Inspection Report We are the regulator: Our job is to check whether hospitals, care homes and care services are meeting essential standards. Future Babies Ltd 48 London Street, Reading, RG1 4SQ Tel: 01189585050 Date of Inspection: 07 May 2013 Date of Publication: June 2013 We inspected the following standards as part of a routine inspection. This is what we found: Respecting and involving people who use services Consent to care and treatment Care and welfare of people who use services Safety and suitability of premises Requirements relating to workers Complaints Met this standard Met this standard Met this standard Met this standard Action needed Action needed Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 1
Details about this location Registered Provider Registered Manager Overview of the service Type of service Regulated activity Future Babies Ltd Mrs. Anna Ede Future Babies is a small independent health care service offering 2D, 3D and 4D pregnancy ultrasound scanning services. Diagnostic and/or screening service Diagnostic and screening procedures Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 2
Contents When you read this report, you may find it useful to read the sections towards the back called 'About CQC inspections' and 'How we define our judgements'. Summary of this inspection: Page Why we carried out this inspection 4 How we carried out this inspection 4 What people told us and what we found 4 What we have told the provider to do 5 More information about the provider 5 Our judgements for each standard inspected: Respecting and involving people who use services 6 Consent to care and treatment 7 Care and welfare of people who use services 8 Safety and suitability of premises 9 Requirements relating to workers 11 Complaints 12 Information primarily for the provider: Action we have told the provider to take 13 About CQC Inspections 15 How we define our judgements 16 Glossary of terms we use in this report 18 Contact us 20 Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 3
Summary of this inspection Why we carried out this inspection This was a routine inspection to check that essential standards of quality and safety referred to on the front page were being met. We sometimes describe this as a scheduled inspection. This was an unannounced inspection. How we carried out this inspection We looked at the personal care or treatment records of people who use the service, carried out a visit on 7 May 2013, observed how people were being cared for and talked with people who use the service. We talked with staff. What people told us and what we found At the time of the inspection the registered manager was unavailable. We were able to speak to three administration staff and one sonographer about the service. A sonographer is the term used for a specialised healthcare worker who performs a scan or ultrasound. We also spoke with three people using the service to gain their views. The service website contained information required for people to make an informed choice about which service they required, however it did not contain information about any potential risks of having an ultra sound scan. People were asked for their consent before being scanned and signed a form which explained the terms and conditions of the service. We observed staff talking to people in a friendly; professional way. People spoken with told us they felt staff showed them respect. The building was on the ground floor and was able to accommodate people who use wheelchairs. The premises were well maintained. There was a large private room in which the ultrasound took place which could accommodate family members. We observed sonographers' training certificates were on display. The service did not have clear systems in place to obtain people's feedback. We noted there was no complaints procedure in place. People were not provided with information about how to complain about the service. We reviewed six staff recruitment records and found these did not contain the relevant information required in line with the regulation. You can see our judgements on the front page of this report. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 4
What we have told the provider to do We have asked the provider to send us a report by 20 June 2013, setting out the action they will take to meet the standards. We will check to make sure that this action is taken. Where providers are not meeting essential standards, we have a range of enforcement powers we can use to protect the health, safety and welfare of people who use this service (and others, where appropriate). When we propose to take enforcement action, our decision is open to challenge by the provider through a variety of internal and external appeal processes. We will publish a further report on any action we take. More information about the provider Please see our website www.cqc.org.uk for more information, including our most recent judgements against the essential standards. You can contact us using the telephone number on the back of the report if you have additional questions. There is a glossary at the back of this report which has definitions for words and phrases we use in the report. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 5
