Services - 255495-2017

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04/07/2017    S125

Spain-Santiago de Compostela: Research and experimental development services

2017/S 125-255495

Contract notice

Services

Directive 2004/18/EC

Section I: Contracting authority

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

Official name: Agencia Gallega para la Gestión del Conocimiento en Salud, ACIS (Health Knowledge Agency)
Postal address: av. Fernando de Casas Novas, 37, portal A-B, 1º piso
Town: Santiago de Compostela
Postal code: 15707
Country: Spain
For the attention of: Susana Fernandez Nocelo
E-mail: susana.fernandez.nocelo2@sergas.es
Telephone: +34 981568055

Internet address(es):

General address of the contracting authority: http://www.acis.sergas.es

Address of the buyer profile: http://www.empattics.eu

Further information can be obtained from:
The above mentioned contact point(s)

Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained from:
The above mentioned contact point(s)

Tenders or requests to participate must be sent to:
The above mentioned contact point(s)

I.2)Type of the contracting authority
Regional or local agency/office
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

Official name: Region Midtjylland, CDR
Postal address: Skottenborg 26
Town: Viborg
Postal code: 8800
Country: Denmark

Official name: Servicio Aragonés de la Salud
Postal address: Via Universitas, 34
Town: Zaragoza
Postal code: 50071
Country: Spain

Official name: Groupment de cooperation sanitaire pour le developpement des systèmes d'information partagés en Île-de-France, GCS-SESAN, GCS D-SISIF
Postal address: 10 rue du Faubourg-Montmartre
Town: Paris
Postal code: 75009
Country: France

Section II: Object of the contract

II.1)Description
II.1.1)Title attributed to the contract by the contracting authority:
New ICT solutions for patients with chronic diseases — EMPATTICS PCP.
II.1.2)Type of contract and location of works, place of delivery or of performance
Services
Service category No 25: Health and social services
Main site or location of works, place of delivery or of performance: EU countries and H2020 associated countries.
NUTS code
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
Number of participants to the framework agreement envisaged: 6

