Laboratory reagents (Румыния - Тендер #48612208)

1. Section I
   1. Name and addresses
      SPITALUL CLINIC JUDETEAN DE URGENTA SIBIU
      Strada: Coposu Corneliu, nr. 2-4, Sector: -, Judet: Sibiu
      Sibiu
      550245
      Romania
      Telephone: +40 744774831
      E-mail: dorica.nastase@yahoo.com
      Fax: +40 269215434
      
   2. Joint procurement
      
   3. Communication
      The procurement documents are available for unrestricted and full direct access, free of charge, at
      https://e-licitatie.ro/pub/notices/c-notice/v2/view/100173436
      Additional information can be obtained from the abovementioned addressto the abovementioned address
      
   4. Type of the contracting authority:
      Body governed by public law
      
   5. Main activity:
      Health
      
2. Section II
   1. Scope of the procurement:
      1. Title:
         

         Acord-cadru de furnizare pachete de reactivi si consumabile 2023-V

         Reference number: 4240898_2023_7.5
         
      2. Main CPV code:
         33696500
         
      3. Type of contract:
         Supplies
         
      4. Short description:
         

         Acord-cadru de furnizare pachete de reactivi si consumabile 2023-V : toate detaliile legate de valori si cantitati estimate se regasesc in caietul anexat, in fisa de date si in sectiunea loturi.

         Frecventa si valoarea contractelor ce urmeaza sa fie atribuite: lunar, in functie de solicitarile sectiilor clinice si de fondurile alocate cu aceasta destinatie.

         AC va raspunde în mod clar şi complet tuturor solicitărilor de carificare/informaţiilor suplimentare in a 11 a zi de la termenul limita de depunere a ofertelor.

         Numarul zile pana la care se pot solicita clarificari inainte de data limita de depunere a ofertelor/candidaturilor este 18.

      5. Estimated total value:
         Value excluding VAT: 8 430 056.03 RON
         
      6. Information about lots:
         maximum number of lots: 5
         Maximum number of lots that may be awarded to one tenderer: 5
         The contracting authority reserves the right to award contracts combining the following lots or groups of lots:

         Oferta se poate depune pe unul sau mai multe loturi.

   2. Description
      1. Title:
         

         Test rapid imunocromatografic pentru detectarea calitativa a Clostridium difficile - toxina A / B / GDH in materii fecale umane

         Lot No: 2
         
      2. Additional CPV code(s):
         33696500
         
      3. Place of performance:
         Main site or place of performance:

         sediul SCJU Sibiu

      4. Description of the procurement:
         

         cut x 10 teste

      5. Award criteria:
         
      6. Estimated value:
         Value excluding VAT: 198 000.00 RON
         
      7. Duration of the contract, framework agreement or dynamic purchasing system:
         Duration in months: 24
         This contract is subject to renewal: no
         
      8. Information about the limits on the number of candidates to be invited:
         
      9. Information about variants:
         Variants will be accepted: no
         
      10. Information about options:
          Options: no
      11. Information about electronic catalogues:
          
          
      12. Information about European Union funds:
          The procurement is related to a project and/or programme financed by European Union funds: no
      13. Additional information:
          

          cantitate min- max estimata /lot/ctr. subs lunar ; cant min max estimata/lot/ 2 ani: 15-25 ; 360-600

      14. Title:
          

          PACHET DE REACTIVI SI CONSUMABILE COMPATIBIL SAU ECHIVALENT CU APARATUL ALINITY C

          Lot No: 5
          
      15. Additional CPV code(s):
          33696500
          
      16. Place of performance:
          Main site or place of performance:

          sediul SCJU Sibiu

      17. Description of the procurement:
          

          pachet; conform caiet de sarcini atasat

      18. Award criteria:
          
      19. Estimated value:
          Value excluding VAT: 6 596 644.67 RON
          
      20. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 24
          This contract is subject to renewal: no
          
      21. Information about the limits on the number of candidates to be invited:
          
      22. Information about variants:
          Variants will be accepted: no
          
      23. Information about options:
          Options: no
      24. Information about electronic catalogues:
          
          
      25. Information about European Union funds:
          The procurement is related to a project and/or programme financed by European Union funds: no
      26. Additional information:
          

          cantitate min- max estimata /lot/ctr. subs lunar ; cant min max estimata/lot/ 2 ani: conform anexa la caiet, atasata

      27. Title:
          

          Pachet reactivi compatibil sau echivalent cu analizorul VITEK 2 COMPACT

          Lot No: 1
          
      28. Additional CPV code(s):
          33696500
          
      29. Place of performance:
          Main site or place of performance:

          sediul SCJU Sibiu

      30. Description of the procurement:
          

          pachet; conform caiet de sarcini atasat

      31. Award criteria:
          
      32. Estimated value:
          Value excluding VAT: 1 446 048.00 RON
          
      33. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 24
          This contract is subject to renewal: no
          
