622908-2024 - Competition Competition Romania: Medical equipments DIVERSE ECHIPAMENTE MEDICALE PENTRU NEUROCHIRURGIE Estimated value excluding VAT: 3 572 190,00 RON Type of procedure: Open Buyer Buyer: Spitalul Clinic de Urgenta Bagdasar-Arseni Email: achizitii@bagdasar-arseni.ro Romania, Bucureşti (RO321), Bucuresti LOT-0001: Platforma pentru monitorizarea intraoperatorie a functiilor nervoase Medical equipments Romania, Bucureşti (RO321) Duration: 12 Months Deadline for receipt of tenders: 20/11/2024 - 15:00:00 (UTC+2) LOT-0002: Aspirator ultrasonic pentru interventii neurochirurgicale Medical equipments Romania, Bucureşti (RO321) Duration: 12 Months Deadline for receipt of tenders: 20/11/2024 - 15:00:00 (UTC+2) 622908-2024 - Competition Romania – Medical equipments – DIVERSE ECHIPAMENTE MEDICALE PENTRU NEUROCHIRURGIE OJ S 201/2024 15/10/2024 Contract or concession notice – standard regime Supplies 1. Buyer 1.1. Buyer Official name: Spitalul Clinic de Urgenta Bagdasar-Arseni Email: achizitii@bagdasar-arseni.ro Legal type of the buyer: Body governed by public law Activity of the contracting authority: Health 2. Procedure 2.1. Procedure Title: DIVERSE ECHIPAMENTE MEDICALE PENTRU NEUROCHIRURGIE Description: - Procedura de achizitie implica - Incheierea unui contract de furnizare cu clauza suspensiva - Perioada de valabilitate a contractului propusa: 12 de luni de la data comunicarii rezultatului procedurii. Conform art. 161 din Legea 98/2016 termenul pentru raspuns la clarificari este in a 11 a zi inainte de data limita de depunere a ofertelor. Numarul de zile pana la care se pot solicita clarificari inainte de data limita de depunere a ofertelor: 18 zile Procedure identifier: 56801d79-2400-4938-b102-a9628802432f Internal identifier: 4943871.2024.14 Type of procedure: Open 2.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33100000 Medical equipments 2.1.3. Value Estimated value excluding VAT: 3 572 190,00 RON 2.1.4. General information Additional information: Cerintele tehnice definite la nivelul anuntului de participare, caietului de sarcini sau altor documente complementare, prin trimiterea standardelor, la un anumit producator, la marci, brevete, tipuri, la o origine sau la o productie/metoda specifica de fabricatie/prestare/executie, vor fi intelese ca fiind insotite de mentiunea ”sau echivalent”. Legal basis: Directive 2014/24/EU 2.1.5. Terms of procurement Terms of submission: Maximum number of lots for which one tenderer can submit tenders: 2 Terms of contract: Maximum number of lots for which contracts can be awarded to one tenderer: 2 2.1.6. Grounds for exclusion Participation in a criminal organisation: Participare la o organizatie criminala Corruption: Coruptie Fraud: Frauda Terrorist offences or offences linked to terrorist activities: Infractiuni teroriste sau infractiuni legate de activitati teroriste Money laundering or terrorist financing: Spalare de bani sau finantarea terorismului Child labour and other forms of trafficking in human beings: Exploatarea prin munca a copiilor si alte forme de trafic de persoane Payment of taxes: Plata impozitelor Payment of social security contributions: Plata asigurarilor sociale 5. Lot 5.1. Lot: LOT-0001 Title: Platforma pentru monitorizarea intraoperatorie a functiilor nervoase Description: Conform Caiet de sarcini Internal identifier: 1 5.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33100000 Medical equipments 5.1.2. Place of performance Country subdivision (NUTS): Bucureşti (RO321) Country: Romania Additional information: Magazia SCUBA 5.1.3. Estimated duration Duration: 12 Months 5.1.4. Renewal Maximum renewals: 0 5.1.6. General information Reserved participation: Participation is not reserved. The names and professional qualifications of the staff assigned to perform the contract must be given: Not required Procurement Project not financed with EU Funds. The procurement is covered by the Government Procurement Agreement (GPA): no 5.1.9. Selection criteria Criterion: Type: Suitability to pursue the professional activity Name: III.1.1.a) Situatia personala a candidatului sau ofertantului Description: 1. Declaratie privind neincadrarea in prevederile Art. 59,60 din Legea nr. 98/2016 privind achizitiile publice. Declaratia privind neincadrarea in prevederile Art. 59, 60 se va atasa in SEAP odata cu DUAE. Modalitate de indeplinire 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 vor fi solicitate de catre autoritatea contractanta doar operatorului clasat pe primul loc in clasamentul intermediar, dupa finalizarea evaluarii ofertelor. (art.173 din Legea 98/2016). Încadrarea în situatiile prevazute la Art. 59, 60, 164, 165,167 din Legea nr. 98/2016 privind achizitiile publice atrage excluderea ofertantului din procedura aplicata pentru atribuirea contractului de achizitie publica. Persoane cu functii de decizie in cadrul autoritatii contractante implicate in procedura de achizitie in ceea ce priveste organizarea, derularea si finalizarea procedurii de atribuire: - Andi NODIȚ – Manager, - Dr. Narcisa BUCUR - Director Medical, - As. Med. Principal (S) Ana MARES – Director Ingrijiri, - Ec. Marian ROŞOI - Director Financiar Contabil, - Asist. Univ. Dr. Petrescu George Emil Dragos – Medic Specialist SNC IV - Dr. Viorel PRUNA – Sef sectie Neurochirurgie SNC V - Dr. Mircea Felix Brehar – Medic Primar, Sef Sectie SNC I - Ing. Cristina ŢUŢU – Șef Serviciu Achiziții Publice Contractare, - Ec. Simona Gigi Tăvârlău – Persoana desemnata viza CFP, - Av. Elena Vătrai – Societatea Pricop și Asociații S.P.A.R.L., - Ref. Spec. Elena POPA – Serviciul APC-AT - Ec. Elisabeta CORCAN – Serviciul APC-AT 2. Certificate constatatoare privind plata impozitelor, taxelor sau a contributiilor la bugetul general consolidat (buget local, buget de stat etc.) valabile la momentul prezentarii, pentru sediul principal, iar pentru sediile secundare/punctele de lucru, o declaraţie pe propria răspundere privind îndeplinirea obligaţiilor de plată a impozitelor, taxelor sau contribuţiilor la bugetul general consolidat datorate (art.173 din Legea 98/2016); În cazul operatorilor economici straini se vor prezenta documente echivalente emise în conformitate cu legislatia aplicabila în tara de rezidenta. Modalitate de indeplinire 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 vor fi solicitate de catre autoritatea contractanta doar ofertantului clasat pe primul loc in clasamentul intermediar, dupa finalizarea evaluarii ofertelor. (art 196 alin 2 din Legea 98/2016 si art 132 din HG 395/2016). Potrivit prevederilor art. 193 din Legea 98/2016, autoritatea contractanta va accepta in cadrul ofertelor DUAE in locul documentelor solicitate in vederea demonstrarii cerintelor de calificare, ca dovada preliminara. 3. Cazierul judiciar al operatorului economic și al membrilor organului de administrare, de conducere sau de supraveghere al respectivului operator economic, sau a celor ce au putere de reprezentare, de decizie sau de control în cadrul acestuia, așa cum rezultă din certificatul constatator emis de ONRC / actul constitutiv; Modalitate de indeplinire 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 îndeplinirea celor asumate prin completarea DUAE, sau în cazul ofertantilor straini, documente echivalente emise în tara de rezidenta, urmeaza sa fie prezentate, la solicitarea autoritatii contractante, doar ofertantului clasat pe primul loc in clasamentul intermediar dupa finalizarea evaluarii ofertelor. (art 196 alin 2 din Legea 98/2016 si art 132 din HG 395/2016) Cerinta obligatorie pentru persoanele juridice straine: Prezentare de catre persoanele fizice/juridice straine a documentelor care dovedesc o forma de înregistrare ca persoana fizica sau juridica sau de atestare ori apartenenta din punct de vedere profesional in conformitate cu prevederile din tara in care ofertantul este stabilit. 4. 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) si art. 171 din Legea 98/2016 privind achizitiile publice; 5. Alte documente edificatoare, dupa caz. Use of this criterion: Used Criterion: Type: Suitability to pursue the professional activity Name: III.1.1.b) Capacitatea de exercitare a activitatii profesionale Description: Cerința nr.1. Certificatul constatator emis de ONRC - Operatorii economici care depun ofertă trebuie să dovedească o formă de înregistrare în condițiile legii din țara rezidentă, din care să reiasă că operatorul economic este legal constituit, că nu se află în niciuna din situațiile de anulare a constituirii, precum și faptul că are capacitatea profesională de a realiza activitățile ce fac obiectul contractului de achiziție publică. Cerința se aplică inclusiv pentru subcontractanț care completează informațiile aferente situației lor la nivelul unui DUAE distinct. Toate documentele trebuie sa fie valabile la momentul prezentarii. Modalitatea de îndeplinire: Se va completa DUAE de către operatorii economici participanți la procedura de atribuire a contractului de achiziție publică cu informațiile solicitate de către autoritatea contractantă – informații referitoare la îndeplinirea cerințelor privind capacitatea de exercitare a activității profesionale. Documentul justificativ care probează îndeplinirea celor asumate prin completarea DUAE, respectiv certificatul constatator emis de ONRC, sau în cazul ofertanților persoane juridice/fizice străine, documentele echivalente emise în țara de rezidență, traduse în limba română, urmează să fie prezentate, la solicitarea autorității contractante, doar de catre ofertantul clasat pe primul loc in clasamentul intermediar, dupa finalizarea evaluarii ofertelor. (art 196 alin 2 din Legea 98/2016 si art 132 din HG 395/2016) Use of this criterion: Used Criterion: Type: Technical and professional ability Name: Diplome de studii și calificări profesionale Description: Operatorii economici ce depun oferta trebuie sa detina atestare ori