CARE (Sheffield) Limited Quality Accounts APRIL MARCH 2015

Transcription

1 CARE (Sheffield) Limited Quality Accounts APRIL MARCH

2 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 seven main clinics in Nottingham, Manchester, Northampton, Sheffield, London, Tunbridge Wells 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 recognises and welcomes the commitment that CARE Sheffield have to delivering a quality service and this is evident throughout this Quality Account. CARE Sheffield has been fully engaged with Rotherham CCG as lead commissioner as well as Bassetlaw and Doncaster CCG s as associate commissioners throughout 2014/15 through quarterly performance meetings and regular communication between provider and commissioners. For the third year that CARE Sheffield has produced a Quality Account, NHS Rotherham Clinical Commissioning Group wishes to commend CARE Sheffield on the quality standards that have been both maintained and improved throughout 2014/15. In particular, NHS Rotherham Clinical Commissioning Group recognises the consistent achievement of high pregnancy rates, live birth rates and the continuous commitment to reducing the incidence of multiple births, as set out in the Human Fertilisation and Embryology Authority (HFEA) Code of Practice. This is evidenced by the increase in the level of elective single 2

3 embryo transfer from 39% in to 45.5% in and the improvement in the live birth rates per transfer which have increased from 34.0% for all ages to 40.24%. NHS Rotherham Clinical Commissioning Group supports the quality priorities outlined in the quality account for 2015/16. Improvement targets that have been set against all three quality domains are thought to be realistic and achievable, however recognising that these present stretch targets for CARE particularly in relation to the following: 1. The ambition to reduce the multiple birth rate to within the HFEA target range of 10% and maintain pregnancy outcomes above 40% concentrating on patients under 35 whose rate in the last year has risen to 17.3%, and 2. The ambition to reduce the percentage to below 10% in relation to negative feedback for communication. In the highest area for negative feedback was communication at 18.6% of the comments received from patients. 3. Progress throughout 2014/15 has shown the above is possible and NHS Rotherham CCG looks forward to continuing to work in partnership with CARE Sheffield throughout 2015/16 to ensure the successful delivery of these priorities. Sue Cassin, Chief Nurse Rotherham Clinical Commissioning Group August

4 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 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 represents 20% of the total income generated from the provision of NHS services by CARE Sheffield. Participation in clinical audit CARE Sheffield participated in 16 clinical audits that were assessed by the governance team during , with the actions taken to improve the quality of health care provided: Audit Purpose / Tools Monitoring results Results Audit - Including: Embryology stats Executive meeting results Treatments performance key indicator s Monthly Super report (KPI s) to monitor results and performance of treatments Bi Monthly at Joint Lab Managers/Directors Practitioner outcomes - Including: Clinician Broad-shoulders Embryology Broad- Clinician and Embryology Broad-shoulder reports to ensure performance of each practitioner is in 4 Monthly

5 shoulders Clinic Clinician results Expired storage consent report Patient Records audit Including: Consent Audit optimum range. In line with guidance from HFEA Code of Practice Support best practice in patient documentation, professional body guidelines e.g. HFEA Monthly Quarterly Compliance to Consent Policy Critical Equipment Audit Patient Safety, compliance with HFEA Code of Practice Infection Control Audit - Compliance to Infection Including: Prevention Society and Hand Hygiene Health and Social Care Sharps Management Act 2008 Waste Management Smoking Cessation Audit Staff training to provide advice, refer to stop smoking services, to provide stop smoking medications Waiting Times Audit Ensure waiting times in departments are within acceptable range Inter Lab Inspection Ensure all processes meet regulatory framework set Electronic Witnessing Mismatch Audit Incident/Complaints Reporting Witnessing by HFEA Assessment process issues and errors linked to electronic witnessing To monitor for trends and implement prevention and corrective actions To ensure no omissions For witnessing during treatment and investigate as appropriate. Traceability Audit To ensure consumables and media used in the laboratory can be link to patient use NEQAS To monitor quality control of semen analysis Audit of stored material Frozen stored patient gametes and embryos checked against records for non-conformity Quarterly Quarterly Quarterly Bi-annual Annual Monthly Monthly Monthly Monthly Quarterly Bi-annual 5

