captured within the clientwaiver form, which service users were asked tocomplete by signing with their initials.

• The service had a consent policy which containedlimited information about needing to complete aconsent form.

• The client waiver form detailed consent for theultrasound scan procedure. The manager stated theservice saw only medically fit individuals and did notperceive there had been any service users who lacked

mental capacity or who had a need relating to theirmental health. We reviewed records which indicatedwomen may have been having a miscarriage at thetime of their scan, therefore the provider was notfollowing this guidance in practice.

• At the time of our inspection staff had not completedany training in consent or the Mental Capacity Act(2005) and the consent policy did not reference theMental Capacity Act (2005).

Are diagnostic imaging services caring?

Good –––

We rated this service as good.

Compassionate care

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

• Staff were welcoming and informative to people usingthe service. We observed staff communicating withsensitivity and understanding when engaging withservice users and their families.

• Scans were conducted in a closed room to ensureprivacy and dignity was maintained. The ultrasoundassistant spoke calmly to explain what was happeningduring the scan and what was being observed on thescan images.

• The ultrasound assistant checked women werecomfortable during the scan and where needed, gaveclear guidance if women needed to change theirposition.

• During the inspection we reviewed feedback frompeople who had used the service. Commentsincluded, “staff were really great” and “the imageswere really good”. One said their favourite part of theexperience was, “seeing our little girl and not feelingrushed”.

Emotional support

Staff provided emotional support for service usersto minimise their distress.

Diagnosticimaging

Diagnostic imaging

Inadequate –––

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• Staff were aware of the emotional needs of womenduring their appointments and providedencouragement and reassurance to reduce anyanxieties about the scan procedure.

• Reception staff supported women and their familiesappropriately when choosing a scan image. Staffwelcomed any children and family membersattending with the woman for the scan, providing acomfortable and relaxing environment.

• Staff described how they supported women if theyneeded to communicate any concerns andappointment times allowed for flexibility if this arose.Staff described how they would support women whensharing information regarding possible anomalies,using calmness and clear language. We observed howstaff were sensitive and supported a woman who hadexperienced a positive scan result after having lost apregnancy in the past.

Understanding and involvement of patients andthose close to them

Staff involved service users and those close to themin decisions about their care.

• During our inspection we observed staff supportingand involving women, their partners and families tounderstand their condition and make decisions abouttheir care

• The ultrasound assistant made sure that women andthose close to them, felt able to ask questions abouttheir care and treatment. They gave people who usethe services time to ask questions.

• Information regarding the different types of scans andpackages available for people to purchase was clearlypresented on the provider’s website. Feedback fromservice users indicated they were happy with theservice they had received and felt supportedthroughout.

Are diagnostic imaging servicesresponsive?

Requires improvement –––

We rated this service as requires improvement.

Service delivery to meet the needs of local people

The service planned and provided care in a way thatmet the needs of local people.

• The premises were located in the town centre on theground floor, with a reception area, a scanning room, astorage room, office and toilet facilities.

• In the scan room there was an ultrasound machine,chairs and a clinical treatment couch. In addition,there was a raised television screen on the wall forscan images to be displayed. The service provided asecond computer terminal for women to choose theirscan pictures.

Meeting people’s individual needs

The service did not always take account of patients’individual needs and preferences. Staff did notalways identify reasonable adjustments to helppatients access services.

• The premises were accessible for wheelchair usersalthough toilet facilities were not accessible. Staffwould direct any service users to nearby retail facilitiesfor this need. The treatment couch was heightadjustable and accessible for service users.

• Staff described how they would respond to differentindividual needs on a case by case basis, althoughthese were not identified at the time of booking.

• The website and other clinic information was onlyprovided in English language format. The managerstated the service had used internet translationservices on previous occasions where there had beena need for language translation.

• Staff had not completed any Equality and Diversitytraining, but had some awareness of differentindividual needs.

Access and flow

Women could access the service when they needed itand received the right care in a timely way.

• Appointments were booked at a time to suitindividuals’ preference; appointments and staffingwere planned according to demand.

• The service allocated a fifteen-minute gap betweenappointments to ensure sufficient time for any

Diagnosticimaging

Diagnostic imaging

Inadequate –––

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questions and for service users to not feel rushed. Thisalso allowed extra time in cases where staff needed toshare any negative findings, such as if there was anabsent foetal heartbeat.

• The service had a system in place for service userswho required a rescan. Rescans were provided whereit had not been possible for the ultrasound assistant toobtain a clear image due to the baby’s stage ofgestation.

• No planned appointments were cancelled or delayedfor a non-clinical reason such as breakdown ofequipment.

• The service did not have a waiting list.