apartenenta din punct de vedere profesional, respectiv sa detina: a. Avizul de functionare emis de Agentia Nationala a Medicamentului si Dispozitivelor Medicale in conformitate cu Art. 926 al Titlul XX din Legea 95/2006, cu modificarile si completarile ulterioare si potrivit Ordinului nr. 566 din 3 aprilie 2020 pentru aprobarea Normelor metodologice de aplicare a titlului XX din Legea nr. 95/2006 privind reforma în domeniul sănătăţii, referitoare la avizarea activităţilor în domeniul dispozitivelor medicale. Nu se accepta ofertanti in curs de avizare. (art 173 alin.2 din Legea 98/2016) b. Anexa la Avizul de functionare va cuprinde, la data depunerii ofertei, in mod obligatoriu producatorul dispozitivelor medicale ofertate. (art 173 alin.2 din Legea 98/2016) In cazul unei oferte depuse de catre o asociere, avand in vedere ca acestia raspund solidar in fata autoritatii contractante, fiecare asociat in parte are obligatia de a prezenta Avizul de functionare emis de catre Ministerul Sanatatii pentru activitatile mentionate anterior. Toate documentele se vor depune in SEAP semnate cu semnatura electronica extinsa, conform art. 60 alin. (4) din HG nr. 395/2016Toate documentele se vor depune in SEAP semnate cu semnatura electronica extinsa, conform art. 60 alin. (4) din HG nr. 395/2016 Use of this criterion: Used Criterion: Type: Suitability to pursue the professional activity Name: Înscrierea în registrul comerțului Description: Certificatul constatator emis de ONRC - Operatorii economici care depun ofertă trebuie să dovedească o formă de înregistrare în condițiile legii din țara rezidentă, din care să reiasă că operatorul economic este legal constituit, că nu se află în niciuna din situațiile de anulare a constituirii, precum și faptul că are capacitatea profesională de a realiza activitățile ce fac obiectul contractului de achiziție publică. Cerința se aplică inclusiv pentru subcontractanț care completează informațiile aferente situației lor la nivelul unui DUAE distinct. Toate documentele trebuie sa fie valabile la momentul prezentarii. Modalitatea de îndeplinire: Se va completa DUAE de către operatorii economici participanți la procedura de atribuire a contractului de achiziție publică cu informațiile solicitate de către autoritatea contractantă – informații referitoare la îndeplinirea cerințelor privind capacitatea de exercitare a activității profesionale. Documentul justificativ care probează îndeplinirea celor asumate prin completarea DUAE, respectiv certificatul constatator emis de ONRC, sau în cazul ofertanților persoane juridice/fizice străine, documentele echivalente emise în țara de rezidență, traduse în limba română, urmează să fie prezentate, la solicitarea autorității contractante, doar de catre ofertantul clasat pe primul loc in clasamentul intermediar, dupa finalizarea evaluarii ofertelor. (art 196 alin 2 din Legea 98/2016 si art 132 din HG 395/2016) Use of this criterion: Used Criterion: Type: Economic and financial standing Use of this criterion: Not used 5.1.10. Award criteria Criterion: Type: Price Name: Pretul ofertei Description: Punctajul se acorda astfel: a) Pentru cel mai scazut dintre preturi se acorda punctajul maxim alocat; b) Pentru celelalte preturi ofertate punctajul P(n) se calculeaza proportional, astfel: P(n) = (Pret minim ofertat / Pret n) x punctaj maxim alocat. Weight (percentage, exact): 40 Criterion: Type: Quality Name: 1. Reducerea artefactelor de stimulare prin descărcare întârziată – 5 pct Description: Pentru un sistem ce nu dispune de reducerea artefactelor de stimulare prin descărcare întârziată – se acorda 0 puncte Pentru un sistem ce dispune de reducerea artefactelor de stimulare prin descărcare întârziată – se acorda punctajul maxim 5 puncte Weight (percentage, exact): 5 Criterion: Type: Quality Name: 2. Stimulare prin curent ridicat, minim 12 canale, cu măsurarea impedanței simultan in toate canalele de stimulare – 5 pct Description: Pentru stimulare prin curent ridicat cu minim 12 canale, fara măsurarea impedanței simultan in toate canalele de stimulare – se acorda 0 puncte Pentru stimulare prin curent ridicat cu minim 12 canale, cu măsurarea impedanței simultan in toate canalele de stimulare - se acorda punctajul maxim 5 puncte Weight (percentage, exact): 5 Criterion: Type: Quality Name: 3. Sistem de inregistrare cu minim 32 canale de inregistrare, cu posibilitate de upgrade la 64 de canale – 10 pct Description: Pentru un sistem de inregistrare cu 32 canale de inregistrare, dar fara posibilitate de upgrade – se acorda 0 puncte • Pentru un sistem de inregistrare cu 32 canale de inregistrare cu posibilitate de upgrade la 64 de canale – se acorda punctajul maxim 10 puncte Weight (percentage, exact): 10 Criterion: Type: Quality Name: 4. Performanta energetica a echipamentului – 15 puncte Description: Pentru cel mai mic consum de energie - se va acorda punctaj de 15 puncte Pentru alt consum de energie se va calcula punctajul in raport cu cel mai mic ofertat, conform urmatorului algoritm de calcul : Punctaj = (cel mai mic consum energetic / consum energetic ofertat) x 15 puncte (punctajul maxim acordat) Weight (percentage, exact): 15 Criterion: Type: Quality Name: 5. Instructaj pentru optimizarea eficienței energetice – 10 puncte Description: • Instruire introductiv -generala cu o durata: - Pentru o durată minima de instructaj de 2 ore pentru maxim 5 persoane – se acorda 0 puncte - Pentru o durată maxima de instructaj de 8 ore pentru maxim 5 persoane – se acorda 10 puncte - Pentru fiecare ora suplimentară ofertată față de cele minimum solicitate, dar nu mai mult de 8 h pentru maxim 5 persoane, punctajul se va calcula conform urmatorului algoritm de calcul: Durata(o) = (Durata instructaj ofertata/Durata instructaj maxima ofertata)x 10 Pentru o durata a instructajului mai mica de 2 ore, oferta va fi considerata neconforma. • Pentru o durata a instructajului mai mare de 8 ore, nu se acorda punctaj suplimentar. Weight (percentage, exact): 10 Criterion: Type: Quality Name: • 6. Garantia echipamentului – 15 puncte Description: Pentru cel mai mare termen de garantie ofertat - se acorda punctaj de 15 puncte Pentru alt termen de garantie ofertat se va calcula punctajul in raport cu cel mai mare ofertat, conform urmatorului algoritm de calcul : • Punctaj = (garantia ofertata / garantia maxim ofertata) x 15 puncte (punctajul maxim acordat) Pentru perioada de garantie ofertata mai mica de 24 de luni, oferta va fi declara neconforma. Perioada de garantie va exprimata in luni. Weight (percentage, exact): 15 5.1.11. Procurement documents Address of the procurement documents: https://e-licitatie.ro/pub/notices/c-notice/v2/view/100185799 5.1.12. Terms of procurement Terms of submission: Electronic submission: Required Address for submission: https://www.e-licitatie.ro Languages in which tenders or requests to participate may be submitted: Romanian Electronic catalogue: Not allowed Variants: Not allowed Deadline for receipt of tenders: 20/11/2024 15:00:00 (UTC+2) Deadline until which the tender must remain valid: 6 Months Information about public opening: Opening date: 20/11/2024 15:00:00 (UTC+2) Place: In SEAP Terms of contract: The execution of the contract must be performed within the framework of sheltered employment programmes: No Conditions relating to the performance of the contract: Procedura de atribuire a contractului de achiziție publică este inițiată sub incidența prezentei clauze suspensive, în sensul că încheierea contractului de achiziție publică este condiționată de alocarea creditelor bugetare cu această destinație, semnarea contractului făcându-se cu respectarea dispozițiilor referitoare la angajarea cheltuielilor din bugetele care intră sub incidența legislației privind finanțele publice. Având în vedere dispozițiile Legii nr. 98/2016 privind achizițiile publice și H.G. nr. 395/2016, cu modificările și completările ulterioare, Autoritatea Contractantă precizează că va încheia contractul cu ofertantul declarat câștigător numai în măsura în care fondurile necesare achiziției vor fi asigurate prin alocarea creditelor bugetare cu această destinație. Durata clauzei suspensive: 12 luni de la data comunicarii rezultatului procedurii. Electronic invoicing: Required Electronic ordering will be used: no Electronic payment will be used: no Legal form that must be taken by a group of tenderers that is awarded a contract: Asociere conform art. 53. din Legea privind achizitiile publice nr 98/2016 Information about review deadlines: Legea 101/2016 5.1.15. Techniques Framework agreement: No framework agreement Information about the dynamic purchasing system: No dynamic purchase system 5.1.16. Further information, mediation and review Review organisation: Consiliul National de Solutionare a Contestatiilor Organisation providing additional information about the procurement procedure: Spitalul Clinic de Urgenta Bagdasar-Arseni Organisation receiving requests to participate: Spitalul Clinic de Urgenta Bagdasar-Arseni Organisation processing tenders: Spitalul Clinic de Urgenta Bagdasar-Arseni TED eSender: Operator SEAP 5.1. Lot: LOT-0002 Title: Aspirator ultrasonic pentru interventii neurochirurgicale Description: Conform Caiet de sarcini Internal identifier: 2 5.