Детали проекта

Общая информация

Название проекта

Former Yugoslav Republic of Macedonia-Skopje: Blood-testing reagents

Contract notice
11 Фев 2019

Опубликован

11 Февраль 2019

Срок подачи

20 Март 2019

Бюджет

25 300 000 MKD


Тип тендера

Поставки

Номер

ECZ226040-Candidate countries

Донор

EC - Европейская комиссия (ЕК)

Лоты

LOT 1. Reagents and Calibrators for the Basic Hemostasis Tests and Coagulation Factors Applicative for Automated Coagulometer BCS-XP or the Equivalent

LOT 2. Reagents and Calibrators Tracking Fibrinolysis Application for Automated Koagulometar BCS-XP or the Equivalent

LOT 3. Reagents and Calibrators for Monitoring the Activity of Inhibitors of Hemostasis Applicative for Automated coagulometar BCS-XP or Equivalent

LOT 4. Dilution Buffer Coagulation Tests Compatible for BCS XP or Equivalent

LOT 5. Rotor Cells with 20 Segmented Cells that have 6 Dilution Chambers Compatible for BCS XP or Equivalents

LOT 6. Solution for Cleaning of BCS XP Analyzer Compatible for BCS XP or Equivalent

LOT 7. Solution for Washing the BCS XP System, Compatible for BCS XP or the Equivalent

LOT 8. Disinfectants for BCS XP System Compatible for BCS XP or the Equivalent


Страны

Северная Македония

Former Yugoslav Republic of Macedonia-Skopje: Blood-testing reagents

2019/S 029-065849

Contract notice

Supplies
Legal Basis:

Directive 2014/24/EU

Section I: Contracting authority
I.1)Name and addresses
Institute of Transfusion Medicine
Vodnjanska 17
Skopje
1000
The former Yugoslav Republic of Macedonia
Contact person: Bobi Bozinovski
Telephone: +38 923226923
E-mail: transfuziologija@gmail.com
Fax: +38 923119227
NUTS code: MK0

Internet address(es):

Main address: www.itm.org.mk
I.2)Information about joint procurement
I.3)Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at: www.e-nabavki.gov.mk
Additional information can be obtained from the abovementioned address
Tenders or requests to participate must be submitted electronically via: www.e-nabavki.gov.mk
Tenders or requests to participate must be submitted to the abovementioned address
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at: www.e-nabavki.gov.mk
I.4)Type of the contracting authority
Other type: Institute of Transfusion Medicine
I.5)Main activity
Health

Section II: Object
II.1)Scope of the procurement
II.1.1)Title:

Reagents, Materials, Calibrators for Hemostasis Applicative for Automated Coagulometer BSC-XP or the Equivalent and Maintaining Devices for Automated Coagulometer BCS-XP or the Equivalent

Reference number: 04/2019
II.1.2)Main CPV code
33696200
II.1.3)Type of contract
Supplies
II.1.4)Short description:

Reagents, materials, calibrators for hemostasis applicative for automated coagulometer bsc-xp or the equivalent and maintaining devices for automated coagulometer bcs-xp or the equivalent according to technical specification.

II.1.5)Estimated total value
Value excluding VAT: 25 300 000.00 MKD
II.1.6)Information about lots
This contract is divided into lots: yes
Tenders may be submitted for all lots
II.2)Description
II.2.1)Title:

Reagents and Calibrators for the Basic Hemostasis Tests and Coagulation Factors Applicative for Automated Coagulometer BCS-XP or the Equivalent

Lot No: 1
II.2.2)Additional CPV code(s)
33696200
II.2.3)Place of performance
NUTS code: MK
Main site or place of performance:

Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at St Mother Tereza 17., SKOPJE

II.2.4)Description of the procurement:

Eagents and calibrators for the basic hemostasis tests and coagulation factors applicative for automated coagulometer BCS-XP or the equivalent:

1) Reagent for determining prothrombin time, compatible for BCS-XP or the equivalent ml 18 000;

2) Reagent for calibration of prothrombin time in INR and %, compatible for BCS-XP or the equivalent ml 72;

3) Reagent for determining the active partial thromboplastin time, compatible for BCS-XP or the equivalent ml 500;

4) Reagent for determining the active partial thromboplastin time in human citrated plasma,compatible for BCSXP or the equivalent ml 9 000;

5) Reagent for quantitative determining the thrombin time in human citrated plasma, compatible for BCS-XP or the equivalent ml 5 000;

6) Reagent for determining the thrombin time in human plasma, compatible for BCS-XP or the equivalent ml 7 500;

