Full tender Source status Β· 8 documents Β· Completeness: 83%
- 20491AVVISOAGGIUDICAZ.pdf (avviso, 1 pp.)
- Allegati_A_e_B.docx (allegato, 1 pp.)
- DGUE-editabile.doc (dgue, 1 pp.)
- estratto.pdf (estratto, 1 pp.)
- Informativa_di_sicurezza.pdf (privacy, 3 pp.)
- lettera_invito.pdf (lettera_invito, 18 pp.)
- patto_integrit.pdf (privacy, 6 pp.)
- SDE.xlsx (altro, 1 pp.)
π΄ NO-GO
Focus: coagulazione POCT; test rapidi Β· Deadline: historical/outcome Β· Exclusivity risk: high
Tender already awarded to Instrumentation Laboratory (single-supplier procedure, deadline expired 10/11/2023); POCT requirements with ACT-LR oriented toward a single platform.
π― Merit only (ignore deadline): NO-GO β Single-supplier negotiated procedure awarded to Instrumentation Laboratory (Werfen): not contestable by design.
TENDER ANALYSIS No. 9394022
Document generated on 04/06/26 15:23
TENDER IDENTIFICATION DATA
| TENDER SUBJECT | Negotiated procedure for the service-based supply of 5 coagulation tests and related consumablesSource: lettera_invito.pdf: pagina 1 |
| CONTRACTING AUTHORITY | Fondazione IRCCS Policlinico San Matteo - Pavia (Tax code 00303490189 - VAT 00580590180, V.le Golgi 19, 27100 Pavia)Source: lettera_invito.pdf: pagina 1 |
| CIG (tender ID) | A02268F6A9Source: lettera_invito.pdf: pagina 1 |
| PROCEDURE TYPE | Negotiated procedure without prior publication of a contract notice, pursuant to art. 50 paragraph 1 of Legislative Decree 36/2023Source: lettera_invito.pdf: pagina 1 |
| PLATFORM | SINTEL - Lombardy Region / ARIA (www.aria.regione.lombardia.it)Source: lettera_invito.pdf: pagina 1 |
| PLACE OF PERFORMANCE | Pavia - Fondazione IRCCS Policlinico San Matteo, V.le Golgi 19Source: lettera_invito.pdf: pagina 1 |
| AWARD CRITERION | Lowest price (art. 108 paragraph 3 of Legislative Decree 36/2023), subject to verification of the conformity of the proposed material with the needs of the departmentSource: lettera_invito.pdf: pagina 13 |
| BID SUBMISSION DEADLINE | 10/11/2023 at 16:00 (mandatory deadline)Source: lettera_invito.pdf: pagina 8 |
| TOTAL AMOUNT | Auction base not stated in the documents; award amount β¬ 214.920,00 (excluding 22% VAT) for 36 monthsSource: 20491AVVISOAGGIUDICAZ.pdf: pagina 1 |
| PNRR (recovery funds) | NoSource: estratto.pdf: pagina 1 |
PARTICIPATION REQUIREMENTS
| ELIGIBILITY REQUIREMENTS | Not stated |
| ECONOMIC CAPACITY | Not stated |
| TECHNICAL CAPACITY | Not stated |
| SOA CATEGORY | Not stated (supply contract, SOA not applicable) |
| CREDIT LICENCE | Not stated |
| ADDITIONAL REQUIREMENTS | Not stated |
| WHITE LIST | Not stated |
| REQUISITI IDONEITA | Registration in the professional/commercial register (ESPD Part IV sec. A par. 1 and 2)Source: lettera_invito.pdf: pagina 3 |
| REQUISITI CAPACITA ECONOMICA | ESPD Part IV sec. B par. 1a), 2a), 3 (if relevant), 5; turnover thresholds/amounts not specified in the documentsSource: lettera_invito.pdf: pagina 3 |
| REQUISITI CAPACITA TECNICA | ESPD Part IV sec. C par. 1b), 2), 3), 5), 6), 8), 10); conformity of the products with national/EU standards and with the IVD Regulation (EU) 2017/746Source: lettera_invito.pdf: pagina 3 |
