CS Partners Medical Ltd - The Baby Scan Studio Colchester · Colchester, Essex. We rated this...

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 –––

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

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

CCSS PPartnerartnerss MedicMedicalal LLttdd -- TheTheBabyBaby ScScanan StStudioudio ColchestColchestererQuality Report

B7 Colchester Business CentreWyncolls RoadColchesterEssex CO4 9HTTel: 0844 858 0543Website: http://www.thebabyscanstudio.co.uk

Date of inspection visit: 21 November 2019Date of publication: 24/01/2020

1 CS Partners Medical Ltd - The Baby Scan Studio Colchester Quality Report 24/01/2020

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

Overall summary

CS Partners Medical Ltd The Baby Scan Studio Colchesteris operated by CS Partners Medical Limited. The serviceprovides diagnostic pregnancy ultrasound,gynaecological and fertility scans.

The service offers non-invasive prenatal testing (NIPTs) toself-funding women predominantly across Essex. NIPTscan be used to assess if a woman’s foetus is at a higherrisk of having certain genetic and chromosomalconditions, using a venous blood sample taken from thepregnant woman. It is referred to as non-invasive becauseit does not involve the insertion of a needle into thewoman’s abdomen or cervix, as is the case with moreinvasive testing, where cells are taken from the amnioticsac or placenta.

The registered manager also runs an ultrasound clinic inMarlow and another clinic at an independent hospital inOxford. They work alongside a consultant to provideconsultations and ultrasound scanning. The equipment ismaintained by CS Partners Medical Limited.

The Marlow clinic (The Baby Scan Studio) providesdiagnostic imaging for patients aged 18 years and over. Itis registered with the Care Quality Commission (CQC) toprovide the regulated activity of diagnostic and screeningprocedures. It has one ultrasound machine with onewaiting area.

We inspected this service using our comprehensiveinspection methodology. We carried out the announcedpart of the inspection on 21 November 2019. We gavestaff four working days’ notice that we were coming toinspect, to ensure the availability of the registeredmanager and clinics.

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

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

Services we rate

We have not previously rated this service. At thisinspection we rated it as Good overall.

• The service had enough staff to care for patients andkeep them safe. Staff had training in key skills,understood how to protect patients from abuse, andmanaged safety well. The service controlled infectionrisk well. Staff assessed risks to patients, acted onthem and kept good records.

• Staff provided good care and treatment. Managersmonitored the effectiveness of the service and madesure staff were competent. Staff worked welltogether for the benefit of patients.

• Staff were caring, compassionate, kind and engagedwell with patients and their families.

• Patients could access services and appointments ina way and a time that suited them.

• The manager promoted a positive culture thatsupported and valued staff. Staff reported their teamworked well together and staff trusted and respectedeach other.

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

• The door at the back of the scanning room whichgave access to a communal corridor to the staffkitchen and the toilets, was left unlocked when apatient was being scanned. This meant that thepatient’s privacy and dignity might not have beenmaintained at all times.

• The twice yearly team meetings were not formallyminuted and therefore there was no evidence ifactions were being followed up.

Summary of findings


Following this inspection, we told the provider that itshould make improvements, even though a regulationhad not been breached, to help the service improve.Details are at the end of the report.

Heidi Smoult

Deputy Chief Inspector of Hospitals - Central region

Summary of findings


Our judgements about each of the main services

Service Rating Summary of each main service

Diagnosticimaging

Good –––

This is a diagnostic imaging service run by CSPartners Medical Ltd. The service is based inColchester, Essex.We rated this service as good overall as it was good insafe, caring, responsive and the well led domains. Wecurrently do not rate effective for this type of service.

Summary of findings


Contents

PageSummary of this inspectionBackground to CS Partners Medical Ltd - The Baby Scan Studio Colchester 7

Our inspection team 7

Why we carried out this inspection 7

Information about CS Partners Medical Ltd - The Baby Scan Studio Colchester 7

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

Detailed findings from this inspectionOverview of ratings 12

Outstanding practice 25

Areas for improvement 25

Summary of findings


CS Partners Medical Ltd TheBaby Scan Studio Colchester

Services we looked atDiagnostic imaging

CSPartnersMedicalLtdTheBabyScanStudioColchester

Good –––


Background to CS Partners Medical Ltd - The Baby Scan Studio Colchester

CS Partners Medical Ltd The Baby Scan Studio Colchesteris operated by CS Partners Medical Limited. The servicehas been registered with CQC since April 2011 andprovides diagnostic pregnancy ultrasound services toself-funding women, who are more than six weekspregnant and aged 18 years and above. All ultrasoundscans performed at CS Partners Medical Ltd The BabyScan Studio Colchester are in addition to those providedthrough the NHS for women who have chosen the NHSroute of care.

The service also offers non-invasive prenatal testing(NIPTs), which is used to assess if a woman’s foetus is at ahigher risk of having certain genetic and chromosomalconditions, using a venous blood sample taken from thepregnant woman.

The service is registered with the CQC to undertake theregulated activity of diagnostic and screeningprocedures. The service has had a registered manager inpost since April 2011.

The service did not use or store any medicines

Our inspection team

The team that inspected the service comprised a CQClead inspector and one other CQC inspector. Theinspection team was overseen by Fiona Allinson, Head ofHospital Inspection for East of England.

Why we carried out this inspection

We inspected this service using our comprehensiveinspection methodology. We carried out the announced

part of the inspection on 21 November 2019. We gavestaff four working days’ notice that we were coming toinspect, to ensure the availability of the registeredmanager and clinics.

Information about CS Partners Medical Ltd - The Baby Scan Studio Colchester

The service provides diagnostic imaging service(ultrasound scans) to self-funding patients predominantlyacross Essex. The service is situated on a single storeyoffice building in business park with ample free parkingspaces for patients and visitors.