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33100000 Medical equipments 5.1.2. Place of performance Country subdivision (NUTS): Bucureşti (RO321) Country: Romania Additional information: Magazia SCUBA 5.1.3. Estimated duration Duration: 12 Months 5.1.4. Renewal Maximum renewals: 0 5.1.6. General information Reserved participation: Participation is not reserved. The names and professional qualifications of the staff assigned to perform the contract must be given: Not required Procurement Project not financed with EU Funds. The procurement is covered by the Government Procurement Agreement (GPA): no 5.1.9. Selection criteria Criterion: Type: Suitability to pursue the professional activity Name: III.1.1.a) Situatia personala a candidatului sau ofertantului Description: 1. Declaratie privind neincadrarea in prevederile Art. 59,60 din Legea nr. 98/2016 privind achizitiile publice. Declaratia privind neincadrarea in prevederile Art. 59, 60 se va atasa in SEAP odata cu DUAE. Modalitate de indeplinire 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 vor fi solicitate de catre autoritatea contractanta doar operatorului clasat pe primul loc in clasamentul intermediar, dupa finalizarea evaluarii ofertelor. (art.173 din Legea 98/2016). Încadrarea în situatiile prevazute la Art. 59, 60, 164, 165,167 din Legea nr. 98/2016 privind achizitiile publice atrage excluderea ofertantului din procedura aplicata pentru atribuirea contractului de achizitie publica. Persoane cu functii de decizie in cadrul autoritatii contractante implicate in procedura de achizitie in ceea ce priveste organizarea, derularea si finalizarea procedurii de atribuire: - Andi NODIȚ – Manager, - Dr. Narcisa BUCUR - Director Medical, - As. Med. Principal (S) Ana MARES – Director Ingrijiri, - Ec. Marian ROŞOI - Director Financiar Contabil, - Asist. Univ. Dr. Petrescu George Emil Dragos – Medic Specialist SNC IV - Dr. Viorel PRUNA – Sef sectie Neurochirurgie SNC V - Dr. Mircea Felix Brehar – Medic Primar, Sef Sectie SNC I - Ing. Cristina ŢUŢU – Șef Serviciu Achiziții Publice Contractare, - Ec. Simona Gigi Tăvârlău – Persoana desemnata viza CFP, - Av. Elena Vătrai – Societatea Pricop și Asociații S.P.A.R.L., - Ref. Spec. Elena POPA – Serviciul APC-AT - Ec. Elisabeta CORCAN – Serviciul APC-AT 2. Certificate constatatoare privind plata impozitelor, taxelor sau a contributiilor la bugetul general consolidat (buget local, buget de stat etc.) valabile la momentul prezentarii, pentru sediul principal, iar pentru sediile secundare/punctele de lucru, o declaraţie pe propria răspundere privind îndeplinirea obligaţiilor de plată a impozitelor, taxelor sau contribuţiilor la bugetul general consolidat datorate (art.173 din Legea 98/2016); În cazul operatorilor economici straini se vor prezenta documente echivalente emise în conformitate cu legislatia aplicabila în tara de rezidenta. Modalitate de indeplinire 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 vor fi solicitate de catre autoritatea contractanta doar ofertantului clasat pe primul loc in clasamentul intermediar, dupa finalizarea evaluarii ofertelor. (art 196 alin 2 din Legea 98/2016 si art 132 din HG 395/2016). Potrivit prevederilor art. 193 din Legea 98/2016, autoritatea contractanta va accepta in cadrul ofertelor DUAE in locul documentelor solicitate in vederea demonstrarii cerintelor de calificare, ca dovada preliminara. 3. Cazierul judiciar al operatorului economic și al membrilor organului de administrare, de conducere sau de supraveghere al respectivului operator economic, sau a celor ce au putere de reprezentare, de decizie sau de control în cadrul acestuia, așa cum rezultă din certificatul constatator emis de ONRC / actul constitutiv; Modalitate de indeplinire 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 îndeplinirea celor asumate prin completarea DUAE, sau în cazul ofertantilor straini, documente echivalente emise în tara de rezidenta, urmeaza sa fie prezentate, la solicitarea autoritatii contractante, doar ofertantului clasat pe primul loc in clasamentul intermediar dupa finalizarea evaluarii ofertelor. (art 196 alin 2 din Legea 98/2016 si art 132 din HG 395/2016) Cerinta obligatorie pentru persoanele juridice straine: Prezentare de catre persoanele fizice/juridice straine a documentelor care dovedesc o forma de înregistrare ca persoana fizica sau juridica sau de atestare ori apartenenta din punct de vedere profesional in conformitate cu prevederile din tara in care ofertantul este stabilit. 4. 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) si art. 171 din Legea 98/2016 privind achizitiile publice; 5. Alte documente edificatoare, dupa caz. Use of this criterion: Used Criterion: Type: Suitability to pursue the professional activity Name: III.1.1.b) Capacitatea de exercitare a activitatii profesionale Description: Cerința nr.1. Certificatul constatator emis de ONRC - Operatorii economici care depun ofertă trebuie să dovedească o formă de înregistrare în condițiile legii din țara rezidentă, din care să reiasă că operatorul economic este legal constituit, că nu se află în niciuna din situațiile de anulare a constituirii, precum și faptul că are capacitatea profesională de a realiza activitățile ce fac obiectul contractului de achiziție publică. Cerința se aplică inclusiv pentru subcontractanț care completează informațiile aferente situației lor la nivelul unui DUAE distinct. Toate documentele trebuie sa fie valabile la momentul prezentarii. Modalitatea de îndeplinire: Se va completa DUAE de către operatorii economici participanți la procedura de atribuire a contractului de achiziție publică cu informațiile solicitate de către autoritatea contractantă – informații referitoare la îndeplinirea cerințelor privind capacitatea de exercitare a activității profesionale. Documentul justificativ care probează îndeplinirea celor asumate prin completarea DUAE, respectiv certificatul constatator emis de ONRC, sau în cazul ofertanților persoane juridice/fizice străine, documentele echivalente emise în țara de rezidență, traduse în limba română, urmează să fie prezentate, la solicitarea autorității contractante, doar de catre ofertantul clasat pe primul loc in clasamentul intermediar, dupa finalizarea evaluarii ofertelor. (art 196 alin 2 din Legea 98/2016 si art 132 din HG 395/2016) Use of this criterion: Used Criterion: Type: Technical and professional ability Name: Diplome de studii și calificări profesionale Description: Operatorii economici ce depun oferta trebuie sa detina atestare ori apartenenta din punct de vedere profesional, respectiv sa detina: a. Avizul de functionare emis de Agentia Nationala a Medicamentului si Dispozitivelor Medicale in conformitate cu Art. 926 al Titlul XX din Legea 95/2006, cu modificarile si completarile ulterioare si potrivit Ordinului nr. 566 din 3 aprilie 2020 pentru aprobarea Normelor metodologice de aplicare a titlului XX din Legea nr. 95/2006 privind reforma în domeniul sănătăţii, referitoare la avizarea activităţilor în domeniul dispozitivelor medicale. Nu se accepta ofertanti in curs de avizare. (art 173 alin.2 din Legea 98/2016) b. Anexa la Avizul de functionare va cuprinde, la data depunerii ofertei, in mod obligatoriu producatorul dispozitivelor medicale ofertate. (art 173 alin.2 din Legea 98/2016) In cazul unei oferte depuse de catre o asociere, avand in vedere ca acestia raspund solidar in fata autoritatii contractante, fiecare asociat in parte are obligatia de a prezenta Avizul de functionare emis de catre Ministerul Sanatatii pentru activitatile mentionate anterior. Toate documentele se vor depune in SEAP semnate cu semnatura electronica extinsa, conform art. 60 alin. (4) din HG nr. 395/2016Toate documentele se vor depune in SEAP semnate cu semnatura electronica extinsa, conform art. 60 alin. (4) din HG nr. 395/2016 Use of this criterion: Used Criterion: Type: Suitability to pursue the professional activity Name: Înscrierea în registrul comerțului Description: Certificatul constatator emis de ONRC - Operatorii economici care depun ofertă trebuie să dovedească o formă de înregistrare în condițiile legii din țara rezidentă, din care să reiasă că operatorul economic este legal constituit, că nu se află în niciuna din situațiile de anulare a constituirii, precum și faptul că are capacitatea profesională de a realiza activitățile ce fac obiectul contractului de achiziție publică. Cerința se aplică inclusiv pentru subcontractanț care completează informațiile aferente situației lor la nivelul unui DUAE distinct. Toate documentele trebuie sa fie valabile la momentul prezentarii. Modalitatea de îndeplinire: Se va completa DUAE de către operatorii economici participanți la procedura de atribuire a contractului de achiziție publică cu informațiile solicitate de către autoritatea contractantă – informații referitoare la îndeplinirea cerințelor privind capacitatea de exercitare a activității profesionale. Documentul justificativ care probează îndeplinirea celor asumate prin completarea DUAE, respectiv certificatul constatator emis de ONRC, sau în cazul ofertanților persoane juridice/fizice străine, documentele echivalente emise în țara de rezidență, traduse în limba română, urmează să fie prezentate, la solicitarea autorității contractante, doar de catre ofertantul clasat pe primul loc in clasamentul intermediar, dupa finalizarea evaluarii ofertelor. (art 196 alin 2 din Legea 98/2016 si art 132 din HG 395/2016) Use of this criterion: Used Criterion: Type: Economic and financial standing Use of this criterion: Not used 5.1.10. Award criteria Criterion: Type: Price Name: Pretul ofertei Description: Punctajul se acorda astfel: a) Pentru cel mai scazut dintre preturi se acorda punctajul maxim alocat; b) Pentru celelalte preturi ofertate punctajul P(n) se calculeaza proportional, astfel: P(n) = (Pret minim ofertat / Pret n) x punctaj maxim alocat. Weight (percentage, exact): 40 Criterion: Type: Quality Name: 1. Debitul pompei de irigatie sa fie cuprins intre: 3 si 40 ml/min si sa poata fi ajustat in trepte – 10 puncte Description: Pentru Debitul pompei de irigatie cuprins intre: 3 si 40 ml/min fara posibilitatea de a fi ajustat in trepte – 0 puncte Pentru Debitul pompei de irigatie cuprins intre: 3 si 40 ml/min cu posibilitatea de a fi ajustat in trepte – 10 puncte Weight (percentage, exact): 10 Criterion: Type: Quality Name: 2. Sa prezinte tehnologie RFID, ceea ce permite recunoasterea varfului de lucru aplicat piesei de mana– 5 puncte Description: Pentru Tehnologie RFID pentru