My baby and i scan Ltd

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• Overview
• Shared direction and culture
• Capable, compassionate and inclusive leaders
• Freedom to speak up
• Workforce equality, diversity and inclusion
• Governance, management and sustainability
• Partnerships and communities
• Learning, improvement and innovation

This means we looked for evidence that service leadership, management and governance assured high-quality, person-centred care; supported learning and innovation; and promoted an open, fair culture. This is the first assessment for this service Baby and I scan Ltd. This key question has been rated Inadequate. This meant there were widespread and significant shortfalls in service leadership. Leaders and the culture they created did not ensure the delivery of high-quality care.

We have not awarded this service a score for Well-led.

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

The evidence showed significant shortfalls. The service did not have a shared vision, strategy and culture based on transparency, equity, equality and human rights, diversity and inclusion, and engagement. They did not understand the challenges and the needs of people and their communities.

There were no documented discussions around shared direction and culture; there were no meeting minutes available to demonstrate that considerations had been made to meet the needs of the community.

The evidence showed significant shortfalls. The service did not have inclusive leaders who understood the context in which they delivered care, treatment, and support, or who embodied the culture and values of their workforce and organisation. Leaders did not have the skills, knowledge, experience, and credibility to lead effectively, and they did not do so with integrity, openness, and honesty.

The service did not have leaders who had the skills or knowledge to lead effectively.

We found several examples that the manager did not have the knowledge and skills to provide a safe and effective service, which met the requirements of the Health and Social Care Act 2008 (Regulated Activities) Regulations and were in breach of the regulations. We found breaches in Regulation 12,13,15, and 17.

The evidence showed significant shortfalls. People did not feel they could speak up and that their voice would be heard.

Patients did not have opportunities to give feedback on the service in a manner that reflected their individual needs. Managers and staff did audit feedback from patients and staff to use feedback for meaningful learning.

The evidence showed some shortfalls. The service did not always work towards an inclusive and fair culture by improving equality and equity for people who work for them. We observed on inspection that the provider did not undertake equality monitoring of staff within the service to ensure it is diverse in its make-up and representative of the patient group

The evidence showed significant shortfalls. The service did not have clear responsibilities, roles, systems of accountability and good governance. They did not act on the best information about risk, performance and outcomes, or share this securely with others when appropriate.

Staff files were incomplete. There were no staff references and no staff induction processes recorded. Staff did not complete mandatory training suitable for their role as a healthcare professional. Staff and the registered manager did not have appropriate Disclosure and Barring Service checks in place.

The manager did not undertake structured reviews or audits of the service and did not have processes in place to mitigate clinical and environmental risks. The. learning from incidents and complaints was recorded, reviewed and actioned. This meant governance information was not shared, discussed and improvements made when appropriate. Following the inspection, the registered manager sent in evidence of an audit overview document; there were no demonstrable audits used.

There were no clear processes to demonstrate and review the escalation of concern for women receiving scans, aside from a note on an ultrasound report. The client information and waiver form, referred to as the consent form by staff, did not meet General Data Protection Regulations (GDPR) and Information Commissioners Office standards. The consent form was not explicit about storage limitations and rights of access under GDPR guidance.

On the day of inspection, some policies, such as the chaperone policy and scanning policy, were available. However, others, such as an escalation policy, were unavailable.

The registered manager stated the service only scanned clients over 18 years of age and that ID would be checked, but no ID checks were recorded or observed on the day of inspection.

The waiver/consent form did not state that clients should also attend NHS scan appointments, although the sonographer enquired about the client’s NHS scan during their scan.

On the day of inspection, service contracts for clinical waste disposal were unavailable. However, a waste contract was secured following the inspection.

Staff explained images were transferred from the ultrasound machine when the memory was full, to the “cloud”. We saw no evidence of this, and the staff could not assure us that this process had taken place. The registered manager also said that information about the length of time images were stored was available on the consent form, but we did not see evidence of this.

The provider website advertised non-invasive prenatal testing (NIPTs). However, this service was not being provided at the time of the inspection. We observed other website inaccuracies, such as misspellings and grammatical errors, but we were told a third party was responsible for the accuracy of the website. However, we later observed staff removing advertising for NIPTs from the website.

The evidence showed significant shortfalls. The service did not understand their duty to collaborate and work in partnership, so services work seamlessly for people. They did not share information and learning with partners or collaborate for improvement.

There were no peer review processes in place for the service to ensure the quality of the images being taken.

No evidence could be demonstrated to establish links with the early pregnancy unit or patients’ GPs.

The evidence showed significant shortfalls. The service did not focus on continuous learning, innovation, and improvement across the organisation and local system. They did not encourage creative ways of delivering equality of experience and outcome for people. They did not actively contribute to safe, effective practice and research.

We inspected staff files and observed there were no recorded conversations with staff in supervision or appraisals to support any learning, improvement, or innovation.

Staff told us that they themselves had looked at external development, not service related development. There were no discussions recorded around research in practice or any quality improvement methods at the service.