Waters Xevo TQ Absolute w/ Acquity Premier and Andrew+ Robot Procurement

expired opportunity(Expired)
From: Federal Government(Federal)
started - 27 Jun, 2022 (7 months ago)

Start Date

27 Jun, 2022 (7 months ago)
due - 27 Jun, 2022 (7 months ago)

Due Date

01 Jul, 2022 (7 months ago)
Bid Notification

Opportunity Type

Bid Notification
75N95022Q00300

Opportunity Identifier

75N95022Q00300
HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Customer / Agency

HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Rockville ,
 MD  20850  USA

Location

Rockville , MD 20850 USA
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(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95022Q00300 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a Firm Fixed Priced contract without providing for full and open competition (including brand-name) to Waters Technologies Corporation, 34 Maple Street, Milford, MA 01757 to replace Waters Xevo TQ Absolute w/ Acquity Premier and Andrew+ Robot with a new unit. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). The rationale for the sole source justification is that Water Corporation is the manufacturer of the equipment, and this is a direct trade/upgrade of existing lab equipment. It is a specific bioanalytical instrument purchase from the original vendor that designs and manufactures the instrument. Due to the complexity of drug molecules created from drug discovery research, physical and chemical properties of these molecules are very different. Thus, a sophisticated bioanalytical instrument with high sensitivity, reproducibility, and fully automation that can be operated remotely is required. Waters UPLC-MS/MS instrument meets all these requirements. In addition, the newly released unit has improved the nonspecific binding on tubing, which further improves the analyte peak shape and reduces the carry over in the system. Furthermore, the tech service from Waters is excellent. This is very important for drug discovery and development research, in that the time/pace of sample analysis is critical for a project timeline. As discussed earlier, the sample analysis by this instrument will provide very important information on drug disposition in vivo after oral and IV administration of a new drug candidate. Data gained from pharmacokinetic studies will guide the drug candidate selection and support clinical trials in patients with unmet medical needs. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2022-04/01-30-2022. (iv) The associated NAICS code 811219 – Other Electronic and Precision Equipment Repair and Maintenance and the size standard in millions of dollars is $20.5. (v) This requirement is for Waters Xevo TQ Absolute w/ Acquity Premier and Andrew+ Robot Procurement (vi) The agreement will include depot hardware and software maintenance/support. Background: The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) develops new candidate drugs for individuals with rare and neglected disease, and HEAL and APP projects. NCATS’ facilitates drug discovery from the basic research lab to the pre-clinical stage, concentrating its efforts on the pre-clinical stage of drug discovery and development. In doing so, NCATS will help bridge the wide gaps in time and resources that often exist between basic research and clinical testing of new drugs. Liquid Chromatography (LC) and Mass Spectrometry (MS) capability is required in order to conduct the necessary comprehensive pharmacokinetic (PK) analysis of drug candidates. The LC-MS instrumentation will allow the Drug Metabolism & Pharmacokinetics Core Lab to further characterize drug candidates’ ADME properties. The procurement of the LC-MS instrumentation will bring the Drug Metabolism & Pharmacokinetics Core Lab up to current standards which will provide the group with more accurate and reliable results. Purpose: Trade in of Xevo TQ-S and Exion UPLC for ADME. To replace and trad-in the 10 yrs old Waters UPLC-MS/MS instrument with a new unit. This instrument is used daily in the lab to quantify drug concentrations in biological samples collected from pharmacokinetic studies. Project Requirements: All components of the system and software shall be manufactured and serviced by the same company/organization. In order to conduct the proper PK analyses of drug candidates in various matrices and improve sample recovery, the UPLC system must have the following capabilities: • Shall have biocompatible and inert, including High Performance Surfaces (HPS) Ultra-Performance Liquid Chromatography sample introduction systems to include pumps with integrated degassers, flow through needle autosamplers, and column compartments. This will improve separation and detection of metal-sensitive analytes by mitigating non-specific binding. Such analytes include organophosphates, oligonucleotides, peptides, and phospholipids. This will improve the detection of previously undetected analytes and increase efficiency by eliminating time consuming system and column passivation. • The sample manager shall be able to accommodate at least ninety six (96) of the standard 2-mL vials or >2 microplates (96 or other wellplates), and be optionally extended to accommodate a total of 21 well-plates. The sample manager must have primary and secondary fluidic paths that are made of biocompatible and inert materials including HPS. • The column manager compartment shall support independently controlled temperature zones for each of the individual columns and the flow path must have HPS technology (or equivalent) as found in the MaxPeak HPS columns. • Shall be able to support eCord Technology which documents the methods and usage of Acquity UPLC columns, up to 50 sample sets, the minimum and maximum pressure and temperature, sample and injection totals for the column can be stored and accessed using Acquity UPLC system console software. The eCord must be part of each individual column for traceability. • The