6 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: 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 Simon Fishel, Founder and President 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 2015 to March This Quality Account to be submitted by CARE Sheffield 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. 6

7 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. 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 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 Founder and President CARE Fertility Group 7

8 PART 2 QUALITY PRIORITIES FOR CARE Fertility has identified 4 priorities for quality improvement in three areas identified within High Quality Care for All: Clinical Effectiveness Patient Safety Patient Experience 2.1 Clinical Effectiveness 2.2 Patient Safety 2.3 Patient Experience QUALITY OBJECTIVE To reduce the incidence of multiple births, as set out in the HFEA Code of Practice guidance To introduce a standardised perioperative pathway for all our surgical services to include the WHO checklist To reduce the incidence of any actual breach of confidentiality To monitor feedback from our patients via our on-line patient questionnaire, and review any trends that may occur, with a view to improving the service we offer. IMPROVEMENT TARGET Priority 1: Reduce the multiple birth rate to within the HFEA target range of 10% and maintain pregnancy outcomes above 40%. Concentrating on patient under 35 whose rate in the last year has risen to 17.3% Priority 1: To be compliant with WHO guidance by adapting the current procedure pathways to incorporate the WHO surgical safety checklist and to ensure best practise is carried out, reducing any near misses relating to never events or safety incidents Priority 2: There were 7 actual incidents of this in the last year which we aim to reduce in Priority 1: In our highest area for negative feedback was communication at 18.6% of the comments we received from patients. We would want to reduce this figure to below 10% in the coming year. 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. 8

9 2.1 Clinical Effectiveness Priority 1: Maintain 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 increased from 39% in to 45.5% in through raising awareness of the risks associated with multiple-birth and maintaining high clinical pregnancy results for ESET patients. CARE Sheffield as of April 2015 has a 15.24% multiple pregnancy rate (MPR) which is within the range expected by the HFEA. 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 CARE will; Continue its education of patients and aim to increase elective single embryo transfer to 48% of patients. Maintain the multiple birth rate further to within the accepted target range of 10% by March We will particularly concentrate on the patient group under 35 whose rate in the last year has risen to 17.3%. 2.2 Patient Safety Priority 1: Introduction of standardised peri-operative pathway to surgical procedures CARE has not experienced any Never Events in the last year. Whilst the surgical procedures undertaken are minor, CARE as an organisation is introducing a standardised peri operative pathway to incorporate all aspects of Best Practice for the care of patients in a minor procedure room or theatre environment. This will incorporate the WHO checklist. The aim is to minimise the risk of Never Events or any patient safety incidents as well as ensuring staff who work across our units are adhering to similar practice. We currently have a working group of nurse managers/a unit manager and Governance Director adapting the current procedure pathways to incorporate the WHO surgical safety checklist and to ensure best practise is carried out in each unit. The amended pathway will be presented to the CARE Clinical Governance and Quality group for review and sign off. Individual peri operative pathways will be available for all surgical procedures. CARE Sheffield will ensure that these pathways are fully implemented by March This will be led by the Nurse Manager, Medical Director and Unit Manager. 9

