National Microbiology Framework – Public Health England

National Microbiology Framework – Public Health England

The Framework Agreement relates to the supply of diagnostics goods for the qualitative/quantitative examination of specimens/samples. 4 Lots.

United Kingdom-Colindale: Medical equipments, pharmaceuticals and personal care products

2020/S 217-533940

Contract notice

Supplies

Legal Basis:

Directive 2014/24/EU

Section I: Contracting authority

I.1)Name and addresses

Official name: Public Health England
Postal address: 61 Colindale Avenue
Town: Colindale
NUTS code: UK UNITED KINGDOM
Postal code: NW9 5EQ
Country: United Kingdom
Contact person: Nilesh Pattani
E-mail: srm.scientific@phe.gov.uk
Internet address(es):
Main address: www.gov.uk/government/organisations/public-health-england

I.2)Information about joint procurement

The contract is awarded by a central purchasing body

I.3)Communication

The procurement documents are available for unrestricted and full direct access, free of charge, at: https://phe.bravosolution.co.uk/web/login.shtml
Additional information can be obtained from the abovementioned address
Tenders or requests to participate must be submitted electronically via: https://phe.bravosolution.co.uk/web/login.shtml
Tenders or requests to participate must be submitted to the abovementioned address

I.4)Type of the contracting authority

National or federal agency/office

I.5)Main activity

Health

Section II: Object

II.1)Scope of the procurement

II.1.1)Title:

National Microbiology Framework

 

II.1.2)Main CPV code

33000000 Medical equipments, pharmaceuticals and personal care products

II.1.3)Type of contract

Supplies

II.1.4)Short description:

 

The Secretary of State for Health and Social Care acting through Public Health England (PHE) is seeking to appoint suppliers to a multi-lot national microbiology framework agreement. The framework agreement relates to the supply of diagnostics goods for the qualitative/quantitative examination of specimens/samples and the development or manufacturing of assays/kits/medication and related services. It also relates to the supply of diagnostics services for the qualitative/quantitative examination of specimens/samples or the development or manufacturing of assays/kits/medication. The framework also covers clinical laboratory diagnostic testing services.

The term of the framework will be for an initial 2 years with options to extend by up to a further 2 years.

 

II.1.5)Estimated total value

Value excluding VAT: 22 000 000 000.00 GBP

II.1.6)Information about lots

This contract is divided into lots: yes
Tenders may be submitted for all lots
Maximum number of lots that may be awarded to one tenderer: 4
II.2)Description

II.2.1)Title:

Diagnostic Goods and Services

 

Lot No: 1

II.2.2)Additional CPV code(s)

33000000 Medical equipments, pharmaceuticals and personal care products
33100000 Medical equipments
33600000 Pharmaceutical products
38430000 Detection and analysis apparatus
38431000 Detection apparatus
38433100 Mass spectrometer
38434000 Analysers
38434500 Biochemical analysers
38434510 Cytometers
38434520 Blood analysers
38434540 Biomedical equipment
38434550 Blood-cell counters
38434570 Haematology analysers
38434580 Immunoassay analysers
50400000 Repair and maintenance services of medical and precision equipment
50410000 Repair and maintenance services of measuring, testing and checking apparatus
50411000 Repair and maintenance services of measuring apparatus
50412000 Repair and maintenance services of testing apparatus
50413000 Repair and maintenance services of checking apparatus
50433000 Calibration services
71900000 Laboratory services
85111800 Pathology services

II.2.3)Place of performance

NUTS code: UK UNITED KINGDOM

II.2.4)Description of the procurement:

Lot 1 is for the supply of in-vitro diagnostic medical devices and associated services including equipment, consumables, maintenance, and peripheral equipment and associated services. All goods supplied must comply with the European Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998) or Regulation (EU) 2017/746 (IVDR) as applicable. All reagents and consumables must be marked in accordance with current CE regulations (or, once superseded, the UKCA mark).

 

II.2.5)Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6)Estimated value

Value excluding VAT: 3 000 000 000.00 GBP

II.2.7)Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48
This contract is subject to renewal: no

II.2.10)Information about variants

Variants will be accepted: no

II.2.11)Information about options

Options: yes
Description of options:

 

The framework agreement will be for an initial period of 24 months with options exercisable by the Authority under the framework agreement to extend the duration in increments by up to a maximum of 24 months. Therefore, the total maximum duration of the framework agreement is 48 months.

