-Business Case
[This front sheet should reflect the branding requirements of the Trust. The
below is only a guide and local Trust Business Case template which may
require additional information. Costs are for guidance only and vary between
Trusts/regions. Green text is for your guidance and should be removed
before business case sent for submission or review]
Project Name:
IV Iron Anaemia Clinic
Date:
Release:
Draft/Final
Author:
Owner:
Client:
Document Number:
[Major headings are included in contents list – edit as required]
Contents
Executive Summary
Introduction
Drivers for change that support the need for a
coordinated approach to anaemia management:
Reason, aims and purpose
Expected Benefits & Outcomes
Outcome measures:
Expected Dis-benefits
Timescale
Financial Appraisal
Clinical / Non-Financial Benefits Assessment
Environmental Impact Assessment
1
Risk Assessment and Management
Service Description/Care Pathway
Evidence Base for an IV iron anaemia clinic
Conclusion and approvals
Appendices
Appendix 1: Intravenous iron preparations licensed
in the UK
Appendix 2: Patient Information
Appendix 3: HRG code/tariff
References
Acknowledgements
Executive Summary
[Highlight the key points in the Business Case, which should include
important benefits and the return on investment. These could be from the
template below but should be made specific to the Trusts decision and aims
you hope to achieve]
Introduction
Pre-operative iron deficiency anaemia (IDA) is common and associated with
poor post-operative outcomes. It is good clinical practice to diagnose and
appropriately treat preoperative anaemia. This is likely to reduce the risk of
such patients requiring intra/post-operative blood transfusion which may
expose patients to additional risks and increased morbidity as well as risk of
operation cancellation if patient found to be anaemia. This strategy is likely
to improve clinical outcomes for patients undergoing planned major surgery.
A standardised approach for the detection, evaluation and management of
2
anaemia in the pre-operative setting has been internationally identified as an
unmet medical need.
A 2012 data briefing by The Kings Fund (Tian et al 2012) indicated IDA as an
ambulatory care-sensitive condition (ACSC – a condition for which effective
management and treatment should prevent admission to hospital). It went
on to say that, high levels of admissions for ACSAs often indicate poor coordination between the different elements of the health care system and that
an emergency admission for an ACSC is a sign of the poor overall quality of
care.
(See Evidence Base for an IV iron anaemia clinic)
Drivers for change that support the need for a coordinated approach
to anaemia management:

[Add in information from local audit or results from national comparative
audit surgical PBM, that show the size of the problem within Trust – expand
this point as required to make issue a local concern that needs an anaemia
clinic to improve situation]

NHS Outcomes Framework 2013/14, Domain 2, Improvement area 2.3:
Enhancing quality of life for people with long-term conditions> Reducing time
spent in hospital
by people with long-term
conditions – unplanned
hospitalisations for chronic ambulatory care sensitive patients. (CCG Quality
Premium attached to this service) [Add in other NHS Outcomes Framework
domains and indications that fit your Trust]

National
Blood
Transfusion
Recommendations
2014
Committee
Patient
Blood
Management
(http://www.transfusionguidelines.org/uk-
transfusion-committees/national-blood-transfusion-committee/patient-bloodmanagement) advise the following:
o
Provide
arrangements
for
the
timely
identification
and
correction of anaemia before elective surgery which is likely to
involve significant blood loss using WHO definitions of anaemia
i.e. Hb in adult males<130g/l and adult females <120g/l
o
Avoid transfusion for managing anaemia if alternatives are
available e.g. oral iron for iron deficiency and intravenous iron
for functional iron deficiency
3
o
Identify and correct the underlying cause of the anaemia
before considering transfusion

The NHS Plan (DH 2000) recommends the setting up of “preparing
patients for surgery” clinics where all aspects of the patient’s health relevant
to their possible transfusion requirements should be investigated.

The National Institute for Health and Clinical Excellence (NICE) guidance
on preoperative testing of patients

(BCSH
Guidelines:
The
management
of
anaemia
pre-operatively:
Alternatives to allogeneic transfusion- soon to be published)

NHS Enhanced Recovery partnership programme (Department of Health
2010)
has
an
element
on
preoperative
assessment,
planning,
and
preparation before operation and recommends that anaemia is investigated
and treated before planned surgery.

