window to the womb - cqc

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?

Are services caring? Good –––

Are services responsive? Good –––

Are services well-led? Good –––

WindowWindow TToo TheThe WombWombQuality Report

1st Floor Medical SuiteColne HouseUpton RoadWatfordHertfordshireWD18 0JPTel: 01923 241516Website: www.windowtothewomb.co.uk

Date of inspection visit: 8 January 2019Date of publication: 15/02/2019

1 Window To The Womb Quality Report 15/02/2019

Letter from the Chief Inspector of Hospitals

Window To The Womb in Watford is owned by New Beginnings South Ltd, and operates under a franchise agreementwith Window To The Womb (Franchise) Ltd. The service provides diagnostic pregnancy ultrasound services toself-funding women across Hertfordshire, Bedfordshire, and Buckinghamshire.

We inspected this service using our comprehensive inspection methodology. We carried out a short-notice announcedinspection on 8 January 2019. We gave staff two working days’ notice that we were coming to inspect to ensure theavailability of the registered manager and clinics.

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

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

Services we rate

We have not previously inspected this service. At this inspection, we rated the service as good overall.

We found areas of good practice:

• The facilities and premises met the needs of the range of people who accessed the service. This included childrenwho accompanied women to their scans. The service also recognised that women’s preferred method ofcommunication had changed, and as a result, they had developed a range of innovative products to tailor theirservices and meet the needs of local people.

• The service took a proactive approach to understand women’s individual needs, and delivered care in a way thatmet these needs, which was accessible and promoted equality.

• Women could access services and appointments in a way and at a time that suited them. Technology was usedinnovatively to ensure women had timely access to treatment.

• The service treated concerns and complaints extremely seriously. The registered manager completedcomprehensive investigations, which frequently involved input from other professionals, such as the leadsonographer. Lessons learned were shared with all staff.

• Staff were caring, kind and engaged well with women and their families.

• Managers promoted a positive culture that supported and valued staff. Staff confirmed they felt respected andvalued.

• The service used current evidence-based guidance and good practice standards to inform the delivery of care andtreatment. Staff demonstrated a good understanding of the national legislation that affected their practice.

• Window To The Womb had a clear vision and strategy for what they wanted to achieve, with quality andsustainability as the top priorities.

However, we found the following areas of practice that the service needed to improve:

• While most of the governance arrangements were clear and appropriate to the size of the service, there were noteffective recruitment processes in place. Managers also did not have full oversight of what training thesonographers had completed at their substantive employer. However, these concerns were addressed immediatelyafter our inspection.

Summary of findings


Following this inspection, we told the provider that it should make other improvements, even though a regulation hadnot been breached, to help the service improve. Details are at the end of the report.

Amanda StanfordDeputy Chief Inspector of Hospitals (Central)

Summary of findings


Our judgements about each of the main services

Service Rating Summary of each main service

Diagnosticimaging

Good –––

The provision of ultrasound scanning services, which isclassified under the diagnostic core service, was theonly core service provided at Window To The Womb.We rated the service as good overall because therewere processes in place for the escalation ofunexpected findings during ultrasound scans.Feedback from women and their families wasextremely positive. Women could access services andappointments in a way and at a time that suited them,technology was used innovatively to ensure womenhad timely access to treatment, and the registeredmanager had the appropriate skills and experience tomanage the business.However, at the time of our inspection, there were noteffective recruitment processes in place, andmanagers did not have full oversight of what trainingthe sonographers had completed at their substantiveemployer. This was addressed immediately after ourinspection.

Summary of findings


Contents

PageSummary of this inspectionBackground to Window To The Womb 7

Our inspection team 7

Information about Window To The Womb 7

Detailed findings from this inspectionOverview of ratings 9

Outstanding practice 28

Areas for improvement 28

Summary of findings


Window To The Womb

Services we looked atDiagnostic imaging.

WindowToTheWomb

Good –––


Background to Window To The Womb

Window To The Womb is a private diagnostic servicebased in Watford, Hertfordshire. It is owned by NewBeginnings South Ltd, and operates under a franchiseagreement with Window To The Womb (Franchise) Ltd.Window to the Womb (Franchise) Ltd was established in2003 and now has 36 franchised clinics across the UnitedKingdom.

As part of the agreement, the franchisor (Window To TheWomb Ltd) provides the service with regular on-sitesupport, access to their guidelines and policies, training,and the use of their business model and brand.

Window To The Womb in Watford opened in 2014 andprovides diagnostic pregnancy ultrasound services toself-funding women, who are more than six weeks’gestation and aged 18 years and above. All ultrasoundscans performed at Window To The Womb are in additionto those provided through the NHS.

The service is registered with the CQC to undertake theregulated activity of diagnostic and screeningprocedures. It has had a registered manager in post sinceregistering with the CQC in 2014.

We have not previously inspected this service.

Our inspection team

The inspection team was comprised of two CQCinspectors. The inspection team was overseen by KimHandel, Inspection Manager, and Bernadette Hanney,Head of Hospital Inspection.

Information about Window To The Womb

The service provides diagnostic imaging services(ultrasound scans) to self-funding pregnant womenacross Hertfordshire, Bedfordshire, and Buckinghamshire.It is located on the first floor of a medical centre, whichhas ramp and lift access.

Window To The Womb has separated their services intotwo clinics: the ‘Firstscan’ clinic, which specialises in earlypregnancy scans; and the ‘Window to the Womb’ clinic,which offers later pregnancy scans.

The Firstscan clinic sees approximately 30 women perweek and offers the following scans:

• Viability scans from six to 10+6 weeks’ gestation.

• Dating scans from eight to 12+6 weeks’ gestation.

• Reassurance scans from 12 to 15+6 weeks’ gestation.

The window to the womb clinic sees between 65 to 75women per week and offers the following scans:

• Wellbeing scans from 16 to 40 weeks’ gestation.

• Wellbeing and gender scans from 16 to 22 weeks’gestation.

• Growth and presentation scans from 26 to 42 weeks’gestation.

• 4D baby scans from 24 to 34 weeks’ gestation.

They do not offer nuchal translucency scans or the20-week anomaly scans. This is because these diagnostictests are offered as part of the current NHS pregnancypathway. They also do not offer non-invasive prenataltests (NIPT).

All women accessing the service self-refer to the clinicand are all seen as private (paying) patients.

The service runs six clinics per week. Standardoperational hours are Monday and Tuesday mornings,Wednesday and Thursday evenings, Friday afternoon andevening, and all-day Saturday and Sunday.

At the time of our inspection, Window To The Wombemployed a registered manager who owned the service,

Summaryofthisinspection

Summary of this inspection


and five scan assistants on zero-hour contracts. Foursonographers worked out of the service on aself-employed basis. The service did not use controlleddrugs (CDs).

During our inspection, we visited the registered locationin Watford, Hertfordshire. We spoke with five staffmembers, including the registered manager,sonographer, scan assistants, and the franchise director.We also observed seven ultrasound scans, spoke withfour women and their partners, and reviewed 10 patientrecords.

There were no special reviews or investigations of theservice ongoing by the CQC at any time during the 12months before this inspection.

Activity:

• Window To The Womb performed a total of 5,617ultrasound scans from January to December 2018. Abreakdown of the type of scan can be seen below:

• 1,569 (28%) early pregnancy scans, including; 1,034viability scans, 340 dating scans and 195 reassurancescans.

• 4,048 (72%) later pregnancy scans, including: 2,1244D baby scans, 1,634 gender scans, 180 wellbeingscans and 110 growth and presentation scans

• All women were self-funding.

• For the reporting period of January to December2018, Window To The Womb did not cancel anypatient appointments for non-clinical reasons.

