CARE (Sheffield) Limited Quality Accounts APRIL 2012- MARCH 2013 1 Quality Account 2012/13 Welcome to CARE Sheffield CARE SHEFFIELD LIMITED IS PART OF THE CARE FERTILITY GROUP - the largest provider of assisted conception services in UK CARE was founded in 1997 by Professor Simon Fishel, Mr Ken Dowell and Mr Simon Thornton to provide fertility services to private and NHS patients. Since then CARE has helped thousands of couples achieve their goal of a family. CARE is now the UK’s largest independent provider of assisted conception treatment, with five main clinics in Nottingham, Manchester, Northampton, Sheffield and Dublin, and a number of satellite clinics based around the UK. CARE is regulated by the HFEA and Care Quality Commission, and offers a full range of fertility investigations and treatments. Our staff are recruited for their specialist skills and knowledge, and for their commitment to providing a high quality level of service to our patients. CARE Sheffield opened on the Sheffield site in 1988 and provides comprehensive investigation and management of fertility problems. CARE Sheffield provides a high quality service to NHS funded couples who satisfy the eligibility criteria set out by their CCG. Patient care and satisfaction is our primary focus. We treat all patients on an individual basis, regarding privacy and dignity, and individual needs as a high priority. All feedback by patients is reviewed, and comments to improve the service taken seriously and acted on wherever possible. Being part of the CARE Group offers many advantages, one being that patients can move between clinics and access some of the most sophisticated treatments available, such as Pre-implantation Genetic Diagnosis (PGD), Reproductive Immunology and Array CGH. CARE fertility has been at the forefront of major research breakthroughs in the field for several decades, and we are published in scientific and medical journals on a regular basis. NHS Rotherham Clinical Commissioning Group Statement NHS Rotherham Clinical Commissioning Group (RCCG) welcomes the opportunity to review and comment on CARE Sheffield’s first quality account. Rotherham PCT ceased to exist on 31st March 2013 and Rotherham Clinical Commissioning Group (RCCG) came into full existence on 1st April 2013. 2012/13 has been a challenging year for the NHS and the groundwork for the relationship between CARE Sheffield and Rotherham CCG has been firmly laid during the transition and lead up to this major change in NHS commissioning. NHS Rotherham Clinical Commissioning Group wishes to commend CARE Sheffield on its first quality account and the quality standards that have been both maintained and improved throughout 2012/13. In particular, NHS Rotherham Clinical Commissioning Group recognises the consistent achievement of high pregnancy 2 Quality Account 2012/13 rates, live birth rates and exceptional results for frozen embryo replacement (which has been commended by the Human Fertilisation Embryology Authority). NHS Rotherham Clinical Commissioning Group supports the quality priorities outlined in the quality account for 2013/14 and looks forward to continuing to work in partnership with CARE Sheffield throughout 2013/14 to ensure the successful delivery of these priorities. There is an expectation that progress against the identified priorities will be included in the 2013/14 quality account. 3 Quality Account 2012/13 PART 1 OUR SERVICES: Mandatory Statements The following section contains the mandatory statements common to all Quality Accounts as required by the regulations set out by the Department of Health Review of services During 2012 – 2013 CARE Sheffield provided the following services; These were: In Vitro Fertilisation (IVF) Insemination Processing of Gametes and Embryos Treatment with Donor Gametes or Donor Eggs Procurement and Distribution of Gametes and Embryos Intra Cytoplasmic Sperm Injection (ICSI) Chemical Assisted Hatching Storage of Eggs Storage of Sperm Storage of Embryos Surgical Sperm Recovery Egg Sharing/Sperm Sharing Blastocyst Culture Donor Sperm CARE Sheffield has reviewed all the data available to them on the quality of the NHS services provided. The income generated by the NHS services reviewed in 2012-2013 represents 25.2% of the total income generated from the provision of NHS services by CARE Sheffield. Participation in clinical audit CARE Sheffield participated in 13 clinical audits that were assessed by the governance team during 2012 – 2013, with the actions taken to improve the quality of health care provided: Audit Results Audit - Including: Embryology stats Executive meeting results Super report Purpose / Tools Monitoring results Treatments key Monthly performance indicator’s (KPI’s) to monitor results and performance of treatments Practitioner outcomes Including: Clinician Broad-shoulders Embryology Broad- Clinician and Embryology Monthly Broad-shoulder