Reduction in numbers of inappropriate transfusions

Current unmet need due to the inadequate pre-optimisation of patients
before surgery.
An NHSBT national survey of Patient Blood Management
(2014) indicated that 31% of NHS trusts did not have arrangements in place
for identification and correction of anaemia before surgery.

There is a need for the provision of a rapid access anaemia service to
improve the patient journey :o
Reduction in the number of emergency admissions due to
anaemia
o
Streamlined pre-operative management
o
Efficient out patient investigation and treatment pathways
Reason, aims and purpose
The purpose of an anaemia clinic is to provide a streamlined care pathway for
diagnosis and treatment of anaemia in patients requiring planned major
surgery.
At present patients often have to be referred back to their GP for
investigations of anaemia or onward referral to a haematology clinic.
4
This
often results in last minute cancellations and / or significant delays with their
surgery.
It is good clinical practice to diagnose and appropriately treat pre-operative
anaemia. This is likely to reduce the risk of such patients requiring perioperative blood transfusion which may expose patients to additional risks and
increased morbidity. This strategy is likely to improve clinical outcomes for
patients undergoing planned major surgery.
Various studies as have shown that blood transfusion is an independent risk
factor for mortality and morbidity after surgery. (See Evidence Base for an IV
iron anaemia clinic)
The Health Service Circular Better Blood Transfusion: Appropriate Use of
Blood (HSC 2002/009) recommends that pre-operative haemoglobin (Hb)
levels and haemostasis are optimised in pre-operative assessment clinics
(POAC) for patients with planned surgical procedures.
The National Good Practice Guidance on Pre-operative Assessment for
Inpatient Surgery (2002) states that pre-operative assessment should
identify any condition that may require intervention prior to admission and
surgery and take appropriate action.
The Royal College of Anaesthetists Guidelines for the provision of anaesthetic
services 2014 state that Pre-operative assessment and preparation Business
planning
by
trusts
and
anaesthetic
departments
should
ensure
that
necessary time and resources are directly targeted towards pre-operative
preparation of patients to clearly identify and mitigate, or manage risks in a
planned and consistent way.
They state each trust should have agreed written policies, protocols or
guidelines covering:

pre-operative tests and investigations

management of anaemia to reduce risk of allogenic blood transfusion

management of anticoagulant therapy
5
The National Institute for Health and Clinical Excellence (2003) indicates the
tests required for specific types of surgery. However, there is currently no
guidance on how anaemic patients should be managed by POAC.
BCSH
guidelines are in development.
Expected Benefits & Outcomes
[The benefits that the project will deliver expressed in measurable terms
against the situation as it exists prior to the project. Benefits should be
both qualitative and quantitative – an audit to see the possible impact
may have to be completed (See National Comparative Audit Surgical
Patient Blood Management proforma and results). Expected benefits and
outcomes should be aligned to corporate/Trust strategic aims. Tolerances
should be set for each benefit and for the aggregated benefit. Any
benefits realisation requirements should be stated]
Outcome measures:

% patients having surgery with treatable anaemia uncorrected

% patients having surgery with treatable anaemia corrected

% transfusion rate for surgical patients (pre-op, intra-op, post-op)

Cancellation rate (because of anaemia) might be difficult to capture
systematically – low numbers, variable reasons for cancellation

Complication rate e.g.: transfusion reactions such as TACO and TRALI,
wound infections

Length of stay – in critical care and in hospital

Readmission within 30 days

The patient experience

Compliance to QIPP agenda and QIPP initiatives. Such as;
1. Operate a well planned and clear pathway for anaemia
management (agreed, in place and working) delivering safe,
evidence based care
2. each patient is seen by a person with relevant skills and right
equipment
6
3. Reduce blood transfusions
Expected Dis-benefits
[Outcomes perceived as negative by one or more stakeholders. Below are
general but should be made Trust specific. Balancing factors should be
added to show that the dis-benefit does not outweigh any benefit. This
section can be excluded from the business case]
 Additional staff will be needed to manage the anaemia clinic – these may
come from the areas where post-operative transfusion rates will drop
 An area will be occupied for the anaemia clinic – the clinic will be held
once a week and at a time when surgical outpatients lists are completed
Timescale
[Add details of the period over which the project will run and the period
over which the benefits will be realised.]
Financial Appraisal
[Add details on costs and savings from information available from audits,
blood usage and iron preparation costs. Details about activity based
costs/savings can also be included. Add details as required by your Trust.
Below are lists of cost savings and implications which should be considered.
Others may exist]
Savings to be considered: Decreased costs due to;