      34. Information about the limits on the number of candidates to be invited:
          
      35. Information about variants:
          Variants will be accepted: no
          
      36. Information about options:
          Options: no
      37. Information about electronic catalogues:
          
          
      38. Information about European Union funds:
          The procurement is related to a project and/or programme financed by European Union funds: no
      39. Additional information:
          

          cantitate min- max estimata /lot/ctr. subs lunar ; cant min max estimata/lot/ 2 ani: conform anexa la caiet, atasata

      40. Title:
          

          Pachet medii cromogene

          Lot No: 3
          
      41. Additional CPV code(s):
          33696500
          
      42. Place of performance:
          Main site or place of performance:

          sediul SCJU Sibiu

      43. Description of the procurement:
          

          pachet; conform caiet de sarcini atasat

      44. Award criteria:
          
      45. Estimated value:
          Value excluding VAT: 109 104.00 RON
          
      46. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 24
          This contract is subject to renewal: no
          
      47. Information about the limits on the number of candidates to be invited:
          
      48. Information about variants:
          Variants will be accepted: no
          
      49. Information about options:
          Options: no
      50. Information about electronic catalogues:
          
          
      51. Information about European Union funds:
          The procurement is related to a project and/or programme financed by European Union funds: no
      52. Additional information:
          

          cantitate min- max estimata /lot/ctr. subs lunar ; cant min max estimata/lot/ 2 ani: conform anexa la caiet, atasata

      53. Title:
          

          Pachet Tulpini de referinta

          Lot No: 4
          
      54. Additional CPV code(s):
          33696500
          
      55. Place of performance:
          Main site or place of performance:

          sediul SCJU Sibiu

      56. Description of the procurement:
          

          pachet; conform caiet de sarcini atasat

      57. Award criteria:
          
      58. Estimated value:
          Value excluding VAT: 80 259.36 RON
          
      59. Duration of the contract, framework agreement or dynamic purchasing system:
          Duration in months: 24
          This contract is subject to renewal: no
          
      60. Information about the limits on the number of candidates to be invited:
          
      61. Information about variants:
          Variants will be accepted: no
          
      62. Information about options:
          Options: no
      63. Information about electronic catalogues:
          
          
      64. Information about European Union funds:
          The procurement is related to a project and/or programme financed by European Union funds: no
      65. Additional information:
          

          cantitate min- max estimata /lot/ctr. subs lunar ; cant min max estimata/lot/ 2 ani: conform anexa la caiet, atasata

3. Section III
   1. Conditions for participation:
      1. Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers:
         List and brief description of conditions:

         Ofertantii, tertii sustinatori si subcontractantii nu trebuie sa se regaseasca în situatiile prevazute la art. 164, 165, 167 din Legea nr.98/2016.

         Modalitatea prin care poate fi demonstrata indeplinirea cerintei: se va completa DUAE de catre operatorii economici participanti la procedura de atribuire cu informatiile aferente situatiei lor. Documentele justificative care probeaza indeplinirea celor asumate prin completarea DUAE urmeaza a fi prezentate, la solicitarea autoritatii contractante, doar de catre ofertantul clasat pe locul 1 in clasamentul intermediar intocmit la finalizarea evaluarii ofertelor.

         Aceste documente pot fi:

         1. Certificate constatatoare privind plata impozitelor, taxelor sau a contributiilor la bugetul general consolidat ( buget de stat). Se solicita Certificatul de atestare fiscala, eliberat de ANAF si Certificatul de atestare fiscala privind impozitele si taxele locale- pentru sediul social . Pentru toate sediile secundare, asa cum sunt ele inregistrate in certificatul ONRC, se va prezenta declaratie pe propria raspundere privind neincalcarea obligațiilor privind plata impozitelor sau cele privind contribuțiile la asigurările sociale (model atasat in fisierul "formulare")

         2. Dupa caz, documente prin care se demonstreaza faptul ca operatorul economic poate beneficia de derogarile prevazute la art.166, alin.2, art.167, alin.2, art.171 din Legea 98/2016 privind achizitiile publice. Alte documente edificatoare, dupa caz.

         3. Pentru neincadrarea in prev art.164 din Legea 98/2016 se va prezenta: cazierul judiciar al operatorului economic si al membrilor organului de administrare, de conducere sau de supraveghere al respectivului op. economic, sau a celor ce au putere de reprezentare, de decizie sau de control in cadrul acestuia, asa cum rezulta din certificatul constatator emis de ONRC./actul constitutiv, valabile la momentul prezentarii.

