CARE (Sheffield) Limited
Quality Accounts
APRIL 2013- MARCH 2014
1
Quality Account 2013/14
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 the CCG throughout 2013/14 through
quarterly performance meetings and regular communication between provider and
commissioner. For the second year that CARE Sheffield have 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 2013/14. 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 HFEA Code of Practice. This is evidences by the increase in the level of
elective single embryo transfer from 37% in 2012-2013 to 39% in 2013-2014. This has
been achieved through raising awareness of the risks associated with multiple-birth.
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Quality Account 2013/14
NHS Rotherham CCG welcomes the introduction of online patient experience
questionnaires in February 2014 and is pleased to see that the current achievement
is 85% for post consultation (Feb-Jun14) and 65% for post treatment.
NHS Rotherham Clinical Commissioning Group supports the quality priorities outlined
in the quality account for 2014/15 and looks forward to continuing to work in
partnership with CARE Sheffield throughout 2014/15 to ensure the successful delivery
of these priorities. There is an expectation that progress against the identified
priorities will be included in the 2014/15 quality account.
Sue Cassin, Chief Nurse, Rotherham Clinical Commissioning Group
September 2014
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Quality Account 2013/14
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 2013 – 2014 CARE Sheffield provided the following services;
These were:
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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 2013-2014 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 15 clinical audits that were assessed by the
governance team during 2013 – 2014, 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
Treatments
key
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
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Quality Account 2013/14
Monitoring results
Monthly
Bi Monthly at Joint Lab
Managers/Directors
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 Inspection
Inter Lab Audit
Incident/Complaints
Reporting
Witnessing
Traceability Audit
NEQAS
Audit of stored material
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 Quarterly from end of 2013
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
Ensure all processes meet
regulatory framework set
by HFEA
Assessment of compliance
to HFEA standards and
staff 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 ensure consumables
and media used in the
laboratory can be link to
patient use
To monitor quality control
of semen analysis
Frozen
stored
patient
gametes and embryos
checked against records
for non-conformity
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Quality Account 2013/14
Quarterly
Bi-annual
Annual
Annual
Monthly
Monthly
Monthly
Quarterly
Bi-annual
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:
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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 2014 to March 2015.”
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.
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Quality Account 2013/14
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:
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The Units priorities for improvement for 2014-15.
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
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Quality Account 2013/14
PART 2
QUALITY PRIORITIES FOR 2014/15
CARE Fertility has identified seven priorities for quality improvement in three areas
identified within High Quality Care for All:
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Clinical Effectiveness
Patient Safety
Patient Experience
Clinical
Effectiveness
QUALITY OBJECTIVE
To reduce the incidence of
multiple births, as set out in the
HFEA
Code
of
Practice
guidance
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
bio-chemical 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
IMPROVEMENT TARGET
Reduce the multiple birth
rate to within the HFEA
target range of 10% and
maintain
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
Present results for period
1.4.13-31.3.14 57.3% 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
Maintaining zero incidence
of Never Events
Patient Safety
To adopt processes and
procedures that allow us to
maintain patient safety to the
highest standard
To continue to report incidents We aim to reduce clinical
or near misses so that we can incidents to 4% of patient
reduce the reoccurrence of episodes during 2014-15.
clinical incidents in the future.
Patient Experience
To monitor that patients have
received excellent care and
customer
experience
by
receiving an on-line patient
questionnaire
following
consultation
and
then
treatment
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Quality Account 2013/14
To increase valid email
consent post consultation to
90% of patients seen post
consultation and 75% post
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
To improve the overall
scoring on each area of the
patient
questionnaire
to
above 3.70.
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: 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 marginally from 37% in 2012-2013 to 39% in 2013-2014 the last
two years through raising awareness of the risks associated with multiple-birth by the
CARE team.
CARE Sheffield as of April 2014 has a 11.23% multiple pregnancy rate (MPR), and we
aim to maintain 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 2014-15 CARE will;
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Continue its education of patients and aim to increase elective single
embryo transfer to 41% of patients.
Maintain the multiple birth rate further to within the accepted target range of
10% by March 2014.
Priority 2 and 3: Improve the clinical pregnancy rate per embryo transfer for under 38
year old patients with ICSI to above 48% NHS and Private patients, and to reduce the
bio-chemical loss in ICSI in this age group to 15%
CARE monitors all patient outcomes for clinical pregnancy success – within this
group we have a gold standard set for patients aged 37 years and under who
should have the greatest chance of achieving a clinical pregnancy. In the period
1.4.13-31.3.14 ICSI patients in this group showed a lower clinical pregnancy rate for
embryo transfer compared to the CARE group for of 45.9%, we aim to improve this to
48% by the end of March 2015.