Duration of the framework agreement

Duration in months: 25
II.1.5)Short description of the contract or purchase(s)
What is this? This procurement is for R&D services to develop solutions to tackle the following challenge:
To develop new, cost-effective, scalable, interoperable and non-intrusive Information and Communication Technology solutions for patients with chronic diseases, which provide self-management tools on adherence to their care plan and acknowledgement of their disease in order to increase their empowerment and management of life. To address the need for the solution to support patients with information, monitoring and data analysis of their disease evolution and communication with health professionals responsible for their care plan.
The rationale of the focus by EMPATTICS on these chronic conditions is based on the high incidence, the social costs of these diseases, and the impact that adherence has on them, as well as empirically observed experiences of modifiable self-management behaviours and ICT use in relation to them.
The intended EMPATTICS technological solutions will improve the level of knowledge and involvement of patients in the management of their disease and the prescribed treatments. This requires a multidisciplinary approach that encompasses the following aspects:
— Increasing awareness of and knowledge about the importance of adherence,
— Monitoring and evaluating patient adherence to agreed action plans,
— Providing valuable information for the self-management of patient diseases,
— Helping patients to develop healthy adaptive behaviours,
— Facilitating communication between patients and health professionals.
This is a common challenge shared by all procurers in the buyers group.
Solutions shall be developed considering patient/carers and healthcare professionals experience and preferences during both the design and implementation phases. The products and innovations achieved at this PCP shall arise through co-operation and co-creation between health-care organisations, professionals and patients/families. Bidders are expected to consider the involvement of end-users very early in the product design process. It must be considered that target users will be patients of each of the three chronic disease groups chosen by EMPATTICS (i.e., Diabetes, COPD and Heart failure), a combination of these, and even a combination of these with other conditions, at different stages of their onset and with different personal profiles (adults, elderly dependent/active people, etc.). Owing to this, patients/carers will have specific contexts, circumstances, motivations, preferences, levels of health literacy and digital competences. As the requested solutions must be highly usable and adaptable, bidders shall pay special attention to the use of an iterative design process, especially in phase 1 but also in phases 2 and 3.
The 3 selected diseases in the EMPATTICS project represent a major challenge for health systems across Europe, moving around 163 000 000 000 EUR in direct costs. The three diseases also impact on the wider social systems and economies of Member States, which are calling for adequate prevention and sustainable disease management technologies.
The main quality/efficiency improvements sought for have been agreed on as being solutions that can be demonstrated during the testing phase:
— A measurable increase in patients' empowerment;
— A measurable increase in patients' adherence to the care plan;
— A measurable difference in patients' clinical outcome;
— A measurable decrease in resource consumption.
The metrics and/or indicators which should be used to compare the results obtained before using the solutions and after using them are the following:
— To evaluate the patients' empowerment, the PAM questionnaire will be used.
— To evaluate the patients' adherence, the Moryski and Green test will be used.
— To evaluate clinical outcome, the HbA1C, FEV and MLHQ will be measured for Diabetes, COPD and Heart Failure, respectively.
— To evaluate the resource consumption, the number of events, number of exacerbations, number of hospitalisations, number of re-hospitalisations, days of stay and number of emergency visits will be used. All these data should be related to the three diseases chosen.
To compare these metrics and/or indicators, historical control will be used. The comparator group will be those patients who are selected to test the solutions. These patients will have been treated and monitored for at least 1 year prior to the testing of the solutions and their data will be available through EMR or other databases (retrospective collection of data regarding demographics, clinical and economic outcomes).
In order to achieve these improvements, the EMPATTICS solutions shall be designed for the personal use of the patients/carers suffering from chronic diseases, with the following functional requirements:
Information
1. The solutions shall gather all required information from patient's agreed care plan.
2. The solutions shall support patients and/or carers in following and understanding their care plan.
3. The solutions shall support patients and/or carers to improve their understanding of the illness or illnesses in order to enable better self-management thereof. To do so, they shall at least provide access to suitable information sources adapted to each patient's profile.
Monitoring
4. The solutions shall monitor relevant parameters related with patients' care plan, including vital signs, medication intake in any pharmaceutical form and behavioural data (i.e. physical activity, diet, etc.), and shall be able to do so automatically, with no intervention from the patient.
5. The solutions shall provide patients and/or carers with access to comprehensible information on their monitoring and the course of their illness.
Data analysis
6. The solutions shall detect any failure to comply with the agreed care plan.
7. The solutions shall determine the principal reasons for any shortcoming in the monitoring of the agreed care plan or the patient's withdrawal.
8. The solutions shall learn from the data gathered from patients, in order to provide them with intelligent support which will help to ensure their continued compliance with the agreed care plan (at least through positive reinforcement regarding their achievements and health status).
Communication between patients and health professionals
9. The solutions shall provide a channel for communication between patients and health professionals. It would also be desirable to provide a channel for communication between patients and other stakeholders in their care plan.
10. Subject to authorisation from patients, the solutions shall allow the professionals responsible for their care access to relevant the data gathered and generated by said solution.
Confidentiality and Privacy
11. The solutions shall ensure that patients are the owners of all the information collected and stored by said solution.
12. Patients shall be able to decide over the solution, so as to preserve their privacy and prevent intrusiveness.
Design
13. All those devices pertaining to the solutions which need to be carried by the patient shall be light, non-intrusive and easy to use, even for patients with scant digital skills.
14. The solutions shall include the option of a wearable device that always accompanies the patients, thus avoiding the possibility of forgetting said device.
15. The solutions shall be modular in order to be configured and used in line with patients' individual.
16. The solutions shall function in each of the buyers' languages. It would also be desirable if they could be easily adaptable to function in any other EU language.
17. The solutions shall be applicable to different chronic diseases (other than Diabetes, COPD and Heart Failure), as is or with minor modifications, and shall be flexible enough to cover comorbidities.
18. The solutions shall be sustainable in the medium and long term. Amortisation and maintenance costs must not be a hindrance to the deployment of services.
19. The solutions shall be capable of supporting large-scale deployment.
20. All data and information shall be stored taking into account the security, ethical and data management framework.
21. The solutions must have the potential to accommodate lacks of connectivity.
22. All requirements regarding interoperability, ICT standards, protection of personal health information, interfacing with local systems, etc., as described in section 4.4. Compliance criteria shall be taken into account.
The PCP includes a limited set of prototype(s) and first test products or services resulting from the R&D in order to run the field testing by each successful phase 3 suppliers.
Each contractor keeps ownership of the IPRs attached to the results it generates during the PCP implementation. The tendered price is expected to take this into account.

