Drug Testing Equipment

LIMITED SOURCE JUSTIFICATION

1. IDENTIFICATION OF AGENCY AND CONTRACTING ACTIVITY: This is a Limited Source Justification. The requiring activity is the DoD Drug Demand Reduction Program (DDRP); the contracting activity is Naval Medical Logistics Command.

2. NATURE/DESCRIPTION OF CONTRACT ACTION: This acquisition is conducted under the authority of the Multiple Award Schedule Program (Title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 251, et seq.) and Title 40 U.S.C. 501, Services for Executive Agencies). This is a limited source action to be awarded as a new Federal Supply Schedule order to Agilent Technologies, Inc., 2850 Centerville Rd, Wilmington DE, 19808-16010. The placement of a firm, fixed price orderis anticipated.

3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES: The proposed acquisition is for several High Throughput Solid Phase Extraction (SPE) - Tandem Mass Spectrometer (MS/MS) systems. The first system shall include an SPE unit, MS/MS detector, nitrogen generator, uninterrupted power source (UPS), and any software, hardware or licenses required to operate the system. The system shall be delivered and installed at the Navy Drug Screening Laboratory (NDSL) Jacksonville, Florida in FY19.

The solicitation will also include the option to procure the following systems at the respective laboratory sites: one (1) SPE-MS/MS system (excluding a nitrogen generator and UPS) for the Navy Drug Screening Laboratory, Great Lakes, Illinois; one (1) SPE-MS/MS system with a nitrogen generator and UPS for the Headquarters Air Force Drug Testing Laboratory, Lackland Air Force Base, Texas; two (2) SPE-MS/MS systems with nitrogen generators and UPSs for the Forensic Toxicology Drug Testing Laboratory, Tripler Army Medical Center, Hawaii; one (1) SPE-MS/MS system with a UPS (excluding a nitrogen generator) for the Forensic Toxicology Drug Testing Laboratory, Ft Meade, Maryland; one (1) SPE-MS/MS system (excluding a nitrogen generator and UPS) for the Special Forensic Toxicology Drug Testing Laboratory, Dover, Delaware, and one (1) SPE-MS/MS system with a nitrogen generator and UPS for the Navy Drug Screening Laboratory (NDSL) Jacksonville, Florida.

The requirement also includes operator training.

Essential Characteristics: Minimum Requirements

The system shall include component(s) to rapidly analyze urine samples for tandem mass spectrometry (MS/MS) analysis of multiple and variable analytes of interest at a high rate of throughput.

•1) High-throughput SPE Requirements

•1. The system shall be capable of injecting and separating a minimum of four (4) samples per minute (15 sec or less per sample) and shall not require any additional specimen preparation or cleanup.

•2. The system shall be compatible with samples in micro-well plates prepared by currently-installed Hamilton STAR liquid handling systems.

•3. The system shall be capable of analyzing up to 6,500 samples on multiple plates while unattended.

•4. The system shall provide positive sample identification and traceability for all transfer events.

•5. The system shall provide system feedback, such as pump pressures, cartridge use, etc.

•2) Tandem Mass Spectrometer (MS/MS) Requirements

•1. The MS/MS component shall have an electrospray ionization (ESI) source and be capable of data acquisition in ESI mode.

•2. The system shall be capable of operating in the following modes: precursor and product ion mode, positive/negative scan mode, neutral loss, multiple reaction monitoring (MRM), and dynamic MRM.

•3. The system shall be capable of at least unit mass resolution in all modes

•4. The system shall have a minimum mass/charge range of 10 - 1,000 amu.

•5. The system shall be capable of 5ms dwell times.

•6. The system shall be capable of a minimum scan speed of 10,000 amu/sec without loss of sensitivity or mass accuracy.

•7. The system shall be capable of monitoring up to five (5) separate analytes per injection event.

•8. The system shall have a non-collinear source design.

•9. Source components exposed to the spray of the nebulizer shall be able to be cleaned at atmospheric pressure without breaking the vacuum.

•10. The system shall be capable of measuring current nitrogen supply (i.e. flow).

•11. The system shall allow for infusion from at least one onboard reservoir or integrated infusion pump for calibration and tuning.

•12. The system shall be capable of automated tuning (autotune).

