24 June 2019
During a routine inspection
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:
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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.
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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.
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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.
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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.
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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.
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The was no risk policy in place and risk assessments were not completed for environmental and clinical factors.
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There was no data management policy in place to protect service user’s personal information.
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There was no policy for the training of staff, appraisals and supervision, whistleblowing, recruitment and incidents.
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There were no governance arrangements in place to assure the provider that clinical practice was evidence based and in line with national guidance,
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There were no audits to monitor and review practice.
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There was no evidence or record of staff meetings to monitor and improve the quality of the service.
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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:
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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.
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During the site visit, we observed the premises to be visibly clean.
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The provider had information for service users on how to make a complaint that was to be displayed in the clinic.
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Recruitment and staff training processes were in place.
However:
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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.
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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)