Statement of Requirement (Final).pdf

STATEMENT OF REQUIREMENTS

TITLE: Procurement of a liquid chromatograph with a single quadrupole mass spectrometry detector

I. BACKGROUND INFORMATION

The Organic Chemical Measurement Science Group within the Chemical Sciences Division of the Material Measurement Laboratory, National Institute of Standards and Technology is responsible for chemical measurements leading to the certification of many Standard Reference

Materials (SRMs). Currently, the Organic Chemical Measurement Science Group (OCMSG) is focused on both the development of new methods and utilization of existing (legacy) analytical methods to prepare SRMs for the use in the clinical, food, and nutritional application areas. The

OCMSG also develops analytical methods to assess the purity of organic compounds.

One of the most common assays used for these methods and measurements is liquid chromatography (LC) with mass spectrometry (MS) detection based on a single quadrupole mass analyzer. LC-MS is a powerful tool that enables the separation, identification, and detection of target analytes in complex matrices such as human serum and food materials. The OCMSG has a longstanding history of using LC-MS for accurate and sensitive measurements for value-assigning SRMs required by our NIST customers. For many NIST clinical and nutritional measurements (e.g., creatinine, fat-soluble vitamins, water-soluble vitamins), the OCMSG has established legacy ‘reference methods’ based on LC-MS, which are higher-order methods that have been extensively validated using established instrumentation in our laboratory. Some of these methods are also dependent on optical detection methods, and hence sensitive and selective absorbance and fluorescence detectors are also required in the LC configuration. To ensure the continuity of our measurement service programs and the timely measurement and issuance of

SRMs that are critical to our stakeholders, it is important that the OCMSG is able to easily replicate these existing methods to new instrumentation so that years of staff labor are not needed to create and validate new methodology using different platforms from other manufacturers. In addition to facile method transference, it is critical to our quality system and data management plans that we ensure continued readability and access to our files and data supporting the characterization of our SRMs and supporting our other measurement service activities (e.g., material characterizations for our Quality Assurance Programs). It is therefore essential that the data system for the acquired instrument be able to access and analyze data obtained on other Chemstation based LC-MS systems in our lab.

In addition to accommodating existing methods in the lab, the instrument also must have the capability of providing advanced measurement capabilities to meet emerging needs in our laboratory. Namely, many of our new activities are related to food safety and authentication, which involve the determination of large molecules (e.g., protein allergens) and accurate mass chemical fingerprints. To accommodate these emerging measurement needs, the system must have advanced baseline capabilities but must also be able to be upgraded for enhanced capabilities as our research programs grow. To this end, a LC system coupled to a mass spectrometer with a mass range of up to 2,000 m/z must be standard, with the option to upgrade to 3,000 m/z later. Additionally, to support high-resolution chemical fingerprints, the mass spectrometer must have high isotopic fidelity and the capability of achieving three decimal places of accurate mass through an available upgrade.

II. SPECIFICATIONS

The item to be acquired is an instrument system composed of a liquid chromatograph (used for analyte separation) coupled to a single quadrupole mass spectrometer (for analyte quantitation and identification).

The Contractor shall provide one (1) analytical benchtop instrument system that meets the following minimum technical requirements. The Contractor shall install the instrument, provide warranty and extended service coverage, and provide training as described below.

A.) Liquid Chromatograph (LC) must consist of the following components:

1. An Agilent G7112B binary solvent pump with the following minimum specifications:

o Able to perform chromatography with a flow range of 0.001 to 5.000 mL/min o Capable of pressure limits of up to 600 bar o Must have high pressure mixing, an integrated seal wash, and up to four solvent lines with a solvent selection valve o Must have integrated vacuum degassing unit with 2 channels o Flow accuracy and precision of 1.0 % and ≤ 0.07 % RSD, respectively o Mobile phase composition accuracy must be ± 0.35 % and precision must be ≤

0.15 % RSD

o Designed to be fully compatible with the other components of the LC system

2. An Agilent G7129A autosampler with the following minimum specifications:

o Must hold 132, 2-mL vials o Injection volume range of 0.1 to 100 µL, with injection volume precision of ≤

