Directive 2014/24/EU - Public Sector Directive
Section I: Contracting Change
I.1) Name and addresses
I.1) Name and addresses
I.1) Name and addresses
I.2) Joint procurement
The contract involves joint procurement
The procurement documents are available for unrestricted and full direct access, free of charge at:
Additional information can be obtained from the abovementioned address
Tenders or requests to participate must be sent electronically to:
I.4) Type of the contracting authority
Body governed by public law
I.5) Main activity
Section II: Object
II.1) Scope of the procurement
NHS Scotland PET CT Isolators
Reference number: NP194/19
II.1.2) Main CPV code
II.1.3) Type of contract
II.1.4) Short description
NHS National Services Scotland (NSS) have commissioned the implementation of gallium-68 PET/CT imaging services in 4 Health Boards across Scotland: Lothian; Grampian; Tayside and Greater Glasgow and Clyde (GGC). This procurement is to procure two (2) Gallium-68 Isolators, to be located, one (1) each, within Lothian Health Board and Tayside Health Board.
II.1.5) Estimated total value
Value excluding VAT: 190 000.00 GBP
II.1.6) Information about lots
This contract is divided into lots:
II.2.2) Additional CPV code(s)
II.2.3) Place of performance
Main site or place of performance:
One Gallium-68 isolator will be installed in each of: Royal Infirmary of Edinburgh, Edinburgh, and Ninewells Hospital, Dundee.
II.2.4) Description of the procurement
NHS National Services Scotland (NSS) have commissioned the implementation of gallium-68 PET/CT imaging services in 4 Health Boards across Scotland: Lothian; Grampian; Tayside and Greater Glasgow and Clyde (GGC). Gallium-68 (Ga68) is now the gold standard for the detection and localisation of neuroendocrine tumours (somatostatin receptor imaging) and is an emerging prospect for improved prostate cancer imaging.
The location of the Ga68 manufacturing and dispensing service in each Health Board will differ, depending on local requirements, however each Health Board will be required to dispense Ga68 radiopharmaceuticals in an appropriately shielded clean air device, such as an isolator, hot cell or biological safety cabinet that meets the requirements of a Grade A environment, as stipulated in the European Commission’s Guidance for Good Manufacturing Practice (EU GMP), Annex 1.
Gallium-68 for use in the preparation of Ga68-radiopharmaceuticals can be generated from a Ga68 generator or a cyclotron, with each Health Board having a preference for how they will generate Ga68 to provide the service to their patients.
NHS Scotland has commissioned the procurement of PET isolators for the dispensing of Ga68-radiopharmaceuticals in up to 4 centres across Scotland. The isolator must provide sufficient radiation protection to ensure the radiation dose to operators is as low as reasonably practicable (ALARP), while providing a sterile environment to protect the patient against microbial contamination in their dose.
This procurement exercise is to procure two (2) isolators, suitable for handling Ga68, and other PET isotopes, which will be located, one (1) each, within Lothian Heath Board (at Royal Infirmary of Edinburgh, Edinburgh) and Tayside Health Board (at Ninewells Hospital, Dundee).
II.2.5) Award criteria
Quality criterion: Technical
/ Weighting: 60
Cost criterion: Cost
/ Weighting: 40
II.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 12
This contract is subject to renewal: No
II.2.9) Information about the limits on the number of candidates to be invited
II.2.10) Information about variants
Variants will be accepted:
II.2.11) Information about options
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
Section III: Legal, economic, financial and technical information
III.1) Conditions for participation
III.1.2) Economic and financial standing
Minimum level(s) of standards required:
The following list provides details of the sections within the European Single Procurement Document (ESPD) that must be completed. The ESPD is located within the ITT_29158 NHS Scotland PET CT Isolators.
4B.1.1 Contractors will be required to have a minimum “general” yearly turnover of 380 000 GBP for the last 3 years.
4B.2.1 Contractors will be required to have a minimum yearly turnover of 380 000 GBP for the last 3 years in the business area covered by the contract.
4B.5.1/4B.5.2 It is a requirement of this contract that contractors hold, or can commit to obtain prior to the commencement of any subsequently awarded contract, the types and levels of insurance indicated below:
— Employer’s (Compulsory) Liability Insurance = 5 000 000 GBP.
— Public Liability Insurance = 10 000 000 GBP.
— Product Liability Insurance = 10 000 000 GBP.
III.1.3) Technical and professional ability
Minimum level(s) of standards required:
The following sections within the ESPD must be completed.
All tendered services and products must fully comply with the NHS Requirement in the tender documents.
4C.1.2 Contractors will be required to provide examples that demonstrate that they have the relevant experience to deliver the services/supplies as described in part II.2.4) of the OJEU Contract Notice.
