Inspection Report We are the regulator: Our job is to check whether hospitals, care homes and care services are meeting essential standards. Lozells Medical Practice Finch Road Primary Care Centre, Lozells, Birmingham, B19 1HS Date of Inspections: 27 June 2014 30 May 2014 Tel: 08451489041 Date of Publication: July 2014 We inspected the following standards in response to concerns that standards weren't being met. This is what we found: Consent to care and treatment Care and welfare of people who use services Safeguarding people who use services from abuse Cleanliness and infection control Assessing and monitoring the quality of service provision Inspection Report Lozells Medical Practice July 2014 www.cqc.org.uk 1
Details about this location Registered Provider Registered Manager Overview of the service Type of services Regulated activities Lozells Medical Practice Dr Syed Ahmed Lozells Medical Practice provides primary medical service to the local population. It also provided minor surgery, which included circumcisions. Doctors consultation service Doctors treatment service Diagnostic and screening procedures Maternity and midwifery services Surgical procedures Treatment of disease, disorder or injury Inspection Report Lozells Medical Practice July 2014 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: Consent to care and treatment 6 Care and welfare of people who use services 8 Safeguarding people who use services from abuse 9 Cleanliness and infection control 10 Assessing and monitoring the quality of service provision 11 Information primarily for the provider: Action we have told the provider to take 12 About CQC Inspections 14 How we define our judgements 15 Glossary of terms we use in this report 17 Contact us 19 Inspection Report Lozells Medical Practice July 2014 www.cqc.org.uk 3
Summary of this inspection Why we carried out this inspection We carried out this inspection in response to concerns that one or more of the essential standards of quality and safety were not being met. 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 30 May 2014 and 27 June 2014, talked with carers and / or family members and talked with staff. We talked with other regulators or the Department of Health and were accompanied by a specialist advisor. What people told us and what we found In order to target our inspections effectively we continually gather information about services. This may include information from health professionals and other staff; people who use services and family members. We had received information which led us to review circumcision procedures at a number of GP practices. CQC inspectors were accompanied by a specialist advisor in urology as part of these inspections. We visited the practice twice. The first visit was unannounced; this meant that the provider and staff at the practice did not know we were coming. The second visit to the practice was announced. This was to ensure we had the opportunity to speak to the GP and staff working at the practice. One of the GPs at Lozells Medical Centre was undertaking non therapeutic circumcisions, the term used for male circumcisions that are performed where there is no health need. They are generally completed for cultural reasons. The process to gain consent from people with parental responsibility was inadequate and the consent was not appropriately recorded. The planning and delivery of care and treatment did not ensure the welfare and safety of patients. The safeguard procedures were inadequate and did not protect the patient against the risk of harm or potential harm. The systems in place for cleanliness and infection control were not robust. The lack of cleaning for some equipment generated the risk of healthcare acquired infection. The practice did not have systems in place to assess and monitor the quality of the service for patients who required a circumcision. We were given assurance by the provider that circumcision procedures would no longer be undertaken at the practice. Should the provider wish to undertake the procedure in the future then they must satisfy CQC prior to commencing that the essential standards of quality and safety are being met. Inspection Report Lozells Medical Practice July 2014 www.cqc.org.uk 4
You can see our judgements on the front page of this report. What we have told the provider to do We have asked the provider to send us a report by 25 August 2014, 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 Lozells Medical Practice July 2014 www.cqc.org.uk 5
Our judgements for each standard inspected Consent to care and treatment Before people are given any examination, care, treatment or support, they should be asked if they agree to it Our judgement The provider was not meeting this standard. The process for obtaining and recording consent was inadequate. We have judged that this has a major 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 organisation must have suitable arrangements in place for obtaining, and acting in accordance with, the consent of people who use the service in relation to the care provided for them. The provider told us that children and adults were circumcised at the practice. Where a child is unable to consent for themselves consent should be sought from the adults who had parental responsibility for the child. Although parents who have parental responsibility are usually allowed to take decisions for their children alone, non-therapeutic circumcision has been described by the courts as an "important and irreversible" decision which should not be taken against the wishes of a parent. Where a child has two parents with parental responsibility, doctors considering circumcising a child should satisfy themselves that both have given valid