CARE (Sheffield) Limited
Quality Accounts
APRIL 2014- MARCH 2015
1
Quality Account 2014/15
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
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Quality Account 2014/15
embryo transfer from 39% in 2013-2014 to 45.5% in 2014-2015 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 2014-15 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 2015
3
Quality Account 2014/15
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 2014 – 2015 CARE Sheffield provided the following services;
These were:

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
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
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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 2014-2015 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 2014 – 2015, 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 2014/15
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
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
Prevention Society and
Health and Social Care
Act 2008
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
by HFEA
Electronic Witnessing Mis- Assessment process issues
match Audit
and
errors
linked
to
electronic witnessing
Incident/Complaints
To monitor for trends and
Reporting
implement prevention and
corrective actions
Witnessing
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
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Quality Account 2014/15
Quarterly
Bi-annual
Annual
Monthly
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 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 2016.”
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 2014/15
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 2015-16.
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
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Quality Account 2014/15
PART 2
QUALITY PRIORITIES FOR 2015-16
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
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
To reduce the incidence of Priority 2: There were 7
any actual breach of actual incidents of this in the
confidentiality
last year which we aim to
reduce in 2015-16.
To monitor feedback from Priority 1: In 2014-15 our
our patients via our on-line highest area for negative
patient questionnaire, and feedback
was
review any trends that may communication at 18.6% of
occur, with a view to the comments we received
improving the service we from patients. We would
offer.
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.
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Quality Account 2014/15
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 2013-2014 to 45.5% in 2014-2015 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 2015-16 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 2016.
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
procedures
standardised peri-operative
pathway to
surgical
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
2016. This will be led by the Nurse Manager, Medical Director and Unit Manager.
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Quality Account 2014/15
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
2014-15 we had 7 actual breaches of confidentiality relating to the following;

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

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 2015-16 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.
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Quality Account 2014/15
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.
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Quality Account 2014/15
PART 3
QUALITY PRIORITES UPDATE 2014-15
This section includes a range of information relating to CARE Sheffield’s quality
performance in 2014-15. Although we did not prepare a Quality Account these
were the targets we set ourselves.
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
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
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
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Quality Account 2014/15
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%
OUTCOME
Overall MB rate
14.2%
Above target.
Target
achieved
below
see
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
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
Target
achieved
below
see
Target
achieved
below
see
Maintaining
incidence of
Events
zero Target
Never attained.
We aim to reduce
clinical incidents to 4%
of patient episodes
during 2014-15.
This was not
achieved
as
the
incidents
rose to 8.7% in
reoccurrence
of
clinical incidents in the
future.
Patient
Experience
2014-15.
This
could be due
to
more
stringent
reporting
as
the
percentage of
incidents
per
group
analysed
is
small.
76%
post
treatment valid
email consent
was achieved.
To
monitor
that
patients
have
received
excellent
care and customer
experience
by
receiving an on-line
patient questionnaire
following consultation
and then treatment
In order to obtain
feedback, we aimed
to have consent to use
valid email address
post consultation for
90% of patients, and 84%
post
for
75%
following consultation
treatment.
valid
email
consent during
this time – we
will continue to
try and raise
this
figure
during
the
coming year.
To improve the overall This was not
scoring on each area achieved as 7
of
the
patient of the 8 areas
questionnaire
to targeted
on
above 3.70 (4.0 top).
the
questionnaire
fell below 3.7.
To
revise
and Audits carried
implement the Internal out in line with
Audit framework.
HFEA
requirements.
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
3 Clinical Effectiveness Indicators
3.1 Multiple Birth rate: all cycles (IVF/ICSI and FET all egg types)
All
treatments Below 35
IVF/ICSI/FET/Recips
Multiple Birth Rates:
13.1%
01/04/13- 31/03/14
18/137
Live birth/ ET
01/04/13- 31/03/14
35 -39
47.07%
137/291
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Quality Account 2014/15
All Ages
17%
9/53
14.2%
33/233
30.46%
53/174
40.24%
233/579
Multiple Pregnancy
Rates:
01/04/14- 31/03/15
Clinical preg/ET:
01/04/14-31/03/15
17.3%
27/103
13.09%
11/84
15.2%
43/282
53.06%
156/294
47.19%
84/178
48.53%
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 2013/14 17.5% 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 2014-15 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 5.
3.1.2/3.1.3 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
Clinical pregnancy per
cycle started
Clinical pregnancy per
transfer
Implantation rate
Biochemical loss
Multiple pregnancy rate
CARE Sheffield
ICSI patients
Under 37
*53.6%
89/166
*56.32%
89/158
46.75
106/227
**11.88%
12/101
15.1%
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Quality Account 2014/15
CARE group average
ICSI patients
Under 37
44.67%
716/1603
49.69%
716/1441
41.9%
808/1927
15.4%
131/847
11.1%
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 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
April14-March15
Clinical pregnancy per
cycle started
Clinical pregnancy per
transfer
Implantation rate
Biochemical loss
Multiple pregnancy rate
CARE Sheffield
IVF patients
Under 37
*57.14%
56/98
*59.6%
56/94
48.50%
65/134
9.68%
6/62
16%
9/56
This high level of clinical pregnancy outcomes has been maintained above the
standard achieved in 2013/2014.
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 2013-March 2014
Number of treatments started 98.5%
within 18 weeks
Number of treatments started 1.5%
over 18 weeks
April 2014-March 2015
98.9%
1.1%
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
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
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Quality Account 2014/15
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 2014-15.
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
2014/15
Number of incidents Percentage
of Number reported to
/total number of clinical incidents HFEA
patient cycles
40/757
5.3%
8.7%
57/650
7
7
In 2014-15 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 2014-15. 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.
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Quality Account 2014/15

