Has scans Source status · 11 documents · Completeness: 89%
- POCT_DISCIPLINARE.pdf (disciplinare, 44 pp.)
- Allegato_2_Schema_domanda_partecipazione.doc (allegato, 1 pp.)
- Allegato_3_Dichiarazione_sostitutiva_familiari_conviventi.doc (allegato, 1 pp.)
- Allegato_4_Modulo_attestazione_pag_bollo.doc (allegato, 1 pp.)
- Allegato_5_SchedaOffertaEconomica.xlsx (offerta_economica, 1 pp.)
- Allegato_6_Dich__giustificativi_di_prezzo.xlsx (offerta_economica, 1 pp.)
- Allegato_7_Patto_di_integrit_.doc (allegato, 1 pp.)
- Allegato_8_DUVRI_rev05_18-07-22.doc (allegato, 1 pp.) · ⚠ unreadable scan (needs OCR)
- Allegato_9_Schema_di_contratto.doc (allegato, 1 pp.)
- Allegato_Det-00831-24-03-2026.pdf (allegato, 8 pp.)
- Estratto_gazz_cee_060_208750-2026.pdf (estratto, 6 pp.)
ℹ️ Some documents are text-less scans: some data cannot be extracted until OCR is run. 'Not stated' fields may be due to this.
🔴 NO-GO
Focus: coagulation POCT; molecular biology (respiratory) · Deadline: expired · Exclusivity risk: high
Doubly in focus and of enormous value, but deadline expired (06/05/2026); moreover the AQURE middleware constraint (Lot 1) and the anti-China IPI measure (≤50% Chinese devices) are potential showstoppers.
🎯 Merit only (ignore deadline): TO EVALUATE — Enormous prize: Lot 2 (4-target molecular respiratory panel) would have been a great opportunity if Firsteck had the CE-IVDR combo; Lot 1, however, is penalised by the AQURE middleware constraint and the anti-China IPI measure.
TENDER ANALYSIS No. AUSL Romagna - POCT E TEST COMBO (TED 208750-2026, CUI F02483810392202500088)
Document generated on 04/06/26 15:10
TENDER IDENTIFICATION DATA
| TENDER SUBJECT | Open procedure above the European thresholds for the award of public supply contracts for diagnostic systems: POCT for coagulation (Lot 1) and for respiratory viruses (Lot 2), using the most economically advantageous tender criterion based on the best quality/price ratio.Source: POCT_DISCIPLINARE.pdf: pagina 1 |
| CONTRACTING AUTHORITY | Azienda Unità Sanitaria Locale della Romagna - Registered office: via De Gasperi 8, 48121 Ravenna. Goods and Services Procurement Unit (Director avv. Morris Montalti), Viale 1° Maggio 280, Pievesestina di Cesena (FC). PEC: acquisti@pec.auslromagna.it. Project RUP: dott.ssa Silvia Francia; award-phase RUP: dott.ssa Giulia Rossi.Source: POCT_DISCIPLINARE.pdf: pagina 4 |
| CIG (tender ID) | One CIG for each lot, published on the company website (Amministrazione Trasparente), on ANAC's PVL and on the Intercenter website. CUI (Single Intervention Code): F02483810392202500088. Decision to contract no. 831 of 24/03/2026.Source: POCT_DISCIPLINARE.pdf: pagina 4 |
| PROCEDURE TYPE | Open procedure above the EU threshold (Directive 2014/24/EU; Legislative Decree 36/2023). Procedure identifier: 5e44fa82-314a-48ce-944d-fd1491e31881.Source: Estratto_gazz_cee_060_208750-2026.pdf: pagina 1 |
| PLATFORM | PAD SATER - Emilia-Romagna Electronic Procurement System of Intercent-ER (http://intercenter.regione.emilia-romagna.it). Registration and identification via SPID/CIE/CNS (for non-EU operators, digital identity LoA ≥ 3). Electronic submission and digital signature are mandatory.Source: POCT_DISCIPLINARE.pdf: pagina 4 |
| PLACE OF PERFORMANCE | The entire territory of the Azienda USL della Romagna - Provinces of Forlì-Cesena, Ravenna and Rimini (NUTS ITH57, ITH58, ITH59).Source: POCT_DISCIPLINARE.pdf: pagina 4 |
| AWARD CRITERION | Most economically advantageous tender (MEAT) identified on the basis of the best quality/price ratio. Awardable per individual lot.Source: POCT_DISCIPLINARE.pdf: pagina 4 |
| BID SUBMISSION DEADLINE | 06/05/2026 at 12:00 (CET). NB: deadline already expired as of the date of this analysis (04/06/2026). Tender validity: 365 days.Source: Estratto_gazz_cee_060_208750-2026.pdf: pagina 3 |