4C.2 Contractors will be required to confirm details of the technicians or technical bodies who they can call upon, especially those responsible for quality control.
4C.8.1 Contractors will be required to confirm their average annual manpower for the last 3 years.
4C.8.2 Contractors will be required to confirm their number of managerial staff for the last 3 years.
4C.10 Contractors will be required to confirm whether they intend to subcontract and, if so, for what proportion of the contract.
4C.12 If awarded to the Contract Potential Contractors must provide evidence that tendered products are CE marked. Evidence should be in the form of certification issued by a notified body.
4D.1 Quality Management Procedures.
1) The contractor must hold a UKAS (or equivalent) accredited independent third party certificate of compliance in accordance with BS EN ISO 9001 (or equivalent), or
2) The contractor must have the following:
(a) a documented policy regarding quality management. The policy must set out responsibilities for quality management demonstrating that the contractor has and continues to implement a quality management policy that is authorised by their Chief Executive, or equivalent, and is periodically reviewed at a senior management level. The policy must be relevant to the nature and scale of the work to be undertaken and set out responsibilities for quality management throughout the organisation,
(b) documented procedures for periodically reviewing, correcting and improving quality performance including processes for ensuring that the contractor’s quality management is effective in reducing/preventing incidents of sub-standard delivery, this must include the quality of output and general performance,
(c) a documented process for ensuring that quality management is effective in reducing/preventing incidents of sub-standard delivery, this must include the quality of output and general performance. The contractor must be able to provide copies of their organisation’s documentation procedures, that meet current agreed good practice. These must include the arrangements for quality management throughout the contractor’s organisation. They must set out how the contractor’s organisation will carry out its policy, with a clear indication of how the arrangements are communicated to the workforce,
(d) documented arrangements for providing the contractor’s workforce with quality related training and information appropriate to the type of work for which this organisation is likely to bid. This will demonstrate that the organisation has in place and implements training arrangements to ensure that its workforce has sufficient skills and understanding to discharge their various responsibilities. These must include a programme of training that will keep the workforce up to date with required knowledge about quality related issues, including copies of job profiles; training manuals and records,
(e) documented arrangements that your organisation has a system for monitoring quality management procedures on an on-going basis. The contractor’s organisation must be able to provide evidence of systematic, periodic review and improvement of quality in respect of output and general performance,
(f) documented arrangements for ensuring that the contractors apply quality management measures that are appropriate to the work for which they are being engaged,
(g) a documented process demonstrating how the contractor deals with complaints. The contractor must be able to provide details of how their organisation maintains records of any complaints received and how corrective measures are carried out to prevent reoccurrence.
III.2) Conditions related to the contract
III.2.2) Contract performance conditions
Included in the Procurement documents.
Section IV: Procedure
IV.1.1) Type of procedure
IV.1.8) Information about Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement:
IV.2) Administrative information
IV.2.2) Time limit for receipt of tenders or requests to participate
Local time: 12:00
IV.2.4) Languages in which tenders or requests to participate may be submitted
IV.2.6) Minimum time frame during which the tenderer must maintain the tender
Duration in months: 3 (from the date stated for receipt of tender)
IV.2.7) Conditions for opening of tenders
Local time: 12:00
Section VI: Complementary information
VI.1) Information about recurrence
This is a recurrent procurement:
VI.2) Information about electronic workflows
Electronic ordering will be used
VI.3) Additional information
While the Authority is conducting this Procurement Exercise, the intention upon award of contract is that both Lothian Health Board and Tayside Health Board will place a purchase order with the successful contractor for the supply of their specific requirements.
The estimated Contract value entered at Section II.1.5) is based on the supply, installation and warranty under the Contract.
The buyer is using PCS-Tender to conduct this ITT exercise. The project code is 13240. For more information see: http://www.publiccontractsscotland.gov.uk/info/InfoCentre.aspx?ID=2343
(SC Ref: 578207)
VI.4) Procedures for review
VI.4.1) Review body
The Common Services Agency (more commonly known as NHS National Services Scotland) ("NSS")
Gyle Square (NSS Head Office), 1 South Gyle Crescent
Telephone: +44 1698794540
VI.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 notification has previously been made) applied to be selected to tender, of its decision to award the contract agreement which notification will contain among other information, a summary of the reasons why the economic operators was unsuccessful. The notification will incorporate a “standstill period” of a minimum of 10 clear calendar days (or a minimum of 15 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 contract agreement. The bringing of court proceedings against the authority during the standstill period will automatically continue the prohibition on entering into the contract agreement until the court proceedings are determined, discontinued or disposed of, or the court, by interim order, brings to an end the prohibition. The remedies that may be awarded by the courts before the contract 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 may be awarded by the courts where the contract agreement has been entered into are limited to the award of damages.
VI.5) Date of dispatch of this notice