Full tender Source status Β· 5 documents Β· Completeness: 55%
- ALLEGATO__INFORMATIVA_PRIVACY.pdf (allegato, 2 pp.)
- AVVISO_SISTEMI_PER_ACT.pdf (avviso, 6 pp.)
- estratto_188017721.pdf (estratto, 2 pp.)
- MODALITA_UTILIZZO_SINTEL_MAGGIO_2024.pdf (altro, 15 pp.)
- MODDICHIARAZIONE_SOSTITUTIVA_per_avviso_indagine.doc (avviso, 1 pp.)
π΄ NO-GO
Focus: coagulazione POCT; POCT Β· Deadline: expired Β· Exclusivity risk: high
Offer deadline expired on 28/08/2024 (historical tender) and the Celite method + TD-Synergy interface requirement is oriented towards a specific supplier (Hemochron/Werfen).
π― Merit only (ignore deadline): NO-GO β The 'Celite method' requirement is typical of Hemochron systems (Werfen/Accriva): effectively oriented towards the incumbent, low contestability regardless of timing.
TENDER ANALYSIS No. 188017721
Document generated on 04/06/26 12:44
TENDER IDENTIFICATION DATA
| TENDER SUBJECT | Market survey for the service-based supply of no. 1 system for the determination of ACT for the monitoring of coagulation in patients treated with infusion of high doses of heparin during haemodynamic procedures (Cardiology, Legnago Hospital)Source: AVVISO_SISTEMI_PER_ACT.pdf: pagina 1 |
| CONTRACTING AUTHORITY | Azienda ULSS 9 Scaligera - Via Valverde, 42, 37122 Verona - U.O.C. Procurement, Economato and Logistics ManagementSource: AVVISO_SISTEMI_PER_ACT.pdf: pagina 1 |
| CIG (tender ID) | Not stated (CIG code: - in the extract; this is a preliminary market survey)Source: estratto_188017721.pdf: pagina 1 |
| PROCEDURE TYPE | Market survey for direct award pursuant to art. 50 par. 1 lett. b) Legislative Decree 36/2023; award as a single lot pursuant to art. 58 par. 2; with subsequent direct negotiation via MEPA or SINTELSource: AVVISO_SISTEMI_PER_ACT.pdf: pagina 2 |
| PLATFORM | SINTEL (ARIA S.p.A. - www.ariaspa.it); subsequent direct negotiation on MEPA or SINTELSource: AVVISO_SISTEMI_PER_ACT.pdf: pagina 2 |
| PLACE OF PERFORMANCE | Cardiology of the Legnago Hospital (Azienda ULSS 9 Scaligera, Verona)Source: AVVISO_SISTEMI_PER_ACT.pdf: pagina 1 |
| AWARD CRITERION | Direct award following a market survey; ULSS vested with the broadest discretionary power. Economic offer method: economic value. Optional characteristics for quality assessment indicated in the noticeSource: estratto_188017721.pdf: pagina 1 |
| BID SUBMISSION DEADLINE | 28/08/24 at 23.59.00 CESTSource: estratto_188017721.pdf: pagina 1 |
| TOTAL AMOUNT | Estimated annual amount not exceeding β¬ 17.000,00 VAT excluded; direct award threshold not exceeding β¬ 139.990,00 VAT excluded; five-year duration (60 months)Source: AVVISO_SISTEMI_PER_ACT.pdf: pagina 2 |
| PNRR (recovery funds) | NoSource: estratto_188017721.pdf: pagina 1 |
PARTICIPATION REQUIREMENTS
| ELIGIBILITY REQUIREMENTS | Not being in the conditions of exclusion under arts. 94 to 98 Legislative Decree 36/2023; possession of the professional requirement (registration with the C.C.I.A.A. for the activity covered by the procedure) pursuant to art. 100 par. 1 lett. a) and par. 3 Legislative Decree 36/2023Source: AVVISO_SISTEMI_PER_ACT.pdf: pagina 2 |
| ECONOMIC CAPACITY | Not stated |
| TECHNICAL CAPACITY | Documented prior experience suitable for the performance of the contractual services, with a list of public/private entities, subject, date, amount of the supplies and award measuresSource: AVVISO_SISTEMI_PER_ACT.pdf: pagina 4 |
| SOA CATEGORY | Not stated |
| CREDIT LICENCE | Not stated |
| ADDITIONAL REQUIREMENTS | Not stated |
| WHITE LIST | Not stated |
PRELIMINARY OBLIGATIONS
| BID BOND | Not stated |
| ANAC FEE | Not stated |
| SITE INSPECTION | Not stated |
| SAMPLING | Not stated (technical data sheets and a technical report are requested, not physical samples)Source: AVVISO_SISTEMI_PER_ACT.pdf: pagina 4 |
| TIMESTAMP / DIGITAL SIGNATURE | Not explicitly required for the survey; the Sintel platform guarantees time validation and digital signature of the offer documentsSource: MODALITA_UTILIZZO_SINTEL_MAGGIO_2024.pdf: pagina 4 |
| TECHNICAL OFFER | Yes: technical data sheets and a technical report including the support service; declaration of conformity MDR/IVDR (Reg. EU 2017/746); CE marking certification for instrumentation and IVD devices; all digitally signedSource: AVVISO_SISTEMI_PER_ACT.pdf: pagina 4 |
| STAMP DUTY | Not stated |
| LABOUR CONTRACT (CCNL) | Not stated |
| ACCELERATION BONUS | Not stated |
| SUBCONTRACTING | Not stated |
| RELIANCE (avvalimento) | Not stated |
| RTI / CONSORTIUM | Not stated |
| CLARIFICATIONS DEADLINE | Not stated |
| FVOE (virtual file) | Not stated |
| DOCUMENTAZIONE AMMINISTRATIVA | Single offer envelope on Sintel: synthetic substitute declaration digitally signed (absence of grounds for exclusion arts. 94 ff., professional requirement CCIAA, list of prior experience, authorisation to process data). At the direct negotiation stage: DGUE, supplementary DGUE declaration, Integrity Pact, power of attorney if applicable, certifications of prior suppliesSource: AVVISO_SISTEMI_PER_ACT.pdf: pagina 5 |
| OFFERTA ECONOMICA | Since this is a survey, enter the symbolic value '1' in the Economic Offer field on Sintel; the detailed quotation must be uploaded as a separate documentSource: AVVISO_SISTEMI_PER_ACT.pdf: pagina 5 |
Custom questions
Is the CPV declared?
