A02. Part 13 - JA Sole Source FAR Part 13.5 Redact_Redacted.pdf

CUI

Control Number: JA-25-10-1663

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

The supplies being requested on the Blank Purchase Agreement are below:

No. Item Name No. Item Name No. Item Name

1 STA® CONTROL LA

1+2 33 STA®-Neoplastine® CI

Plus 10 64 STart® Cuvettes

2 Asserachrom® Total

TFPI

34 STA®-Thrombin 10 65 Ball Dispenser

3 Asserachrom® sEPCR

35 STA®-Stachrom® Protein C

66 Finnpipette

4 Staclot® VIIa-rTF 36 STA®-Fibrinogen 5 67 Finn Tips 1.25mL (Finnpipette Only)

5 STA®-Liquid Anti-Xa

37 STA®-Unicalibrator 68 Finn Tips 2.5mL (Finnpipette Only)

6 STA®-Liquid Anti-Xa

38 STA® Coag Control N + Abn Plus

69 Immulon 2HB Plate

7 STA®-Staclot® DRVV Screen 5

39 STA®-System Control N+P

70 Thrombin Calibrator

8 STA®-Staclot® DRVV Confirm

40 STA®-Heparin Control 71 PPP Reagent

9 STA®-Staclot® DRVV Screen 2

41 STA®-Hepanorm® H 72 PPP-Reagent LOW

10 STA®-Stachrom®

TAFI

42 STA®-Quality

HBPM/LMWH

73 PPP-Reagent HIGH

11 STA®-Multi Hep Calibrator

43 STA®-Deficient XII 74 PRP Reagent

12 STA®-Owren-Koller 44 STA®-Deficient IX 75 FluCa kit 13 STA®-CaCl2 0.025

M 45 STA®-Deficient VIII 76 MP Reagent

14 STA®-Quality

HNF/UFH2

46 STA®-Deficient X 77 K-ASSAY FACTOR XIII

CONTROL2

15 STA®-Procoag-PPL 47 STA®-Microcontainer (500/box)

78 K-ASSAY FACTOR XIII2

16 PLT VASP/P2Y12 48 STA®-Deficient VII 79 K-ASSAY FACTOR XIII

CALIBRATOR2

17 STA®-Liatest® D-Di 49 STA®-Deficient V 80 TRINCLOT FACTOR XI 18 STA®-Liatest® Free

Protein S 6 50 STA®-Deficient II 81 STA-R In-house (Parsippany, NJ)

Basic Operator Training 19 STA®-Liatest®

VWF:Ag 51 STA®-Staclot® Protein

S 82 STA®-Neoplastine® CI Plus 5

20 STA®-VWF:Ag Calibrator

52 STA®-Staclot® Protein C 1

83 STA®-Thrombin 2

21 STA®-Liatest® Control N+P

53 STA®-Mini Reducer 84 STA®-Reptilase®

22 STA®-Liatest® FM 54 STA®-Maxi Reducer 85 STA®-Stachrom® Plasminogen 23 STA®-FM Calibrator 55 STA®-Microcups

(100/box) 86 Thermal Paper

24 STA®-FM Control 56 Stachrom® PAI 87 5mL Reduction Ring 25 Liatest® AT III 57 Stachrom® Heparin 88 White stirring magnet (for STA®-

Neoplastine®)

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

26 Liatest® Protein S 58 Asserachrom® Protein C

89 Teflon syringe tip and O-Ring kit

27 Staclot® LA 20 59 Asserachrom® tPA 90 Hamilton syringe and o-ring 28 STA®-PTT Automate

60 Asserachrom® PF4 91 STA®-Cuvettes (6 rolls of 1000 cuvettes/box) 29 STA®-Stachrom®

AT III 3

61 STA®-Cleaner Solution 92

Megamix-Plus SSC2 30 STA®-C.K. Prest® 5 62 STA®-Desorb U 93 Ball Extractor 31 PTT-LA Screen 63 Magnetic Stir Bars

(white triangular)

Ball Vial (1850/vial) 32 Staclot® LA

Estimated Ordering Period: 02 March 2025 to 01 March 2030 Estimated BPA Ceiling:

4. Authority Cited: 41 United States Code (USC) 1901 as implemented in Federal Acquisition Regulation (FAR) 13.501(a)(1), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited:

Diagnostica Stago, Inc. is the only source that can provide the supplies needed to perform the research with the STA R Max® Hemostasis Analyzers that the USAISR uses to fulfil their mission. The USAISR purchased two STA R Max® hemostasis analyzers to replace aging systems in November 2018. These analyzers currently support numerous research protocols examining hemostasis during injury. Various reagents, controls, and disposable supplies are required to process samples for analysis. The STA R Max® is Food and Drug Administration (FDA) approved, but only with the use of the original manufacturer’s consumable supplies. These consumables are specific to the instruments and generic substitutions are not validated by the FDA nor will the manufacturer support the use of such supplies on the instruments. During the Government’s market research, Diagnostica Stago, Inc. provided confirmation via email that “Diagnostica Stago, Inc. is the sole distributor of these products.”

