Section 5

Response Requirements

1Introduction

The Tenderer must use the templates set out in the tables below to present its ITT Response to the Specification, Technical Requirements, Mandatory Information Requirements.

2Tenderers Response to the Specification

Tenderers Response to Section 3 - Specification - The requirements as stated within the Specification(s) are provided below. Tenderers are invited to respond to each requirement ensuring all points are answered in the right hand boxes. Responses should be in full and supported by evidence, allowing evaluators to gain a good understanding of how the Tenderer intends to provide and support the supply of custom procedure packs.
No / Specification Reference / Requirement / Response Requirement / Tenderers Response
1 / Section 3
Chapter 1
para. 1.1 / The Tenderer shall advise which packs they can provide / This detail shall be included within Section 6, Schedule 7 where each pack requires individual pricing / Pacing Pack
Cardio Pack
Manifold
Paediatric Cardio Pack
CVC Insertion Pack
Urinary Catheter Pack 1
Urinary Catheter Pack 2
2 / Section 3
Chapter 1
para. 1.2 / Sufficient packaging / Tenderer is to provide a statement that does not exceed 500 words detailing how the packs will be packaged / Packs will be contained in polythene bags that have a breathable strip that allows the passage of Ethylene Oxide gas for sterilisation. These are then packed in cardboard outer cases.
3 / Section 3
Chapter 1
para. 1.3 / Multiples / Tenderer is to advise in what multiples they intend to supply the packs and how they will be packaged / We have a range of 5 standard sizes of outer case. The size to be used is determined upon production of the first batch on the basis of best fit physically, to minimize waste. Accordingly, we are unable to provide this information at this time
4 / Section 3
Chapter 1
Para. 1.5 / Specifications / Tenderer is to provide full specification in the form of pdf/ drawing/catalogue for each individual item included within each pack. / Tendered to complete and attach documents where necessary to support their bid
5 / Section 3
Chapter 3
para. 3.1 / Sterilisation compliance / Tenderer is to provide a method statement that does not exceed 500 words that includes where the sterilisation process shall be carried out, and which standard it complies to / Sterilisation is carried out in accordance with ISO 17665-1 by:
Sterigenics UK Ltd.
Cotes Park Estate
Somercotes
Alfreton,
Derby DE55 4NJ
6 / Section 3
Chapter 4
para. 4.1 / Medical Directives Standards / Tenderer to confirm compliance with this requirement / Unisurge hold a Production Quality Assurance certificate issued by BSi copy enclosed

3 Tenderers Response to the Technical Requirements

Tenderers Response to Section 4 – Technical Requirements - The requirements as stated within the Technical Requirement(s) are provided below. Tenderers are invited to respond to each requirement ensuring all points are answered in the right hand boxes. Responses should be in full and supported by evidence, allowing evaluators to gain a good understanding of how the Tenderer intends to meet the Technical Requirements in the provision of the supply of custom procedure packs.
No / Technical Requirement Reference / Requirement / Response Requirement / Tenderers Response
1 / Technical Requirements Section A MR1 / Tenderers must comply with the Health & Safety at Work Act 1974 / Tenderers to confirm compliance an provide copy of Health & Safety Policy / Copy of operating procedure 1.1.11 enclosed
2 / Technical Requirements Section A MR2 / Tenderers must supply samples of each pack for which they are bidding / Tenderers must send samples clearly labelled to Joanne Stokes, Supplies Dept to Goods In at Royal Brompton / Samples to follow
3 / Technical Requirements Section A MR3 / Addition of new products shall be agreed in writing prior to introduction and any such proposals shall be made with at least three months notice / Tenderers to confirm compliance with this requirement / Compliance confirmed
4 / Technical Requirements Section A MR4 / Changes to the specification of packaging, quantity or format shall be notified three months in advance and any changes shall be subject to the written agreement of the Trust / Tenderers to confirm compliance with this requirement / Compliance confirmed
5 / Technical Requirements Section A MR5 / Prices quoted are to be fixed for the duration of the contract 2 years / Tenderers to confirm compliance with this requirement / Compliance confirmed
6 / Technical Requirements Section A MR9 / Tenderers shall be required to submit a report on a quarterly basis / Tenderers to confirm compliance with this requirement / Compliance confirmed
7 / Technical Requirements Section A MR10 / Qtrly contract review meetings will be required / Tenderers to confirm compliance with this requirement / Compliance confirmed
8 / Technical Requirements Section A MR11 / Details of complaints received within the last 12 mths / Tenderers to provide details of any customer complaints received within the last 12 mths to include how these complaints were dealt with and what corrective action was carried out, were any procedures amended etc. Not to exceed 500 words or a report can be provided / All quality issues are logged using our ASCF form as part of our complaints procedure. Each individual complaint is investigated and any outcome feedback to the customer. All complaints are then analysed as part of our management review meetings
9 / Technical Requirements Section A MR12 / Details of any product recalls within the last 12 mths / Tenderers to provide details including how the issue was originally identified, what % of overall products was recalled i.e. reject rate/PPM. What communication methods were used etc. Not to exceed 500 words / No recalls
10 / Technical Requirements Section A MR13 / Details of any internal quality issues/non-conformance issues within the last 12 mths / Tenderers to provide details, not to exceed 500 words. To include any procedure amendments or corrective action taken
11 / Technical Requirements Section A MR16 / Technical Support / Tenderers to provide a statement of how they intend to provide technical support including access to advice and information on a 24 hour basis / Technical support and advice is provided via our Customer Service team during normal office hours. Outside these times, the local Business Manager, Michael White, will provide support. Michael can be contacted on 07841 930820.
12 / Technical Requirements Section A DR1 / Sustainability Policy / Tenderers to provide details of their sustainability policy and also what actions have already been taken. Not to exceed 500 words. / Our sustainability policy is only at the draft stage, and no actions have been taken at the time of tendering. However, we do have the following statement:
Unisurge recognises the importance of the role it has to play in promoting principles of sustainability .
Unisurge will manage and control its environmental risks in a sustainable manner
by complying with relevant legislation and adopting where appropriate best practice.
Unisurge will also endeavour to integrate the principles of sustainability into its
strategies, policies and procedures.
13 / Technical Requirements Section A DR2 / Collection of Recyclable Packaging / Tenderers to provide details of this service. Not to exceed 500 words / This is a service that we currently provide to Harefield. We are happy to roll this out to other sites and a formal process will be agreed following contract award
14 / Technical Requirements Section A DR3 / Recycled and Recyclable Packaging / Tenderers to provide details of their ability to provide recycled or recyclable packaging, Not to exceed 500 words / Our outer cases are made using 33% re-cycled material. We are piloting a service using recyclable containers to replace outer cases
15 / Technical Requirements Section A DR4 / Carbon Footprint / Tenderer to provide details of what steps they have already taken to reduce it’s carbon footprint and also any future plans / We are piloting a service using recyclable containers to replace outer cases
16 / Technical Requirements Section A DR5 / Reduction in Packaging/Alternative Packaging / Tenderers to provide details of how they intend to reduce the amount of packaging where possible or suggest alternative packaging that is better for the environment/carbon footprint/more cost effective. Not to exceed 500 words / We are piloting a service using recyclable containers to replace outer cases