Who is procuring? The procurement will be carried out jointly by the following organisations: Agencia Gallega para la Gestión del Conocimiento en Salud (ACIS), Central Denmark Region, Servicio Aragonés de la Salud and GCS SESAN (see www.empattics.eu). ACIS will act as the lead procurer and will coordinate and lead the joint procurement in the name and on behalf of the other organisations.

How does it work? The procurement will take the form of a pre-commercial procurement (PCP) with a phased approach, under which R&D service contracts will be awarded to a number of R&D providers in parallel, in order to be able to compare competing alternative solutions.
Each selected operator will conclude a framework agreement that covers three R&D phases.
The 3 phases are:
— solution design,
— prototyping,
— original development and validation and testing of a limited set of first products or services.
After each phase, intermediate evaluations will be carried out to progressively select the best competing solutions. The contractors with the best-value-for-money solutions will be offered a specific contract for the next phase.
Testing is expected to take place in the four buyer regions. This testing may also serve as a first customer test reference for the contractors.
Proposals may be submitted in English. All communication (before, during and after the procurement) can be made in English.
For more information see:

the project website (see www.empattics.eu),

the open market consultation Q&A (see http://empattics.eu/call-for-tender/faq),

the PCP section on the Europa website (http://ec.europa.eu/digital-agenda/en/innovation-procurement),

or contact:

info@empattics.eu.

II.1.6)Common procurement vocabulary (CPV)

73100000 Research and experimental development services

II.1.7)Information about Government Procurement Agreement (GPA)
The contract is covered by the Government Procurement Agreement (GPA): no
II.1.8)Lots
This contract is divided into lots: no
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:
Estimated value excluding VAT:
Range: between 187 500 and 212 500 EUR
II.2.2)Information about options
Options: no
II.2.3)Information about renewals
This contract is subject to renewal: no
II.3)Duration of the contract or time limit for completion
Duration in months: 25 (from the award of the contract)

