Tender for Bone Cement Products

Tender for Bone Cement Products

Supply of Orthopaedic Bone Cement and related products. Scope includes all Bone Cements and Mixing Systems, Pulse Lavage Systems and related Accessories such as plugs, restrictors, spacers and pressurisers to all entities constituted pursuant to the National Health Service (Scotland) Act 1978, (ie all NHS Scotland Health Boards, Special Health Boards and the Authority).

UK-Edinburgh: orthopaedic supplies

2012/S 202-332164

Contract notice

Supplies

Directive 2004/18/EC

Section I: Contracting authority

I.1)Name, addresses and contact point(s)

The Common Services Agency (commonly known as NHS National Services Scotland) (“Authority”)
Gyle Square (NSS Head Office), 1 South Gyle Crescent
For the attention of: Brian Roach
EH12 9EB Edinburgh
UNITED KINGDOM
Telephone: +44 1312757620
E-mail: brian.roach@nhs.net

Internet address(es):

General address of the contracting authority: http://www.nhsscotlandprocurement.scot.nhs.uk/

Address of the buyer profile: http://www.publiccontractsscotland.gov.uk/search/Search_AuthProfile.aspx?ID=AA11883

Further information can be obtained from: The Common Services Agency (commonly known as NHS National Services Scotland) (“Authority”)
Gyle Square (NSS Head Office), 1 South Gyle Crescent
For the attention of: Brian Roach
EH12 9EB Edinburgh
UNITED KINGDOM
Telephone: +44 1312757620
E-mail: brian.roach@nhs.net
Internet address: http://www.nhsscotlandprocurement.scot.nhs.uk/

Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained from: The Common Services Agency (commonly known as NHS National Services Scotland) (“Authority”)
Gyle Square (NSS Head Office), 1 South Gyle Crescent
For the attention of: Brian Roach
EH12 9EB Edinburgh
UNITED KINGDOM
Telephone: +44 1312757620
E-mail: brian.roach@nhs.net
Internet address: http://www.nhsscotlandprocurement.scot.nhs.uk/

Tenders or requests to participate must be sent to: The Common Services Agency (commonly known as NHS National Services Scotland) (“Authority”)
Gyle Square (NSS Head Office), 1 South Gyle Crescent
For the attention of: Brian Roach
EH12 9EB Edinburgh
UNITED KINGDOM
Telephone: +44 1312757620
E-mail: brian.roach@nhs.net
Internet address: http://www.nhsscotlandprocurement.scot.nhs.uk/

I.2)Type of the contracting authority

Body governed by public law
I.3)Main activity

Health
I.4)Contract award on behalf of other contracting authorities

The contracting authority is purchasing on behalf of other contracting authorities: yes

Golden Jubilee (National Waiting Times Centre Board)

Health Improvement Scotland

NHS 24

NHS Ayrshire and Arran

NHS Borders

NHS Dumfries and Galloway

NHS Education for Scotland

NHS Fife

NHS Forth Valley

NHS Grampian

NHS Greater Glasgow and Clyde

NHS Health Scotland

NHS Highland

NHS Lanarkshire

NHS Lothian

NHS Orkney

NHS Quality Improvement Scotland

NHS Shetland

NHS Tayside

NHS Western Isles

Scottish Ambulance Service

The Common Services Agency for the Scottish Health Service (a.k.a the NHS Shared Services)

The State Hospital for Scotland

Section II: Object of the contract

II.1)Description
II.1.1)Title attributed to the contract by the contracting authority:

Bone Cement Products.
II.1.2)Type of contract and location of works, place of delivery or of performance

Supplies
Purchase
Main site or location of works, place of delivery or of performance: Any or all locations of all NHS Scotland Health Boards, all NHS Scotland Special Health Boards, NSS National Distribution Centre and/or the Authority (altogether hereinafter referred to as “NHS Scotland”).
NUTS code UKM

II.1.3)Information about a public contract, a framework agreement or a dynamic purchasing system (DPS)

The notice involves the establishment of a framework agreement
II.1.4)Information on framework agreement