reports to ensure performance of each practitioner is in 4 Quality Account 2012/13 shoulders Clinic Clinician results Expired storage consent report Patient Records audit Including: Consent Audit Critical Equipment Audit Infection Control Audit Including: Hand Hygiene Sharps Management Waste Management Smoking Cessation Audit Waiting Times Audit Inter Lab Audit Incident/Complaints Reporting Witnessing NEQAS optimum range. In line with guidance from Monthly HFEA Code of Practice Support best practice in Quarterly patient documentation, professional body guidelines e.g. HFEA Compliance to Consent Policy Patient Safety, Quarterly compliance with HFEA Code of Practice Compliance to Infection Annual Prevention Society and Health and Social Care Act 2008 Staff training to provide advice, refer to stop smoking services, to provide stop smoking medications Ensure waiting times in departments are within acceptable range Assessment of staff skills and competence in lab processes and procedures To monitor for trends and implement prevention and corrective actions To ensure no omissions For witnessing during treatment and investigate as appropriate. To monitor quality control of semen analysis Quarterly Bi-annual Annual Monthly Monthly Quarterly Safeguarding statement The Department of Health requires all healthcare providers to safeguard people who use services from abuse. The Care Quality Commission outcome statement says that ‘people who use services should be protected from abuse, or the risk of abuse, and their human rights are respected and upheld’. CARE Sheffield has clear safeguarding policies in place. In line with the Department of Health’s guidance on Quality Accounts, the report below summarises CARE Sheffield’s approach to safeguarding: 5 Quality Account 2012/13 CARE Sheffield meets the statutory requirement with regard to the carrying out of Criminal Record Bureau checks on all staff Safeguarding policies for children and vulnerable adults are up to date, robust and reviewed within the last year. Named professionals are clear about their roles and have sufficient time and support to undertake them There is a board-level executive director lead for safeguarding PART 1.1 Statement on quality from the Simon Fishel, Managing Director “CARE Sheffield has successfully delivered NHS services to local providers for a number of years. Contracts run annually from April to March and we have a new acute contract in place for the year commencing April 2013 to March 2014.” This is the first Quality Account to be submitted by CARE Sheffield, and it has been produced to demonstrate our commitment to measuring all feedback from patients about their experience, clinical treatment and clinical outcomes. This allows us to continually review, reflect and improve the patient’s journey. CARE’s mission is to ‘achieve the best chance of pregnancy for our patients, providing a discreet professional and caring service; delivering concise information to our patients and maintaining our position as the UK’s leading independent fertility healthcare provider. We will continue our commitment to research, developing new procedures to assist those seeking our help’. Patient safety is our highest priority and our robust recruitment processes and training programmes ensure that staff are competent and fully trained in all aspects of service provision. CARE Sheffield continually achieves consistently high pregnancy rates and live birth rates. By analysing results throughout the year, we constantly seek ways to further improve the patient experience and outcome. CARE Sheffield is committed to ensuring that patients are kept fully informed about their treatment, which is also a significant factor associated with improving treatment outcomes. We involve our patients in treatment decisions at the earliest stage so that the options and benefits are fully discussed before patients consent to treatment. Our medical and clinical teams recognise the importance of devoting time to patient preparation for day surgery, which not only reduces risk but also improves patient understanding and confidence, and reduces anxiety. Whilst patient feedback and involvement is extremely important to us, we also rely heavily on other measures of safety and clinical effectiveness which we use to satisfy ourselves that treatment is evidence-based and delivered by appropriately qualified and experienced doctors, nurses, embryologists and other key healthcare professionals. Examples of these are detailed in this Quality Account. 