0.25 % o Must have an integrated needle wash system o Integrated thermostat capable of sample temperature control over the range of 4.0

- 40 °C o Must be capable of overlapping injections and advanced injection programming

3. An independent Agilent G7116A column compartment with the following minimum specifications:

o A column switching valve (Agilent G4231A) with at least 2 positions/6 ports o Capacity for at least two 4.6 mm x 150 mm columns o Column temperature control over the range from 10 °C below ambient to 85 °C with stability of ± 0.1 °C.

o Two independent temperature zones o A heat exchanger for pre-column solvent heating

4. A sensitive Agilent G7117C photodiode array detector with the following minimum specifications:

o A detection wavelength range of 190 nm to 640 nm o Noise specifications ≤ ± 3 µAU for high sensitivity, low limits of detection o Capable of simultaneously acquiring data at up to 8 different wavelengths o A 1024 element diode array for full spectral detection with high resolution o Fast analysis speeds with a high sampling rate of 120 Hz o Includes an analytical flow cell

5. An Agilent G7121B fluorescence detector with the following minimum specifications:

o Multi-signal wavelength detection with rapid on-line scanning capabilities and spectral data analysis o Includes lamp and analytical flow cell o An inline pressure relief valve (Agilent 0100-3150) to protect the flow cell

6. Any additional parts and supplies required for installation and instrument operation and testing such as tubing, connectors, vials, a toolkit, a column, etc.

B.) Agilent G6125BA Single Quadrupole Mass Spectrometer must have the following minimum specifications:

o A single quadrupole mass analyzer o A dedicated atmospheric pressure Electrospray Ionization (ESI) source included o The ability to support dedicated atmospheric pressure chemical ionization (APCI) and atmospheric pressure photoionization sources (APPI) o Mass resolution of at least 0.7 Dalton (determined at FWHM) o Mass range of at least 10 to 2000 m/z, with the potential to extend the mass range up to 3,000 m/z through an upgrade at a later date o Linear dynamic range of at least > 6 × 106 (electronic) o SIM sensitivity using ESI positive of 1 pg of reserpine injected on column, quantifying the m/z 609 ion, Signal-to-Noise ratio, RMS > 100:1 o System must be upgradable at a later date to add accurate mass compound identification and elemental composition identification to achieve mass accuracy of ± 0.005 Dalton and 99.0% spectral accuracy

C.) Data System:

To provide the greatest functionality and ease of use, both the liquid chromatography and mass spectrometry instruments must work together using one instrument control software package with combined analysis methods. The data system must consist of:

• A computer with monitor and necessary hardware and accessories to operate the software, control all components of the instrument, and store and process spectral data from the three detectors (diode array, fluorescence and mass spectrometric detectors)

• ChemStation Software that can 1) control all components of the LC and MS listed in the specifications, 2) acquire data, and 3) perform subsequent data analysis o Software provided must be intuitive graphic-based package o Software must be able to read and analyze data files collected using Chemstation

Software, Revision B.04.02 o Data system can analyze data from legacy MS systems such as G1946, G1956, G6110, G6120, G6130, G6150 and process both GC and LC data

• Agilent Lab Advisor Advanced Software

D.) Operations and Maintenance Manual must be provided that:

• Covers proper operation, routine maintenance, and troubleshooting for all instrument components and controlling software.

o The manual may be supplied in hard copy or electronic format (or both).

E.) Initial Warranty:

The Contractor shall provide, at a minimum, a one-year warranty for the equipment. The warranty shall cover all parts, labor and travel. The warranty shall commence upon successful completion of delivery, installation, familiarization, and demonstration of all required specifications.

F.) Extended Repair Service Agreement (Agilent Part SYS-LM-QUAD-E, CrossLab

Bronze – 4yrs total):

The contractor shall provide a 4-yr extended service agreement for the instrument commencing immediately upon the expiration of the standard, one-year warranty. The extended repair service agreement shall include the following:

• Preferred response times for service

• Hardware telephone support

• Travel and labor for all required on-site repair visits

• All parts and consumables required for repair (including any shipping expenses)

• The use of OEM-trained technicians/engineers for all repairs and the use of OEM parts

For any services performed either under initial warranty or the repair service agreement, the contractor must provide the NIST Technical Point of contact (TPOC) with a service report that contains the following information:

• Model number.

