procurement of apparatus and tests for metabolic screening for early diagnosis of hereditary metabolic disorders in newborns for an established method with defined reference values ​​based on a study

Public Health Institution Clinic for children diseases

procurement of apparatus and tests for metabolic screening for early diagnosis of hereditary metabolic disorders in newborns for an established method with defined reference values ​​based on a study of a healthy population (newborns) from the region and for early diagnosis of hereditary metabolic disorders in neonatal and pediatric populations with comorbidities or equivalent

Рок

Рокот за прием на понудите беше 2023-01-16. Набавката беше објавена на 2022-12-20.

Кој? Што? Каде?
Историја на набавките
Датум Документ
2022-12-20 Оглас за договор
Оглас за договор (2022-12-20)
Предмет
Опсег на набавката
Наслов: Laboratory reagents
Краток опис:
procurement of apparatus and tests for metabolic screening for early diagnosis of hereditary metabolic disorders in newborns for an established method with defined reference values ​​based on a study of a healthy population (newborns) from the region and for early diagnosis of hereditary metabolic disorders in neonatal and pediatric populations with comorbidities or equivalent
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Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Лабораториски реагенси 📦
Дополнителен CPV: Лабораториски реагенси 📦
Место на извршување
NUTS регион: Северна Македонија 🏙️

Постапка
Вид на постапка: Отворена постапка
Вид на понуда: Поднесување за сите делови
Критериуми за доделување
Најниска цена

Договорен орган
Идентитет
Земја: Северна Македонија 🇲🇰
Вид на органот кој доделува: Друго
Име на органот кој доделува: Public Health Institution Clinic for children diseases
Поштенска адреса: st. Vodnjanska, 17
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: http://ukdetskibolesti.mk/ 🌏
Е-пошта: jzuklinikazadetskibolesti@yahoo.com 📧
Телефон: +38 923147521 📞
Факс: +38 923129027 📠
URL за документи: https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/a04d4a42-e92e-4420-b625-f46afdc40d54/1 🌏
URL за учество: https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/a04d4a42-e92e-4420-b625-f46afdc40d54/1 🌏

Референца
Датуми
Датум на испраќање: 2022-12-20 📅
Рок за поднесување: 2023-01-16 📅
Датум на објавување: 2022-12-23 📅
Идентификатори
Број на огласот: 2022/S 248-720456
OJ-S издание: 248

Предмет
Опсег на набавката
Наслов на делот: 1.Apparatus and tests for metabolic screening for early diagnosis of hereditary metabolic disorders in newborns for an established method with defined reference values ​​based on a study of a healthy
Број на дел: 1
Краток опис:
LC inlet for the mass detector-consisting of the following components
Quaternary pump with a minimum of 4 solvents – to be connected and mixed on the instrument in any configuration at the same time
Flow in the minimum range of 0.001 – 2,200 mL/min in increments of 0.001 mL or better
Flow Accuracy: 0.075% RSD or better
Precision of mobile phase composition: <0.15% RSD or better
Total system delay volume should not be greater than <400 µL. Dwell volume of the system <300 µL
Maximum volume during peak spread (Band spread) of the system 12 µL
An autosampler with a capacity of a minimum of 2 96-well plate holders
Injection volume in the minimum range: 0.1 – 1000 µL
Temperature for samples in the range of 4°C to 40°C or better, in increments of 0.1°C minimum
Tandem quadrupole MS - composed of the following components
The mass tandem quadrupole detector must have a compact design so that it can be placed on a table (benchtop)
Mandatory Atmospheric Pressure Ionization Liquid Chromatography Interface (API) to include source and spray unit
A minimum of two built-in tanks for system tuning and calibration automatically included in the instrument control software. Classic syringe pumps and tuning from autosampler vials are not acceptable
Ion source needle with appropriate angle for optimal formation of fine droplets
In-analyzer transfer optics with double orthogonal design to reduce source contamination and separation of ion clusters formed under atmospheric pressure and for ultra-high resistance to matrix effects
Easy removal of ion source and cone elements and desolvation mechanisms for cleaning and maintenance without turning off instrument vacuum to allow maximum instrument uptime
The ion transfer interface and optics in the analyzer are not subject to routine maintenance, replacement of spare parts or cleaning of spare parts such as transfer lines or capillaries
Positive and negative ionization modes are included as standard instrument options and can be used in the same injection.
Time to change from positive to negative polarity during one analysis to be a maximum of 20 msec
Standard ESI/APCI combined ion source (ESCi or equivalent) with a mode switching time of 20 msec maximum
The instrument must have two quadrupole mass analyzers, a collision cell, and mass prefilters to protect against contamination of the main mass analyzers and increase ion resolution with a linear geometric design.
Mandatory change from MS to MS/MS (MRM) scan mode of operation at automated optional intervals of maximum 3 msec to allow validation of methods under ion suppression and matrix effects. The Scan option should be enabled by default in the software.
Adequate documentation must be submitted to verify performance.
The instrument must be able to work in the following acquisition modes or scan options:
• Full scan MS and SIM for both quadrupoles (Q1 and Q2)
Multi reaction monitoring (MRM)
• Precursor Ion Scan
• Product Ion Scan
• Neutral Loss Scan
The instrument should have built-in ion concentration enhancement technology in the mass analyzer to achieve additional selectivity and sensitivity for the following acquisition and scan modes:
Full Scan MS triggered product Ion Scan
Precursor Ion Scan triggered Product Ion Scan
Constant Neutral Loss triggered Product Ion Scan
MS Full Scan Q2 and MS/MS (MRM) parallel
In tandem quadrupole mode of operation, the instrument must have a scan rate of at least 10,000 Da/sec
A suitable at least one air-cooled turbomolecular pump included
A pre-vacuum pump must be supplied to support the turbomolecular pump
The linearity of the detector response for a specific component in the sample must be at least 5 orders of magnitude relative to the concentration at the LOD level
Mass range 5 to 2040 m/z or better
The detector must be a photomultiplier to ensure a minimum of 10 years of operation of the detector without the need for maintenance
MRM sensitivity (ESI+) with standard ESI ion source
- 1 pg of reserpine when i
Времетраење: 24 месеци