• For the reporting period of January to December2018, no procedures were delayed due tonon-clinical reasons.

Track record on safety:

• The service reported zero never events from Januaryto December 2018.

• The service had recorded two incidents fromJanuary to December 2018.

• The service reported zero serious injuries fromDecember 2017 to November 2018.

• The service received eight complaints from Januaryto December 2018.

• Window To The Womb received hundreds of writtencompliments from January to December 2018.

• Window To The Womb reported zero incidents ofhealth associated MRSA, Methicillin-sensitivestaphylococcus aureus (MSSA), Clostridium difficile(C. diff), and Escherichia Coli (E-Coli).

Summaryofthisinspection

Summary of this inspection


Overview of ratings

Our ratings for this location are:

Safe Effective Caring Responsive Well-led Overall

Diagnostic imaging Good N/A Good Good Good Good

Overall Good N/A Good Good Good Good

NotesWe do not rate effective.

Detailed findings from this inspection


Safe Good –––

Effective

Caring Good –––

Responsive Good –––

Well-led Good –––

Are diagnostic imaging services safe?

Good –––

We have not previously inspected this service. At thisinspection, we rated safe as good.

Mandatory training

• The service provided mandatory training coursesin key skills to scan assistants and the registeredmanager. However, there was no oversight onwhat training the sonographers had completed attheir substantive employer; this was rectifiedafter our inspection.

• The sonographers who worked for Window To TheWomb on a self-employed basis, completed theirmandatory training at their substantive NHSemployment. However, the service did not haveoversight on what training these individuals hadcompleted or when. We raised this as a concern to theregistered manager and the franchise director.Following our inspection, we were provided withevidence that the sonographers’ mandatory trainingmatrix had been requested and stored in their staffpersonnel files. The managers had also shared thislearning with the other franchised clinics across theUK.

• The registered manager ensured that any sonographerwho did not work within the NHS, accessed andcompleted the mandatory training provided byWindow To The Womb.

• Scan assistants completed their mandatory trainingon a rolling training programme. Training courses were

provided through ‘e-learning’ modules or ‘face-to-face’sessions at their team meetings. They covered keyareas, such as: equality and diversity, fire safetyawareness, consent and mental capacity, infectionprevention and control, safeguarding adults, andsafeguarding children training.

• At the time of this inspection, all five scan assistants(100%) were compliant with their required trainingmodules.

• The registered manager attended an externalmandatory training course each year. The coursecovered important topics such as: safeguarding adultsand children training, basic life support, fire safety,information governance, complaints handling, conflictresolution, and moving and handling training.

Safeguarding

• Staff understood the need to protect people fromabuse, and had completed safeguarding trainingat the required level to ensure they had theappropriate knowledge to do so.

• At the time of our inspection, 100% of the scanassistants were compliant with safeguarding adultstraining level two, which was the level appropriate totheir role.

• Although Window To The womb did not provideultrasound services to adolescents under the age of 18years, children frequently attended ultrasound scanappointments with their mothers. From review of thestaff files, we saw that four of the five scan assistantshad received safeguarding children’s training leveltwo, and one of the scan assistants had received

Diagnosticimaging

Diagnostic imaging

Good –––


safeguarding children’s training level three. This metthe intercollegiate guidance ‘Safeguarding childrenand young people: roles and competences for healthcare staff’ (March 2014).

• The sonographers did not receive safeguardingtraining from Window To The Womb as theycompleted this training at their substantive NHSemployer. At the time of our inspection, the service didnot have a copy of their training certificates, whichmeant we could not be assured the sonographers hadcompleted training at the required level. Following ourinspection, the registered manager provided evidencewhich showed that all the sonographers hadcompleted both level two adults’ and childrentraining. This meant the safeguarding training was inaccordance with national legislation.

• < >he registered manager ensured that any sonographerwho did not work within the NHS, accessed andcompleted the safeguarding training provided byWindow To The Womb.

The service had a designated lead for both childrenand adults’ safeguarding, who was the registeredmanager. They were available during working hours toprovide support to staff, and had completed bothadults and children’s level three safeguarding training.

• Staff we spoke with had not made any safeguardingreferrals; however, they were able to confidently tell ushow they would identify a safeguarding issue andwhat action they would take. This included informingthe safeguarding lead for the service.

• There were up-to-date safeguarding adults andchildren’s policies for staff to follow, which includedthe contact details of the local safeguarding boards.There was also a copy of the local authority’s‘Safeguarding children, young people, and adults atrisk’ policy, which reflected relevant nationallegislation and local requirements.

• A separate female genital mutilation (FGM) policyprovided staff with clear guidance on how to identifyand report FGM. Staff we spoke with were aware of theDepartment of Health’s ‘Female genital mutilation andsafeguarding guidance for professionals’ (March 2016).If staff were concerned about any woman, they wouldrefer to the local safeguarding team.

Cleanliness, infection control and hygiene

• The service controlled infection risk well. Staffkept themselves, the equipment, and thepremises clean. The clinic room, toilets, receptionand waiting areas were visibly clean and clutter freeon the day of our inspection.

• Window To The Womb had infection prevention andcontrol (IPC) policies and procedures in place, whichprovided staff with guidance on appropriate IPCpractice.

• Cleaning was recorded on daily and weekly checksheets, which were reviewed by the registeredmanager. We reviewed the cleaning checklists and sawcleaning had been consistently completed. Thestandards of cleanliness were also monitoredthroughout the day by staff. For example, the scanassistants checked the toilets, studio floor (whenraining), and reception area every hour to confirm theywere clean and tidy.

• The sonographers followed the manufacturer’s andIPC guidance for routine disinfection of equipment.Staff decontaminated the ultrasound equipment withdisinfectant wipes between each woman and at theend of each day. We observed staff cleaningequipment and machines during our inspection.

• Staff used paper towel to cover the examination couchduring the scanning procedure. We observed staffchanging the towel at the end of the woman’sappointment.

• Women were given a towel to use during theirultrasound scan to help maintain their dignity.Following their appointment, the used towels wereplaced in a laundry bin, and were laundered at aminimum temperature of 60 degrees.

• A supply of personal protective equipment (PPE) wasavailable and accessible to all staff. Staff used the PPEappropriately when interacting with women, and allhad their ‘arms bare below the elbows’ in clinical areas(to help prevent the transfer of infection from clothingthat could be contaminated, and allow staff to washtheir hands thoroughly).

• Staff washed their hands using the correct handhygiene techniques before, during and after patient

Diagnosticimaging

Diagnostic imaging

Good –––


contact. Handwashing basins and sanitiser gels wereavailable in the clinic room and toilets. Hand sanitiserwas also available for staff, women, and visitors to useat the reception desk.

• At the time of our inspection, hand hygiene auditswere not undertaken to measure staff compliance withthe World Health Organisation’s (WHO) ‘Five Momentsfor Hand Hygiene’. These guidelines are for all staffworking in healthcare environments and define thekey moments when staff should perform hand hygieneto reduce the risk of cross contamination betweenpatients. We raised this as a concern during ourinspection, and were told that the service wouldintroduce hand hygiene audits immediately. Followingour inspection, the registered manager sent us a copyof their newly developed hand wash audit proforma.

• A risk assessment for Legionnaires’ disease had beencompleted in September 2018 against the waterdispenser in the reception area. The assessmentidentified actions the service was taking to mitigatethe risk, including biannual servicing and sanitisationof the dispenser. Legionnaires’ disease is a seriouspneumonia caused by the legionella bacteria. Peoplebecome infected when they inhale water dropletsfrom a contaminated water source such as watercoolers and air conditioning systems.

• There had been no instances of healthcare acquiredinfections from January to December 2018.

Environment and equipment

• The service had suitable premises and equipmentand looked after them well. The environmentpromoted the privacy and dignity of women usingthe service.

• The service facilities were located on the first floor of amedical centre and were accessible to all women.There was ramp and lift access to the building, and theclinic room contained an adjustable couch, which staffused to support women with limited mobility.

• The waiting room for the service had adequateseating, and there were two toilets situated close tothe clinic and waiting area, including a disabled toiletwith baby changing facilities.

• The environment in which the scans were performedwas spacious, homely, and well arranged. Staff turned

the lights off and pulled down the black-out blindswhen undertaking a scan to darken the room, whichmeant scans could be observed clearly. This alsopromoted the privacy and dignity of women. Similarly,the scan assistants locked the clinic room door andprovided a dignity screen for women to get changedbehind before their transvaginal scans.

• Blue mood lighting and soothing music was playedduring the scan appointments to create a relaxing andcalming environment for the woman and her family.

• The clinic room had adequate seating available forthose accompanying the women to theirappointments. There were also two wall-mountedmonitors, which projected the images from theultrasound machine. This enabled the women andtheir families to view the baby scan more easily.

• An external company completed the servicing of theultrasound machine. The service record for themachine confirmed it had been serviced annually, thelast completed in August 2018. Where faults aroseoutside of the planned services, staff called outengineers to assess and perform repairs.

• Electrical equipment was regularly serviced and safetytested to ensure it was safe for patient use. Wereviewed five pieces of equipment, including printers,computers, and the ultrasound machine, and foundall equipment had been serviced within the dateindicated.

• Fire extinguishers were accessible, storedappropriately, and had all been serviced within thedate indicated. Fire drills were held every six months,with the last completed in December 2018.

• Substances which met the ‘Control of SubstancesHazardous to Health Regulations’ (COSHH) (Healthand Safety Executive, 2002), were stored in a lockedcupboard in the staff room. There was clear signageon the cupboard door to alert staff to its contents. Thecupboard also contained the service’s most recentCOSHH risk assessment and policy.

• Waste was handled and disposed of according to bestpractice. Staff used the correct system to handle andsort clinical and non-clinical waste, and there was aservice level agreement in place for its removal.

Assessing and responding to patient risk

Diagnosticimaging

Diagnostic imaging

Good –––


• The service had appropriate arrangements inplace to assess and manage risks to women, theirbabies, and families.

• There were clear processes in place to guide staff onwhat actions to take if any suspicious findings werefound on the ultrasound scan. If they had concerns,the sonographer followed the service’s referralpathway and referred the woman to the mostappropriate healthcare professional, with her consent.For example, if the sonographer detectedpolyhydramnios (too much amniotic fluid), they wouldrefer the woman to the fetal medicine unit or theantenatal clinic at the local NHS trust. If thesonographer suspected placental abruption (wherethe placenta separates early from the uterus) or anectopic pregnancy, they immediately dialled 999 foremergency assistance.

• Staff documented referrals on dedicated referralforms, which were reviewed by the registered managerand input onto an electronic log.

• During our inspection, we reviewed four referral forms.All contained a description of the scan findings, thereason for referral, who the receiving healthcareprofessional was and what action they were going totake. For example, a sonographer made a referral to anearly pregnancy unit as they identified no fetalheartbeat during the ultrasound scan. The earlypregnancy unit informed the scan assistant that theywould contact the woman immediately and arrangefor them to come in and have another scan to confirmthe findings.

• Upon booking their appointment, women wereadvised to bring their NHS pregnancy records withthem to their appointment at Window To The Womb.This meant the sonographers had access to women’sobstetric and medical history, if required. It also meantthat staff could contact the most relevant medicalprovider if a concern was detected.

• The sonographers could contact a lead sonographerfor advice and support during their clinics. The leadsonographer was employed by the franchisor and wasavailable to review any ultrasound scan remotelywithin one to two hours.

• Staff advised women about the importance of stillattending their NHS scans and appointments. The

sonographers made sure women understood that theultrasound scans they performed were in addition tothe routine care they received as part of theirmaternity pathway.

• The service accepted women who were physically welland could transfer themselves to a couch with littlesupport. The service did not offer emergency tests ortreatment.

• Due to the nature of the service provided, there wasno emergency resuscitation trolley on site. However,staff had access to a first aid box. There was also clearguidance for staff to follow if a woman suddenlybecame unwell whilst attending the clinic. If staff hadconcerns about a woman’s condition during theirultrasound scan, they stopped the scan andtelephoned 999 for emergency support.

• Both the scan assistants and the registered managerhad completed first aid or basic life support (BLS)training, and would put their training to use until theambulance arrived. BLS training gives staff a basicoverview of how to deal with a patient who may havestopped breathing, such as starting cardiopulmonaryresuscitation.

• The service used the ‘Paused and Checked’ checklistdevised by the British Medical Ultrasound Society(BMUS) and Society of Radiographers, which wasdisplayed in the clinic room and helped to remind staffto carry out checks. Although it was not formallydocumented, we observed the sonographercompleting the checks during appointments, whichincluded: confirming the woman’s identity andconsent; providing clear information and instructions,including the potential limitations of the ultrasoundscan; following the BMUS safety guidelines; andinforming the woman about the results.

• Scan reports were completed immediately after thescan had taken place, which we observed during ourinspection.

• The service only used latex-free covers for thetransvaginal ultrasound probe, which minimised therisk of an allergic reaction for women with a latexallergy.

Staffing

Diagnosticimaging

Diagnostic imaging

Good –––


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

• There were five scan assistants employed onzero-hour contracts. They were responsible formanaging enquiries, appointment bookings,supporting the sonographers during the ultrasoundscans and helping the families print their scan images.One of the scan assistants had recently beenpromoted to a team leader, and was responsible forthe day-to-day running of the service in the absence ofthe registered manager.

• Sonographers were not directly employed, however,four sonographers worked for the service on aself-employed basis. The sonographers were allexperienced radiographers, doctors, or midwives, andall had previous obstetrics and gynaecologyexperience.

• The ultrasound clinics were scheduled in advance andthe sonographers assigned themselves to the clinics,which fitted around their permanent employmentpositions.

• All staff we spoke with felt that staffing was managedappropriately. At all times, there were at least threestaff in the clinic; this included two scan assistants anda sonographer. No staff members were required towork as a ‘lone worker’. Where staffing levels fell belowthis agreed threshold, all appointments would berearranged.

• Window To The Womb did not use agency staff. In theevent of a staff member going off sick, the scanassistants and sonographers would cross-coverbetween themselves to help prevent cliniccancellations. In circumstances where this was notpossible, the registered manager covered the scanassistant role. This helped to prevent cliniccancellations.

• The registered manager monitored staff sickness rates.From January to December 2018, there had been nostaff sickness absences.

• Information provided by the service indicated that onescan assistant had left the service within the last 12months. However, one scan assistant and onesonographer had joined the service within the lastyear.

Records

• Staff kept detailed records of women’s’appointments, referrals to NHS services andcompleted scan consent documents. Recordswere clear, up-to-date, and easily accessible tostaff providing ultrasound scans.

• The sonographer undertaking the ultrasound scancompleted the paper scan report during the woman’sappointment with the support of the scan assistant. Acopy of the scan report was given to the woman totake away with her. The service also stored apaper-copy of the scan report, in case they needed torefer to the document in future.

• Where appropriate, and with consent, thesonographer would also send a paper copy of the scanreport to the woman’s GP or another relevanthealthcare professional when a referral was made.

• The ultrasound images were saved onto a USB stick,which could be purchased by the woman at the end ofher appointment. The woman was also given freeaccess to the a mobile phone application (‘app’),which had been developed by the franchisor. The appenabled women to have instant access to their scanimages.

