C01_J&A_FBO_POSTING_FAR_8.405-6.pdf

Limited Source Justification

Pursuant to FAR 8.405-6

1. Contracting activity:

This justification supports a limited source procurement action to be conducted under the authority of the Federal Acquisition Regulation (FAR) Subpart 8.4 – Federal Supply Schedules. The procurement action is generated by:

Pretrial Services Agency for the District of Columbia (PSA) Office of Finance and Administration/Procurement 633 Indian Avenue, NW Washington, DC 20004-2908

2. Nature and/or description of the action:

The Office of Forensic Toxicology Services (OFTS) is requesting a delivery order off the General Services Administration (GSA) Federal Supply Schedule (FSS) 66 - Scientific Equipment and Services, Special Item Number (SIN) 615 9 - Liquid Chromatographer (LC) And Liquid Chromatographer/ Mass Spectrometer (LC-MS) Systems and Related Chemistries, Supplies and Consumables.

3. Supplies or services required to meet the Agency’s needs:

OFTS requires one (1) QTRAP 4500 liquid chromatography-tandem mass spectrometer (LC-MS/MS) system. The anticipated cost is $353,454.36.

4. Authority permitting acquisition using limited sources:

FAR 8.405-6(a)(1)(i)(B). Only one source is capable of providing the item required at the level of quality required because the item is unique or highly specialized.

5. Demonstration of the contractor’s or manufacturers unique qualifications to support the authority cited:

The AB SCIEX QTRAP LC-MS/MS system is the only triple quadrupole system currently in production equipped with Linear Ion Trap (LIT) technology. The LIT or QTRAP enables enhanced sensitivity and resolution, simultaneous quantitation and library searching, and enhanced selectivity in complex matrices. OFTS intends to harness the power of the QTRAP system by utilizing its ion trap sensitivity to identify, characterize, and quantitate low abundance analytes in oral fluid and urine. The QTRAP technology allow for workflows, which enable fast, efficient identification, characterization, confirmation, and quantitation of analytes all in one single injection. Currently, OFTS has a LC-MS system, which does not meet the sensitivity or capability requirements for OFTS. The AB SCIEX QTRAP system has more than twice the functionality of a standard triple quadrupole system. OFTS requires a LC-MS/MS for furthering OFTS’s in-house screening and confirmatory analysis of synthetic cannabinoids in urine and in-house confirmatory analysis of drugs abuse in oral fluid, and instituting a new and emerging drug surveillance program. The AB SCIEX QTRAP® 4500 LC-MS/MS system is the only LC-MS/MS system that meets OFTS’s needs to perform these functions, in addition to running a robust surveillance program out of the laboratory. The QTRAP® functionality can perform multi-target screening. The system can be used as an adjunct to drug screening in support of the immunoassay procedures, especially for synthetic cannabinoids. The QTRAP can simultaneously identify additional unsuspected drugs by cross-referencing with an integrated library of hundreds of drugs. The QTRAP can simultaneously perform qualitative and quantitative methodologies. It has high sensitivity, 100X more sensitive than the standard triple quadrupole system and selectivity, which is advantageous for improving low-level drug quantification. These characteristics are essential for oral fluid analysis.

The instrument required for this type of analysis is a LC-MS/MS, specifically one equipped with QTRAP® technology. The AB SCIEX QTRAP 4500 is the only instrument on the market that meets the criteria below.

• In order to meet OFTS’s sensitivity requirements, the instrument shall possess a true orthogonal source capable of switching between both electrospray (ESI) and atmospheric pressure chemical ionization (APCI) modes without changing the source.

• Due to the wide range of masses and concentrations of the molecules OFTS analyzes, a mass range of 5 – 2000 Da and a linear dynamic range of 5 orders of magnitude for the mass spectrometer is required.

• For increased confidence in identification of OFTS’s compounds while not sacrificing the analytical quantitative capabilities of a quadrupole based mass spectrometer, OFTS requires the instrument to have the capability to perform as an ion trap for identification as well as quantitation as a quadrupole based mass spectrometer. The AB SCIEX range of QTRAPs are the only instruments commercially available capable of performing these types of analyses.

