Statement of Requirement (Revised 9.9.20).pdf

STATEMENT OF REQUIREMENTS

TITLE: Procurement of a triple quadrupole mass spectrometer and high-performance liquid chromatography system

LAB REQUESTING SERVICE: Material Measurement Laboratory, Biomolecular

Measurement Division, Bioanalytical Science Group

I. BACKGROUND INFORMATION

The Bioanalytical Science Group of the Biomolecular Measurement Division is involved in the development of reference materials, primarily of protein and peptide analytes, for use in the in vitro diagnostics and biologic pharmaceutical industries. This work entails the analytical chemistry characterization of several properties of the reference material including concentration, purity, density and post-translational modification state. Determination of concentration of these materials is required to be performed by the most advanced methods having high accuracy, high precision, and traceability to the International System of units. The accepted method for this measurement is isotope-dilution mass spectrometry which consists of a high-performance liquid chromatography system (HPLC) coupled to a triple quadrupole mass spectrometer. An objective of the group is to provide reference materials at the same concentration level as found in the laboratory specimen, which are often at very low levels. Therefore, it is also required that the triple quadrupole instrument be of the class having the greatest sensitivity.

II. SCOPE OF WORK

The current procurement covers the purchase, installation, training and extended warranty of a system which will allow for isotopic-dilution mass spectrometry for the measurement of protein/peptide in a variety of backgrounds including, but not limited to water, composed buffer, serum, plasma, urine. The type of measurement is required in order to provide certified reference values for NIST-issued Standard Reference Materials to be used by the industry to establish calibrators, quality controls, etc. for laboratory diagnostic products for the betterment of health within the United States.

III. SPECIFICATIONS

The Contractor shall provide one (1) high performance liquid chromatography system coupled with a triple quadrupole mass spectrometer that meets the following minimum technical requirements. The Contractor shall install the instrument and provide training as described below.

Triple quadrupole mass spectrometer

• Working mass spectrometry range from 50 m/z to 2,000 m/z

• Positive and negative polarity

• Electrospray ionization

• Linear dynamic range equal to at least six (6) orders of magnitude

• Sensitivity: at least 500,000:1 in both positive and negative mode using 1 pg of reserpine or chloramphenicol injection, respectively.

• Polarity switching time less than 25 ms

• Mass resolution capability of 0.5 Da (full width at half maximum)

• Acquisition scan modes including: MS1, MS2, product ion, neutral loss, neutral gain, precursor ion, selected ion mode, multiple reaction mode.

• Maximum scan rate at least 15,000 Da/s

• Minimum MRM dwell time not to exceed 0.5 ms

• MRM acquisition rate at least 500 MRM/s

• Mass stability: deviation less than 0.1 Da within 24 h.

High-performance liquid chromatography system

• Binary pump with 700 bar maximum pressure

• Flow range from 0.05 mL/min to 5 mL/min

• Autosampler with temperature control from 1 °C to ambient

• Degassing system

• Column compartment with temperature control from 15 ° C below ambient to 85 ° C

• Column compartment with capacity for columns having length of 300 mm and column switching valve.

Computer and Software

• Computer installed with Windows 10 operating system

• Installation of controlling and analysis software for both HPLC and mass spectrometer

• Monitor, keyboard and mouse

IV. WARRANTY:

The Contractor shall include a three (3) year warranty on all parts, materials, and labor for the computer, monitor, and HPLC and mass spectrometer instruments. Warranty must include one preventative maintenance visit per year to be performed in second and third year of the warranty period. Preventive maintenance to include all routine activities necessary to ensure long-term performance, reliability, and verification of adherence to instrument performance specifications.

V. TRAINING

Training for four NIST personnel to be conducted with preference for on-site training at NIST.

Alternative training via video conference may be acceptable with approval of Technical Point of

Contact (TPOC) and Contracting Officer (CO).

VI. DELIVERY

Shall be FOB DESTINATION and shall occur within 60 calendar days after award, with

Installation and Training completed within 90 calendar days after award. However, due to current access restrictions delivery shall not take place until the contractor coordinates with the designated Technical Point of Contact (TPOC) or Contracting Officer Representative (COR)

(whichever applies) and Contracting Officer (CO).

No special packaging or shipping beyond standard manufacturer practice is required for this item. Standard shipping methods for scientific instrumentation will be appropriate.

Prior to shipment, the Contractor must ensure the NIST Gaithersburg campus is open and accepting deliveries. If the restrictions of access to the campus impacts delivery schedules, a modification may be executed by the CO to establish an extended delivery timeframe.

VII. PLACE OF PERFORMANCE

All work shall be completed at the Contractor’s facility. Installation of the instrument and training shall be accomplished at NIST, Gaithersburg, Maryland. As noted under paragraph “V.

Training,” alternative training via video conference may be acceptable with approval of

Technical Point of Contact (TPOC) and Contracting Officer (CO). Normal duty hours are

Monday through Friday, 8:30 a.m. to 5:00 p.m. except for Federal holidays.

VIII. DELIVERABLES

Description Quantity Due Date

HPLC and Mass spectrometer-triple quadrupole

One Within 60 days after award

Operations and Maintenance Manual

(print and electronic format)

One Within 60 days after award

Installation One Within 90 days after award

Training of 4 NIST personnel at NIST, Gaithersburg, MD

Once Within 90 days after award

IX. ACCEPTANCE CRITERIA

The Contractor shall demonstrate that all specifications have been met. Installation of the new instrument at NIST, Gaithersburg, MD, will be performed by a service engineer who performs sufficient tests to demonstrate that the product meets all acceptance criteria stated by the manufacturer and specifically mentioned on the procurement specification. Inspection and acceptance of the product will occur at NIST, Gaithersburg, MD.

X. GENERAL INFORMATION

Safety: The Contractor employee shall be responsible for knowing and complying with NIST 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.