recunoasterea varfului de lucru aplicat piesei de mana – 0 puncte Pentru Tehnologie RFID pentru recunoasterea varfului de lucru aplicat piesei de mana si implicit afisarea pe ecranul consolei a datelor referitoare la varful de lucru cuplat: tipul varfului, parametrii de utilizare – 5 puncte Weight (percentage, exact): 5 Criterion: Type: Quality Name: 3. Softul sa permita crearea a minim 70 de presetari (profile de lucru pentru personalul medical) pentru diferiti parametri de operare – 5 puncte Description: Pentru Soft care permite crearea a unui numar de presetari >70, dar <80 – 2 puncte Pentru Soft care permite crearea a unui numar de presetari ≥ 80, dar <100 – 5 puncte Weight (percentage, exact): 5 Criterion: Type: Quality Name: 4. Performanta energetica a echipamentului – 15 puncte4. Performanta energetica a echipamentului – 15 puncte Description: Pentru cel mai mic consum de energie - se va acorda punctaj de 15 puncte Pentru alt consum de energie se va calcula punctajul in raport cu cel mai mic ofertat, conform urmatorului algoritm de calcul : Punctaj = (cel mai mic consum energetic / consum energetic ofertat) x 15 puncte (punctajul maxim acordat) Weight (percentage, exact): 15 Criterion: Type: Quality Name: 5.Instructaj pentru optimizarea eficienței energetice pondere – 10 puncte Description: • Instruire introductiv -generala cu o durata: - Pentru o durată minima de instructaj de 2 ore pentru maxim 5 persoane – se acorda 0 puncte - Pentru o durată maxima de instructaj de 8 ore pentru maxim 5 persoane – se acorda 10 puncte - Pentru fiecare ora suplimentară ofertată față de cele minimum solicitate, dar nu mai mult de 8 h pentru maxim 5 persoane, punctajul se va calcula conform urmatorului algoritm de calcul: Durata(o) = (Durata instructaj ofertata/Durata instructaj maxima ofertata)x 10 Pentru o durata a instructajului mai mica de 2 ore, oferta va fi considerata neconforma. Pentru o durata a instructajului mai mare de 8 ore, nu se acorda punctaj suplimentar. Weight (percentage, exact): 10 Criterion: Type: Quality Name: 6. Garantia echipamentului – 15 puncte Description: Pentru cel mai mare termen de garantie ofertat - se acorda punctaj de 15 puncte Pentru alt termen de garantie ofertat se va calcula punctajul in raport cu cel mai mare ofertat, conform urmatorului algoritm de calcul : • Punctaj = (garantia ofertata / garantia maxim ofertata) x 15 puncte (punctajul maxim acordat) Pentru perioada de garantie ofertata mai mica de 24 de luni, oferta va fi declara neconforma. Perioada de garantie va exprimata in luni. Weight (percentage, exact): 15 5.1.11. Procurement documents Address of the procurement documents: https://e-licitatie.ro/pub/notices/c-notice/v2/view/100185799 5.1.12. Terms of procurement Terms of submission: Electronic submission: Required Address for submission: https://www.e-licitatie.ro Languages in which tenders or requests to participate may be submitted: Romanian Electronic catalogue: Not allowed Variants: Not allowed Deadline for receipt of tenders: 20/11/2024 15:00:00 (UTC+2) Deadline until which the tender must remain valid: 6 Months Information about public opening: Opening date: 20/11/2024 15:00:00 (UTC+2) Place: In SEAP Terms of contract: The execution of the contract must be performed within the framework of sheltered employment programmes: No Conditions relating to the performance of the contract: Procedura de atribuire a contractului de achiziție publică este inițiată sub incidența prezentei clauze suspensive, în sensul că încheierea contractului de achiziție publică este condiționată de alocarea creditelor bugetare cu această destinație, semnarea contractului făcându-se cu respectarea dispozițiilor referitoare la angajarea cheltuielilor din bugetele care intră sub incidența legislației privind finanțele publice. Având în vedere dispozițiile Legii nr. 98/2016 privind achizițiile publice și H.G. nr. 395/2016, cu modificările și completările ulterioare, Autoritatea Contractantă precizează că va încheia contractul cu ofertantul declarat câștigător numai în măsura în care fondurile necesare achiziției vor fi asigurate prin alocarea creditelor bugetare cu această destinație. Durata clauzei suspensive: 12 luni de la data comunicarii rezultatului procedurii. Electronic invoicing: Required Electronic ordering will be used: no Electronic payment will be used: no Legal form that must be taken by a group of tenderers that is awarded a contract: Asociere conform art. 53. din Legea privind achizitiile publice nr 98/2016 Information about review deadlines: Legea 101/2016 5.1.15. Techniques Framework agreement: No framework agreement Information about the dynamic purchasing system: No dynamic purchase system 5.1.16. Further information, mediation and review Review organisation: Consiliul National de Solutionare a Contestatiilor Organisation providing additional information about the procurement procedure: Spitalul Clinic de Urgenta Bagdasar-Arseni Organisation receiving requests to participate: Spitalul Clinic de Urgenta Bagdasar-Arseni Organisation processing tenders: Spitalul Clinic de Urgenta Bagdasar-Arseni TED eSender: Operator SEAP 8. Organisations 8.1. ORG-0004 Official name: Spitalul Clinic de Urgenta Bagdasar-Arseni Registration number: 4943871 Postal address: Strada: Berceni, nr. 10-12 Town: Bucuresti Postcode: 041914 Country subdivision (NUTS): Bucureşti (RO321) Country: Romania Contact point: CRISTINA TUTU Email: achizitii@bagdasar-arseni.ro Telephone: +40 21337387 Fax: +40 0213347387 Internet address: https://www.bagdasar-arseni.ro Buyer profile: https://www.e-licitatie.ro Roles of this organisation: Buyer Organisation providing additional information about the procurement procedure Organisation receiving requests to participate Organisation processing tenders 8.1. ORG-0002 Official name: Consiliul National de Solutionare a Contestatiilor Registration number: 20329980 Postal address: Str. Stavropoleos nr. 6, sector 3 Town: Bucuresti Postcode: 030084 Country subdivision (NUTS): Bucureşti (RO321) Country: Romania Email: office@cnsc.ro Telephone: +40 213104641 Fax: +40 213104642 Internet address: http://www.cnsc.ro Roles of this organisation: Review organisation 8.1. ORG-0001 Official name: Operator SEAP Registration number: RO42283735 Postal address: Strada: Italiană, nr. 22, Sector: -, Judet: Bucuresti, Localitate: Bucuresti, Cod postal: 020976 Town: Bucuresti Postcode: 020976 Country subdivision (NUTS): Bucureşti (RO321) Country: Romania Contact point: Roxana Popescu Email: contact.autoritati@e-licitatie.ro Telephone: +40 3032997 Fax: +40 3052889 Internet address: https://www.adr.gov.ro/ Roles of this organisation: TED eSender 11. Notice information 11.1. Notice information Notice identifier/version: 96ab24d0-0ef7-44f1-81d2-5ba192c7a027 - 01 Form type: Competition Notice type: Contract or concession notice – standard regime Notice subtype: 16 Notice dispatch date: 14/10/2024 14:30:36 (UTC+3) Notice dispatch date (eSender): 14/10/2024 12:00:37 (UTC+3) Languages in which this notice is officially available: Romanian 11.2. Publication information Notice publication number: 622908-2024 OJ S issue number: 201/2024 Publication date: 15/10/2024 Czech document download: https://ted.europa.eu/cs/notice/622908-2024/pdf Danish document download: https://ted.europa.eu/da/notice/622908-2024/pdf German document download: https://ted.europa.eu/de/notice/622908-2024/pdf Greek document download: https://ted.europa.eu/el/notice/622908-2024/pdf Spanish document download: https://ted.europa.eu/es/notice/622908-2024/pdf English document download: https://ted.europa.eu/en/notice/622908-2024/pdf Estonian document download: https://ted.europa.eu/et/notice/622908-2024/pdf Finnish document download: https://ted.europa.eu/fi/notice/622908-2024/pdf French document download: https://ted.europa.eu/fr/notice/622908-2024/pdf Irish document download: https://ted.europa.eu/ga/notice/622908-2024/pdf Croatian document download: https://ted.europa.eu/hr/notice/622908-2024/pdf Hungarian document download: https://ted.europa.eu/hu/notice/622908-2024/pdf Italian document download: https://ted.europa.eu/it/notice/622908-2024/pdf Lithuanian document download: https://ted.europa.eu/lt/notice/622908-2024/pdf Latvian document download: https://ted.europa.eu/lv/notice/622908-2024/pdf Maltese document download: https://ted.europa.eu/mt/notice/622908-2024/pdf Dutch document download: https://ted.europa.eu/nl/notice/622908-2024/pdf Polska document download: https://ted.europa.eu/pl/notice/622908-2024/pdf Portuguese document download: https://ted.europa.eu/pt/notice/622908-2024/pdf Romanian document download: https://ted.europa.eu/ro/notice/622908-2024/pdf Slovak document download: https://ted.europa.eu/sk/notice/622908-2024/pdf Slovenian document download: https://ted.europa.eu/sl/notice/622908-2024/pdf Swedish document download: https://ted.europa.eu/sv/notice/622908-2024/pdf Bulgarian document download: https://ted.europa.eu/bg/notice/622908-2024/pdf