CS Partners Medical Ltd The Baby Scan Studio Colchesteroffers many different scans and investigative testsincluding:

• Early pregnancy scans from six weeks gestation viathe abdomen or trans-vaginal scan.

• 12 to 40-week reassurance scans which includegrowth measurements, fluid levels, a core dopplerscan of the heart (after 26 weeks)

• 12-week nuchal scans with the blood tests to test forchromosomal abnormalities. A nuchal translucencyscan is a screening test for Down's syndrome thatinvolves measuring the fluid at the back of thefoetus’ neck (nuchal translucency) with anultrasound scan.

• Gender scans at 16 weeks which includemeasurements of the baby, the position and generalwellbeing.

Summaryofthisinspection

Summary of this inspection


• 20-week anomaly scan for women who have chosenprivate healthcare for their entire pregnancy or inaddition to their NHS scan.

• 4D scans between 28 to 32 weeks.

• Non-invasive prenatal testing (NIPTS)

During the inspection, we visited the service’s location inColchester, Essex. We spoke with three members of staffincluding the registered manager, one sonographer and areceptionist. We spoke with two women and reviewed sixsets of records.

There were no special reviews or investigations of theservice ongoing by the CQC at any time during the 12months before this inspection. This was the service’s firstinspection using the next phase methodology.

Activity (January 2019 to October 2019)

• In the reporting period January 2019 to October2019, there were 1338 ultrasound scans completedincluding 277 anomaly, 439 growth, 233 nuchal

translucency, 54 bonding, 191 early pregnancy, 91gender, 24 reassurances and 29 gynaecologicalscans. In the same period, they carried out 19non-invasive prenatal tests.

Track record on safety

• No never events.

• No clinical incidents.

• No serious injuries.

• No incidences of hospital acquiredMeticillin-resistant Staphylococcus aureus (MRSA),Meticillin-sensitive staphylococcus aureus (MSSA)hospital acquired Clostridium difficile (C.diff) orincidences of hospital acquired E-coli

• No complaint.

Services provided at the clinic under service levelagreement:

• Non-invasive prenatal testing (NIPTS).

• Maintenance of medical equipment




The five questions we ask about services and what we found

We always ask the following five questions of services.

Are services safe?Are services safe?

We rated it as Good because:

• The service provided mandatory training in key skills to all staffand made sure everyone completed it.

• Staff understood how to protect patients from abuse and theservice worked well with other agencies to do so. Staff hadtraining on how to recognise and report abuse, and they knewhow to apply it.

• The service controlled infection risk well. Staff used equipmentand control measures to protect patients, themselves andothers from infection. They kept equipment and the premisesvisibly clean.

• The design, maintenance and use of facilities, premises andequipment mostly kept people safe. Staff were trained to usethem. Staff managed clinical waste well.

• Staff completed and updated risk assessments for each patientand removed or minimised risks.

• The service had enough staff with the right qualifications, skills,training and experience to keep patients safe from avoidableharm and to provide the right care and treatment.

• Staff kept detailed records of patients’ care and treatment.Records were clear, up-to-date, stored securely and easilyavailable to all staff providing care.

• The service managed patient safety incidents well. Staffrecognised and reported incidents and near misses.

Good –––

Are services effective?We do not currently rate effective for this type of service, however wefound:

• The service provided care and treatment based on nationalguidance and evidence-based practice. Managers checked tomake sure staff followed guidance.

• Staff monitored the effectiveness of care and treatment. Theyused the findings to make improvements and achieved goodoutcomes for patients

• The service made sure staff were competent for their roles. Theregistered manager appraised staff’s work performance.

• Staff worked together as a team to benefit patients. Theysupported each other to provide good care and communicatedeffectively with other agencies.




• Staff supported patients to make informed decisions abouttheir care and treatment. They followed national guidance togain patients’ consent.

Are services caring?We rated it as Good because:

• Staff treated patients with compassion and kindness, respectedtheir privacy and dignity, and took account of their individualneeds.

• Staff provided emotional support to patients, families andcarers to minimise their distress. They understood patients’personal, cultural and religious needs.

• Staff supported and involved patients, families and carers tounderstand their condition and make decisions about theircare and treatment.

Good –––

Are services responsive?We rated it as Good because:

• The service planned and provided care in a way that met theneeds of local people and the communities served. It alsoworked with others in the wider system and local organisationsto plan care.

• The service was inclusive and took account of patients’individual needs and preferences. The service coordinated carewith other services and providers.

• People could access the service when they needed it andreceived the right care promptly.

• It was easy for people to give feedback and raise concernsabout care received. The service treated concerns andcomplaints seriously, investigated them and shared lessonslearned with all staff. The service included patients in theinvestigation of their complaint.

Good –––

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

• Leaders had the integrity, skills and abilities to run the service.They understood and managed the priorities and issues theservice faced. They were visible and approachable in theservice for patients and staff.

• The service had a vision for what it wanted to achieve and astrategy to turn it into action. Leaders and staff understood andknew how to apply them and monitor progress.

Good –––




• Staff felt respected, supported and valued. They were focusedon the needs of patients receiving care. The service had anopen culture where patients, their families and staff could raiseconcerns without fear.

• The service had governance processes in place. Staff at alllevels were clear about their roles and accountabilities and hadregular opportunities to meet, discuss and learn from theperformance of the service.

• Leaders and staff identified and escalated relevant risks andissues and identified actions to reduce their impact. They hadplans to cope with unexpected events.

• The service collected reliable data and analysed it. Staff couldfind the data they needed, in easily accessible formats, tounderstand performance, make decisions and improvements.