6 Quality Account 2012/13 CARE Sheffield is accustomed to the disciplines of regulatory and contractual requirements to assure healthcare commissioners of our clinical performance and to report complaints and serious incidents to them. This report details: The Units priorities for improvement for 2013-14. Statements relating to the quality of services provided by the Unit. What others say about us. How the Unit has performed over the past year on key indicators of quality. To the best of my knowledge, as requested by the regulations governing the publication of this document, the information in this report is accurate. Simon Fishel Managing Director CARE Fertility Group 7 Quality Account 2012/13 PART 2 QUALITY PRIORITIES FOR 2013/14 CARE Fertility has identified seven priorities for quality improvement in three areas identified within High Quality Care for All: Clinical Effectiveness Patient Safety Patient Experience Clinical Effectiveness Patient Safety Patient Experience QUALITY OBJECTIVE To reduce the incidence of multiple births, as set out in the HFEA Code of Practice guidance IMPROVEMENT TARGET Reduce the multiple birth rate to within the HFEA target range of 10% and maintain pregnancy outcomes To ensure the HFEA CD Significantly reduce error consent form is: rate of completion of HFEA discussed and understood by CD forms for research to all patients and completed consent by patients correctly To ensure the HFEA CD Improve error rate for consent form data is submission of HFEA CD forms transferred to our patient information system so that it matches the paper version To adopt processes and Maintaining zero incidence procedures that allow us to of Never Events maintain patient safety to the highest standard To continue to report incidents To reduce clinical incidents or near misses so that we can down to 3.8% of total patient reduce the reoccurrence of episodes clinical incidents in the future. To monitor that patients have received excellent care and customer experience by asking the question of all patient users – ‘Would you recommend this service to your friends and family? To audit the processes that are essential to the treatment episode being delivered to a high standard 8 Quality Account 2012/13 To increase score for all areas above 3.70/4.0 To revise and implement the Internal Audit framework. Progress against these priorities will be reported on a quarterly basis to the Unit Executive, Corporate Quality team or Commissioners, and where applicable key issues will be presented to the board of directors. 2.1 Clinical Effectiveness Priority 1: Reducing the multiple birth rate to HFEA target of 10% CARE Sheffield is committed to reducing the incidence of multiple births, as set out in the HFEA Code of Practice. We achieve this by teaching patients the ‘One at a time’ ethos of having a single embryo transfer. The level of elective single embryo transfer has been maintained at 37% in the last two years through raising awareness of the risks associated with multiple-birth by the CARE team. CARE Sheffield as of April 2013 has a 16.4% multiple pregnancy rate (MPR), and we aim to reduce this further in the coming year by monitoring the MPR on a monthly basis and as necessary adjusting the criteria to be met by patients undergoing treatment to ensure that it remains within the accepted range specified by the HFEA. Therefore in 2013-14 CARE will; Continue its education of patients and aim to increase elective single embryo transfer to 40% of patients. Reduce the multiple birth rate further to within the accepted target range of 10% by March 2014. Priority 2 and 3: Improve completion and submission of HFEA CD form for research to consent In our last HFEA inspection September 2012, it was noted that the Consent to Disclosure for research options was either being filled in incorrectly by patients, or had not been recorded correctly on the EDI system linked back to the HFEA. The rate of error on the first audit was 67%, which reduced to 42% when the second audit was conducted. This form is known to be difficult to understand and complete by the HFEA who are trying to make it more user friendly. However, it is CARE Sheffield’s aim to ensure the CD consent form is; discussed, understood, and completed correctly by all patients, and that the data is then fed onto our patient information system, so that the electronic form and paper form match. We intend to reduce the incidence of error from 42% down to 25% by March 2014. We will review how these targets are being met at our Senior Management meetings, reporting to the Executive team also on a quarterly basis. 