622908-2024 - Competition Competition Romania: Medical equipments VARIOUS MEDICAL EQUIPMENT FOR NEUROSURGERY Estimated value excluding VAT: 3 572 190.00 RON Type of procedure: Open Buyer Buyer: Spitalul Clinic de Urgenta Bagdasar-Arseni Email: achizitii@bagdasar-arseni.ro Romania, Bucharest (RO321), Bucharest LOT-0001: Platform for intraoperative monitoring of nerve functions Medical equipments Romania, Bucharest (RO321) Duration: 12 Months Deadline for receipt of tenders: 20/11/2024 - 15:00:00 (UTC +2) LOT-0002: Ultrasonic aspirator for neurosurgical interventions Medical equipments Romania, Bucharest (RO321) Duration: 12 Months Deadline for receipt of tenders: 20/11/2024 - 15:00:00 (UTC+2) 622908-2024 - Competition Romania – Medical equipments – VARIOUS MEDICAL EQUIPMENT FOR NEUROSURGERY OJ S 201/2024 15/10/2024 Contract or concession notice – standard regime Supplies 1. Buyer 1.1. Buyer Official name: Spitalul Clinic de Urgenta Bagdasar-Arseni Email: achizitii@bagdasar-arseni.ro Legal type of the buyer: Body governed by public law Activity of the contracting authority: Health 2. Procedure 2.1. Procedure Title: VARIOUS MEDICAL EQUIPMENT FOR NEUROSURGERY Description: - The procurement procedure involves - The conclusion of a supply contract with a suspensive clause - The validity period of the proposed contract: 12 months from the date of communication of the result of the procedure. According to art. 161 of Law 98/2016, the deadline for answering clarifications is the 11th day before the deadline for submitting offers. The number of days until which clarifications can be requested before the deadline for submitting offers: 18 days Procedure identifier: 56801d79-2400-4938-b102-a9628802432f Internal identifier: 4943871.2024.14 Type of procedure: Open 2.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33100000 Medical equipments 2.1.3. Value Estimated value excluding VAT: 3,572,190.00 RON 2.1.4. General information Additional information: The technical requirements defined at the level of the participation announcement, specifications or other complementary documents, by sending the standards, to a specific manufacturer, to brands, patents, types, to an origin or to a specific production/manufacturing method /performance/execution, will be understood as being accompanied by the mention "or equivalent". Legal basis: Directive 2014/24/EU 2.1.5. Terms of procurement Terms of submission: Maximum number of lots for which one tenderer can submit tenders: 2 Terms of contract: Maximum number of lots for which contracts can be awarded to one tenderer: 2 2.1.6. Grounds for exclusion Participation in a criminal organization: Participation in a criminal organization Corruption: Corruption Fraud: Fraud Terrorist offenses or offenses linked to terrorist activities: Money laundering or terrorist financing:Money laundering or terrorism financing Child labor and other forms of trafficking in human beings: Exploitation through child labor and other forms of human trafficking Payment of taxes: Payment of taxes Payment of social security contributions: Payment of social insurance 5. Lot 5.1. Lot: LOT-0001 Title: Platform for intraoperative monitoring of nerve functions Description: According to the specifications Internal identifier: 1 5.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33100000 Medical equipments 5.1.2. Place of performance Country subdivision (NUTS): Bucharest (RO321) Country: Romania Additional information: Magazia SCUBA 5.1.3. Estimated duration Duration: 12 Months 5.1.4. Renewal Maximum renewals: 0 5.1.6. General information Reserved participation: Participation is not reserved. The names and professional qualifications of the staff assigned to perform the contract must be given: Not required Procurement Project not financed with EU Funds. The procurement is covered by the Government Procurement Agreement (GPA): no 5.1.9. Selection criteria Criterion: Type: Suitability to pursue the professional activity Name: III.1.1.a) Personal situation of the candidate or tenderer Description: 1. Declaration regarding non-compliance with the provisions of Art. 59,60 of Law no. 98/2016 regarding public procurement. The declaration regarding non-compliance with the provisions of Art. 59, 60 will be attached to SEAP together with DUAE. Method of fulfillment by which the fulfillment of the requirement can be demonstrated: - DUAE will be completed by the economic operators participating in the award procedure with the information related to their situation. The supporting documents will be requested by the contracting authority only to the operator ranked first in the intermediate ranking, after the evaluation of the offers has been completed. (art. 173 of Law 98/2016). Falling into the situations provided for in Art. 59, 60, 164, 165, 167 of Law no. 98/2016 on public procurement involves the exclusion of the bidder from the procedure applied for the award of the public procurement contract. Persons with decision-making functions within the contracting authority involved in the procurement procedure regarding the organization, development and completion of the award procedure: - Andi NODIȚ – Manager, - Dr. Narcisa BUCUR - Medical Director, - As. Med. Principal (S) Ana MARES – Care Director, - Ec. Marian ROŞOI - Financial Accounting Director, - Asst. Univ. Dr. Petrescu George Emil Dragos – Medical Specialist SNC IV - Dr. Viorel PRUNA – Head of Department of Neurosurgery SNC V - Dr. Mircea Felix Brehar – Primary Physician, Head of Department of SNC I - Eng. Cristina ŢUŢU – Head of Public Procurement Service Contracting, - Ec Simona Gigi Tăvârlău – CFP visa appointee, - Av. Elena Vătrai – Societatea Pricop and Associații SPARL, - Ref. spec. Elena POPA – APC-AT Service - Ec. Elisabeta CORCAN – APC-AT Service 2. Certificates verifying the payment of taxes,taxes or contributions to the consolidated general budget (local budget, state budget, etc.) valid at the time of presentation, for the main headquarters, and for the secondary headquarters/work points, a declaration on personal responsibility regarding the fulfillment of the obligations to pay taxes, fees or due contributions to the general consolidated budget (art. 173 of Law 98/2016); In the case of foreign economic operators, equivalent documents issued in accordance with the legislation applicable in the country of residence will be presented. Method of fulfillment by which the fulfillment of the requirement can be demonstrated: - DUAE will be completed by the economic operators participating in the award procedure with the information related to their situation. The supporting documents will be requested by the contracting authority only to the bidder ranked first in the intermediate ranking, after the evaluation of the bids has been completed. (art. 196 paragraph 2 of Law 98/2016 and art. 132 of HG 395/2016). According to the provisions of art. 193 of Law 98/2016, the contracting authority will accept in DUAE offers instead of the documents requested to demonstrate the qualification requirements, as preliminary evidence. 3. The criminal record of the economic operator and the members of the administrative, management or supervisory body of the respective economic operator, or of those who have the power of representation, decision or control within it, as it results from the ascertaining certificate issued by ONRC / constitutive act; Method of fulfillment by which the fulfillment of the requirement can be demonstrated: - DUAE will be completed by the economic operators participating in the award procedure with the information related to their situation. The supporting documents that prove the fulfillment of those assumed by completing the DUAE, or in the case of foreign bidders, equivalent documents issued in the country of residence, are to be presented, at the request of the contracting authority, only to the bidder ranked first in the intermediate ranking after the evaluation of the bids has been completed. (art. 196 paragraph 2 of Law 98/2016 and art. 132 of HG 395/2016) Mandatory requirement for foreign legal entities: Presentation by foreign natural/legal entities of documents proving a form of registration as a natural or legal entity or attestation or membership from a professional point of view in accordance with the provisions of the country where the bidder is established. 4. As the case may be, documents proving that the economic operator can benefit from the exemptions provided for in art. 166 para. (2), art. 167 para. (2) and art. 171 of Law 98/2016 on public procurement; 5. Other edifying documents, as the case may be. Use of this criterion: Used Criterion: Type: Suitability to pursue the professional activity Name: III.1.1.b) Capacity to pursue the professional activity Description: Requirement no.1.The ascertaining certificate issued by ONRC - Economic operators who submit an offer must prove a form of registration under the conditions of the law of the resident country, from which it can be seen that the economic operator is legally constituted, that it is not in any of the situations of annulment of incorporation, such as and the fact that he has the professional capacity to carry out the activities that are the subject of the public procurement contract. The requirement also applies to the subcontractor who completes the information related to their situation at the level of a separate DUAE. All documents must be valid at the time of presentation. Method of fulfillment: DUAE will be completed by the economic operators participating in the public procurement contract award procedure with the information requested by the contracting authority - information regarding the fulfillment of the requirements regarding the ability to exercise professional activity. The supporting document that proves the fulfillment of those assumed by completing the DUAE, respectively the ascertaining certificate issued by the ONRC, or in the case of foreign legal/natural person bidders, the equivalent documents issued in the country of residence, translated into Romanian, are to be presented, at the request of the contracting authority , only by the bidder ranked first in the intermediate ranking, after the evaluation of the bids has been completed. (art. 196 paragraph 2 of Law 98/2016 and art. 132 of HG 395/2016) Use of this criterion: Used Criterion: Type: Technical and professional ability Name: Diplomas of studies and professional qualifications Description: Economic operators submitting the offer must holds attestation or membership from a professional point of view, respectively to hold: a. Operating permit issued by the National Agency of Medicines and Medical Devices in accordance with Art. 926 of Title XX of Law 95/2006, with subsequent