J n A Redaction_Redacted.pdf

CUI

Control Number: FY25-0179

Controlled by: Defense Health Agency (DHA) Controlled by: Healthcare Contracting Division - West CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON POC: Raphael Badagbor

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

1 NOV 2024

Justification and Approval (J&A) Modified for Federal Acquisition Regulation (FAR) 13.501

1. Identification of the Agency and Contracting Activity:

This justification is executed by the Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division – West (HCD – W), San Diego, CA, on behalf of the Navy to meet the requirements of the United States Naval Hospital Okinawa (USNHO) Pacific Command Armed Services Blood Bank Center (PACOM ASBBC), Japan.

2. Nature and/or Description of Action being Approved:

USNHO PACOM ASBBC is one of two Department of Defense (DoD) blood donor testing laboratories. PACOM ASBBC is mandated to screen donated blood to produce Food and Drug Administration (FDA)-licensed blood products for the Indo-Pacific region. The Procleix Panther analyzer is an FDA cleared and approved platform for testing human immunodeficiency virus ribonucleic acid, hepatitis C virus ribonucleic acid, hepatitis B virus deoxyribonucleic acid, and West Nile Virus ribonucleic acid, and Babesia, utilizing Nucleic Acid Testing. The analyzer requires annual onsite maintenance not available from Biomed resources within USNHO. This J&A is for a new contract award to continue annual preventative maintenance services. The contract type will be Firm-Fixed-Price. This is a follow-on to contract N6264520P2059, and this is an individual J&A Modified for FAR 13.501.

3. Description of Supplies/Services:

USNHO, the customer, requests procurement of non-personal services to perform preventative maintenance and telephone support for the Grifols Procleix Panther analyzer, an FDA cleared and approved Government-owned equipment. These services will ensure that the equipment is performing in compliance with Original Equipment Manufacturer (OEM) standards and that preventive maintenance will be conducted to minimize risk of equipment failure. Requirement:

The contractor shall provide telephone technical support, onsite emergency maintenance and onsite preventive maintenance (PM) services for the PROCLEIX PANTHER Nucleic Acid Test system. The contractor shall provide qualified technicians; OEM replacement parts; perform system calibrations; and provide all supervision, equipment, supplies and transportation for

3 NOV 2024

A Notice of Intent (NOI) to Sole Source under solicitation number HT941025N0071 was issued on 1 April 2025 and closed 16 April 2025 allowing potential vendors to provide capability statements meeting the Government's minimum requirements. No responses were received, and no additional sources submitted capabilities statements for the Government consideration.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition:

USNHO and the DHA Western Markets Contracting Division will continue to survey and engage the market of maintenance service providers for the Procleix Panther equipment currently in place at USNHO and consider competing future requirements if there are other vendors capable of meeting the Government’s requirements. In addition, review and due diligence will be conducted by the Government for any vendor submitting capability statements for preventive maintenance on the Procleix Panther equipment.

8. Market Research:

Market research was conducted by technical experts in March 2025, utilizing various methods including reviews of similar previous procurements, online search engines, and mandatory sources. The research efforts, which included posting a NOI to Sole Source on SAM.gov under notice number HT941025N0071 from 01 April 2025 to 16 April 2025, revealed that only Grifols Diagnostic Solutions can meet the Government's requirements. Previous procurements were reviewed utilizing Federal Procurement Data System (FPDS) searches under North American Industry Classification System (NAICS) code 811210 and keywords related to Panther preventive maintenance. These reviews did not identify any other vendors with demonstrated experience servicing the Procleix Panther system.

Additionally, searches on websites like Google (using search terms ‘Procleix Panther maintenance’), FPDS, AbilityOne, Unicor, Dynamic Small Business Search (DSBS) utilizing NAICS code 811210, resulted in negative results. General Services Administration Advantage search yielded no other vendors capable of meeting the Government's minimal requirements. The limited number of qualified vendors is attributed to the Procleix Panther system’s proprietary technology and Grifols’ exclusive control over maintenance and parts distribution. The possibility of utilizing a third-party maintenance provider with OEM parts was explored, but Grifols maintains exclusive control over parts distribution. This thorough market research demonstrates a meaningful attempt to identify all relevant sources.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No

4 NOV 2024

(2) If 9.a.(1) is No, was the action just prior to this one competed? No

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? Not applicable.

b. Additional Information: None

10. Interested Sources:

Grifols Diagnostic Solutions is the only source identified that can meet the Government's minimum requirements. To date, no other sources have written to express an interest in this acquisition. The notices required by FAR 5.201 were published via a Notice of Intent to Sole Source on SAM.gov under solicitation number HT941025N0071 from 01 April 2025 to 16 April 2025. Any bids or proposals received in response to this notice will be considered.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

5 NOV 2024

11. 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.

12. 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 this determination is price analysis, market research, and an Independent Government Estimate (IGE). Due to the sole-source nature of this acquisition and the proprietary nature of the Procleix Panther system, a comprehensive cost analysis is not feasible. The proposed price will be evaluated against Grifols’ historical pricing, if available, and compared to the IGE developed by technical experts. The market research demonstrating the lack of alternative qualified vendors further supports the determination that the proposed price is fair and reasonable.

13. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

6 NOV 2024

Jillian Kaido Attorney Office of General Counsel

14. Contracting Officer Certification:

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