9 Quality Account 2012/13 2.2 Patient Safety Priority 1: Maintaining ‘0’ incidence of Never Events ‘Never Events’ - are serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented. For further details see: http://www.nrls.npsa.nhs.uk/resources/collections/never-events/ From the core never events, there are 5 that affect CARE Sheffield. Wrong route administration of oral/enteral treatment Wrong gas administered Failure to monitor and respond to oxygen saturation Air embolism Misidentification of patients CARE Sheffield will adopt processes and procedures that allow us to maintain patient safety to the highest standard. Priority 2: Incident reporting and analysis in 2012 CARE fosters a culture of learning from adverse events or reactions. This is achieved by the accurate reporting, investigation and analysis of all incidents; and the sharing of the resulting information across the organisation. In 2012/13 there were eighteen clinical incidents (18/427 = 4.2% of patient episodes). Five of these and four non-clinical incidents were reportable to our regulator the HFEA during this period, two of which were in relation to breach of confidentiality. CARE has reviewed all incidents and implemented actions to address the root cause of them by discussion with staff and adopting changes to policy where appropriate. We will continue to report incidents or near misses so that we can reduce the reoccurrence of clinical incidents down to 3.8% in 2013/14. We will review how these targets are being met at our Corporate Quality meetings held quarterly and report to the Heads of Unit team on an annual basis, during the Management Review Meeting of our quality management system. 2.3 Patient Experience Priority 1: Patient Experience A key element of CARE’s strategy is that patients should be in control of their care and involved in the decisions made, which means we must be more open and accountable, and must properly involve individuals throughout the patient journey. A modernised service will publish more information about the quality of its care so that patients can hold CARE Fertility to account and clinicians can see where they need to improve. 10 Quality Account 2012/13 CARE Fertility will ensure that all of our out-patients are given the opportunity via on line or paper questionnaire to feedback on the service provided, with an average of a 35% return rate. The results will be reported to the Unit executive, the CARE Board, and Commissioners. We will track performance regularly, and analyse results alongside other measures of clinical quality. This will enable staff to understand areas of concern. Therefore in 2013/14 CARE Sheffield aims to improve the overall score on our patient questionnaire in the following categories; Facilities and environment Admin services Recommendation to CARE by friends and family CARE Sheffield has plans to improve the facility by the rearrangement and redecoration of some areas in the Clinic to enable more space for clinical work to be undertaken. Staffing will also be reviewed to ensure the staff mix is sufficient to cope with the demands on the service. This in turn will provide a better service to our patients improving the feedback on recommending the Clinic to friends and family. Admin services will be made aware of any areas within their remit that have fallen below standard so that they can address these issues improving their overall score in the coming year. Priority 2: Internal audits The development and completion of internal audits has received significant focus during the past twelve months with the aim of driving compliance to basic patient safety measures and patient processes such as achieving informed consent, accurate documentation in patient records in addition to the programme of internal clinical audit. It is our intention to have done a full review of internal audits against the HFEA quality indicators contained within the Code of Practice, and implemented them before the end of 2013/14. This will give us guidance on the areas that we can improve the service given to patients. 2.4 2.4.1 Review of Services During 2012-2013 CARE Fertility Sheffield provided NHS contracted services to four PCT’s – Doncaster, Rotherham, Bassetlaw, and East Midlands. We have reviewed the data available on the Quality of Care for all of these PCT’s at the year-end 2012/13. 11 Quality Account 2012/13 2.4.2 Participation in Clinical Audits CARE Sheffield has undertaken the following clinical audits: 1. Success rates against the national average supplied by HFEA (National). 2. The multiple birth rate against the set limit enforced by the HFEA (National). 3. ICSI results for SSR fresh and frozen samples compared to fresh and frozen ejaculates- no difference in outcomes. 4. Audit on when to freeze:- 2pn, cleavage or blastocyst, evidence to support freezing on day 5 over cleavage stage embryos. 5. Day 4 versus Day 5 transfers audit of results- no difference in clinical outcomes. 6. Audit on Short protocol use on patients who were between 38 – 42 years, FSH >10 and from 2007 – 2011. In the same group of patients but with Nottingham using a LP 300iu protocol (735 cycles) it was found a success rate of 27.8% CP/ET. Sheffield using the same patients but using short protocol was 19.33% CP/ET. 7. Audit on AMH to determine whether a patient proceeds with eSET? Outcome of audit is that patients with an AMH <5.0 should be excluded from MB. 2.4.3 Research CARE fertility is actively involved in clinical research, and is currently involved in a multicentre randomised control trial to assess the effectiveness of embryo glue when compared to standard transfer media. 