Reduction in length of stay

Reduction in number of red cell transfusions

Avoidance of re-admission especially emergency re-admission

Reduction in time spent investigating transfusion related incidents

Reduction in treatment of wound infections
7

Early (or earlier)
detection of the cause of anaemia which may be
secondary to previously undiagnosed disease (E.g malignancy)
Cost implications:

Consultant time

Nursing staff time

Secretarial support

Drugs cost

Investigation costs

Capital costs and variable costs
Revenue:

Tariff for treatment of IDA (with/without complications)
Projected saving/revenue:
[Table below is a worked example of use of Red cells vs. an IV iron
preparation. Cost are those as per the SPC and National Price lists as of
2015/16, nursing cost excludes as weighted premiums as are taken from
Curtis 2014. 2 units of RBC used as a comparison as Shander A. et. Al states
that one unit of blood contains 190-210 mg of heam iron (mean 200mg).
Update example as required. Additional lab testing has not been included in
worked example as its assumed test frequency will not be affected – if this is
to be affected in your Trust factor this into the example below]
Intervention
Amount
Cost of Drug per unit/g (£)
time in required hours
band 5 nurse (cost per Hour)
cost of nurse per infusion
Giving set Cost
Cost of Treatment
Day case Payment via HRG
Income to dept per patient
Current
Situation
Red blood cells
2 units
£243.70
6
£84.00
£504.00
£6.75
£754.45
£406.00
(SA13A)
-£348.45
8
Proposed Iron
Service
Ferinject
1g
£154.23
0.45
£84.00
£37.80
£6.75
£198.78
£294.00
(SA04F)
£95.22
If all patients treated during
audit period
Annual scope for patients
[from audit]
[from audit]
[from scope]
[from scope]
Clinical / Non-Financial Benefits Assessment

Lower risk to patients due to lower probability of receiving an allogeneic
transfusion

Decreased length of stay post-operatively.

Meets best practice for surgical patients.

Reduced risk of hospital acquired infection

Improved patient experience.