Framework agreement with several operators
maximum number of participants to the framework agreement envisaged: 8
Duration of the framework agreement

Duration in years: 5
Justification for a framework agreement, the duration of which exceeds four years: Complex invasive products require detailed and long training. Depending on the extent of this development throughout the framework as the clinical practice is developed, this framework may make use of the last 12 month extension taking it to a maximum of 5 years.
Estimated total value of purchases for the entire duration of the framework agreement

Estimated value excluding VAT: 9 750 000 GBP

II.1.5)Short description of the contract or purchase(s)

Supply of Orthopaedic Bone Cement and related products. Scope includes all Bone Cements and Mixing Systems, Pulse Lavage Systems and related Accessories such as plugs, restrictors, spacers and pressurisers to all entities constituted pursuant to the National Health Service (Scotland) Act 1978, (ie all NHS Scotland Health Boards, Special Health Boards and the Authority).
Note: The authority has indicated that they are using the PCS-Tender Module to carry out this procurement process. To access the PCS-Tender Module and record your interest in this notice please visit https://www.publictendersscotland.publiccontractsscotland.gov.uk.

If you are not already registered with the PCS-Tender Module registration will be required.

II.1.6)Common procurement vocabulary (CPV)

33141700

II.1.7)Information about Government Procurement Agreement (GPA)

The contract is covered by the Government Procurement Agreement (GPA): yes
II.1.8)Lots

This contract is divided into lots: yes
Tenders may be submitted for one or more lots
II.1.9)Information about variants

Variants will be accepted: no
II.2)Quantity or scope of the contract
II.2.1)Total quantity or scope:

A framework agreement for the supply of Bone Cement, Bone Cement Mixing Systems (Bowl,Cartridge, Syringe, Vacuum), Pulse Lavage Systems and accessories relating to Bone Cement (plugs, pressurisers, restrictors spacers) The framework will be a non ranked, multi supplier framework with 8 suppliers envisaged to be awarded per lot.
Estimated value excluding VAT: 9 750 000 GBP
II.2.2)Information about options

Options: yes
Description of these options: The Authority is entitled at its sole discretion to extend the 36 month duration of the Framework Agreement by up to 2 times 12 months by giving a minimum of 3 months notice of such extensions as required.
II.2.3)Information about renewals

This contract is subject to renewal: yes
Number of possible renewals: 2
II.3)Duration of the contract or time limit for completion

Starting 21.3.2013. Completion 20.3.2016

Information about lots

Lot No: 1 Lot title: Bone Cement

1)Short description

Orthopaedic Bone Cement with and without antibiotics.
2)Common procurement vocabulary (CPV)

33141700

3)Quantity or scope

The provision of Bone Cement for use in Orthopaedic procedures.
Estimated value excluding VAT: 1 100 000 GBP
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots

Estimated spend is per annum.
Specific minimum required standards in order to tender a submitted offering for this lot are as follows:
Breadth/depth of range which includes cement with and without antibiotic.
BS EN ISO5833 or equivalent.
Evidence of conformity to EC Medical Device Directive 93/42/EEC Class 3.
Evidence of outcome data from Arthroplasty Registers, RSA or randomised controlled clinical trials.
Lot No: 2 Lot title: Bone Cement Vacuum Mixing Systems

1)Short description

Vacuum Mixing Systems for the purpose of mixing orthopaedic bone cement for application.
2)Common procurement vocabulary (CPV)

33141700

3)Quantity or scope

The provision of Vacuum Mixing Systems for orthopaedic Bone Cement.
Estimated value excluding VAT: 327 000 GBP
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots

Estimated spend is per annum.
Specific minimum required standards in order to tender a submitted offering for this lot are as follows:
Confirmation of compatibility with all commonly used cements.
Lot No: 3 Lot title: Bone Cement Cartridge Mixing Systems

1)Short description

Cartridge Mixing Systems for the purpose of mixing Orthopaedic Bone Cement for application.
2)Common procurement vocabulary (CPV)