consent. We looked at 42 consent forms which had been completed for patients undergoing male circumcision. We found the forms contained incomplete information. Of the 42 consent forms viewed 33 were not signed by a doctor. None of the consent forms were signed by both parents or legal guardians. Nine did not have any parental signature. The provider did not take suitable steps to confirm the identity of the adults presenting with the child. The provider told us that he took the word of the accompanying adult that they were related to the child. The provider was unable to demonstrate that suitable arrangements were in place for obtaining consent on behalf of the patient in relation to the care and treatment provided to them. Parents were asked to consent to the surgical procedure in the clinical room immediately prior to the surgery commencing. This meant that people giving consent did not have the time or opportunity to consider the risks before signing the consent form. There was little Inspection Report Lozells Medical Practice July 2014 www.cqc.org.uk 6
opportunity for people to digest the information and have the opportunity to change their decision Inspection Report Lozells Medical Practice July 2014 www.cqc.org.uk 7
Care and welfare of people who use services People should get safe and appropriate care that meets their needs and supports their rights Our judgement The provider was not meeting this standard. Care and treatment was not planned and delivered in a way that was intended to ensure patient's safety and welfare. We have judged that this has a moderate 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 essential standards of quality and safety state that the registered person should take proper steps to ensure that each patient is protected against the risk of receiving care or treatment which is inappropriate. During the inspection on 30 May 2014 we were told by the practice manager that the consent forms were also the clinical notes. Nineteen of the forms included brief notes. The remaining forms held no detail. The weight of the patient was not recorded. We asked whether the provider had requested information from the adults who brought the children about allergies and other health information that would ensure the health and wellbeing of patients undergoing this procedure. The provider said that they asked about allergies and health concerns; these were not recorded. In order to numb the skin prior to a local anaesthetic injection the provider told us that they did not use a skin numbing local anaesthetic cream as it did not work. The provider was asked for how long the cream had been applied. The provider told us that the cream had been applied for 15-20 minutes. Guidance from the British National Formulary is that anaesthetic cream should be applied one to four hours prior to the procedure. The provider did not demonstrate that they were considering the care and welfare and individual needs of patients. Published research evidence and guidance was not followed. The practice manager told us that the practice had access to a defibrillator stored in the reception area. The GP told us that they did not use a nurse or an assistant for the circumcision procedure and that the child's accompanying adult assisted him. This meant that should an emergency arise which required the use of the defibrillator there was no member of practice staff immediately available to help with the emergency. The defibrillator was only accessible to practice staff. The provider was unable to demonstrate that that they had procedures in place for dealing with emergencies. Inspection Report Lozells Medical Practice July 2014 www.cqc.org.uk 8
Safeguarding people who use services from abuse People should be protected from abuse and staff should respect their human rights Our judgement The provider was not meeting this standard. Patients were not protected against the risk of unlawful or excessive control or restraint because the provider did not have suitable arrangements in place. We have judged that this has a major 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 asked the provider about how he ensured that children were safe and comfortable during the circumcision procedure. The provider told is that an accompanying parent or adult was present and assisted in the procedure by holding the child's legs. Where any form of control or restraint is used in the carrying out of the regulated activity, the registered person must have suitable arrangements in place to protect the patient against the risk of such control or restraint being unlawful or otherwise excessive. The provider did not demonstrate an awareness or understanding of when restraint may be excessive or unlawful. There was no guidance or risk assessment available to demonstrate that the risk of excessive or unlawful restraint had been considered or that the technique used was appropriate. The practice had not considered using an appropriate commercial support which would provide safe and suitable positioning for the child and which would reduce the risk of possible harm from an inappropriate hold. Inspection Report Lozells Medical Practice July 2014 www.cqc.org.uk 9
