Early Days Baby Scan Ltd

On this page

• 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

We checked that risks to people’s safety were identified, assessed and managed well, and that systems were in place to prevent mistakes and reduce the likelihood of harm. We also looked for evidence that when things went wrong, the service learnt from incidents and took action to improve safety.

At our last assessment we rated this key question good. At this assessment the rating has remained good.

This meant people were safe and protected from 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.

The service had a proactive and positive culture of safety, based on openness and honesty. They listened to concerns about safety and investigated and reported safety events.

The service had systems in place to manage patient safety incidents. A provider policy and procedure outlined incidents that should be reported externally, including those requiring notification to CQC.

The registered manager understood their responsibilities to identify, record and report safety incidents, concerns and near misses. They described how incidents would be reviewed to identify learning and any actions required to reduce the risk of recurrence.

The registered manager demonstrated an open and transparent approach and told us they would be honest with patients should something go wrong and provide appropriate support in line with the duty of candour principles.

In the 12 months prior to inspection, there had been no patient deaths, never events or serious incidents, and no duty of candour notifications had been required. As the service had not experienced any reportable safety incidents during the previous 12 months, there was limited opportunity to demonstrate how learning had been embedded in practice. However, the registered manager demonstrated a clear understanding of the processes for managing incidents and promoting learning where required.

The service worked with people and healthcare partners to establish and maintain safe systems of care, in which safety was managed or monitored. They made sure there was continuity of care, including when people moved between different services.

Staff maintained comprehensive and contemporaneous records of women's care and treatment. Records were clear, accurate, up to date and readily accessible to authorised staff involved in delivering care, supporting safe and effective clinical decision-making.

The service obtained informed consent before scans were undertaken. Consent documentation captured relevant information about the woman's pregnancy and medical history, including gestational age, previous pregnancies and any factors that could affect the scan. Women were asked to disclose recent medical treatment, symptoms such as bleeding or abdominal pain, and any pre-existing conditions, including gestational diabetes or uterine fibroids. This enabled staff to identify potential risks and determine whether further medical assessment or advice may be required.

The service had robust systems in place for the management of patient information. An up-to-date policy provided guidance on the creation, storage, handling and retention of records, promoting consistency and compliance with information governance requirements. The provider was registered with the Information Commissioner's Office (ICO) and held a valid registration certificate.

Patient records were maintained electronically through secure systems protected by password-controlled access. Electronic records were encrypted and stored securely using cloud-based technology. Any paper documentation was promptly scanned and uploaded to the electronic patient record before being securely destroyed in line with the service's records management procedures.

The service had arrangements for sharing relevant information with external healthcare providers when necessary. With the patient's consent, records could be shared with GPs, NHS maternity services and gynaecology services to support continuity of care and ensure appropriate onward referral where required. These processes helped facilitate effective communication between services and supported safe pathways for women requiring additional assessment or treatment.

The service worked with people and healthcare partners to understand what being safe meant to them and the best way to achieve that. The service shared concerns quickly and appropriately.

The service had an up-to-date safeguarding policy covering both children and adults at risk. The policy outlined the different forms of abuse, staff responsibilities, reporting arrangements, referral pathways and contact details for local authority safeguarding teams. It also included guidance relating to domestic abuse, forced marriage, sexual exploitation and the scanning of individuals under the age of 16.

The scan practitioner was the safeguarding lead for both children and adults. The practitioner was a registered midwife and had completed safeguarding children training to level 3, including multi-agency elements, and safeguarding adults training to level 2. The business manager had completed safeguarding children and safeguarding adults training to level 2.

The safeguarding policy referenced national safeguarding guidance; however, it did not specify the level of safeguarding training required for each staff role within the service. Despite this, staff had completed safeguarding training relevant to their responsibilities and were able to describe how they would identify, escalate and report safeguarding concerns.

In the 12 months prior to inspection, the service had not made any safeguarding referrals.

We reviewed staff records and saw evidence that all staff had a current Disclosure and Barring Service (DBS) check.

Staff were clear about arrangements for children accompanying family members to appointments. For example, where an individual attending for a scan did not wish a child to be present during the examination, staff ensured another responsible adult remained with the child in the waiting area.

Staff demonstrated an understanding of domestic abuse and the support available to individuals experiencing abuse or coercion. The service had a discreet mechanism that enabled people to indicate they required help without drawing attention to themselves. Staff understood how to respond to concerns and signpost individuals to appropriate support services when required.

All staff had also completed training in learning disability and autism awareness to support the delivery of person-centred care.

The service worked with people to understand and manage risks by thinking holistically. Staff provided care to meet people’s needs that was safe, supportive and enabled people to do the things that mattered to them.

The provider involved women in managing risks associated with their care by ensuring they received clear information before, during and after their scan. The service had an up-to-date risk assessment policy and procedures which supported safe service delivery.

Women were provided with information about the scans available and were required to complete consent forms specific to the type of scan being undertaken. Staff told us these forms were used to support discussions about the purpose and limitations of scans, enabling women to make informed decisions about their care and raise any concerns before proceeding.

The provider took steps to ensure women understood the role of the service within their wider maternity care. Information available on the service's website and within consent documentation strongly advised women to remain engaged with their NHS maternity pathway. Women were required to confirm they had contacted their GP regarding their pregnancy and were receiving appropriate antenatal care.