amendments and additions and according Order no. 566 of April 3, 2020 for the approval of the Methodological Norms for the application of title XX of Law no. 95/2006 on health reform, regarding the approval of activities in the field of medical devices. Bidders in the process of approval are not accepted. (art. 173 para. 2 of Law 98/2016) b. The Annex to the Operating Approval will, on the date of submission of the offer, compulsorily include the manufacturer of the offered medical devices. (art. 173 paragraph 2 of Law 98/2016) In the case of an offer submitted by an association, considering that they are jointly and severally liable to the contracting authority, each individual associate has the obligation to present the Operating Notice issued by the Ministry Health for the previously mentioned activities. All documents will be submitted in SEAP signed with the extended electronic signature, according to art. 60 para. (4) from HG no. 395/2016 All documents will be submitted in SEAP signed with the extended electronic signature, according to art. 60 para. (4) from HG no.395/2016 Use of this criterion: Used Criterion: Type: Suitability to pursue the professional activity Name: Registration in the commercial register Description: Certificate of verification issued by ONRC - Economic operators who submit an offer must prove a form of registration under the law of the country resident, from which it can be seen that the economic operator is legally constituted, that it is not in any of the situations of annulment of incorporation, as well as the fact that it has the professional capacity to carry out the activities that are the subject of the public procurement contract. The requirement also applies to the subcontractor who completes the information related to their situation at the level of a separate DUAE. All documents must be valid at the time of presentation. Method of fulfillment: DUAE will be completed by the economic operators participating in the procedure for awarding the public procurement contract with the information requested by the contracting authority - information regarding the fulfillment of the requirements regarding the ability to exercise professional activity. The supporting document that proves the fulfillment of those assumed by completing the DUAE, respectively the ascertaining certificate issued by the ONRC, or in the case of foreign legal/natural person bidders, the equivalent documents issued in the country of residence, translated into Romanian, are to be presented, at the request of the contracting authority , only by the bidder ranked first in the intermediate ranking, after the evaluation of the bids has been completed. (art 196 paragraph 2 of Law 98/2016 and art 132 of HG 395/2016) Use of this criterion: Used Criterion: Type: Economic and financial standing Use of this criterion: Not used 5.1.10. Award criteria Criterion: Type: Price Name: Price of the offer Description: The score is awarded as follows: a) For the lowest of the prices, the maximum score is awarded; b) For the other prices offered, the score P(n) is calculated proportionally, as follows: P(n) = (Minimum price offered / Price n) x maximum score allocated. Weight (percentage, exact): 40 Criterion: Type: Quality Name: 1. Reduction of stimulation artifacts by delayed download – 5 points Description: For a system that does not have reduction of stimulation artifacts by delayed download – 0 points are given For a system that has the reduction of stimulation artefacts by delayed discharge - the maximum score is 5 points Weight (percentage, exact): 5 Criterion: Type: Quality Name: 2. High current stimulation, minimum 12 channels, with simultaneous impedance measurement in all stimulation channels – 5 points Description: For high current stimulation with at least 12 channels, without simultaneous impedance measurement in all stimulation channels – 0 points are awarded For high current stimulation with at least 12 channels, with simultaneous impedance measurement in all stimulation channels stimulation - the maximum score is 5 points Weight (percentage, exact):5 Criterion: Type: Quality Name: 3. Recording system with at least 32 recording channels, with the possibility of upgrading to 64 channels - 10 points Description: For a recording system with 32 recording channels, but without the possibility of upgrading - 0 points are awarded • For a recording system with 32 recording channels with the possibility of upgrading to 64 channels – the maximum score is 10 points Weight (percentage, exact): 10 Criterion: Type: Quality Name: 4. Energy performance of of the equipment - 15 points Description: For the lowest energy consumption - a score of 15 points will be given For other energy consumption the score will be calculated in relation to the lowest offered, according to the following calculation algorithm: Score = (the lowest energy consumption / offered energy consumption) x 15 points (maximum score awarded) Weight (percentage, exact): 15 Criterion: Type: Quality Name: 5. Training for optimizing energy efficiency – 10 points Description: • Introductory - general training with a duration : - For a minimum training duration of 2 hours for a maximum of 5 people - 0 points are awarded - For a maximum training duration of 8 hours for a maximum of 5 people - 10 points are awarded - For each additional hour offered compared to the minimum requested , but no more than 8 h for a maximum of 5 people, the score will be calculated according to the following calculation algorithm: Duration(o) = (Duration of instruction offered/Maximum instruction duration offered)x 10 For an instruction duration of less than 2 hours , the offer will be considered non-compliant. • No additional points are given for an instruction duration of more than 8 hours. Weight (percentage, exact): 10 Criterion: Type: Quality Name: • 6. Equipment warranty – 15 points Description: For the longest warranty period offered - a score of 15 points is given For another warranty period offered, the score will be calculated in relation to the highest offered, according to the following calculation algorithm: • Score = (guarantee offered / maximum guarantee offered) x 15 points (maximum score awarded) For the offered guarantee period of less than 24 months, the offer will be declared non-compliant . The warranty period will be expressed in months. Weight (percentage, exact): 15 5.1.11. Procurement documents Address of the procurement documents: https://e-licitatie.ro/pub/notices/c-notice/v2/view/100185799 5.1.12. Terms of procurement Terms of submission: Electronic submission: Required Address for submission: https://www.e-licitatie.ro Languages ​​in which tenders or requests to participate may be submitted: Romanian Electronic catalogue: Not allowed Variants: Not allowed Deadline for receipt of tenders: 20/11/2024 15:00:00 (UTC+2) Deadline until which the tender must remain valid: 6 Months Information about public opening: Opening date: 20/11/2024 15:00:00 (UTC +2) Place: In SEAP Terms of contract:The execution of the contract must be performed within the framework of sheltered employment programs: No Conditions relating to the performance of the contract: The procedure for awarding the public procurement contract is initiated under the present suspensive clause, in the sense that the conclusion of the public procurement contract is conditioned by the allocation of budget credits for this purpose, the signing of the contract being done in compliance with the provisions regarding the commitment of expenses from the budgets that fall under the legislation on public finances. Considering the provisions of Law no. 98/2016 on public procurement and HG no. 395/2016, with subsequent amendments and additions, the Contracting Authority specifies that it will conclude the contract with the bidder declared the winner only to the extent that the funds necessary for the purchase will be secured by allocating budget credits for this purpose. Duration of the suspensive clause: 12 months from the date of communication of the result of the procedure. Electronic invoicing: Required Electronic ordering will be used: no Electronic payment will be used: no Legal form that must be taken by a group of tenderers that is awarded a contract: Association according to art. 53. from the Law on public procurement no. 98/2016 Information about review deadlines: Law 101/2016 5.1.15. Techniques Framework agreement: No framework agreement Information about the dynamic purchasing system: No dynamic purchasing system 5.1.16. Further information, mediation and review Review organization: National Complaints Resolution Council Organization providing additional information about the procurement procedure: Bagdasar-Arseni Clinical Emergency Hospital Organization receiving requests to participate: Bagdasar-Arseni Clinical Emergency Hospital Organization processing tenders: Bagdasar-Arseni Clinical Hospital Organization processing tenders: Clinical Hospital of Emergency Bagdasar-Arseni TED eSender: SEAP Operator 5.1. Lot: LOT-0002 Title: Ultrasonic aspirator for neurosurgical interventions Description: According to specifications Internal identifier: 2 5.