10 Priority 2: Reducing the incidence of actual breach of confidentiality It is part of our HFEA requirement that the centre ensures that information provided in confidence, including all information relating to donors, patients and children born as a result of treatment, is kept confidential and disclosed only in the circumstances permitted by law. If confidentiality is breached, the centre investigates, and deals with the breach, immediately submitting a full explanation to the HFEA at the time of the incident. In we had 7 actual breaches of confidentiality relating to the following; Wrong paper work being sent to a patient showing another patient s name Prescription being sent to wrong fax number 2 patient identifiers not being cross-checked to correctly identify a patient prior to releasing confidential information Wrong patient number used to update an address on our Patient Information System Whenever a breach in confidentiality occurs, the learning points from it are discussed at the most relevant internal meeting/s, so that key staff are made aware of the breach how it occurred and what measure are being putting in place to prevent further incidence. To address the above issues; The autodial facility on the fax machine was restricted to other CARE units and our home drug delivery service only to minimise the wrong number being selected and sensitive information going to the wrong recipient. We amended our process, so that before paperwork is sent out to a patient, all pages are reviewed to ensure the correct name and CARE numbers are shown on each page. Staff were advised to check 2 patient identifiers when telephoning patients their full name, and date of birth so that they know they are talking to the correct person. Staff were advised to check 2 patient identifiers before updating demographic information on CIS (computerised PAS system) to ensure that the correct patient information is updated. If there is a change of address, this had to be received in writing from the patient before it is fully actioned, though the provisional new address can be added and then confirmed. In staff will continue to report any breach that arises and appropriate investigation will be undertaken. Corrective actions will be put in place to ensure there is a reduction in these incidents. 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. 10

11 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. CARE Fertility ensures that all of our out-patients are given the opportunity via an online questionnaire to feedback on the service we provide. We track performance regularly, and analyse results alongside other measures of clinical quality particularly looking at trends. As part of the questionnaire we include a question on whether patients would recommend us to Friends and Family. Actions to improve patient experience include; Reviewing all patient feedback comments/forms. Contacting patients to discuss their issues or concerns. Discussing feedback with the most relevant team leader who in turn will cascade any actions to the rest of the team. Discussing patient feedback in the monthly Clinical Governance Unit Meetings and Senior Management meetings. Looking for trends on an annual basis to determine areas of weakness in our systems, and addressing in the above meetings. In 2015/16 the highest area of negative feedback received were issues surrounding communication. Out of the 650 patient episodes in this period, we received 59 (9%) comments about the service and out of these 11 (18.6%) related to communication issues. This is the area we will focus our attention on to understand the finer detail of the issues raised and we aim to reduce the overall fair/poor feedback rate to below 10%. The questionnaire feedback enables staff to understand areas of concern, and these results will be reported to the Unit executive, the CARE Board, and Commissioners as is appropriate. In addition to our own feedback CARE commissioned an experienced independent consultancy to review customer care at all levels of our and other fertility organisations and to determine what patients require from a patient centric fertility service. They provided CARE with a number of recommendations that the Board reviewed and we are now implementing many of these to enhance the care we give to our patients. CARE has recently set up a Patient Champion Group which includes a representative from all disciplines across the CARE group in addition to patient representatives. The purpose is to assist the organisation in becoming truly patient centric by proactively engaging patients in designing the delivery of services by CARE Fertility. The group will feedback to the Board through the Group Medical Governance director. 11

12 PART 3 QUALITY PRIORITES UPDATE This section includes a range of information relating to CARE Sheffield s quality performance in Although we did not prepare a Quality Account these were the targets we set ourselves. Clinical Effectiveness QUALITY OBJECTIVE IMPROVEMENT TARGET OUTCOME To reduce the Reduce the multiple Overall MB rate incidence of multiple birth rate to within the 14.2% births, as set out in the HFEA target range of Above target. HFEA Code of Practice 10% and maintain guidance pregnancy outcomes To meet the gold standard on clinical pregnancy outcome per embryo transfer set by the CARE group against the national average To meet the gold standard for biochemical loss set by the CARE group against the national average Maintain over 50% outcomes for IVF clinical pregnancies per embryo transfer for gold standard patients To improve the clinical pregnancy rate for ICSI patients 37 and under to =/>48% CP/ET CARE group average April 13-Mar 14 48% To reduce the incidence of biochemical loss in ICSI patients aged 37 years and under < 15% current value 16.8% CARE group average 15% Apr 13-Mar 14 Present results for period % for under 37 year old patients proceeding with IVF. Aim to maintain these exceptional results above 50% for the period Apr 14 to Mar 15 Target achieved below Target achieved below Target achieved below see see see Patient Safety To adopt processes and procedures that allow us to maintain patient safety to the highest standard To continue to report incidents or near misses so that we can reduce the Maintaining zero incidence of Never Events We aim to reduce clinical incidents to 4% of patient episodes during Target attained. This was not achieved as the incidents rose to 8.7% in 12

13 Patient Experience reoccurrence of clinical incidents in the future. To monitor that patients have received excellent care and customer experience by receiving an on-line patient questionnaire following consultation and then treatment To maintain standards to a high level of satisfaction on the services we provide, reflected by the feedback we receive from our service users To audit the processes that are essential to the treatment episode being delivered to a high standard In order to obtain feedback, we aimed to have consent to use valid address post consultation for 90% of patients, and for 75% following treatment. To improve the overall scoring on each area of the patient questionnaire to above 3.70 (4.0 top). To revise and implement the Internal Audit framework This could be due to more stringent reporting as the percentage of incidents per group analysed is small. 76% post treatment valid consent was achieved. 84% post consultation valid consent during this time we will continue to try and raise this figure during the coming year. This was not achieved as 7 of the 8 areas targeted on the questionnaire fell below 3.7. Audits carried out in line with HFEA requirements. 3 Clinical Effectiveness Indicators 3.1 Multiple Birth rate: all cycles (IVF/ICSI and FET all egg types) All treatments IVF/ICSI/FET/Recips Multiple Birth Rates: 01/04/13-31/03/14 Live birth/ ET 01/04/13-31/03/14 Below All Ages 13.1% 18/ % 137/ % 9/ % 53/ % 33/ % 233/579

14 Multiple Pregnancy Rates: 01/04/14-31/03/15 Clinical preg/et: 01/04/14-31/03/ % 27/ % 156/ % 11/ % 84/ % 43/ % 282/581 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 regularly reviews its compliance to the Multiple Birth Rate. We have made improvements on the multiple birth rate comparing 2012/2013 to 2013/ % vs 14.2%. The present clinical pregnancy rates are in line with the Multiple birth rates and are within the accepted range for compliance for the HFEA. We keep a log of all patients that refuse to have single embryo transfer when it is advised by the clinic. The greatest improvement has been in the live birth rates per transfer which despite the lowering of the multiple birth rate have increased from 34.0% for all ages to 40.24%. Providing patients with a greater chance of pregnancy with a lower risk of multiple pregnancy providing evidence to support the selection criteria in place for eset. We will continue to target patients under 35 years as their rate of multiple pregnancy has increased in the period concentrating on patients having a fresh cycle IVF/ICSI as the rate of MPR is 18.6 ( 21/113). From 202 embryo transfers 58% were SET and 42% DET. The patients that make up this percentage are those declining to proceed with eset (15%) and those that do not comply with the requirements for eset (85%). DET decision is made on the quality and development stage of the cohort of embryos, on day 3 less than 3 with suitable quality and development and no good quality blastocysts on day 4 or /3.1.3 Clinical Pregnancy Outcomes: *To improve the clinical pregnancy rate for ICSI patients 37 and under to =/>48% CP/ET CARE group average April 13-Mar 14 48% **To reduce the incidence of bio-chemical loss in ICSI patients aged 37 years and under < 15% current value 16.8% CARE group average 15% Apr 13-Mar 14 April14-March15 CARE Sheffield ICSI patients Under 37 Clinical pregnancy per *53.6% cycle started 89/166 Clinical pregnancy per *56.32% transfer 89/158 Implantation rate /227 Biochemical loss **11.88% 12/ CARE group average ICSI patients Under % 716/ % 716/ % 808/ % 131/847 Multiple pregnancy rate 15.1% 11.1%

