Archived: Ultrasound Baby Face

Updated 21 June 2021

The service provides 2D, 3D and 4D ultrasound scans for non-diagnostic purposes and can project images into augmented reality (a type of virtual reality) to facilitate a bonding experience. The service sees women over 13 weeks in gestation following their 12-week NHS dating scan.

The service is registered to see patients from 13-18 years and 18-65 years

The service re-opened on 15 May 2021 following a period of dormancy due to the ongoing Covid-19 pandemic.

The service is registered to provide the following regulated activities:

• Diagnostic and screening procedures

The service has a registered manager, who has been in post since December 2014 when the service initially registered. The service had two employees including the registered manager. We have not previously inspected this service.

Prior to our unannounced inspection on 15 May 2021, we issued the service with a section 29 Warning Notice for non-compliance with Regulation 12 (1), safe care and treatment, of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and Regulation 17, (1) Good Governance, of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014

We issued this warning notice because we were concerned about to following;

Regulation 17, (1) Good Governance:

Risks to infections had not been assessed and actions taken to ensure these were managed in line with best practice guidance.

Policies were not reviewed to indicate essential training required for staff to perform their role.

The information submitted around consent lacked clarity on the process of obtaining informed consent from service users including those under 18.

The organisational structure chart submitted was not in line with previous reports of staffing levels.

There was no evidence there were systems to assess, monitor and improve quality and safety of the services provided and audits of scan quality had not been undertaken.

There was no business continuity plan and no evidence that the governance arrangements ensured a sustainable and responsive service.

Regulation 12, (1) Safe care and treatment:

Consent documentation submitted referenced trainee doctors and treatment options such as medical treatment, immunisation, investigation or operation, which was not in line with the regulated activity the service was registered for.

There was no evidence that information about the limitations and potential risk of ultrasound scans was readily available to service users.

No evidence was submitted of staff completing the applicable safeguarding training. The ‘Adults at Risk Policy’ provided was not specific to the service and the ‘Safeguarding Children’ policy was incomplete.

Disclosure and Barring Service (DBS) application for the registered manager was in progress but there was no evidence to confirmed that staff members had a DBS check undertaken.

Training records and continuing professional development (CPD) for the registered manager was not submitted and a training policy was not provided.

There was no breakdown of training required per employee role, although there were listed six mandatory courses. There was no evidence that all staff had received the required training to enable them to fulfil their roles.

The patient pathway document suggested diagnostic procedures (such as thyroid and testicular ultrasound scans) were undertaken, which was not in line with information previously supplied during engagement.

The legionella policy and risk assessment were incomplete, so we were not assured that the risk of legionella was adequately managed.

There was no evidence that staff had completed infection prevention and control (IPC) training, or that there was an IPC policy for the service.

No risk assessments for BME had been undertaken and the registered manager did not how to differentiate between the needs of BME non-BME staff.

There was no COVID-19 risk assessment and the service had not been able to access personal protective equipment (PPE) and was still attempting to source PPE.

Following a review of information supplied under section 64 of our powers and in response to the inspection, we have continued to monitor the provider’s compliance and this inspection was undertaken to review whether the provider had made improvements to comply with the relevant regulations.

Updated 21 June 2021

We carried out this unannounced focused inspection on 15th May 2021 because we had some concerns about the safety, quality, and leadership of the services.  We did not inspect all key questions as defined within our methodology but focused on those areas highlighted in the warning notice issued by us on 8 October 2020.The inspection on 15 May 2021 was the first opportunity to follow up on the warning notice as the ongoing pandemic meant the service had been closed.

Focused inspections can result in an updated rating for any key questions that are inspected if we have inspected the key question in full across the service and/or we have identified a breach of regulation and issued a requirement notice, or taken action under our enforcement powers. In these cases, the ratings will be limited to requires improvement or inadequate.

Following the inspection, we issued a warning notice to the provider as we found significant improvement was required to improve governance systems and management and oversight of risks. The warning notice has given the provider 1 month to act on the significant improvements we identified.

This service has not previously been rated and as we only inspected parts of the key questions ratings only applied to the well-led question, which we have rated as inadequate. Please refer to the ‘areas of improvement’ section for more details.

Following a review of information supplied under section 64 of our powers and in response to the warning notice on 8 October 2020 and subsequent inspection on 15 May 2021, we have continued to monitor the provider’s compliance and assess whether the provider had made improvements to comply with the relevant regulations.

Following the unannounced inspection, we found the service had made some improvements in relation to the concerns set out in the warning notice. Specifically;

• The service had an up to date safeguarding policy for children which set out the referral process for concerns, and who to contact. We also saw a referral process for women had been developed if a concern was noted during the ultrasound wellbeing check.
• The service had carried out a risk assessment for black and minority ethnic (BME) staff, and there were initial COVID-19 risk assessments for all patients and visitors including doorstep temperature checks prior to entering the clinic.
• Consent forms for patients over 18 years of age had been introduced to capture patient information, including confirmation of 12-week scan on NHS pathway and details of the patient’s GP or Midwife in case of the need for a referral following the scan.
• Ultrasound equipment and the scan room were cleaned in-between all patients using appropriate anti-microbial wipes and checklists had been developed to monitor compliance with cleaning.

However;

• The service did not have an up to date Statement of Purpose (SOP). The SOP showed the service still offered transvaginal scans as part of its early pregnancy scan package. The patient pathway document still referenced diagnostic examinations and non-obstetric scans.
• There was also no business continuity plan or a record of pre employment checks the service would undertake for future staff if the current sonographer or any other staff member was off work. The service also did not have an incident reporting system or any other system to record any adverse incidents or near misses.
• The new safeguarding and abnormality referral processes were untested as they had been written as a response to the warning notice. The adult safeguarding policy which was submitted was incomplete, and the child safeguarding policy referenced out of date guidance and referred to staff and policies the service did not have.
• Consent forms labelled for use for anyone under 18 years of age stated they needed to be countersigned by a parent or guardian which. contradicted the consent policy.
• There was no evidence of any data to support the newly developed infection prevention and control checklist or hand hygiene audit checklist as they had not yet been implemented.
• There was no evidence or workplace risk assessments about lone working or manual handling in relation to use of the scan equipment.
• There was no established job specific training matrix for all staff. The service did not supply complete training data for any staff other than the sonographer. There was also no evidence of staff undertaking any basic life support training and there was no deteriorating patient policy.
• Scan quality was not monitored and there were no audits or a system for peer review. There was no evidence the service gave or signposted women to information around repeat scans and associated risks. Images which were stored on the ultrasound machine were not password protected.
• There was not an up to date organisational structure chart to reflect the number of staff working in the service.

Updated 21 June 2021