7) Reagent for determining the batroxombin time, compatible for BCS-XP or the equivalent ml 40;

8) Reagent for determining the endogenous thrombin reagents, compatible for BCS-XP or the equivalent ml 4,8;

9) Calcium chlorid, CaCl2,compatible for BCS-XP or the equivalent ml 15 000;

10) Reagent for determining the precision and analytic deviation of certain analytes: prothromin time, active partial time, thrombin time, batroxobin, fibinogen, coagulation factors, inhibitors, complementary activity, plasminogen, protein C, Lupus Anticoagulant compatible for BCS-XP or the equivalent. ml 1 500;

11) Reagent for calibration of prothrombin time, fibrinogen, coagulation factors, von willebrand, Inhibitors, total complementary activity and plasminogen, compatible for BCS-XP or the equivalent ml 100;

12) Reagent for quantitative determination of fibrinogen in the plasma,compatible for BCS-XP or the equivalent ml 600;

13) Reagent for preparation of fibrinogen reference curve by Claus method, compatible for BCS-XP or the equivalent ml 48;

14) Reagent for determining the activity of coagulation factor 2 in the plasma, compatible for BCS-XP or the equivalent ml 15;

15) Reagent for determining the activity of coagulation factor 5, compatible for BCS-XP or the equivalent ml 40;

16) Reagent for determining the activity of coagulation factor 7, compatible for BCS-XP or the equivalent ml 15;

17) Reagent for determining the activity of coagulation factor 8 in human plasma, compatible for BCS-XP or the equivalent ml 272;

18) Reagent for determining the activity of coagulation factor 8 in human plasma with homogeneuous method, compatible for BCS-XP or the equivalent - ml 20;

19) Reagent for determining the activity of coagulation factor 9 in human plasma compatible for BCS-XP or the equivalent — ml 112 12;

20) Reagent for determining the activity of coagulation factor 10, compatible for BCS-XP or the equivalent — ml 18;

21) Reagent for determining the activity of coagulation factor 11 in human plasma compatible for BCS-XP or the equivalent — ml 36;

22) Reagent for determining the activity of coagulation factor 12 in the human plasma, compatible for BCS-XP or the equivalent — ml 36;

23) Reagent for determining the activity of coagulation factor 13 in human plasma, compatible for BCS-XP or the equivalent — ml 75;

24) Reagent for determining the activity of ristocetin cofactor of Von Willebrand factor in human plasma through platelet compatible for BCS-XP or the equivalent — ml 300;

25) Reagent for determining the activity of Ristocetin cofactor of Von Willebrand factor in human plasma by binding Glycoprotein 1b, compatible for BCS-XP or the equivalent -ml 18;

26) Reagent for immunoturbidimetric quantitative determination of Von Willebrand External Antigen Factor in the human plasma compatible for BCS-XP or the equivalent — ml 64.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
Value excluding VAT: 25 300 000.00 MKD
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in days: 365
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.12)Information about electronic catalogues
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Reagents and Calibrators Tracking Fibrinolysis Application for Automated Koagulometar BCS-XP or the Equivalent

Lot No: 2
II.2.2)Additional CPV code(s)
33696200
II.2.3)Place of performance
NUTS code: MK
Main site or place of performance:

Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at St Mother Tereza 17., SKOPJE

II.2.4)Description of the procurement:

1) Reagent for the quantitative immunoturbidimetric determination of D-dimer in human plasma compatible for BCS XP or the equivalent — ml 3 840;

2) Reagent for control for assessment and analytical comparison of normal and pathological values in the determination of D-dimer in human plasma, compatible for BCS XP or the equivalent — ml 240;

3) Reagents for rapid qualitative or semi quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products in human plasma,Compatible for BCS XP or the equivalent — test 2 400;

4) Reagent for the quantitative determination of biological activity of plasminogen compatible for BCS XP or the equivalent — ml 15;

5) Reagent for the determination of the activity of plasminogen activator inhibitor in human plasma compatible for BCS XP or equivalent — ml 40;

6) Reagent for the quantitative determination of biological activity of the alpha 2 antiplasmin compatible for BCS XP or equivalent — ml 15.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
Value excluding VAT: 25 300 000.00 MKD
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in days: 365
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.12)Information about electronic catalogues
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Reagents and Calibrators for Monitoring the Activity of Inhibitors of Hemostasis Applicative for Automated coagulometar BCS-XP or Equivalent

Lot No: 3
II.2.2)Additional CPV code(s)
33696200
II.2.3)Place of performance
NUTS code: MK
Main site or place of performance:

Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at St Mother Tereza 17., SKOPJE

II.2.4)Description of the procurement:

1) Reagent for the quantitative determination of the activity of protein C, compatible for BCS XP or equivalent — ml 300;

2) Reagent for resistance screening of activated protein C in plasma in individuals with a genetic defect in factor, 5 (Leiden) compatible for BCS XP or equivalent — ml 20;

3) Reagent for the determination of the functional activity of protein S in plasma compatible for BCS XP or equivalent — ml 320;

4) Reagent for the quantitative determination of the activity of antithrombin III in plasma compatible for BCS XP or equivalent — ml 450;

5) Reagent for the determination of heparin activity in plasma monitoring heparin therapy compatible for BCS XPor equivalent — ml 120;

6) Low level of control for quantitative determination of unfractionated heparin compatible for BCS XP or equivalent — ml 6;

7) A high level of control for quantitative determination of unfractionated heparin compatible for BCS XP or equivalent ml 6;

8) Low-level of control for the quantitative determination of heparin with low molecular weight,compatible for BCS XP or equivalent — ml 6;

9) High level of control for the quantitative determination of heparin with low molecular weight,compatible for BCS XP or equivalent — ml 6;

10) Reagent for calibration of unfractionated heparin compatible for BCS XP or equivalent — ml 6;

11) Reagent for calibration of the low molecular weight heparin, compatible for BCS XP or equivalent — ml 6;

12) Reagent for screening of the lupus anticoagulant, compatible for BCS XP or equivalent — ml 300;

13) Reagent validation of lupus anticoagulant compatible for BCS XP or equivalent — ml 80;

14) Reagent for checking the functional capacity of the entire complementary system (complement-1 complement 3 and complement 4) compatible for BCS XP or equivalent — ml 25.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
Value excluding VAT: 25 300 000.00 MKD
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in days: 365
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.12)Information about electronic catalogues
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Dilution Buffer Coagulation Tests Compatible for BCS XP or Equivalent

Lot No: 4
II.2.2)Additional CPV code(s)
33696200
II.2.3)Place of performance
NUTS code: MK
Main site or place of performance:

Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at St Mother Tereza 17.,

II.2.4)Description of the procurement:

The dilution bufer for coagulation tests compatible for BCS XP or equivalent — ml 9 000.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
Value excluding VAT: 25 300 000.00 MKD
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in days: 365
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.12)Information about electronic catalogues
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Rotor Cells with 20 Segmented Cells that have 6 Dilution Chambers Compatible for BCS XP or Equivalents

Lot No: 5
II.2.2)Additional CPV code(s)
33696200
II.2.3)Place of performance
NUTS code: MK
Main site or place of performance:

Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at St Mother Tereza 17., SKOPJE

II.2.4)Description of the procurement:

Rotor cells 20 with segmented cells that have 6 dilution chambers compatible for BCS XP or equivalents 111 340 pieces.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
Value excluding VAT: 25 300 000.00 MKD
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in days: 365
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.12)Information about electronic catalogues
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Solution for Cleaning of BCS XP Analyzer Compatible for BCS XP or Equivalent

Lot No: 6
II.2.2)Additional CPV code(s)
33696200
II.2.3)Place of performance
NUTS code: MK
II.2.4)Description of the procurement:

Solution for cleaning the BCS XP analyzer compatible for BCS XP or equivalent — ml 60

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
Value excluding VAT: 25 300 000.00 MKD
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in days: 365
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.12)Information about electronic catalogues
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Solution for Washing the BCS XP System, Compatible for BCS XP or the Equivalent

Lot No: 7
II.2.2)Additional CPV code(s)
33696200
II.2.3)Place of performance
NUTS code: MK
Main site or place of performance:

Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at St Mother Tereza 17., SKOPJE

II.2.4)Description of the procurement:

Solution for washing the BCS XP System, compatible apparatus BCS XP or equivalent — ml 5 700.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
Value excluding VAT: 25 300 000.00 MKD
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in days: 365
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.12)Information about electronic catalogues
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Disinfectants for BCS XP System Compatible for BCS XP or the Equivalent

Lot No: 8
II.2.2)Additional CPV code(s)
33696200
II.2.3)Place of performance
NUTS code: MK
Main site or place of performance:

Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at St Mother Tereza 17., SKOPJE

II.2.4)Description of the procurement:

Disinfectant for BCS XP System compatible for BCS XP or equivalent — ml 2 000.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
Value excluding VAT: 25 300 000.00 MKD
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in days: 365
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.12)Information about electronic catalogues
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information

