National Contract for the Supply and Maintenance of Equipment for

14/56
NHSBT BLOOD AND TRANSPLANT
22 MAY 2014
Title
NATIONAL CONTRACT FOR THE SUPPLY AND
MAINTENANCE OF EQUIPMENT FOR STERILE
CONNECTION OF TUBING BETWEEN BLOOD PACKS
Executive Summary
This paper sets out the contract recommendations for the
supply and maintenance of sterile connection equipment
and associated consumables. These are critical systems
used by manufacturing to produce key blood
components.
The recommendations are to award contracts for:
1. Equipment to Terumo BCT
2. Maintenance to Technopath
3. Consumables to Terumo BCT
Action requested
from Board
Strategic Priority,
Regulatory
Requirement or
Corporate Risk that
this item relates to
Organisational forums
where the paper (or
equivalent paper) has
been considered
Consultation and
Review
Equality and Diversity
Impact Assessment
The Board is asked to approve award of contracts as
recommended.
Blood Safety and Compliance
Efficiency and effectiveness
Executive Team
Marnie Watkins (Procurement)
John Spence (Finance)
Vaughan Sydenham (Finance)
Lucy Osmond (Finance)
Is a Full assessment required: N
Sustainability Impact
Assessment
Is a Full assessment required: N
Author
Michelle Ashford AD Manufacturing Development
Responsible Director
Clive Ronaldson
NED Reviewers
Shaun Williams and Keith Rigg
Page 1 of 9
NHSBT BLOOD AND TRANSPLANT
22 MAY 2014
NATIONAL CONTRACT FOR THE SUPPLY AND MAINTENANCE
OF EQUIPMENT FOR STERILE CONNECTION OF TUBING
BETWEEN BLOOD PACKS
EXECUTIVE SUMMARY
NHSBT is required, during various manufacturing processes, to connect different
blood packs and transfer packs together such that sterility is maintained and
bacterial contamination prevented, for example, during platelet production from
whole blood and washed red cell production. This connection procedure is
carried out using a sterile connection device which hot welds the two ends of
tubing together using a disposable copper wafer.
The existing contract for this technology, with Terumo BCT, expires at the end of
June 2014. A new OJEU tender was initiated by NHSBT on behalf of all the UK
Blood Services, and the Irish Blood Transfusion Service (IBTS).
Two responses have been received, from Terumo BCT for all three lots included
in the tender (equipment, maintenance and consumables), and from Technopath
for maintenance only.
Fresenius, who do manufacture a sterile connection device (SCD), did not
respond to the tender. The Fresenius machines have previously been used by
manufacturing departments in NHSBT but were removed and replaced by
Terumo systems due to the very high failure rates.
Following detailed assessment of the tender responses from both companies the
recommendation is to award a four year contract for supply of new machines and
consumables to Terumo BCT and the contract for maintenance of existing
machines to Technopath.
The total contract awards are valued at £7.6M as shown below. It should be
noted that there have been no price increases over the four years of the current
contract, for any of the tender lots. Although there have been significant price
increases in the new tender, the prices in all lots are fixed for the full four year
term of the new contract.
Capital costs of £1.1M. For new equipment the price increased by £2,200
to £12,940 per machine, an increase of 20.5% over four years. These
machines are robust and reliable and through careful maintenance
programmes NHSBT has increased life expectancy of these from the
recommended seven years to over ten. It is expected on this basis to
replace 83 machines over the term of the contract.
Page 2 of 9
Consumable costs of £5.8M. The consumable price increases by 6%,
from £1.31 per unit to £1.39. On the basis of expected usage over the
term of the contract this is an overall increase over the previous contract
of £332,000.
Maintenance costs of £0.7M. The maintenance price increases by 18%
from £1,071 to £1,260 per machine. On the basis that NHSBT has 140
machines that will require ongoing maintenance the impact is £107,000
over four years.
The number of machines in routine use is reviewed on an annual basis and
again when new processes are introduced to ensure that there is improved
utilisation of existing equipment, and that older machines are replaced on a need
only basis.
RECOMMENDATION
The Board is asked to approve the award four year contracts (with no
extensions) to the following suppliers:
1. The award of contract for new TSCD machines and consumables to
Terumo BCT
2. The award of contract for the maintenance of existing machines to
Technopath.
Page 3 of 9
1.
BACKGROUND
Sterile connection devices (SCD) are used to connect blood packs to additional
pack systems for secondary manufacture to enable the production of some blood
components. They are essential to the manufacture of whole blood derived
pooled platelets, cryoprecipitate, and some red cell components (e.g. washed
red cells). They are also required for the connection of sampling devices for
bacterial testing of finished platelet components.