15 16/106 90/808 Our target for these patients has been achieved for both the clinical pregnancy rate and the reduction in biochemical loss. The MPR rate is in our target for the next period 2015/2016 Results for period % for under 37 year old patients proceeding with IVF. *Aim to maintain these exceptional results above 50% for the period Apr 14 to Mar 15 April14-March15 CARE Sheffield IVF patients Under 37 Clinical pregnancy per *57.14% cycle started 56/98 Clinical pregnancy per *59.6% transfer 56/94 Implantation rate 48.50% 65/134 Biochemical loss 9.68% 6/62 Multiple pregnancy rate 16% 9/56 This high level of clinical pregnancy outcomes has been maintained above the standard achieved in 2013/ 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. Number of treatments started within 18 weeks Number of treatments started over 18 weeks April 2013-March 2014 April 2014-March % 98.9% 1.5% 1.1% The number of patients consistently treated within 18 weeks is in the target range of 95% as outlined in the NHS contract Patient Safety Priority 1: Maintaining 0 incidence of Never Events Patient safety is paramount to CARE Sheffield and is addressed both clinically and environmentally. 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 15

16 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 Priority 2: Incident reporting and analysis in 2014 CARE fosters a culture of learning from adverse events or reactions. CARE Sheffield is committed to reducing healthcare risk, and to undertaking risk management at every level in the organisation. An important part of minimising 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. Clinical incidents 2013/14 Number of incidents /total number of patient cycles Percentage of clinical incidents Number reported to HFEA 40/ % /15 57/ % 7 In there were 57 clinical incidents 57/650 (8.7%) of patient treatment episodes). The highest ratio of these incidents 14 (2.1%), related to clinical complications, (8 relating to Ectopic pregnancy or OHSS), which are a recognised risk associated with IVF treatment. 11 (1.6%), related to actual or potential breach of confidentiality see Patient Safety priority 2. 7 (1%) related to clinical care and 7 (1%) Lab incidents. Other categories of clinical incidents were 5 medication errors, 4, third party non-conformity, 4 patient errors, 3 equipment consumable issues, 2 failures to follow policy. Our target to maintain scoring below 4% was not achieved, as the percentage of clinical incidents rose to 8.7% in This could be due to more stringent reporting as the percentages of incidents per category are small. CARE reviews all incidents and implements actions to address the root cause of them by discussion with staff and adopting changes to policy where appropriate. This has included; Taking any clinical care or clinical complication incidents to the unit clinical meeting for discussion and action. Liaising with third parties when any non-conformities arise to address issues raised. Calling out engineers or technicians to repair or review faults on equipment. Changing admin processes so that it reduces information governance incidents of breach of confidentiality. Updating patient information to give clearer instructions on information connected to clinical treatment. 16

17 Reviewing policies following incidents to check they are up to date and relevant, and changing practice where appropriate. CARE s Clinical Governance and Quality Team holds a Management review Meeting on an annual basis where all incidents are reviewed and discussed for trends, and actions allocated according to the area of concern Patient Experience Priority 1: To increase valid consent In February 2014 the online questionnaires were introduced to enable easy access for patients to complete their feedback in the comfort of their own home or surroundings. We set a 90% target for valid consent to be in place for patients to receive the questionnaire for both Post Consultation and Post Treatment. In 2014 we were achieving 85% for post consultation (Feb-Jun14) and 65% for post treatment. Concentrating on the post treatment questionnaire, we aim to increase the percentage rate for valid consent from 65% to 75%. In the period we did increase valid consent for post procedure questionnaires to 76%, so our target was achieved. For post consultation valid consent the target was to raise this from 85% to 90%. In the period we maintained the target at 84% but it did not increase, therefore we will continue to increase awareness of staff to request consent to put addresses onto our system as patients visit for their appointment. Priority 2 To improve the overall scoring on our questionnaire to above 3.7 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 13-Jan 14 April 14-Mar 15 Arrival Admin Services Procedures Facilities/Environment Consultation/staff Professional Services Communicating with you Would you recommend CARE/Overall rating In we aimed to increase score for all areas above 3.70/4.0. These targets were not met, but remain at the top end of our scoring system. We will continue to monitor these areas, specifically reviewing Communicating with You, Admin Services, and Arrival, to improve these scores over the coming year. 17

