Public procurement notice: Prior Information Notice Without Call For Competition
Published: 2016-01-08
Buyer: University Hospitals Birmingham NHS Foundation Trust
Country: UK
Region: Birmingham
Contract type: Services
CPV classification: 85111200: Medical services | 85121200: Specialist medical services | 85145000 | 85148000
Estimated value: 50000 GBP

Technical requirements: University Hospitals Birmingham NHS Foundation Trust is calling for expressions of interest to this Prior Information Notice from suitably qualified service providers of tissue / human skin biopsies. This prior information notice is servicing three purposes: 1) To advise the market that the Trust will be tendering this project within the next 12 months. 2) To improve our knowledge of the market and its players and to have the opportunity to undertake early market engagement prior to the publication of the tender. 3) To undertake market testing before the publication of the tender documents The Trust currently has a contract in place for the provision of tissue / human skin biopsies until 31st March 2016 and it is envisaged that a new contract arrangement will be commissioned shortly after this date using standard NHS Terms and conditions. The Trust's estimated annual spend across this portfolio is between 50 000 GBP and 150 000 GBP per annum, depending on demand. These products/service are used by the Tissue Services department who are based within clinical division A of the Trusts structure. The Trust will be keen to engage with the market prior to publishing the tender discuss the opportunities for streamlining the order process, discuss cost saving opportunities, lean process implementation and added value options. We would request that all communication regarding this PIN publication is made either through the portal or via the Procurement department. No engagement should be made with the clinical staff at this point. Please ensure that you only express an interest if you can genuinely provide a tissue service providing human skin biopsies. Suppliers are asked to complete the attachment located in the e-procurement portal and return through the discussions area by DATE .It is the intention that engagement will be made with registered supplied within the next 35 days. Suppliers should follow the additional instructions within the e-procurement portal once they have logged in to this opportunity.
Holds a Human Tissue Authority (HTA) Licence granted under Regulation 7(1) and (2) and Schedule 2 of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 for procurement, testing and/or distribution of tissues and/or cells intended for human application and the storage of tissues and/or cells for human application
The HTA licence requires the company to have written agreements with any third parties procuring tissue, taking informed consent, taking blood samples for the purpose of testing for transmissible diseases detailed in HTA directions 003/2010, storing, packaging, labelling and transporting tissue
Holds a Medicines and Healthcare products Regulatory Authority (MHRA) — Manufactures Special Licence under EU GMP to supply Advanced Therapy Medicinal Products (ATMPs)
The company must be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture Advanced Therapy Medicinal Products (ATMPs) under the Manufactures Special Licence under Good Manufacturing Practice (cGMP)
MHRA regulations and HTA directions must be complied with regarding the retention of records and the notification of Serious Adverse Events and Serious Adverse Reaction and with the parent Directive, Article 5(1) and 6(1) of the Second Commission Directive and Regulation 15 of the Regulations regarding the identification, investigations, reporting, recording notification of serious adverse events and/or serious adverse reactions in accordance with Directions 003/2010
Couriers — HTA regulations — signed 3rd party agreements — delivered in a controlled manner — validated packaging.
The company must offer a secure, quality service which satisfies the conditions of the HTA/MHRA Licence.
Embedded and robust controlled quality management system in place which includes patient and product safety and describes the GMP of all activities i.e. processing, validated packaging, and labelling and transport distribution including signed 3rd party agreements with couriers.
The company must be responsible for receiving the tissue and maintaining traceability of all samples/documentation received for a period of 30 years.
A tender process may follow this Prior Information notice. The contracting authority considers that this contract may be suitable for economic operators that are small or medium enterprises (SME's). However, any selection of tenderers will be based solely on the criteria set out for the procurement of this contract in the event its is advertised.
University Hospitals Birmingham NHS Foundation Trust promotes equal opportunity and this is central to our aims and the delivery of the services.
This includes Racial, gender, Age and Disability Equality. Any Contracts awarded will commence following a full tendering process and evaluation of all tenders submitted.
Interested supplier must register on the ProContract e-procurement system at: https://www.supplying2nhs.com/procontract/healthservice/supplier.nsf in order to take part in the process.