We rated it as Inadequate overall.

We found areas of practice that required improvement:

• There was no mandatory training programme in key skills for staff, and no formal induction programme.

• There was no safeguarding policy and no written protocols available for staff to follow to help identify and manage any safeguarding concerns.

• There was no chaperone policy in place and there was no access to a suitable chaperone for intimate gynaecological scans.

• The service did not control infection risk well. There was no infection prevention and control policy in place and no standard cleaning schedule and no clear arrangements for the management, collection and disposal of clinical waste.

• There were no arrangements in place for maintenance and calibration of scanning equipment.

• There was no schedule or process for secure destruction of paper records in line with legislation. This posed a risk to the confidentiality of client information.

• There was not an effective governance framework in place to deliver good quality care. There were no written policies, processes or protocols in place to govern and monitor activity.

• The provider had an overall vision for what they wanted to achieve but no clear plans or strategy to turn it into action.

• The provider did not ensure that all staff underwent appropriate checks as required by schedule 3 of the HSCA 2008 (regulated activities) regulation 2014.

• There was no mechanism for monitoring the quality and safety of the provider’s practice.

• The service had no systems in place to identify, record or manage risks and cope with both the expected and unexpected.

• There was no systematic programme of clinical and internal audit.

• Information on the provider’s website advertised services that were no longer being provided; sonographers and a manager who no longer worked at the location; and did not include the provider’s name.

We found good practice in relation to providing compassionate care;

• The provider and receptionist worked especially hard to make the patient experience as pleasant as possible. They recognised and responded to the holistic needs of their patients and ensured comfortable waiting areas and provided refreshments to clients who had travelled a long way.

• They provided a seating area in the ultrasound room for partners and siblings to enjoy the experience of seeing their unborn baby together.

• The receptionist provided a very warm welcome to all clients and their families and kept people informed of any delays.

• There were many thank you cards which described the overwhelmingly kind and compassionate manner women and families had received from the provider in sad situations.

• The provider was extremely motivated to ensuring that women and their families enjoyed the experience and ensured that the client was satisfied with the number of images they had seen before ending the procedure and printing the images.

• The provider gave a detailed explanation of the procedure and what to expect prior to the scan and very comprehensive explanation of the images during the scan procedure.

Following this inspection, we told the provider that it must take some actions to comply with the regulations and that it should make other improvements.

We also wrote to the provider outlining our main concerns and issued the provider with a warning notice that affected Brayford Studio Limited. Details are at the end of the report.

Actions the provider MUST take to meet the regulations;

• Ensure that persons providing chaperone services have the skills and experience to do so safely. Regulation 12(2) (c). Safe care and treatment.

• Ensure that measures are taken to assess, prevent and control the risk of infections, including those that are healthcare associated. Regulation 12 (2) (h).

  Safe care and treatment.

• Ensure a DBS check is completed for all staff acting in the chaperone role when recruited, or complete a risk assessment to mitigate the risk. 13(1) Safeguarding service users from abuse and improper treatment.

• Ensure they have and implement robust procedures and processes that make sure people are protected and safeguarded from abuse and improper treatment. Ensure that chaperones used have the knowledge and skills to perform this role. Regulation 13(1) Safeguarding service users from abuse and improper treatment

• Ensure that staff receive safeguarding training that is relevant and at a suitable level for their role. Staff should be kept up to date and able to recognise different forms of abuse and ways they can report concerns. Regulation 13(2) Safeguarding service users from abuse and improper treatment.

• Ensure they have systems and processes in place to audit, monitor and improve the quality and safety of the service. The systems and processes should be continually reviewed to make sure they remain fit for purpose. Regulation 17(2) (a) Good governance

• Ensure they assess, monitor and mitigate the risks relating to the health, safety and welfare of service users and others who may be at risk from the carrying on of the regulated activity. Regulation 17 (2) (b) Good governance.

• Ensure records are maintained and destroyed securely with systems and processes that support the confidentiality of people using the service and not contravene the Data protection Act 1998.

   Regulation 17 (2) (c) Good governance.

Actions the provider SHOULD take to improve;

• Make arrangements for the provider’s practice to be regularly assessed and appraised with regard to providing ultrasound service in the independent healthcare setting.

• Provide basic life support and emergency equipment and ensure staff are trained in basic life support.

• Consider making hand-washing facilities available within the ultrasound room.

• Consider installing washable flooring in the ultrasound room.

We issued a section 29 Warning Notice under the Health and Social Care Act 2008 (‘the Act’)  because the quality of the care  fell below what is legally required. Details can be seen at the end of this report.

We told the provider they needed to make significant improvements to address the breaches.

I am placing the service into special measures.

Services placed in special measures will be inspected again within six months. If insufficient improvements have been made such that there remains a rating of inadequate overall or for any key question or core service, we will take action in line with our enforcement procedures to begin the process of preventing the provider from operating the service. This will lead to cancelling their registration or to varying the terms of their registration within six months if they do not improve. The service will be kept under review and, if needed, could be escalated to urgent enforcement action. Where necessary another inspection will be conducted within a further six months, and if there is not enough improvement we will move to close the service by adopting our proposal to vary the provider’s registration to remove this location or cancel the provider’s registration.

Amanda Stanford

Deputy Chief Inspector of Hospitals (Central Region)

Women were provided with appropriate information and support in relation to their scanning procedure. The provider's website had detailed information about the varied scanning packages offered, what the package included and the cost.

Women who had scans at Brayford Studio were fully informed about the nature and conduct of the examination at the time of attendance. This enabled the person to give their informed consent freely and voluntarily.

We looked at the maintenance and service records of the ultrasound machine. The provider told us the machine had not been serviced or calibrated since 2009.

We were shown a copy of the complaints policy and saw people were given information on how to complain. We noted the policy was also displayed prominently in the waiting area.