| TOTAL AMOUNT | FIVE-YEAR base auction amount (5 years): € 4,950,000.00 net of VAT, of which Lot 1 € 425,000.00 and Lot 2 € 4,525,000.00 (interference safety costs € 0.00). GLOBAL estimated value of the contract, including all options (24-month renewal, 12-month extension, 9-month bridge contract, 40% increase, catalogue purchases, mandatory fifth, price revision, contingencies): € 22,151,250.00. Estimated value published on TED/OJEU: € 39,352,500.00.Source: POCT_DISCIPLINARE.pdf: pagina 8 |
| PNRR (recovery funds) | Not stated: the contract is financed with the contracting authority's ordinary funds (not financed with EU funds).Source: POCT_DISCIPLINARE.pdf: pagina 9 |
| CPV code | 33124110-9 - Diagnostic systems (ATECO 325 - Manufacture of medical and dental instruments and supplies).Source: POCT_DISCIPLINARE.pdf: pagina 8 |
| NUMBER OF LOTS | 2 lots awardable individually. A tenderer may submit a tender for and be awarded both lots.Source: POCT_DISCIPLINARE.pdf: pagina 8 |
PARTICIPATION REQUIREMENTS
| ELIGIBILITY REQUIREMENTS | Registration in the Companies Register or in the Register of Artisan Enterprises for activities relevant to the subject of the tender. For operators from another Member State: registration in professional/commercial registers pursuant to annex II.11 of the Code. Proof obtained ex officio through FVOE.Source: POCT_DISCIPLINARE.pdf: pagina 15 |
| ECONOMIC CAPACITY | No special economic and financial capacity requirements are foreseen for participation.Source: POCT_DISCIPLINARE.pdf: pagina 15 |
| TECHNICAL CAPACITY | No special technical and professional capacity requirements are foreseen for participation. (Quality and environmental certificates from independent bodies are nonetheless required at the tender stage - see OJEU.)Source: POCT_DISCIPLINARE.pdf: pagina 15 |
| SOA CATEGORY | Not stated (supply contract). |
| CREDIT LICENCE | Not stated. |
| ADDITIONAL REQUIREMENTS | Not stated |
| WHITE LIST | Not stated. |
| GENERAL REQUIREMENTS | Absence of automatic (art. 94 Legislative Decree 36/2023) and non-automatic (art. 95) grounds for exclusion. Verification through FVOE. Self-cleaning is allowed (art. 96, para. 6). Exclusion for breach of the integrity pact / legality protocol.Source: POCT_DISCIPLINARE.pdf: pagina 12 |
| CLAUSOLA IPI (ORIGINE CINESE) | WARNING: pursuant to Reg. (EU) 2022/1031 and Implementing Reg. (EU) 2025/1197 (IPI measure), tenders from economic operators originating in the People's Republic of China are EXCLUDED. Other operators may not offer or supply medical devices of Chinese origin for a value exceeding 50% of the total value of the tender (origin determined pursuant to art. 60 Reg. EU 952/2013). Constraint extended to subcontracting (max 50% to Chinese operators).Source: POCT_DISCIPLINARE.pdf: pagina 14 |
PRELIMINARY OBLIGATIONS
| BID BOND | Required on pain of exclusion: 2% of the total value of the contract for each lot. Lot 1: € 38,037.50 (on an amount of € 1,901,875.00); Lot 2: € 404,987.50 (on an amount of € 20,249,375.00). Validity 365 days, with a commitment to renew for a further 180 days. Reductions pursuant to art. 106, para. 8: -30% (ISO 9001), -50% (SME), -10% (guarantee on platform / electronically verifiable), -20% (certifications/marks annex II.13). Deposit or surety bond.Source: POCT_DISCIPLINARE.pdf: pagina 18 |
| ANAC FEE | Required for each lot in which one participates (admissibility condition): Lot 1 € 165.00; Lot 2 € 560.00. ANAC Resolution no. 598 of 30/12/2024.Source: POCT_DISCIPLINARE.pdf: pagina 21 |
| SITE INSPECTION | Not required.Source: POCT_DISCIPLINARE.pdf: pagina 20 |
| SAMPLING | Not required.Source: POCT_DISCIPLINARE.pdf: pagina 31 |
