Oslo universitetssykehus HF 993 467 049 Postboks 4950 Nydalen Oslo 0424 Trine Kjellsen +47 91667242 trikje@ous-hf.no www.ous-hf.no 75075 USKLM Dep. of Pharmacology LC-MSMS. 75075 Oslo University Hospital, Department of Pharmacology at Ullevål Hospital shall procure a new LC-MSMS instrument for analyses of medicines and drugs and alcohol in blood and urine. The section has a broad range of analyses, from drugs and alcohol and poison substances to different groups of medicines. The analysis activity has increased in recent years and in 2017 the section carried out approx. 40,000 chromatographic analyses. 12500000.00 Oslo University Hospital. Our analysis methods have, as a rule, only simple sample preparation (thinning) before injection into the instrument, something that is a conscious choice in order to save time in sample preparation. Several of our analysis methods include many analytes in each run. Our rante includes analysis methods for both serum, urine and full-blood and we use the same instrument for different matrixes and methods. The concentration levels for the substances we look for have a broad range. The section offers drugs and alcohol analyses that are both medical and subject to sanctions. The sample results for drugs and alcohol analyses that are subject to sanctions can stand alone as a basis for serious sanctions for the sample provider. Most of the analytes in the analysis range are analysed in gathered series, on scheduled analysis days. There are, however, a number of exceptions that require a change to the scheduled set-up so that quick analysis results can be given. Due to the above reasons, we need an instrument that is both sufficiently sensitive (for low concentrations) and that has an option for more analytes in the same run. At the same time we need an instrument that is robust for regular routine use at high capacity and for the analysis of different matrixes and at different levels of concentration. The instrument is also required to be IVD certified, due to the EU Directive. The LC-MSMS must be CE-IVD certified. Our analyses require CE-IVD instrumentation in accordance with the EU Directive. Tenderers must have ready established and documented internal routines for CE-IVD that include documentation and reports for all types of service visits, such as maintenance, repairs or break downs. Must have room for at least 4 columns in the column oven. Must have an auto-sampler with the capacity for at least 2 racks that can be used for a 96-well plate or 2 ml vials. Must have a fixed loop. The high pressure pump must be able to deliver up to 1000 bar. The LC-MSMS must have an ion source with specific technology for ionising a broad area of analytes, so that in many cases there does not have to be a switch between different ion sources such as ESI, APCI and APPI, where the analytes have different characteristics. The ion source gives considerably better sensitivity than the normal traditional electro spray. The LC-MSMS must have parallel MRM - and full-scan that enables quantification of fixed MRM transitions, at the same time that a full-scan is carried out in the background. This means that we can discover irregularities in the matrix of a sample, hence pollutions, degradation components and/or metabolites. In this way the operator will have considerably greater control over the sample as a whole and sample results can be confidently reported with the knowledge that there are no elements in the sample that have affected the sample result in any way. In addition, if the sample result is outside what the operator, from experience, knows is within the normal area, the full-scan will be able to give an answer as to whether any pollutions or other things caused of the irregularity. This is particularly useful during method development or troubleshooting. The LC-MSMS must have a function that triggers a full-scan right after the apex of a chromaotographical top (MRM) has been evaluated. In this way the analysis has an extra safety factor where you get a full mass spectrum of the molecule ion that can be used in the MRM window. This helps to identify irregularities (matrix) in the sample in question. This gives a more secure identification of drugs and alcohol. The instrument must be able to determine buprenorphine in serum down to 1 nmol/L with good response. It must also be possible to determine phosphatideyletanol in full-blood down to 30 nmol/L. The section currently has three Waters LC-MS/MS instruments where analysis methods for medicines and intoxication substances are run in. Due to the laboratory´s need for regular routine operations in order to ensure continual, good services, the time for training and running in the new instrument ought to be rationalised. It will be significantly easier to transfer these methods to a new instrument from the same supplier, especially as a new Waters instrument uses the same software and because the need for training will be significantly less. 2 LC-MSMS Service agreements. The LC-MSMS must be CE-IVD certified. Our analyses require CE-IVD instrumentation in accordance with the EU Directive. Tenderers must have ready established and documented internal routines for CE-IVD that include documentation and reports for all types of service visits, such as maintenance, repairs or break downs. Must have room for at least 4 columns in the column oven. Must have an auto-sampler with the capacity for at least 2 racks that can be used for a 96-well plate or 2 ml vials. Must have a fixed loop. The high pressure pump must be able to deliver up to 1000 bar. The LC-MSMS must have an ion source with specific technology for ionising a broad area of analytes, so that in many cases there does not have to be a switch between different ion sources such as ESI, APCI and APPI, where the analytes have different characteristics. The ion source gives considerably better sensitivity than the normal traditional electro spray. The LC-MSMS must have parallel MRM — and full-scan that enables quantification of fixed MRM transitions, at the same time that a full-scan is carried out in the background. This means that we can discover irregularities in the matrix of a sample, hence pollutions, degradation components and/or metabolites. The operator will have considerably greater control over the sample as a whole and sample results can be confidently reported with the knowledge that there are no elements in the sample that have affected the sample result in any way. If the sample result is outside what the operator, from experience, knows is within the normal area, the full-scan will be able to give an answer as to whether any pollutions or other things caused of the irregularity. This is particularly useful during method development or troubleshooting. The LC-MSMS must have a function that triggers a full-scan right after the apex of a chromaotographical top (MRM) has been evaluated. In this way the analysis has an extra safety factor where you get a full mass spectrum of the molecule ion that can be used in the MRM window. This helps to identify irregularities (matrix) in the sample in question. This gives a more secure identification of drugs and alcohol. The instrument must be able to determine buprenorphine in serum down to 1 nmol/L with good response. It must also be possible to determine phosphatideyletanol in full-blood down to 30 nmol/L. The contract award is based on the fact that Waters is only supplier that, due to technical reasons, can deliver in accordance with the requirements. The intention notice is pursuant to the public procurement regulations § 21-5. The terms in FOA § 13-4 (2) and 13-1 (5) are deemed to be fulfilled as well as the value of the full service contract for the instrument´s lifetime. 75075 75075 US KLM Department for Pharmacology LC-MSMS 2018-05-30 Waters 971069023 Gaustadalleen 21 Oslo 0372 +47 63846050 norway@waters.com www.waters.com 12500000.00 Oslo Universitetssykehus HF Sognvannsveien 20 Oslo 0372 +47 23071580 mtu-anbud@ous-hf.no www.ous-hf.no 12.06.18. 2018-05-31
See tender at TED: http://ted.europa.eu/udl?uri=TED:NOTICE:238627-2018:TEXT:EN:HTML