• Leaders and staff actively and openly engaged with patients,and the public to plan and manage services.

• All staff were committed to continually learning and improvingservices. They had a good understanding of qualityimprovement methods and the skills to use them.




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

Detailed findings from this inspection


Safe Good –––

Effective

Caring Good –––

Responsive Good –––

Well-led Good –––

Are diagnostic imaging services safe?

Good –––

We rated it as good.

Mandatory training

Staff had completed mandatory training in keyskills.

Mandatory training for the reception staff includedsafeguarding vulnerable adults and children level 1 and 2,chaperone training and basic life support. We sawevidence that staff had completed the training and it wasup to date.

The sonographers who worked for the service completedall their statutory and mandatory training in theirsubstantive role within the NHS. The registered managertold us at the beginning of each year, sonographers wereexpected to provide their NHS mandatory training record.Evidence of this was submitted after the inspection. Themandatory training included infection prevention andcontrol, information governance, fire safety, equalitydiversity and human rights, conflict resolution,safeguarding adults and children level 1 and 2, basic lifesupport and the mental capacity act.

Safeguarding

Staff understood how to protect patients from abuseand the service worked well with other agencies todo so. Staff had training on how to recognise andreport abuse, and they knew how to apply it.

There were clear safeguarding processes and proceduresin place for safeguarding vulnerable adults and children.

The policy set out responsibilities of staff and contactdetails of local authority referral. The policy also coveredchild sexual exploitation (CSE) and female genitalmutilation (FGM).

At the time of our inspection, 100% of sonography andreception staff were compliant with adult and children’ssafeguarding training. Staff records showed all staff hadcompleted the appropriate level of training in children’ssafeguarding training. This was in line with theIntercollegiate guidance ‘Safeguarding children andyoung people: roles and competencies for health carestaff (January 2019)’ that states all staff who have contactwith children should complete levels 1 and 2 children’ssafeguarding training.

The service had clear processes in place to raise concernsto the local authority safeguarding board.

Staff we spoke with during the inspection could describehow they would make a safeguarding referral and wereaware of the situations when they would be required todo so.

Cleanliness, infection control and hygiene

The service controlled infection risk well. Staff usedequipment and control measures to protectpatients, themselves and others from infection.They kept equipment and the premises visibly clean.

All the areas the service used were visibly clean and freefrom clutter.

Staff completed cleaning of all areas of the unit beforethe day’s appointments started and at the end of theappointment list, this was recorded on a daily checksheet. We reviewed records which demonstrated thatcleaning had taken place whenever the clinic was open.

Diagnosticimaging

Diagnostic imaging

Good –––


The scanning room floor had carpets which was not inkeeping with Department of Health guidelines for clinicalareas. We raised our concern with the registered managerwho told us that this was already in the risk register andwork was already underway to replace the carpet with awipeable and washable surface. Following the inspection,the registered manager provided evidence that the floorhad been replaced within eight working days from ourvisit.

The service had an up-to-date infection prevention andcontrol policy in place, which set out staff responsibilitiesin relation to infection prevention, including handhygiene.

The scanning room did not include a hand washing basin,but the kitchen and toilet were accessible next doorwhich included appropriate hand washing facilities. TheDepartment of Health’s Health building note 00-003clinical and clinical support spaces recommends an areawhere patients are having tests should have a clinicalhand washing basin installed.

We saw hand sanitiser gel dispensers placed inprominent positions in the scanning room. We observedstaff used the hand sanitiser appropriately.

Staff correctly cleaned and stored equipment such asprobes used for intimate ultrasound investigations (forexample, trans vaginal investigations). Staff covered theprobes with an appropriate sheath during investigationsand cleaned them with the recommended sporicidalwipes post ultrasound scan. This eliminated the risk ofcross infection between patients. Personal protectiveequipment such as gloves were available when staff weretaking blood samples for the non-invasive prenatal tests(NIPTs) tests.

The service had a blood spillage kit to ensure any bloodspillages would be cleaned correctly and avoid anypotential risk to patients and staff from blood borneviruses

We observed staff were compliant with hand hygiene and'bare below the elbow' guidance, however they did notcomplete hand hygiene audits which would assure theservice that staff were following the World Health’sOrganisations “five moments for hand hygiene”recommendations.

Environment and equipment

The design, maintenance and use of facilities,premises and equipment mostly kept people safe.Staff were trained to use them. Staff managedclinical waste well.

The Baby Scan Studio Colchester was situated in a singlestorey, brick-built business unit located on a businesspark.

The service was accessed by a single front entrance whichleads to the waiting area with seating and a water-coolingmachine. There was a toilet and staff kitchen accessedthrough the scanning room.

The scanning room could comfortably accommodate upto six people and included a scanning couch, chairs and alarge screen for patients to view the images.

There was door at the rear of the scanning room, whichled to a communal corridor giving access to the toiletsand staff kitchen. During our inspection this door was notlocked and there was a potentially risk where a patient’sprivacy and dignity may not have been maintainedduring a scan. The registered manager and sonographertold us the door would be locked when performing transvaginal investigations.

Waste was handled and disposed of in a way that keptpeople safe. Staff used the correct system to handle andsort different types of waste and these were labelledappropriately.

Staff had correctly assembled sharps boxes to dispose ofneedles used for the NIPTs. An external companycollected clinical waste bags and sharps boxes under acontract.

The service used one company for NIPTs which had theirown packs and processes for labelling and sending theblood samples to the laboratory for analysis. The servicetracked when these were sent.

The ultrasound machine was maintained and servicedannually We reviewed service records for the equipment,which detailed the maintenance history and service duedates. The last date of service for the machine was 15 May2019 which meant it had been serviced within the lastyear.