• Serial number.

• Date and time of arrival to NIST.

• Description of service performed.

• Name and quantity of any parts that were repaired.

• Name and quantity of any parts that were replaced.

• Date and time of departure from NIST.

• Diagnostic test results or narrative summary demonstrating that the instrument is meeting the performance standards.

• Any additional comments or recommendations.

• Printed name and signature of service technician. Signature block for NIST personnel accepting the services rendered.

Installation:

The Contractor shall install the instrument at NIST Gaithersburg, MD campus. Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up and hook-up of all equipment, start-up, demonstration of specifications, and removal of all trash. Instrument will operate to manufacturer’s specifications upon installation. Installation will take place during normal business hours, between 8:30 am and 5:00 pm Eastern Time, Monday through Friday except Federal Holidays, and will be coordinated with the NIST Technical Point of Contact

(TPOC). Contractors must comply with NIST COVID-19 safety protocols. Installation is to occur within 120 calendar days of award.

Training:

Training shall include instrument familiarization, which shall take place at NIST Gaithersburg, MD, for at least 4 NIST personnel. Instrument familiarization shall cover normal operation, demonstration of specifications, operation of software, troubleshooting, and routine maintenance.

Familiarization will be provided during normal business hours, between 8:30am and 5:00pm

Eastern Time, Monday through Friday, except Federal Holidays, and will be coordinated with the NIST Technical Point of Contact (TPOC) to ensure maximum availability of NIST personnel. Familiarization is to occur within 14 calendar days of installation.

III. PERIOD OF PERFORMANCE

Delivery of equipment, installation, and familiarization to be completed within 134 calendar days after contract award. One-year warranty shall begin upon NIST acceptance of equipment, installation and familiarization. The four (4)-year service agreement shall commence upon the expiration of the one-year warranty.

IV. PLACE OF PERFORMANCE

All work shall be completed at the Contractor’s facility. Installation of the instrument, familiarization, and on-site repairs (for both the warranty and the service agreement) shall be accomplished at NIST, Gaithersburg, Maryland. Normal duty hours are Monday through Friday, 8:30 a.m. to 5:00 p.m. with the exception of Federal holidays.

V. DELIVERABLES

Description Quantity Due Date

(1) Delivery and installation of the analytical instrument

One (1) 120 calendar days after award of this requirement.

(2) Operations and maintenance manual for the analytical instrument

One (1) 120 calendar days after award of this requirement.

(3) Training/Familiarization of NIST personnel at NIST, Gaithersburg, MD

One (1) 14 calendar days after installation.

(4) One-year initial warranty One (1) Commencing upon completion of (1), (2), and (3)

(5) Four-year repair service agreement One (1) Commencing upon expiration of the initial warranty

VI. ACCEPTANCE CRITERIA

After installation, the Contractor shall demonstrate that all performance specifications are met.

VII. GENERAL INFORMATION

Safety: The Contractor employee shall be responsible for knowing and complying with commercial installation safety prevention regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

Security: NIST is a restricted campus. An identification badge is required for access for entry into buildings and also is shown to the armed Security Police when entering the campus.

Identification Badges: Contractor employees shall comply with NIST identification and access requirements. The Contractor shall provide the name and citizenship information of employees for on-site visits to the NIST Technical Point of Contact (TPOC) prior to arrival. The TPOC will submit the name(s) and citizenship information to the NIST Office of Security in order for a given Contractor employee to enter the NIST campus. The Contractor employee is responsible for absences due to missing or expired identification and access documents. Each Contractor employee shall wear a visible identification badge provided by the NIST Security Office.

Vehicle Registration: All Contractor employees must register their vehicles with the NIST

Security Office to gain access to the campus. A valid driver’s license, Government-furnished civilian ID (which in most cases can be a valid driver's license), proof of insurance and current registration must be presented to the NIST Security Office.