•13. The system shall be compatible with the SPE System without modification or customization.

•3) Data Acquisition and Processing Requirements

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2. The system shall include computer(s), software, and all necessary licensing to operate all system components and allow for data acquisition and processing concurrent with sample analysis.
   
3. The system shall include software tools to identify target analytes including but not limited to transition ratios and abundances.
   
4. The system shall be capable of setting and viewing limits on acquisition parameters.
   
5. The software shall be capable of generating system diagnostic reports.
   

•4) Additional Requirements

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2. The system shall include a nitrogen generator that is compatible with the operational requirements of the MS/MS component. Note: Some laboratory sites included in the option do not require a nitrogen generator.
   
3. The system shall include an uninterruptible power supply (UPS) that is compatible with all system components, is capable of conditioning the power to the system, and allows the operator sufficient time to shut down the system safely, in the event of a power outage. Note: Some laboratory sites included in the option do not require a UPS.
   
4. All software licensing, warranty and service associated with the system shall be in accordance with the original equipment manufacturer (OEM) terms and conditions.
   
5. The system shall be installed in compliance with Occupational Health and Safety Administration (OSHA) requirements.
   
6. The system shall require less than eight (8) linear feet of bench space, including floor space for pump and waste.
   

•5) Training Requirements

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2. The Contractor shall provide familiarization training at the laboratory site in association with system installation no more than five (5) individuals.
   

•6) LIMS Interface Requirements

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2. The contractor shall provide all necessary hardware and software as well as operational and technical support to interface the system with the existing military drug testing Laboratory Information Management System (LIMS) through the laboratory's Data Innovations (DI) Instrument Manager.
   
3. The contractor shall provide to the government or its designated representative the operational and technical support to interface the system with the existing military drug testing LIMS. This support will be provided for the duration of the warranty period.
   

Enhancing Factors

•a. The system should be within manufacturer(s) service life (i.e., repair parts, maintenance, etc.) for a minimum of 5 years from the date of installation.

•b. All components of the system should be distributed and serviced by one vendor to ensure component compatibility.

•c. The system should have a current Department of Defense Risk Management Framework (RMF) certification.

•d. A reduced footprint for the instrument bench space, including floor space, is desirable.

Cybersecurity Requirements:

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2. The system, including all contractor and subcontractor-provided hardware and software, shall undergo Cybersecurity Risk Management Framework (RMF) for the Department of Defense Drug Demand Reduction Program; adherence to the attached guidelines will assist successful RMF completion. The system shall successfully receive Authority to Operate (ATO) certification for the Department of Defense Drug Demand Reduction Program. If the RMF process identifies issues which would lead to denial of ATO, contractor shall remedy the issues to the satisfaction of the government within six (6) months of notification. If the RMF process identifies issues which would lead to denial of Interim Authority to Operate (IATO), contractor shall remedy the issues to the satisfaction of the government within six (6) months of notification. The vendor shall meet with the government to provide a plan to address the issues identified. The vendor shall provide a monthly status report on the progress addressing the issues. The vendor shall provide ongoing Information Assurance support to remedy vulnerability alerts and security compliance deficiencies. Vendor will work with the Department of Defense Drug Demand Reduction IT Department to resolve compliance issues that would impact the RMF Certification and/or the security of Laboratory IT systems.
   
3. The contractor shall comply with USN Cybersecurity Cont Lang 13MAY16.docx (See List of Attachments: Attachment I - USN Cybersecurity Cont Lang 13MAY16.docx). As part of the proposal, the contractor shall submit the enclosed Medical Device Risk Assessment (MDRA) Questionnaire (See List of Attachments: Attachment II -MDRA 3.0-20160330RX.pdf with the Blue Section completely filled out.
   

DDRP OP funds in the amount of $705,335.61 will be used to procure the required system during the Base period. The total cost for the base system plus all options is $5,539,559.62.

4. IDENTIFICATION OF THE JUSTIFICATION RATIONALE AND/OR DEMONSTRATION OF CONTRACTOR'S UNIQUE QUALIFICATIONS: The statutory authority which permits restricting consideration of schedule contractors to fewer than that required in FAR 8.405-1 is 41 U.S.C. 251, as implemented by FAR 8.405-6(a)(1)(i)(B) - Only one source is capable of providing supplies required.