Diagnosticimaging

Diagnostic imaging

Good –––


Due to the nature of the service they did not needresuscitation equipment however, they did have a first aidbox. The contents of the first aid box were all in date.

Fire extinguishers were accessible, stored appropriately,and were all up to date with servicing. There weresuitable arrangements in place for fire safety, including afire risk assessment and clear instructions for staff tofollow in the event of a fire.

The service completed formal environmental riskassessments audits in areas such as water quality(Legionnaire’s disease) and performed weekly fire alarmchecks.

The service did not use any cleaning products required byControl of Substances Hazardous to Health (COSHH)regulations 2002 to be stored in a locked cupboard. Staffstored all cleaning products out of sight in the ultrasoundroom.

Assessing and responding to patient risk

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

The service had systems and processes in place to referwomen to the local NHS trust or their GP if the scanningprocedure indicated unexpected findings. The servicereferred women to the early pregnancy unit or the foetalmedicine unit within the local NHS trust.

The service provided diagnostic reports following thebaby scan and staff would advise women to take thereport and the images to their NHS hospital, GP ormidwife appointments.

Staff signposted women to the early pregnancy unit, GP,Midwife or other clinicians, if they reported symptomssuch as vaginal bleeding or pain.

Due to the nature of service provided, there was noemergency resuscitation equipment on site. The serviceperformed low risk baby ultrasound scans. In the event ofa medical emergency or if a patient collapsed, staff called999. In addition, the sonographers were trained in adultbasic life support.

The registered manager reported they had not had anyincidences where a patient requested frequent scans, butthey did advise patients their scanning time wasrestricted to 10 -15 minutes as per the British medicalultrasound societies (BMUS) guidelines.

The service followed the ‘as low as reasonablyachievable’ (ALARA) principles, outlined in the ‘Guidelinesfor Professional Ultrasound Practice 2017’ by the Societyand College of Radiographers (SCOR) and BMUS. Detailsof this guidance was available for patients to read on theback of the registration form.

We saw the sonographer remind women on the NHSmaternity care pathway about the importance of stillattending their NHS scans and appointments. Thesonographer made sure women understood theultrasound scans they performed were in addition to theroutine care they received as part of their NHS maternitypathway.

The service included current guidance on their websiteabout the potential risks associated with all types ofscans that were carried out at the clinic. Their websiteand terms and conditions stated clearly the 4D scanswere in addition to the 12-week anomaly scans.

Staffing

The service had enough staff with the rightqualifications, skills, training and experience tokeep patients safe from avoidable harm and toprovide the right care and treatment.

The service employed two sonographers and tworeceptionists on zero hours contract.

The registered manager owned the clinic, with twofurther directors that were not involved in the running ofthe business.

The service did not use bank or agency staff, since thetwo trained sonographers could cover each other’ssickness or leave between them and there were no staffvacancies at the time of inspection. The registeredmanager was also a qualified sonographer and worked atthe clinic when there was a need to cover sickness orannual leave.

The registered manager communicated updates and shiftcover requirements using an online application. All staffwe spoke with reported this worked very well.

Staff worked flexibly to ensure all ultrasound scanningappointments were staffed with a sonographer and areceptionist/chaperone. The service did not allow loneworking and there were never less than two staff on duty.

Diagnosticimaging

Diagnostic imaging

Good –––


Records

Staff kept detailed records of patients’ care andtreatment. Records were clear, up-to-date, storedsecurely and easily available to all staff providingcare.

Patients having ultrasound scans would receive a writtenreport by the sonographer at the time of the scan. AllNIPTs results were communicated to the patients viaemail or a phone call by the registered manager if theresults were abnormal.

Staff saved the images on to a compact disc which theypassed on to the patients for the obstetric scans. Imagesfor other scans could be emailed to the patient to sharewith their GP’s or consultants.

We reviewed six scan reports and six registration forms.Staff recorded information in a clear and correct way. Thisincluded the reason for the scan, the findings, and anyrecommendations if relevant.

The service kept completed records securely. Recordswere either stored securely on a password protectedlaptop or were locked in a filing cabinet in the scanningroom. The ultrasound machine was also passwordprotected restricting unauthorised access to patients’ultrasound pictures.

Staff removed records in the filing cabinet and shreddedthe records once a year. The reports on the laptopremained indefinitely to enable staff access to previousscan reports and use as a comparison with new ones.Article 5 (e) of the General Data Protection Regulation(GDPR) states personal data shall be kept for no longerthan is necessary for the purposes for which it is beingprocessed.

Medicines

The service did not store or administer any medicines.

Incidents

The service managed patient safety incidents well.Staff recognised and reported incidents and nearmisses.

The service had an up-to-date incident reporting policyand procedure in place to guide staff in the process ofreporting incidents. Staff understood their responsibilitiesto raise concerns, to record safety incidents, andinvestigate and record near misses.

The service used a paper-based incident reportingsystem and had an accident book available in the clinicfor staff to access. The registered manager wasresponsible for handling investigations into all incidents.

The adverse incident forms included a risk score on theimpact and likelihood of the incident occurring again.However, from July 2018 to August 2019 the service hadnot reported on any adverse or serious incidents,therefore we were unable to review the completeness ofthe incident forms.

Staff we spoke with knew their responsibility to reportincidents or near miss events and gave examples of thetypes of incidents they would report.

When things went wrong, staff apologised and gavepatients honest information and suitable support. Theduty of candour is a regulatory duty that relates toopenness and transparency and requires providers ofhealth and social care services to notify patients (or otherrelevant persons) when things go wrong with care andtreatment, giving them reasonable support, truthfulinformation and a written apology.

