D.03._LSJ_Redacted.pdf

Control No: JA-19-04-096 Contractor: AB Sciex

Program/Equipment: X500R QTOF and Maintenance

Version – September 2018 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR 8.405-6 LIMITED SOURCES JUSTIFICATION

UNDER THE GENERAL SERVICES ADMINISTRATION

FEDERAL SUPPLY PROGRAM

Program/Equipment The AB Sciex LLC X500R QTOF can make accurate mass measurements and high resolving power permit the user to elucidate unknown compounds.

Authority Title III of the Federal Property and Administrative Services Act of 1949 (41U.S.C. 251, et. Seq) and Title 40 U.S.C 501, Services for Executive Agencies, as implemented by FAR 8.405-6.

Amount:

Prepared by:

Contracting Officer:

Technical:

Requirements:

Reviews: I have reviewed this justification and find it adequate to support sole source.

Program Manager:

Legal Counsel:

Program/Equipment: X500R QTOF and Maintenance

Version – September 2018 FOR OFFICIAL USE ONLY

FAR 8.405-6 Limited Sources Justification Under the General Services Administration (GSA)

Federal Supply Schedule (FSS) Program

1. Contracting Activity The Contracting activity for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014.

2. Description of Action The requiring activity for this action is the Defense Health Agency (DHA), Armed Forces Medical Examiner System (AFMES), Division of Forensic Toxicology (DFT), located at Dover Air Force Base in Delaware. AFMES requests a Firm Fixed Contract (FFP) contract with AB Sciex using Fiscal Year 2019, Operations and Maintenance funding for the procurement of their X500R QTOF and corresponding maintenance. The Government will execute this action against FSS contract GS-07F-0092X. Government projects award for September 2019.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

FAR 8.405.6 approved an acquisition plan in accordance with DFARS 207.103(d)(i)(B) on 07/18/19).

The required acquisition plan in accordance with DFARS 207.103(d)(i)(B) is currently awaiting approval.

3. Description of Supplies/Services The AB Sciex LLC X500R Qualitative Time of Flight (QTOF) can make accurate mass measurements and high resolving power permit the user to elucidate unknown compounds. This ability is critical in keeping pace with constantly evolving novel psychoactive substances (NPS) trends currently challenging forensic toxicology laboratories. The AB Sciex operating system software allows for data acquisition and processing, including large customizable targeted screening databases and spectral libraries. Finally, retrospective data analysis can be performed to screen for newly discovered drugs in historical data.

This instrument is compatible with Microsoft Window 10; the proprietary software and OS comply with Department of Defense (DoD) requirements for laboratory networks.

AFMES is procuring one (1) X500R QTOF to include maintenance for a period of five (5) years. The estimated value of the X500R QTOF to include delivery and installation is approximately .

The maintenance plan for the option years will use future Fiscal Year funding and not current funds.

Maintenance will begin after installation and the initial warranty period ends. The estimated timeframe for the maintenance plan along with the value for each year is as follows:

Base Period: 09/20/19 to 09/19/20 Value:

Option Period I: 09/20/20 to 09/19/21 Value:

Option Period II: 09/20/21 to 09/19/22 Value:

Option Period III: 09/20/22 to 09/19/23 Value:

Option Period IV: 09/20/23 to 09/19/24 Value:

The total estimated value to include delivery, installation and maintenance for five (5) years is

Program/Equipment: X500R QTOF and Maintenance

Version – September 2018 FOR OFFICIAL USE ONLY

4. Authority Cited Title III of the Federal Property and Administrative Services Act of 1949 (41U.S.C. 251, et. Seq) and Title 40 U.S.C 501, Services for Executive Agencies, as implemented by FAR 8.405-6 and substantiated by the following

FAR 8.405-6(a)(1)(i)(A). An urgent and compelling need exists, and following the procedures would result in unacceptable delays.

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

FAR 8.405-6(a)(1)(i)(C). In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with applicable Federal Supply Schedule ordering procedures. The original order or BPA was not previously issued under a sole-source or limited-sources procedures.