Through market research, it was determined that Agilent Technologies, Inc. is the only vendor capable of providing a High-Throughput Solid Phase Extraction (SPE) - Tandem Mass Spectrometer (MS/MS) system that meets the minimum requirements of the Government and is on Federal Supply Schedule (FSS). Only SPE-MS/MS systems available from Agilent are capable of injecting and separating a minimum of four (4) samples per minute, for up to 6,500 samples on multiple plates while unattended, without specimen preparation or cleanup. No other manufacturer is capable of providing SPE-MS/MS systems capable of injecting and separating a minimum of four (4) samples per minute, for up to 6,500 samples on multiple plates while unattended, without specimen preparation or cleanup. Furthermore, Agilent Technologies, Inc. is the only vendor capable of meeting the minimum requirements and is on Federal Supply Schedule.

5. DETERMINATION OF THE BEST VALUE:

In accordance with FAR 8.404(d), Pricing, GSA has already determined the prices of supplies and fixed-price services, and rates for services offered at hourly rates, under schedule contracts to be fair and reasonable. GSA's determination does not relieve the ordering activity contracting officer from the responsibility of making a determination of fair and reasonable pricing for individual orders, BPAs, and orders under BPAs, using the proposal analysis techniques at FAR 15.404-1. Therefore, ordering activities are responsible for making a separate determination of fair and reasonable pricing for individual orders. The Contracting Officer will determine, using the procedures in FAR 15.404-1, that the prices are fair and reasonable and will document such determination with a level of detail commensurate with the complexity and circumstances of each order. The Contracting Officer may also seek additional discounts before placing the order.

6. DESCRIPTION OF MARKET RESEARCH: Market research was conducted in March and April 2019. The market research conducted included research on the internet and review of product literature. The internet search was done using Google, Bing, GSA Advantage, and the ECRI sourcebook.

It was found that Agilent Technologies, Inc. (Agilent) is the only vendor which can provide an SPE-MS/MS system capable of injecting and separating a minimum of four samples per minute, for up to 6,500 samples on multiple plates while unattended, without specimen preparation or cleanup, and is on the Federal Supply Schedule. Other manufacturers that can provide high throughput MS/MS based analytic systems include BrukerDaltronics Inc. (Bruker), AB Sciex LLC (AB Sciex), Shimadzu Scientific Instruments Inc. (Shimadzu), Thermo Fisher Scientific, and Waters Corp. (Waters).

Products available from Bruker, AB Sciex, Shimadzu, Thermo Fisher Scientific, and Waters use multiplex liquid chromatography (LC) to achieve high throughput. Multiplex LC is not capable of processing up to 6,500 samples on multiple plates while unattended, without specimen preparation or cleanup, and thus does not meet the minimum requirements of the Government. Thus the systems available from Bruker, AB Sciex, Thermo Fisher Scientific, and Waters do not meet the minimum requirements. Another high throughput system available from Shimadzu utilizes a laser diode thermal desorption (LTDT) ion source and automated plate handling. This technology does not allow for processing up to 6,500 samples on multiple plates while unattended and it is not capable of effectively processing urine samples without cleanup. Thus the LTDT high throughput system from Shimadzu does not meet the minimum requirements. Only SPE-MS/MS systems manufactured by Agilent can meet the minimum requirements. Market research revealed that Agilent products are available on Federal Supply Schedule from two vendors, Agilent and Technical Communities, Inc (TCI). However, TCI is only capable of providing the MS/MS component of the required system, which is a minority of the required components, on a FSS contract. Agilent is the only vendor capable of providing a majority of the required system components, including the SPE component, on a FSS contract.

7. ANY OTHER SUPPORTING FACTS: This procurement uses a FSS Schedule and will be solicited and awarded in accordance with FAR Subpart 8.4.

8. ACTIONS TAKEN TO REMOVE BARRIERS TO COMPETITION: All future requirements will be handled on a case-by-case basis. As the barriers that preclude the agency from the requirements of section 8.405-1 (SUPPLIES) are due to limited vendors on schedule, no actions can be taken by this agency to remove those barriers. If additional vendors are added to the FSS for this equipment, they will be considered as applicable.

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