         4. Decl. conf. art.60 din Legea 98/2016 care va fi prezentata de toti participantii odata cu depunerea DUAE. Persoanele din cadrul Autoritatii contractante cu functie de decizie referitoare la organizarea, derularea si finalizarea prezentei proceduri de atribuire, conform prevederilor art. 58-63, din Legea nr. 98/2016, sunt, dupa cum urmeaza:

         Membrii Comitetului Director

         Manager Dr. Daniel Chelcea

         Director Medical Conf.Univ.Dr. Calin Cipaian

         Director Financiar contabil ec. Dragos Bunaciu

         Director Ingrijiri as. Laurentiu Ghinoiu

         Medic coordonator S.P.I.A.A.M Dr. Dana Rusu

         Comisia de evaluare:

         Presedinte comisie fara drept de vot, responsabil procedura, Nastase Dorica

         Membri: Dr. Ciprian Ion Olteanu, Medic Laborator Clinic

         Chimist Gabriela Gross -Laborator Clinic de Analize

         Teodora Tudosie - Sef Serviciu Achizitii Publice

         Operatorii economici ce depun oferta trebuie sa dovedeasca o forma de inregistrare in conditiile legii din tara de rezidenta, sa reiasa ca operatorul economic este legal constituit, ca nu se afla in niciuna dintre situatiile de anulare a constituirii precum si faptul ca are capacitatea profesionala de a realiza activitatile care fac obiectul contractului.

         Modalitate prin care poate fi demonstrata indeplinirea cerintei: se va completa DUAE de catre operatorii economici participanti la procedura de atribuire cu informatiile aferente situatiei lor.

         Documentele justificative care probeaza indeplinirea celor asumate prin completarea DUAE vor fi:

         1 . Certificat constatator emis de ONRC,

         2. Aviz de functionare eliberat de catre ANMDM pentru activitatile de import, distributie si punere in functiune pentru dispozitive medicale in conf. cu prevederile art. 3 din Ordinul nr. 1008/2016 - pentru aprobarea Normelor metodologice de aplicare a titlului XX din Legea nr. 95/2006 privind reforma în domeniul sanatatii(art. 926 alin. (2)), republicata, cu modificarile si completarile ulterioare, referitoare la avizarea activitatilor în domeniul dispozitivelor medicale.

         Documentele solicitate in sustinerea cerintei urmeaza sa fie prezentate la solicitarea autoritatii contractante, doar de catre ofertantul clasat pe primul loc in clasamentul intermediar intocmit la finalizarea evaluarii ofertelor. Ofertantul de pe locul I va face dovada autorizarii ANM-DM pentru import, distributie, depozitare prezentand avizul ANM cu anexele in care sunt mentionati producatorii produselor ofertate.

         Ofertantii straini vor prezenta documente echivalente, emise in conformitate cu legislatia aplicabila in tara de rezidenta.

         Conform art.173, alin.2 din Legea 98/2016)sau in cazul ofertantilor straini, documente echivalente emise in tara de rezidenta, urmeaza sa fie prezentate la solicitarea autoritatii contractante, doar de catre ofertantul clasat pe locul 1 in clasamentul intermediar intocmit la finalizarea evaluarii ofertelor.

      2. Economic and financial standing:
         Selection criteria as stated in the procurement documents
      3. Technical and professional ability:
         List and brief description of selection criteria:

         Loturile: 1,2,3,4,5Certificate emise de organisme independente cu privire la standardele de asigurare a calitatiiDovada implementarii unui sistem de management al calitatii in conformitate cu SR EN ISO 9001, sau echivalent, pentru activitatea care face obiectul achizitiei.

         Minimum level(s) of standards possibly required:

         La termenul limita se completeaza si prezinta DUAE, urmand ca documentele justificative se se prezinte doar de ofertantul clasat pe primul loc in clasamentul intermediar intocmit la finalizarea evaluarii ofertelor. Se va permite prezentarea oricarui document prin care se sustine cerinta, de exemplu: un certificat emis de un organism de certificare sau alte documente care probeaza în mod concludent îndeplinirea cerintei: spre exemplu, proceduri/manuale de calitate, activitate procedurata, etc. similare cu cele prevazutedrept conditie pentru obtinerea unei certificari SR EN ISO 9001.

      4. Information about reserved contracts:
         
   2. Conditions related to the contract:
      1. Information about a particular profession:
         
      2. Information about staff responsible for the performance of the contract:
         
4. Section IV
5. Description:
   1. Type of procedure:
      Open procedure
   2. Information about a framework agreement or a dynamic purchasing system:
      Framework agreement with a single operator
   3. Information about reduction of the number of solutions or tenders during negotiation or dialogue:
      
   4. Information about negotiation:
      
   5. Information about electronic auction:
      
   6. Information about the Government Procurement Agreement (GPA):
      The procurement is covered by the Government Procurement Agreement: yes
6. Administrative information:
   1. Previous publication concerning this procedure:
      
   2. Time limit for receipt of tenders or requests to participate:
      Date: 2024-01-10
      Local time: 15:00
      
   3. Estimated date of dispatch of invitations to tender or to participate to selected candidates:
      
   4. Languages in which tenders or requests to participate may be submitted:
      RO
   5. Minimum time frame during which the tenderer must maintain the tender:
      Tender must be valid until: 2024-04-10
      (from the date stated for receipt of tender)
      
   6. Conditions for opening of tenders:
      Date: 2024-01-10
      Local time: 15:00
      Place:

      In SEAP

      Information about authorised persons and opening procedure:

      Comisia de evaluare

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