PRELIMINARY OBLIGATIONS
| BID BOND | Not expressly required in the invitation letter; the Integrity Pact mentions enforcement of the provisional guarantee only in case of breach (amount not specified)Source: patto_integrit.pdf: pagina 6 |
| ANAC FEE | CIG payment receipt to be attached, if dueSource: lettera_invito.pdf: pagina 4 |
| SITE INSPECTION | No site inspection obligation appears in the letter; a site inspection report template is included among the attachments (Safety Information), to be attached to the technical documentationSource: lettera_invito.pdf: pagina 6 |
| SAMPLING | Possible: sampling/demo/viewing of the offered device may be requested, with procedures communicated laterSource: lettera_invito.pdf: pagina 7 |
| TIMESTAMP / DIGITAL SIGNATURE | Not stated |
| TECHNICAL OFFER | Required in the technical envelope (single zip file + unsigned PDF copies): technical data sheets, declarations of minimum regulatory requirements, CE certification, description of maintenance/training service, completed Annexes A and B, copy of the offer without prices with product codes, safety informationSource: lettera_invito.pdf: pagina 6 |
| STAMP DUTY | Not stated |
| LABOUR CONTRACT (CCNL) | Declaration required of the collective bargaining agreement applied to the staff employed in the contract, pursuant to art. 11 of Legislative Decree 36/2023Source: lettera_invito.pdf: pagina 3 |
| ACCELERATION BONUS | Not stated |
| SUBCONTRACTING | Permitted pursuant to art. 119 of Legislative Decree 36/2023; to be declared in ESPD Part II sec. DSource: lettera_invito.pdf: pagina 17 |
| RELIANCE (avvalimento) | Permitted (art. 89 - ESPD Part II sec. C); to be completed only in case of reliance on third-party capacitiesSource: lettera_invito.pdf: pagina 3 |
| RTI / CONSORTIUM | Permitted: in case of a temporary grouping (RTI), the PassOE must list the lead company and all the mandators; each operator submits a separate ESPD and signs the Integrity PactSource: lettera_invito.pdf: pagina 4 |
| CLARIFICATIONS DEADLINE | Specific date not stated; clarifications are submitted via the 'Procedure Communications' function on SINTELSource: lettera_invito.pdf: pagina 9 |
| FVOE (virtual file) | PassOE mandatory: requirements verified via the Economic Operator's Virtual File (FVOE) of ANAC; registration with the FVOE is mandatorySource: lettera_invito.pdf: pagina 4 |
Custom questions
Is the tender still open or already concluded?
Concluded/historical: awarded by decision no. 5/D.G. 297 of 15/03/2024 to Instrumentation Laboratory for β¬ 214.920,00 excluding VAT. Bid deadline expired on 10/11/2023. Source: 20491AVVISOAGGIUDICAZ.pdf: pagina 1
How many operators were invited and participated?
1 company invited, 1 participant, 0 excluded: effectively a single-supplier negotiated procedure. Source: 20491AVVISOAGGIUDICAZ.pdf: pagina 1
What is the duration of the contract?
36 months (service-based supply); the first 12 months are guaranteed even if an ARIA/Consip framework agreement is activated. Source: lettera_invito.pdf: pagina 1
Is a mandatory branded IT interface (middleware) required?