2.4.4 Training CARE Sheffield has always placed an emphasis on the training and professional development of the staff employed. Each staff member is facilitated to undertake their individual training plans and to enhance their competence. CARE Sheffield has continued to develop their commitment to staff training and development, both to those employed by the company and to provide educational opportunities to external establishments. 2.4.5 What Others Say About the Provider Care Quality Commission Registration (CQC) CARE Sheffield is required to register with the Care Quality Commission and its current registration status is active. CARE Sheffield are required to comply with the Health and Social Care Act 2008 (regulated activities) Regulations (2010) and the CQC (registration) Regulations 2009 (Essential Standards of Quality and Safety 2010). CARE Sheffield has no conditions of registration and the CQC has not taken enforcement action against CARE Sheffield during April 2012- March 2013 The Care Quality Commission inspected CARE Sheffield in February 2013 against five outcomes. There were no non-conformances noted at the inspection which was reflected in the inspection report. 12 Quality Account 2012/13 ‘We found that people had consented to and been involved in decisions about their care and treatment, and that couples had been provided with both written and verbal information in order to enable them to make an informed decision about their treatment.’ ‘We found that the provider had an effective process to ensure that employees were of good character and held the necessary checks, skills and qualifications to work at the clinic.’ CQC inspection reports are circulated to staff, and are discussed at local and strategic Clinical Governance Meetings. Human Fertilisation and Embryology Authority (HFEA) The HFEA inspected the unit in June 2012. Two major non-compliances were identified, and three areas of recommendation made. The first major area correlated to the consent to disclosure to researchers which had been incorrectly reported to the HFEA. This has been addressed and an audit has shown a reduction in the number of errors, however this is an on-going process to reduce errors further. See 2.1 above. The second major area related to revalidation of re-commissioned equipment, which was not appropriately performed for one piece of critical equipment. Our policy has been updated to include as a standard the revalidation of equipment that is taken out of use. The other recommendations have been reviewed and measures taken to address areas of concern. ‘Patient feedback was very positive with six of the individuals providing written feedback to the HFEA commenting that they have compliments about the care that they received.’ ‘Staffing levels observed in the course of the on-site inspection appeared to be suitable for the activities being carried out, with patients being seen promptly on arrival.’ 2.4.6 Information Governance CARE Sheffield takes the protection and maintenance of confidentiality in all aspects of the management of patient information and identifiable records very seriously. The Operations Director is the Caldecott guardian, and holds the responsibility for the security of patient information. All staff have access to a wide range of policies to guide their actions, and all staff are trained in the management of patient information, security and confidentiality upon induction and thereafter annually. 13 Quality Account 2012/13 Breaches of security are reported internally and where relevant to the HFEA. A full investigation to identify the cause and to drive changes in process to prevent reoccurrence is carried out. Any serious breaches would be reported to the Person Responsible, the CARE Board and the relevant Commissioning Body, as well as the Information Commissioner as is applicable. 2.4.6 Data Quality CARE Sheffield treats data quality as an integral part of our governance programme and is subject to continual monitoring and improvement. Audit reports are run by the IT team to ensure compliance with IG Toolkit standards. Clinical data is reviewed, audited and validated as part of the governance framework to ensure that a patient’s care record is complete from referral to discharge. Clinical outcomes reports detailing all key performance indicators (KPIs), and adverse events are discussed at CARE Sheffield Clinical and Executive meetings. Information Governance Toolkit attainment levels CARE Sheffield Information Governance Assessment report overall score for 2012 – 2013 was 66% at level 2 of achievement as is required. 