DOC 7 SPECIFICATION

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Framework Agreement for the Supply of Licensed Intravenous Nutrition Product for Trusts Within the Yorkshire and Humber
NHS Pharmaceuticals Purchasing Consortium
Tender: 9LND-SBFYWN
OJEU Reference: 2014/S 168-298778
Period of Contract: 2 years with an option to extend for up to a further 2 years commencing 1st February 2015
DOCUMENT 7
SPECIFICATION
1. Background
1.1. The Yorkshire and Humber NHS Pharmaceuticals Purchasing Consortium has
membership from acute Trusts in the Yorkshire and Humber Strategic Health
Authority. Consortium members are listed in Appendix 1.
1.2. Consortium Trusts are responsible for the care of adult and paediatric patients who
require intravenous nutrition (IVN) in hospital.
1.3. The Consortium is tendering for the provision of licensed multi-chamber intravenous
nutrition bags, licensed components of intravenous nutrition (such as amino acid
solutions and lipid emulsions), intravenous multivitamin, trace element and
electrolyte products, and consumables such as containers for intravenous nutrition.
1.4. The annual total value of the framework agreement is estimated as £1.3M.
1.5. Consortium annual usage of multi-chamber bags in 2013/14 is estimated as 29,000.
2. Service proposals
A. Adult, paediatric and neonatal IVN
2.1. The Consortium provides the majority of adult inpatient IVN using licensed multichamber bags. A smaller number of IVN patients per year will require ‘custom’ IVN
regimen prepared by Trust pharmacy departments using IVN components in bottles
or bags, (eg, amino acid solutions, glucose solutions, and lipid emulsions).
2.2. The successful contractors must be able to demonstrate a proven track record in the
provision of licensed IVN products in the UK.
2.3. The majority of paediatric and neonatal IVN will be supplied using IVN components
licensed for use in neonates and children.
2.4. A smaller number of paediatric patients may be suitable for infusion of one or more
of the licensed multi-chamber bags.
2.5. Clinical acceptability is an important factor in deciding between suppliers of IVN
products. Factors that have been identified by the Consortium’s project group
include: innovation in product development, completeness of range of products, and
identification of specific products with perceived patient benefits. Contractors are
requested to consider clinical acceptability in their tender submissions.
B. Automated IVN compounding equipment
2.6. Some Consortium member Trusts use BAXA automated compounding machines in
the aseptic preparation of IVN.
2.7. The tender allows contractors to submit prices for the provision of BAXA equipment
(now marketed by Baxter) used on BAXA compounding machines.
3. IVN Compatibility and Stability Data
3.1. Compatibility information must be available for all licensed multi chamber bags and
for all potential combinations of IVN components, using either only the contractor’s
or both the contractor’s and competitor’s IVN component products.
3.2. Compatibility information must be available for the following additives. Ideally expiry
should be greater than 24 hours and ideally 7 days or more:
3.2.1. Trace Elements: zinc, selenium, magnesium, iron, and commercial licensed
trace element products;
3.2.2. Electrolytes: sodium, potassium, calcium, magnesium, and phosphate;
DOCUMENT 7
Framework Agreement for the Supply of Licensed Intravenous Nutrition Product for Trusts Within the Yorkshire and Humber
NHS Pharmaceuticals Purchasing Consortium
Tender: 9LND-SBFYWN
OJEU Reference: 2014/S 168-298778
Period of Contract: 2 years with an option to extend for up to a further 2 years commencing 1st February 2015
3.2.3. Ranges of stability for all trace elements and electrolytes must be stated for all
regimens;
3.3. Access to stability information must be available 5 days a week during normal
working hours, defined as 8am to 5pm. Written confirmation of stability must be
available within 2 hours of a telephone enquiry.
3.4. The contractor must work with IVN compounding software suppliers to provide
information required to accommodate the products on the pharmacy parenteral
nutrition computer systems used by Consortium member Trusts (for example
specific gravity, osmolarity)
4. Labelling
4.1. Labels on components used in compounding should include a unique bar code
capable of being read by bar code reader on automated parenteral nutrition
compounder (such as the Baxa “EM 2400” compounder)
5. Ordering and Delivery
5.1. Supplies must be available within three working days of placing the order.
5.2. An option for twice weekly placement of orders must be available if needed.
5.3. Deliveries will be flexible to meet the Consortium member Trusts’ needs.
5.4. Vehicles must be suitably equipped for the transportation and delivery of
medicines.
5.5. There must be a validated cold chain delivery system in place, for items that
require refrigerated storage.
5.6. The outer container must comply with Health and Safety regulations on lifting
heavy goods.
5.7. The outer boxes of products must be clearly labeled on the outside of the box with
the contents, quantity, expiry date and storage conditions of products therein.
5.8. The contractor must be able to demonstrate the suitability of the transport
arrangements to ensure that the integrity of the product is not compromised.
Particular attention must be paid to the provision of a validated cold chain from
manufacture to delivery.
5.9. The contractor shall be responsible for ensuring security of delivery to the
appropriate delivery point.
5.10. In the event of leakage from the licensed multi-chamber bags on delivery or where
the integrity of the product is compromised in any way, the Consortium member
Trust will contact the Supplier who will be responsible for stock replenishment at
no additional charge to the Purchaser.
5.11. The contractor is responsible for obtaining a signature against the delivery note to
confirm a complete delivery.
5.12. Any product usage/delivery discrepancies should be reported immediately to the
Purchaser’s pharmacy department and steps taken to rectify the error, ensuring
that patient safety is not compromised.
6. Failure to Supply
6.1. The contractor shall manufacture and deliver the exact quantity as ordered within
the agreed time. In the event that the contractor is unable to supply in full or in part a
prescribed product the Purchasing Authority must be informed immediately to agree
alternative arrangements.
7. Implementation of the Framework agreement
7.1. The implementation of the framework agreement must be in agreement of the
Purchaser’s nutrition teams and be handled in a staged process as agreed with the
DOCUMENT 7
Framework Agreement for the Supply of Licensed Intravenous Nutrition Product for Trusts Within the Yorkshire and Humber
NHS Pharmaceuticals Purchasing Consortium
Tender: 9LND-SBFYWN
OJEU Reference: 2014/S 168-298778
Period of Contract: 2 years with an option to extend for up to a further 2 years commencing 1st February 2015
Consortium’s regional medicines contracting team based at Leeds Teaching
Hospitals NHS Trust.
7.2. A proposed implementation/change management plan must be submitted by
Contractors.
8. Pricing Schedules (refer to documents 6A and 6B)
8.1. Consortium annual usage of multi-chamber bags in 2013/14 is estimated as 29,000.
8.2. Contractors are required to submit prices based on a percentage share of the
estimated Consortium annual total usage of multi-chamber bags (see price
submission matrix for each contractor in Document 6A).
8.3. The pricing matrix includes pricing bands above the current estimated Consortium
annual usage of multi-chamber bags to allow for growth in product usage over the
duration of the framework agreement.
8.4. Contractors are required to complete and submit the relevant pricing schedule
8.5. An “equivalence” spreadsheet must be fully completed by Contractors (see
Document 6B); instructions for completion are on the spreadsheet. Cost
comparisons produced during the tender analysis period will be based on the
information provided.
DOCUMENT 7
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