Sole Source Justification Qiagen for Redaction_Redacted.pdf

Control Number:

NOV 2024

Sole Source Justification (SSJ) for Requirements under the Simplified Acquisition Threshold

1. Identification of the Agency and Contracting Activity: The Defense Centers for Public Health – Aberdeen (DCPH-A), Defense Health Agency (DHA), United States Army Medical Research Acquisition Activity (USAMRAA).

2. Description of Action: The DCPH-A Laboratory Sciences (LS) Directorate has a requirement for annual preventative maintenance, repair services and part replacements of Qiagen laboratory equipment as well as at least one (1) emergency visit per year. The Contractor shall provide non-personal service(s) to troubleshoot, diagnose and repair the Qiagen laboratory equipment serviced by Qiagen.

New Requirement Purchase Order Blanket Purchase Agreement (BPA) Order against BPA # Order against Multiple Award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract Order against Single Award IDIQ Contract # Order against Federal Supply Schedule Contract #

Follow-on Requirement to Contract/Order # HT942524F0327. Work was part of this requirement that included other equipment from other OEMs.

Modification against existing Contract/Order and Modification #

Contract Type Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid

3. Description of Services or Supplies and Estimated Value: This is a non-personal services contract to provide annual preventive maintenance, repair support visits, parts, and software support for Qiagen equipment. This service is required to meet manufacturer standards, but more importantly, it is mandatory to meet laboratory quality and accreditation standards. The preventative maintenance services will be for the following instruments.

Vendor Nomenclature Serial No. Model No. ECN

QIAcube HT/QIAxtractor, platform, 15124 QIAcube HT TissueLyser II (100-240 V, 50/60Hz), 1219020726E TissueLyser II

QIAcuity Eight Digital PCR System Instrument, 355 QIAcuity Eight QIAcuity Four Digital PCR System Instrument 1360 QIAcuity Four

Period Period of Performance Estimated Value Type of Funding Base Period 09/25/2025 - 09/24/2026

Total

4. Authority:

FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold, only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name, or industrial mobilization).

5. Reason for Authority Cited: Qiagen LLC is the only vendor that meets the requirements of the contract’s Performance Work Statement (PWS). Qiagen is the proprietary service provider for Qiagen Instrumentation. Per the Qiagen organization: “Qiagen does not authorize or certify third party service providers of our services in the United States; only Qiagen engineers are trained by Qiagen for the purposes of selling such maintenance services in the United States. For optimal system performance, it is best to ensure Qiagen instruments are maintained with the latest firmware and hardware revisions.

6. Market Research: Market Research was conducted between November 2024 and January 2025 by via an internet search to locate all potential sources present in the marketplace that could potentially meet the Government’s requirements.

contacted the Original Equipment Manufacturer (OEM) to confirm maintenance requirements and available service providers. The manufacturer noted that Qiagen was the only authorized service agent in North America for all Qiagen product lines. All parts, consumables, service requests and contracts can only be supplied by Qiagen LLC. Additionally, a Google search for ‘Qiagen Instruments maintenance services’ did not result in any organizations (other than Qiagen) that service the equipment.

The requirement was synopsized on the Governmentwide Point of Entry (SAM.gov) via a Notice of Intent to Sole Source on 23 April 2025 for a period of 15 days (in accordance with FAR subpart 5.2). The synopsis did not receive any responses from capable vendors for this requirement that would result in additional competition for the Qiagen Equipment Maintenance, Repair, and Preventive Maintenance Services.

7. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No.

(2) If 7.a.(1) is No, was the action just prior to this one competed? No

(3) If 7.a.(2) is Yes, what has changed where this action cannot be competed? Not Applicable.

b. Additional Information: Failure to award to the sole-service Qiagen will hamper the DCPH-A LS Directorate’s ability to provide timely routine and emergency mission-critical public health lab services. Preventive equipment maintenance and repair support does not happen promptly. DCPH-A LS Directorate’s client agreements and sample life efficacy require results to be returned within a specified turn-around-time.

Without a reliable service contract, required services for these robotic analyzers will have to be acquired via Government Purchase Card and one-time service contracts, which will result in extended instrument downtimes and increased service costs.

Extended downtime will require the DCPH-A LS to outsource the testing, resulting in excess time and unnecessary cost to the organization.

The experience of DCPH-A LS Directorate is that third-party organizations often bid on these equipment service contracts. We have worked with several groups and have found that the turn-around-time for instrument support increases substantially. This delay is because they must schedule with the proprietary vendor to perform the work.

The third-party organizations do not have priority service agreements and cannot meet the necessary turn-around-times needed to support the DCPH-A LS Directorate’s mission. In addition, there are higher costs included in their bids that are associated with logistical administration, which is unnecessary because the DCPH-A LS Directorate tracks this internally.

8. Technical Certification:

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

9. Requirements Certification:

I certify 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. Fair and Reasonable Cost Determination: I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for Determination: The basis for determination to determine a fair and reasonable price based upon price analysis in accordance with FAR 13.106-3(a)(2)(vi).

11. Contracting Officer Determination:

I certify this justification is accurate and complete to the best of my knowledge and belief.