Limited Source Justification GeneXpert Maintenance.pdf

CUI//SP-SSEL

Control Number: 23-

Purchase Request Number: 0

Solicitation Number: W91YTZ-23-Q-0008

(Source Selection Information - See FAR 2.101 and 3.104-4)

CUI//SP-SSE

JUSTIFICATION REVIEW DOCUMENT

SOLE SOURCE JUSTIFICATION

Under FAR 13.106

Program/Equipment: Annual contract to provide maintenance and support for the GeneXpert PCR Testing Equipment at Martin Army Community Hospital, Fort Benning, GA 31905

Authority: FAR 13.106-1(b) (1). For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g. urgency, exclusive licensing agreements, brand name, or industrial mobilization).

Amount: Base Year = $49,590.00, Estimated Total (Base + 4 years) = $207,950.00.

Prepared by: Lisa D. Branch

Contract Specialist Email: lisa.d.branch.civ@health.mil

Contracting Officer: Francine Brown Contracting Officer Email: Francine.brown.civ@health.mil

Technical: Punnavit Puckpibul Healthcare Technology Management Chief Email: punnavit.d.puckpibul.mil@health.mil

Requirements: Roylon K. Allen HTM Sustainment Manager Email: roylon.k.allen.civ@health.mil

Reviews: I have reviewed this justification and find it adequate to support limiting competition.

FRANCINE BROWN

Contracting Officer Gordon Health Contracting Branch mailto:lisa.d.branch.civ@health.mil mailto:Francine.brown.civ@health.mil mailto:punnavit.d.puckpibul.mil@health.mil mailto:roylon.k.allen.civ@health.mil

Purchase Request Number: 00

Solicitation Number: W91YTZ-23-Q-0008

SOLE SOURCE JUSTIFICATION UNDER FAR PART 13.106

1. Contracting Activity: Medical Readiness Contracting Office-East (MRCO-E) Gordon Health Contracting Branch (GHCB) Building 332, 43 Central Hospital Court Fort Gordon, GA 30905

2. Description of Action: Annual contract to provide maintenance and support for the GeneXpert PCR Testing Equipment at Martin Army Community Hospital, Fort Benning, GA 31905. Projected award is August 1, 2023, and fiscal year 2023, Funds Type: DHP

PR#0011791276-0003

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)

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

3. Description of Supplies/Services: Base plus four years contract to provide maintenance and support for the GeneXpert PCR Testing Equipment at Martin Army Community Hospital, Fort Benning, GA 31905.

Estimated Period of Performance Base Period: 1 Aug 2023 to 31 Jul 2024 Value: $ 49,590.00 Period 1: 1 Aug 2024 to 31 Jul 2025 Value: $ 39,590.00 Option Period 2: 1 Aug 2025 to 31 Jul 2026 Value: $ 39,590.00 Option Period 3: 1 Aug 2026 to 31 Jul 2027 Value: $ 39,590.00 Option Period 4: 1 Aug 2027 to 31 Jul 2028 Value: $ 39,590.00 Option

Total: $207,950.00

Controlled by: USAHCA CUI Category: SP-SSEL Limited Dissemination Control: FED ONLY POC: Francine Brown (706)787-2376

Purchase Request Number: 00

Solicitation Number: W91YTZ-23-Q-0008

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

5. Reason for Authority Cited:

Cepheid US, as the original equipment manufacturer (OEM), is the only provider authorized to furnish the technical support and expertise required for maintenance (including preventive maintenance) of the Cepheid US equipment.

Cepheid is currently the only authorized provider of service for GeneXpert systems to customers within the United States, excluding territories. A copy of the proprietary letter dated _15 November 2022_is included in the PCF cabinet in folder _A02 .

6. Efforts to Obtain Competition: A Notice of Intent to award a sole source contract to Cepheid US (a large business) will be posted to SAM.gov in accordance with FAR Parts

5.2. All interested small businesses able and interested in submitting a quote will be considered for future requirements.

7. Actions to Increase Competition: Cepheid US is the OEM. No further action will be taken to increase competition. Synopsis not required IAW FAR 5.202 exception (a)(13).

8. Market Research: Market Research was conducted in accordance with FAR Part 10.

The search revealed that there is no small businesses that provide the service and support of the equipment. Market research was conducted to determine if other vendors are capable of providing this service. Market research revealed that Cepheid US is the Original Equipment Manufacturer with proprietary service information and its parts are certified and/or verified as compliant with the equipment currently in place at Martin Army Community Hospital, Fort Benning, GA. Research results indicate that other companies do not have the capability or permissions to provide maintenance and support for the GeneXpert PCR Testing Equipment.

9. Other Facts: Several MTF’s have procured the PCR Testing Equipment and the requirement for maintenance of this equipment is new. All of the maintenance agreements are with Cepheid US and are sole source procurements. One such contract within Medical Readiness Contracting Office-East (MRCO-E) is listed below.

a. Procurement history.

(1) W91YTZ22P0113 awarded on 8/31/2022 to Cepheid US. Award Amount:

$37,450.00 Annually.

(2) The competitive status of these actions. Sole Source

Purchase Request Number: 0

Solicitation Number: W91YTZ-23-Q-0008

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

Unsure, could not locate a copy of the J&A.

(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. See paragraph 3 above

(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. N/A

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. None

(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. None

b. Other facts.

If not approved, Martin Army Community Hospital will not have the capability to provide immediate laboratory PCR Testing. This will negatively affect clinician’s abilities to provide immediate clinical diagnosis and treatment for patients who may have Covid. Patient specimens will be sent to reference laboratories at an increase cost and delay to the government. Patient care will be negatively impacted.

Purchase Request Number: 0

Solicitation Number: W91YTZ-23-Q-0008

10. 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.

Typed Name: Punnavit Puckpibul Title: Healthcare Technology Management Chief Date: 24 Jan 2023 Signature:

Purchase Request Number: 00

Solicitation Number: W91YTZ-23-Q-0008

11. 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.

Typed Name: Roylon K. Allen Title: HTM Sustainment Manager Date: 24 Jan 2023

Signature:

Purchase Request Number: 0

Solicitation Number: W91YTZ-23-Q-0008

12. 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 13.106-1(b) (1). Additionally, I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

In accordance with FAR 13.106-3(a), the proposed price is determined to be fair and reasonable based on the Comparison of proposed price with prices found reasonable on previous purchases for same/similar items.

This determination will be made using the following: price analysis IGCE other: identify the methodology or combination of methodologies that will be used.

Certified cost or pricing data is not required per FAR 15.403-1(b)(3).

Typed Name: Francine Brown Date:

Title: Contracting Officer Signature:

Purchase Request Number: 0

Solicitation Number: W91YTZ-23-Q-0008

Purchase Request Number:

Solicitation Number: W91YTZ-23-Q-0008

Approval

Based on the foregoing justification, I hereby approve the procurement of the GeneXpert PCR Testing Equipment Maintenance Agreement under FAR 13.106-1(b)(1). In the interest of economy and efficiency, the new service is a logical follow-on to an original order provided that the original order was placed in accordance with applicable ordering procedures and provided that the service herein described have otherwise been authorized for acquisition. The original order purchased the equipment which provided one year maintenance and support.

FRANCINE BROWN

Contracting Officer Gordon Health Contracting Branch