Babysteps

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• Overview
• Assessing needs
• Delivering evidence-based care and treatment
• How staff, teams and services work together
• Supporting people to live healthier lives
• Monitoring and improving outcomes
• Consent to care and treatment

This means we looked for evidence that people’s care, treatment and support achieved good outcomes and promoted a good quality of life, based on best available evidence.

This is the first assessment for this newly registered service. This key question has been rated Inadequate: This meant there were widespread and significant shortfalls in people’s care, support and outcomes. The service was in breach of legal regulation in relation to people’s safe care and treatment. We found people’s involvement in their care was not sought, and processes were not in place to review best outcomes for people.

We have not awarded this service a score for Effective.

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

We scored the service as 1. The evidence showed significant shortfalls. The service did not make sure people’s care and treatment was effective because they did not check and discuss people’s health, care, wellbeing and communication needs with them.

There were no processes for recording who was booking appointments and whether the appointment was appropriate. Due to the lack of information taken from people, the service could not ensure their care and treatment was safe or effective. This meant women’s needs were not assessed, discussed or identified before the appointment.

Due to not having pre-appointment screening when women present for an appointment, for example, determining the person's date of birth meant the service did not have any inclusion and exclusion criteria, and could be inappropriately scanning underage women when holding registration for an adult only service.

On the day of inspection, we observed that no information was taken from women on arrival, and when we asked how the last menstrual cycle date would be established, the responsible individual stated it could not. We saw evidence of a woman who had escalated anxiety because she had been scanned too early. The responsible individual said they recognised this was a problem area within the service and stated they would only ask for this information after the scan if there was a concern. We also saw evidence of rescanning a week later, where people had been scanned too early, no consideration or discussions had taken place around risks of scanning weekly, and there was no policy available on scanning frequencies. This was not in line with British Medical Ultrasound Society (BMUS) guidance and competencies for ultrasound practice in private baby scan clinics by the Society of Radiographers.

Processes were not in place to ensure there was no discrimination, including on the grounds of protected characteristics under the Equality Act, when assessing a woman’s needs before making care and treatment decisions. We assessed how communication needs were supported for people who required additional support for protected characteristics and whose first language wasn’t English. No consideration was given to the use of technology for communication, mental capacity for women who may struggle understanding information, or translation to ensure needs were assessed fully.

We scored the service as 1. The evidence showed significant shortfalls. The service did not plan and deliver people’s care and treatment with them. They did not follow legislation and current evidence-based good practice and standards.

Women's physical, mental health, and social needs were not holistically assessed through the booking or triage process, so the responsible individual was unable to demonstrate that the service delivered was in line with legislation, standards and evidence based guidance to achieve effective outcomes. Such standards are set out in The Society of Radiographers (SoR) competencies for ultrasound practice in private baby scan clinics. This meant the service did not plan and deliver women's care and treatment with them. Where there may be a need for additional support for people, equipment, and technology was not used or considered to enhance the delivery of effective care, and the service was not found to promote people's independence.

The responsible individual had not participated in clinical audit, benchmarking, and quality improvement initiatives. There was no process for peer review of images. This guidance is considered best practice by the Society of Radiographers (SoR) competencies for ultrasound practice in private baby scan clinics and by British Medical Ultrasound Society (BMUS) guidance. Following this best practice ensures an independent quality review of scan images undertaken by the sonographer. The responsible individual did not record any patient information to support any audit of their practice.

We scored the service as 1. The evidence showed significant shortfalls. The service did not work well across teams and services to support people. We looked at how the service worked with other services and found they did not share their assessment of people’s needs when moving between different services.

There was no formal process of appropriate escalation for women who may require review at the NHS gynaecology or maternity service in the event of bleeding, absent foetal heartbeat, or possible ectopic pregnancy. This meant women who needed appropriate follow on care were at risk of harm, and the service was not adhering to best practice. Therefore, we were not assured that women would be reviewed in a timely manner to ensure safety when services needed to work together.

On the day of inspection, we asked about the local safeguarding team and whether there had ever been a referral made by the service. The responsible individual was unable to give us details of the safeguarding team and did not know how to contact them should the need arise. There were no examples given as to when appropriate escalation would be used.

We scored the service as 1. The evidence showed significant shortfalls. The service did not support people to manage their health and wellbeing, so people could not maximise their independence, choice, and control. The service did not support people to live healthier lives, or, where possible, reduce their future needs for care and support.

During the inspection, we saw women were not given appropriate and timely support and information to cope emotionally with their care when abnormalities were identified. When there were concerns, people were not told the degree of the concern on the day of the scan, nor offered support and signposting. Instead, the responsible individual only advised women there was a general concern that required follow up with the NHS, and no more information was given.

When we asked about information leaflets, the responsible individual said the service did not provide people who use the service with information leaflets / written information to explain the procedure of the scan they are having. Women receiving scans could not reflect on or consider the potential risks associated with scans of this type.

We scored the service as 1. The evidence showed significant shortfalls. The service did not routinely monitor people’s care and treatment to continuously improve it. They did not ensure that outcomes were positive and consistent, or that they met both clinical expectations and the expectations of people themselves.

There was no formal process to monitor the care women received; information about the outcomes of people's care was not collected and monitored. No audits were available to improve women's experience and outcomes. People's views were not captured to ensure women's expectations were met, and there was no formal complaints process to identify when women were dissatisfied with the service. We saw evidence where a woman had complained on a mobile phone message, but this was not acted upon.

We could not be assured the responsible individual met the Society of Radiographers Competencies for Ultrasound Practice in Private Baby Scan Clinics. Although this assessment toolkit had been completed, it did not reflect what was happening at the service. For example, this includes safety around the As Low As Reasonably Achievable principle and understanding gestational age limitations. Limiting scanning frequency and the monitoring of this is vital to minimise unnecessary ultrasound exposure, in line with British Medical Ultrasound Society (BMUS) safety guidelines. We saw evidence of repeat scans on women who were too early in gestation to be scanned. This was because the responsible individual did not make enquiries about the woman's last menstrual period. There was no monitoring of this, so outcomes could not be improved.

We scored the service as 1. The evidence showed significant shortfalls. The service did not tell people about their rights around consent or respect these when delivering care and treatment. There was no evidence of informed consent prior to the procedure taking place. Therefore, informed consent could not be established; the service could not ensure that people using the service were informed of the limitations and risks associated with souvenir scans, so they could make an informed decision on proceeding with the scan. Protocols should be in place for all examinations performed by the service and included in the consent processes. These should include information about referral pathways, should an unexpected finding or unexpected physical condition be found during the scan. The information was not in place to support people in understanding why they were required, and the need to clearly follow escalation processes to refer women to relevant services if abnormalities were identified.

The responsible individual did not understand the relevant consent and decision making requirements of legislation, including the Mental Capacity Act 2005, or other relevant national standards or guidance as set out in the Department of Health reference guide to consent for examination or treatment. The responsible individual could not demonstrate when a consideration had been made, for example, where there may be a possible lack of mental capacity or the age of the person presenting for the scan. Clearance from the Disclosure and Barring Service restricted the responsible individual from working with women under the age of 18 years. We observed on the day of inspection that, because no identification was asked for, the age of the customer could not be determined, and underage consent could not be assessed, and service refused.