33141700

3)Quantity or scope

The provision of Bone Cement Cartridge Mixing Systems.
Estimated value excluding VAT: 65 000 GBP
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots

Estimated spend is per annum.
Specific minimum required standards in order to tender a submitted offering for this lot are as follows:
Confirmation of compatibility with all commonly used cements.
Lot No: 4 Lot title: Bone Cement Syringe Set Mixing Systems

1)Short description

Syringe Set Mixing Systems for the purpose of mixing and appliying orthopaedic bone cement.
2)Common procurement vocabulary (CPV)

33141700

3)Quantity or scope

The provision of Syringe Set Bone Cement Mixing Systems.
Estimated value excluding VAT: 65 000 GBP
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots

Estimated spend is per annum.
Specific minimum required standards in order to tender a submitted offering for this lot are as follows:
Confirmation of compatibility with all commonly used cements.
Lot No: 5 Lot title: Bone Cement Bowl Mixing Systems

1)Short description

Bowl Mixing Systems for the purpose of mixing orthopaedic bone cement for application.
2)Common procurement vocabulary (CPV)

33141700

3)Quantity or scope

The provision of Bone Cement Bowl Mixing Systems.
Estimated value excluding VAT: 30 000 GBP
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots

Estimated Spend is per annum.
Specific minimum required standards in order to tender a submitted offering for this lot are as follows:
Confirmation of compatibility with all commonly used cements.
Lot No: 6 Lot title: Pulse Lavage

1)Short description

Pulse Lavage systems for the purpose of preparing the bone for orthopaedic procedure. Includes all disposable equipment, ininital startup equipment and consumables required.
2)Common procurement vocabulary (CPV)

33141700

3)Quantity or scope

The provision of Pulse Lavage systems.
Estimated value excluding VAT: 300 000 GBP
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots

Estimated spend is per annum.
Specific minimum required standards in order to tender a submitted offering for this lot are as follows:
Evidence of conformity to EC Medical Device Directive 93/42/EEC.
Lot No: 7 Lot title: Bone Cement Accessories

1)Short description

Accessories to assist the application of Bone Cement- plugs, cement restrictors, pressurisers, spacers.
2)Common procurement vocabulary (CPV)

33141700

3)Quantity or scope

The provision of Bone Cement Accessories- plugs, restrictors, spacers, pressurisers.
Estimated value excluding VAT: 86 000 GBP
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots

Estimated spend is per annum.
Specific minimum required standards in order to tender a submitted offering for this lot are as follows:
Confirmation of compatibility with all commonly used cements.

Section III: Legal, economic, financial and technical information

III.1)Conditions relating to the contract
III.1.1)Deposits and guarantees required:
III.1.2)Main financing conditions and payment arrangements and/or reference to the relevant provisions governing them:
III.1.3)Legal form to be taken by the group of economic operators to whom the contract is to be awarded:

The Prime Contractor shall be liable in the event of a consortium bid.
III.1.4)Other particular conditions

The performance of the contract is subject to particular conditions: no
III.2)Conditions for participation
III.2.1)Personal situation of economic operators, including requirements relating to enrolment on professional or trade registers

Information and formalities necessary for evaluating if the requirements are met: Economic operators should confirm that neither it, its directors, nor any person who has power or representation decision or control of the economic operator has been convicted of any of the offences detailed in Regulation 23 (1) of the Public Contracts (Scotland) Regulations 2012 and that the grounds detailed in Regulation 23(4) of the Regulations do not apply to the economic operator.
III.2.2)Economic and financial ability

Information and formalities necessary for evaluating if the requirements are met: All candidates will be required to provide a statement, covering the 3 previous financial years including the overall turnover of the candidate and the turnover in respect of the activities which are of a similar type to the subject matter of this notice.
Minimum level(s) of standards possibly required: All candidates will be required to confirm and provide evidence that the overall annual turnover of the candidate is equal to or in excess of three times the advertised annual value of the relevant contract lots to which an offer is being submitted.
III.2.3)Technical capacity