14 Quality Account 2012/13 PART 3 QUALITY PRIORITES UPDATE 2012-13 This section includes a range of information relating to CARE Sheffield’s quality performance in 2012-13. Although we did not prepare a Quality Account these were the targets we set ourselves. Quality Domain Quality Objective Clinical Effectiveness Reduce Multiple Birth Rate Patient Safety Patient Experience Improvement Target Reduce the multiple birth rate from 15% to within the HFEA target range of 10% Improve pregnancy rate for Increase clinical pregnancy age group 35-37 years results in 2012-13 Maintaining 18 week wait To maintain meeting the 18 week wait above 95% for the year To maintain Infection control Audit score to remain or overall score above 85% improve from 85% Evaluate patient feedback Improve percentage of people recommending CARE to friends and family Monitoring complaints To maintain or improve the number of complaints received during the year Monitoring incidents To reduce the number of clinical incidents 3 Clinical Effectiveness Indicators 3.1 Multiple Birth rate: All treatments Below 35 IVF/ICSI/FET/Recips Live Birth Rates: 17.6% 01/05/201124/136 30/04/2012 Clinical pregnancy 9.7% data: 01/10/20127/72 31/03/2013 35 -39 All Ages 14.45% 12/83 16.4% 36/219 23.7% 14/59 16.0% 21/131 The HFEA set a multiple birth rate (MBR) of 10%, meaning no more than 10% of a centre’s annual birth events, from treatment started on or after 1 October 2012, should be multiple births. CARE Sheffield therefore reviewed its performance against the 15% MRR and revised our strategy to try and reduce further the incidence of multiple births. In 2012/13 we aim to meet the target range set by the HFEA of 10%. Our focus will be on the age group 35-39 to reduce the percentage 15 Quality Account 2012/13 with a multiple birth outcome. Currently our multiple birth policy applies to the under 37’s – this will be reviewed to see if the criteria needs to be changed. 3.1.2/3.1.3 Clinical Pregnancy Outcomes: 01/04/201131/03/2012 Treatment started IVF/ICSI Egg Collections Embryo Transfers Frozen Embryo Transfers 01/04/201231/03/2013 Treatment started IVF/ICSI Egg Collections Below Age 35 Age 35-37 Age 38-39 All ages 39.4% 108/274 41.4% 108/263 44.1% 108/245 35.2% 31/88 Below Age 35 22.0% 18/82 22.5% 18/80 25.0% 18/72 50.0% 13/26 Age 35-37 30.5% 18/59 31.6% 18/57 33.3% 18/54 36.8% 7/19 Age 38-39 34.7% 144/415 36.0% 144/400 38.8% 144/371 38.3% 51/133 41.7% 100/240 42.9% 100/233 45.0% 100/222 34.8% 24/69 45.1% 41/91 46.6% 41/88 49.4% 41/83 40.0% 10/25 25.0% 13/52 28.9% 13/48 28.9% 13/45 61.6% 11/18 40.2% 154/383 41.7% 154/369 44.0% 154/350 40.2% 45/112 Embryo Transfers Frozen Embryo Transfers It was noted that the clinical pregnancy rate per embryo transfer was low for the age group 35-37 in 2011/12, the team concentrated their efforts in monitoring this age group and in 2012/13 this rose from 25.0% to 49.4% CP/ET. The overall clinical pregnancy rate per cycle started rose from 34.7% to 40.2%. We maintained exceptional results for frozen embryo replacement of 40.2% CP/ET, which has been commended by the HFEA. 3.1.4 Referral to treatment waiting times In order to ensure that patients receive timely treatment CARE Fertility Sheffield monitors the 18 week wait for NHS patients. April 2011-March 2012 Number of treatments started 99.7% within 18 weeks Number of treatments started 0.3% over 18 weeks April 2012-March 2013 97.5% 2.5% The number of patients consistently treated within 18 weeks is in the target range of 95% as outlined in the NHS contract. 16 Quality Account 2012/13 3.2. Patient Safety Patient safety is paramount to CARE Sheffield and is addressed both clinically and environmentally. 3.2.1 Infection Control The CARE group has an Infection Prevention and Control Committee, which comprises the infection control lead from each CARE unit, a Medical Director, an Embryologist and a Consultant Microbiologist as Infection Control Adviser. At meetings, any suspected events of infection, incidence of medical sharps injury and results of legionella testing are discussed, along with published guidance and consultation documents. All policies are reviewed at least annually. Each CARE unit carries out an annual infection audit using the ICNA audit tool. The results of CARE Sheffield’s most recent audit are noted below: Overall score for all standards = 83% (Partial compliance) 4 standards fell below 85% There was a drop in compliance from 93% the previous year, therefore the areas that we will focus on improving in 2013/14 are: Environment Ward department/kitchen We will monitor and re-audit during 2013/14 to ensure these areas have improved. 3.3.1 Patient Experience CARE Sheffield monitors patient feedback by means of our Patient Questionnaire. This is broken down into seven main categories with a maximum score of 4. Category April 2011-March 2012 April 2012-March 2013 Arrival 3.77 3.74 Admin Services 3.67 3.68 Procedures 3.81 3.87 Facilities/Environment 3.72 3.69 Consultation 3.76 3.81 Professional Services 3.82 3.86 Communicating with you 3.73 3.82 Would you recommend 3.87 CARE/Overall rating 3.63 17 Quality Account 2012/13 CARE Sheffield analyses the results of patient feedback via our questionnaire on a monthly basis. Comments written by patients are discussed at Senior Management meetings to determine any actions required and these actions are minuted and circulated as necessary. We receive a lot of positive feedback on our service and although our scoring is high we still look at areas that have fallen to determine how we can improve the feedback in those areas. 