Oslo universitetssykehus HF 993 467 049 Postboks 4950 Nydalen Oslo 0424 Trine Kjellsen +47 91667242 trikje@ous-hf.no www.ous-hf.no 74914 E2017 BAR newborn screening LC-MSMS 74914 Oslo University Hospital, Paediatrics Department, shall procure a new LC-MSM for newborn screening, diagnostics and patient monitoring. The newborn screening has a national treatment service for the screening of approx. 60,000 newborns per year for 23 severe congenital diseases, diagnostics, and follow-up of patients with PKU. The analyses require CE-IVD instrumentation in accordance with the EU Directive. 3900000.00 Oslo. Oslo University Hospital, Paediatrics Department, shall procure a new LC-MSM for newborn screening, diagnostics, and patient monitoring. The newborn screening has a national treatment service for the screening of approx. 60,000 newborns per year for 23 severe congenital diseases, diagnostics, and follow-up of patients with PKU. The analyses require CE-IVD instrumentation in accordance with the EU Directive. Tre Waters LC-MS/MS CE-IVD instruments are used daily for the screening newborns for 19 metabolic conditions, diagnostics, quantifying hormones for diagnostics of congenital adrenal cortex hyperplasia and monitoring diets of PKU patients. All methods for quantifying amino acids, acyl-carnitines, 17OHP, Cortisol, Androstenedione, 21-Deoxycortisol, and 11-Deoxycortisol are validated and run daily with the waters LC-MS/MS technology. All the analyses are equivalently regularly checked in the CDC QC programme and the Mayo Region4 cooperation. Approx. 4.5 million LC-MS/MS analysis replies are validated annually in newborn screening. It is, thus, important that the new instrument can use established methods with the same techniques and programmes interchangeably in the routine environment. All methods and routines are validated and operated with Waters LC-MS/MS instrumentation. The new instrument will not involve an introduction of new technology, only an upgrade/replacement of the existing old instrument. Procurement of different technology will create disproportionately large technical challenges 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. 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. Documentation based on population screening is also required. The requirements: — LC-MSMS must be CE-IVD certified. — LC-MSMS must have Unispray ion source in order to analyze the actual analytes. Unispray ion source gives considerably better sensitivity than the usual traditional electro-spray. In addition, the Unispray technology covers a broader area of analytes, which means that, in many cases, there is no need to switch between different ion sources such as ESI, APCI, and APPI, where the analytes have different characteristics. — tenderers must have a ready established and documented internal routines for CE-IVD that deal with documentation and reporting for all types of service visits, such as maintenance, repairs or breakdowns. — the LCMSMS shall have parallel MRM - and full scan so that we can quantify fixed MRM transitions, at the same time that a full scan is being done 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 has considerably greater control over the sample as a whole and can comfortably report sample replies safe in the knowledge that there are no elements in the sample that have influenced the sample reply in any way, or, if the sample reply is outside what the operator knows from experience is within the normal area, the full scan will be able to give an answer regarding any pollution or other things that could have caused the irregularity. This is particularly useful during method development or troubleshooting. — the LCMEME shall be able to use MRM so that it triggers a full scan right after the apex of a chromatographic top has been evaluated. In this way, the analysis has an extra safety factor where you get a full mass spectrum of the subsidiary ions that can be used in the MRM window. This helps to remove irregularities in the sample in question. The contract award is based on the fact that Waters is the only supplier that, due to technical reasons, can provide the service. The terms in FOA § 13-4 (2) are deemed to be fulfilled as well as the value of the full-service contract for the instrument´s lifetime. The analyses require CE-IVD instrumentation in accordance with the EU Directive. All methods for quantifying amino acids, acyl-carnitines, 17OHP, Cortisol, Androstenedione, 21-Deoxycortisol, and 11-Deoxycortisol are validated and run daily with the waters LC-MS/MS technology. All the analyses are equivalently regularly checked in the CDC QC programme and the Mayo Region4 cooperation. The new instrument must be able to use established methods with the same techniques and programmes. All methods and routines are validated and operated with Waters LC-MS/MS instrumentation. Procurement of different technology will create challenges 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, as well as the operation and maintenance of several different technological platforms and technologies. The LC-MSMS must be CE-IVD certified, the LC-MSMS must have Unispray ion source in order to be able to analyze the actual analytes. Unispray ion source gives considerably better sensitivity than the usual traditional electro-spray. In addition, the Unispray technology covers a broader area of analytes, which means that, in many cases, there is no need to switch between different ion sources such as ESI, APCI, and APPI, where the analytes have different characteristics. The LCMSMS shall have parallel MRM - and full scan so that we can quantify fixed MRM transitions, at the same time that a full scan is being done 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 has considerably greater control over the sample as a whole and can comfortably report sample replies safe in the knowledge that there are no elements in the sample that have influenced the sample reply in any way, or, if the sample reply is outside what the operator knows from experience is within the normal area, the full scan will be able to give an answer regarding any pollution or other things that could have caused the irregularity. This is particularly useful during method development or troubleshooting. The LCMEME shall be able to use MRM so that it triggers a full scan right after the apex of a chromatographic top has been evaluated. In this way, the analysis has an extra safety factor where you get a full mass spectrum of the subsidiary ions that can be used in the MRM window. This helps to remove irregularities in the sample in question. The contract award is based on the fact that Waters is the only supplier that, due to technical reasons, can provide the service. The terms in the PPR § 13-4 (2) are considered to be fulfilled. 74914 74914 E2017 BAR newborn screening LC-MSMS 2017-12-11 Waters Gaustadalleen 21 Oslo 0349 +47 63846050 norway@waters.com 3900000.00 Oslo Universitetssykehus HF Sognvannsveien 20 Oslo 0372 +47 23071580 mtu-anbud@ous-hf.no www.ous-hf.no Deadline for appeals: Thursday 21.12.17. 2017-12-11
See tender at TED: http://ted.europa.eu/udl?uri=TED:NOTICE:499347-2017:TEXT:EN:HTML