Redacted JA Qiagen MAS.pdf

Control No: Gordon-2021-6 Qiagen, Inc.

Qiagen Master Service Agreement

Version – March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: The Defense Forensic Science Center (DFSC) has a mission essential requirement for the purchase of the Qiagen Master Service Agreement to perform annual preventative maintenance and service repair of Qiagen instruments.

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Amount: $ 385,998.00

Prepared by: Keith Larson (404) 469-7118

Contract Management Specialist Date: 20 NOV 20 Email: keith.a.larson3.civ@mail.mil

Contracting Officer: Jason L. King (706) 791-1833 Contracting Officer Date: 20 NOV 20 Email: Jason.l.king1.civ@mail.mil

Technical/Requirements: Keith Larson (404) 469-7118 Contract Management Specialist (CMS) Date: 20 NOV 20 Email: keith.a.larson3.civ@mail.mil

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Program Manager:

Thomas H. Tatum (404) 469-4610 DFSC Chief of Staff Email: Thomas.h.tatum2.civ@mail.mil

Date: See Digital Signature TATUM THOMAS HA Digitally signed by TATUM.THOMAS.HARVEY.JR.106646640

RVEY.JR.1066466406 6

Date: 2020.12.07 07:38:10 -05'00' mailto:keith.a.larson3.civ@mail.mil mailto:Jason.l.king1.civ@mail.mil mailto:keith.a.larson3.civ@mail.mil mailto:Thomas.h.tatum2.civ@mail.mil

KING.JASON.L.1282596861 Digitally signed by KING.JASON.L.1282596861 Date: 2020.12.09 11:18:57 -05'00'

Small Business Specialist, Small Business Program:

Rufus Gates

DSN:

Legal Counsel: Chief, Administrative and Civil Law Terence Cleary DSN:

CLEARY.TERENCE.MI

CHAEL.1072798836 Date: 2020.12.09 12:31:37 -05'00'

Contracting Office Division Chief: DSN:

Jason King

GATES.RUFUS.J GATES.RUFUS.JR.11849659

Digitally signed by

R.1184965930 Date: 2020.12.10 13:17:27 -05'00'

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity: Mission and Installation Contracting Command (MICC) - Fort Gordon, GA, 271 Heritage Park Lane, Building 35200, Fort Gordon, GA 30905

2. Description of Action: The Defense Forensic Science Center requests a firm-fixed-price delivery order with Qiagen, Inc., 19300 Germantown Road, Germantown, MD 28074. The projected award is December 2020 and fiscal year 2021, funds type Operations and Maintenance, Army funds will be used.

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).

This action is a follow-on contract/order to W91249-18-P-0023. That contract/order was competed under authority “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. [FAR 13.5(a)(2)]”

3. Description of Supplies/Services: The Defense Forensic Science Center (DFSC) has a mission essential requirement for the purchase of the Qiagen Master Service Agreement to perform annual preventative maintenance and service repair for Qiagen EZ1 Advanced XL, QIAcube, QIAgility HEPA VU (including laptop), Rotor-Gene Q 5plex HRM Platform laboratory instruments. Services include preventative maintenance service, repairs, costs for any replacement parts and supplies, and technical support line.

Period of Performance: The period of performance consists of a base of twelve (12) months and two (2) twelve months option periods as follows:

Base Year: 1 JAN 21 – 31 DEC 22 $ 128,666.00 Option Year 1: 1 JAN 22 – 31 DEC 22 $ 128,666.00 Option Year 2: 1 JAN 22 – 31 DEC 23 $ 128,666.00

Total Value: $ 385,998.00

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5:

Other. Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5. Reason for Authority Cited:

a. The Defense Forensic Science Center (DFSC) located at the Gillem Enclave in Georgia, provides forensic laboratory services to the Department of Defense investigative agencies and other Federal law enforcement agencies and overseas contingency operations support. The U.S. Army Criminal Investigation Laboratory (USACIL) DNA Branch and DDB Branch, along with the Office of the Chief Scientist (OCS) require the Qiagen Master Agreement to support forensic laboratory accreditation compliance of installed instruments and equipment. (ISO 17025 ANSI-ASQ National Accreditation Board). USACIL must also maintain compliance with the Federal Bureau of Investigation (FBI) Quality Assurance Standards. Standard 10 specifies equipment maintenance and calibration for critical instruments within the laboratory. The Qiagen instruments are considered a critical instrument according to standard 10.2.1.4.

b. This maintenance agreement is required for accurate performance of these instruments and is critical to the mission of the USACIL DNA Branch and the DDB Branch. Failure to perform repairs to manufacturer’s specifications could result in sub-standard performance of the instrumentation resulting in inaccurate data. Inaccurate data could result in samples not being carried forward for further analysis. The QIAGEN instruments are used for extraction of DNA form questioned and known samples, automated PCR setup, normalization of DNA and RNA concentrations, liquid sample transfers from varied tube formats and for serial dilutions with variable dilution ratios.

These instruments can be utilized in numerous processes utilized within the USACIL DNA Branch to include: quantification, amplification, and capillary electrophoresis.They contain proprietary technologies that allow users to fully automate several hundred protocols using QIAGEN consumable products. Utilization of these instruments reduces manual manipulations by the DNA examiner thereby decreasing the possible occurrences of sample handling errors or contamination.

c. Qiagen is the sole provider of factory-trained service engineers who have exclusive access to the manufacturer’s proprietary technical manuals, repair and maintenance procedures, and software application updates for this equipment. Qiagen maintains intellectual property rights to its software and service tools software. Qiagen does not authorize any third-party service provider in North America to perform maintenance and repair on Qiagen Instruments. Qiagen is the only source of replacement parts and manufacturer authorized service provider for Qiagen instruments. Qiagen is the only vendor capable of providing the necessary service inspections to maintain calibration and qualification services required for laboratory ISO accreditation. The vendor supplied a proprietary letter.

d. Impacts.

1) Award of this contract to any third party vendor will result in repair technicians attempting services without accurate or complete technical manuals, maintenance procedures, and access to proprietary software application updates required for this maintaining and calibrating this equipment to manufacturer standards, (ISO 17025 ANSI- ASQ National Accreditation Board).

2) Engineer services from third party vendors would require that should the instrument in question need to be serviced by a Qiagen engineer or placed back under service contract with Qiagen, the instrument would need to be inspected first by an authorized Qiagen field service engineer and preventative maintenance performed at the customers expense, prior to any new maintenance, service or repair.

3) Failure to award this contract will result in failure to meet the standard 10.2.1 of the FBI Quality Assurance Standards which require that critical instruments are performance checked at least annually. Failure to meet this standard will negatively impact the USACIL maintaining status as an accredited laboratory.

6. Efforts to Obtain Competition: A sources sought notice was posted by MICC-Fort Gordon on 20 October 2020. Two potential vendors provided capability statements or market survey quotes that stated that they could provide maintenance services for Qiagen instruments. They were both evaluated and not technically capable in accordance with the PWS posted.

7. Efforts to Increase Competition: To increase competition the MICC-Fort Gordon will continue to synopsize and conduct market research to ensure there are no other vendors that can provide the requirement. The Government will issue a sole source synopsis and address any responses accordingly.

8. Market Research: DFSC research scientists are continually researching sources of information and services to enable forensic examiners to conduct effective and reliable examinations. Market research consists of internet research, literature reviews, discussions with vendors, and other professional resources attending forensic science and technical conferences and industry events. If DFSC identifies a similar requirement, every effort will be made to compete it to the maximum extent possible. No alternative vendor including from the GSA Schedule, or the open market is available to provide manufacturer authorized warranty maintenance and repair programs. No other company offers the sale of manufacturer certified warranty maintenance of the proprietary instruments produced by Qiagen. Only the Qiagen solution was found. The vendor has provided a sole source letter. The Government will issue a sole source synopsis and address any responses accordingly. A sources sought notice was posted to beta.SAM on 20 October 2020, a total of two small business responses were received. The Requiring Activity reviewed all responses and determined that both were not technical acceptable. The vendors do not satisfy the requirements for in-place agreements to calibrate, maintain and repair all critical installed instruments and equipment to manufacturer specifications for compliance with the DFSC forensic laboratory accreditation.

9. Interested Sources: There were three interested sources. Cen-Med Enterprises Inc., The Remi Group, LLC, and Government Scientific Source.Upon review by the requiring activity, it was determined that the proposed Equipment Maintenance Management services by Cen-Med Enterprises Inc. and The Remi Group, LLC for Qiagen instruments do not satisfy the requirements for in-place agreements to calibrate, maintain and repair all critical installed instruments and equipment to manufacturer specifications for compliance with the DFSC forensic laboratory accreditation. Further, Qiagen, Inc. the manufacturer verified that none of the three vendors were authorized distributors of their Master Service Agreement.

10. Other Facts: Procurement History

D o

Contract Number

Contractor Contract Type

Award Amount

Period of Performance

Non- Competitive Authority

W91249- 18-P-0023

Qiagen Inc.

Firm Fixed Price

$330,183.00 1 Jan 2018 - 31 Dec 2020

FAR

13.5(a)(2)

W91249-14- P-0261

Qiagen Inc. Firm Fixed Price

$338,802.00 1 Oct 2014 – 30 Sept 2017

FAR 6.302-1

W91249-12- P-0131

Qiagen Inc Firm Fixed Price

$40,512.63 1 Oct 2012 – 30 Sept 2013

FAR 6.302-1

11. Technical / 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.

Submitted By: Thomas H. Tatum Position Title (Division Chief or higher): DFSC Chief of Staff Email address: thomas.h.tatum2.civ@mail.mil

10. Fair and Reasonable Cost Determination: 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 IGCE other: identify the methodology or combination of methodologies that will be used.

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.

Digitally signed by KING.JASON.L.1282596861 Date: 2020.12.09 11:22:08 -05'00'

Jason King Date: See Digital Signature Contracting Officer

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

Digitally signed by KING.JASON.L.1282596861 Date: 2020.12.09 11:22:34 -05'00'

Jason King Date: See Digital Signature Contracting Officer

TATUM THOMAS HA Digitally signed by TATUM.THOMAS.HARVEY.JR.10664664

RVEY.JR.1066466406 06

Date: 2020.12.09 09:36:42 -05'00'

KING.JASON.L.1282596861

KING.JASON.L.1282596861

mailto:thomas.h.tatum2.civ@mail.mil