Our judgements for each standard inspected Respecting and involving people who use services Met this standard People should be treated with respect, involved in discussions about their care and treatment and able to influence how the service is run Our judgement The provider was meeting this standard. People's privacy and dignity were respected and their preferences were taken into account in the way the service was provided and delivered in relation to their care. Reasons for our judgement People who used the service understood the scanning choices available to them. We viewed the provider's website which described the service in detail. It contained the different services people could buy with clear pricing information. The website explained what the service would do if a scan's quality was unable to provide the information requested by the person, for example to tell the sex of the baby. The website also contained information that the service operated to current internationally agreed safety standards by the British Medical Ultrasound Society (BMUS). This was confirmed by staff members and the sonographer. However the website did not provided information in regards to guidance provided by the (BMUS) on risks of ultrasound scans. We spoke with staff about creating a link to guidance on Future Babies' website. We saw the scanning room was in a separate area from the waiting area. We noted people in the waiting area could not overhear what was being discussed in the scanning room. People we spoke with told us they felt their privacy was respected. We noted the website explained the type of scan available depending upon the stage of pregnancy. We saw, for example, that a gender scan was only appropriate for women who were over 16 weeks pregnant. We observed staff explaining to people the relevant scans available to them. Staff told us most people who called for a booking already knew which service they wished to purchase by looking at the website. Staff spoken with told us if any abnormalities or concerns were found during the scan, a report and supporting images would be given to the person to take to their GP or midwife. We noted this was also written in the consent form. This information enabled people to make an informed choice and to participate in decisions relating to their care. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 6
Consent to care and treatment Met this standard Before people are given any examination, care, treatment or support, they should be asked if they agree to it Our judgement The provider was meeting this standard. Before people received any care or treatment they were asked for their consent and the provider acted in accordance with their wishes Reasons for our judgement People attending the clinic did so by private arrangement and were required to pay for the service. Staff told us when people called to make bookings most people were aware of the service they required. However, staff were able to explain the different services available to people in relation to the number of weeks they were pregnant. This ensured people were aware of the correct services available to them and able to consent to a scan based on this information. When people arrived for their scan, staff talked through the service they wanted and gave people time to read and sign a consent form. People we spoke with told us they spoke to staff before signing the consent form and any questions were answered first before signing. We reviewed the consent form. Information on the consent form included adhering to codes of conduct set out by the British Medical Ultrasound Society (BMUS). Information also included scans being carried out by qualified sonographers and what would happen if abnormalities were found. Staff spoken with told us they did not ask for information in regards to people's GP's or midwives and therefore did not pass information on to other professional bodies. We noted this was confirmed on the consent form. This informed people that reports and scans for any abnormalities found, would be given to the person only. This meant people were aware that no information was given to other professional bodies about their care without their consent. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 7
Care and welfare of people who use services Met this standard People should get safe and appropriate care that meets their needs and supports their rights Our judgement The provider was meeting this standard. People experienced care and support that met their needs and protected their rights. Reasons for our judgement People who used the service were provided with appropriate support, to meet their individual needs. We spoke with people who had used the service and asked what they thought of the care and support they received. People spoken with were happy with their experience of the service. One person told us "it is a positive experience and stopped a lot of worry." Another told us "staff were really lovely and the sonographer was explaining things to us throughout the scan." Staff told us appointment time was approximately 30 minutes and people were encouraged to talk and discuss their worries whilst being scanned. If any abnormalities or concerns were discovered during the scan, these were discussed with the person at the time. Printouts of the scan and a written explanation were given to the person to take back to their GP or midwife. One person we spoke with confirmed this "they printed out a picture for me to take to my midwife and wrote information down, so that I could discuss it further with her." We observed people using the service accompanied by several members of their family. All of them could be in the scanning room if they wished. Before being scanned the sonographer spoke to the person and confirmed the number of weeks pregnant, if they wanted to know the sex of the baby and confirmed the service they wanted before taking them into the room. Staff informed us they were able to talk with people about any concerns they may have in regards to the scan. They also reassured people they were working to internationally agreed safety standards by the British Medical Ultrasound Society (BMUS). For example, exposure times for ultrasounds were As Low As Reasonably Achievable (ALARA). The website explained the service would not continue to scan if they had obtained satisfactory images or measurements. We noted the service did not display health and safety information in regards to scans or refer people to guidance provided by the Health Protection Agency (HPA) or the British Medical Ultrasound Society (BMUS). The provider may like to note people using their service were unaware of guidance available to them. Staff spoken with knew what to do if there was an emergency and fire extinguishers were readily available. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 8
Safety and suitability of premises Met this standard People should be cared for in safe and accessible surroundings that support their health and welfare Our judgement The provider was meeting this standard. People who use the service, staff and visitors were protected against the risks of unsafe or unsuitable premises. Reasons for our judgement People we spoke with thought the premises were well maintained and suitable for purpose. One person told us "it is clean and tidy and you are made to feel welcome." Another told us, "to be honest I did not notice but the scanning room was nice and the couch was comfortable." We toured the building and found the premises were in good condition, light, warm and pleasantly decorated. Future Babies was situated over three floors, with the two upper floors being used for storage and staff only. The ground floor consisted of a reception area which was also a waiting room, a second waiting room, a separate scanning room, a kitchen and two toilets for staff and customers. The scanning room was large enough to accommodate family members. We noted there was a window in the scanning room for ventilation. Staff told us that whilst people were scanned the blind was pulled down to ensure people's privacy. We saw the sonographer cleaning the couch after each person was scanned and noted on the wall of the scanning room antibacterial gel available. To access the scanning room people were required to walk down a small number of steps in the corridor. We talked with staff regarding people with mobility problems having access to the service. Staff told us there was a ramp available for wheelchair users. People accessed the service through the reception area and were accompanied by a member of staff into the other waiting room or the scanning room. We noted the premises had an alarm system. We saw the fire extinguishers were easily available and were regularly checked and maintained. Staff were able to tell us what they would do in the event of a fire. However the provider may like to note there were no policies or procedures in place for emergencies. We were told by staff the landlord was responsible for building maintenance however, the manager ensured the premises were regularly decorated. The provider may like to note there were no policy or procedures in place for maintenance issues or written confirmation Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 9
of regular checks done to ensure the safety and upkeep of the premises. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 10
Requirements relating to workers Action needed People should be cared for by staff who are properly qualified and able to do their job Our judgement The provider was not meeting this standard. The provider did not always undertake the appropriate checks prior to staff taking up employment, to ensure that people who use the service were not placed at risk. We have judged that this has a minor impact on people who use the service, and have told the provider to take action. Please see the 'Action' section within this report. Reasons for our judgement We looked at the Future Babies recruitment and selection procedures and found appropriate checks prior to staff taking up employment were not done. We spoke to staff about the recruitment process. We were told staff had sent in a CV and had an interview before starting employment. There were eight members of staff employed by Future babies. We looked at six recruitment records. We found some evidence required by the regulations missing from all of them. No files contained CRB checks, four files did not contain proof of identity and five files did not contain photo identification. Four files did not contain CV's therefore there was no record of employment history. This meant any gaps in employment history could not be explored. Five files did not contain references. We found the provider was not aware of the requirements of the regulations in relation to recruitment. Sonographers' files did not contain information about the employees' registration with their professional body. The provider was placing people who use the service at risk of being cared for by staff who may not be of good character, have appropriate knowledge, skills or experience. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 11
Complaints Action needed People should have their complaints listened to and acted on properly Our judgement The provider was not meeting this standard. There was no effective complaints system available. We have judged that this has a minor impact on people who use the service, and have told the provider to take action. Please see the 'Action' section within this report. Reasons for our judgement The service did not have a complaints process for people using the service. This meant the service did not have an effective system for identifying, receiving, handling and responding to complaints or comments. The service did not publicise a complaints system on their website or on literature produced. There was no information on display within the reception area for people to know how and who to contact in the event of complaint. Therefore the service did not encourage feedback on the service provided. Shortfalls in service, could not be identified and acted upon. People we spoke with were not aware of a complaints procedure. They told us they would call and speak to the manager if needed. We asked to see the complaints procedure and complaints records, however, staff told us there was not one. Staff spoken with told us people could call or e-mail if they had a complaint and it would be responded to by whoever was on duty. If the complaint was serious it would be passed on to the manager to deal with. We were able to see one example of a complaint e-mailed to the service. The manager had investigated the circumstances of the incident and had responded in a timely manner, to the satisfaction of the complainant. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 12