Increase in day case and community management

Early (or earlier)
detection of the cause of anaemia which may be
secondary to previously undiagnosed disease (E.g malignancy)
Environmental Impact Assessment
The clinic will necessitate the patient travelling to clinic for up to a maximum
of 6 visits, dependent upon iron preparation. However a number of IV iron
preparations can be administered as a total dose infusion. The ability to
administer IV iron in the clinic will negate the need for a further hospital visit.
Risk Assessment and Management
[Check other risks that may exist within your Trust. It is important that the
service before and after is audited to ensure correct resources are allocated
and outcomes expected are being realised]
9
Risk
Mitigation plan
Other service providers may not feel Collect evidence to provide compelling case for
that this new service is necessary
change,
liaise
closely
with
other
divisions,
develop complimentary service
Trust may feel that activity is being Probable large unmet need – need accurate
diverted rather than genuinely new figures to predict referral patterns and change
activity
in patient flow
Clinical Commissioning Groups may not 1)
support new service
Iron
deficiency
is
an
Ambulatory
Care
Sensitive (ACS) condition and the case needs to
support
management
of
anemia
in
the
community (including education and training,
and availability of expert telephone advice as
well as rapid access clinic)
2) Should meet NHS targets for reduction in
emergency admissions and 18 week pathway
Single handed nurse specialist
Service
co-delivered
by
consultant
haematologist, work as part of transfusion team
Nurse specialist may be difficult to Person spec: post graduate qualification in
recruit – will require specialist skills haematology nursing, competent in assessment
including:
history
taking,
physical of adult patients.
Will require supervision by
examination, use of investigations, use consultant until experienced and competent in
of treatment modalities etc
management of adult patients with anaemia;
willing to undertake nurse prescribing course
and
complete
training
to
allow
nurse
authorisation of blood components
Service may be underused
Develop
appropriate
communication
plan,
ensure available on choose and book etc
Service may become overwhelmed
Review after 1 year, Audit capacity used /
available and service demand, make case for
additional staff/clinic days as required
10
Service Description/Care Pathway
[Add brief details of service being commissioned. This could be a new service
improvement, redesign or expansion of current anaemia management
service. Add in: overview algorithm; below one from the NATA guidelines on
detection, evaluation and management of preoperative anaemia (Goodnough
et al 2011), location of service, patient access/referral systems patient follow
up/review processes, interdependence with other services/providers and
administration requirements]
11
Evidence Base for an IV iron anaemia clinic
There is strong evidence to show that pre-operative anaemia is a modifiable
risk factor for surgery.
The identification and management of pre-operative anaemia is important as
it has the potential to identify previously undiagnosed disease, reduces the
likelihood of the patient requiring a blood transfusion and therefore avoids
exposing them to the risks associated with transfusion and allows for the
treatment anaemia and modification of associated risks.
Both prospective and retrospective studies have looked at the effects of preoperative anaemia on patient outcome and have consistently shown that
patients with pre-operative anaemia have poorer post-operative outcomes
than non anaemic patients. Patients who were anaemic pre-operatively had
a higher rate of post-operative complications (37% vs. 22%) (Lasocki S et al
2015) with reduced admission Haemoglobin levels shown to have an impact
both on functional post-operative recovery and the quality of life of patients.
(Lawrence VA et al 2013), (Conlon NP 2008), (Kotze et al 2012).
Pre-operative anaemia of chronic disease is a strong independent risk factor
for Surgical site infection (Everhart JS, 2013) with Prosthetic joint infection
for patients shown to occur at an incidence of 4.3% compared to 2% in nonanaemic patients (Greenky M 2012).
Pre-operative anaemia has been shown to be an independent predictor for
the need for peri-operative allogeneic blood transfusion (Beattie et al) and
has also been found to be strongly predictive of morbidity and mortality.
(Sarhane and Flores 2013). This has been found to be true even in mildly
anaemic patients, increasing the relative risk of morbidity and mortality by
30-40% (Mussallam et al, 2015). Historically, management of pre-operative
anaemia has focussed on the use of blood transfusion. Allogeneic blood
transfusions have been associated with increased rates of infectious
complications, delay in wound healing, renal dysfunction and a longer
necessity for mechanical ventilation, all of which lead to increased length of
post-operative stays. Preoperative anaemia has been independently shown to
12
be linked to increased patient length of stay regardless of whether allogenic
transfusion took place. (Munoz, Gomez-Ramirez, Jose 2014)
Identification and Correction of pre-operative anaemia with the use of a well
defined Patient Blood management programme to improve outcomes can
lead to a reduction in peri and post-operative complications and improve
post-operative recovery. In addition the associated risks to the patient, costs
of extended care due to longer stays in hospital and potential requirement for
allogenic blood and associated risk would be reduced (Munoz, GomezRamirez, Campos 2014) (Litton 2013) (Carrascal 2010).
If allogeneic blood components can be avoided by adequately pre-optimising
patients pre-operatively, then the cost of blood component usage will be
reduced.
This will help make better use of resources, the donor pool and
ensure that blood is available for those patients where there are no
alternatives available (Vetter 2013)
Recognising and managing pre-operative anaemia aids overall risk reduction
by giving clinicians the opportunity to pre-optimise patients. This gives the
chance to reduce allogeneic blood use and potentially improve recovery from
surgery and reduce length of stays for patients (Clevenger and Richards
2015)
13
Conclusion and approvals
[Set out clearly the recommendation you are making to be approved]
Sign off
Name
Job role
Signature and date
Customer
representative
Transfusion
Practitioner
Consultant
Haematologist
HTC Chair
Pathology Manager
Finance Director
Chief Executive
Medical Director
Pharmacy Manager
Other
approvals
necessary (list)
14
as
Appendices
Appendix 1: Intravenous iron preparations licensed in the UK
[Prices taken from general NHS national prices as of 2014/15. Prices will be
available from commercial representatives or from Trust procurement
frameworks]