Providers of healthcare services must be open andhonest with service users and other ‘relevant persons’(people acting lawfully on behalf of service users)

Never events are serious largely preventable patientsafety incident that should not occur if the availablepreventative measures have been implemented byhealthcare providers. From July 2018 to August 2019, theservice did not report any incidents classified as a neverevent taking place in their diagnostics services.

The registered manager was aware of the requirementsfor reporting incidents and sending notifications to theCQC and documented these in the service’s riskmanagement policy. However, at the time of inspectionthe registered manager had not been required to submitany notifications.

Diagnosticimaging

Diagnostic imaging

Good –––


Are diagnostic imaging serviceseffective?

We do not currently rate effective in diagnostic imaging.

Evidence-based care and treatment

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

Sonographers followed national guidelines such as fromthe British Medical Ultrasound Society (BMUS) and theSociety of Radiographers (SCoR). Staff also followed NHSfoetal anomaly screening programme (FASP) guidelineswhen completing diagnostic ultrasound scan procedures.

The service had protocols to ensure they offered patientsthe right ultrasound scans or diagnostic tests to meettheir specific needs. We reviewed the protocols which allreferenced national guidance such as the Royal College ofRadiographers (RCR) and British Medical UltrasoundSociety (BMUS).

We reviewed seven policies, procedures and protocolswhich were version controlled and current. The policesreferred to current legislation, local and nationalguidelines and best practice guidance, including NationalInstitute for Health and Care Excellence (NICE), RoyalCollege of Radiologists (RCR), Royal College of Obstetricsand Gynaecology (RCOG), British Medical UltrasoundSociety (BMUS) and Society of Radiographers (SoR).

All staff we spoke with were aware of the policies, contentand where to find them.

The service followed as low as reasonably achievable(ALARA) principles outlined by the Society and College ofRadiographers. Sonographers did not scan for longerthan 20 minutes and would not repeat scans within sevendays of the earlier scan, which reduced any risks thatprolonged scans may cause to the unborn baby.

The registered manager updated the protocols based onthose used at the local NHS trust. There were protocolsfor non-invasive prenatal tests (NIPTs) provided by thesuppliers of the blood sampling packs and protocolsbased on best practice guidance for foetal anomaly.

Nutrition and hydration

Due to the nature of service provided, food and drinkwere not required or provided. However, patients andvisitors had access to a water cooler in the waiting room.

Staff gave women information on drinking water before ascan to ensure they attended with a full bladder whichenabled the sonographer to gain a better view of theunborn baby.

Pain relief

Staff did not formally check pain levels as the procedurewas pain free. However, we saw that staff asked patients ifthey were comfortable during their scan.

Patient outcomes

Staff monitored the effectiveness of care andtreatment. They used the findings to makeimprovements and achieved good outcomes forpatients

The service had an audit programme to assure itself ofthe quality and safety of the clinic. For example, theregistered manager reviewed six randomly pickedultrasound scans from each sonographer and the reportsfor each sonographer on a quarterly basis. The registermanager emailed each sonographer with the results andto discuss any improvements which may have beenrequired in both the reporting and image quality.

Staff reported this was a good process and helped themto identify areas of improvement in both the imagequality and report writing. We saw the July 2019 audit.The image and report from were mostly of good qualityand those that did not meet the standards, the registeredmanager highlighted and addressed the issue with theindividual sonographer.

The service used audits to continually improve patientservices. For example, the service completed a waitingtimes audit which highlighted patients did not know theyneeded to arrive five minutes earlier to complete aregistration form. The pre-appointment informationemail was updated to reflect this information. Furtheraudits completed included the length of time spent ontelephone calls and the subjects discussed.

When sonographers identified any unusual or abnormalimages that needed further referral to NHS or non-NHS

Diagnosticimaging

Diagnostic imaging

Good –––


specialists, where appropriate, they followed up theoutcomes to both offer support and to assess theaccuracy of the diagnoses through a phone call or emailcommunication.

The service sought feedback from patients on theoutcomes of their scans, and we saw this feedbackindicated patients were satisfied with the results due tothe high level of positive responses.

The registered manager told us there were no instanceswhere patients were rescanned due to errors followingtheir initial scan between July 2018 and August 2019.

Competent staff

The service made sure staff were competent for theirroles. The registered manager appraised staff’s workperformance.

All sonographers working at the clinic were employed insubstantive NHS posts and therefore received appraisalsthere. These were kept as part of their personnel file bythe registered manager.

The two-reception staff had been appraised by theregistered manager in the last 12 months. An appraisal isan opportunity for staff to discuss areas of improvementand development within their role in a formal manner.We saw evidence of this in the appraisal paperwork andstaff also reported development needs discussions tookplace whenever required, either formally, or informally.We saw evidence of the registered manager’s appraisalfrom July 2019.It detailed a review of ultrasound scansand reports which were very positive and the personaldevelopment the registered manager had undertaken.

All sonographers working within the service wereregistered with the Health and Care Professional’s Council(HCPC) and on the voluntary register with the Society ofRadiographers.

The service had an induction pack for staff, whichincluded local information such as health and safety, firedrill and infection prevention and control. The registeredmanager supervised new staff until they felt confident intheir role. The receptionists had a list of duties they wereexpected to complete for each clinic session and theregistered manager reported they would review thatthese were completed each day.

Multidisciplinary working

Staff worked together as a team to benefit patients.They supported each other to provide good care andcommunicated effectively with other agencies.

There was effective daily communication and teamworking between the sonographers and reception staff soscan procedures were coordinated and deliveredeffectively.

Staff reported they all worked well together, andcommunication was positive. During inspection weobserved positive communication between theregistered manager, the receptionist and thesonographer.