The authority will also have the option to purchase new and/or updated goods and/or services which the supplier proposes should be added to its range as described in section VI.3) below.

 

II.2.13)Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: no

II.2.14)Additional information

The value attributed to each lot is an approximate estimate only. As indicated in section VI.3). of this notice, the actual values will be to such level as those purchasing under the framework agreement consider necessary to provide suitable requirements.

 

II.2)Description

II.2.1)Title:

Research and Development Goods and Services

 

Lot No: 2

II.2.2)Additional CPV code(s)

33000000 Medical equipments, pharmaceuticals and personal care products
33100000 Medical equipments
33600000 Pharmaceutical products
38430000 Detection and analysis apparatus
38433100 Mass spectrometer
38434500 Biochemical analysers
38434510 Cytometers
38434520 Blood analysers
38434540 Biomedical equipment
38434550 Blood-cell counters
38434570 Haematology analysers
38434580 Immunoassay analysers
50410000 Repair and maintenance services of measuring, testing and checking apparatus
50411000 Repair and maintenance services of measuring apparatus
50412000 Repair and maintenance services of testing apparatus
50413000 Repair and maintenance services of checking apparatus
50430000 Repair and maintenance services of precision equipment
71900000 Laboratory services
73111000 Research laboratory services
85111800 Pathology services

II.2.3)Place of performance

NUTS code: UK UNITED KINGDOM

II.2.4)Description of the procurement:

Lot 2 consists of goods and services mainly for research and development, experimentation and study. The supplies may form a part of the whole diagnostic product life cycle. Products and services do not need to be CE marked (or, once superseded, UKCA marked) as they are under development and primarily used for research and development.

 

II.2.5)Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6)Estimated value

Value excluding VAT: 1 500 000 000.00 GBP

II.2.7)Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48
This contract is subject to renewal: no

II.2.10)Information about variants

Variants will be accepted: no

II.2.11)Information about options

Options: yes
Description of options:

 

The framework agreement will be for an initial period of 24 months with options exercisable by the authority under the framework agreement to extend the duration in increments by up to a maximum of 24 months. Therefore, the total maximum duration of the framework agreement is 48 months.

The authority will also have the option to purchase new and/or updated goods and/or services which the supplier proposes should be added to its range as described in section VI.3) below.

 

II.2.13)Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: no

II.2.14)Additional information

The value attributed to each lot is an approximate estimate only. As indicated in section VI.3) of this notice, the actual values will be to such level as those purchasing under the framework agreement consider necessary to provide suitable requirements.

 

II.2)Description

II.2.1)Title:

Manufacturing, Product Development and Commercialisation

 

Lot No: 3

II.2.2)Additional CPV code(s)

33000000 Medical equipments, pharmaceuticals and personal care products
33124100 Diagnostic devices
33124110 Diagnostic systems
38540000 Machines and apparatus for testing and measuring
38950000 Polymerase Chain Reaction (PCR) equipment
38970000 Research, testing and scientific technical simulator
71900000 Laboratory services
72244000 Prototyping services
73100000 Research and experimental development services

II.2.3)Place of performance

NUTS code: UK UNITED KINGDOM

II.2.4)Description of the procurement:

 

Lot 3 is for the manufacture of diagnostic and/or therapeutic products for the purpose of research, experimentation, study, development or to establish commercial viability or to recover research and development costs. Manufacturers must adhere to the relevant regulations for example for in vitro medical devices/medical devices, the current IVDD/MDD respectively and from May 2022 the new IVDR or from May 2021 the new MDR.

The supplier may be required to discount or agree preferential terms for the products sold on the open market where the authority has given input into the development and validation of the product, including the sharing or use of the authority’s intellectual property.

The supplier may be required to supply products, materials and other services related to the sale and/or distribution of the manufactured products. There may also be other commercial exploitation arrangements, which may include the licensing of the authority’s intellectual property in return for a license fee.

 

II.2.5)Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6)Estimated value

Value excluding VAT: 2 500 000 000.00 GBP

II.2.7)Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48
This contract is subject to renewal: no

II.2.10)Information about variants

Variants will be accepted: no

II.2.11)Information about options

Options: yes
Description of options:

 

The framework agreement will be for an initial period of 24 months with options exercisable by the authority under the framework agreement to extend the duration in increments by up to a maximum of 24 months. Therefore, the total maximum duration of the framework agreement is 48 months.