Additionally, these consumable supplies will be used to support ongoing protocols which have relied on these exact supplies since initiation. Utilizing different supplies on these machines may lead to variation in processes and/or testing results. Consistency in all aspects of testing is paramount to USAISR’s research efforts and introducing variables, such as different consumables and reagents, may have a negative impact on research results. Based on past experience and the continual increases in samples submitted for hemostasis analysis, the purchase of these consumable reagents and supplies will be recurring; therefore, a sole source BPA to Diagnostica Stago, Inc. is the only reasonable route forward for the Government.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

6. Efforts to Obtain Competition: A Request for Information (RFI) was posted to the Government Point of Entry (GPE), SAM.gov, on 22 October 2024 for a period of five days. Diagnostica Stago, Inc. was the only respondent to the RFI. The requirement was synopsized to the GPE via a Notice of Intent to Sole Source (NOI) on 28 October 2024 for a period of 15 days. Only one qualified source, Diagnostica Stago, Inc., responded to this notice. Please reference Paragraph 8 of this document, for further discussion of market research.

7. Actions to Increase Competition: Based on the results of the market research and the known history of this requirement, no further actions have been taken to increase competition as Diagnostica Stago, Inc. is the only source available to provide these consumables. The USAISR will continually monitor market advances and offerings. In the event another vendor starts offering these supplies and they become FDA approved for use with the machines, the USAISR and USAMRAA will pursue the appropriate level(s) of competition. In addition, when the existing instruments (Stago STA R Max®) require replacement, USAISR will determine if acceptable substitutes exist which may alter future acquisition strategies for the items to be purchased under this BPA.

8. Market Research: The Contracting Office posted an RFI on SAM.gov, as discussed above in Section 6, and received one response from Diagnostica Stago, Inc. As a result, the Contracting Office posted a NOI to Diagnostica Stago, Inc. on SAM.gov on 28 October 2024. The only correspondence was from Diagnostica Stago, Inc. No additional market research was conducted, as Diagnostica Stago, Inc. is the only vendor that can provide these products.

9. Interested Sources: The notices required by FAR 5.201 have been published and the only correspondence received in response to the RFI nor the NOI was from Diagnostica Stago, Inc. In addition, this justification shall be posted to SAM.gov within 14 days after contract award in accordance with FAR 13.501(a)(1)(iii) and 6.305(a). In accordance with FAR 5.207(c)(16)(i), inquiries from any interested offerors would have been evaluated accordingly prior to issuance of the sole source contract.

10. Other Facts:

a. Procurement history.

(1) Contract numbers and dates of all awarded contracts for these same requirements.

W81XWH-12-A-0013, 30 September 2012 to 29 September 2013 W81XWH-15-A-0002, 13 October 2014 to 12 October 2017 W81XWH-17-A-0021, 13 October 2017 to 12 October 2022 W81XWH-20-A-0002, 02 March 2020 to 01 March 2025

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

(2) Competitive status of these actions.

All of the BPAs listed above were awarded on a sole source basis to Diagnostica Stago, Inc.

(3) Authority previously cited if less than full and open competition was used.

W81XWH-12-A-0013: The authority for this award is unknown, as the file is too old to have been placed in the Virtual Contracting Enterprise Paperless Contract File system and the sole source justification is unrecoverable.

W81XWH-15-A-0002: 10 USC 2304(c)(1), FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

W81XWH-17-A-0021: 41 USC 1901 as implemented in FAR 13.501(a)(1), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

W81XWH-20-A-0002: 41 USC 1901 as implemented in FAR 13.501(a)(1), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

The USAISR currently has two Stago STA R Max® hemostasis analyzers that were purchased in November 2018. These pieces of equipment support multiple research protocols examining hemostasis during injury. The Stago STA R Max® is FDA approved, but only with the use of the original manufacturer’s supplied consumables. These consumables are specific to the instruments and generic substitutions are not FDA validated nor will the manufacturer support the use of such supplies on the instruments.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

The circumstances of this requirement have not changed, as all prior acquisitions for these products have been made directly to Diagnostica Stago, Inc. using a sole source authority.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

There are no unusual patterns in the history of this requirement.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

As discussed above, Diagnostica Stago has been, and remains, the only source capable of providing the consumables and reagents required for the machines currently operating at the USAISR. When the existing instruments (Stago STA R Max®) require replacement, USAISR will determine if acceptable substitutes exist which may alter future acquisition strategies for the items to be purchased under this BPA.

b. Other facts. Not applicable.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

Approval

Based on the foregoing justification, I hereby approve the procurement of Diagnostica Stago consumable supplies for a total of on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature:

Typed Nam