Archived: Brayford Studio Limited Also known as Brayford Studio

Updated 2 April 2024

Brayford Studio Limited is an independent ultrasound service based in Lincoln. The service offers a range of obstetric and gynaecology ultrasound scans providing both medical and diagnostic scans, 4D bonding and pregnancy reassurance scans. People generally self-refer to this service. Brayford Studio Limited has a registered manager who is also the owner and the only sonographer. At the time of our inspection there were no other staff employed at the service.

The service has been registered with CQC to carry out the regulated activity of Diagnostic and Screening procedures since 6 April 2022.

At our previous inspection we found the following breaches of regulation:

• The service must ensure that infection prevention and control audits are completed in such a way that they identify risks and areas for improvement, and that surfaces are free from dust. (Regulation 12, safe care and treatment).
• The service must ensure there is a clear protocol and record of decontamination of the ultrasound transducer and equipment used for decontamination is fit for purpose. Transducer sheaths must be in line with manufacturer recommendations and within the expiry date to minimise the risk of infection. (Regulation 12, safe care and treatment).
• The service must ensure sharps bins for the storage of used needles and sharp instruments are disposed of in line with National Institute for Health and Care Excellence best practice guidelines (2012) Healthcare-associated infections: prevention and control in primary and community care. (Regulation 12, safe care and treatment).
• The service must ensure quality assurance testing of equipment is carried out in line with the manufacturer’s recommendations, ensuring that scanning machines are fit for purpose. (Regulation 15, premises and equipment).
• The service must ensure environmental safety and fire safety maintenance checks are embedded within the service. They must ensure that all risks are identified, and action taken to mitigate them. (Regulation 15, premises and equipment).
• The service must ensure service user records are stored securely. (Regulation 17, good governance).
• The service must ensure records are complete, legible, dated, signed and must include clearly identifiable information of the service user, scan findings and recommendations. (Regulation 17, good governance).
• The service must ensure there is a clear policy for the retention and destruction of records, including how destruction will be carried out in line with information governance and safety requirements. (Regulation 17, good governance).
• The service must ensure it actively seeks service user feedback to evaluate and improve the quality of the service provided. (Regulation 17, good governance).
• The service must ensure there are regular quality assurance and improvement audits and reviews of the quality of treatment and care provided by the service in line with the service’s clinical governance policy. (Regulation 17, good governance).
• The provider must ensure any staff employed by the service have full checks and reviews in line with employment law and statutory requirements, and a record of their employment is maintained. (Regulation 19, fit and proper persons employed).

Updated 2 April 2024

We rated the service as inadequate because:

• Safe care was not provided at all times. The service did not consistently assess risks to patients and information to support care and treatment was not always available or recorded. The service did not have accurate and complete care records and patients’ paper records were not stored securely. There was no policy for the destruction of records and the manager was unable to describe how this would be done within legal guidelines. There was no effective comprehensive programme of equipment and premises maintenance and checks to ensure safety. Not all training modules including safeguarding were up to date. The service did not control infection risk well, equipment cleaning was not recorded, and cleaning products were not fit for purpose. Some single use items of equipment had expired.
• The effectiveness of the service was not monitored. There was no clear inclusion criterion for scans and the process for referring patients to other services was not always followed. Consent forms were not always properly completed with the requested information and there was a lack of evidence available to show the manager had followed this up. Not all consent forms had been signed.
• The manager did not demonstrate clearly they ran the service safely and with good governance. The manager described a vision for the service but not a clear strategy. The service did not operate effective governance processes. There was insufficient evidence of assessment of the quality and safety and effective monitoring of the service. The service lacked processes to identify and manage risk. The service did not seek feedback from patients and there was limited continuous improvement and learning activities.

Updated 3 November 2023

• We rated this service as inadequate. See main summary above.