This section is primarily information for the provider Action we have told the provider to take Compliance actions The table below shows the essential standards of quality and safety that were not being met. The provider must send CQC a report that says what action they are going to take to meet these essential standards. Regulated activity Diagnostic and screening procedures Regulation Regulation 21 HSCA 2008 (Regulated Activities) Regulations 2010 Requirements relating to workers How the regulation was not being met: The provider failed to ensure information specified in Schedule 3 of the regulations was available in respect of staff employed for the purposes of carrying on the regulated activity. Regulation 21(a), Regulation 21(b) Regulation 21(c). Regulated activity Diagnostic and screening procedures Regulation Regulation 19 HSCA 2008 (Regulated Activities) Regulations 2010 Complaints How the regulation was not being met: The provider failed to provide an effective complaints system and failed to bring the complaints procedure to the attention of the service user; in accordance with Regulation 19(1) and regulation 19(2). This report is requested under regulation 10(3) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010. The provider's report should be sent to us by 20 June 2013. CQC should be informed when compliance actions are complete. We will check to make sure that action has been taken to meet the standards and will report on our judgements. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 13
This section is primarily information for the provider Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 14
About CQC inspections We are the regulator of health and social care in England. All providers of regulated health and social care services have a legal responsibility to make sure they are meeting essential standards of quality and safety. These are the standards everyone should be able to expect when they receive care. The essential standards are described in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and the Care Quality Commission (Registration) Regulations 2009. We regulate against these standards, which we sometimes describe as "government standards". We carry out unannounced inspections of all care homes, acute hospitals and domiciliary care services in England at least once a year to judge whether or not the essential standards are being met. We carry out inspections of other services less often. All of our inspections are unannounced unless there is a good reason to let the provider know we are coming. There are 16 essential standards that relate most directly to the quality and safety of care and these are grouped into five key areas. When we inspect we could check all or part of any of the 16 standards at any time depending on the individual circumstances of the service. Because of this we often check different standards at different times. When we inspect, we always visit and we do things like observe how people are cared for, and we talk to people who use the service, to their carers and to staff. We also review information we have gathered about the provider, check the service's records and check whether the right systems and processes are in place. We focus on whether or not the provider is meeting the standards and we are guided by whether people are experiencing the outcomes they should be able to expect when the standards are being met. By outcomes we mean the impact care has on the health, safety and welfare of people who use the service, and the experience they have whilst receiving it. Our inspectors judge if any action is required by the provider of the service to improve the standard of care being provided. Where providers are non-compliant with the regulations, we take enforcement action against them. If we require a service to take action, or if we take enforcement action, we re-inspect it before its next routine inspection was due. This could mean we re-inspect a service several times in one year. We also might decide to reinspect a service if new concerns emerge about it before the next routine inspection. In between inspections we continually monitor information we have about providers. The information comes from the public, the provider, other organisations, and from care workers. You can tell us about your experience of this provider on our website. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 15
How we define our judgements The following pages show our findings and regulatory judgement for each essential standard or part of the standard that we inspected. Our judgements are based on the ongoing review and analysis of the information gathered by CQC about this provider and the evidence collected during this inspection. We reach one of the following judgements for each essential standard inspected. Met this standard This means that the standard was being met in that the provider was compliant with the regulation. If we find that standards were met, we take no regulatory action but we may make comments that may be useful to the provider and to the public about minor improvements that could be made. Action needed This means that the standard was not being met in that the provider was non-compliant with the regulation. We may have set a compliance action requiring the provider to produce a report setting out how and by when