Section one: Contracting authority
one.1) Name and addresses
The Common Services Agency (more commonly known as NHS National Services Scotland) ("NSS")
Gyle Square (NSS Head Office), 1 South Gyle Crescent
Edinburgh
EH12 9EB
Contact
Brian Roach
Telephone
+44 7966214573
Country
United Kingdom
NUTS code
UKM - Scotland
Internet address(es)
Main address
http://www.nss.nhs.scot/browse/procurement-and-logistics
Buyer's address
https://www.publiccontractsscotland.gov.uk/search/Search_AuthProfile.aspx?ID=AA11883
one.2) Information about joint procurement
The contract is awarded by a central purchasing body
one.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at
https://www.publictendersscotland.publiccontractsscotland.gov.uk
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
https://www.publictendersscotland.publiccontractsscotland.gov.uk
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Supply of Cochlear Implants
two.1.2) Main CPV code
- 33185200 - Cochlear implant
two.1.3) Type of contract
Supplies
two.1.4) Short description
This requirement is for the purchase, provision and support of Cochlear Implants, Sound Processors and associated accessories for NHSS.
two.1.5) Estimated total value
Value excluding VAT: £13,500,000
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.3) Place of performance
NUTS codes
- UKM - Scotland
Main site or place of performance
All entities constituted pursuant to the National Health Service (Scotland) Act 1978, (i.e. all NHS Scotland Health Boards
two.2.4) Description of the procurement
This requirement is for the purchase and provision of Cochlear Implants, Sound Processors and associated accessories for NHSS.
two.2.5) Award criteria
Quality criterion - Name: Implementation & Product Support / Weighting: 25
Quality criterion - Name: Customer Service / Weighting: 5
Price - Weighting: 70
two.2.6) Estimated value
Value excluding VAT: £13,500,000
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
36
This contract is subject to renewal
Yes
Description of renewals
2 (Two) optional extension period, each of 12 (twelve) months in duration
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section three. Legal, economic, financial and technical information
three.1) Conditions for participation
three.1.2) Economic and financial standing
List and brief description of selection criteria
Minimum level(s) of standards required:
(1)All candidates will be required to provide a statement, covering the 3 previous financial years including the overall turnover of the
candidate in respect of the activities which are similar type to the subject matter of the notice.
(2)All candidates will be required to provide statement of accounts or extracts relating to their business. See contract/tender documentation which incorporates the requirements of the SPD(Scotland)and the financial period of reporting is the previous 3 financial years.
Employer's (Compulsory) Liability Insurance of 2 million pounds sterling (This requirement relates to SPD 4B.5.1a) and
-
Public Liability Insurance of 5 million pounds sterling (This requirement relates to SPD 4B.5.1b)
three.1.3) Technical and professional ability
Minimum level(s) of standards possibly required
1. Compliance with BS EN ISO 13485 or equivalent for Quality Management.
2. Compliance with BS EN ISO 14708 or equivalent for Implants for Surgery (active implantable medical devices).
3. Tendered products are CE marked
4. Declaration of implant or sound processor refused approval by any worldwide regulatory body.
5. Provision of technical specifications for the receiver stimulator package, including dimensions, weight and materials etc.
6. Provision of information on safety features as a minimum: biocompatibility, impact resistance, hermetic sealing, max. current density, DC leakage, controlled delivery of stimulation.
7. Provision of technical specifications for the electrode array, including as a minimum dimensions, number of physical contacts, description of contacts, spacing of contacts, markers, ground electrode.
8. Provision of technical specifications for electrical stimulation, including as a minimum modes of stimulation, current amplitude, pulse width, stimulation rates (overall and per channel), input dynamic range, telemetry.
9.Provision of technical specifications for the sound processor, including as a minimum dimensions, weight and materials together with a picture or diagram. Details must also include wearing options and accessories including remote controls, adapters and lapel microphones
10. Evidence a proven track record in worldwide clinical use in both adults and children. Candidates will be required to provide numbers of adults and children implanted with each version of the cochlear Implant both in the UK and worldwide (annually).