Cleanliness and infection control People should be cared for in a clean environment and protected from the risk of infection Our judgement The provider was not meeting this standard. Patients were not protected from the risk of infection because appropriate guidance had not been followed. We have judged that this has a major 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 registered person must ensure that patients, staff and visitors to the service were protected against the risk of infection by having systems in place to control the spread of health care associated infections. We were told by the provider and practice staff that all equipment used for surgical procedures was single use. However we saw a piece of equipment which was blood stained and was not single use. In the absence of decontamination and serialising equipment the provider was unable to tell us how they ensured the equipment was appropriately cleaned. The lack of suitable cleaning created the potential risk that a patient could be subjected to a healthcare acquired infection. We looked at the practice policy for infection control. The policy stated that all staff would be trained in the control of cross infection. We saw that only the practice nurse had received this training. Inspection Report Lozells Medical Practice July 2014 www.cqc.org.uk 10
Assessing and monitoring the quality of service provision The service should have quality checking systems to manage risks and assure the health, welfare and safety of people who receive care Our judgement The provider was not meeting this standard. The provider did not have an effective system to regularly assess and monitor the quality of service that patients receive. 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 A service must have appropriate systems for gathering, recording and evaluating accurate information about the quality and safety of the care, treatment and support the service provides. We spoke with the provider and the practice manager about the quality monitoring systems in place in relation to the circumcision procedures. The provider and the practice manager confirmed they did not have systems in place to assess and monitor the quality of the service for patients who requested a circumcision. We discussed the complaints process with the practice manager who was the named lead for complaints in the practice policy. The practice manager said that circumcision procedures were carried out as part of the private practice of the provider and as such any complaint would be forwarded directly to them. They confirmed that complaints relating to circumcision procedures would not be handled in line with the practice policy. We looked at the practice policy for complaints. There was no information about how to make a complaint about private circumcision procedures. There was no reference in the policy to show that for these procedures, complaints would be managed directly by the provider. This meant there was no guidance for staff or patients about how to progress a complaint in regard to circumcision procedures. The provider did not have a system for recording any complaints made about the procedure. The practice manager told us that there had been no patient satisfaction surveys sent out in relation to the circumcision procedures. The provider confirmed this. This meant that there were no mechanisms in place to seek the views of patients and or their families about the standard of care and treatment provided to the patients. Inspection Report Lozells Medical Practice July 2014 www.cqc.org.uk 11
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 Surgical procedures Regulation Regulation 18 HSCA 2008 (Regulated Activities) Regulations 2010 Consent to care and treatment How the regulation was not being met: Regulation 18 - The process for obtaining and recording consent was inadequate. Regulated activity Surgical procedures Regulation Regulation 9 HSCA 2008 (Regulated Activities) Regulations 2010 Care and welfare of people who use services How the regulation was not being met: Regulation 9 - (1) (a) (b) (I) (ii) (iii) (2) Care and treatment was not planned and delivered in a way that was intended to ensure patient's safety and welfare. Regulated activity Surgical procedures Regulation Regulation 11 HSCA 2008 (Regulated Activities) Regulations 2010 Safeguarding people who use services from abuse How the regulation was not being met: Inspection Report Lozells Medical Practice July 2014 www.cqc.org.uk 12
This section is primarily information for the provider Regulation 11 (2) (a) (b) Patients were not protected against the risk of unlawful or excessive control or restraint because the provider did not have suitable arrangements in place. Regulated activity Surgical procedures Regulation Regulation 12 HSCA 2008 (Regulated Activities) Regulations 2010 Cleanliness and infection control How the regulation was not being met: Regulation 12 - (1) (a) (2) (a) Patients were not protected from the risk of infection because appropriate guidance had not been followed. Regulated activity Surgical procedures Regulation Regulation 10 HSCA 2008 (Regulated Activities) Regulations 2010 Assessing and monitoring the quality of service provision How the regulation was not being met: Regulation 10 (1) (a) (b) (2) (b) (I) The provider did not have an effective system to regularly assess and monitor the quality of service that patients receive. 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 25 August 2014. 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 Lozells Medical Practice July 2014 www.cqc.org.uk 13
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 Lozells Medical Practice July 2014 www.cqc.org.uk 14
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. 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 Lozells Medical Practice July 2014 www.cqc.org.uk 15
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 Lozells Medical Practice July 2014 www.cqc.org.uk 16
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 Lozells Medical Practice July 2014 www.cqc.org.uk 17
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 Lozells Medical Practice July 2014 www.cqc.org.uk 18
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 Lozells Medical Practice July 2014 www.cqc.org.uk 19