Any bidirectional interfacing with the hospital IT systems is included in the full-risk service, but no specific branded middleware is imposed. Source: lettera_invito.pdf: pagina 10
TECHNICAL ANALYSIS
Subject: Service-based supply of 5 coagulation tests and related consumablesTotal base amount: β¬ 214.920,00 (excluding VAT) - award amount for 36 months (~β¬ 71.640,00/year); auction base not stated in the documentsNo. of lots: 1
LOT 1 β Service of POCT systems for coagulation tests (PT/APTT/ACT/ACT-LR)
| CIG | A02268F6A9 |
| Description / what it is | Single lot. The Foundation requires on a service basis (full-risk rental + consumables) 5 portable systems for performing coagulation tests at the point-of-care. What is purchased: the rental fee for the 5 instruments, including ordinary/extraordinary maintenance, training, spare parts and all charges, plus the consumables (reagents/cartridges) to perform the PT, APTT, ACT and ACT-LR tests on whole/citrated blood. A quotation is also provided for the possible final buyout of the 5 systems. |
| System / instrumentation | Battery-powered portable instrument (POCT) for coagulation on whole blood; brand-new factory system, not refurbished. PT and APTT can also be performed on citrated blood. |
| Base amount | Not stated in the tender documents. Award amount: β¬ 214.920,00 excluding VAT for 36 months (~β¬ 71.640,00/year). |
| Volumes | Annual consumption from the Economic Detail Sheet: ACT 4,300 tests/year, ACT-LR 2,400 tests/year, APTT 200 tests/year. (NB: in the SDE file 'ACT' appears as the OCR typo 'ATC'). PT volumes not reported in the extracted SDE table. |
| Duration | 36 months (service-based); the first 12 months are guaranteed even if an ARIA/Consip framework agreement is activated |
| Required tests | - PT - monitoring of oral anticoagulant therapy and screening
- APTT - monitoring of heparin therapy at therapeutic levels and screening
- ACT - monitoring of moderate/high heparin levels during surgical procedures
- ACT-LR (Low Range) - monitoring of low/moderate heparin levels during surgical procedures
- PT and APTT on citrated blood
|
| Technical requirements | - Battery-powered portable instrument (POCT)
- Brand-new factory system, not refurbished
- Declaration of conformity with the IVD Regulation (EU) 2017/746, in force since May 2022
- CE marking, CND code and device registry number
- Conformity with CEI/IEC standards for the electrical parts; safety devices on motorized systems
- Full-risk assistance/maintenance included: intervention within 8 working hours, resolution within 16-24 hours, supply of a back-up instrument of the same model, machine downtime max 7 days/year
- User manuals in Italian (2 copies), staff training, acceptance testing with report
- Possible bidirectional interfacing with the hospital IT systems
- Annex A (supplier commitments) and Annex B (preliminary technical data sheet) completed, under penalty of possible exclusion
|
| Sampling | Possible: the Foundation reserves the right to request sampling/demo/viewing of the offered device, with procedures communicated later |
| Notes | MAIN SHOWSTOPPER: procedure ALREADY AWARDED (decision of 15/03/2024) to INSTRUMENTATION LABORATORY (Werfen group), single-supplier tender (1 invited, 1 participant, 0 excluded). Bid deadline expired on 10/11/2023: cannot be participated in. The required profile (PT/APTT/ACT/ACT-LR on a battery-powered portable instrument, with ACT-LR low range) is typical of the Hemochron / GEM PCL platform of Instrumentation Laboratory: requirements oriented toward a single supplier (high exclusivity risk, confirmed by the single-supplier outcome). No branded middleware explicitly mandatory. No action possible for Firsteck; useful only as a benchmark to intercept a possible future re-tender by the same entity (known volumes). |
| Sources | - lettera_invito.pdf: pagina 1
- lettera_invito.pdf: pagina 9
- lettera_invito.pdf: pagina 10
- SDE.xlsx: pagina 1
- 20491AVVISOAGGIUDICAZ.pdf: pagina 1
|
Assessment for Firsteck Bio
The product falls within Firsteck's focus (POCT coagulation / rapid tests): 5 battery-powered portable systems for PT/APTT/ACT/ACT-LR at the point-of-care, with known volumes (~4,300 ACT + 2,400 ACT-LR + 200 APTT/year). However, the tender is a single-supplier negotiated procedure ALREADY AWARDED to Instrumentation Laboratory (Werfen) on 15/03/2024 for β¬ 214.920,00, with the bid deadline expired in November 2023: no possibility of participating. The requirements (portability, battery, ACT-LR low range) appear designed around a single platform, with high exclusivity risk. Residual value: monitor San Matteo Pavia in view of the next POCT coagulation re-tender.