Learning from complaints and concerns

The service had a limited complaints policy and didnot have a process to investigate complaints orshare any learning from complaints.

• The service had a complaints policy containing limitedinformation to say complaints would be responded toby the manager.

• The service recorded no complaints in the reportingperiod July 2018 to July 2019. The manager statedthey were aware of a potential complaint currently butdid not know any further details regarding this issue.

• Staff in the service informed us any concerns would beresponded to if they arose and raised to the managerif these could not be resolved in the first instance.

• The service reviewed comments from feedback formsto identify any changes or improvements needed.

Are diagnostic imaging services well-led?

Inadequate –––

We rated this service as inadequate.

Leadership

Leaders had the abilities to run the service andunderstood the issues the service faced but did notidentify priorities. They were visible andapproachable for service users and staff.

• The leadership team was made up of two directors,one of whom was the registered manager andultrasound technician. The registered manager did notinform us of any specific leadership training they hadcompleted for their role but had an understanding oftheir service.

• The manager was visible and approachable; staff inthe service said they were well supported.

Vision and strategy

The service did not have a vision or current strategy.

The service did not have a vision for what it wanted toachieve or a strategy to turn this into action.

• We were told the previous business plan had reacheda stage where it had achieved its current objectives,with the proposed opening of a fourth location

• Staff we spoke with expressed a general aspiration todevelop the service, and to complete ultrasoundtraining, but were unaware of any further detailedplans.

Culture

Staff felt respected, supported and valued. Theservice had an open culture where service users,their families and staff could raise concerns withoutfear.

• The manager promoted a positive culture across theservice that supported and valued staff.

• There was an open and transparent culture within theservice; staff we spoke with were enthusiastic aboutthe service and proud of their work.

• Staff felt able to raise concerns to the managerwithout any fear of retribution.

• During the inspection when we shared informationabout areas of the service where improvements mayneed to be made, the manager was positive inresponse to this.

Governance

Diagnosticimaging

Diagnostic imaging

Inadequate –––

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Leaders did not operate effective governanceprocesses and were unclear about theiraccountabilities. There was no process to overseekey items and a lack of systematic performancemanagement.

• The service did not have systems or procedures inplace to ensure that policies and practice wereappropriate, regularly reviewed or referenced currentbest practice guidelines.

• Whilst we saw for some areas of service activity, theprovider had created a policy, these comprised astatement of intention only, without any detail for howthe policy would be implemented or monitored.

• There was no governance framework to support thedelivery of good quality care. Although the statedaspiration for the service was to ‘deliver the highestquality treatment and care possible’, the service didnot complete quality audits or use this information todrive improvement.

• The service did not have recruitment processes foremployees and staff files did not contain certificates ofDisclosure and Barring Service (DBS) checks; this alsoincluded DBS checks for one of the company directors.We did not see any evidence of references requestedor received in staff files, or photographic ID foremployees. Following inspection, the registeredmanager confirmed they had current DBS certificationassociated with their CQC registration, also anothermember of staff had current DBS certification inassociation with their NHS employment.

Managing risks, issues and performance

The service did not have systems to identify risks,plan to eliminate or reduce them. There was littleunderstanding or management of risks and issues,and there were significant failures in performancemanagement and audit systems and processes.

• The service had a business continuity plan whichidentified actions to take in case of power failure, ITsystems failure or phone systems failure. There wereno risks identified in relation to clinical aspects of carefor women using the service.

• There were no arrangements in place for identifying,recording and managing day to day risks for service

users and staff in the service. During the inspection weidentified key areas of risk in mandatory training,safeguarding and recruitment procedures, whichleaders had not been aware of.

Managing information

The service collected, analysed and usedinformation well to support its activities usingsecure electronic systems and security safeguards.

• Computers used by staff and for service userschoosing scan images in the reception area werepassword protected.

• The ultrasound scan machine was passwordprotected and we were told digital images weremanually deleted from here after three months. Scanimages were transferred via a data stick to a receptioncomputer for service users to choose their images. Thedata stick was kept in a locked drawer when not inuse.

• The service kept paper records of past client waiverforms from 2018 and 2019, which were stored in alocked office.

• Information on the website was clear about servicesprovided and the various costs of these. The clientwaiver form confirmed terms and conditions of theservice.

• The service did not have a confidentiality and GeneralData Protection Regulation (GDPR) policy in place andwere unable to demonstrate how they fulfilled therequirements of GDPR and related legislation. Staffhad not received any training in informationgovernance.

Engagement

Leaders and staff openly engaged with service usersand staff, to help improve services.

• The provider engaged with service users through theservice’s website and social media accounts, topromote its services. The provider monitoredfeedback from service users via follow up surveys andsocial media comments.

