Statement of Work for Waters G2-XS UPLC-MS-MS System FY2020 (1).docx

Statement of Work for Equipment Purchase Request

Project Title: Purchase Waters UPLC-MS/MS Quadrupole Time of Flight Mass Spectrometer for Pharmacy CPRU Laboratory

Department: NIH Clinical Center, Pharmacy Department Pharmcokinetics Research Unit

Project Officer: Richard DeCederfelt Acting Pharmacy Chief, Section Chief, Procurement and Control Pharmacy Department NIH Clinical Center

1. Background

1.1 The National Institutes of Health (NIH) Clinical Center (CC) is a clinical research hospital providing all medical services for patients participating in human research protocols of the NIH. The CC provides patient facilities and services for clinical investigations by the NIH Institutes, research in related areas and supervises residency and other training programs.

1.2 The NIH Clinical Center Pharmacy Department Pharmacokinetics Research Unit collaborates and participates in the design and analysis of patient clinical research studies with various NIH institutes. The Pharmacokinetics Research Unit develops and validates bioanalytical assays for testing and analysis of human patient samples to determine pharmaceutical drug levels which are subsequently used to perform pharmacokinetic and pharmacodynamic analyses.

2. Purpose

2.1 Purchase a Waters Xevo G2-XS UPLC-MS/MS Quadrupole Time of Flight Mass Spectrometer System to replace existing UPLC-MS/MS system . The new UPLC-MS/MS system will replace an existing LC-MS system which has become obsolete after 14 years of use. Repair parts are becoming scarce, and some are no longer available should repairs be required.

3. Scope of Work

3.1 The Waters UPLC-MS/MS system will be replacing and older and obsolete Waters UPLC-MS/MS triple quadrupole mass spectrometer system that is used on a weekly basis to analyze clinical research patient samples from currently ongoing as well as new clinical research studies being conducted in collaboration with NIAID, NIDDK, NHGRI, and NICHD.

The CPRU needs a UPLC-MS/MS system that has the following:

1. Waters Acquity UPLC system that is compatible with existing laboratory UPLC systems for seamless interchangeability of system components as well as management software compatibility.

2. Sample organizer that is compatible with Waters Acquity UPLC system, which has a temperature regulated sample compartment of 4.0 - 40.0 degrees Celsius as well as 10 storage shelf assemblies for 96 & 384 well microtiter plates or 48 position 2.0ml vial plates.

3. Column manager and auxiliary devices that are compatible with Waters Acquity UPLC systems which have temperature regulated column compartments of 10.0 - 90.0 degrees Celsius.

4. Instruments should be compatible with Empower, Unifi, and/or MassLynx software management suites.

5. Mass Spectrometer must have the following capabilities and options:

· Dynamic linear range up to four orders of magnitude from detection threshold

· High resolution and enhanced stability quadrupole mass analyzer (MS1) with a mass range m/z of 20 to 4,000 in resolving mode and m/z of 20 to16,000 in non-resolving mode.

· Quadrupole analyzer with pre-filters to maximize resolution and transmission while preventing contamination to the MS2 analyzer.

· High performance oaTOF mass analyzer (MS2) with a mass range up to m/z 100,000 and a resolving power of >40,000 FWHM.

· Rapid ionization mode switching with the ability to switch between electrospray (ESI) and atmospheric pressure ionization (APCI) modes in 20 ms using the standard ion source.

· Rapid switching between MS and MS/MS with the ability to switch between MS (full scan) and MS/MS (which includes MRM; product ion scanning; parent ion scanning; and neutral loss scanning) acquisition modes in 14 ms without compromising data quality in either mode.

· Unispray Ion source – tool free ESI, APCI, and APPI single run analysis

· Muli-mode source – tool free ESI, APCI, and ESCi single run analysis

6. All instruments must come with a 1-year service plan, and repair must be completed using only original quality parts, which should be covered under service plan.

7. Repair and/or preventive maintenance (PM) must be initiated within 72 hours of initial service call and completed within 5-7 days.

8. One preventive maintenance (PM) service must be included as part of the plan, and the PM should include replacement of all parts and testing of instrument as indicated by the Waters Corp. service preventive maintenance protocol.

9. Service engineers must have complete systems-certified training on all Waters Corp instruments and components.

10. Software applications support specialists must be available during business hours via phone.