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.
3.3.1 Patient Experience
Priority 1: To increase valid email 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 email 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 email consent from 65% to 75%.
In the period 1.4.14 – 31.3.15 we did increase valid email consent for post procedure
questionnaires to 76%, so our target was achieved.
For post consultation valid email consent – the target was to raise this from 85% to
90%. In the period 1.4.14-31.3.15 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 email 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
Arrival
Admin Services
Procedures
Facilities/Environment
Consultation/staff
Professional Services
Communicating with you
Would you recommend
CARE/Overall rating
April 13-Jan 14
3.80
3.77
3.86
3.80
3.85
3.90
3.81
3.78
April 14-Mar 15
3.63
3.49
3.67
3.68
3.67
3.77
3.54
3.64
In 2014-15 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.
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Quality Account 2014/15
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 2013-14 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.
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Quality Account 2014/15
Part 4
4.1 Review of Services
During 2014-2015, 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
2015
7. 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 2015
8. To re-freeze or not to re-freeze? That is the question a review of refrozen
embryo outcomes comparative to one time frozen embryo outcomesAbstract/Poster ACE 2015
9. Are split IVF-ICSI cycles an effective way of managing unexplained
infertility? Abstract/ poster ACE 2015
10. Review of Day 4 program for embryo transfer – literature review and
investigation of current outcomes.
11. Feasibility study into freezing on Day 4
12. 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
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Quality Account 2014/15
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 2014 - March 2015.
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
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Quality Account 2014/15
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 2015. 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 2013. 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.
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Quality Account 2014/15
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 2014 –
2015 was 66% at level 2 of achievement as is required.
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Quality Account 2014/15
Part 5
Risk Management
performance
and
clinical
governance
–
monitoring
and
improving
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:
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Quality Account 2014/15

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
No of complaints Percentage
of
received/total
patients complaints
number of patient
cycles
April 2013 - March
2014
April 2014 – March
2015
19/757
2.5%
10/650
1.5%
Percentage
of
responses
sent
within
standard
targets
95%
(1 letter was out of
the 20 day
response time)
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.
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Quality Account 2014/15
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 2015.
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
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Quality Account 2014/15
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
Simon Fishel
Unit Manager
Founder and President
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Quality Account 2014/15