Yes: main CPV 33124110-9 - Diagnostic systems Source: estratto_188017721.pdf: pagina 1
Is a CIG envisaged at this stage?
No: in the Sintel extract the CIG code shows as '-'; this is a preliminary market survey, the CIG will be acquired at the direct negotiation stage Source: estratto_188017721.pdf: pagina 1
Which product technical requirements are binding?
POCT system for ACT, whole blood, Celite method, bidirectional interfacing to the LIS TD-Synergy, automatic internal QC, barcode reader, full risk with corrective interventions within 24h Source: AVVISO_SISTEMI_PER_ACT.pdf: pagina 1
Is IVDR conformity required?
Yes: declaration of conformity to the Regulation on in vitro diagnostic medical devices (cited MDR 2017/746) and CE marking for instrumentation and IVD devices Source: AVVISO_SISTEMI_PER_ACT.pdf: pagina 4
TECHNICAL ANALYSIS
Subject: Market survey for the service-based supply of no. 1 POCT system for the determination of ACT (Activated Clotting Time) for the monitoring of coagulation in patients treated with high doses of heparin in haemodynamic procedures - Cardiology, Legnago HospitalTotal base amount: β¬ 17.000,00/year VAT excluded (estimate) - approx. β¬ 85.000,00 over five years; direct award threshold β¬ 139.990,00No. of lots: 1
LOT 1 β POCT system for ACT determination - coagulation monitoring in haemodynamics
| CIG | Not stated (CIG '-' at survey stage) |
| Description / what it is | A Point-of-Care system is required to measure ACT (activated clotting time) directly in the Cardiology ward, used by ward staff on highly heparinised patients during haemodynamic procedures. Service-based supply (rental + consumables + full risk support) for 5 years, ~500 tests/year. Brand-new, latest-generation instrument, simple and reliable as a typical POCT device. |
| System / instrumentation | POCT analyser for ACT on whole blood, with Celite method (required) and optionally Kaolin method; automatic internal quality control; external or integrated barcode reader for operator/sample ID; bidirectional interface to the laboratory LIS TD-Synergy |
| Base amount | β¬ 17.000,00/year VAT excluded (estimated annual amount not exceeding); approx. β¬ 85.000,00 over the 5 years |
| Volumes | no. 500 ACT tests per year in total (Cardiology, Legnago Hospital) |
| Duration | Five-year period (60 months), possibly extendable |
| Required tests | - ACT - Activated Clotting Time with Celite method
- ACT with Kaolin method (optional, quality assessment)
|
| Technical requirements | - Use of whole blood
- ACT test with Celite method
- Coagulation time measuring range higher than that of the laboratory aPTT
- ACT monitoring over a wide range of heparin administration
- Automatic internal quality control
- External or integrated barcode reader (operator and sample ID)
- Interfaceability with bidirectional connection to the LIS TD-Synergy
- Possibility of use even without connection to the LIS
- Staff training, technological updating
- Full risk technical support: preventive maintenance + unlimited corrective interventions within 24h from the call
- IVDR conformity (Reg. EU 2017/746) and CE marking for instrumentation and IVD devices
|
| Sampling | No physical sample required; technical data sheets, technical report, IVDR declaration of conformity and CE marking certification are requested |
| Notes | SHOWSTOPPER / tailored constraints: (1) Celite method MANDATORY - technology historically tied to the Hemochron system (Accriva/Werfen) and to certain ACT cartridges; many modern competitors use kaolin -> risk of a tailored requirement. (2) Bidirectional interfacing to the LIS TD-Synergy (CGM) required -> verify available driver/middleware. ACT POCT market dominated by few players (Werfen/Hemochron, Medtronic ACT Plus, Abbott i-STAT). Five-year service with full risk 24h. Modest amount (~17k/year) -> limited margins but low competitive barrier for those who already have the system with the Celite method. Assess whether Firsteck has a POCT ACT system with Celite method + TD-Synergy interface. |
| Sources | - AVVISO_SISTEMI_PER_ACT.pdf: pagina 1
- AVVISO_SISTEMI_PER_ACT.pdf: pagina 2
- AVVISO_SISTEMI_PER_ACT.pdf: pagina 4
- estratto_188017721.pdf: pagina 1
|
Assessment for Firsteck Bio
The product falls fully within the Firsteck focus (POCT coagulation / POCT): bench/ward ACT system in haemodynamics. Market survey for direct award as a single lot, modest amount (~17k/year, ~85k over five years). The main critical point is the binding requirement of the CELITE METHOD, typically associated with the Hemochron system (Werfen/Accriva) and not with all ACT POCT analysers: if Firsteck does not distribute an ACT system with Celite method, the requirement is potentially excluding. Second constraint: bidirectional interface to the LIS TD-Synergy. The offer deadline has already expired (28/08/2024) relative to today 04/06/2026, so it is a historical tender: useful only as a reference for future similar ULSS 9 procedures.