Babysteps

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• Overview
• Learning culture
• Safe systems, pathways and transitions
• Safeguarding
• Involving people to manage risks
• Safe environments
• Safe and effective staffing
• Infection prevention and control
• Medicines optimisation

This means we looked for evidence that people were protected from abuse and avoidable harm.

This is the first assessment for this newly registered service. This key question has been rated Inadequate. The service was in breach of legal regulations in relation to safe care and treatment and safeguarding, which meant people were not safe and were at risk of avoidable harm.

We have not awarded this service a score for Safe.

Find out about when we will not publish a key question score and what we look at when we assess Safe.

We scored the service as 1. The evidence showed significant shortfalls. The service did not have a culture of safety based on openness and honesty. They did not have systems in place to raise concerns about safety and did not investigate or report safety events. There was no process to capture lessons learnt to continually identify and embed good practice.

There were no audits in place to review incidents, and when asked, the provider stated they had an incident logbook. When we viewed the logbook, there was 1 incident recorded, which did not have a date and was partially completed. There was no follow up action to review, and no systems in place to show any incidents had been considered. A lack of recorded incidents meant there was an inability to review and, when appropriate, learn from these incidents.

The responsible individual told us they had not received formal people's feedback and did not want to encourage feedback from women who used the service. They stated they did not use social media or other processes to capture people’s experiences. Patient feedback on the day of our inspection was generally positive.

During our assessment, we identified concerns around the frequency of scanning in early pregnancies. When asked, the responsible individual stated, they had recognised that women were presenting too early for scans, and rescanning was often being done without consideration being made around why this was frequently happening. There were no processes embedded in the service to inform and review when changes to practice were required.

We scored the service as 1. The evidence showed significant shortfalls. The service did not work well with people and health system partners to establish and maintain safe systems of care. They did not manage or monitor people’s safety. They did not make sure there was continuity of care, including when people moved between different services.

The service self-referral and appointment processes could not ensure that all essential information about the person was received to determine if the woman’s needs could safely be met. On the day of inspection, the responsible individual could not demonstrate they had involved all the necessary healthcare services to ensure people had continuity of safe care. We saw evidence where no name, GP or NHS details were taken before the appointments, and unless provided retrospectively by the customer, no person identification could be determined.

Policies and processes were not in place to refer women to relevant services if abnormalities were identified. There was no clear documentation of escalation/referral to the early pregnancy assessment unit (EPAU). It was stated if there was a concern over the weekend, they would wait until Monday to contact the NHS. This would be done by means of a telephone call, although this was not documented on a patient record or a process of appropriate recorded escalation. Therefore, records were not complete, and a failure to do this may delay review and timely actions to ensure patient safety.

There was no clear system for storing data, and scanned images on the ultrasound machine were anonymised. The responsible individual stated they would look in a diary to establish the name and time of the scan to identify a woman. This meant if an image needed to be recalled or a person wanted access to their data, there were no accountable systems to support this.

We observed women being scanned frequently, without documented discussion as to why there had been a deviation from the recommended guidance set out in The Society of Radiographers (SoR) competencies for ultrasound practice in private baby scan clinics. Although the responsible individual had undertaken this self-assessment tool, their systems did not reflect the assessment, and this had not been completed with any women who were presenting frequently.

We scored the service as 1. The evidence showed significant shortfalls. The service did not work well with people and healthcare partners to understand what being safe meant to them and how to achieve that. They did not concentrate on improving people’s lives or protecting their right to live in safety, free from bullying, harassment, abuse, discrimination, avoidable harm, and neglect. They did not share concerns quickly and appropriately

The responsible individual did not have identity checks to determine the age of the women. This is pertinent as the responsible individual had an adult only Disclosure and Barring Service (DBS) check. This check meant they were only cleared to scan adults aged 18 years or older.

The responsible individual did not have an appropriate DBS in place. The DBS in place was not location based and did not list Babysteps as the employer. This meant the check that had been undertaken was not compliant with regulations.

We saw in training files that the responsible individual did not have the appropriate level of safeguarding training for a registered healthcare professional in accordance with the Intercollegiate Guidelines Adult Safeguarding: Roles and Competencies for Health Care Staff (2024). The safeguarding training was at Level 2 and significantly out of date since January 2024.

The responsible individual was the safeguarding lead, yet there was no comprehensive safeguarding policy in place, just a safeguarding policy statement, which did not contain contact numbers for the local safeguarding team. We noted on the day of inspection that the safeguarding statement was not adhered to. When asked, the responsible individual had a limited understanding of the safeguarding referral process and did not have any contacts for the local Safeguarding Team or the Local Authority. When we asked the responsible individual what they would do if they suspected a woman might be at risk, they told us they would telephone the police. This is not in line with safeguarding procedures, therefore putting people at risk of harm.

There was no process for communicating with women and a lack of appropriate interpretation available, which meant risks were not appropriately assessed. Women were not supported to have an active voice, and there was no consideration of coercive control or modern-day slavery.

No information on chaperoning was available on the provider website, and no chaperone policy available on the day of inspection. There was a lack of understanding around the role of a chaperone and when there may be a need for one to be present. Chaperones are usually trained staff members according to the General Medical Care guidance, and a relative or friend of the woman is not considered a suitable chaperone, although they would still be allowed to be present. Chaperones provide crucial safeguarding by acting as witnesses and emotional support during intimate examinations and trained to safeguard people and have a duty to report incidents should the need arise.