Minimum level(s) of standards possibly required:
Submission of 3 clinical based reference sites, CE Marking and BS EN ISO13485 or equivalent accreditation are required.
Lot specific minimum level(s) of standard are as follows-.
Lot 1-.
A breadth and depth of range containing Cement with and without antibiotics inserted, BS EN ISO5833 or equivalent, evidence of conformance to EC Medical Device Directive 93/42/EEC Class 3, and evidence of outcome data from Arthroplasty Registers, RSA or randomised controlled clinical trials.
Lots 2-5 confirmation of compatibility with all commonly used cement brands.
Lot 6- Evidence of conformance to EC Medical Device Directive 93/42/EEC Class 2a.
Lot 7- confirmation of compatibility with all commonly used cement brands, declaration of previous 5 years product failure rates.
III.2.4)Information about reserved contracts
III.3)Conditions specific to services contracts
III.3.1)Information about a particular profession
III.3.2)Staff responsible for the execution of the service

Section IV: Procedure

IV.1)Type of procedure
IV.1.1)Type of procedure

Open
IV.1.2)Limitations on the number of operators who will be invited to tender or to participate
IV.1.3)Reduction of the number of operators during the negotiation or dialogue
IV.2)Award criteria
IV.2.1)Award criteria

Lowest price
IV.2.2)Information about electronic auction

An electronic auction will be used: no
IV.3)Administrative information
IV.3.1)File reference number attributed by the contracting authority:

NP117/12
IV.3.2)Previous publication(s) concerning the same contract

Other previous publications

Notice number in the OJEU: 2009/S 151-220999 of 6.8.2009

IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document
IV.3.4)Time limit for receipt of tenders or requests to participate

3.12.2012 – 12:00
IV.3.5)Date of dispatch of invitations to tender or to participate to selected candidates
IV.3.6)Language(s) in which tenders or requests to participate may be drawn up

English.
IV.3.7)Minimum time frame during which the tenderer must maintain the tender
IV.3.8)Conditions for opening tenders

Section VI: Complementary information

VI.1)Information about recurrence
VI.2)Information about European Union funds
VI.3)Additional information

Collaborative Arrangements:
Selected organisations Golden Jubilee Hospital (National Waiting Times Centre Board), NHS 24, NHS Ayrshire and Arran, NHS Borders, NHS Dumfries & Galloway, NHS Education for Scotland, NHS Fife, NHS Forth Valley, NHS Grampian, NHS Greater Glasgow & Clyde, NHS Health Scotland, NHS Highland, NHS Lanarkshire, NHS Lothian, NHS Orkney, NHS Health Improvement Scotland, NHS Shetland, NHS tayside, NHS Western Isles, Scottish Ambulance Service, The Common Services Agency for the Scottish health Service (a.k.a. the NHS Shared Services), The State Hospital for Scotland.
Any or all locations of all NHS Scotland Boards all NHS Scotland Special Health Boards, NSS National Distribution Centre and/or the Authority (altogether hereinafter referred to as “NHS Scotland”).
(SC Ref:239119).
VI.4)Procedures for appeal
VI.4.1)Body responsible for appeal procedures
VI.4.2)Lodging of appeals

Precise information on deadline(s) for lodging appeals: 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 framework agreement which notifcation will contain among other information, a summary of the reasons why the economic operator 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 despatches 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 an end 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 2012 can be established. Otherwise the remedies that may be awarded by the courts where the framework agreement has been entered into are limited to the award of damages. Economic operators are entitled to write to the Authority after receipt of the notification should they require further clarification. The Authority will respond within 15 days of such a written request, but it should be noted that receipt by the Authority of such request during the standstill period may not prevent the Authority from awarding the framework agreement following the expiry of the standstill period. Where an economic operator is dissatisfied with the Authority’s response to its request for clarification, or considers that the framework agreement has been concluded in breach of The Public Contracts (Scotland) Regulations 2012, such economic operator is advised to promptly seek independent legal advice.
VI.4.3)Service from which information about the lodging of appeals may be obtained
VI.5)Date of dispatch of this notice:

17.10.2012