| TIMESTAMP / DIGITAL SIGNATURE | Tender and documentation signed with a digital signature or other qualified/advanced electronic signature (eIDAS Reg. EU 910/2014). Submission exclusively via PAD SATER within the deadline, on pain of inadmissibility.Source: POCT_DISCIPLINARE.pdf: pagina 21 |
| TECHNICAL OFFER | Required, one for each lot in which one participates. Technical/scientific documentation also accepted in English without translation; the rest in Italian.Source: POCT_DISCIPLINARE.pdf: pagina 21 |
| STAMP DUTY | Required: € 16.00 on the application to participate, via F24 / virtual stamp duty (subject to authorisation from the Revenue Agency) / @e.bollo / revenue stamp with serial number (Annex 4). Foreign operators via bank transfer (dedicated IBAN).Source: POCT_DISCIPLINARE.pdf: pagina 25 |
| LABOUR CONTRACT (CCNL) | Not specified in the tender rules (see Special Specifications / Draft Contract - Annex 9). |
| ACCELERATION BONUS | Not stated |
| SUBCONTRACTING | Allowed: the competitor indicates the services to be subcontracted (failing which, prohibited). Full execution may not be subcontracted. SME share ≥ 20% of the subcontracted services. IPI constraint: no more than 50% of the contract value to operators of Chinese origin.Source: POCT_DISCIPLINARE.pdf: pagina 17 |
| RELIANCE (avvalimento) | Permitted for special requirements (par. 6) and/or to improve the tender (reward-based reliance). NOT permitted for general requirements and for registration with the Chamber of Commerce. Reliance contract natively digital and digitally signed; joint and several liability.Source: POCT_DISCIPLINARE.pdf: pagina 16 |
| RTI / CONSORTIUM | Participation allowed in single or associated form (RTI, consortia, EEIG, network aggregations) pursuant to arts. 67-68 of the Code. Rules on signing and requirements for the various forms are regulated.Source: POCT_DISCIPLINARE.pdf: pagina 11 |
| CLARIFICATIONS DEADLINE | 15/04/2026 at 14:30 (CET). Queries are forwarded only via PAD SATER; replies are published anonymously at least 6 days before the tender deadline.Source: Estratto_gazz_cee_060_208750-2026.pdf: pagina 3 |
| FVOE (virtual file) | Required: the contracting authority verifies possession of the general and special requirements by accessing the Virtual File of the Economic Operator (FVOE).Source: POCT_DISCIPLINARE.pdf: pagina 12 |
| DUVRI (interference risks) | Required: Single Interference Risk Assessment Document (Annex 8), duly completed and signed by the employer (art. 26, para. 1, Legislative Decree 81/2008). Interference safety costs € 0.00.Source: POCT_DISCIPLINARE.pdf: pagina 24 |
| INTEGRITY PACT | Required (Annex 7) pursuant to art. 1, para. 17, Law 190/2012. Failure to accept is grounds for exclusion.Source: POCT_DISCIPLINARE.pdf: pagina 24 |
| REVISIONE PREZZI | Foreseen upon cost variations > 5% of the total amount: automatic adjustment of 80% of the value exceeding 5%, on the PPI ATECO 325 index. Dedicated provision € 4,331,250.00.Source: POCT_DISCIPLINARE.pdf: pagina 9 |
Custom questions
Is the tender still open?
No: the tender deadline (06/05/2026) has expired relative to the analysis date (04/06/2026). A useful document as a reference/benchmark for similar tenders. Source: Estratto_gazz_cee_060_208750-2026.pdf: pagina 3
Are there restrictions on products of Chinese origin?
Yes, a strong restriction (IPI measure): operators originating in the PRC are excluded; for others, medical devices of Chinese origin may not exceed 50% of the tender value, on pain of exclusion/termination. A constraint to be carefully verified against the Firsteck portfolio. Source: POCT_DISCIPLINARE.pdf: pagina 14
Is a specific middleware required?
Yes: final acceptance testing is conditional on the positive verification of connection to the AQURE middleware of Radiometer Medical ApS (an indispensable requirement, on pain of exclusion, especially for Lot 1). Source: POCT_DISCIPLINARE.pdf: pagina 9
Can both lots be won?
