DL4216861_-_just.pdf

HHS Template and Instructions for a Justification for Other than Full and Open Competition

Completion Instructions: HHS has established a standard template for preparation of a Justification for Other than Full and Open Competition (JOFOC) for non-Federal Supply Schedule acquisitions exceeding the simplified acquisition threshold. Operating Divisions (OPDIVs) shall prepare the template in accordance with these completion instructions. (NOTE: The Project Officer (PO) has responsibility for completing all of the information items included in the template, with any necessary assistance from the cognizant Contracting Officer (CO) and Contract Specialist (CS) -- especially for items 3.(b), 4., 6., 7., 8. and 10. listed below.

The instructions for preparing a JOFOC are specified in “red” and should be deleted prior to processing the document for review and approval. Also, do not include the completion instructions in the completed document.

A completed JOFOC must contain all of the applicable bolded headings in the order specified. Place the required information directly next to, or under, the applicable heading. If a heading does not apply to a specific JOFOC, indicate “not applicable” (N/A) next to it. Reference and attach any additional information necessary to support the JOFOC.

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS/NIH/NIEHS/DIR

b. Sponsoring organization. National Institutes of Health, National Institute of Environmental Health Sciences, Division of Intramural Research.

c. Project Officer information.

• Project Officer name.

• Mailing address. NIEHS, P O Box 12233, Mail Drop F0-04, Research Triangle Park, NC 27709

• E-mail address.

• Telephone number.

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

a. Acquisition purpose and objectives. Proposed is the acquisition of a Thermo Scientific TSQ Quantiva Triple Quadrupole system and Thermo Scientific Q-Exactive Plus hybrid quadrupole-orbitrap system. These systems allow for the highly sensitive and highly selective measurement of chemicals, peptides, and proteins of biological and environmental origins. The objective is to aid the Mass Spectrometry Research and Support Group in providing state of the art chemical, protein, and post-translational modification identification and quantitation to intramural researchers.

b. Project background. The Mass Spectrometry Research and Support Group provides mass spectrometric analysis for a large number of investigators in the Division of Intramural Research and the National Toxicology Program. Triple quadrupole based mass spectrometers offer an unparalleled ability to isolate, identify, and quantify small molecules from a variety of sample matrices. Orbitrap-based instruments are recognized as one of the most powerful analytical platforms currently used for proteomic based applications. The Group currently is using quadrupole based or ion trap based instrumentation that is several generations behind the state of the art. These instruments are all 10-16 years old and no longer supported by the manufacturer or will not be within a year. This acquisition will provide approximately 100-fold higher sensitivity than the Mass Spectrometry Research and Support Group’s current instruments while simultaneously providing higher selectivity, faster analysis time, and less instrument maintenance and down time.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Procurement of triple quadrupole and hybrid quadrupole-orbital trap mass spectrometric systems

b. Project description.

The project requires the provision of a triple quadrupole based mass spectrometry system and a quadrupole orbitrap hybrid mass spectrometry system. The contractor should manufacture and provide ongoing support for all components of the system including a 1 year warranty.

The triple quadrupole mass spectrometer shall be capable of operating resolutions of 0.2 amu FWHM for selected reaction monitoring. The minimum sensitivity required for reserpine analysis at a level of 1 pg is a signal to noise ratio of 100,000:1. Software facilitating the quantitative analysis of large samples sets is to be included.

The hybrid quadrupole orbitrap instrument shall be able to acquire data from 50 to 6000 m/z and be capable of operating at a resolution of 140,000 at 1 Hz or better and 17,500 resolution at 12 Hz or better. The mass accuracy should be less than 1 ppm RMS error with internal calibration and the quadrupole should allow for isolation of the precursor ion from 0.4 amu to full mass resolution

• Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) X Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

• Type of action.

X New requirement Follow-on Other (specify): ______________________

• Proposed contract/order type.

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

• Acquisition identification number. Requisition number

c. Total estimated dollar value and performance/delivery period.

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

X This acquisition is conducted under the authority of 41 United

States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302- 1(b)(1).

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services

Acquisition Reform Act of 2003 (41 U.S.C. 428a).

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

a. Name and address of the proposed contractor(s).

Thermo Electron North America LLC 1400 Northpoint Parkway West Palm Beach, FL 33407

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). The acquisition shall consist of triple quadrupole tandem mass spectrometry (MS/MS) instrument as well as hybrid quadrupole-orbitrap MS/MS instrument. These instruments will provide tandem mass spectrometry capabilities that will allow for the highest degree of selectivity and sensitivity for the quantitative analysis of chemicals, peptides, post-translational modifications, and proteins in complex environmental and biological matrices.

The triple quadrupole instrument shall consist of a TSQ Quantiva mass spectrometer. Mass spectrometry is a quickly evolving field. The Mass Spectrometry Research and Support Group is currently operating an atmospheric pressure triple quadrupole instrument that was manufactured 16 years ago. In that time the manufacturer has introduced 4 new generations of instruments. The TSQ Quantiva represents the current state of the art, having been introduced in June 2013. The TSQ Quantiva uses an atmospheric pressure ionization source and shall be capable of both electrospray ionization and chemical ionization. These so-called ‘soft’ ionization techniques generate primarily a single ion from a given analyte maximizing the mass spectral signal. The TSQ Quantiva has a unique orifice and ion optic design allowing for a high flux of ions to be transferred from the LC to the MS/MS. The Thermo Electron Quantiva also features unique quadrupole geometry and electronics that enable Highly Selective Reaction Monitoring (H-SRM) experiments to be run.