The registered manager and sonographers workedclosely with healthcare professionals in the NHS,including early pregnancy assessment units, foetalmedicine and GPs to provide a seamless treatmentpathway. The service contacted the relevant foetalmedicine unit at the local NHS trust directly if theyidentified a patient who was discovered to have, forexample, an anomaly, or an ectopic pregnancy.

The service liaised effectively with the non-invasiveprenatal tests (NIPT) equipment providers, to ensureresults were communicated within the three to five dayexpected window to patients.

Seven-day services

The service did not open every day however, staff workedto provide appointment flexibility to accommodate theneeds of patients.

The service ran clinic sessions designed to accommodatethe needs of patients and their families. For example,evening and weekend appointments enabled patients toattend with their family, partners and children.

Health promotion

The service provided families with information leafletsabout the non-invasive pre-natal testing (NIPTs) andnuchal scanning. The sonographer would refer thewomen back to their NHS or private midwife, GP or trust ifthey had specific questions or concerns relating to theirpregnancy or ultrasound scan result.

Consent and Mental Capacity Act

Diagnosticimaging

Diagnostic imaging

Good –––


Staff supported patients to make informed decisionsabout their care and treatment. They followednational guidance to gain patients’ consent.

We reviewed six consent records which demonstratedthat written documented consent was obtained prior toscan.

All patients received written information to read and signbefore their scan. This included a consent form, termsand conditions including the 4D scan not being areplacement for the NHS anomaly scan.

All staff were aware of the importance of gaining consentfrom patients before conducting an ultrasound scan. Thesonographer confirmed names, spellings and dates ofbirth prior to the scan and obtained verbal consent tobegin.

Staff understood their responsibility to gain consent frompatients attending the clinic for ultrasound scanningservices. The registered manager explained theprocedure and patients had the opportunity to withdrawif they wished. The sonographers always confirmed withpatients what they wanted from the scan, the limitationsof the scan and how long the procedure would take.

The registered manager and sonographers completedtraining in relation to the Mental Capacity Act 2005 whichformed part of their NHS mandatory training.

The registered manager told us that there had never beenan instance where a patient attended who had lacked thecapacity to consent.

Are diagnostic imaging services caring?

Good –––


Compassionate care

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

During the inspection, we saw that staff greeted patientsand relatives in a warm and friendly manner, introducingthemselves by name.

The service carried out their own feedback survey andreceived consistently positive praise. A review of thefeedback showed patients were positive about theirexperience at the service and also indicated that patientshad returned to the service for further scans at laterstages in their pregnancy.

The feedback we reviewed also described staff as‘wonderful, friendly, helpful, kind and caring’. We alsonoted the vast majority of feedback was positive aboutthe speed of access to the scan and the personalisedservice that was offered.

The two patients we spoke with during the inspectiontold us that the service was recommended to them byothers and that they had used it more than once. Bothpatients had had the clinic recommended to them andwould be happy to recommend the clinic to their friendsand family.

Patients were able to give feedback through feedbackforms in the clinic, an email to the service, or via opensocial media platforms.

Emotional support

Staff provided emotional support to patients,families and carers to minimise their distress. Theyunderstood patients’ personal, cultural and religiousneeds.

During our inspection we observed two scans.Throughout these scans the sonographer described whatthey saw and explained findings in a way the patientcould understand. For example, we saw the sonographermeasuring each part of the baby and clarifying theirfindings to reassure the patient.

The patients we spoke with told us staff were professionaland supported them well. They considered their privacyand dignity had been maintained throughout their timein the unit.

The service allowed family members to accompanywomen during their scans.

Staff recognised that providing emotional support towomen was an important part of their role. Staffdescribed how they explained distressing findings, tohelp people understand the scan report and know whatto do next. The service did not provide links tocounselling services, but recommended patients speak

Diagnosticimaging

Diagnostic imaging

Good –––


with the health professionals involved in their care. Forexample, if a woman had concerns about foetalmovements, staff advised to liaise with their midwife orGP for further guidance and reassurance.

The sonographer saw patients back in the scanning roomto discuss the report and relevant pictures, or DVD’s inprivate. This also enabled patients who had received badnews privacy to absorb the information and ask furtherquestions.

Understanding and involvement of patients andthose close to them

Staff supported and involved patients, families andcarers to understand their condition and makedecisions about their care and treatment.

Staff actively included women and those close to them tobe involved in the scanning process. Women told us thatstaff provided care to them and involved those close tothem.

During our inspection we saw patients and their familiestreated with kindness and respect by staff. Staffwelcomed patients and their families including childrenand there was enough room to accommodate five guestswith the patient, in the clinic room. This especially helpedchildren to bond with their unborn sibling.

Staff took time to explain the procedure before andduring the scan. We saw the sonographer fully explainwhat was going to happen throughout the scan. Theyused appropriate language to explain the position of theunborn baby and the images on the monitors. They askedpatients if they had any questions throughout and at theend of the scan.

The sonographer explained the findings and ifappropriate gave the patient the report from the scan,photos and a compact disc. All patients we spoke withafter the appointment reported to have been very wellinformed of the ultrasound findings and their next stepsto take.

The service’s website provided clear information aroundthe costs of ultrasound scanning and non-invasiveprenatal testing. When patients arrived in the clinic,receptionists reviewed the prices of the scans with thepatients to ensure they had booked the correct scan fortheir requirements and were aware of the charges.

Are diagnostic imaging servicesresponsive?

Good –––


Service delivery to meet the needs of local people

The service planned and provided care in a way thatmet the needs of local people and the communitiesserved. It also worked with others in the widersystem and local organisations to plan care.

The clinic was in a single storey, brick built business unitlocated on a business park on which housed theultrasound scanning clinic and a waiting area. There wasclear signage on the premises, there was free car parkingon site and the unit was on a bus route.

