Public procurement notice: Voluntary Ex Ante Transparency Notice
Published: 2016-02-19
Buyer: St Olavs Hospital HF
Country: NO
Region: NORGE
Contract type: Supplies
Procedure: Contract award without prior publication
CPV classification: 33100000
Estimated value: 9000000 NOK

Technical requirements: Xevo TQ-S IVD with Dual Vacuum Roughing Pump; Acquity UPLC I-Class IVD; Info Set IVD; MassLynx Perf WS IVD; Monitor Dell 27” Ultrasharp; Acquity BEH C18 1,7um 2,1x10; MS Ref Stds; Xevo TQ-S; Installsjon; Maint MassLynx; TAW Xevo TQ-S (1 PM); TAW Acquity I-Class BSM (1 PM) og TAW Acquity I-Class SM FTN (1 PM).
St Olavs Hospital HF; Clinical Pharmacology Department (AKF) currently has six UPLC-MSMS (Acquity UPLC/ XevoTQ-S), which were delivered by Waters AS. They are used for analysing medicines and drug and alcohol in urine, serum and blood samples. AKF has financed a large share of the analysis instruments via leasing over many years. The two oldest instruments shall, according to the plan, be replaced with new leasing financed instruments this year. In addition, due to increased demand, the department has asked the clinic management for permission to procure a new leasing financed LC-MSMS-instrument this year. The department develops all its chromatographical/mass spectroscopic analysis methods itself. This is very time consuming, in which every methods must go through a long development and validation period before it can be implemented in routine activities. Less than a year ago we completed a comprehensive change in drug and alcohol analyses in urine from LC-MS instruments to UPLC-MSMS. This was a process that in total took approx. 2-3 years. An increased demand for different medicine and drug and alcohol analyses from clinicians who work closely with patients also means that the department must continually develop new UPLC-MSMS analysis methods. The UPLC-MSMS capacity is almost used up in the work with the existing analysis volume. The development of new methods is thus considerably delayed and the implementation of new methodology is as good as impossible unless other analyses are stopped. Furthermore, the department is now in a phse where we are assessing whether the current UPLC-MSMS based drug and alcohol screening in urine is what we will continue with in the next decade, or whether it shall be replaced with QTOF based drug and alcohol screening. The development of methods and the evaluation of analysis instruments are time consuming processes for which the department binds many of the available resources within the Section for Analytical R&D If, in a new tender process, we end up having to procure equipment from another supplier, there will be considerably more work in the form of: — Training employees in the Analytical R&D and medicine/drug and alcohol sections — Method adaptations/development — Validation of our self-developed, accredited analysis methods — ICT. There will also be a much more time and costs involved in the re-accreditation of the analysis methods and a suspension for a few months of the accredited methods is not desirable. — Training in the handling of analysis instruments and software for the entire production chain; from method development — validation — sample analysis — data processing to sending replies — New procurement and adaptation of IT systems. This includes connecting the supplier's analysis tool with the health company's LIMS-system, as well as other applications that quality assure analysis replies. This is a tool that is absolutely essential in order to prevent the wrong reply being sent. — Acquisition of special expertise within instrument fault finding. This competence is absolutely fundamental for allowing method development and routine analysis to occur as well as for ensuring stable operation. We have previously experienced that a long time is need to acquire sufficient knowledge on new instruments and carry out good fault finding. Some instruments are in many ways to be seen as ‘individuals’, which in addition change slightly in different ways when used. These changes affect the different substances to different degrees during analyses. — The operation of several different software programmes increases the possibility of misinterpretation of chromatomgrams/data and thereby increases the risk of sending wrong replies. As we have now only had our UPLC-MSMS systems for less than five years, we are still in a phase where we, in addition to developing new methods, are transferring methodology from old and practically discarded instruments. This requires method development, validation and implementation. A change of instrument supplier will greatly delay this work. In addition to the financial reasons, it is not desirable for HSE reasons. Old LC-MS methodology uses manual sample development including manual pipetting and, in addition, we use large amounts of organic substances in these methods (e. g. hexane and dichloromethane), which, in the event of an accident, can give serious heath problems. We have tried to stipulate the resource use if we end up procuring equipment from another supplier and we have found out that approx. 6 man-labour years will be required if we have to change suppliers at this point in time. This procurement is to be seen as a supplement to the existing routine analysis instruments. The department would like to continue to spend time in the future together with the procurement department to plan a new tender for the desired routine instruments. For these reasons St Olavs Hospital HF, Clinical Pharmacology Department, would like to enter into a direct procurement contract with Waters AS for the delivery of three instrument packages in accordance with the prior intention notice based on the above arguments.