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33100000 Medical equipments 5.1.2. Place of performance Country subdivision (NUTS): Bucharest (RO321) Country: Romania Additional information: Magazia SCUBA 5.1.3. Estimated duration Duration: 12 Months 5.1.4. Renewal Maximum renewals: 0 5.1.6. General information Reserved participation: Participation is not reserved. The names and professional qualifications of the staff assigned to perform the contract must be given: Not required Procurement Project not financed with EU Funds. The procurement is covered by the Government Procurement Agreement (GPA): no 5.1.9. Selection criteria Criterion: Type: Suitability to pursue the professional activity Name: III.1.1.a) Personal situation of the candidate or tenderer Description: 1. Declaration regarding non-compliance with the provisions of Art. 59,60 of Law no. 98/2016 regarding public procurement.The declaration regarding non-compliance with the provisions of Art. 59, 60 will be attached to SEAP together with DUAE. Method of fulfillment by which the fulfillment of the requirement can be demonstrated: - the DUAE will be completed by the economic operators participating in the award procedure with the information related to their situation. The supporting documents will be requested by the contracting authority only to the operator ranked first in the intermediate ranking, after the evaluation of the offers has been completed. (art. 173 of Law 98/2016). Falling into the situations provided for in Art. 59, 60, 164, 165, 167 of Law no. 98/2016 on public procurement involves the exclusion of the bidder from the procedure applied for the award of the public procurement contract. Persons with decision-making functions within the contracting authority involved in the procurement procedure regarding the organization, development and completion of the award procedure: - Andi NODIȚ – Manager, - Dr. Narcisa BUCUR - Medical Director, - As. Med. Principal (S) Ana MARES – Director of Care, - Ec. Marian ROŞOI - Director of Financial Accounting, - Asst. Univ. Dr. Petrescu George Emil Dragos – Medical Specialist SNC IV - Dr. Viorel PRUNA – Head of Department of Neurosurgery SNC V - Dr. Mircea Felix Brehar – Primary Physician, Head of Department of SNC I - Eng. Cristina ŢUŢU – Head of Public Procurement Service Contracting, - Ec Simona Gigi Tăvârlău – CFP visa appointee, - Av. Elena Vătrai – Societatea Pricop and SPARL Associations, - Ref. spec. Elena POPA – APC-AT Service - Ec. Elisabeta CORCAN – APC-AT Service 2. Certificates verifying the payment of taxes, fees or contributions to the general consolidated budget (local budget, state budget, etc.) valid at the time of presentation, for the headquarters main, and for secondary offices/workpoints, a declaration on personal responsibility regarding the fulfillment of obligations to pay taxes, fees or contributions to the general consolidated budget due (art. 173 of Law 98/2016); In the case of foreign economic operators, equivalent documents issued in accordance with the legislation applicable in the country of residence will be presented. Method of fulfillment by which the fulfillment of the requirement can be demonstrated: - the DUAE will be completed by the economic operators participating in the award procedure with the information related to their situation. The supporting documents will be requested by the contracting authority only to the bidder ranked first in the intermediate ranking, after the evaluation of the bids has been completed. (art. 196 paragraph 2 of Law 98/2016 and art. 132 of HG 395/2016). According to the provisions of art. 193 of Law 98/2016, the contracting authority will accept in DUAE offers instead of the documents requested to demonstrate the qualification requirements, as preliminary evidence. 3. The criminal record of the economic operator and the members of the administrative, management or supervisory body of that economic operator,or of those who have the power of representation, decision or control within it, as it results from the ascertaining certificate issued by ONRC / the constitutive act; Method of fulfillment by which the fulfillment of the requirement can be demonstrated: - DUAE will be completed by the economic operators participating in the award procedure with the information related to their situation. The supporting documents that prove the fulfillment of those assumed by completing the DUAE, or in the case of foreign bidders, equivalent documents issued in the country of residence, are to be presented, at the request of the contracting authority, only to the bidder ranked first in the intermediate ranking after the evaluation of the bids has been completed. (art. 196 paragraph 2 of Law 98/2016 and art. 132 of HG 395/2016) Mandatory requirement for foreign legal entities: Presentation by foreign natural/legal entities of documents proving a form of registration as a natural or legal entity or attestation or membership from a professional point of view in accordance with the provisions of the country where the bidder is established. 4. As the case may be, documents proving that the economic operator can benefit from the exemptions provided for in art. 166 para. (2), art. 167 para. (2) and art. 171 of Law 98/2016 on public procurement; 5. Other edifying documents, as the case may be. Use of this criterion: Used Criterion: Type: Suitability to pursue the professional activity Name: III.1.1.b) Capacity to pursue the professional activity Description: Requirement no.1. The ascertaining certificate issued by ONRC - Economic operators who submit an offer must prove a form of registration under the conditions of the law of the resident country, from which it can be seen that the economic operator is legally constituted, that it is not in any of the situations of annulment of incorporation, such as and the fact that he has the professional capacity to carry out the activities that are the subject of the public procurement contract. The requirement also applies to the subcontractor who completes the information related to their situation at the level of a separate DUAE. All documents must be valid at the time of presentation. Method of fulfillment: DUAE will be completed by the economic operators participating in the procedure for awarding the public procurement contract with the information requested by the contracting authority - information regarding the fulfillment of the requirements regarding the ability to exercise professional activity. The supporting document that proves the fulfillment of those assumed by completing the DUAE, respectively the ascertaining certificate issued by the ONRC, or in the case of foreign legal/natural person bidders, the equivalent documents issued in the country of residence, translated into Romanian, are to be presented, at the request of the contracting authority , only by the bidder ranked first in the intermediate ranking, after the evaluation of the bids has been completed.(art. 196 paragraph 2 of Law 98/2016 and art. 132 of HG 395/2016) Use of this criterion: Used Criterion: Type: Technical and professional ability Name: Diplomas of studies and professional qualifications Description: Economic operators submitting the offer must holds attestation or membership from a professional point of view, respectively to hold: a. Operating permit issued by the National Agency of Medicines and Medical Devices in accordance with Art. 926 of Title XX of Law 95/2006, with subsequent amendments and additions and according Order no. 566 of April 3, 2020 for the approval of the Methodological Norms for the application of title XX of Law no. 95/2006 on health reform, regarding the approval of activities in the field of medical devices. Bidders in the process of approval are not accepted. (art. 173 para. 2 of Law 98/2016) b. The Annex to the Operating Approval will, on the date of submission of the offer, compulsorily include the manufacturer of the offered medical devices. (art. 173 paragraph 2 of Law 98/2016) In the case of an offer submitted by an association, considering that they are jointly and severally liable to the contracting authority, each individual associate has the obligation to present the Operating Notice issued by the Ministry Health for the previously mentioned activities. All documents will be submitted in SEAP signed with the extended electronic signature, according to art. 60 para. (4) from HG no. 395/2016 All documents will be submitted in SEAP signed with the extended electronic signature, according to art. 60 para. (4) from HG no. 395/2016 Use of this criterion: Used Criterion: Type: Suitability to pursue the professional activity Name: Registration in the commercial register Description: Certificate of verification issued by ONRC - Economic operators who submit an offer must prove a form of registration under the law of the country resident, from which it can be seen that the economic operator is legally constituted, that it is not in any of the situations of annulment of incorporation, as well as the fact that it has the professional capacity to carry out the activities that are the subject of the public procurement contract. The requirement also applies to the subcontractor who completes the information related to their situation at the level of a separate DUAE. All documents must be valid at the time of presentation. Method of fulfillment: DUAE will be completed by the economic operators participating in the procedure for awarding the public procurement contract with the information requested by the contracting authority - information regarding the fulfillment of the requirements regarding the ability to exercise professional activity. The supporting document that proves the fulfillment of those assumed by completing the DUAE, respectively the ascertaining certificate issued by the ONRC, or in the case of foreign legal/natural person bidders, the equivalent documents issued in the country of residence, translated into Romanian, are to be presented,at the request of the contracting authority, only by the bidder ranked first in the intermediate ranking, after the evaluation of the bids has been completed. (art 196 paragraph 2 of Law 98/2016 and art 132 of HG 395/2016) Use of this criterion: Used Criterion: Type: Economic and financial standing Use of this criterion: Not used 5.1.10. Award criteria Criterion: Type: Price Name: Price of the offer Description: The score is awarded as follows: a) For the lowest of the prices, the maximum score is awarded; b) For the other