3.3.2 Learning from Complaints April 2012-March 2013 No of complaints Percentage of Percentage of received/total patients complaints responses sent number of patients within standard targets April 2011- March 2012 April 2012- March 2013 3/450 6/427 0.6% 100% 1.4% 84% (1 letter was out of the 20 day response time) CARE Sheffield has a rigorous policy in place which ensures a rapid response to the receipt of any complaints. The approach is open and welcoming, and we adopt the principles of ‘being open’ with all patients. Complaints are acknowledged within two working days, with a full response within 20 working days. For more complicated complaints, particularly if they involve more than one organisation, a longer time period will be agreed with all individuals concerned. Causes for complaints, together with outcomes of investigations, are shared with the Centre staff and the organisation takes the opportunity to learn and share any lessons resulting from a patient’s expression of dissatisfaction. CARE Sheffield takes an inclusive approach to complaints, and we aim to capture and resolve concerns expressed by patients at any stage of their pathway of care. CARE Sheffield has always had low levels of complaints – but this did increase during 2012/13. We have looked at each individual complaint carefully and where possible implemented actions to avoid future re-occurrence. 3.3.3 Patient safety incidents Clinical incidents 2011/12 2012/13 Number of incidents Percentage of Number reported to /total number of clinical incidents HFEA patients 22/450 4.8% 6 18/427 4.2% 5 CARE Sheffield is committed to reducing healthcare risk, and to undertaking risk management at every level in the organisation. An important part of minimising 18 Quality Account 2012/13 risk involves the reporting and learning from incidents. All staff have a responsibility to report incidents and near miss events, in order to assist in our aim to reduce risks to patients, staff and members of the public. CARE Sheffield has reviewed all incidents and where possible implemented actions to avoid future re-occurrence. Part 4 Risk Management performance and clinical governance – monitoring and improving 4.1 Governance The governance structure within CARE Sheffield has been deeply embedded within the culture of the organisation, from front line centre-based staff, doctors and administrators through the Medical Director and to the Board. Clinical governance meetings are held on a bi-monthly basis, dedicated time having been allocated to allow the maximum number of staff, medical, clinical and managerial to attend. This system allows for best practice and learning to be shared and cascaded throughout the organisation. The governance agenda encompasses review and benchmarking of Key Performance Indicators, clinical outcomes, complaints and concerns, adverse events and accidents, review of national alerts (MHRA, MDA, NPSA) and clinical guidance (NICE), infection prevention and control, risk management, information governance and review of all Root Cause Analyses or Serious Incident requiring Investigation reports. Action and improvement plans are evolved as necessary and disseminated throughout the organisation. ‘Never events’ – those incidents that should never happen, and serious incidents requiring investigations are subject to intensive investigation in line with the NPSA guidance and investigation templates. The emphasis is to identify the cause of the event and implement changes in processes or practice to minimise the possibility of a similar incident occurring in the future. CARE Sheffield has not had any Never Events or serious incidents during 2012-13. 4.2 Infection Prevention and Control CARE Sheffield complies with the criteria set out under the Health and Social Care Act 2008: Code of Practice for health and adult social care on the prevention and control of infections and related guidance. An Infection Prevention and Control Team is in place that covers the CARE fertility Group, with an Infection Prevention Control Lead in place together with Unit linked practitioners. CARE Sheffield is able to evidence compliance with the Code of Practice and is therefore able to assure that monitoring of healthcare infection prevention and control is in line with Care Quality expectations. 