The authority will also have the option to purchase new and/or updated goods and/or services which the supplier proposes should be added to its range as described in section VI.3) below.

 

II.2.13)Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: no

II.2.14)Additional information

The value attributed to each Lot is an approximate estimate only. As indicated in section VI.3). of this notice, the actual values will be to such level as those purchasing under the framework agreement consider necessary to provide suitable requirements.

 

II.2)Description

II.2.1)Title:

Clinical Laboratory Diagnostic Testing Services

 

Lot No: 4

II.2.2)Additional CPV code(s)

33000000 Medical equipments, pharmaceuticals and personal care products
64120000 Courier services
71900000 Laboratory services
73111000 Research laboratory services
85111800 Pathology services
85145000 Services provided by medical laboratories
85148000 Medical analysis services

II.2.3)Place of performance

NUTS code: UK UNITED KINGDOM

II.2.4)Description of the procurement:

 

Lot 4 is to provide access to a range of clinical laboratory diagnostic testing services. The exact specification for each requirement will be detailed in the call-off order form. The volumes of services contracted via this lot are expected to be scalable to meet evolving demand over time taking account of long term and short term (surge) requirements, combined with small-scale or large-scale service provisions being sought.

Lot 4 is intended to enable access to clinical laboratory diagnostic testing services using extant techniques and allow for the addition of new techniques or existing techniques utilised in a new manner in the future.

The aim for this lot is to ensure that there is consistent and affordable provision of high quality, safe and compliant testing services which should be delivered efficiently and effectively to support wider clinical services.

With regards to the clinical laboratory diagnostic testing services to be offered through the framework the authority is seeking suppliers that can undertake the following types of testing:

— molecular biology; and

— microbiology including:

• Bacteriology;

• Virology; and

• Serology.

Suppliers will also be expected to provide all necessary supporting services including but not limited to the receipting of samples, storage, accessioning, laboratory informatics and clinical waste disposal. Where necessary it is also envisaged that suppliers may be required to provide their own sample kits and logistical services.

 

II.2.5)Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6)Estimated value

Value excluding VAT: 15 000 000 000.00 GBP

II.2.7)Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48
This contract is subject to renewal: no

II.2.10)Information about variants

Variants will be accepted: no

II.2.11)Information about options

Options: yes
Description of options:

 

The framework agreement will be for an initial period of 24 months with options exercisable by the authority under the framework agreement to extend the duration in increments by up to a maximum of 24 months. Therefore, the total maximum duration of the framework agreement is 48 months.

The authority will also have the option to purchase new and/or updated goods and/or services which the supplier proposes should be added to its range as described in section VI.3) below.

 

II.2.13)Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: no

II.2.14)Additional information

The value attributed to each lot is an approximate estimate only. As indicated in section VI.3) of this notice, the actual values will be to such level as those purchasing under the framework agreement consider necessary to provide suitable requirements.

 

Section III: Legal, economic, financial and technical information

III.1)Conditions for participation

III.1.2)Economic and financial standing

Selection criteria as stated in the procurement documents

III.1.3)Technical and professional ability

Selection criteria as stated in the procurement documents
III.2)Conditions related to the contract

III.2.2)Contract performance conditions:

 

If it is considered appropriate by the authority, an indemnity, guarantee, bond or other form of appropriate security may be required.

The authority reserves the right to require groupings of economic operators to take a particular legal form or to require a single economic operator to take primary liability for a contract to be performed by a group of economic operators or to require each party to undertake joint and several liability in respect of the entire contract irrespective of the form the grouping takes.

 

Section IV: Procedure

IV.1)Description

IV.1.1)Type of procedure

Open procedure

IV.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

IV.1.8)Information about the Government Procurement Agreement (GPA)

The procurement is covered by the Government Procurement Agreement: yes
IV.2)Administrative information

IV.2.1)Previous publication concerning this procedure

Notice number in the OJ S: 2020/S 108-263375

IV.2.2)Time limit for receipt of tenders or requests to participate

Date: 04/12/2020
Local time: 14:00
IV.2.3)Estimated date of dispatch of invitations to tender or to participate to selected candidates

IV.2.4)Languages in which tenders or requests to participate may be submitted:

English

IV.2.6)Minimum time frame during which the tenderer must maintain the tender

Duration in months: 6 (from the date stated for receipt of tender)

IV.2.7)Conditions for opening of tenders

Date: 04/12/2020
Local time: 14:00

Section VI: Complementary information

VI.1)Information about recurrence

This is a recurrent procurement: no

VI.2)Information about electronic workflows

Electronic ordering will be used
Electronic invoicing will be accepted
Electronic payment will be used

VI.3)Additional information:

 

The framework is intended to be accessed by:

Public Health England;

Department of Health and Social Care;

Public Health Wales;

Public Health Scotland;

Department for Health for Northern Ireland;

Health and Social Care Northern Ireland;

NHS Authorities, NHS Trusts, NHS Foundation Trusts, Special Health Authorities, NHS Scotland Health Boards, NHS Wales Health Boards, NHS Northern Ireland Health Boards, Special NHS Boards and any other NHS entity;

Local Authorities;

Any other bodies governed by public law (as defined in regulation 2 of the Public Contracts Regulations 2015 (SI 2015/102) (as amended); and

Academic or charitable institutions (including any such institutions that are not Contracting Authorities).

Examples of such bodies can be found at the following links (as of date of publication):

https://www.gov.uk/government/organisations/charity-commission

https://www.nhs.uk/servicedirectories/pages/nhstrustlisting.aspx

The framework value is an approximate estimate only. The actual values will be to such level as those purchasing under the framework agreement consider necessary to provide suitable requirements. PHE works with DHSC and the NHS in its role as a national and international emergency responder to current and emerging threats to public health. As demonstrated by the Covid-19 pandemic, the exact nature, timing and escalation of such threats (and the corresponding required responses) can be difficult to foresee, making any exercise in future value estimation unpredictable.

The scope of this framework agreement covers goods and services that are subject to rapid and frequent improvements, advancements and new scientific and technical developments. Therefore, to keep this framework agreement in line with the latest market and scientific developments so as to ensure that patients and other end users have ongoing access to state of the art diagnostics for the duration of this framework agreement successful suppliers will be able to propose new and/or updated goods and/or services to be added to a supplier’s range under the framework agreement if one or more of the following circumstances apply:

• where the proposed updated goods or services fall within the general scope of this procurement as set out as part of this OJEU contract notice (i.e. fall within an existing main or supplementary CPV code as may be referred to in this contract notice and/or the description sections of this Contract Notice);

• where the proposed new goods or services fall within the broad categories of goods or services covered by this framework agreement (i.e. fall within an existing main or supplementary CPV code as may be referred to in this contract notice and/or the broad categories of goods and/or services referred to in any of the description sections of this contract notice), but are new to the market. For the avoidance of doubt, for the purposes of any testing services, this will allow suppliers to offer new types of tests, new test kits, related new equipment/products, related new consumables and related new services as and when they become available during the duration of the framework agreement provided they fall within an existing main or supplementary CPV code as may be referred to in this contract notice and/or the broad categories of goods and/or services referred to in any of the description sections of this contract notice);

• where the proposed new or updated goods or services reflect a product or service line extension (i.e. are new, modified or updated products or services in the same category of goods or services already supplied by a supplier under this framework agreement); or

• where the proposed new or updated goods or services reflect a range extension (i.e. are new, modified or updated products or services that reflect an expansion of the supplier’s range in the same category of goods or services already supplied by a supplier under this framework agreement).

 

VI.4)Procedures for review

VI.4.1)Review body

Official name: Public Health England
Postal address: 61 Colindale Avenue
Town: Colindale
Postal code: NW9 5EQ
Country: United Kingdom

VI.4.3)Review procedure

Precise information on deadline(s) for review procedures:

The authority will allow a standstill period at the point the decision regarding the award of the framework is communicated to tenderers. The standstill period shall be in accordance with Regulation 87 of the Public Contracts Regulations 2015 (as amended). Chapter 6 of the Regulations provides for aggrieved parties who have been harmed or are at risk of harm by a breach of the Regulations to take legal action. Any such action must be started in the High Court within the applicable limitation period set out in Chapter 6. The purpose of the standstill period referred to above is to allow aggrieved parties to apply to the Courts to set aside the award decision before the framework is entered into.

 

VI.5)Date of dispatch of this notice:

02/11/2020