• Enhanced Product Ion (EPI) scan for fast, sensitive full scan MS/MS of the precursor of a multiple reaction monitoring (MRM) parent ion. It shall be possible to automatically trigger an EPI scan when a MRM transition exceeds a user defined threshold.

• The lab intends to screen and quantitate samples at the same time. The system shall generate quantitative MRM data and qualitative, library searchable EPI scans from the same sample in the same run.

• As the nature of OFTS’s sample types includes complex matrices with interferences, which may prohibit good MRM based analyses, the system shall possess the capability to perform MRM3 analyses. The AB SCIEX line of mass spectrometers is the only system capable of performing MRM3 analyses.

• In order to eliminate mass spectral cross-talk while reducing the chemical noise present in OFTS’s samples, a curved linear accelerator (LINAC) collision cell is required. The AB SCIEX QTRAP instrument with its LINAC collision cell is the only one of this type available.

• Many of OFTS’s sample mixtures contain analytes, which respond to either positive or negative ionization but not both. To reduce the number of injections made as OFTS’s samples are extremely valuable, a polarity switching time of 50 ms or less is required.

• The sample mixtures are complex with multiple co-eluting analytes. OFTS requires a system with a scan rate of 20,000 Da/sec or greater. This scan rate will allow proper separation, identification, and quantitation of the analytes of interest.

• As a measure of the sensitivity required for the analysis of the low-level analytes, a sensitivity measurement of 2000:1 for an amount of 200 fg of reserpine injected on column is required.

OFTS, for the reasons listed above, requires a LC-MS/MS. Therefore, it is in the best interest of the Government to issue a sole source delivery order to AB SCIEX, LLC on the GSA FSS.

6. Determination by the contracting officer that the anticipated order will represent the best value:

Based on the nature of the requirement, the RFQ will be issued to AB SCIES, LLC. Competition will not be sought. The vendor will be requested to provide any discounts available beyond the published GSA price. Price reasonableness shall be based on price analysis.

7. Description of the market research conducted and the results or statement of the reason market research was not conducted:

OFTS performed extensive market research. Based upon this research, OFTS has concluded that only one Contractor can meet OFTS’s requirements.

Market research shows that the AB Sciex QTRAP 4500 LC-MS/MS system is the only triple quadrupole system currently in production equipped with LIT technology. Other LC-MS/MS systems only have basic MRM capabilities. The QTRAP gives more than twice the functionality than a standard MRM system. In addition, the AB SCIEX QTRAP instrument is the only LC-MS/MS system on the market that has LINAC collision cell.

Furthermore, the CO posted a sources sought synopsis of the Government’s requirement (RFQ1385517) on the GSA eBuy! database on August 8, 2019 to all the Contractors awarded the GSA FSS 66, SIN 615 9 and to determine the Contractors that are capable of providing the required items and services. The CO received only one (1) response from AB SCIEX, LLC regarding the company’s capabilities.

8. Other facts supporting the justification

Overall, OFTS requires a LC-MS/MS system with several key designs and hardware capabilities that only the QTRAP 4500 LC-MS/MS system provides (i.e. sensitivity, ruggedness, and speed of analysis).

The unique LIT technology has the capability to perform a multitude of additional workflows beyond basic MRM, resulting in better specificity and quantitative performance.

This specific instrument can add significant capability to PSA. If PSA intends to stay at the top of the drug testing arena, the Agency must seriously plan for including this type of LC-MS/MS technology.

Having in-house capabilities to test oral fluid specimens and synthetic cannabinoids significantly widens the aperture of OFTS’ testing prowess. The unique QTRAP® functionality offers OFTS the ability to screen for multiple analytes.

9. Statement of actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

For future similar requirements, the Government will continue to conduct market research to determine what other Contractors offer the triple quadrupole system currently with LIT technology and LINAC collision cell or any advance technology to allow for full competition.