19 Quality Account 2012/13 CARE Sheffield reported no infection events, and no medical sharps injury incidents during the year. 4.3 Cleanliness – Patient feedback on our questionnaire is generally positive on the cleanliness of the environment. However the general appearance of the toilets has been questioned and these have been reviewed and upgraded to improve the facilities. 4.4 Privacy & Dignity - Mixed Sex Accommodation CARE Sheffield can confirm that there have been no breaches of the Department of Health Mixed Sex Accommodation guidance during the past year. CARE Sheffield respects the privacy and dignity of all patients and all clinical areas are designed so that patients can be seen as a couple. 4.5 Medical Staff relicensing and recertification The General Medical Council implemented Revalidation in December 2012 for all UK doctors as a statutory process. Revalidation is the process by which doctors will have to demonstrate to the GMC, normally every five years, which they are up-to-date and fit to practise. This process will ensure that doctors practising in the UK maintain high standards of good clinical care. In order to facilitate and manage the process of medical revalidation, each organisation must identify an appropriately qualified and trained Responsible Officer (RO) in line with legislation. The Responsible Officer for CARE Sheffield is the Group Medical Director, Mr Simon Thornton. CARE Sheffield has an established appraisal process for all doctors, to ensure that doctors working within the organisation are supported towards their relicensing and revalidation with the GMC. An appraisal software package was introduced by the CARE fertility Group to help manage the process, which supports the creation of portfolios of supporting evidence for individual doctors. For the year ending March 2013, CARE Sheffield submitted data to the GMC Revalidation Support Team detailing The number and status of doctors for whom CARE Sheffield is the designated body The number of doctors who have in date and valid appraisal The number of trained appraisers within the organisation 4.6 Complaints – CARE encourages and welcomes feedback from patients – both positive and negative. Patients and relatives can raise concerns with the Unit Manager regarding clinical and non-clinical treatment issues. Patients have shown gratitude for the willingness of senior staff, medical, nursing and management to engage in discussing their concerns face-to-face. 4.7 Patient Experience - Overall patient feedback gained from unannounced inspection from our regulators is extremely positive. This is evidenced by the overall positive feedback that is received on the patient questionnaires. 20 Quality Account 2012/13 4.8 Measuring & Improving Performance CARE Sheffield has well-established mechanisms in place for checking the quality of services as part of our well developed and longstanding Quality Management System (QMS). The monitoring includes audit against the Quality Indicators developed from the licence conditions contained in HFEA Code of Practice. The Unit has agreed with the commissioners to monitor welfare of the child, referral criteria, and number of smoking cessation referrals. How to provide Feedback on the Account CARE Sheffield welcomes feedback on the content of its quality accounts and suggestions for inclusion in future reports. Comments should be directed to: Mrs D Mansfield Unit Manager CARE (Sheffield) Limited 26 Glen Road Sheffield S7 1RA Or Prof Simon Fishel Managing Director CARE Fertility John Webster House Lawrence Drive Nottingham Business Park Nottingham NG8 6PZ Statement of directors’ responsibilities in respect of the Quality Report The directors are required under the Health Act 2009 and the National Health Service (Quality Accounts) Regulations 2010 as amended to prepare Quality Accounts for each financial year. In preparing the quality report, directors are required to take steps to satisfy themselves that: the content of the Quality Report meets the requirements set out in the NHS Guidance the content of the Quality Report is not inconsistent with internal and external sources of information including: Unit/Board minutes and papers for the period April 2012 to March 2013 Papers relating to quality reported to the Board over the period April 2012 to March 2013 21 Quality Account 2012/13 Feedback from the HFEA Feedback from CQC Quarterly Quality Reports submitted to the Corporate Quality Team The performance information reported in the Quality Account is reliable and accurate The Quality Report is robust and reliable, conforms to specified data quality standards and prescribed definitions, is subject to appropriate scrutiny and review; and the Quality Report has been prepared in accordance with Monitor’s annual reporting guidance. The directors confirm to the best of their knowledge and belief that they have complied with the above requirements in preparing the Quality Report. Debbie Mansfield Simon Fishel Unit Manager Managing Director 22 Quality Account 2012/13