Archived: Baby It's You Limited

Baby It’s You Limited is operated by Baby It’s You Limited. The service is a single speciality independent healthcare provider offering 3D, 4D and early pregnancy scans to self-funding people who use the services.

Following a comprehensive inspection in February 2019, the provider was issued with a suspension notice and a warning notice. The suspension lasted for two months and a further site visit was carried out on 1 April 2019 to assess whether the provider had addressed the urgent and immediate concerns which had resulted in the imposition of the suspension notice. The provider was issued with a warning notice, which all related to Regulation 17: Good governance.

The provider was issued with a warning notice because:

• There were no policies and procedures in place to support staff to monitor, assess and record risks in relation to health and safety for both staff and service users.

• There was no privacy and dignity policy in place. There was no lock on the scan room door and the privacy curtain could not be closed.

• There was no consent and mental capacity policy in place to enable services users to make an informed decision about their scan and potential risks to their pregnancy.

• There was no complaints policy, information or leaflets in place, there was no signage in place to advise service users how to make a complaint.

• There was no infection protection and control policy in place which included cleaning schedules and audits to monitor compliance with the policy. The premises were visibly dirty during the inspection.

• The was no risk policy in place and risk assessments were not completed for environmental and clinical factors.

• There was no data management policy in place to protect service user’s personal information.

• There was no policy for the training of staff, appraisals and supervision, whistleblowing, recruitment and incidents.

• There were no governance arrangements in place to assure the provider that clinical practice was evidence based and in line with national guidance,

• There were no audits to monitor and review practice.

• There was no evidence or record of staff meetings to monitor and improve the quality of the service.

• The provider did not consider risk or hold a risk register.

Following issue of the warning notice, the provider sent information and evidence to demonstrate how they were meeting the regulation. We carried out a review of this evidence to ensure the provider had taken action to comply with the regulations. We found that there had been improvements made; however, there was still work to do in some areas.

We found the following improvements had been made:

• The provider had a privacy and dignity policy. During a site visit to check improvements had been made to enable the suspension to be lifted, we observed a lock had been bought for the scanning room door and the curtains could be fully closed.

• During the site visit, we observed the premises to be visibly clean.

• The provider had information for service users on how to make a complaint that was to be displayed in the clinic.

• Recruitment and staff training processes were in place.

However:

• Although new policies had been written for privacy and dignity, consent and mental capacity, complaints, infection prevention and control, risk, data management, staff training and development, assessing and managing risk, whistleblowing, recruitment, emergency referral process and governance, some of them referenced old CQC guidance and referred to other services. Further improvements therefore needed to be made to the policies.

• The provider had carried out a workplace risk assessment, but this only identified one risk. It was not clear how regular review of the risk would be evidenced. The provider could not identify any other risks to the service.

Following this inspection, we told the provider that it must take some actions to comply with the regulations and to help the service improve. We also issued the provider with one requirement notice. Details are at the end of the report.

Ann Ford

Deputy Chief Inspector of Hospitals (North)

Baby Its You Limited is operated by Baby Its You Limited. The service is a single speciality independent healthcare provider offering 3D, 4D and early pregnancy scans to self-funding or private people who use the services.

Baby Its You Limited is situated in a small business unit, along a busy central road within Doncaster. The unit is wheelchair accessible and has designated car parking at the front of the building. People who use the services enter directly into a large waiting area with a separate scanning room, customer toilet, small kitchen and second toilet area accessed through separate doors. The central reception has adequate seating and two reception desks.

The studio provides a screening and ultrasound scan service for people who use the services aged 17 to 65 in relation to pregnancy (from seven through to 38 weeks gestation).

We inspected this service using our comprehensive inspection methodology. We carried out the short-announced inspection on 08 February 2019. We had to conduct a short-announced inspection because the service was only open if people who used the services required it.

To get to the heart of people who use the services’ experiences of care and treatment, we ask the same five questions of all services: are they safe, effective, caring, responsive to people's needs, and well-led? Where we have a legal duty to do so, we rate services’ performance against each key question as outstanding, good, requires improvement or inadequate.

Throughout the inspection, we took account of what people told us and how the provider understood and complied with the Mental Capacity Act 2005.

Services we rate

We had not previously inspected this service.

This is the first time we have rated this service. We rated it as Inadequate overall because:

• Safety systems, processes and standard operating procedures were not fit for purpose.

• There was insufficient attention to safeguarding children and adults.

• Care premises were unclean.

• Staff did not assess, monitor or manage risks to people who used the services.

• Opportunities to prevent harm to individuals were missed.

• Individuals care, and treatment was not delivered in accordance with evidenced based practice or national guidance.

• People received care and treatment from staff that did not have the skills or knowledge to deliver effective care.

• Staff did not protect the privacy and dignity of people who used the service.

• Leaders did not have the necessary experience, knowledge capacity and integrity to lead effectively.

• Governance process were unclear and there was a lack of systematic performance management which included the failure to identify and manage risk.

  Following this inspection, we undertook due process regarding the significant safety concerns and told the provider to suspend regulated activities at the location.

  Services which have been suspended must be re-inspected before they can re-open. 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.

  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.’

  In addition, we issued a warning notice in relation to Regulation 10, 12 and 17 and told the provider that it must take some actions to comply with the regulations. We also issued the provider with one requirement notice with 15 actions they must complete that affected Baby Its You Limited.

  Following a further visit to the provider to check compliance, the suspension of the service was lifted.

  Details are at the end of the report.

Ellen Armistead

Deputy Chief Inspector of Hospitals (North)