• We reviewed ten scan reports from both the Firstscanand Window to The Womb clinics. Staff recorded allthe specified information in a clear and accurate way.This included the woman’s estimated due date, thetype of ultrasound scan performed, the findings,conclusions, and recommendations.

• The service had an up-to-date informationgovernance policy in place for staff to refer to. Thepolicy detailed staff responsibilities, documentationstandards, and the retention of records.

• The service kept completed service user recordssecurely. The consent records and referral forms werearchived and stored securely on site. Staff kept

Diagnosticimaging

Diagnostic imaging

Good –––


completed records in locked filing cabinets. Anyelectronic records or systems were passwordprotected, and the passwords were changed everytime a staff member left the service.

Medicines

• The service did not use any controlled drugs ormedicines for any of their procedures.

Incidents

• Processes were in place for staff to raise concernsand report incidents. Staff understood their rolesand responsibilities to raise concerns and recordsafety incidents. Lessons learned were sharedwith the whole team and the wider service.

• The service used a paper-based reporting system, andthe accident and incident book was available in theclinic for staff to access, if required. The registeredmanager was responsible for conductinginvestigations into all incidents. They collated theincidents into an electronic log, which was used toidentify any themes and learning, and was shared withstaff at their team meetings. The registered manageralso submitted a monthly incident return to thefranchisor.

• All staff we spoke with described the process forreporting incidents and provided examples of whenthey would do this, such as information governancebreaches or equipment breakdown. The process forincident reporting and investigating was outlined inthe service’s incident reporting policy.

• From January to December 2018, the service hadreported two incidents, which related to concerns withthe air-conditioning unit and the building’s carpark.We saw that these incidents received an appropriatereview by the service, and action was taken tominimise the risk of recurrence. For example, allair-conditioning units within the clinic were reserviced.

• Window To The Womb did not have any never eventsin the 12 months before our inspection. A never eventis a serious incident that is wholly preventable asguidance, or safety recommendations providingstrong systemic protective barriers, are available at a

national level, and should have been implemented byall providers. The event has the potential to causeserious patient harm or death, has occurred in thepast and is easily recognisable and clearly defined.

• In accordance with the Serious Incident Framework2015, the service did not report any serious incidentsin the 12 months before our inspection.

• Regulation 20 of the Health and Social Care Act 2008(Regulated Activities) Regulations 2014 is a regulationwhich was introduced in November 2014. Thisregulation requires the organisation to be open andtransparent with a patient when things go wrong inrelation to their care and the patient suffers harm orcould suffer harm, which falls into defined thresholds.The duty of candour regulation only applies toincidents where severe or moderate harm to a patienthas occurred.

• Staff understood the duty of candour and the need forbeing open and honest with women and their familiesif errors occurred. The registered manager couldexplain the process they would undertake if theyneeded to implement the duty of candour followingan incident, which met the requirements. However, atthe time of our inspection, they had not needed to dothis.

• The registered manager was aware of therequirements for reporting incidents to the CQC usingthe statutory notification route if this met the criteria,under Regulation 18 of the Care Quality Commission(Registration) Regulations 2009.

Are diagnostic imaging serviceseffective?

We do not rate effective.

Evidence-based care and treatment

• The service used current evidence-basedguidance and good practice standards to informthe delivery of care and treatment.

• Local policies and protocols were in line with currentlegislation and national evidence-based guidancefrom professional organisations, such as the NationalInstitute for Health and Care Excellence (NICE) and the

Diagnosticimaging

Diagnostic imaging

Good –––


British Medical Ultrasound Society (BMUS). Thepolicies also contained links to further reading. Forexample, the service’s fetal abnormality policyreferenced the NHS fetal anomaly screeningprogramme as additional reading.

• Staff demonstrated a good understanding of nationallegislation that affected their practice. For example,sonographers followed the ‘Ectopic pregnancy andmiscarriage: diagnosis and initial management’guidance (NICE, 2012) when they identified a fetus didnot have a visible heartbeat and measured less than7.0mm.

• In addition, the service followed the ALARA (as low asreasonably achievable) principles, outlined in the‘Guidelines for professional ultrasound practice, 2017’by the Society and College of Radiographers (SCoR)and BMUS. Where possible, sonographers completedall ultrasound scans within 10 minutes to help reduceultrasound patient dose.

• All policies and protocols contained a next renewaldate, which ensured they were reviewed in a timelymanner.

• Staff were aware of how to access policies, which werestored electronically on an internal computer drive.Paper copies were also accessible to staff.

• Staff ensured women understood that the ultrasoundscans performed at Window To The Womb were inaddition to those provided as part of their NHSpregnancy pathway and were not designed to replaceany NHS care.

• We observed a sonographer providing clearinformation to women about their ultrasound scans,including the potential limitations of the scan.Similarly, staff verbally signposted women to NHSservices if they experienced symptoms, such asvaginal bleeding or pain at the end of their scanningappointment.

• There was an audit programme in place to provideassurance of the quality and safety of the service. Peerreview audits were undertaken in accordance withrecommendations made by the British MedicalUltrasound Society, and the franchisor completedannual sonographer competency assessments. Otheraudits, such as clinic and local compliance audits

were undertaken regularly. They monitored patientexperience, cleanliness, health and safety, ultrasoundscan reports, equipment, and policies and procedures.For example, audit results for the audit completed inSeptember 2018 indicated that the service needed toremove their fire extinguishers directly from the floor,and re-do the fire risk assessment. We found that allthe required actions had been completed at the timeof our inspection.

• The service was inclusive to all pregnant women andwe saw no evidence of any discrimination, includingon the grounds of age, disability, pregnancy andmaternity status, race, religion or belief, and sexualorientation when making care and treatmentdecisions.

Nutrition and hydration

• To improve the quality of the ultrasound image,women were asked to drink an extra two glasses ofwater per day on the lead up to their appointment,and to have a snack a couple of hours before theirscan. Women who were having a gender scan wereencouraged to attend their appointment with a fullbladder. This information was given to women whenthey contacted the clinic to book their appointment. Itwas also included in the ‘frequently asked questions’on the service’s website.

• Due to the nature of the service, food and drink wasnot routinely offered to women. However, there was adrinking water dispenser in the waiting area, whichwas accessible to women and visitors. There was alsoa fridge containing soft drinks and confectionary,which could be purchased by the women and theirfamilies for a small fee.

Pain relief

• Staff asked women if they were uncomfortable duringtheir ultrasound scans, however, no formal pain levelmonitoring was undertaken as the procedures werepain free.

Patient outcomes

Diagnosticimaging

Diagnostic imaging

Good –––


• Staff monitored the effectiveness of care andtreatment and used the findings to improve theirpractice. The service monitored patient outcomesthrough their activity, annual patient satisfactionsurvey and clinical audits.

• The service used key performance indicators (KPIs) tomonitor performance, which were set by thefranchisor. This enabled the service to benchmarkthemselves against the 35 other franchised clinics. Atthe time of our inspection, the registered managerreported that they were in the top five performingclinics for both their later and early pregnancyservices.

• Service data was also collected and reported to thefranchisor every month to monitor performance. Thisincluded information about the number of ultrasoundscans completed including the number of rescans,and the number of referrals made to other healthcareservices.

• From September to December 2018, the laterpregnancy clinic completed 125 re-scans, which was9% of the total number of scans completed. Most ofthe rescans were completed because it was notpossible for the sonographer to confirm the gender ofthe baby at the time of the appointment. For the sameperiod, the Firstscan clinic did not complete anyrescans.

• From January to December 2018, the service referred85 women to their GP, midwife, or the local NHS trustdue to the detection of potential concerns.