They work by creating a sterile weld between compatible tubing of separate
blood pack systems which can be carried out by the machines in the open
workspace in manufacturing without the risk of environmental contamination to
blood components. These systems and processes have been extensively
validated as safe, the components produced, therefore, have a full shelf life.
Prior to availability of sterile connection systems secondary blood components
were produced using open systems that carried a high risk of contamination
reduced the shelf life of blood components produced to 24 hours only. Without
these sterile connection systems blood services would not be able to produce
many secondary blood components such as pooled platelets.
There are currently two manufacturers of these systems, Terumo and Fresenius.
NHSBT and most other blood services have used the Terumo devices
successfully for over 20 years. The Fresenius machines have been used by
manufacturing departments in NHSBT but were removed and replaced by
Terumo systems due to the very high failure rate of the welds leading to loss of
product and concerns over the bacterial safety of the system.
The Blood Supply Manufacturing Development team are actively working with
other manufacturers on the development of alternative solutions for sterile
connection systems, however, to date none have been produced that are safe,
effective and reliable. No other solution has been introduced to the market.
The tender for a new contract was initiated as three separate lots:
Equipment
Maintenance
Consumables
Terumo BCT responded for all three lots, and Technopath responded for the
maintenance contract only. Fresenius did not respond to the tender. Technopath
has operated as a third party supplier of the Terumo SCD (TSCD) equipment
and consumables for other UK Blood Services, however, this arrangement with
Terumo has ceased, but they are able to offer a robust maintenance programme
for this equipment.
Page 4 of 9
2.
PROCUREMENT
Contract Strategy
In line with the UK Government initiative on collaborative procurement all UK
Blood Services have been consulted and included as contract parties to this
agreement. In addition, it was agreed with other UK blood services i.e. Scottish
National Blood Transfusion Service (SNBTS), and Welsh Blood Service (WBS),
and in addition the Irish Blood Transfusion Service (IBTS), that NHSBT would
lead the tender process and they would accept our technical and commercial
decision. The Northern Ireland Blood Transfusion Service (NIBTS) declined to
join the tender process and may decide to join as beneficiary at a later date.
Procurement reviewed available procedures under the EU Procurement
Directives and considered the open procedure as the most appropriate for the
time available. Under the European Procurement Directives it is generally
accepted that four years is the term to contract with suppliers. As a result of
discussions with the tender evaluation panel, it was decided that in order to
encourage competition the tender be divided into three lots, i.e.
Lot 1 - Supply and Maintenance of New SCDs,
Lot 2 - Maintenance of Existing SCDs and
Lot 3 - Supply of Consumables for New and Existing SCDs.
Supplier Selection
As part of the tender response there were only two suppliers to respond i.e.
Technopath and Terumo BCT.
Evaluation Criteria and supplier assessments are shown in the table below.
Table one: Evaluation criteria and supplier assessments
Lot
Criteria Weighting
Technical General
Cost
(pass/fail) (pass/fail)
Supplier Score
Terumo Technopath
Lot one
30
20
50
72
Lot two
30
20
50
68
Lot three
12
25
55
70
82
Terumo and Technopath scored well on all sections with the exception of cost
where there are significant increases in costs from the previous contract.
Page 5 of 9
Of note regarding the maintenance element Technopath has committed to
service and repair all machines on site, and that they will continue to maintain
and service machines over ten years of age at the same price of £1,260 per
machine per annum. Terumo has increased their maintenance costs for
machines over seven years and require all machines for repair to be returned to
Belgium.
External Validations and Quality Audits
Good Manufacturing Practice (GMP) and Business Continuity audits were carried
out at Terumo BCT by Head of Business Continuity Management and NHSBT s
Quality Project Specialist. Terumo BCT has demonstrated that their processes
are controlled under a well established quality management plan. As a sole
provider of TSCD wafers and equipment to NHSBT, the supplier has presented
evidence of a corporate risk management programme, and a full assessment has
been carried out on the risks to the activities provided. Full operational
validations will occur upon installation of new equipment utilising validation
protocols fully approved by NHSBT Quality.
3.
TERMS AND CONDITIONS
NHS Terms and Conditions, including termination, will govern the contract.
The monitoring of the overall performance of the suppliers will be managed by a
nominated manufacturing manager, and all details of servicing, breakdown and
repair will be recorded in the NHSBT Quality System (Q-Pulse). This allows the
lead customer to check for related faults, poor delivery or servicing.
If the lead customer is not satisfied with the performance of the equipment, the
delivery of the maintenance or the consumables the contract allows NHSBT six
monthly contract review meetings. These will be facilitated by the procurement
lead for this contract.