Yes: a tenderer may submit a tender for both lots and be awarded both. Source: POCT_DISCIPLINARE.pdf: pagina 8
TECHNICAL ANALYSIS
Subject: Supply of POCT diagnostic systems for coagulation (Lot 1) and for the identification of respiratory viruses by molecular biology (Lot 2), including instrumentation on free loan and consumables.Total base amount: Five-year base auction € 4,950,000.00 (Lot 1 € 425,000 + Lot 2 € 4,525,000). Global value with options € 22,151,250.00; TED/OJEU value € 39,352,500.00.No. of lots: 2
LOT 1 — Coagulation POCT (ACT) — at least 20 systems on loan
| CIG | A dedicated CIG (see Amministrazione Trasparente / ANAC / Intercenter). |
| Description / what it is | WHAT IS NEEDED: POCT systems for the determination of the activated clotting time (ACT), with instrumentation on FREE loan (no rental or service fees) and consumables (reagents/kits). Supplied across the entire AUSL Romagna territory. |
| System / instrumentation | At least 20 POCT systems on loan (as per Annex E - List of locations). For each system: a printer (if not integrated, ON PAIN OF EXCLUSION) and a transport bag. KEY CONSTRAINT: MANDATORY connection to the AQURE middleware of Radiometer Medical ApS (final acceptance testing is subject to verification of the connection - on pain of exclusion). |
| Base amount | Five-year base auction (5 years): € 425,000.00 (€ 85,000/year indicative). Total contract amount for guarantee/ANAC purposes: € 1,901,875.00. TED estimated value: € 3,378,750.00. |
| Volumes | Number of ACT tests/year for each location, including quality controls - details in Annex 5 (Economic Tender Form) and Annex E. (To be precisely quantified from the economic form.) |
| Duration | 5 years from positive acceptance testing + options (24-month renewal, 12-month extension, 9-month bridge contract, increase up to 40%). |
| Required tests | - ACT test (Activated Clotting Time) on whole blood, POCT, including quality controls
|
| Technical requirements | - Instrumentation on free loan (no rental/service fee)
- A printer for each system, if not integrated — ON PAIN OF EXCLUSION
- Connection to the AQURE middleware of Radiometer Medical ApS — ON PAIN OF EXCLUSION
- Transport bag, 1 per system (indispensable device requirement)
- Reagents/kits/consumables with declared CND, Repertory no., UDI-ID
- Devices of Chinese origin ≤ 50% of the tender value (IPI measure)
|
| Sampling | Not required. |
| Notes | FOR TECHNICAL/SALES: the AQURE (Radiometer) constraint and the free loan strongly steer the tender towards suppliers already integrated with that middleware; assess whether the ACT system in the Firsteck catalogue can interface with AQURE. Possible competitive advantage for the incumbent. |
| Sources | - POCT_DISCIPLINARE.pdf: pagina 8
- POCT_DISCIPLINARE.pdf: pagina 9
- Allegato_5_SchedaOffertaEconomica.xlsx: pagina 1
|
LOT 2 — Respiratory virus POCT — molecular COMBO panel (SARS-CoV-2 / Flu A / Flu B / RSV)
| CIG | A dedicated CIG (see Amministrazione Trasparente / ANAC / Intercenter). |
| Description / what it is | WHAT IS NEEDED: POCT diagnostic systems for the simultaneous identification of the respiratory viruses SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV), with NUCLEIC ACID AMPLIFICATION TECHNOLOGY (molecular biology / NAAT), including reagents/kits/consumables. It is by far the largest lot. |
| System / instrumentation | Molecular POCT systems for a 4-target respiratory combo test (details in Specifications/Annex E). Instrumentation supplied with the goods. |
| Base amount | Five-year base auction (5 years): € 4,525,000.00 (≈ € 905,000/year). Total contract amount for guarantee/ANAC purposes: € 20,249,375.00. TED estimated value: € 35,973,750.00. |
| Volumes | Numbers/year per location in Annex 5 (Economic Tender Form) / Annex E. (To be quantified from the economic form.) |
| Duration | 5 years from positive acceptance testing + options (renewal, extension, bridge, 40% increase). |
| Required tests | - Respiratory COMBO panel by molecular biology (nucleic acid amplification): SARS-CoV-2 + Influenza A + Influenza B + Respiratory Syncytial Virus (RSV) in a single determination
|
| Technical requirements | - SIMULTANEOUS (combo) identification of SARS-CoV-2, Influenza A, Influenza B and RSV
- Nucleic acid amplification technology (molecular / NAAT)
- Quality (ISO) and environmental certificates from independent bodies
- Devices of Chinese origin ≤ 50% of the tender value (IPI measure)
|
| Sampling | Not required. |
| Notes | FOR TECHNICAL/SALES: falls within the 'molecular biology / rapid POCT tests' focus. Lot of enormous value (≈ €4.5M base, over €20M with options). Verify whether Firsteck has a 4-target molecular respiratory combo panel with CE-IVDR marking and the related POCT platform. |
| Sources | - POCT_DISCIPLINARE.pdf: pagina 9
- Estratto_gazz_cee_060_208750-2026.pdf: pagina 4
|
Assessment for Firsteck Bio
CAN WE COMPETE? A tender doubly in focus (Lot 1 coagulation POCT/ACT; Lot 2 respiratory molecular biology POCT), with a very high overall value. TWO SHOWSTOPPERS to verify immediately with technicians and management: (1) IPI measure — Chinese operators and devices of Chinese origin exceeding 50% of the tender value are excluded: check the origin of the catalogue products; (2) Lot 1 requires mandatory integration with Radiometer's AQURE middleware (on pain of exclusion), which may favour the incumbent. NB tender deadline already expired (06/05/2026): treat as a strategic benchmark and as a model for similar future tenders in coagulation POCT and molecular respiratory.