Ferinject (Ferric carboxymaltose) :o
Complex of ferric carboxymaltose containing 5% (50mg/mL) of
iron

o
Maximum single dose = 1000mg
o
Duration of infusion = 15 mins
o
Test dose needed : No
o
Cost: £154.23 (1x100mg), £405.88 (5x500mg)
Cosmofer (Iron dextran) :o
Complex of ferric hydroxide with dextran containing 5% (50mg/mL)
of iron

o
Maximum single dose = 1600mg
o
Duration of infusion = 6 hrs
o
Test dose needed : yes
o
Cost: £79.70 (2 x 10ml) £39.85 ( 5 x 2mls)
Venofer (Iron sucrose) :o
Complex ferric hydroxide with sucrose containing 2% (20mg/ml) of
iron.
o
Maximum single dose = 200mg
o
Duration of infusion = 1 hr
o
Test dose needed ; yes
o
Cost: £43.52 (5x100mg)
15

Monofer (Iron Isomaltoside 1000) :o
Complex
of
ferric
iron
and
isomaltoside
containing
10%
(100mg/mL) of iron
o
Maximum single dose = 1600mg
o
Duration of infusion = 1hr
o
Test dose needed : No
o
Cost: £339 ( 2 x 10ml) £423.75 (5 x 5ml) £84.75 (5 x 1ml)
Appendix 2: Patient Information
[Trust can develop own tailored patient information. Below are examples of
what is available for clinical staff to access and give to patients.]

Commercial iron preparations – contact suppliers for patient information
material

NHSBT Patient Information Leaflet – ‘What is Anaemia?’ and ‘Iron in your
diet’ http://hospital.blood.co.uk/