Page 6 of 9
4.
FINANCIAL INFORMATION
There are three separate financial elements:
Cost of Consumables
Cost of Annual Maintenance
Cost of New TSCD Machines
Cost of consumables (Terumo)
NHSBT s expected usage volumes of TSCD wafers over the period of the
contract is 4.15M.
Table Two: Expected Volumes by Contract Year.
Year 1
Year 2
Year 3
Year 4
Total
898,042 997,214 1,123,969 1,132,386 4,151,612
These consumable volumes would result in a unit cost (per wafer) of £1.39, an
increase of £0.08 (6.1%) on the previous contract; this would be an additional
cost of £332,000 over the four year period of the contract.
Table Three: Consumable Costs per Financial Year (£ 000s)
Volume
New Contract
Price
(£1.39/unit)
Old Contract
Price
(£1.31/ unit)
Additional Cost
2014/2015
2015/2016
2016/2017
2017/2018
2018/2019
Total
£ 000
£ 000
£ 000
£ 000
£ 000
£ 000
659,127
955,660
1,121,878
1,130,244
284,703
4,151,612
916
1,328
1,559
1,571
396
5,771
863
1,252
1,470
1,481
373
5,439
53
76
90
90
23
332
Notes:
Volumes in 2014/2015 and 2018/2019 reflect part year effect
Increases in volumes due to implementation of platelet additive solution
(PAS) from October 2015, and increasing number of whole blood derived
platelets year on year.
Reduction in use due to implementation of new bacterial screening
sampling system from June 2014
Volumes based on latest demand planning forecast, including divestment
of North Wales
Page 7 of 9
Cost of goods by inflation has increased by 12.4% since the award of the
previous contract (2010). Increase in tender price of 6% is on the basis of
a fixed cost over the four year period of the contract.
Cost of Annual Maintenance (Technopath)
NHSBT currently has 141 Terumo Sterile Connecting Devices (TSCD) that
require annual maintenance. Under the new contract the annual price of
maintenance per machine would be £1,260 an increase of £189 or 18%. The
total additional cost to NHSBT would be £107,000 over the life of the contract.
Table Four: Maintenance Costs Per Financial Year (£ 000s)
2014/2015
2015/2016
2016/2017
2017/2018
2018/2019
Total
£ 000
£ 000
£ 000
£ 000
£ 000
£ 000
No. of
Machines
141
141
141
141
141
141
New Contract
(£1,260/unit)
133
178
178
178
44
711
Old Contract
(£1,071/unit)
113
151
151
151
38
604
20
27
27
27
6
107
Additional cost
Cost of New TSCD Machines (Terumo)
Under the proposed contract the capital cost to purchase a new TSCD II
machine has increased by £2,200 to £12,940, an increase of 20.5%. The
potential total cost to the NHSBT is dependant on how many machines are
replaced in the contract period. The machines are under warranty for two years,
and would not attract maintenance charges in the warranty period.
These machines have proven to be very robust and from operational experience
they are expected to have a usable life for at least ten years. On this basis it
would be expected to replace approximately 83 machines over the life of the
contract. The estimated capital requirement is £1.1M. In addition the number of
machines in use is reviewed annually, during capital planning, to ensure that all
machines are fully and appropriately utilised.
Page 8 of 9
5.
IMPLEMENTATION
There are no implementation issues with these machines as they are currently in
use throughout NHSBT. All new machines and those that have been serviced or
repaired would be subject to appropriate re-validation prior to re-introduction into
routine use.
6.
RISK MANAGEMENT
No specific risks have been identified as a result of this contract.
7.
EXPERIENCE AND TRACK RECORD
Terumo
Terumo BCT, a global leader in blood component and cellular technologies, is
the only company with the unique combination of apheresis collections, manual
and automated whole blood processing, and pathogen reduction coupled with
leading technologies in therapeutic apheresis and cell processing.
Terumo BCT has been a supplier to NHSBT since 2001, with a good record of
performance against agreed KPIs.
Technopath
Technopath initially focused on the clinical diagnostic and food technology
markets, the company has grown exponentially to become a market leading
supplier across the Healthcare and Biotechnology sectors. As part of this
development they have transitioned from a third party supplier to one which,
develops and manufactures market driven and solution led technologies in their
customers.
Technopath have not been a supplier to the NHSBT previously but are currently
sole suppliers of TSCDs and consumables to the Irish Blood Transfusion Service
(IBTS) Scottish National Blood Transfusion Service (SNBTS), with a good record
of performance.
Clive Ronaldson
Director of Blood Supply
Michelle E. Ashford
Assistant Director Manufacturing Development
May 2014
Page 9 of 9

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