Learning, continuous improvement and innovation

Diagnosticimaging

Diagnostic imaging

Inadequate –––

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• Although we did not hear of any specific developmentplans, staff in the service were keen to improveservices where they could and were open toopportunities to do this.

Diagnosticimaging

Diagnostic imaging

Inadequate –––

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Areas for improvement

Action the provider MUST take to improve

• The provider must review and develop specific policyguidance in relation to mental capacity and consentand ensure staff have the necessary training andunderstanding in order to support service users tomake an informed decision regarding their care andtreatment. Regulations 12 (1) (2) (c),13 (1) (2)

• The provider must review safeguarding systems andprocesses and operate these effectively to preventabuse of service users. Regulation 13 (1)(2).

• The provider must ensure staff are trained in andfollow infection prevention and control guidance,and use personal protective equipmentappropriately at all times. Regulation 12 (1) (2)(c)

• The provider must review and identify training andpolicies as appropriate for the service, includingsafeguarding training, to ensure this meets withSafeguarding Intercollegiate document guidance(2018) Regulation 12 (1)(2)(c)

• The provider must review and implement robustsystems to identify, assess and mitigate any risksrelating to the safety, health and welfare of peoplewho use the service. Regulation 12(1)(2)(a), (b)

• The provider must assess, monitor and improve thequality and safety of the services provided, andimplement systems to evaluate and improve theirpractice. Regulation 17(1)(2)(a)

• The provider must establish effective systems toassess, monitor and mitigate the risks relating to thehealth, safety and welfare of service users and otherswho may be at risk from the carrying on of theregulated activity. Regulation 17(1)(2)(b)

• The provider must establish effective systems toensure records are maintained in accordance withthe requirements of the General Data ProtectionRegulation Regulation 17 (1) (2) (c)

• The provider must ensure an appropriate inductionprogramme is provided for new staff in the service.Regulation 18 (2) (a)

• The provider must ensure there are robust systemsin place for the recruitment and employment ofpersons employed in the service. Regulation 19 (1)(a) (b) (2)

Action the provider SHOULD take to improve

• The provider should consider displaying handwashing signs in the toilet facilities.

• The provider should continue to implementappraisal and supervision systems for staff.

• The provider should continue to develop incidentinvestigation procedures to ensure there are systemsfor sharing learning with staff.

• The provider should review arrangements for safestorage of helium canisters in the stock room andconsider a security lock.

Outstandingpracticeandareasforimprovement

Outstanding practice and areasfor improvement

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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 5 HSCA (RA) Regulations 2014 Fit and properpersons: directors

The provider did not have robust recruitment andemployment procedures and one of the directors did nothave a completed DBS check, employment references, orphotographic ID.

Regulation 5 (1) (2)(a) (3)(a)(e)

Regulated activity

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

The provider did not have effective systems in place toassess, monitor and improve the quality and safety ofthe services provided.

The provider did not have effective systems in place toassess, monitor and mitigate the risks relating to thehealth, safety and welfare of service users and otherswho may be at risk from the carrying on of the regulatedactivity.

The provider did not have effective systems formaintaining records to meet the requirements of theGeneral Data Protection Regulation

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

Regulated activity

Regulation

Regulation

Regulation

This section is primarily information for the provider

Requirement noticesRequirementnotices

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Diagnostic and screening procedures Regulation 18 HSCA (RA) Regulations 2014 Staffing

The provider did not have an appropriate inductionprogramme for new staff in the service.

The provider did not identify mandatory trainingappropriate for the service.

Regulation 18 (1) (2) (a)

This section is primarily information for the provider

Requirement noticesRequirementnotices

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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

The service did not have systems in place to

Identify and mitigate any risks relating to the safety,health and welfare of people who use the service

Staff had not completed training in consent and were notaware of the requirements of the Mental Capacity Act2005 with regard to consent.

Staff had not completed training in infection preventionand control.

Regulation 12 (1) (2) (a) (b) (c)

Regulated activity

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

Staff had not completed the appropriate level ofsafeguarding children and adults training andsafeguarding systems were not embedded.

Regulation 13 (1)(2).

Regulated activity

Diagnostic and screening procedures Regulation 19 HSCA (RA) Regulations 2014 Fit and properpersons employed

Regulation

Regulation

Regulation

This section is primarily information for the provider

Enforcement actionsEnforcementactions

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The provider did not have robust recruitment andemployment procedures and staff did not havecompleted DBS checks, employment references , orphotographic ID.

Regulation 19 (1) (a) (b) (2)

This section is primarily information for the provider

Enforcement actionsEnforcementactions

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