changes will be made to make sure they comply with the standard. We monitor the implementation of action plans in these reports and, if necessary, take further action. We may have identified a breach of a regulation which is more serious, and we will make sure action is taken. We will report on this when it is complete. Enforcement action taken If the breach of the regulation was more serious, or there have been several or continual breaches, we have a range of actions we take using the criminal and/or civil procedures in the Health and Social Care Act 2008 and relevant regulations. These enforcement powers include issuing a warning notice; restricting or suspending the services a provider can offer, or the number of people it can care for; issuing fines and formal cautions; in extreme cases, cancelling a provider or managers registration or prosecuting a manager or provider. These enforcement powers are set out in law and mean that we can take swift, targeted action where services are failing people. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 16
How we define our judgements (continued) Where we find non-compliance with a regulation (or part of a regulation), we state which part of the regulation has been breached. Only where there is non compliance with one or more of Regulations 9-24 of the Regulated Activity Regulations, will our report include a judgement about the level of impact on people who use the service (and others, if appropriate to the regulation). This could be a minor, moderate or major impact. Minor impact people who use the service experienced poor care that had an impact on their health, safety or welfare or there was a risk of this happening. The impact was not significant and the matter could be managed or resolved quickly. Moderate impact people who use the service experienced poor care that had a significant effect on their health, safety or welfare or there was a risk of this happening. The matter may need to be resolved quickly. Major impact people who use the service experienced poor care that had a serious current or long term impact on their health, safety and welfare, or there was a risk of this happening. The matter needs to be resolved quickly We decide the most appropriate action to take to ensure that the necessary changes are made. We always follow up to check whether action has been taken to meet the standards. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 17
Glossary of terms we use in this report Essential standard The essential standards of quality and safety are described in our Guidance about compliance: Essential standards of quality and safety. They consist of a significant number of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and the Care Quality Commission (Registration) Regulations 2009. These regulations describe the essential standards of quality and safety that people who use health and adult social care services have a right to expect. A full list of the standards can be found within the Guidance about compliance. The 16 essential standards are: Respecting and involving people who use services - Outcome 1 (Regulation 17) Consent to care and treatment - Outcome 2 (Regulation 18) Care and welfare of people who use services - Outcome 4 (Regulation 9) Meeting Nutritional Needs - Outcome 5 (Regulation 14) Cooperating with other providers - Outcome 6 (Regulation 24) Safeguarding people who use services from abuse - Outcome 7 (Regulation 11) Cleanliness and infection control - Outcome 8 (Regulation 12) Management of medicines - Outcome 9 (Regulation 13) Safety and suitability of premises - Outcome 10 (Regulation 15) Safety, availability and suitability of equipment - Outcome 11 (Regulation 16) Requirements relating to workers - Outcome 12 (Regulation 21) Staffing - Outcome 13 (Regulation 22) Supporting Staff - Outcome 14 (Regulation 23) Assessing and monitoring the quality of service provision - Outcome 16 (Regulation 10) Complaints - Outcome 17 (Regulation 19) Records - Outcome 21 (Regulation 20) Regulated activity These are prescribed activities related to care and treatment that require registration with CQC. These are set out in legislation, and reflect the services provided. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 18
Glossary of terms we use in this report (continued) (Registered) Provider There are several legal terms relating to the providers of services. These include registered person, service provider and registered manager. The term 'provider' means anyone with a legal responsibility for ensuring that the requirements of the law are carried out. On our website we often refer to providers as a 'service'. Regulations We regulate against the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and the Care Quality Commission (Registration) Regulations 2009. Responsive inspection This is carried out at any time in relation to identified concerns. Routine inspection This is planned and could occur at any time. We sometimes describe this as a scheduled inspection. Themed inspection This is targeted to look at specific standards, sectors or types of care. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 19
Contact us Phone: 03000 616161 Email: enquiries@cqc.org.uk Write to us at: Care Quality Commission Citygate Gallowgate Newcastle upon Tyne NE1 4PA Website: www.cqc.org.uk Copyright Copyright (2011) Care Quality Commission (CQC). This publication may be reproduced in whole or in part, free of charge, in any format or medium provided that it is not used for commercial gain. This consent is subject to the material being reproduced accurately and on proviso that it is not used in a derogatory manner or misleading context. The material should be acknowledged as CQC copyright, with the title and date of publication of the document specified. Inspection Report Future Babies Ltd June 2013 www.cqc.org.uk 20