A.02 Sole Source Mini JA-W91YTZ23Q0124 JA APPROVED -revised amount_Redacted.pdf

CUI//SP-PROCURE

Control Number: 23-RHCO-A-401

RFQ/RFP #: W91YTZ23Q0124

Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold

(Simplified Acquisition Threshold is $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: DHA - Total Dollar Value:

Name of Intended Contractor: Biolase, Inc Street Address: 27042 Towne Centre Dr Ste 270 City, State, Zip: Foothill Ranch, CA 92610

Phone: 1-833-246-5273

Delivery Date: 30 days after contract award.

3. Description of Supplies/Services: This requirement is a supply buy to purchase one each Waterlase Express Endodontic Laser and Cart. The device will be used in the Womack Army Medical Center, Dental Clinic.

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

Controlled by: USAHCA CUI Category: SP-PROCURE Limited Dissemination Control: FED ONLY POC: Cynthia A. Richardson-Rhone

(910) 907-9310 Cynthia.a.richardson-rhone.civ@health.mil

RFQ/RFP #: W91YTZ23Q0124

(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

(d) FAR 8.405-6(a)(1)(i)(B): Only one source is capable of providing 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: Womack Army Medical Center, Fort Liberty, NC has a requirement for one each Waterlase Express Endodontic Laser and Cart. Biolase, Inc.is the sole manufacturer and distributor of the Waterlase iPlus Laser in the USA as indicated in the proprietary letter dated 1 May 2023 and uploaded into PCF A.02. According to the letter, there are no other item available for purchase that utilizes the proprietary wavelength that would serve the same purpose or function.

There are no authorized third-party distributors or competitors since this product is proprietary. There are no authorized third-party distributors or competitors since this product is proprietary and the requested item is precluded by the existence of a patent, copyright, secret process, or monopoly.

This is the only unit on the market of this wavelength and wattage, which is necessary for our endodontic applications (including soft and hard tissue removal). Requested equipment allows a more safe, efficient, and effective disinfection of the root canal system during endodontic treatment.

Additionally, the laser will be used to further enhance the educational residency training program and increase the level of Soldier patient care; allow more procedures to be done due to increasing the efficiency of root canal treatment, and to be done more safely by reducing some blade and bur tissue removal. If the dental laser is not approved, the Dental Clinic cannot meet their mission of servicing Soldiers and their families.

6. Actions to Increase Competition: Biolase Inc. is the only manufacturer of this equipment, and they sell directly to consumer only. However, this action will be posted to SAM.gov to increase competition.

7. Market Survey: Market Research was conducted on 12 June 2023 in accordance with FAR Part

10. A search of the Small Business Administration (SBA) Quick Market Research website for NAICS Code 339114 (Dental Equipment and Supplies Manufacturing), and key words “Biolase Endodontic Laser” showed the following results:

Search using NAICS and Keywords “Biolase Endodontic Laser”

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

RFQ/RFP #: W91YTZ23Q0124

Search using NAICS 339114

8. Procurement History:

Previous Contract or Purchase Order Number: or N/A 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, but delivery cannot be made by the required delivery date.

Submitted By: Steven Delgado, DDS Position Title: OIC and Program Director, Endodontic Residency, Email address: Steven.p.delgado3.mil@mail.mil

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name: MICHAEL J. MCCOLLUM Position Title: Contracting Officer

Email address: Michael.j.mccollum12.civ@health.mil

Woman or Women Owned 0 Veteran 0

Economic Group Number of Firms Found Service-Disabled Veteran 245 Currently SDB Certified 1 Currently HUBZone Certified 45 Currently 8(a) Certified 33 Woman or Women Owned 206 Veteran 293

MCCOLLUM.MICHAE

L.JAMES.1287594409

Digitally signed by

MCCOLLUM.MICHAEL JAMES.12875

94409 Date: 2023.08.07 14:01:38 -04'00'