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