• The service reported a 99.9% accuracy rate for theirgender confirmation scans. This figure was based onover 20,000 gender scans completed at the 36franchised clinics across the UK. There was abreakdown figure for the individual clinics. There wasa rescan guarantee in place for when it was notpossible for the sonographer to confirm the gender ofthe baby at the time of the appointment. If the womanreceived incorrect information with regards to theirbaby’s gender, they were offered a complimentary 4Dbaby scan. The sonographer involved also receivedadditional support from the lead sonographer, whowas employed by the franchisor.

• Window To The Womb had recently introducedsonographer peer review audits. The sonographers

reviewed each other’s work and determined whetherthey agreed with their ultrasound observations andreport quality. This was in line with BMUS guidance,which recommends peer review audits are completedusing the ultrasound image and written report. At thetime of our inspection, seven peer review audits hadbeen completed since November 2018. We reviewed asample of the peer review audits and found that noconcerns were identified.

• Service activity, audit results and patient feedbackwere regularly discussed during the monthly teammeetings.

Competent staff

• Staff had the skills, knowledge and experience todeliver effective care and treatment. While thesonographer staff files did not contain evidenceof appraisals or references, there were processesin place to assess sonographer competence andsuitability for their role.

• As part of our inspection, we reviewed the staffpersonnel files for the registered manager,sonographers, and scan assistants. We found they allcontained evidence of a recruitment and selectioninterview, employment history, identification,employment contract, and disclosure and barringservice (DBS) checks. DBS checks help employersmake safer recruitment decisions and preventunsuitable people from working with vulnerablegroups.

• The sonographer staff files did not contain evidence ofemployment references. This meant we could not beassured effective recruitment processes had beenfollowed and staff were of good character. We raisedthis as a concern with the registered manager and thedirector of the franchise during our inspection.

• Similarly, none of the four sonographer personnel filescontained evidence of appraisals, which had beencompleted by their substantive employer. Appraisalsprovide evidence that individuals still hold thenecessary skills and competencies to undertake theirrole safely and effectively. There was no formalarrangement in place to ensure Window To The Wombwas informed of any performance problems or otherconcerns relating to a sonographer’s practice. We

Diagnosticimaging

Diagnostic imaging

Good –––


raised this as a concern during our inspection, and wewere told the registered manager regularly checkedthe professional register for any indication ofconcerns. In addition, the lead sonographercompleted initial (when the sonographers first joinedthe service) and annual competency assessments. Aspart of these assessments, the lead sonographerchecked the sonographers’ registration, indemnityinsurance and revalidation status. If any concerns wereidentified, the registered manager was expected toaddress them immediately, and additional training orfurther observation was provided to the sonographer.The staff files we reviewed confirmed that all foursonographers had received a competency assessmentwithin the last 12 months.

• Following our inspection, the registered manager anddirector reviewed their current recruitmentrequirements. We were provided with evidence whichshowed that references and appraisal copies hadbeen requested from the sonographers’ substantiveemployers. The recruitment policy was also amendedto reflect the staff file changes.

• All four sonographers were registered with the Healthand Care Professionals Council (HCPC), the Society ofRadiographers, the General Medical Council or theNursing and Midwifery Council. There was evidence oftheir professional registration in their personnel files.Most of the sonographers had previous obstetrics andgynaecology experience within an NHS acute trust,and three of the four sonographers still worked for theNHS.

• Each staff member completed a local induction, whichincluded mandatory and role-specific training. Staffaccessed their role-specific training through theservice’s electronic training portal. Training recordsconfirmed that all staff had completed theirappropriate role-specific training.

• Window To The Womb also provided ‘in-house’training videos to the sonographers, which weredeveloped by the franchisor. The videos coveredobstetric and fetal anomalies, including ectopicpregnancy, triploid syndrome (a condition where afetus has three copies of every chromosome instead of

the normal two) and anencephaly (a condition wherethe brain or spinal cord of a fetus does not developproperly). The sonographers also had workbooks tocomplete once they had watched the videos.

• Throughout the year, the scan assistants assessed thesonographers for their quality of customer care andservice, standard of communication, and overallcustomer experience. The sonographers receivedverbal and written feedback, and the registeredmanager ensured any identified learning points wereimplemented by the sonographers immediately. At thetime of our inspection, five customer care and serviceaudits had been completed since October 2018.

• The service manager was responsible for appraisingthe scan assistants. Appraisals were completed on anannual basis and once completed, were stored in stafffiles. Information provided by the service showedthere was a 100% appraisal compliance rate for allscan assistants that had been employed for more than12 months.

Multidisciplinary working

• Staff of different disciplines worked together as ateam to benefit women and their families.

• During our inspection of Window To The Womb, weobserved positive examples of the sonographer andscan assistants working well together. Theirprofessional working relationship promoted a relaxedenvironment for women and helped to put womenand their families at ease.

• Although there were no formal meetings between theregistered manager and the sonographers, they hadregular informal catch-up sessions, and thesonographers were consulted about changes toservice provision.

• The service had established pathways in place to referwomen to their GP or local NHS trust if any concernswere identified during their appointment. Staffcommunicated their referral to the local NHS trust orGPs by letter and telephone. The service used aprinted referral template and hand wrote the woman’sdetails and the reason for referral, and attached a copyof the scan report and images.

Seven-day services

Diagnosticimaging

Diagnostic imaging

Good –––


• Although Window To The Womb was not an acuteservice and did not offer emergency tests ortreatment, it still operated seven days a weekand worked in a flexible way to accommodate theneeds of the women.

• Clinics were generally held on a Monday morning;Tuesday morning; Wednesday evening; Thursdayevening; Friday afternoon and evening; all-daySaturday and Sunday.

Consent and Mental Capacity Act

• Staff understood how and when to assesswhether a woman had the capacity to makedecisions about their care. They followed theservice policy and procedures when a womancould not give consent. All staff were aware of theimportance for gaining consent from womenbefore conducting any ultrasound scan.

• There were processes to ensure women consented toprocedures. All women received written information toread and sign before their scan appointment, whichwas available in different languages. This informationincluded terms and conditions, such as scanlimitations, consent, prices and use of data. The scanassistants checked the form was signed before thewomen’s appointments.

• Women’s verbal consent was also sought before thesonographer commencing the ultrasound scan. Thesonographers discussed the potential risks to theunborn child from additional use of ultrasound withthe women. This enabled the women to make aninformed decision on whether to proceed with thescan.

• Staff gave women the option of withdrawing theirconsent and stopping the scan at any time, and weobserved this during our inspection.

• Staff understood their roles and responsibilities underthe Mental Capacity Act (2005). They knew how tosupport women who lacked the capacity to makedecisions about their care.

• While staff had completed training in relation to theMental Capacity Act (2005) as part of their mandatorytraining, they reported that they had not seen awoman who lacked capacity since the service openedin 2014.

• There was a Mental Capacity Act (2005) policy for staffto follow, which clearly outlined the service’sexpectations and processes.

Are diagnostic imaging services caring?

Good –––

We have not previously inspected this service. At thisinspection, we rated caring as good.

Compassionate care

• Staff cared for women with compassion.Feedback from women and their familiesconfirmed that staff treated them well and withkindness.

• All staff were very passionate about their roles andwere dedicated to making sure women receivedpatient-centred care.

• We observed staff treating and assisting women andtheir families in a compassionate manner. The scanassistants and sonographer were very reassuring andinteracted with the women and their relatives in aprofessional, respectful, and supportive way.