The facilities and premises mostly met the needs ofpatients and their families, including children, thataccompanied the patients to their scan. However thewaiting area did not have toys or books to keep thechildren occupied.

The patients we spoke with said the clinic was easy tofind, and provided a calm, professional environment.There was a comfortable waiting room, with magazinesand a water cooler. The waiting room was separate fromthe scanning room, which helped promote privacy.Separate from the waiting room on the same floor was atoilet for patients and staff and a staff kitchen which wasaccessed through the scanning room. All areas of theservice were accessible to wheelchair users.

At the time of our inspection the service only providedprivate ultrasound scans and did not complete anyimaging on behalf of the NHS or other private providers.The service had a range of packages with different priceoptions which were clearly displayed on the website.Patients could book appointments online, over thephone or be referred by a health care professional. Theservice offered out of hours appointment times, in theevenings and on Saturdays.

Diagnosticimaging

Diagnostic imaging

Good –––


Reception staff discussed the ultrasound packages withthe patients upon entering the clinic to ensure thepackage met the patient’s needs. All obstetric packagesincluded a wellbeing scan.

Meeting people’s individual needs

The service was inclusive and took account ofpatients’ individual needs and preferences. Theservice coordinated care with other services andproviders.

The service was accessible to all individuals. All areas ofthe service were accessible to wheelchair users.

Patients book appointments online or by telephone at atime to suit them.

The service’s website included a range of information forpatients in relation to ultrasound scan procedures andsupporting information relating to pregnancy.

Patients we spoke with reported their appointment timeswere long enough for them to ask questions and gainreassurance. The registered manager reported half anhour was allocated to each appointment slot to ensurepatients had time to complete their questionnaires andfor the sonographer to complete the report. It alsoallowed time for the woman undergoing obstetric scansto go for a walk to encourage the foetus to move toimprove the scan image.

Staff told us that the registered manager was alwaysavailable via telephone, if there were any patient or staffconcerns, for advice or in the event of an adverseincident.

Access and flow

People could access the service when they needed itand received the right care promptly.

Access to the service was on a self-referral basis only.Appointments for early reassurance, gender, growth andwellbeing and 4D scanning packages were offered in atimely manner.

The service did not have a waiting list for ultrasoundappointments. Patients could self-refer to the service onthe same day, particularly for obstetric viabilityappointments. Patients could book their scans throughthe website, via telephone or email.

Booking was managed by the administration team in thehead office. Therefore, booking requests or queries weremanaged centrally whilst the clinic was closed, whichmeant there was someone available to answer patients’questions and book appointments.

The sonographer gave the results of the ultrasound scansto the patients immediately after the scan which enabledthem to discuss their results with the relevant health careprofessional in a timely manner.

On the day of inspection, we saw patients arrive in thereception area and wait no longer than five minutes fortheir scan. The reception audit showed the longest apatient had to wait for an appointment during August2019 to October 2019 was 30 minutes which happenedonce. Because of the audit, the service had madechanges to the information letter sent when patientsbooked their appointment which advised them to arrivefive minutes early to complete the registration form.

The booking system was flexible and allowed changes topackages to meet patients’ choices. Patients paid a smalldeposit upon booking the scan and could change thepackage when they attended for their scan appointmentif they wished.

The service performed 1338 scans from January 2019 toOctober 2019. These scans included 277 anomaly, 439growth, 233 nuchal translucency, 54 bonding, 191 earlypregnancy, 91 gender scans, 24 reassurances and 29gynaecological scans. For the same period, they carriedout 19 non-invasive prenatal tests.

From July 2018 to August 2019 the service had notcancelled any scans.

Learning from complaints and concerns

It was easy for people to give feedback and raiseconcerns about care received. The service treatedconcerns and complaints seriously, investigatedthem and shared lessons.

The service had an up to date policy for managingcomplaints, which included timescales foracknowledging a complaint (three working days) andinvestigated and responded within 10 working days.

Diagnosticimaging

Diagnostic imaging

Good –––


There was information on the service’s website on how tomake a complaint, and there was a comments andcompliments box in the waiting area for patients to givefeedback on the service.

Patients we spoke with during the inspection saw noreasons to make a complaint and could not suggest anyimprovements the service could make.

The service received no written complaints from July2018 to August 2019.

CQC had not received any complaints about the service inthe last 12 months prior to the inspection

The registered manager told us that information aboutany complaints received would have been shared withstaff through the electronic application or face to faceand would discuss in the twice a year team meetings.

Are diagnostic imaging services well-led?

Good –––


Leadership

Leaders had the integrity, skills and abilities to runthe service. They understood and managed thepriorities and issues the service faced. They werevisible and approachable in the service for patientsand staff.

CS Medical Partners Limited was owned and run by theregistered manager who took responsibility for allaspects of the service, including governance, clinicalmanagement, health and safety and quality. The servicehad three other directors who were financial investorsand were not directly involved in the daily running of thebusiness.

Staff told us the registered manager was accessible andapproachable. The registered manager kept staffinformed of any developments for the service.

Staff told us the registered manager had the skills andexperience to appreciate the roles they completed andoffered valuable support.

Vision and strategy

The service had a vision for what it wanted toachieve and a strategy to turn it into action. Leadersand staff understood and knew how to apply themand monitor progress.

The service’s vision was to provide accurate, detailed anddiagnostically correct information to patients, whateverthe type of scan they have attended for.

The registered manager was able to identify areas ofdevelopment for the service and had a strategy in placeto meet these requirements. For example, until August2019, the service had a contract with a local privatemidwifery provider to provide all their ultrasoundscanning. This meant that the service had full daybookings dedicated to the midwifery service. Despitelosing this contract without any notice, the service hasmanaged to continue to provide a viable business andservice from the Colchester site.