11. Declaration to support cochlear implant users throughout their lifetime. This should include plans for the ongoing support of existing patients using older technology (implants and processors), backwards compatibility of new sound processors with previous generations of cochlear implants, worldwide support (should the patient move overseas) and details of contingency plans in the case of the company ceasing to trade.
12. Reliability data must be provided for each cochlear implant device that is currently commercially available, providing definitions for any terms used e.g. device failure, survival time, clinical benefit, reduced clinical benefit etc.
13. Provision of at least two (2) Demonstration Kits free of charge "FOC" when a new device is launched.
14. Provision of appropriate written information, online resources and inhouse training for staff at the Scottish Cochlear Implant programme to ensure that they are adequately informed and knowledgable in the management of all implants and sound processors that they provide. In particular when new products become available (including software).
15. Information for counselling patients pre-implant and instruction manuals for Adults and young cochlear implant recipients on the use of sound processor and its accessories must be user friendly and provided in an accessible format (e.g. quick refrence guides, booklet, DVD, online resources, helplines etc.) Provision in other languages is also desirable.
16. Rehabilitation tools / resources should be available for implant centre staff CI recipients or for recipients to use themsleves in their own homes (including online resources).
17. Confirm adherence to UK GDPR guidelines and provide any applicable documentation relating to this standard
18. Evidence of measures taken to ensure IT systems cyber security conforms to UK GDPR on a rolling basis.
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
four.1.3) Information about a framework agreement or a dynamic purchasing system
The procurement involves the establishment of a framework agreement
Framework agreement with several operators
Envisaged maximum number of participants to the framework agreement: 4
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
four.2) Administrative information
four.2.2) Time limit for receipt of tenders or requests to participate
Date
27 September 2021
Local time
12:00pm
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.6) Minimum time frame during which the tenderer must maintain the tender
Tender must be valid until: 27 December 2021
four.2.7) Conditions for opening of tenders
Date
27 September 2021
Local time
12:00pm
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: No
six.2) Information about electronic workflows
Electronic ordering will be used
Electronic invoicing will be accepted
Electronic payment will be used
six.3) Additional information
The buyer is using PCS-Tender to conduct this ITT exercise. The Project code is 19287.
For more information see:
http://www.publiccontractsscotland.gov.uk/info/InfoCentre.aspx?ID=2343
The buyer is using PCS-Tender to conduct this ITT exercise. The Project code is 19287. For more information see: http://www.publiccontractsscotland.gov.uk/info/InfoCentre.aspx?ID=2343
(SC Ref:664884)
six.4) Procedures for review
six.4.1) Review body
Sheriff Court House
27 Chambers Street
Edinburgh
EH1 1LB
Country
United Kingdom
Internet address
http://www.nhsscotlandprocurement.scot.nhs.uk/
six.4.3) Review procedure
Precise information on deadline(s) for review procedures
The Authority will notify economic operators who submitted a tender or(where no deselection process has previously been made)applied to be selected to tender, of its decision to award the Framework Agreement which notification will contain, among other information, a summary of the reasons as to why the economic operator was unsuccessful. The notification will incorporate a ‘standstill period’ of a minimum of 10(ten) clear calendar days (or a minimum of 15(fifteen)if the communication method used is not electronic) between the date on which the Authority dispatches the notice(s)and the date on which the Authority proposes to conclude the relevant Framework Agreement. The bringing of court proceedings against the Authority during the standstill period will automatically continue the prohibition on entering into the Framework Agreement until the court proceedings are determined, discontinued or disposed of, or the court, by interim order, brings to amend the prohibition. The remedies that may be awarded by the courts before the Framework Agreement has been entered into include the setting aside of the decision to award the Framework Agreement to the winning tenderer(s). The bringing of court proceedings against the Authority after the Framework Agreement has been entered into will not affect the Framework Agreement unless grounds for the imposition of special penalties under the Public Contracts (Scotland) Regulations 2015 can be established. Otherwise the remedies that maybe awarded by the courts where the Framework Agreement has been entered into are limited to the award of damages.