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:
In phase 1, a single payment shall be made once the EMPATTICS Monitoring Board has verified the satisfactory completion of the phase and the Buyers Evaluation Board has given its approval.
In phases 2 and 3, an interim payment of the 50 % of the value of the relevant phase contract shall be made after the satisfactory evaluation by the EMPATTICS Monitoring Board of the interim milestones and deliverables submitted by the bidders and of the approval of the Buyers Evaluation Board.
In phases 2 and 3, the payment of the balance shall be made once the EMPATTICS Monitoring Board has verified the satisfactory completion of each phase and the Buyers Evaluation Board has given its approval.
III.1.3)Legal form to be taken by the group of economic operators to whom the contract is to be awarded:
Tenders may be submitted by any type of natural or legal persons (including properly registered non-profit entities, such as Universities), as a single entity or in collaboration with others. The latter can involve either submitting a joint tender or subcontracting, or a combination of the 2 approaches.
III.1.4)Other particular conditions
The performance of the contract is subject to particular conditions: yes
Description of particular conditions: — At least 70 % of the total value of activities covered by the contract must be performed in the EU Member States or in H2020 associated countries. The principal R&D staff working on each specific contract must be located in the EU Member States or H2020 associated countries.
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: — If the bidder is a natural person, a certified copy of the national official identity card or of the passport shall be provided; if the bidder is a legal person, legal capacity shall be accredited by means of a certified copy of the deed or document of incorporation and/or amendment registered in the official Commercial Register when registration is compulsory in accordance with the applicable law. Otherwise, the capacity to act shall be accredited by means of a certified copy of the deed or document of incorporation and/or amendment, the founding act or the articles of association wherein the rules by which the bidder regulates its activity are stated, and registered, where applicable, in the corresponding official register.
— In the event of indirect representation, the powers under which the signatory of the proposal acts shall be demonstrated. If the represented party is a natural person, an authenticated copy of the notarised power of attorney shall be provided; if the represented party is a legal person, representation shall be accredited by the submission of a certified copy of the deed or document of incorporation and/or amendment, the founding act, or the articles of association from which the representation is derived. If the representation cannot be accredited through any of the described means, an authenticated copy of the notarised power of attorney shall be provided.
Should there be any doubt as to the legal capacity or representation, bidders may be requested to provide additional information and/or evidence.
III.2.2)Economic and financial ability
Information and formalities necessary for evaluating if the requirements are met: Bidders shall demonstrate that they have the necessary economic and financial solvency to perform R&D up to the original development of the first products or services and to commercially exploit the results of the PCP, including intangible results, in particular IPRs. The economic and financial solvency to assure the coverage of the costs related to the execution and implementation of the project must be accredited by means of at least one of the following forms of evidence:
a) The annual accounts presented in the corresponding official Commercial Register referring to the last 3 available years. Bidders not obliged to present the accounts in an official Register may, as an alternative means of accreditation, provide duly legalised accounting books. Solvency shall be understood as accredited by those bidders whose annual net profits on the profit and loss account give an average of equal to or greater than 50 000 EUR.
b) Statement issued by an accredited financial institution attesting the availability by the bidder of an amount equal or greater than 50 000 EUR or the existence of a credit granted for the same amount.
c) Statement made by one of more investors providing a financial guarantee in an amount equal or greater than 50 000 EUR for the performance of the contract.
In spite of the above, for recently established businesses which have not yet existed for three financial years for which accounts have been closed, the annual accounts for one year only – if available – and a simple declaration on turnover will be required but supplemented by at least one of the following declarations providing a financial guarantee for the performance of the contract: bank declaration or declaration from an insurance company.
Minimum level(s) of standards possibly required: Section above.
III.2.3)Technical capacity
Information and formalities necessary for evaluating if the requirements are met:
Bidders shall demonstrate that they have the necessary technical and professional solvency to perform the contract to an appropriate quality standard. More precisely, bidders shall accredit that they possess the necessary experience and human and technical resources to perform R&D up to the original development of the first products or services and to commercially exploit the results of the PCP, including intangible results, in particular IPRs. This technical and professional solvency must be accredited by means of the following evidence:
A list of the main services or works similar to the present contract (see the last paragraph of this section) made by the bidder in the last 5 years, including amounts, dates and the recipients, public or private. In the description of the services or works carried out, bidders should detail the results obtained and the way in which they were commercially exploited. In the case of bidders whose activity period does not cover the last 5 years, the list of services or works will be those of the period corresponding to the bidder's activity. The required solvency shall be understood to be accredited by the satisfactory completion of at least one service or work on the indicated fields.
In spite of the above, recently established businesses such as start-ups may also compete in this PCP procedure, even if they have not satisfactorily completed any service or work similar to the purpose of the present contract provided that the personnel assigned to the execution of the project do have the required experience. In such cases, in addition to the list of the services or works referred to in the previous paragraph performed during their period of activity, bidders shall submit a list of the services and works carried out by the staff allocated to the performance of the project in the previous 5 years and the profiles and curricula of said personnel, which shall contain a detailed description of their academic background and their previous professional experience. In this case, the required solvency shall be understood to be accredited by the satisfactory completion by the personnel allocated to the project of at least one service or work in the aforementioned areas or by the execution of a research project in an academic field similar to the purpose of the present contract.
Note: EMPATTICS considers a service or work similar to the present contract the previous realisation of R&D services or R&D projects in the following fields:
— R&D services or R&D projects that pursue to develop ICT technologies that support Patient Empowerment initiatives or increase their adherence to treatments.
— R&D services or R&D projects in mobile-health and e-health.
— R&D services or R&D projects performed in other sectors or markets that pursue to develop technologies based on big data, virtual reality, wearables, serious games, artificial intelligence, smart sensors or Machine Learning.
Minimum level(s) of standards possibly required:
Section above.
III.2.4)Information about reserved contracts
III.3)Conditions specific to services contracts
III.3.1)Information about a particular profession
Execution of the service is reserved to a particular profession: no
III.3.2)Staff responsible for the execution of the service
Legal persons should indicate the names and professional qualifications of the staff responsible for the execution of the service: yes