18 The CARE group are currently looking to streamline the scoring system of our questionnaires in line with the NHS scoring system of 6, which will help us to analyse our data more effectively and be able to compare our scoring to that of the NHS. Priority 3: To implement the internal audit framework in line with HFEA requirements 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. There is a schedule of internal audits that the Unit carries out, which must be done within a 2 year period as stipulated by the HFEA. These monitor the quality indicators linked to the process we carry out in the Unit. In the following audits were completed; Patient records audit Donation audit Lab inspection QMS/Admin audit Third party agreement audit Confidentiality audit Unit management audit EDI audit Infection control audit Health and safety audit Any non-conformances noted were reported to the appropriate line manager for action and then a date given to re-audit the non-conformances. Once it is established that the actions are complete the audits are closed. The actions instigated from the audits included; Updating policy to current practice Initiating any training with staff to confirm the correct processes to follow Taking actions back to staff meeting for learning and understanding Instigating changes to practice where appropriate Liaising with third parties to feedback any elements that they are responsible for. The Unit has agreed to continue monitoring; welfare of the child, referral criteria, and number of smoking cessation referrals for our NHS patients. 18

19 Part Review of Services During , CARE Fertility Sheffield provided NHS contracted services to four main CCG s Doncaster, Rotherham, Bassetlaw, and East Midlands. We have reviewed the data available on the Quality of Care for all of these CCG s at the year-end 2014/15 meeting. 4.2 Participation in Clinical Audits CARE Sheffield has undertaken the following clinical audits: 1. AHM results and the pregnancy outcomes for different AMH levels v age. 2. Audit of results from new Axsym machine used for our patient samples at CARE Nottingham. 3. Courtesy call being offered to patient following embryo transfer or IUI outcome to help assist with next step when required. 4. Success rates against the national average supplied by HFEA (National). 5. The multiple birth rate against the set limit enforced by the HFEA (National). 6. OR time to insemination time impact on outcome Abstract /poster ACE Case report: the possible causes and effects of non-apposition of pronuclei in three out of seven embryos cultured in time-lapse culture.- Abstract/Poster ACE To re-freeze or not to re-freeze? That is the question a review of refrozen embryo outcomes comparative to one time frozen embryo outcomes- Abstract/Poster ACE Are split IVF-ICSI cycles an effective way of managing unexplained infertility? Abstract/ poster ACE Review of Day 4 program for embryo transfer literature review and investigation of current outcomes. 11. Feasibility study into freezing on Day Day 2 vs Day 3 for patients with only low fertilisation outcome requiring SET best day for transfer- a review of the CARE group strategy and results. 13. Day 5 vs Day 6 review of outcomes for clinical pregnancy and survival following thaw for frozen replacement 14. Investigation into 3pn rate rise across practitioners for IVF insemination process following a broadshoulder analysis. 15. CAREmaps comparison to Standard incubation data summary for outcomes to date. 16. ICSI practitioner variation in 2pn rate investigation. 17. Procedure time audit. 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 19

