Laboratory solution for Cellular Therapy at Oslo University Hospital Trust (OUS)

Helse Sør-Øst RHF Avd. Sykehuspartner

Oslo University Hospital Trust (OUS) is conducting a project for procurement of a Laboratory solution for Celluar Theraphy.
The Department of Cellular Therapy (CT), The Radium Hospital, Oslo University Hospital HF (OUS), produces Cellular Therapy products of high quality for use in cancer treatment.
The Department of ExVivo Cell laboratory (ExVivo), The Division of Transplantation Immunology, Oslo University Hospital HF (OUS), produces Cells outside the body for later patient treatment.
Each year CT produce 30 vaccines, accomplish almost 400 vaccine injections and 160 stem cell preparations.
The new software system should secure the patient security through documentation and traceability in the manufacturing process. The solution will also establish stable and secure maintenance and management, in addition to satisfying governmental regulation terms and international accreditation requirements.
NOTE: To register your interest in this notice and obtain any additional information please visit the Doffin Web Site at http://www.english.doffin.no/Search/Search_Switch.aspx?ID=300535

Frist

Fristen for mottak av tilbud var 2013-08-22. Anskaffelsen ble publisert 2013-07-17.

Hvem?

• Helse Sør-Øst RHF Avd. Sykehuspartner

Hva?

Hvor?

• Norge

Anskaffelseshistorikk

Dato	Dokument
2013-07-17	Kunngjøring av konkurranse

Kunngjøring av konkurranse (2013-07-17)
Gjenstand
Anskaffelsens omfang
Tittel: IT services: consulting, software development, Internet and support
Antall eller omfang:

The system would be developed for healthcare / hospital cell / gene / therapy laboratories. It will be required that the candidate has knowledge of the EU / US Good Manufacturing Practice (GMP), the EU Cell Directive and ISBT 128 . The software for CT also has to comply with the regulation FOR-2008-03-07 Nr. 222 . The technical requirements for keeping track of information and receiving alerts accordingly.Laboratory software for CT would include (the list is not exhaustive):*Cellular Therapy at the Radium Hospital (CT)— The system needs to provide process support in the production of Dendritic Cell vaccines, harvesting, processing, storage and distribution of therapeutic cells used as Stem cell Support for High Dose Treatment (autologous and allogeneic hematopoietic progenitor cells from bone marrow and peripheral cells), reception, storage, distribution and tracing of umbilical cord blood units for use in stem cell transplantation.*Cellular Therapy (ExVivo)— The system needs to provide process support for the production of cells for cell-therapy.The Hospital Trust departments that use these solutions will provide national services and have accreditation after both international and national standards.The Laboratory software for CT and ExVivo must satisfy requirement set by GAMP in a way that we will be able to validate in order to document to supervisory authorities that GAMP is fulfilled.The procurement of the system solution includes such as:*System software*Consultant services in conjunction with— Deployment of the solution— Installation(s)— Integration(s)— Connections of modalities— Customization (Adjustment and Adaptations to systems and functions)— Configuration— Data migration— Test— Training of users— Documentation*Other consultancy services*Support and maintenance of the software and system solutionIt will in the tender documents be complementary described whether or not some of the items in the enumeration above will be added as options.The Laboratory software for CT should preferably be a fully developed system on the market as 'Off the shelf'.There is uncertainty about the amount and scope.1 500 0005 000 000

Metadata for kunngjøring
Originalspråk: engelsk 🗣️
Dokumenttype: Kunngjøring av konkurranse
Kontraktens art: Tjenester
Forskrift: Det europeiske økonomiske samarbeidsområdet (EØS), med deltakelse av GPA-land
Felles innkjøpsordliste (CPV)
Kode: Datatjenester: rådgivning, programvareutvikling, internett og systemstøtte 📦

Prosedyre
Prosedyretype: Konkurranse med forhandling
Tilbudstype: Innlevering for alle delkontrakter
Tildelingskriterier
Det mest økonomisk fordelaktige tilbudet

Oppdragsgiver
Identitet
Land: Norge 🇳🇴
Type tildelende myndighet: Offentligrettslig organ
Navn på tildelende myndighet: Helse Sør-Øst RHF Avd. Sykehuspartner
Postadresse: Postboks 3562
Postnummer: 3007
Poststed: Drammen
Kontakt
Internettadresse: http://www.sykehuspartner.no 🌏
E-post: innkjop-sp@sykehuspartner.no 📧
Telefon: +47 95059573 📞

Referanse
Datoer
Sendt dato: 2013-07-17 📅
Innleveringsfrist: 2013-08-22 📅
Publiseringsdato: 2013-07-19 📅
Identifikatorer
Kunngjøringsnummer: 2013/S 139-242728
OJ-S-utgave: 139
Tilleggsinformasjon
(NT Ref:301246)

Gjenstand
Anskaffelsens omfang
Kort beskrivelse:

Oslo University Hospital Trust (OUS) is conducting a project for procurement of a Laboratory solution for Celluar Theraphy.

The Department of Cellular Therapy (CT), The Radium Hospital, Oslo University Hospital HF (OUS), produces Cellular Therapy products of high quality for use in cancer treatment.

The Department of ExVivo Cell laboratory (ExVivo), The Division of Transplantation Immunology, Oslo University Hospital HF (OUS), produces Cells outside the body for later patient treatment.

Each year CT produce 30 vaccines, accomplish almost 400 vaccine injections and 160 stem cell preparations.

The new software system should secure the patient security through documentation and traceability in the manufacturing process. The solution will also establish stable and secure maintenance and management, in addition to satisfying governmental regulation terms and international accreditation requirements.