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Quality Account 2013/14
Between 1.4.13-31.3.14 ICSI treatments showed a 16.8% bio-chemical loss. We would
aim to reduce this to 15% by March 15.
We will review how these targets are being met at our Senior Management
meetings, reporting to the Executive team also on a quarterly basis.
Priority 4: Maintain exceptional results in IVF treatment clinical pregnancy per
embryo transfer for under 38 year old patients above 50% and maintain biochemical loss rate in this age group below 12%
Between 1.4.13-31.3.14 the gold standard patients aged 37 and under had a
success rate with IVF of 57.3% clinical pregnancy rate per embryo transfer with a
biochemical loss rate of 6.0%. We aim to maintain these exceptional results in the
coming year to the end of March 15.
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.
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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 2013
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 2013/14 there were 40 clinical incidents (40/757 = 5.3% of patient treatment
episodes). The majority of these incidents related to 13 = 1.7% clinical care, 11 =
1.5% laboratory incidents, and 10 = 1.3% relating to clinical complications of Ectopic
and OHSS cases.
In 2014/15 we aim to reduce clinical incidents to 31 = 4% concentrating on reduction
of clinical care errors and laboratory incidents.
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Quality Account 2013/14
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.
CARE’s Corporate 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.
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.
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 40% 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 2014/15 CARE Sheffield aims to improve the overall score on our patient
questionnaire in the following categories;
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Valid email consent to receive on-line questionnaires
Improving and maintaining the overall score on all areas of the patient
questionnaire to above 3.70.
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 have set a 90% target for valid email consent to be in place for
patients to receive the questionnaire for both Post Consultation and Post Treatment.
Currently we are 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 email consent from 65% to 75%.
We also aim to improve or maintain the overall scoring on each area of the patient
questionnaire to above 3.70.
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,
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Quality Account 2013/14
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.
2.4
2.4.1 Review of Services
During 2013-2014, 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 2013/14 meeting.
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. Sperm preparation –time from ejaculation to insemination and possible
impact on clinical pregnancy outcomes
4. Review of refrozen embryo outcomes comparative to one time frozen
embryo outcomes
5. Oocyte freezing and thawing audit of results
6. Full cryopreservation audit comparing slow rate freezing performance to
vitrification. Result of audit to remove slow rate freezing option and only
vitrify.
7. Validation and introduction of new culture dishes that promoted better
heat transfer and therefore better stability of temperature for embryo
culture and development.
8. Assessment of performance of day 4 transfers compared to day 5 transfer
9. ICSI process audit following higher than average bio-chemical loss rates.
10. ICSI practitioner questionnaire to assess any difference in practice for
oocyte stripping of cummulas cells prior to injection.
11. Relevance of E2 measurements during IVF monitoring.
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.
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Quality Account 2013/14
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 via 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 2013 - March 2014.
The Care Quality Commission inspected CARE Sheffield in November 2013 against
five outcomes.
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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
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.
Human Fertilisation and Embryology Authority (HFEA)
The HFEA inspected the unit in July 2013. There were 2 major non-compliances
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
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Quality Account 2013/14
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.’
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.
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.
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Quality Account 2013/14
Information Governance Toolkit attainment levels
CARE Sheffield Information Governance Assessment report overall score for 2013 –
2014 was 66% at level 2 of achievement as is required.
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
Multiple Birth Rates:
15.8%
01/04/201219/120
31/03/2013
Clinical pregnancy
rates
01/04/201238.9%
31/03/2013
130/334
35 -39
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Quality Account 2013/14
All Ages
20.8%
15/72
17.5%
38/216
38.7%
86/225
34.0
240/704
Multiple Pregnancy
Rates: 01/10/201331/04/2014
Clinical pregnancy
Rates: 01/10/201331/04/2014
10.6%
11/103
11.36%
5/44
11.2%
20/179
49.3%
103/209
34.9%
44/126
42.7%
178/417
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 reviews its performance against the HFEA
targets on a regular basis and noted a rise in the MPR in 2012/2013 especially in the
Frozen Embryo Replacements and Recipient cycles. This prompted a drive to move
to offering freezing at the blastocyst stage with eset at thaw and further education
of all patients. We have seen a dramatic improvement in our multiple pregnancy
rates with no reduction in the outcomes, in fact the overall results have improved
from 34.0% to 42.7%. Currently our multiple birth policy applies to the under 37’s –
this will continued to be reviewed regularly to see if the criteria needs to be
changed.