Staff we spoke with were aware of the direction of theservice and any developments or changes werecommunicated by the registered manager.

Culture

Staff felt respected, supported and valued. Theywere focused on the needs of patients receivingcare. The service had an open culture wherepatients, their families and staff could raiseconcerns without fear.

Staff told us they worked together well as a team andthere was an open and honest culture. The registeredmanager addressed performance issues through openand honest, one to one feedback with staff.

All staff spoke proudly about their roles within the serviceand staff felt supported in their work. Staff told us theyfelt valued and supported by colleagues and theregistered manager.

There was a strong emphasis on the care of patients andtheir families. Staff promoted openness and honesty andunderstood how to apply the duty of candour.

We saw the registered manager effectively engage withstaff. All staff we spoke with told us the registeredmanager was supportive accessible and visible.

Diagnosticimaging

Diagnostic imaging

Good –––


Following the inspection at another location, theregistered manager responded positively to feedback.The improvements were made and implemented at bothlocations following feedback. This showed a culture ofopenness and willingness to learn and improve.

Governance

The service had governance processes in place. Staffat all levels were clear about their roles andaccountabilities and had regular opportunities tomeet, discuss and learn from the performance of theservice.

The service had systems and processes to support thedelivery of a safe and caring service.

The registered manager oversaw and made soledecisions about all governance arrangements across theservice. Governance information was cascaded to thestaff through use of an electronic application and at thetwice-yearly staff meetings as well as informally daily.

The service improved service quality through regularaudits and clinical reviews by the registered manager.Governance arrangements were clear and appropriate tothe size of the service.

The registered manager reviewed results of audits,feedback from patients and other stakeholders quarterlyincluding any incidents or complaints and any newlegislation relating to the clinic.

Staff understood their roles and only carried out scansand procedures in line with their competencies.

Information shared with team members via the electronicapplication included general service updates, incidentand complaint outcomes and cover arrangements for theservice. However, the twice yearly team meetings werenot formally minuted. The registered manager providedtheir informal notes from the meeting held in January2019. This did not provide assurance team members whomissed the meeting were fully informed of the service’schanges and performance. However, the registeredmanager reported all staff attended these meetings.

Managing risks, issues and performance

Leaders and staff identified and escalated relevantrisks and issues and identified actions to reducetheir impact. They had plans to cope withunexpected events.

The registered manager understood the risks relating tothe premises, service delivery and business. There wasevidence that risks had been identified and mitigated andthese were formally recorded within a risk managementframework. For example, a risk document included thecarpets in the scanning room needing to be replaced andthis was documented on the risk register including theimpact, dates the risks were added and dates of nextreview.

The service identified, and documented risks associatedwith the environment and had health and safety auditsincluding fire and legionnaires audits. The service hadpublic liability insurance and staff were covered bymedical indemnity.

To mitigate the risks of lone working, there were always atleast two staff on site when the service was open.

The audit program undertaken by the registered managerhelped them to identify any risks to the provision of aquality service rating to performance and adherence withpolicies and guidance.

Managing information

The service collected reliable data and analysed it.Staff could find the data they needed, in easilyaccessible formats, to understand performance,make decisions and improvements.

The service was registered with the InformationCommissioners Office (ICO) and detailed this on theirwebsite. They were also compliant with the PaymentCard Industry Data Security Standard (PCIDSS) whichevery business taking card payments is required to have.It includes a yearly PCI DSS compliance assessment toensure the service protects cardholder data to thehighest standard.

Patients consented for the service to store their records.This was part of their signed agreement within the formdetailing the ultrasound process. This showed theservice’s compliance with the General Data ProtectionRegulation (GDPR) 2018.

Diagnosticimaging

Diagnostic imaging

Good –––


The service had an up to date privacy notice policy whichreferred to all relevant legislation regarding staffresponsibilities, documentation standards and theretention of records.

There was enough information technology equipment forstaff to work with across the service. This meant staff hadaccess to the required information at the time theyneeded it.

The service had not experienced any informationbreaches.

Engagement

Leaders and staff actively and openly engaged withpatients, and the public to plan and manageservices.

The service welcomed feedback from patients andvisitors through a variety of methods including theservice’s website and a variety of social media platforms.In addition, patients and their families could fill in acomment card whilst they were waiting for their scan.

The Baby Scan studio had received high levels ofsatisfaction ratings from their users. Feedback we

reviewed (13 comments) were very complimentary. Wealso reviewed 10 comments from the comments box inthe reception area, where each patient had spoken veryhighly of the service.

The service had a system and process in place to referpatients to NHS services and other health providers. Theregistered manager and the sonographers told us thatthey had a good relationship with the local NHS trust.

Staff told us that the registered manager consistentlysought feedback from all staff members with regards toimproving the safety and quality of the service and stafffelt their ideas were listened to. Staff we spoke withappreciated the twice a year social events to bring theteam together.

Learning, continuous improvement and innovation

All staff were committed to continually learning andimproving services. They had a good understandingof quality improvement methods and the skills touse them.

Staff took pride in their work and aimed to makeimprovements where possible. The registered managersaid they shared learning from the sonographers workingin the NHS trusts and found this useful.

Diagnosticimaging

Diagnostic imaging

Good –––


Areas for improvement

Action the provider SHOULD take to improve

• The provider should consider formal minuted teammeetings to share feedback to all staff.

• The provider should consider installing a hand washbasin within the ultrasound room.

• The provider should consider having access tointerpreting services.

Outstandingpracticeandareasforimprovement

Outstanding practice and areasfor improvement


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