Justification_and_Approval_Redacted.pdf

(Temperature Sensitive Monitoring Product System)

CUI//SP-PROCURE

SOURCE SELECTION INFORMATION (See FAR 2.101 and 3.104-4)

Page 1 of 5 (19 April 2022)

24-RHCO-A-128

Sole Sources Justification and Approval Under FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office – East (MRCO-E), Belvoir Health Contracting Branch, 9275 Doerr Road, Building 1221, Fort Belvoir, VA 22060-5505

2. Description of Action: This requirement is for a new Firm-Fixed-Priced contract for

Temperature Sensitive Medical Product (TSMP) Monitoring System Maintenance on Government Owned equipment, to include preventive maintenance, repair, and system software support/upgrades for Defense Health Agency (DHA) Military Treatment Facility, Blanchfield Army Community Hospital, Fort Campbell, KY and will be funded using Defense Health Agency (DHA) funding.

3. Description of Supplies/Services: This requirement is for preventive maintenance, repair, validation/calibration, hardware, and system software support/upgrades for the Government-owned TSMP Monitoring Systems located at Fort Campbell KY, Rock Island Arsenal IL, and Fort McCoy Wi. The system was procured in July 2023 and the warranty will expire 28 July 2024. Rees TSMP Monitoring Systems components requires preventive maintenance and software updates for System uptime functionality. The estimated price for this contract is for a 12-month base and four 12-month option years. FAR 52.217-8, Option to Extend Services will be included in the contract. The total value of the requirement inclusive of the -8 is

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: Rees Scientific Inc. is the sole manufacturer authorized to perform services for its TSMP Monitoring Systems. Rees Scientific is the only source available for maintenance of its products and software. It is the only TSMP Monitoring System that meets all DoD/DHA Information Cybersecurity requirements to include active DHA eMASS ID and Risk Management Framework (RMF) approval and Ability to Operate (ATO) certification for use on DHA Information Management Network.

The required maintenance is cost effective and ensures the TSMP system in place is fully operational and a maintenance agreement for a base and four option years will ensure operability during the duration of the systems anticipated life cycle. In the event that the TSMP system becomes inoperable because of the lack of a maintenance agreement, it would cost the Government considerably more to procure a new system than to have the TSMP on site repaired.

Controlled by: USAHCA

SOURCE SELECTION INFORMATION (See FAR 2.101 and 3.104-4)

Page 2 of 5 (19 April 2022)

CUI Category: SP-PROCURE Limited Dissemination Control: FEDCON POC: Justin C Balster Telephone: 757-869-5995 Email: justin.balster2.civ@health.mil

6. Efforts to Obtain Competition. Based on the proprietary nature of the supplies and services, it is not possible to compete the current acquisition due to DoD/DHA Information Management Cybersecurity requirements for medical devices being placed on the network. Rees Scientific is the sole source manufacturer and distributor of the system, software, and components. There are no other authorized vendors, distributors, or installers for the system. The government will continue to monitor the market for future competitive options and this justification will be posted to SAM.gov as part of the continued market research.

a. Effective competition. There is no effective competition expected for this requirement. Rees Scientific is the sole manufacturer and provider to the TSMP system.

b. Subcontracting competition. In accordance with FAR 19.702(a)(1)(i) a subcontracting plan is not required since this acquisition is expected to be less than $750,000.00 in total value. Additionally, historical research shows no subcontracting possibilities exist concerning TSMP maintenance.

7. Actions to Increase Competition: There will be no further action taken on this requirement to increase competition as the system and maintenance services are proprietary to Rees Scientific Inc. Market research will be performed throughout the life of the contract to identify potential offerors for future requirements.

8. Market Research: Market Research was conducted in accordance with FAR Part 10 to identify all qualified sources. Research consisted of direct vendor contact, online searches utilizing multiple venues (GSA Advantage, SAM.gov), and review of prior contracts for the same or like products. All searches revealed that there are no vendors that offer this maintenance. Additionally, Rees Scientific Corporation is the sole source vendor for the manufacture, sale and service of software and hardware for the TSMP system. There are no third-party vendors approved or trained to provide services on Rees Scientific monitoring systems. A sole source letter is filed in the Paperless Contract File (PCF) along-side this justification.

9. Interested Sources: To date, no other sources have written to express an interest in this requirement, in writing or otherwise.

10. Other Facts:

a. Procurement history.

SOURCE SELECTION INFORMATION (See FAR 2.101 and 3.104-4)

Page 3 of 5 (19 April 2022)

(1) Previous Contract or Purchase Order Number:

a) GS-07F-248AA, Delivery Order W91YTZ23F0047, Delivery Date 1 February 2023.

The competitive status of these actions: The previous contract was awarded on a sole source basis for the TSMP equipment installation. At the time of award, Rees Scientific was the only vendor that provided a TSMP Monitoring System that met all DoD/DHA Information Security Requirements for net worthiness.

(1) Authority previously cited if less than full and open competition was used: 10

U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

(2) 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. Blanchfield Army Community Hospital operates the previous TSMP Monitoring Equipment procured under delivery order W91YTZ23F0047. There are no significant changes in the market and technology since that time.

(3) 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

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

(5) 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. N/A

b. Other facts. All Temperature Sensitive Medical Product (TSMP) must be continuously monitored to ensure that storage ranges are between 2-8 Degrees Celsius IAW Food and Drug Administration, Manufacturer, and DHA AI 4140.01, TSMP Management Program. The MTF’s existing TSMP Monitoring System was identified in a 27 May 22 ICS Advisory by the U.S. Industrial Control Systems Cyber Emergency Response Team (ICSCERT) as having Cybersecurity Violations which make the system not in compliance with Privacy Act of 1975 and Healthcare Information Portability and Accounting Act of 1996.

Without purchase of compliant TSMP Monitoring System Maintenance, over $1M in TSMP is at risk of loss. This TSMP is used in the direct medical care and readiness services for over 65,000 Active-Duty Soldiers and 200,000 beneficiaries in supporting the 101st Airborne Division’s various National Defense missions stateside and abroad.

SOURCE SELECTION INFORMATION (See FAR 2.101 and 3.104-4)

Page 4 of 5 (19 April 2022)

CUI//SP-PROCURE

24-RHCO-A-128

TSMP Monitoring System must be immediately available upon expiration of Rees Scientific Inc. TSMP Monitoring System warranty on 28 July 2024 and must guarantee at least 98% uptime to sustain medical mission.

The government will continue to monitor the marketplace for any future competition.

Once the equipment currently in use has reached the end of its life cycle, the marketplace will be surveyed to determine if there are any other sources which can provide the equipment and services to satisfy the Government’s requirement.

11. 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: Date:

Title: Equipment Specialist Signature:

12. 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: Date:

Title: Equipment Specialist Signature:

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will