Правни, економски, финансиски и технички информации
Услови за учество
Способност за вршење на стручната дејност:
statement of the economic operator that in the last 5 years the economic operator or the person who is a member of the management or supervisory body of that economic operator or who has the authority to represent or make decisions or supervise him, in the last five years has not a final court verdict for a crime that has elements of criminal complicity in criminal association, corruption, tax evasion and contributions, terrorism
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or criminal offenses related to terrorist activities, money laundering and terrorist financing and abuse of child labor and trafficking in human beings; in the Criminal Code;
- Certificate for paid taxes, contributions and other public duties from a competent authority of the country where the economic operator is registered;
- confirmation that no bankruptcy procedure has been opened by a competent authority or a single document proving the ability;
- confirmation that no liquidation procedure has been opened by a competent body or a single document to prove the ability;
- Confirmation from the Registry of Penalties for committed criminal acts of legal entities that he has not been sentenced to a secondary penalty ban on participation in public call procedures, awarding public procurement contracts and public-private partnership contracts or a single document proving the ability;
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- confirmation from the Registry of fines for committed criminal acts of the legal entities that he / she has not been pronounced a secondary penalty of temporary prohibition to perform a certain activity or a single document for proving the ability;
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- a certificate from the Registry of Penalties for committed criminal acts of the legal entities that he / she has not been sentenced to a secondary penalty of permanent prohibition to perform a certain activity or a single document for proving the ability;
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- confirmation that no misdemeanor sanction has been pronounced with a final judgment - prohibition to perform a profession, activity or duty or a single document to prove the ability, and
- confirmation that he / she has not been pronounced a misdemeanor sanction with a final judgment - temporary prohibition to perform a certain activity or a single document to prove the ability.
In order to prove the ability to perform a professional activity, the economic operator must submit:
- Certificate for registered activity as proof that it is registered as a natural or legal person for performing the activity related to the subject of procurement or proof that it belongs to an appropriate professional association in accordance with the regulations of the country where it is registered
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- Decision for wholesale of medical devices in accordance with the Law on Drugs and Medical Devices.
Техничка и професионална способност:
with the educational and professional qualifications of the service provider or the contractor or his management staff, provided that they are not evaluated as a criterion for selecting the most favorable offer: To qualify as capable of performing the public procurement contract in question in terms of his technical or professional ability should provide: minimum: 1 engineer in biology
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- The economic operator should be authorized by the manufacturer of the equipment and tests to participate in the procedure
The economic operator should be authorized by the manufacturer of the service equipment and have a trained service technician from the manufacturer for the offered equipment
- The economic operator must install the equipment, set the method and train the staff
- The economic operator must submit a reference list according to the subject of procurement and submit at least one confirmation from a user of the same/similar system for metabolic screening
Минимално ниво(а) на стандарди:
Statement from the economic operator that he has at least 1 engineer in biology and proof that those persons are employed by him or engaged in another way by attaching a contract for business and technical cooperation
- The economic operator must, with the offer, submit an authorization…
… directly from the manufacturer of the equipment and tests for participation in the procedure.
… issued directly by the manufacturer of the equipment for an authorized service in R. Macedonia. In addition to the authorization, he must submit a statement of a trained service technician with a certificate from the manufacturer for the offered equipment
The economic operator must submit a statement that he will install the equipment, set up the method and train the staff. The training should be carried out in the premises of the Contracting Authority, for a duration of at least 20 working hours.
- The economic operator must submit a reference list according to the subject of procurement and submit at least one confirmation from a user of the same/similar metabolic screening system as proof of the realization of a contract for metabolic screening in the territory of R. North Macedonia.
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Постапка
Правна основа: 32014L0024
Време за прием на понуди: 15:00
Јазици на кои може да се поднесат понуди или барања за учество: македонски 🗣️
Период на важност на понудата: 3 месеци
Датум на отворање на понудите: 2023-01-16 📅
Време на отворање на понудите: 15:00

Договорен орган
Идентитет
Друг вид договорен орган: authority of clinic
Контакт
URL на документи: https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/a04d4a42-e92e-4420-b625-f46afdc40d54/1 🌏

Дополнителни информации
Тело за преглед
Име: State Comission on public Procurement
Поштенско место: Skopje
Поштенски број: 1000
Земја: Северна Македонија 🇲🇰
Телефон: +389 23251251 📞
Е-пошта: dkzjn@gs.gov.mk 📧
Факс: +389 23251250 📠
Интернет-адреса: http://dkzjn.mk 🌏
Извор: OJS 2022/S 248-720456 (2022-12-20)
Нови набавки во поврзани категории 🆕
Поврзани пребарувања 🔍
Регион:
Северна Македонија Северна Македонија
Производи/услуги:
Медицинска опрема, фармацевтски производи... Фармацевтски производи Разни лекови Реагенси и контрастни средства Лабораториски реагенси