3.1In order to be considered for award of the contract Tenderers must:

Satisfy all of the Mandatory (MR) Requirements; and

Respond to all of the Mandatory Information Requests (MIR) listed in this Section 5

3.2The Trust reserves the right to reject any Tender in which a response to a MR is evaluated as not having been satisfactorily met or in which an MIR has not been satisfactorily addressed.

3.3A statement that a particular technical requirement will be met is not in itself sufficient. Such responses, or responses that are ambiguous, may be taken as failing to meet the Technical Requirement. Detailed information regarding how, when and to what extent a Technical Requirement can be met must be provided where appropriate – and, in evaluating a given requirement, scores will be awarded accordingly. Furthermore, if any technical requirement or part of a requirement cannot be met, this must be stated explicitly along with reason why.

3.4Where a Tenderer has already provided information to the Trust that addresses a specific technical requirement, this information should be re-stated in their Tender, not simply referenced.

4Tenderers Response to the Mandatory Information Requirements

4.1In addition to any information requested elsewhere the Tenderer must provide a Response to the following Mandatory Information Requirements.

Tenderers Response to Section 4 – Technical Requirements (Mandatory Information Requests) - The Mandatory Information Requirements as set out within the Technical Requirement(s) are provided below. Tenderers are invited to respond to each MIR ensuring all points are answered in the right hand boxes. Responses should be in full and supported by evidence, allowing evaluators to gain a good understanding of how the Tenderer intends to meet the MIRs.
No / Mandatory Information Requirements Reference / Mandatory Information Requirement / Tenderers Response
1 / Technical Requirement: MIR1 / Tenderers to provide details of the key risks involved in providing these goods and how they propose to mange those risks / Key risks and how they are managed are detailed in Operating Procedure 2.1.5 – copy enclosed
2 / Technical Requirement: MIR2 / For the proposed solution, detail the locations of proposed facilities, roles, responsibilities and relationships for all organizations involved in the delivery of your solution. This should include as a minimum details of the original manufacturers of the individual items, sterilization, packing, warehousing and distribution. / Details of each component manufacturer is detailed in Schedule 7. Packs are assembled in our Class 8 certified cleanroom in Sawston. Sterilisation is carried out using Ethylene Oxide gas by Sterigenics UK Ltd. Raw materials and finished goods are held in separate units in Sawston. Distribution is on our own transport.
3 / Technical Requirement: MIR3 / Tenderers to provide details not to exceed more than 500 words including what period is required between award of the contract and contract performance. Tenderers also to provide a contract implementation plan. Tenderers also to provide lead time details for each part of the supply chain i.e. for parts from manufacturer, packaging, sterilisation, quality checks, delivery etc. / Lead time from contract award to initial product availability is 6-8 weeks. This includes production planning time of 2 weeks, a lead time from manufacturer of 2 – 4 weeks, 1 week for production (including quality checks) and 1 week for sterilisation and delivery

Page 1