NOTE: To register your interest in this notice and obtain any additional information please visit the Doffin Web Site at http://www.english.doffin.no/Search/Search_Switch.aspx?ID=300535

Antall eller omfang:

Laboratory software for CT would include (the list is not exhaustive):

*Cellular Therapy at the Radium Hospital (CT)

— The system needs to provide process support in the production of Dendritic Cell vaccines, harvesting, processing, storage and distribution of therapeutic cells used as Stem cell Support for High Dose Treatment (autologous and allogeneic hematopoietic progenitor cells from bone marrow and peripheral cells), reception, storage, distribution and tracing of umbilical cord blood units for use in stem cell transplantation.

*Cellular Therapy (ExVivo)

— The system needs to provide process support for the production of cells for cell-therapy.

The Hospital Trust departments that use these solutions will provide national services and have accreditation after both international and national standards.

The Laboratory software for CT and ExVivo must satisfy requirement set by GAMP in a way that we will be able to validate in order to document to supervisory authorities that GAMP is fulfilled.

The procurement of the system solution includes such as:

*System software

*Consultant services in conjunction with

— Deployment of the solution

— Installation(s)

— Integration(s)

— Connections of modalities

— Customization (Adjustment and Adaptations to systems and functions)

— Configuration

— Data migration

— Test

— Training of users

— Documentation

*Other consultancy services

*Support and maintenance of the software and system solution

It will in the tender documents be complementary described whether or not some of the items in the enumeration above will be added as options.

The Laboratory software for CT should preferably be a fully developed system on the market as 'Off the shelf'.

There is uncertainty about the amount and scope.

Estimert verdi eksklusive mva: 1 500 000 💰
5 000 000 💰
Beskrivelse av opsjoner:

Other departments/units may use the solution in the form of options. See also the preceding paragraph (contract quantity or Scope).

Referansenummer: 13/00894
Utførelsessted
Hovedsted eller utførelsessted: Oslo.

Juridisk, økonomisk, finansiell og teknisk informasjon
Vilkår for deltakelse
Egnethet til å utøve yrkesvirksomheten:

(1) Company registration certificate.

(2) Value added tax certificate (National requirement)

(3) Company tax certificate (National requirement)

(4) Self-declaration in compliance with Appendix 2 (HSE) of the Norwegian procurement regulations (National requirement)

Økonomisk og finansiell stilling:

(1) Other documentation required (please state below)

Credit rating from a recognised credit rating agency. Candidates achieving a rating equivalent to an A, (credit without collateral) from Dun & Bradstreet (D&B) or equivalent will satisfy the qualification criteria.

The contracting authority reserves the right to obtain a rating from D&B.

Candidates who achieve a rating below A, can document that eligibility requirements are met in alternative ways cf. qualification documents.

Minste nivå(er) av standarder:

The candidate must have the economic and financial capacity to carry out the contract Scope and duties, including that the candidate shall be credithworthy, have satisfactory liquidity and low risk of bankruptcy.

Teknisk og faglig kapasitet:

(1) Other documentation required (please state below)

A brief, general description of the candidate, how it is organised and its business areas.

A brief, general description of any subcontractors, how they are organised and their business areas.

If the candidate shares the contract: A declaration of commitment from the subcontractor demonstrating that the candidate disposes necessary resources, equipment, tools and methods for the entire contract period.

A confirmation that the candidate and any subcontractors have the ability and capacity to fulfil the contract.

An overview of the average number of full time equivalent employees or any consultants working for the contractor the last three years within the areas relevant to the contract, as well as turnover for employees and consultants. The overview shall be given for the prime candidate and for every subcontractor (if any).

Relevant contracts from the last three (3) years shall be summarized. Relevant contracts are solutions delivered which are relevant to the needs. If the candidate has had no new implementations the last three years, the candidate may instead account for solutions currently in use.

A more extensive description shall be made for at least one (1) and no more than three (3) of the most important and relevant deliveries/implementations of similar solutions made the last three (3) years.

Minste nivå(er) av standarder:

The candidate shall have good capacity related to the delivery. This means that the candidate must have the capacity to finalize,implement,support and further develop the solution to the Health authorities that are covered by the contract during the contract period.

Candidate shall have sufficient capacity to carry out contractual obligations. Sufficient capacity means that the Candidate shall have delivered solutions/services that are relevant to the client's needs.

Prosedyre
Minste antall kandidater: 3
Største antall kandidater: 6
Objektive utvelgelseskriterier:

The selection among qualified applicants will be based on an assessment of which applicant that best satisfies the following award criteria:

*Candidate ability (ref. section 4.3.2) weight: 70 %

*Candidate capacity (ref. section 4.3.1) weight: 30 %

Dato for utsendelse av invitasjoner: 2013-09-04 📅
Språk
Språk: engelsk 🗣️

Oppdragsgiver
Kontakt
Kontaktpunkt: Bent Gjøstøl
Adresse til kjøperprofilen: http://www.doffin.no//search/Search_AuthProfile.aspx?ID=AA7010 🌏
Navn: Helse Sør-Øst RHF Avd. Sykehuspartner
URL for ytterligere informasjon: http://www.sykehuspartner.no 🌏
URL for dokumenter: http://www.sykehuspartner.no 🌏

Referanse
Identifikatorer
Referansenummer tildelt av oppdragsgiver: 13/00894
Kilde: OJS 2013/S 139-242728 (2013-07-17)

Nye anskaffelser i relaterte kategorier 🆕

Datatjenester: rådgivning, programvareutvikling, internett og systemstøtte (>20 nye anskaffelser)