• During our inspection of Window To The Womb, wespoke with four women and their partners aboutvarious aspects of their care. Without exception,feedback was consistently positive about the kindnessand care they received from staff. One womandescribed staff as “really friendly and welcoming”.Another woman told us that she would recommendthe service and that she “would definitely use theservice again”.

• We observed staff introducing themselves to womenat the start of the appointments, and the women wespoke with confirmed this.

• Staff protected women’s privacy and dignity. Forexample, the clinic room was locked when ultrasoundscans were being undertaken, and women were

Diagnosticimaging

Diagnostic imaging

Good –––


provided with a gown to cover themselves duringintimate scans. There was also a dignity screen forwomen to get changed behind before theirtransvaginal scans. A woman told us that she felt thatthe sonographer treated her with dignity during herinternal scan.

• The service obtained patient feedback throughfeedback forms, which allowed women to makecomments about their care and provide a rating oftheir overall experience. We reviewed a sample of thefeedback forms (13 forms in total), and found that allthe women had rated their experience as ‘five stars’.Examples of comments included, “amazingexperience, I felt really comfortable”, “very patient andkind staff, made my absolute day”, and “such a lovely,comfy, supportive environment”.

• We also read some feedback from women, that hadbeen sent by letter, email, or on social media. All thefeedback was extremely positive, and includedcomments such as, “staff did everything they could toaccommodate our tricky request and it turned out tobe the best scan we had so far”, “the staff werebrilliant, they made me and my partner verywelcome”, and “I loved every single scan I had here…100% recommend”.

Emotional support

• Staff provided emotional support to women tominimise their distress. We observed staffproviding kind, thoughtful, supportive, andempathetic care.

• Staff were aware that women attending the servicewere often feeling nervous and anxious so providedadditional reassurance and support to these women.The scan assistants acted as chaperones duringintimate ultrasound scans to ensure women receivedemotional support. As part of their mandatorytraining, staff received training in the emotionalaspects of receiving bad news.

• In the case of abnormal results, for example, amiscarriage, women could remain in the scan roomwith their partner or, if they were unaccompanied, calltheir partner or relative in private. If a woman suffereda miscarriage before their appointment, staffimmediately refunded the woman’s deposit payment.

• If a woman became distressed in a public area, suchas the waiting room, they allowed the woman to sit inthe staff room, where a member of staff would supportthem.

Understanding and involvement of patients andthose close to them

• Staff involved women and those close to them indecisions about their care and treatment.

• Staff took the time to explain the procedure to thewoman before and during the ultrasound scan. Staffadapted the language and terminology they usedwhen discussing the procedure with the woman andher family, and feedback from women confirmed this.They told us that the sonographer explained what washappening throughout their appointment, and theywere provided with the opportunity to ask questionsabout their scan and its findings.

• Staff also communicated to relatives in a way theycould understand. This included any children whomay have accompanied the woman to theirappointment. The registered manager told us that upto five people were welcome to attend theappointments with the woman.

• All relatives we spoke with said that they felt involvedin the care given.

Are diagnostic imaging servicesresponsive?

Good –––

We have not previously inspected this service. At thisinspection, we rated responsive as good.

Service delivery to meet the needs of local people

• The facilities and premises met the needs of therange of people who accessed the service. Thisincluded children who accompanied women totheir scans. The service also recognised thatwomen’s preferred method of communicationhad changed, and as a result, they had developeda range of innovative products to tailor theirservices and meet the needs of local people.

Diagnosticimaging

Diagnostic imaging

Good –––


• The clinic was located on the first floor of a medicalcentre, and was accessible to all women and visitors;there was ramp and lift access to the building, and theclinic room contained an adjustable couch, which staffused to support women with limited mobility. Therewas also a comfortable waiting area, with a waterdispenser, a fridge containing soft drinks andconfectionary, and two patient toilets, including adisabled toilet and baby changing facilities.

• Children frequently accompanied women to theirappointments. In these circumstances, staff ensuredthe children felt involved, and gave them a ‘big sister’or ‘big brother’ sticker for any scans completed after16 weeks’ gestation. In addition, the waiting areacontained children’s toys and colouring books.

• There was a small car park to the rear of the building,which offered two hours free parking. The clinic wasalso located close to public car parks and transport,which were all within walking distance. The serviceprovided information on travelling to their clinic on itswebsite.

• Window To The Womb offered a range of ultrasoundscans for pregnant women, such as wellbeing,viability, growth, presentation, and gender scans.

• There was a range of appointment times, includingdaytime, evening, and all-day weekend clinics. Theservice operated seven days a week and worked in aflexible way to accommodate the needs of womenand their families.

• Women were given relevant information about theirultrasound scan when they booked theirappointment, such as needing a full bladder. Thisinformation was also included in the ‘frequently askedquestions’ on the service’s website.

• The service provided payment details in aconfirmation email before the woman’s appointment.Ultrasound scan prices were outlined on the service’swebsite, and we observed staff clearly explaining costsand payment options to women during theirappointments.

• The service recognised that women preferred to usethe internet or mobile phone applications (‘app’) tocontact the clinic and book appointments. Therefore,women could book their scan appointments through

the phone, website or through the free Window To TheWomb phone app. The app also enabled women todocument and share week-by-week images of theirpregnancy ‘bump’ with their family and friends, andcreate a time-lapse video of their pregnancy journey.Any scan image taken during a Window To The Wombappointment was also saved on the app. This enabledwomen to have instant access to their scan images.

• Window To The Womb regularly used social media toengage with the local population and promote theirservice.

Meeting people’s individual needs

• The service took a proactive approach tounderstand women’s individual needs, anddelivered care in a way that met these needs,which was accessible and promoted equality.

• Women received written information to read and signbefore their scan appointment, which was available indifferent languages. Copies of this document, andother key information were also available on thewebsite and could be accessed in any recognisedworld language. For example, the website containedinformation about what an ultrasound scan involvesand advice about some pregnancy conditions,including cleft lip, anencephaly, and spina bifida.

• At the time of our inspection, there was not atranslation service for staff to use during anappointment for non-English speaking women.However, we were told that the franchisor wasdeveloping a bespoke mobile phone app for staff andwomen to use in these circumstances. Oncedeveloped, the app translated both verbal and writteninformation. The franchise director hoped the appwould be implemented by March 2019.

• Easy to read and large print information leaflets wereavailable for women who had sight impairment. Theservice also used an online ‘read aloud’ function.

• Information leaflets were given to women when theyhad a pregnancy of an unknown location, for example,an ectopic pregnancy; a second scan that confirmed acomplete miscarriage; or an inconclusive scan. Theleaflets contained a description of what thesonographer had found, advice, and the next stepsthey should take.

Diagnosticimaging

Diagnostic imaging

Good –––


• All scans were undertaken in a private clinic room withlots of space for any additional relatives, friends, orcarers to accompany the woman. If a woman wasrequired to undress, locked doors and dignity screenswere used to protect her privacy.

• The moveable couches were suitable for veryoverweight women; however, there was no hoistavailable. If a woman required the use of otherbariatric equipment, they would be referred to theNHS.

• Staff did not know if a woman had a learning disabilitybefore they arrived at the clinic. However, staff told usthat they had not seen a woman with a knownlearning disability since they opened in 2014. If theydid see a woman with a learning disability, staff told usthey would provide her with individualised care andensure she was accompanied by a relative, friend orcarer.

• Window To The Womb separated their services intotwo clinics: the ‘Firstscan’ clinic, which specialised inearly pregnancy scans; and the ‘Window to the womb’clinic, which offered later pregnancy scans. Althoughthe Firstscan clinic was operated within Window ToThe Womb and was provided by the same staff,appointments were offered at different times. Thismeant that women who may have experienced amiscarriage did not share the same area with womenwho were much later in their pregnancy.