prices offered, the score P(n) is calculated proportionally, as follows: P(n) = (Minimum price offered / Price n) x maximum score allocated. Weight (percentage, exact): 40 Criterion: Type: Quality Name: 1. The flow rate of the irrigation pump must be between: 3 and 40 ml/min and can be adjusted in steps - 10 points Description: For the flow rate of the irrigation pump included between: 3 and 40 ml/min without the possibility of being adjusted in steps - 0 points For the Flow of the irrigation pump between: 3 and 40 ml/min with the possibility of being adjusted in steps - 10 points Weight (percentage, exact) : 10 Criterion: Type: Quality Name: 2. To present RFID technology, which allows recognition of the working tip applied to the handpiece – 5 points Description: For RFID Technology to recognize the working tip applied to the handpiece – 0 points For RFID Technology for recognizing the working tip applied to the handpiece and implicitly displaying on the console screen the data related to the connected working tip: tip type, usage parameters - 5 points Weight (percentage, exact): 5 Criterion: Type: Quality Name: 3. The software should allow the creation of at least 70 presets (work profiles for medical personnel) for different operating parameters – 5 points Description: For software that allows the creation of a number of presets >70, but <80 – 2 points For software that allows creating a number of presets ≥ 80, but <100 – 5 points Weight (percentage, exact): 5 Criterion: Type: Quality Name: 4. Energy performance of the equipment – ​​15 points4. Energy performance of the equipment - 15 points Description: For the lowest energy consumption - a score of 15 points will be given For other energy consumption the score will be calculated in relation to the lowest offered, according to the following calculation algorithm: Score = ( the lowest energy consumption / energy consumption offered) x 15 points (the maximum score awarded) Weight (percentage, exact): 15 Criterion: Type: Quality Name: 5.Instruction for optimizing energy efficiency weight – 10 points Description: • Introductory training - general with a duration: - For a minimum training duration of 2 hours for a maximum of 5 people - 0 points are awarded - For a maximum training duration of 8 hours for a maximum of 5 people - 10 points are awarded - For each additional hour offered of the minimum required, but no more than 8 hours for a maximum of 5 people,the score will be calculated according to the following calculation algorithm: Duration(o) = (Duration of instruction offered/Maximum instruction duration offered)x 10 For an instruction duration of less than 2 hours, the offer will be considered non-compliant. For a training duration of more than 8 hours, no additional points are awarded. Weight (percentage, exact): 10 Criterion: Type: Quality Name: 6. Equipment warranty - 15 points Description: For the longest warranty period offered - a score of 15 points is given For other warranty terms offered, the score will be calculated in compared to the highest offered, according to the following calculation algorithm: • Score = (guarantee offered / maximum guarantee offered) x 15 points (maximum score awarded) For the offered guarantee period of less than 24 months, the offer will be declared non-compliant. The warranty period will be expressed in months. Weight (percentage, exact): 15 5.1.11. Procurement documents Address of the procurement documents: https://e-licitatie.ro/pub/notices/c-notice/v2/view/100185799 5.1.12. Terms of procurement Terms of submission: Electronic submission: Required Address for submission: https://www.e-licitatie.ro Languages ​​in which tenders or requests to participate may be submitted: Romanian Electronic catalogue: Not allowed Variants: Not allowed Deadline for receipt of tenders: 20/11/2024 15:00:00 (UTC+2) Deadline until which the tender must remain valid: 6 Months Information about public opening: Opening date: 20/11/2024 15:00:00 (UTC +2) Place: In SEAP Terms of contract: The execution of the contract must be performed within the framework of sheltered employment programs: No Conditions relating to the performance of the contract: The procedure for awarding the public procurement contract is initiated under the present suspensive clauses, in the sense that the conclusion of the public procurement contract is conditional on the allocation of budget credits for this purpose, the signing of the contract being done in compliance with the provisions relating to the commitment of expenses from the budgets that fall under the legislation on public finances. Considering the provisions of Law no. 98/2016 on public procurement and HG no. 395/2016, with subsequent amendments and additions, the Contracting Authority specifies that it will conclude the contract with the bidder declared the winner only to the extent that the funds necessary for the purchase will be secured by allocating budget credits for this purpose. Duration of the suspensive clause: 12 months from the date of communication of the result of the procedure. Electronic invoicing: Required Electronic ordering will be used: no Electronic payment will be used: no Legal form that must be taken by a group of tenderers that is awarded a contract: Association according to art. 53. from the Law on public procurement no. 98/2016 Information about review deadlines: Law 101/2016 5.1.15. Techniques Framework agreement:No framework agreement Information about the dynamic purchasing system: No dynamic purchasing system 5.1.16. Further information, mediation and review Review organization: National Complaints Resolution Council Organization providing additional information about the procurement procedure: Bagdasar-Arseni Clinical Emergency Hospital Organization receiving requests to participate: Bagdasar-Arseni Clinical Emergency Hospital Organization processing tenders: Bagdasar-Arseni Clinical Hospital Organization processing tenders: Clinical Hospital of Urgenta Bagdasar-Arseni TED eSender: SEAP Operator 8. Organizations 8.1. ORG-0004 Official name: Spitalul Clinic de Urgenta Bagdasar-Arseni Registration number: 4943871 Postal address: Street: Berceni, no. 10-12 Town: Bucuresti Postcode: 041914 Country subdivision (NUTS): Bucuresti (RO321) Country: Romania Contact point: CRISTINA TUTU Email: achizitii@bagdasar-arseni.ro Telephone: +40 21337387 Fax: +40 0213347387 Internet address: https ://www.bagdasar-arseni.ro Buyer profile: https://www.e-licitatie.ro Roles of this organization: Buyer Organization providing additional information about the procurement procedure Organization receiving requests to participate Organization processing tenders 8.1. ORG-0002 Official name: National Complaints Resolution Council Registration number: 20329980 Postal address: Str. Stavropoleos no. 6, sector 3 Town: Bucharest Postcode: 030084 Country subdivision (NUTS): Bucharest (RO321) Country: Romania Email: office@cnsc.ro Telephone: +40 213104641 Fax: +40 213104642 Internet address: http://www.cnsc .ro Roles of this organization: Review organization 8.1. ORG-0001 Official name: Operator SEAP Registration number: RO42283735 Postal address: Street: Italiană, no. 22, Sector: -, County: Bucuresti, City: Bucuresti, Postal code: 020976 Town: Bucuresti Postcode: 020976 Country subdivision (NUTS): Bucuresti (RO321) Country: Romania Contact point: Roxana Popescu Email: contact.autoritati@e- licitatie.ro Telephone: +40 3032997 Fax: +40 3052889 Internet address: https://www.adr.gov.ro/ Roles of this organization: TED eSender 11. Notice information 11.1. Notice information Notice identifier/version: 96ab24d0-0ef7-44f1-81d2-5ba192c7a027 - 01 Form type: Competition Notice type: Contract or concession notice – standard regime Notice subtype: 16 Notice dispatch date: 14/10/2024 14:30:36 (UTC+3) Notice dispatch date (eSender): 14/10/2024 12:00:37 (UTC+3) Languages ​​in which this notice is officially available: Romanian 11.2. Publication information Notice publication number: 622908-2024 OJ S issue number: 201/2024 Publication date: 15/10/2024 Czech document download: https://ted.europa.eu/cs/notice/622908-2024/pdf Danish document download: https://ted.europa.eu/da/notice/622908-2024/pdf German document download: https://ted.europa.eu/de/notice/622908-2024/pdf Greek document download: https: //ted.europa.eu/el/notice/622908-2024/pdf Spanish document download: https://ted.europa.eu/es/notice/622908-2024/pdf English document download: https://ted.europa.eu/en/notice/622908-2024/pdf Estonian document download: https://ted.europa.eu/et/notice/622908-2024/pdf Finnish document download: https://ted.europa.eu/ fi/notice/622908-2024/pdf French document download: https://ted.europa.eu/fr/notice/622908-2024/pdf Irish document download: https://ted.europa.eu/ga/notice/ 622908-2024/pdf Croatian document download: https://ted.europa.eu/hr/notice/622908-2024/pdf Hungarian document download: https://ted.europa.eu/hu/notice/622908-2024/ pdf Italian document download: https://ted.europa.eu/it/notice/622908-2024/pdf Lithuanian document download: https://ted.europa.eu/lt/notice/622908-2024/pdf Latvian document download : https://ted.europa.eu/lv/notice/622908-2024/pdf Maltese document download: https://ted.europa.eu/mt/notice/622908-2024/pdf Dutch document download: https:/ /ted.europa.eu/nl/notice/622908-2024/pdf Polska document download: https://ted.europa.eu/pl/notice/622908-2024/pdf Portuguese document download: https://ted.europa .eu/pt/notice/622908-2024/pdf Romanian document download: https://ted.europa.eu/ro/notice/622908-2024/pdf Slovak document download: https://ted.europa.eu/sk /notice/622908-2024/pdf Slovenian document download: https://ted.europa.eu/sl/notice/622908-2024/pdf Swedish document download: https://ted.europa.eu/sv/notice/622908 -2024/pdf Bulgarian document download: https://ted.europa.eu/bg/notice/622908-2024/pdf