20 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 all relevant internal audits against the HFEA quality indicators contained within the Code of Practice, and implemented them appropriately before the end of 2014/15. This will give us guidance on the areas that we can improve the service given to patients. 4.3 Research CARE fertility is actively involved in clinical research, and is currently involved in a multicentre appraisal into different media types and any effect on morphokinetics and blastocyst formation. 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 via the following meetings; HFEA/workshops/BFS study days/insights/northern Nurses/SING meetings/ace/bfs/eshre/child Protection/Infection Control/BICA/SING counselling meeting/asrm/bica. 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 March The Care Quality Commission inspected CARE Sheffield in November 2013 against five outcomes. Respecting and involving people who use services Safeguarding people who use services from abuse Cleanliness and infection control Staffing Assessing and monitoring the quality of service provision Records 20

21 There were no non-conformances noted at the inspection which was reflected in the inspection report. Patients overall experience when attending the clinic has been positive. We found patients were fully involved in decisions relating to their treatment and care, and that patient s privacy and dignity was maintained whilst attending the surgery. We found processes were in place to safeguard patients from the risks of abuse. A tour of the promises was conducted and it was found to be clean and tidy. CQC inspection reports are circulated to staff, and are discussed at local and strategic Clinical Governance Meetings. 4.6 Human Fertilisation and Embryology Authority (HFEA) We completed our self-assessment for the HFEA in May 2015, and had an unannounced inspection on 22 July We are now awaiting the report from this inspection to follow, but the feedback given at the time was positive, with only minor areas of non-compliance to address. The previous full HFEA inspection was in July Then 2 major non-compliances were identified, and 6 areas of recommendation made. The first major area related to validation of critical processes specifically semen analysis sperm freezing and embryo thawing. These areas have now been addressed, and documentation subsequently supplied to the HFEA to confirm validation of the above processes has occurred. This was accepted. The second major area related to lack of CPA accreditation of the andrology laboratory providing diagnostic semen analysis. Evidence has again been provided to show that we meet the requirements at a level equivalent to CPA accreditation, and has been accepted by our Inspectorate. The other minor recommendations have been reviewed and measures taken to address each area of concern. Patient feedback was very positive with five of the six individuals providing written feedback to the HFEA commenting that they have compliments about the care that they received. The centre has suitably qualified and competent staff to carry out all of the licensed activities and associated services. The unit has recently completed a self-assessment in May 2015, so we expect to have an interim inspection in the near future. 4.7 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. 21

22 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. 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. 4.8 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. 4.9 Information Governance Toolkit attainment levels CARE Sheffield Information Governance Assessment report overall score for was 66% at level 2 of achievement as is required. 22

23 Part 5 Risk Management and clinical governance monitoring and improving performance 5.1 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. 5.2 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. CARE Sheffield reported no infection events, and no medical sharps injury incidents during the year. 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: 23

24 Overall score for all standards = 82.5% (Partial compliance) 7 standards fell below 85% There has been an increase in compliance from 77% the previous year. The areas of lowest compliance are; Ward/departmental kitchens 56% compliance Environment 68.2 % To address these areas we are working with the cleaning company to get them to improve on the standard of service they provide, and they will be monitored on a quarterly basis going forwards to ensure these areas have improved. 5.3 Cleanliness Patient feedback on our questionnaire is generally positive on the cleanliness of the environment. 5.4 Learning from Complaints April 2014-March 2015 April March 2014 April 2014 March 2015 No of complaints received/total number of patient cycles Percentage of patients complaints 19/ % Percentage of responses sent within standard targets 95% (1 letter was out of the 20 day response time) 10/ % 100% 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. 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. 24

25 5.5 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. 5.6 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 practice. 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 Cath Finn, Group Medical Governance Director. CARE Sheffield employs two doctors that are supported towards their relicensing and revalidation with the GMC. Both clinicians are up to date with their GMC revalidation for the year ending March 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 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 25

26 Prof Simon Fishel Founder and President CARE Fertility John Webster House Lawrence Drive Nottingham Business Park Nottingham NG8 6P 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 2014 to March 2015 Papers relating to quality reported to the Board over the period April 2014 to March 2015 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 Unit Manager Simon Fishel Founder and President 26