This type of experiment is possible by running the quadrupole at high resolution rather than ‘unit’ resolution, ions of similar but not identical mass to the analyte of interest can be ejected. This can raise the signal to noise ratio allowing quantitation of analytes obscured in unit resolution operation. The Thermo quadrupoles also maintain sensitivity at fast scan rates. This is important when looking for multiple analytes with modern, fast LC systems. The Quantiva also features a unique dual mode detection system that enables a 6-fold linear dynamic range. This will be an important feature for the Mass Spectrometry Research and Support Group. We perform analyses involving classes of compounds which are present in biological samples at a wide range of concentrations. For example, on current equipment, epoxyeicosatrienoic acids are near or below lower limits of detection while dihydroxy-octadecamonoenoic acids are above linear range. Moreover, several on-going workflows have already been established on our existing Thermo Electron Quantiva instrument. The acquisition of a second identical instrument will allow for data to be acquired for the same project on two different instruments. It is important that the workflows be identical as this will allow for data acquired in the two instruments to be directly comparable. This will allow for faster turn-around times and more flexibility in workload assignment.

The hybrid quadrupole orbitrap instrument shall be a Q-Exactive Plus mass spectrometer. The Q-Exactive Plus is a high performance quadrupole orbitrap hybrid. This instrument has a proprietary segmented quadrupole design that allows for both high transmission efficiency and precursor isolation from 0.4 amu to full scan which is unique to the Thermo instrument. Moreover, the Q-Exactive Plus has the unique ability to perform spectral multiplexing in curved ion trap (C-trap). Additionally, the orbitrap itself is a proprietary mass analyzer that allows for the unique ability to acquire spectra at least 17,500 mass resolution (m/z 200) and a sampling rate of at least 12 Hz and can provide mass resolution of 280,000 (m/z 200) at a sampling rate of 0.9 Hz. These high resolution and high-duty cycle acquisitions are a requirement of the Mass Spectrometry Research and Support Group.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

The Project Officer overseeing the purchase is a scientist in the DIR and has many years of experience conducting research using chromatographic and mass spectrometric technology. The Project Officer has discussed mass spectrometry products with many different vendors throughout the years and has researched product availability and features on the web. In addition, the Office of Acquisitions will announce this requirement in the FedBizOpps.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

No other vendor provides a product with the same features as the proposed acquisition. Specifically, no other vendor can supply the factory reconditioned QE+ and Quantiva mass spectrometers. The cost is fair and reasonable in comparison to systems based on the same instrumental technologies.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The Project Officer conducted research by phone, in person, and on the web of instrumental systems from a variety of vendors. Agilent, Bruker, Sciex, Shimadzu, and Waters were all evaluated via one or more mechanisms described above. None of these other vendors could provide a triple quadrupole instrument with the unique orifice and ion optic design in the source which would allow for the same high ion flux to be transferred into the mass spectrometer.

Additionally, no other vendor had the unique quadrupole geometry and electronics that enable Highly Selective Reaction Monitoring (H-SRM) experiments to be performed. Furthermore, no other vendor could provide an instrument with an orbital trap mass analyzer that can provide the high mass resolution and high duty cycle described in element 5b. The project officer concludes no other vendor can provide a product with the performance and features required by the Mass Spectrometry Research and Support Group.

As the proposed project is the acquisition of factory reconditioned instruments, the Project Officer also considered third party suppliers of previously used instruments. Via extensive internet searching, emails, and other consultations, multiple third party vendors were found including Atlantic Lab Equipment, Blue Lion Biotech, Cambridge Scientific, McKinley Scientific, International Equipment Trading LTD, Mass Spec Technology Solutions LTD, GB Scientific, and KRSS LTD. Only International Equipment Trading LTD had a Q-Exactive Plus mass spectrometer available and none of these vendors had a TSQ Quantiva triple quadrupole mass spectrometer available. The Q-Exactive Plus mass spectrometer from International Equipment Trading LTD was not reconditioned by the original equipment manufacturer and did not have a 1-yesr warranty as a standard option. Moreover, International Equipment Trading LTD could not fulfill the need for a TSQ Quantiva triple quadupole instrument.

9. Any other facts supporting the use of other than full and open competition.

The items identified in the requisition are commercially available products from Thermo Scientific. They are the sole-source provider for the specific product which contains proprietary technology unavailable from other manufacturers.

One further advantage of the Thermo Scientific systems is operator familiarity with the Quantiva instrument and software packages used to control the instruments. This familiarity of software and instrument controls should speed learning of the new systems and hasten productive sample analysis.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services. No further actions are available. This is a single purchase and subsequent acquisitions are not planned as part of the project.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.