• The service offered women a range of baby keepsakeand souvenir options, which could be purchased for asmall fee at reception. This included heartbeat bears,a selection of photo frames, fridge magnets andgender reveal products. Heartbeat bears contained arecording of the unborn baby’s heartbeat.

Access and flow

• Women could access services and appointmentsin a way and at a time that suited them.Technology was used innovatively to ensurewomen had timely access to treatment.

• All women self-referred to the service. They couldbook their appointment in person, by the telephone,using the online booking form or the app.

• The service operated seven days a week, which meantthere was a range of appointments available. This

included evening and weekend clinics. Same dayappointments were also often available. All thewomen we spoke with confirmed they had a choice ofappointment times.

• At the time of our inspection, there was no waiting listor backlog for appointments. From January toDecember 2018, the service performed 5,617ultrasound scans. This included 1,569 early pregnancyscans and 4,048 later pregnancy scans.

• During our inspection, we observed that the Firstscanand Window to the Womb clinics ran on time.

• The service monitored their rates of patientnon-attendance, and the registered managersubmitted this information to the franchisor everymonth. There was a low rate of non-attendancebecause the service requested a non-refundabledeposit payment on appointment booking. If awoman suffered a miscarriage before theirappointment, staff would refund the deposit paymentimmediately.

• From July to December 2018, data showed that 19women did not attend their booked appointment atthe Firstscan clinic. For the same period, 27 womendid not attend their appointment for the laterpregnancy clinic.

• From January to December 2018, no ultrasound scanswere delayed or cancelled for non-clinical reasons.

Learning from complaints and concerns

• The service treated concerns and complaintsextremely seriously. The registered managercompleted comprehensive investigations, whichfrequently involved input from otherprofessionals, such as the lead sonographer.Lessons learned were shared with all staff.

• The service had an up-to-date complaint handlingpolicy, which set out the complaints process and theresponsibility of staff. The policy confirmed that allcomplaints should be acknowledged within threeworking days and resolved within 21 working days.

Diagnosticimaging

Diagnostic imaging

Good –––


• The registered manager had overall responsibility forreviewing and responding to complaints. Theycollated complaints into an electronic log, which wasused to identify any themes and learning, and wasshared with staff at their team meetings.

• From January to December 2018, the service receivedeight complaints. We saw that action was taken inresponse to the complaints received to help improvepatient experience and service provision. For example,following a concern about a gender confirmation scan,the registered manager asked the lead sonographer toreview the scan images. The woman was also invitedback for another gender scan free of charge andoffered a complimentary 4D scan. The sonographerinvolved was asked to review the scan video andreceived additional support from the leadsonographer.

• While we saw that appropriate action was taken toresolve the complaints, the complaint log did notcontain an ‘acknowledged by’ or ‘responded by’ date.This meant we were unable to determine whethercomplaints were acknowledged, investigated, andclosed within the required timescale. However, theregistered manager assured us that they resolved allcomplaints within 48 hours.

• Following our inspection, the registered managerprovided evidence that the last two complaints theyreceived were acknowledged and resolved within 24hours. Both women were also offered acomplimentary 4D scan for their inconvenience. Wewere also provided with the service’s updatedcomplaints log, which now included an‘acknowledged by’ and ‘responded by’ column.

• Information on how to make a complaint wasavailable on the clinic website and on the back of thepatient feedback form. Staff told us that mostcomplaints were made through social media.Therefore, the registered manager monitored theirsocial media pages daily, which ensured any concernsor complaints were addressed immediately.

• All had staff completed a mandatory training courseon customer care and dealing with complaints.

Are diagnostic imaging services well-led?

Good –––

We have not previously inspected this service. At thisinspection, we rated well-led as good.

Leadership

• The registered manager had the skills,experience, and integrity needed to run asustainable service.

• The manager had an awareness of the service’sperformance, limitations, and the challenges it faced.They were also aware of the actions needed toaddress those challenges.

• The sonographers reported to the registered managerfor matters of administration and to the leadsonographer for clinical matters. The scan assistantsreported to the registered manager. One of the scanassistants had recently been promoted to a teamleader, and was responsible for the day-to-day runningof the service in the absence of the registeredmanager.

• Staff knew the management arrangements and told usthey felt well supported. The lead sonographer wasavailable to review any ultrasound scan remotelywithin one to two hours.

• All staff spoke overwhelmingly positively about theregistered manager of Window To The Womb and thefranchise directors. They said the manager anddirectors were friendly, approachable, and effective intheir roles. Staff felt confident to discuss any concernsthey had with them.

• Management development courses were available,and could be accessed by any member of staff. Thecourses included: customer service skills, managerinduction, negotiating and influencing, problemsolving and performance appraisals. The registeredmanager had successfully completed thedevelopment courses.

• The franchisor was contractually responsible forproviding the registered manager with ongoingtraining, which was undertaken at clinic visits, trainingevents and the biannual national franchise meetings.

Diagnosticimaging

Diagnostic imaging

Good –––


Vision and strategy

• Window To The Womb had a clear vision andstrategy for what they wanted to achieve, withquality and sustainability as the top priorities.

• Their vision was “to provide high quality, efficient andcompassionate care to their customers and families,through the safe and efficient use of obstetricultrasound imaging technology”. There were alsoaims, which identified what the service needed to doto achieve their vision. Examples included: “to providepregnant ladies with medically relevant ultrasoundfindings by way of an obstetric report”, and “to reportany suspected abnormalities identified using thepathways we have established with our local NHShospitals”.

• While some of the staff we spoke with were unable tofully articulate the vision, it was evident they alwaysworked within the ethos of it. Staff told us they “aimedto provide the best possible customer experience”.

• The service had also identified values, whichunderpinned their vision. Their values included:dignity, integrity, privacy, diversity, and safety.

• There were plans to relocate the service to a new,larger location within Watford by the end of thefinancial year. However, at the time of our inspection,this had not yet been formally agreed.

Culture

• Managers promoted a positive culture thatsupported and valued staff, creating a sense ofcommon purpose based on shared values. Thiswas evident during our inspection.

• We spoke with five members of staff who all spokepositively about the culture of the service. Staff feltsupported, respected, and valued, and all reportedthat they felt proud to work for Window To The Womb.There was a sense of ownership and pride in theservice provided, and staff strived for excellence in thequality of service women received.

• The service operated an open and honest culture toencourage team working within the organisation. Thiswas supported by the franchisor’s ‘freedom to raise a

concern’ policy, and the appointment of a ‘freedom tospeak up guardian’. There was also a confidentialphone line for staff to contact should they wish todiscuss anything that had affected them at work.

• Any incidents or complaints raised had a ‘no blame’approach to the investigation. However, incircumstances where errors had been made,apologies would always be offered to the woman, andstaff ensured steps were taken to rectify any errors.Staff were aware of the duty of candour regulation;however, they had not had any incidents which metthe criteria where formal duty of candour had beenrequired to be implemented.

• During and after our inspection, we informed theregistered manager that there were areas of theservice that required improvement. They respondedpositively to this feedback and immediately putactions in place, demonstrating an open culture ofimprovement.

Governance

• While most of the governance arrangements wereclear and appropriate to the size of the service,there were not effective recruitment processes inplace. Managers also did not have full oversightof what training the sonographers had completedat their substantive employer. However, theseconcerns were addressed immediately after ourinspection.

• The registered manager had overall responsibility forclinical governance and quality monitoring. Thisincluded investigating incidents and responding topatient complaints. The registered manager wassupported by the franchisor and attended biannualnational franchise meetings, where clinic compliance,performance, audit, and best practice were discussed.

• There was an audit programme in place to provideassurance of the quality and safety of the service. Peerreview audits were undertaken in accordance withrecommendations made by the British MedicalUltrasound Society, and the franchisor completedannual sonographer competency assessments. Other

Diagnosticimaging

Diagnostic imaging

Good –––


audits, such as clinical and local compliance auditswere undertaken regularly. They monitored patientexperience, health and safety, equipment and privacyand dignity.

• While the service did not hold formal clinicalgovernance meetings, staff meeting minutesdemonstrated that complaints, incidents, auditresults, patient feedback, and service changes werediscussed and reviewed. The registered manager toldus informal discussions with staff were also held inbetween the team meetings.

• At the time of our inspection, there was not a robustprocess in place to monitor and review what trainingthe sonographers had completed at their substantiveemployer. There was also no formal arrangement inplace to ensure the service was informed of anyperformance problems relating to a sonographer’spractice as none of the personnel files containedevidence of appraisals. Similarly, none of thesonographer staff files contained evidence ofemployment references. This meant we could not beassured that Window To The Womb had full oversightof the skills, suitability and capabilities of all staffworking for their service.

• Following our inspection, the service’s recruitmentrequirements were reviewed. The registered managerprovided evidence which showed that sonographerreferences, appraisals and their mandatory trainingmatrix had been requested and stored in their staffpersonnel files. The recruitment policy was alsoamended to reflect the new staff requirements.

• All staff were covered under the service’s medicalmalpractice insurance, which was renewed in October2018. The sonographers also all held their ownindemnity insurance.

Managing risks, issues, and performance

• The service had effective arrangements in placefor identifying and recording risks, and there wasevidence that these risks and their mitigatingactions were discussed with the wider team.

• The service did not hold a risk register; however, riskassessments were completed for any identified risks.At the time of our inspection, five risk assessments hadbeen undertaken, including fire, health and safety,

legionnaires’ disease, the Control of SubstancesHazardous to Health Regulations (COSHH) and anassessment for the registered manager owning twoWindow To The Womb franchised clinics. All five riskshad been graded as ‘low risk’.

• Risk assessments were completed on a standardtemplate to ensure consistent information was used.All templates had the risk identified, mitigating/control measures, the individual responsible formanaging the risk and the risk assessment reviewdate. There was also evidence that the riskassessments had been circulated to all employeesand the management team for review.

• Most staff could clearly articulate the main risks to theservice and what was being done to address them.

• There were appropriate policies in place regardingbusiness continuity and major incident planning,which outlined clear actions staff needed to take inthe event of extended power loss, a fire emergency,severe weather, or other major incident. They alsocontained contact details of relevant individuals orservices and an emergency response checklist.

• The service used key performance indicators (KPIs) tomonitor performance, which were set by thefranchisor. This enabled the service to benchmarkthemselves against the 35 other franchised clinics. Atthe time of our inspection, the registered managerreported that they were in the top five performingclinics for both their later and early pregnancyservices.

• The registered manager compiled a monthlyperformance report, which outlined the number andtype of complaints received, the number of ultrasoundscans completed including the number of rescans, thenumber of women who did not attend theirappointment and the number of referrals made toother healthcare services.

• The service was regularly exceeding the target for thenumber of completed ultrasound scans. Thefranchisor set a KPI of 50 scans per week, and theWatford clinic saw between 65 to 75 women at theirlater pregnancy clinic and approximately 30 womenduring their Firstscan clinic each week.

Diagnosticimaging

Diagnostic imaging

Good –––


• The service also used patient feedback, complaints,and clinical audit results to help identify any necessaryimprovements and ensure they provided an effectiveservice.

Managing information

• The service managed and used information tosupport its activities, using secure electronicsystems with security safeguards.

• The service was aware of the requirements ofmanaging a woman’s personal information inaccordance with relevant legislation and regulations.General Data Protection Regulations (GDPR) had beenreviewed to ensure the service was operating withinthem.

• Window To The Womb was registered with theInformation Commissioner’s Office (ICO), which is inline with ‘The Data Protection (Charges andInformation) Regulations’ (2018). The ICO is the UK’sindependent authority set up to uphold informationrights.

• Patient records and scan reports were easilyaccessible and were kept secure. Paper records werestored in locked filing cabinets and staff lockedcomputer terminals when not in use. All electronicrecords and systems were password protected, andthe passwords were changed every time a staffmember left the service.

• Information from scans could be reviewed remotely byreferrers to give timely advice and interpretation ofresults to determine appropriate patient care.

Engagement

• The service engaged well with women, staff andthe public to plan and manage appropriateservices and collaborated with partnerorganisations effectively.

• Women’s views and experiences were gathered andused to improve service provision. Patient feedbackwas gathered through feedback forms, which allowedwomen to make comments about their care andprovide a rating of their overall experience. We

reviewed a sample of the feedback forms, and foundall the women had rated their experience as ‘five stars’.All the comments made were also overwhelminglypositive.

• There was a website for members of the public to use.This held information regarding the services offeredand the prices for each type of scan. There was alsoinformation about how women could providefeedback regarding their experience. Similarly, womenwere encouraged to leave feedback on the service’ssocial media pages. For example, one womancommented, “the staff were brilliant, they made meand my partner very welcome. Would highlyrecommend”. The social media pages were monitoreddaily as staff recognised that this was women’spreferred method of communication.

• Patient feedback was taken seriously and used toimprove the service. For example, following patientfeedback, the service: increased their staffing to reflecttheir expanding service; purchased a dignity screen forthe clinic room; replaced furniture in the reception,and adjusted their opening times to suit demand.

• Patient feedback and complaints were discussed withthe team during staff meetings.

• Team meetings were held monthly, and staff told usthat the meetings helped to make them feel activelyengaged in service planning and development.

• The registered manger recently introduced a new setagenda to improve the structure and consistency ofthe meetings. We reviewed the team meeting minutesheld in January 2019 and saw that changes to serviceprovision and performance, complaints, patientfeedback, audit results and staff training werediscussed.

• The sonographers were unable to attend the teammeetings due to other work commitments. Therefore,the registered manager sent a monthly email toupdate them on any important information orchanges. The team meeting minutes were alsocirculated by email and a paper-copy was available onthe noticeboard in the staff room.

• The staff noticeboard also contained other importantinformation for staff to read, such as updated policies,the mandatory training schedule, staff rotas and the

Diagnosticimaging

Diagnostic imaging

Good –––


corporate newsletter, called ‘Open Window’. OpenWindow was sent to all franchises every six to eightweeks, and included important updates, such as CQCinspections, new clinics, and changes to e-learning.

Learning, continuous improvement and innovation

• Staff could provide examples of improvementsand changes made to processes based on patientfeedback, incidents, and staff suggestion.

• The service had developed a mobile phoneapplication (‘app’) to support and engage withwomen. The app enabled women to document and

share week-by-week images of their pregnancy bumpwith their family and friends, and create a time-lapsevideo of their pregnancy journey. Any scan imagetaken during a Window To The Womb appointmentwas also saved on the app, which enabled women tohave instant access to their scan images. Womencould also book their scan appointments through theapp.

• The registered manager took immediate and effectiveactions to address some of the concerns we raisedduring the inspection.

Diagnosticimaging

Diagnostic imaging

Good –––


Areas for improvement

Action the provider SHOULD take to improve

• The provider should consider carrying out regularhand hygiene audits to monitor and improveinfection prevention and control practices.

• The provider should ensure there are effectivegovernance arrangements in place to assurethemselves that staff are competent, of goodcharacter and suitable for their role.

• The provider should ensure there are translationservices available for staff and women to use duringan ultrasound appointment.

Outstandingpracticeandareasforimprovement

Outstanding practice and areasfor improvement


window to the womb - cqc

Documents