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
The most economically advantageous tender in terms of the criteria stated in the specifications, in the invitation to tender or to negotiate or in the descriptive document
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:
To be completed
IV.3.2)Previous publication(s) concerning the same contract

Prior information notice

Notice number in the OJEU: 2016/S 174-313210 of 9.9.2016

Other previous publications

Notice number in the OJEU: 2016/S 179-321475 of 16.9.2016

IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document
Time limit for receipt of requests for documents or for accessing documents: 31.7.2017
Payable documents: no
IV.3.4)Time limit for receipt of tenders or requests to participate
31.8.2017
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
until: 24.10.2017
IV.3.8)Conditions for opening of tenders
Date: 11.9.2017

Place:

Avda. Fernando de Casas Novoa, n.º 37, Portal A-B, 1º andar 15707, Santiago de Compostela, A Coruña.

Persons authorised to be present at the opening of tenders: yes
Additional information about authorised persons and opening procedure: Bidders can be present at the opening of envelops B and C.

Section VI: Complementary information

VI.1)Information about recurrence
This is a recurrent procurement: no
VI.2)Information about European Union funds
The contract is related to a project and/or programme financed by European Union funds: yes
Reference to project(s) and/or programme(s): EMPATTICS project (EMpowering PAtients for a betTTer Information and Improvement of the Communication Systems), Horizon 2020 programme — Cofund — PCP.
VI.3)Additional information
This procurement procedure is exempt from the EU public procurement directives as procurers do not retain all the benefits of the R&D (as a general rule, the IPR ownership remains with the contractors) and does not use the classical open procedure.
PCP is also exempted from the WTO Government Procurement Agreement (GPA) because this Agreement does not cover R&D services (the PCP being limited to such services — and any subsequent PPI or similar large-scale innovative procurements activities relating to commercial-scale supply of such solutions not being part of the PCP procurement).
The procurement does not constitute state aid under the EU state aid rules because it follows an open, transparent, competitive procedure with risk- and benefit-sharing at market price. (The division of all rights and obligations (including IPRs) and all selection and award criteria for all phases are published at the outset; the PCP is limited to R&D services and clearly separated from any potential follow-up PPI procurements; PCP contractors are not given any preferential treatment in a subsequent procurement for provision of the final products or services on a commercial scale).
VI.4)Procedures for appeal
VI.4.1)Body responsible for appeal procedures

Official name: Agencia Gallega para la Gestión del Conocimiento en Salud, ACIS (Health Knowledge Agency)
Postal address: av. Fernando de Casas Novoa, nº 37, portal A-B, 1º andar
Town: Santiago de Compostela
Postal code: 15707
Country: Spain
E-mail: empattics@sergas.es
Telephone: +34 981568055

Body responsible for mediation procedures

Official name: Agencia Gallega para la Gestión del Conocimiento en Salud, ACIS (Health Knowledge Agency)
Postal address: av. Fernando de Casas Novoa, nº 37, portal A-B, 1º andar
Town: Santiago de Compostela
Postal code: 15707
Country: Spain
E-mail: empattics@sergas.es
Telephone: +34 981568055
Internet address: www.acis.sergas.es

VI.4.2)Lodging of appeals
Precise information on deadline(s) for lodging appeals: 15.9.2017 — Deadline for remedying deficiencies (Envelop A).
16.10.2017 — Deadline for submitting appeals.
VI.4.3)Service from which information about the lodging of appeals may be obtained

Official name: Agencia Gallega para la Gestión del Conocimiento en Salud, ACIS (Health Knowledge Agency)
Postal address: av. Fernando de Casas Novoa, nº 37, portal A-B, 1º andar
Town: Santiago de Compostela
Postal code: 15707
Country: Spain
E-mail: empattics@sergas.es
Telephone: +34 981568055
Internet address: www.acis.sergas.es

VI.5)Date of dispatch of this notice:
29.6.2017