software: o Shall run on Windows 10 operating systems. o Shall provide a single point of control for all of the LC/MS/MS system’s components, features, and functionality and allow data processing concurrent with sample analysis. o Shall be able to run at the same time as other programs on the computer such as Spreadsheet software. In order to conduct the proper chemical analyses of drug candidates in various matrices and offer the lowest limits of detection possible the mass spectrometer system must have the following capabilities: • The mass spectrometer MRM sensitivity (ESI+) for a 1 pg on-column injection of reserpine must give a chromatographic signal-to-noise greater than 3,000,000:1, using raw unsmoothed data (Gradient separation, LC mobile phase flow rate of 0.6 mL/min, MRM transition m/z 609 > 195). The Instrument Detection Limit (IDL) from ten replicate injections must be calculated to be less than 0.2 fg reserpine • The mass spectrometer MRM sensitivity (ESI-) for a 1 pg on-column injection of chloramphenicol must give a chromatographic signal-to-noise greater than 3,000,000:1, using raw unsmoothed data (Gradient separation, LC mobile phase flow rate of 0.8 mL/min, MRM transition m/z 321 > 152). The Instrument Detection Limit (IDL) from ten replicate injections must be calculated to be less than 0.2 fg chloramphenicol • The mass spectrometer should have width of less than 450 mm to allow use in the laboratory where space is limited. • The mass spectrometer system power consumption (including the mass spectrometer, rough pump and data system) should be less than 2000 W during routine use to reduce heat production and lessen the air conditioning burden on the laboratory. • The mass spectrometer must have UniSpray Ion Source capabilities. This atmospheric pressure ion source provides increased ionization efficiency and desolvation characteristics compared to ESI as well as a broader compound coverage than either ESI, APCI or APPI alone. This is important for detection of difficult analytes. • The mass spectrometer must have a mass range of 2 to 2,048 m/z. • The software: o Shall run on Windows 10 operating systems. o Shall provide a single point of control for all of the LC/MS/MS system’s components, features, and functionality and allow data processing concurrent with sample analysis. o Shall be able to run at the same time as other programs on the computer such as Spreadsheet software. In order to improve sample preparation by reducing human error and offering greater flexibility of an automation device the pipet robot must have the following capabilities: • The pipet robot must have the ability to be placed into a laminar flow hood or biosafety cabinet to support use under sterile conditions. The robot must have dimensions of 42” W x 24” H x29” D when not in use to accommodate space requirements for storage. • The pipet robot must be remote controllable be able to be used with any PC or laptop and viewable with a web browser. • The pipet robot’s liquid handling capabilities need to support a range 0.2uL to 10mL to accommodate diverse sample preparation needs. It must also support Bluetooth-enabled electronic pipettes sourced from Sartorius. Xevo TQ Absolute System with the following configuration - 1 Xevo TQ Absolute on MassLynx - 1 MS Ref StdsXEVO TQ-XS - 1 Dry Vacuum pump - 1 API UniSpray Source - 1 MassLynx Performance Workstation with TL - 1 Monitor, 27" - 1 ACQUITY Premier BSM/FTN - 1 ACQ Premier Col Mgr Active 2 Col (CM-A) - 1 ACQUITY UPLC SO H/I-Class - 1 XEVO Tandem Quad System Install Cert. - 1 NA - Professional Srv Training - 3 Days - 1 Analytical LC-MS Solvent Install Kit - 1 System Disposal-Waters - 1 UPLC/HPLC SYSTEM & SOFTWARE INSTALLATION - 1 Trade in - to include: - 1 Xevo TQ-S - s/n WAA246 Exion UPLC - s/n AB3AD5875089 Andrew Alliance Systems with the following configuration - 1 Andrew+ Pipetting Robot w/Licence - 1 The Andrew+ Start Up Kit - 1 Single channel AA pipette 5-120 uL - 1 8-Channel Pipette (5-120 uL) - 1 8-Channel Pipette (10-300 uL) - 1 Storage Plate Domino - 3 Deepwell Microplate Domino - 3 8-Channel Reservoir (50 PCK) - 1 Andrew+ Robot System Installation Cert. - 1 Andrew+ Standalone server - 1 Single channel AA pipette 50-1000 uL - 1 Single Channel Pipette (100-5000 uL) - 1 BH Tip 0.5-200 uL, Refil (10x96) - 1 BH Tip 100-5000 μl, ST (1x50) - 1 BH Tip 100-5000 μl, ST (1x50) - 1 Pipette Adaptor Single Channel - 1 Implementation Kit - 2 (vii) The Government anticipates award of a firm fixed-price contract for this acquisition, and the anticipated delivery date is sixty (60) days after receipt of order. (viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021) FAR 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification (May 2014) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000). HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2022) NIH Invoice and Payment Provisions (Feb 2021) (ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: a. Technical capability of the item offered to meet the Government requirement; b. Price; and c. Past performance [see FAR 13.106-2(b)(3)]. (x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations. The Uique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All offers must be received by 11:00 a.m., Eastern Daylight/Standard Time, on Friday July 1, 2022, and reference solicitation number 75N95022Q00300. Responses must be submitted electronically to Morgen Slager, Contract Specialist at morgen.slager@nih.gov. Fax responses will not be accepted. Product Service Code:- NAICS Code:- 811219 - Other Electronic and Precision Equipment Repair and Maintenance Primary point of contact:- Morgen Slager morgen.slager@nih.gov Phone Number 3014020952 Secondary point of contact:-

Dates

Start Date

27 Jun, 2022 (7 months ago)

Due Date

01 Jul, 2022 (7 months ago)

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Location

Country : United StatesState : Maryland