JOFOC_Redacted.pdf

Justification for Other than Full and Open Competition (JOFOC)

(1) Identification of the agency and the contracting activity

Department of Commerce National Institute of Standards and Technology (NIST) Acquisition Management Division (AMD) 100 Bureau Drive Gaithersburg, MD 20899

(2) Nature and/or description of the action being approved.

NIST/AMD proposes to enter into a firm fixed price contract for “brand name only” items from Agilent Technologies for an Ultra-high performance liquid chromatograph (UHPLC, used for analyte separation) coupled to a hybrid quadrupole time-of-flight mass spectrometer (QTOF, for analyte detection and identification) equipped with a heated electrospray (HESI) ionization source. The contract will be issued pursuant to Federal Acquisition Regulation (FAR) Part 13.5 Simplified Acquisition Procedures. The acquisition will be completed as a small business set-aside for resellers of the brand name item and services.

(3) A description of the supplies or services required to meet the agency’s needs

The contractor shall provide a turn-key system composed of an Ultra-high performance liquid chromatograph (UHPLC, used for analyte separation) coupled to a hybrid quadrupole time-of-flight mass spectrometer (QTOF, for analyte detection and identification) equipped with a heated electrospray (HESI) ionization source. The UHPLC shall consist of a multisampler, UHPLC pump with degassing capabilities, column oven, fluorescence detector, and variable wavelength UV detector that seamlessly connects in-line to the mass spectrometer. The mass spectrometer shall be a benchtop high resolution LCMS QTOF instrument. The data system, for instrument control and data analysis, shall also be included with the liquid chromatography and mass spectrometry instruments. To provide the greatest functionality and ease of use, both the UHPLC and QTOF shall be controlled via software specifically designed for the concerted system. Additionally, the system must be directly compatible with current NIST/IBBR technologies developed for the Specific instrument components and specifications that will provide this functionality are described in more detail in Section II of the Statement of Work. Acquisition of the proposed UHPLC-QTOF is required to provide NIST the ability to characterize and value-assign NIST Reference Materials of critical significance to the biopharmaceutical industry.

The total cost for this system is estimated to be

(4) Identification of the statutory authority permitting other than full and open competition.

This acquisition is being conducted under the authority of 41 USC 3304(a)(1) FAR 13.501(a)(2). Only one responsible source and no other supplies or services will satisfy the agency requirements.

(5) Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The National Institute of Standards and Technology (NIST) operates a laboratory at the that develops fundamental measurement science, standards, and reference data to enable more accurate and confident characterization of key attributes of protein drugs. The group at is responsible for monoclonal antibody reference materials (RMs) and related therapeutic protein RMs to be made available to the biopharmaceutical industry. The requested UHPLC-QTOF must be capable of a wide range of analytical assays in order to cover the breadth of measurements expected on NIST therapeutic protein reference materials. The requested UHPLC-QTOF must 1) provide state-of-the-art performance for the broad array of required analytical test methods, 2) be a robust and sensitive platform,

3) come equipped with industrially relevant software, and 4) be amenable to the reference methods under development for and other reference materials.

Extensive market research was conducted as described below, which included a sources sought notification published on FBO, as described in section 5 and 7 of this document.

The result of which indicated Agilent UHPLC-QTOF MS as the sole brand name supply capable of meeting the necessary requirements. The unique specifications identified include:

UHPLC pump capable of delivering gradient composition precision of ≤0.15% RSD or ≤0.01 min SD, whatever is greater, for the best retention time precision and identification confidence.

UHPLC pump capable of delivering a gradient delay volume gradient delay volume of 10 µL or less. Low gradient delay volumes are critical for rapid, reproducible sample separations.

Ability to provide a UHPLC Fluorescence detector that can be operated with the same instrument software as the mass spectrometer without the use of third party drivers. The fluorescence detector must work in concert with the mass spectrometer in the same software to couple fluorescence signal with the mass spectrometer signal.

QTOF mass spectrometer including a vent-free capillary removal for easy maintenance/minimal downtime. This feature allows source and sampling capillary maintenance while maintaining system vacuum. This is a critical element to minimize instrument downtime.

QTOF allows five decades of dynamic range without data manipulation.

Dynamic range is imperative to allow for evaluation of samples that may be present at varied concentrations.

To minimize mass error which is introduced by room temperature variation, the flight tube material must contain low thermal expansion rate material. The mass error cannot be more than 1 ppm per 1-degree C.

Software with the ability to support N-glycan analysis using terminal labels (2-aminobenzamide, instaPC, etc.) currently within the NIST workflow.