3.1.2/3.1.3 Clinical Pregnancy Outcomes:
01/04/201231/03/2013
Treatment
started IVF/ICSI
Egg
Collections
Embryo
Transfers
Frozen Embryo
Transfers
01/04/201331/03/2014
Treatment
started IVF/ICSI
Egg
Collections
Embryo
Transfers
Frozen Embryo
Transfers
Below Age
35
Age 35-37
Age 38-39
41.7%
100/240
45.1%
41/91
25.0%
13/52
41.4%
100/233
46.6%
41/88
27.1%
13/48
45.0%
100/222
49.4%
41/83
28.9%
13/45
36.2%
25/69
40.0%
10/25
61.1%
11/18
Below Age
35
Age 35-37
Age 38-39
49.0%
118/241
31.5%
23/73
27.3%
12/44
50.6%
118/233
33.3%
23/69
27.9%
12/43
53.4%
118/221
35.4%
23/65
29.3%
12/41
43.5%
27/62
36.0%
9/25
41.7%
5/12
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Quality Account 2013/14
Age 4042
8.5
4/47
8.9
4/45
10.0%
4/40
33.3%
4/12
Age 4042
30.8%
8/26
30.8%
8/26
32.0%
8/25
23.1%
3/13
All ages
40.2%
154/383
36.7%158/430
41.7%
154/369
38.2%158/414
44.0%
154/350
40.5%158/390
41.0%
46/112
40.3%50/124
All ages
42.7%
153/358
41.9%161/384
43.2%
153/354
42.3%161/380
46.7%
153/327
45.7%161/352
41.4%
41/99
39.3% 44/112
The clinical pregnancy rate per embryo transfer has been greatly improved age
group below 35 in 2012/13 45.0% CP/ET to 53.4% CP/ET in 2013/14 period.
In 2013 it was identified that the patient age range of 40plus years were under
performing with an overall outcome of 10% for the period 2012/13. The team
concentrated their efforts in monitoring this age group and performed an audit into
the provision of different stimulation protocols and in 2013/14 this rose from 10.0% to
32.0% CP/ET.
The overall clinical pregnancy rate per cycle started rose from 36.7% to 41.9%.
We maintained exceptional results for frozen embryo replacement of 40% 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 2012-March 2013
Number of treatments started 97.5%
within 18 weeks
Number of treatments started 2.5%
over 18 weeks
April 2013-March 2014
98.5%
1.5%
The number of patients consistently treated within 18 weeks is in the target range of
95% as outlined in the NHS contract.
3.2. Patient Safety
Patient safety is paramount to CARE Sheffield and is addressed both clinically and
environmentally.
11.2.1 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 = 77% (Partial compliance) 8 standards fell
below 85%
There was a drop in compliance from 83% the previous year, therefore the areas
that we will focus on improving in 2014/15 are:

Hand hygiene (64% compliance)
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Quality Account 2013/14

Ward department/kitchen (64% compliance)
We will monitor and re-audit these during 2014/15 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 2012-March 2013
April 13-Jan 14
Arrival
3.74
3.80
Admin Services
3.68
3.77
Procedures
3.87
3.86
Facilities/Environment
3.69
3.80
Consultation
3.81
3.85
Professional Services
3.86
3.90
Communicating with you
3.82
3.81
Would you recommend 3.63
CARE/Overall rating
3.78
In 2013-14 we aimed to increase score for all areas above 3.70/4.0. This has been
achieved.
The CARE Group introduced an on-line patient questionnaire in February 2014 for
both post consultation and post treatment. Additional information i.e. consent to
email is now available on the report.
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.
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Quality Account 2013/14
3.3.2 Learning from Complaints
April 2013-March 2014
No of complaints Percentage
of
received/total
patients complaints
number of patient
cycles
April 2012 - March
2013
6/427
April 2013 - March
2014
1.4%
19/757
2.5%
Percentage
of
responses
sent
within
standard
targets
84%
(1 letter was out of
the 20 day
response time)
95%
(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
2012/13
2013/14
Number of incidents Percentage
of Number reported to
/total number of clinical incidents HFEA
patient cycles
18/427
4.2%
40/757
5.3%
5
7
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.
CARE Sheffield has reviewed all incidents and where possible implemented actions
to avoid future re-occurrence.
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Quality Account 2013/14
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 2013-14.
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.
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.
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Quality Account 2013/14
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 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 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 2014, 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 in their report
back to us, and by the overall very positive feedback that is received on the patient
questionnaires.
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
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Quality Account 2013/14
Unit has agreed to continue monitoring; welfare of the child, referral criteria, and
number of smoking cessation referrals for our NHS patients.
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 2013 to March 2014
Papers relating to quality reported to the Board over the period April 2013 to
March 2014
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
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Quality Account 2013/14
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
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Quality Account 2013/14