Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2019-11-21
Buyer: Oslo Universitetssykehus HF (hovedenhet)
Country: NO
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33100000
Estimated value: 4900000 NOK
Award criteria: The most economic tender

Technical requirements: The Newborn Screening Department will procure an UHPLC-MS/MS for newborn screening, and diagnostics and monitoring of patients with phenylketonuria (PKU).
Due to a critical breakdown of existing equipment, the new system must be in operation quickly in order to carry out daily routines and fulfil our national mandate for screening newborns. It must, therefore, be simple and quick to transfer the methods to the new system. Procurement of different technology and software will create disproportionately large technical challenges and delays, with documentation of positives finds and no false negatives on a 'population based scale' (tests for rare diseases with conditions that can be less than 1:100 000), training personnel, the operation and maintenance of several different technological platforms and technologies. Documentation must be based on population based screening of newborns. The procurement will not lead to the implementation of new technology and software, only a replacement of an existing/analysis platform. (Subject to financing).
Daily screening of newborns for 20 metabolic conditions, quantitating hormones for congenial adrenocortical hyperplasia and diagnostics and diet monitoring of patients with phenylketonuria (PKU). The methods quantify amino acids, acyl carnitines, succinylaceton, nucleoxides (adenosine, deoxyadenosine) and steroid hormones (cortisol, 17-hydroxyprogestrone, androstendion, 21-deoxycortisol and 11-deoxycortisol). Primary screening is done with the help of FIA-MSMS and the use of commercial kits (NeoBase 2, PerkinElmer), whilst follow-up analyses use chromatographic methods (forked amino acids, simple organic acids, homocysteine and steroid hormones). External quality asusrance is done through the QC-programme for CDC (Newborn Screening Quality Assurance Program, Centers for Disease Control and Prevention, USA). The samples are interpreted with the help of CLIR (Collaborative Laboratory Integrated Reports) from Mayo Clinic, USA. Approx. 4 500 000 LC-MS/MS analysis replies are validated annually in newborn screening. It is, thus, important that the instrument can use established methods with the same techniques and programmes interchangeably in the routine environment. Simple extraction of blood spot with subsequent thinning gives somewhat more dirty extracts than other sample development. It is, therefore, decisive that the new system is robust and stable, but also sensitive, in order to maintain continual routine use with high capacity. Due to a critical breakdown of existing equipment, the new system must be in operation quickly in order to carry out daily routines and fulfil our national mandate for screening newborns. It must, therefore, be simple and quick to transfer the methods to the new system. The new system must be ready installed, validated and in daily routine operation by week 4, 2020 at the latest. Any choice of another supplier would involve a transition to a different technological platform and the supplier would then also have to replace other instrumentation. It is important that the training and implementation of a new instrument is minimised, in order to ensure stable and continual routine operation. The procurement will not lead to the implementation of new technology and software, only a replacement of the existing system/analysis platform. The system must consist of an UHPLC part and a tandem mass spectrometer (trippel-quadruple). The system must be documented for use with applications within neonatal screening and use of NeoBase or NeoBase 2-kit from PerkinElmer (both neonatal samples and CDC-quality controls). Option for electronic logging of columns (pressure, temperature, etc.). The UHPLC-MS/MS system must be CE-IVD certified. Option for having an ion source with specific technology that can efficiently ionise a broader spectrum of analytes than only ESI. This means that, in many cases, you cannot switch between different ion sources such as ESI, APCI and APPI, where the analytes have different characteristics. The switch between ESI and APCI must not be more than 20 msec. Documentation that steroid hormones can be analysed from 3.2 mm dried blood spots (DBS) in low nM-concentration area (>2 nM) must be presented if requested. The tenderer must have ready established and documented internal routines for CE-IVD that deals with documentation and reports for all types of service visits, such as maintenance, repairs or breakdowns. The system must be able to run quantification with MRM and full scan simultaneously. This means that irregularities can be uncovered in the matrix/sample, such as pollution, degradation components and/or metabolites. The system must be able to be delivered with software for quick quantification, processing, interpretation and reports of FIA-MS/MS results without a calibration curve, which can be processed in real-time whilst the analysis series is ongoing. The system must be compatible with existing methods that are currently used in routines. The spray in the ion source must be designed so that a minimum amount of impurities in the extract are lead into the mass spectrometer for robust and stable operation. Software for automated mass calibration, tuning and SIR/MRM method development, as well as automated UHPLC-MS/MS system check, and monitoring and notification of system parameters.
External quality asusrance is done through the QC-programme for CDC (Newborn Screening Quality Assurance Program, Centers for Disease Control and Prevention, USA). The samples are interpreted with the help of CLIR (Collaborative Laboratory Integrated Reports) from Mayo Clinic, USA. It is important that the instrument can use established methods with the same techniques and programmes interchangeably in the routine environment. Our analysis methods consist, as a main rule, of only simple sample development (simple extraction of blood spot with subsequent thinning), which can give more dirty extracts than different sample development. It is important that the system is robust and stable, but also sensitive, in order to maintain continual routine use with high capacity. Due to a critical breakdown of existing equipment, the new system must be in operation quickly in order to carry out daily routines and fulfil our national mandate for screening newborns. It must be simple and quick to transfer the methods to the new system. The new system must be ready installed, validated and in daily routine operation by week 4, 2020 at the latest. Procurement of different technology and software will create disproportionately large technical challenges and delays, with documentation of positives finds and no false negatives on a 'population based scale' (tests for rare diseases with conditions that can be less than 1:100 000). Thorough documentation is required, based on population based screening of newborns. The system must consist of an UHPLC part (sampler organiser, autosampler, binary pump, column manager), and a tandem mass spectrometer (trippel-quaduple). The system must be documented for use with applications within neonatal screening and the use of NeoBase or NeoBase 2-kit from PerkinElmer, (both neonatal samples and CDC quality checks). This means that, in many cases, you cannot switch between different ion sources such as ESI, APCI and APPI, where the analytes have different characteristics. The switch between ESI and APCI must not be more than 20 msec. Documentation that steroid hormones can be analysed from 3,2 mm dried blood spots (DBS) in low nM-concentration area (>2 nM) must be presented if requested. The tenderer must have ready established and documented internal routines for CE-IVD that deals with documentation and reports for all types of service visits, such as maintenance, repairs or breakdowns. The system must be able to run quantification with MRM and full scan simultaneously. This means that irregularities can be uncovered in the matrix/sample, such as pollution, degradation components and/or metabolites. The system must be able to be delivered with software for quick quantification, processing, interpretation and reports of FIA-MS/MS results without a calibration curve, which can be processed in real-time, whilst the analysis series is ongoing. The system must be compatible with existing methods that are currently used in routines. The spray in the ion source must be designed so that a minimum amount of impurities in the extract are lead into the mass spectrometer, (e.g., Z-spray), for robust and stable operation. Software for automated mass calibration, tuning and SIR/MRM method development, as well as automated UHPLC-MS/MS system checks, and monitoring and notification of the system parameters. The basis is that waters is the only supplier who, for technical reasons, can provide the service pursuant to the voluntary ex-ante transparency notice, in accordance with the Public Procurement Regulations §21-5. The terms in PPR § 13-4 (2) and 13-1 (5) are considered fulfilled, as well as the value of the full service contract and a contract for consumables for the lifetime of the equipment.


Winner: Waters NUF
Award value: 4900000