Section III: Legal, economic, financial and technical information
III.1)Conditions for participation
III.1.1)Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers
List and brief description of conditions:

— document for registered activity - DRD form or certificate of registered activity,

— decision for wholesale trade with medical supplies under the Law on Medicines and Medical Appliances,

— a statement by the economic operator that it has not been imposed a legally valid court decision for participation in criminal organization, corruption, fraud or money laundering for the last 5 years,

— a certificate by a competent authority that a bankruptcy procedure has not been initiated,

— a certificate by a competent authority that a liquidation procedure has not been initiated,

— a certificate by a competent authority from the country where that economic operator is register for paid taxes, contributions and other public duties,

— a certificate by the Register of sentences for committed crimes of legal entities that a secondary sentence prohibition on participation in open call procedures, awarding public procurement contracts and contracts for public private partnership, has not been imposed,

— a certificate by the Register of sentences for committed crimes of legal entities that a secondary sentence temporary or permanent prohibition on performing a certain activity has not been inpoused and

— a certificate that a misdemeanor sanction resulting in prohibition for practicing profession activity or duty , i.e.temporary prohibition for performing a particular activity has not been imposed by a legally valid court decision.

III.1.2)Economic and financial standing
III.1.3)Technical and professional ability
List and brief description of selection criteria:

For registered medical supplies:

— for the offered goods the economic operator must have provided an approval for marketing of medical device or temporary or permanent authorization for parallel imports, under the law on medicines and medical devices.

For unregistered medical supplies:

— for the offered goods the economic operator must have provided a document that authorizes the import (Approval for intervention import) under the law on medicines and medical devices.

The economic operator is obliged to provide a service technician for maintenance of the appliance for which he will submit a offer for the reagents, materials and calibrators that will take care of maintenance and servicing of the appliance in order to ensure smooth operation of the appliance during the duration of use of its reagents, materials and calibrators free of charge.

Minimum level(s) of standards possibly required:

For registered medical supplies:

— a decision for marketing of medical device or temporary or permanent authorization for parallel imports, under the law on medicines and medical devices.

For unregistered medical supplies:

— import license (authorization for intervention import) under the law on medicines and medical devices.

Statement that the economic operator will provide a service technician for maintenance of the appliance for which he will submit an offer reagents, materials and calibrators, which will take care of maintenance and servicing of the appliance in order to operate the appliance for the duration of its reagents, materials and calibrators free of charge.

III.1.5)Information about reserved contracts
III.2)Conditions related to the contract
III.2.2)Contract performance conditions:
III.2.3)Information about staff responsible for the performance of the contract

Section IV: Procedure
IV.1)Description
IV.1.1)Type of procedure
Open procedure
IV.1.3)Information about a framework agreement or a dynamic purchasing system
IV.1.4)Information about reduction of the number of solutions or tenders during negotiation or dialogue
IV.1.6)Information about electronic auction
An electronic auction will be used
Additional information about electronic auction:

All qualified contractors will be informed and invited for e-auction

IV.1.8)Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: no
IV.2)Administrative information
IV.2.1)Previous publication concerning this procedure
IV.2.2)Time limit for receipt of tenders or requests to participate
Date: 20/03/2019
Local time: 11:00
IV.2.3)Estimated date of dispatch of invitations to tender or to participate to selected candidates
IV.2.4)Languages in which tenders or requests to participate may be submitted:
Macedonian
IV.2.6)Minimum time frame during which the tenderer must maintain the tender
Duration in months: 3 (from the date stated for receipt of tender)
IV.2.7)Conditions for opening of tenders
Date: 20/03/2019
Local time: 11:00
Place:

Pho Institute of Transfusion Medicine of The Republic of Macedonia Skopje, located on Mother Tereza 17 St Skopje — Meeting Hall.

Information about authorised persons and opening procedure:

Any person mast have authorisation letter from his/her economic operator.

Section VI: Complementary information
VI.1)Information about recurrence
This is a recurrent procurement: no
VI.2)Information about electronic workflows
VI.3)Additional information:
VI.4)Procedures for review
VI.4.1)Review body
State commission on public procurement
Bull. “Ilinden” 63A 1000 Skopje, Republic of Macedonia
Skopje
1000
The former Yugoslav Republic of Macedonia
Telephone: +389 23251251
E-mail: dkzjn@gov.mk
Fax: +389 23251250
VI.4.2)Body responsible for mediation procedures
VI.4.3)Review procedure
VI.4.4)Service from which information about the review procedure may be obtained
VI.5)Date of dispatch of this notice:
07/02/2019