We scored the service as 1. The evidence showed significant shortfalls. The service did not work well with people to understand and manage risks. The responsible individual did not provide care to meet people’s needs that was safe, supportive and enabled people to do the things that mattered to them.

Where English was not a woman’s first language, the responsible individual stated they would look to the person supporting them to interpret if they did not understand their care and treatment. This meant women were not involved in managing their own risks and were not given an opportunity to ask questions or raise concerns. There was no information, signposting or support available to people who had communication difficulties. The responsible individual stated they would expect someone to accompany the individual and make those adjustments, should any woman have additional needs.

The responsible individual did not provide women with information about the risks of scanning frequently. No documentation or discussions were completed or provided on involving women to manage and understand these risks and recommendations made by the British Medical Ultrasound Society (BMUS) and the Society of Radiographers (SoR).

The service did not have a referral pathway for women experiencing acute anxiety or mental health crises during pregnancy. On the day of inspection, we observed there were reasons to consider support and signposting; however, red flag indicators were not considered for women with repeated attendance.

We scored the service as 1. The evidence showed significant shortfalls. The service did not always detect and control potential risks in the care environment. They did not make sure that equipment, facilities and technology supported the delivery of safe care.

There were no comprehensive servicing, maintenance and checks of the ultrasound machines. We observed 2 ultrasound machines on site, which did not have full service records available, and we could not be assured there were service contracts in place to meet necessary requirements. One machine had no checks available; this was described by the responsible individual as the backup machine, whilst the primary machine had not been serviced in the last 12 months, only repaired.

During inspection, we asked if the ultrasound machine had been password protected, which the responsible individual stated it was. Upon checking, we found the ultrasound machine data was accessible to anyone and had not been password protected.

Public Liability Insurance was not displayed or available. This advice was given to the responsible individual when they registered with CQC, but was still not available despite CQC Registration stating it was required. This meant any visitor to the service was not safeguarded by insurance for accidental injury.

There was no fire alarm testing log, and fire drills had never been undertaken. The fire detection was a single point self installed smoke detector based in reception. No hard wired fire detection was in place, which meant that should a fire break out, it may not be detected promptly, and rooms such as the clinic room escape route that have a single hallway could be compromised. We also observed the fire extinguisher was not fit for purpose. It was not wall-mounted and was out of date in 2024. There was no service contract for maintenance of the fire extinguisher, which meant that, should a fire break out, there was no appropriate firefighting equipment available that was fit for purpose.

Control of Substances Hazardous to Health (COSHH) data sheets were not available for all products being used. The cupboard where the COSHH was stored was found to be unlocked and directly accessible to the public.

We scored the service as 1. The evidence showed significant shortfalls. The service did not make sure that staff were qualified, skilled, and experienced. They did not always make sure staff received effective support, supervision, and development.

The service did not have safe and effective staffing because the responsible individual did not have the training to provide a safe service. There was no oversight of what training had been undertaken, when this expired, and when refresher training was next due.

There were no processes in place to make sure the responsible individual received effective support, supervision, and development. No learning or development had been undertaken since registration with CQC.

There were no staff available to the service who had received chaperone training, and the responsible individual did not understand the role of a chaperone.

We scored the service as 1. The evidence showed significant shortfalls. The service did not assess or manage the risk of infection. They did not detect and control the risk of it spreading or share concerns with appropriate agencies promptly.

We observed there was no sink in the clinic room for handwashing, and that the responsible individual did not wash their hands or use sanitiser before putting on gloves

There was no clinical waste bin or service contract for clinical waste. The responsible individual stated they were using a regular bin for all waste disposals. The bin being used outside was in a publicly accessible area and not fully secured. This meant the public could access the contents of the waste bin and the contaminated waste.

Inspectors found ultrasound gel in bottles under the sink, which had been dispensed from another bottle; one of the bottles had remnants in the bottom from a previous day. Good infection prevention practice using ultrasound gel is recommended in the Infection prevention guidance found in good infection prevention practice: using ultrasound gel. This stipulates avoiding refilling bottles, marking the date opened on the bottle, and wiping the tip with disinfectant before using it on the next person. The guidance also stipulates avoiding warming the gel as this can encourage bacterial growth. We observed the responsible individual dispensed gel between containers, did not date bottles, and warmed the gel on a radiator, all of which can present as an infection risk.

Toys were available for children, but there was no cleaning audit for them. This meant children accompanying women could be put at increased risk of contracting and spreading infections. The Royal College of Nursing offers guidance on infection control and toy safety, which highlights the importance of having a responsible person clean and audit the cleaning of any toys in clinics or waiting areas.

We found daily general cleaning audits were inconsistently completed. However, on the day of inspection, the environment did appear to be clean, and the cleaning audit had been completed fully for the previous day.

There was carpet in the clinical room, which is not recommended as per the Department of Health Building Note 00-10: Part Flooring. The carpets throughout the service appeared visibly clean, and the responsible individual told us they were cleaned monthly, but we saw no evidence of this.

We did not look at Medicines optimisation during this assessment. There is no previous rating for the Safe key question so we cannot yet publish a score for this area.