NHS Choices – Iron Deficiency Anaemia http://www.nhs.uk

Royal College of Nursing – Iron Deficiency Anaemia Nursing Guidelines
(June 2015) http://www.rcn.org.uk/
16
Appendix 3: HRG code/tariff
[See local coding department to ensure current and correct codes and
pricing]
HRG: SA04F
Description: Iron Deficiency Anaemia without CC
Sub-Chapter: SA: Haematological Procedures and Disorders
HRG Type: Core HRG
PbRYear: 2014/15
Combined EL/DC Tariff:
£294
Elective Tariff:
Daycase Tariff:
Non-Elective Tariff:
OPA Procedure Tariff:
Elective Trim:
Non-Elective Trim:
Excess Bed Day Tariff:
Short Stay Emergency Applies?:
Short Stay Emergency Tariff:
Spec Service Top-Ups Apply?:
£813
5
6
£236
No
Yes
HRG: SA04D
Description: Iron Deficiency Anaemia with CC
Sub-Chapter: SA: Haematological Procedures and Disorders
HRG Type: Core HRG
PbRYear: 2014/15
Combined EL/DC Tariff:
£417
Elective Tariff:
Daycase Tariff:
Non-Elective Tariff:
OPA Procedure Tariff:
Elective Trim:
Non-Elective Trim:
Excess Bed Day Tariff:
Short Stay Emergency Applies?:
Short Stay Emergency Tariff:
Spec Service Top-Ups Apply?:
£1,929
5
22
£236
No
Yes
17
References
Baron. D et al. Preoperative anaemia is associated with poor outcomes in
non-cardiac surgical patients. British Journal of Anaesthesia (2014) doi:
10.1093/bja/aeu098
Carrascal Y et al. Impact of preoperative anaemia on cardiac surgery in
octogenarians Interactive Cardiovascular and Thoracic Surgery 10 (2010)
249–255
Cladellas M, Jordi BrugueraJ et al. Is pre-operative anaemia a risk marker for
in-hospital mortality and morbidity after valve replacement? European Heart
Journal (2006) 27, 1093–1099
Clevenger B, Richards T. Pre-operative anaemia. Anaesthesia (2015) 70
(suppl. 1), 20-28
Conlon NP, Bale EP, Herbison GP, McCarroll M. Postoperative anaemia and
quality of life after primary hip arthroplasty in patients over 65 years old.
Anaesthesia Analg 2008; 106: 1056–61
Everhart JS, Calhoun JH. Ohio State University, Columbus, OH Everhart JS,
Calhoun JH. Ohio State University, Columbus, OH Preoperative Anaemia of
Chronic Disease is a Strong Independent Risk Factor for Surgical Site
Infection after Total Joint Arthroplasty. http://www.msis-na.org/annualmeetings/2013-annual-meeting/2013-program/320-preoperative-anemia-ofchronic-disease/
Goodnough L et al. Detection, evaluation, and management of preoperative
anaemia in the elective orthopaedic surgical patient: NATA guidelines. British
Journal of Anaesthesia 106 (1): 13–22 (2011)
doi:10.1093/bja/aeq361
Greenky M1 et al (2012) Preoperative anaemia in total joint arthroplasty: is
it associated with periprosthetic joint infection?
18
Kotze´A ,
Carter LA and Scally AJ Effect of a patient blood management
programme on preoperative anaemia, transfusion rate, and outcome after
primary hip or knee arthroplasty: a quality improvement cycle British Journal
of Anaesthesia 108 (6): 943–52 (2012) doi:10.1093/bja/aes135
Lasocki S, Krauspe R, von Heymann C, Mezzacasa A, Chainey S, Spahn DR.
PREPARE: the prevalence of perioperative anaemia and need for patient
blood
management
in
elective
orthopaedic
surgery:
A
multicentre,
observational study. European Journal of Anaesthesiology 2015;32:160-167.
Lawrence VA, Silverstein JH, Cornell JE, et al. Higher Hb level is associated
with better early functional recovery after hip fracture repair. Transfusion
2003; 43: 1717–22
Litton E, Xiao J, Ho K . Safety and efficacy of intravenous iron therapy in
reducing requirement for allogeneic blood transfusion: systematic review and
meta-analysis of randomised clinical trials. BMJ 2013;347:f4822
Muñoz
M,
Gómez-Ramírez
S,
Campos
A
Iron
Supplementation
for
perioperative anaemia in patient blood management. European Medical
Journal Haematology. 2014;1:123-132.
Muñoz M, Gómez-Ramírez S, García-Erce J Implementing Patient Blood
Management in major orthopaedic procedures: orthodoxy or pragmatism?
Blood Transfusion 2014; 12: 146-9 DOI 10.2450/2014.0050-14
Miceli A, Romeo F et al. Preoperative anaemia increases mortality and
postoperative morbidity after cardiac surgery. Journal of Cardiothoracic
Surgery 2014, 9:137
Musallam K, Tamim H, Richards T et al. Preoperative anaemia and
postoperative outcomes in non-cardiac surgery: a retrospective cohort study.
Lancet 2011; 378: 1396–407
19
Otto J et al. Association between preoperative haemoglobin concentration
and cardiopulmonary exercise variables: a multicentre study. Perioperative
Medicine 2013, 2:18
http://www.perioperativemedicinejournal.com/content/2/1/18
Sarhane K, Flores J et al. Preoperative Anaemia and Postoperative Outcomes
in Immediate Breast Reconstructive Surgery: A Critical Analysis of 10,958
Patients from the ACS-NSQIP Database Plasic
Reconstructive Surgery Global Open 2013;1:e30; www.PRSGO.com
Scott Beattie W ,Keyvan Karkouti K et al. Risk Associated with Preoperative
Anaemia
in
Noncardiac
Surgery:
A
Single-centre
Cohort
Study.
Anaesthesiology 2009; 110:574–81
Tian Y, Dixon A, Gao H (2012) Emergency Hospital Admissions for
ambulatory care-sensitive conditions: identifying the potential for reductions
(Data Briefing) The Kings Fund. London.
Tinegate H, (2014) National Survey Red Cell Use. NHSBT
VetterT. Tighten Your Belts! Reduce Your Transfusion Costs
with Preoperative Management of Anaemic Patients
International Anaesthesia Research Society 2013 Review course lectures: 5157 www.iars.org
Acknowledgements
o Leister University Hospital
o
Mid Essex Hospital NHS Trust
o
Kate Pendry, Consultant Haematologist, NHSBT
o
Vifor Pharma
o
NHSBT Patient Blood Management Practitioner Team
20