FAR 8.405-6(b)(1). Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer.

5. Reason for Authority Cited AFMES DFT has a requirement for an AB Sciex LLC X500R QTOF. The Sciex X500R QTOF is the only instrument that provides a heated time of flight path, data acquisition mode that scans across Q1 during a variable window acquisition, and twin sprayer probes with independent calibrant delivery flow path. Due to temperature variation in the instrumentation laboratory from day to night, a heated time of flight path is necessary. This provides continued stability of results and the required exacting accuracy required during extended experiments that may run for 12-hours from start to completion. The data acquisition of scanning across Q1 in during a variable window acquisition is required to target the broadest spectrum of analytes in a single injection. This permits chromatographic screening for 100s of analytes in a single analysis to determine potential cause and manner of a death investigation. The calibrant delivery flow path provides a more robust correction process while being less intrusive mass correction process. Other vendors of QTOF instruments do not meet the needs of AFMES DFT because they do not provide a time of flight path that is temperature controlled and their calibrant delivery system and preparation is very cumbersome and error prone. AFMES DFT has found that alternatives to the Sciex X500R QTOF are not robust or consistent for the high quality results required to meet the mission.. The results obtained from this instrument require exacting accuracy and precision. AB Sciex LLC is the Original Equipment Manufacturer (OEM) and only Sciex can satisfy this requirement. AB Sciex LLC is the only company that can provide the required maintenance services, while ensuring the instrument’s performance, calibration, and functionality are not compromised. No other company is able to provide maintenance on Sciex equipment as they have no authorized third parties to perform this service.

Program/Equipment: X500R QTOF and Maintenance

Version – September 2018 FOR OFFICIAL USE ONLY

6. Actions to Increase Competition The equipment must be maintained within the OEM specifications, in like new or better condition;

therefore, no effort will be made to solicit offers from any other potential sources as there is only one known source capable of providing the required equipment and maintenance service. No effective competition is anticipated.

7. Market Research Based on Market Research, AB Sciex LLC is the OEM and only AB Sciex LLC can provide this instrument and any required maintenance services while ensuring the instrument’s performance, calibration, and functionality are not compromised. Market research included searches on the internet and previous contract history. No other company is able to provide maintenance on Sciex equipment as they have no authorized third parties to perform this service.

8. Other Facts

a. Procurement History

Contract: W81XWH-17-F-B304 Contractor: AB Sciex Award Date: September 2017 Competitive Status: LSJ was approved by Contracting Officer in August 2017 Authority: FAR 8.405-6(a)(1)(i)(B), Only one source is capable of responding

b. N/A

Program/Equipment: X500R QTOF and Maintenance

Version – September 2018 FOR OFFICIAL USE ONLY

9. Technical Certification I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

10. Requirements Certification I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Program/Equipment: X500R QTOF and Maintenance

Version – September 2018 FOR OFFICIAL USE ONLY

11. Best Value Determination/Fair and Reasonable Cost Determination I hereby determine that the order represents the best value to the Government in accordance with FAR 8.405-6(c)(2)(v). Additionally, I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following:

Price analysis

Cost analysis

IGE

Audit:

Other:

AFMES is procuring one (1) X500R QTOF to include maintenance for a period of five (5) years. The estimated value of the X500R QTOF to include delivery and installation is approximately

The maintenance plan for the option years will use future Fiscal Year funding not current funds.

Maintenance will begin after installation and the initial warranty period ends. The estimated timeframe for the maintenance plan along with the value for each year is as follows:

Base Period: 09/20/19 to 09/19/20 Value:

Option Period I: 09/20/20 to 09/19/21 Value:

Option Period II: 09/20/21 to 09/19/22 Value:

Option Period III: 09/20/22 to 09/19/23 Value:

Option Period IV: 09/20/23 to 09/19/24 Value:

The total estimated value to include delivery, installation and maintenance for five (5) years is

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

12. Contracting Officer Certification I certify that this justification is accurate and complete to the best of my knowledge and belief.