The provider supplied women with information about the safety of ultrasound scanning. Consent documentation explained that scans were undertaken in accordance with British Medical Ultrasound Society recommendations and the principle of keeping ultrasound exposure as low as reasonably achievable (ALARA). The service's website also directed women to independent information about the benefits and potential risks associated with ultrasound scans, supporting informed decision-making.

Women were given clear information about the limitations of the service and the scope of assessments provided. Consent forms explained that scan practitioners could not provide a definitive diagnostic opinion or medical advice and that any suspected anomalies would require assessment by the woman's antenatal care provider. During the inspection, we observed that staff reinforced this information verbally and ensured women understood when further medical assessment might be required.

The service had effective arrangements to ensure women received timely information following their scans. Results were available immediately and, with consent, could be shared with GPs, midwives or other healthcare professionals where follow-up was required. We saw examples of appropriate escalation when concerns were identified. For example, one woman was referred promptly to an early pregnancy unit after a scan practitioner was unable to detect a fetal heartbeat.

Staff understood how to respond if a person became unwell while using the service. They told us they would call emergency services and provide basic life support where necessary. The service also had arrangements in place to ensure appropriate staffing was available whenever scans were undertaken.

The service detected and controlled potential risks in the care environment. They made sure equipment, facilities and technology supported the delivery of safe care.

The service environment was suitable for the delivery of ultrasound scanning services. The treatment room contained an ultrasound machine, treatment couch and wall-mounted screen to enable women and their companions to view scan images. The room was spacious, allowing sufficient space for equipment, staff and up to five companions, while maintaining privacy and dignity.

The service provided a comfortable environment for women and their families. The waiting area had adequate seating and access to toilet facilities. Staff used a radio to help maintain confidentiality by reducing the likelihood of conversations being overheard from the scanning room.

The provider had an up-to-date Health, Safety and Environment Risk Assessment Policy. Local environmental risk assessments had been completed. Risks associated with the premises and service delivery were identified and managed appropriately.

The service was visibly clean and well maintained. Personal protective equipment, cleaning materials and consumables were readily available and stored appropriately. Staff told us they routinely monitored stock levels to ensure adequate supplies were maintained.

Equipment was maintained and serviced in accordance with manufacturer's guidance. We reviewed evidence that the ultrasound machine had undergone servicing within the previous 12 months and that arrangements were in place for the next scheduled service.

The provider had commissioned an external fire risk assessment within the 12 months prior to inspection and had acted on the findings. Although we identified that fire exit signage and evacuation information were not displayed within the premises at the time of inspection, the registered manager addressed this immediately. This reduced the risk of people being unaware of evacuation procedures in the event of an emergency.

The service made sure there were enough qualified, skilled and experienced staff, who received effective support, supervision and development. They worked together well to provide safe care that met people’s individual needs.

The service made sure staff were competent for their roles. The scan practitioner was a registered midwife and held diagnostic ultrasound training qualifications. Prior to establishing the service, they had worked in NHS and independent maternity, ultrasound and diagnostic settings. They had also completed counselling and bereavement qualifications.

The scan practitioner demonstrated an awareness of the importance of maintaining competence and seeking external professional challenge. They maintained their professional registration and undertook regular self-directed and formal continuing professional development, including learning related to British Medical Ultrasound Society (BMUS) guidance and attendance at national ultrasound conferences.

The service had established good working relationships with local NHS services and told us they had explored opportunities for their scanning practice to be peer reviewed through these relationships. However, they had been unable to establish a formal peer-review arrangement. As the sole scan practitioner, opportunities for independent review of scan images were therefore limited.

We found no evidence during this inspection to indicate that the absence of formal peer review had adversely affected people using the service. The service had received no complaints from patients or local NHS trusts about the quality of scans, and the practitioner described established pathways for working with local NHS services. Ultrasound equipment was serviced annually, with the servicing company undertaking checks and providing support regarding its use.

While a formal external peer-review arrangement would provide additional independent assurance of scanning practice, we recognised the practitioner's efforts to establish such arrangements and the other measures they had put in place to maintain their professional competence and the quality of the service.

The service assessed and managed the risk of infection. They detected and controlled the risk of it spreading and shared concerns with appropriate agencies promptly.

The service had effective systems in place to prevent and control the risk of infection. An up-to-date infection prevention and control (IPC) policy was in place and staff were aware of their responsibilities. The service had a designated IPC lead who provided oversight of infection prevention arrangements.

During the inspection all areas were observed to be visibly clean, tidy and well maintained. Appropriate handwashing facilities and alcohol hand sanitiser were available throughout the service and staff adhered to bare-below-the-elbows guidance.

The service maintained cleaning records which demonstrated that regular cleaning was undertaken. Examination couches were covered with disposable paper roll which was changed between patients, and surfaces were cleaned between appointments. Ultrasound probes were cleaned before and after each use in accordance with the service's IPC procedures.

The scans undertaken were non-invasive, transabdominal procedures, presenting a low risk of infection transmission. There had been no reported healthcare-associated infections or IPC-related incidents.

We found the service had appropriate arrangements in place to minimise the risk of infection and protect people using the service, staff and visitors.

We did not look at Medicines optimisation during this assessment. The score for this quality statement is based on the previous rating for Safe.