A.02 Sole Source JA - TEEClean.docxkoREDACTED.pdf

Control Number: 24-RHCO-A-260

RFQ#: W91YTZ24Q0109

CUI//SP-PROCURE

Source Selection Information – See FAR 2.101 and 3.104-4

Sole Source Justification For Acquisitions under the Simplified Acquisition Threshold (Currently $250K)

1. Contracting Activity:

Medical Readiness Contracting Office-East (MRCO-E) Fort Liberty Health Contracting Branch 9275 Doerr Road, Building 1221 Fort Belvoir, VA 22060

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _DHP________ Total Dollar Value: XXXX

Name of Intended Contractor: CS MEDICAL, LLC Street Address: 2179 E Lyon Station Rd City, State, Zip: Creedmoor, NC 27522

Phone: 919-255-9472 Delivery Date:

3. Description of Supplies/Services: Trans-esophageal Echocardiogram Transducer Washer and Disinfector Clean System TCD-100S8 Unit with accessories to include printer, neutralizing station, electrical leak tester, and mounting brackets. Full web based in-service training is included with a fifty-user license.

4. Authority Cited:

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

Controlled by: USAHCA CUI Category: SP-PROCURE Limited Dissemination Control: FEDCON

POC: Cynthia Richardson, cynthia.a.richardson-rhone.civ@health.mil

(d) FAR 8.405-6(a)(1)(i)(B): Only one brand can provide the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; OR

(e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.

5. Reason for Authority Cited: The Womack Army Medical Center has a requirement for Trans-esophageal Echocardiogram Transducer Washer and Disinfector Clean System (TEEClean). The TEEClean System provides both manufacturer-recommended cleaning and high-level disinfection of soiled TEE (Transesophageal Echocardiography) transducers in a single device. The TEEClean System will be installed in the Womack Army Medical Center Cardiac Catheter Lab within the soiled utility room. CS Medical LLC, is the sole source manufacturer and distributor of the system in accordance with the letter dated 8 July 2024. Currently, manual cleaning is required to achieve proper high-level disinfection. The TEEClean System streamlines this process by allowing healthcare professionals to simply place a bedside-cleaned transesophageal echocardiography transducer into the device, eliminating the risk of inadequately disinfected units. Improperly cleaned and high-level disinfected transesophageal echocardiography transducers could cause bacteremia and may lead to morbid infection such as endocarditis. Properly high-level disinfected probes can significantly reduce the incidence of post-transesophageal echocardiography infections. TEEClean is the first FDA-cleared product of its kind to not only automate the disinfection process, but the cleaning process for TEE ultrasound probes. If this system is not purchased, staff will continue with manual cleaning and high-level disinfection will not be achieved. This will increase workload in the clinic and cause risk of patient injury. CS Medical, LLC, the manufacturer and distributer has proprietary procedures and records and any unauthorized service performed without the consent of CS Medical, LLC will result in voiding of any warranty.

6. Actions to Increase Competition: There is no effective competition expected for this requirement, the supplier is the only one that carries the product. CS Medical LLC is the sole manufacturer and distributor of TEEClean Automated Cleaner Disinfector for TEE probes, its filters, and components. However, the solicitation will be posted to www.SAM.gov to increase future competition.

7. Market Survey: Market Research conducted in accordance with FAR Part 10. I researched by using the General NAICS code 339112 and found small business contractors having the capability to provide the equipment although when NAICS and Keywords were searched No results were found.

On 21 June 2024 an on-line search was conducted on the Small Business Administration (SBA) Quick Market Research, and nothing was revealed using the words ‘TEEClean Disinfector

Results of the search using the key word: ‘TEEClean Disinfector.”

Economic Group Number of Firms Found Service-Disabled Veteran 0 Currently SDB Certified 0 Currently HUBZone Certified 0 Currently 8(a) Certified 0 Woman or Women Owned 0 Veteran 0 https://www.csmedicalllc.com/news/does-fda-clearance-matter?trk=article-ssr-frontend-pulse_little-text-block https://www.csmedicalllc.com/news/does-fda-clearance-matter?trk=article-ssr-frontend-pulse_little-text-block

Results of the search using the NAICS code 339112 and Keywords “TEEClean Disinfector”:

Economic Group Number of Firms Found Service-Disabled Veteran 0 Currently SDB Certified 0 Currently HUBZone Certified 0 Currently 8(a) Certified 0 Woman or Women Owned 0 Veteran 0

The items are not available on the General Schedule Administration (GSA) contract schedule.

8. Procurement History:

Previous Contract or Purchase Order Number: or UNKNOWN Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: N/A

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this mini-J&A are accurate and complete to the best of my knowledge and belief.

I certify the required product/services are not available using mandatory sources, and delivery cannot be made by the required delivery date.

Submitted By: Kimberly A. Maynard Position Title: CNOIC – Cardiology Clinic

Email address: Kimberly.a.maynard9.civ@health.mil Date: 1 May 2024

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. I have determined that the anticipated cost to the Government for this contract action will be fair and reasonable. Fair and Reasonable determination will be based on historical prices and the Independent Government Estimate. Certified cost or pricing data is not required per FAR 15.403-1(b) (3), because the items are commercial in nature.

Signature:

Typed Name: Donna L. Blossom Position Title: Contracting Officer

Email address:

Date:

mailto:Kimberly.a.maynard9.civ@health.mil