UHPLC Multisampler carryover precision of 9 ppm or less. Larger carryover may cause interference with replicate runs and reduction in measurement precision.

Availability of a dual compartment, independent temperature control column oven as may be necessary for two-dimensional analysis and/or parallel multi-column protocols.

Agilent technologies is the only manufacturer capable of meeting the requirements listed above.

(6) A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

In accordance with FAR 5.203 and 41 U.S.C. 1901(e)(1), a sources sought announcement was publicized to FedBizOpps (FBO) website at www.fbo.gov. The sources sought notification was intended to identify all potential vendors. Sources sought notice NIST- MML-18-SS10 was posted on March 30, 2018 for two weeks. Potential vendors were asked to comment as to their ability to meet or exceed a preliminary set of general specifications written based on TPOC’s expert knowledge of this field. Potential vendors were also able to submit additional items/specifications deemed pertinent to robust characterization of glycoproteins and/or unique features of their mass spectrometry solution for analysis of glycoproteins. Three vendors responded to the sources sought notification. Two of the vendors did not meet the minimum specifications of this requirement. Agilent technologies is the only manufacturer that submitted a mass spectrometer meeting all of the requirements.

(7) A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer will determine that the anticipated price is fair and reasonable in accordance with FAR 13.106. Prior to award of the proposed contract, price information shall be obtained from the Contractor and a price analysis will be performed and documented to sufficiently determine that the cost to the Government of the proposed acquisition will be fair and reasonable.

(8) A description of the market research conducted and the results or a statement of the reason market research was not conducted.

In order to identify all potential vendors, public sources sought notification was utilized in addition to numerous searches discussed below.

Independent research was also conducted by the TPOC to include search engine internet reviews, attending professional conferences (Well Characterized Biologicals and CASSS HOS, for example), reading professional journals, reviewing SAM via search term “Mass spectrometer, review of GSA and evaluating product literature on all of the mass spectrometry manufacturers’ websites. The TPOC also had face to face meetings with each mass spectrometry vendor within the last 6 months. This research also included looking into Agency inventory and excess from other agencies, but this was determined not applicable to this procurement, a new instrument is required. Additional priority sources including www.unicor.gov and www.abilityone.gov did not return any identified sources.

The responses to the sources sought notice were reviewed to determine if the systems could meet the specifications of the required system. Only one system out of the three received were met all the requirements. Other mass spectrometers were not able to meet several of the requirements, such as the following:

a) Hardware configuration to allow vent free capillary removal.

b) Does not allow five decades of dynamic range without data manipulation.

c) Temperature stability of ≤1 ppm.

d) Gradient delay volume

e) Flow rate precision

f) Multi-sampler carryover precision

g) Availability of a dual compartment, independent temperature control column oven

h) Fluorescence detector.

NON-MANUFACTURER RULE AND/OR WAIVER:

The non-manufacture rule is waived for this procurement as the described product fall under the class waiver for NAICS code 334516 with description of a liquid mass spectrometry per FAR 19.102(f)(4).

To locate small businesses, the Contract Specialist performed research by requesting Agilent Technologies to provide a list of any small business resellers that could provide the required items. The small business resellers Government Scientific Source, AttainIt, and Tevet were contacted and indicated they could all provide the required system and services.

(9) Any other facts supporting the use of other than full and open competition, such as:

No other facts.

(10) A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

Company Name or Name/Title of Individual Contacted: Agilent Technologies

How contacted (for example email, phone, in-person, or meeting): email Date Contacted: 3-30-18

Company Name or Name/Title of Individual Contacted:

Date Contacted: 6/26/2018

Company Name or Name/Title of Individual Contacted:

How contacted (for example email, phone, in-person, or meeting): email Date Contacted: 6/26/2018

Company Name or Name/Title of Individual Contacted:

Date Contacted: 6/26/2018

Company Name or Name/Title of Individual Contacted:

Date Contacted: 3-30-18

Company Name or Name/Title of Individual Contacted:

Date Contacted: 3-30-18

(11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

The Government will continue to conduct thorough market research to gauge the marketplace capabilities for future requirements. The expected life cycle of this equipment is five (5) years. During the expected life cycle of this equipment, NIST will work to identify additional products that could meet its requirements. The Government will seek competition on future acquisitions for these products. All future requirements will be handled on a case-by-case basis.

(12) Contracting officer certification that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

This acquisition is being conducted under the procedures in FAR subpart 13.5 in accordance with 41 U.S.C. 1901. The Contracting Officer, in signing below, certifies that the justification is accurate and complete to the best of the Contracting Officer’s knowledge and belief: