JA_ASP_Sterrad_Signed_1.doc_rev.pdf

NAVAL MEDICAL RESEARCH UNIT SAN ANTONIO

Page 1 FY'25

JUSTIFICATION & APPROVAL FOR USE OF OTHER THAN FULL & OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a "Justification for other than full and open competition."

This Justification and Approval (J&A) is executed by Naval Medical Research Command (NMRC), 503

Robert Grant Avenue, Silver Spring, MD 20910, on behalf of the requesting agency, Naval Medical

Research Unit San Antonio (NAMRU SA), 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX 78234.

2. Nature and/or description of the action being approved.

Award of a contract on a sole source basis will be made to provide a Maintenance and Service contract to

Advanced Sterilization Products (ASP) for the maintenance of one (I) STERRAD NX (SN: 4033170097, ECN: l 0281 l) for a base period of 12-months, with three (3) twelve-month option periods for a total of 48 months. The proposed source is:

Advanced Sterilization Products Services, Inc.

33 Technology Drive

Irvine, CA 92618

3. A description of the supplies or services required to meet the agency's needs (including the estimated value).

The requirement is for a sole source fixed price maintenance contract to cover maintenance and repairs of existing NAM RU SA equipment. The manufacturer warranty has expired for all the equipment previously mentioned. The current maintenance contract N32398-2 l-P-0727 expires 19-Sep-2025. The period of performance for this contract is anticipated to be a base period of 12 months followed by three (3) 12-month option period(s) for a total of 48 months. NAM RU SA Advanced Sterilization Products equipment require annual maintenance provided only by the manufacturer. Due to calibrations and the sensitivity of the

Advanced Sterilization Products equipment, Advanced Sterilization Products is the only vendor capable of servicing and repairing the equipment. All possible repairs that may occur will need to be addressed and fixed by an Advanced Sterilization Products technician. NAM RU SA contract will be for a total value of

$XXXX. This includes$ l 0,078.00 for the base period, then $XXXX for each subsequent option period one and two, three.

Estimated Dollar Value

The estimated value of this contract is $XXXX for the 12-month base period, followed by three additional

Option Years (OY) as follows: OY-1 $XXXX, OY-2 $XXXX, OY-3 $XXXX. The total estimated value is

$XXXX.

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C.

2304(c) (I) as implemented by FAR 13.106-1(b); only one responsible source and no other supplies or services will satisfy agency requirements.

Page 2 FY'25

5. A demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited.

Advanced Sterilization Products STERR.A NX sterilizing machines require annual maintenance provided only by the manufacturer, Advanced Sterilization Products. Due to calibrations and the sensitivity of the

STERR.AD NX, Advanced Sterilization Products is the only vendor capable of servicing and repairing the equipment (see sole source letter is included).

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

Market research was performed, the results of which arc in paragraph 8. This requirement will be posted to

FedBizOpps in accordance with FAR 5.202. No other known sources have expressed an interest, and no other source is expected to express interest in this effort.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer will perform a cost and price analysis to determine that the anticipated quotes received by the Government for the services cover by this J&A will be within fair market value and reasonable. Fair and reasonable pricing has been determined by researching FPDS-NG for the same or similar items. In addition, the market research showed that no other vendor could provide a quote to validate that they could provide the services required by the ASP STERR.AD NX.

8. A description of the market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted.

Market research was conducted by technical experts in the August 2024 timeframe. This research consisted of reviews of previous procurements for these types of patient monitoring systems and a market survey through search engines of open market contractors and Federal Supply Schedule contractors.

On 14 AUG 2024 Advanced Sterilization Products was contacted and offered details on service contract and quote was received, plus a sole-source letter on 23 AUG 2024. The quoted pricing for four years of the ALL-

Clear maintenance agreement is $XXXX (base year cost=$XXXX, option year I = $XXXX option year 2 =

$XXXX, option year 3 = $XXXX).

On 8 and 13 AUG 2024, outreach emails were sent to three vendors, Insight Biomedical, Biomedical Repair

Service of Texas and Washer Solutions. On 8 AUG 2024, Insight Biomedical responded stating that they do not work on the STERR.AD NX. On 13 AUG 2024, Biomedical Repair Services of Texas and Washer

Solutions responded stating that they do not work on the STERR.AD NX.

9. Any other facts supporting the use of other than full and open competition.

The requirement is for a maintenance contract to cover maintenance and repairs of existing NAMRU SA equipment. The maintenance is for one (I) STERR.AD NX.

FY '25 Page 3

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

A. Three vendors were contacted by (email, phone, and/or website) to obtain a quote for (their respective service); Advanced Sterilization Products, Insight Biomedical, Biomedical Repair Services of Texas and

Washer Solutions. Only Advanced Sterilization Products were able to provide a quote.

1. Advanced Sterilization Products

2. Insight Biomedical Solutions

3. Biomedical Repair Services of Texas

4. Washer Solutions

B. Standard business provisions and conditions:

Special delivery instructions. Vendor must have access to PlEE/WAWF for NAMRU SA to make payment for service/product.

C. Range of prices encountered and rationale for variance:

1. Advance Sterilization Products can perform the services and provide the original manufacturer parts that satisfy our Government requirement. The quote for pricing for four years of the maintenance agreement is $XXXX (base year cost= $XXXX, option year I = $XXXX, option year 2 =

$XXXX, option year 3 = XXXX heather Summer, Phone:, Email: heather.summer@asp.com.

2. Insight Biomedical Solutions did not provide a quote. Quote requested online. POC: Gregory

Gordon, Phone: 210-378-7838: Email: ggordon@insightbiomed.com.

3. Biomedical Repair Services of Texas did not provide a quote. Quote requested online. POC: Mark

Brandon, Phone: 210-654-1200, Email: mark@texasmedicalrepairs.com.

4. Washer Solutions did not provide a quote. Quote was requested online. POC: Marcus Fields, Phone:

J-800-262-1731, Email: marcus.fields@washersolutions.com.

D. Description of how data was analyzed: Initial research and identification of potential vendors was conducted using the internet. Chosen vendors were then contacted via email and/or telephone and given the information they would need to provide a quote.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

12. Point Of Contact.

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification are the Contracting Officers in the Material Management Department (MMD) and can be reached by emailing usn.detrick.nmrc.mbx.mmd-contracts@health.mil.

mailto:heather.summer@asp.com mailto:ggordon@insightbiomed.com mailto:mark@texasmedicalrepairs.com mailto:marcus.fields@washersolutions.com mailto:canbereachedbyemailingusn.detrick.nmrc.mbx.mmd-contracts@health.mil

Page 4 FY'25 l certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein, are complete and accurate to the best of my knowledge and belief.

Technical Cognizance DI9,lally signed by

DIXON.BENJAMIN.C DIXON BENJAMIN CHARLES 125

HARLES.1254786892 �:1:8;i

MAJ Ben Dixon

Director, Re earch Service

250213 14 47 24 .oo·oo 2/13/25

Date

Naval Medical Research Unit San Antonio

Requirements Cognizance

2 (;A-f 12 2.,y

Commanding Officer

Naval Medical Research Unit San Antonio

LEGAL SUFFICIENCY REVrEW AND CONCURRENCE

I have determined thi Ju tification is legally sufficient.

Office of Counsel Date

CONTRACTING OFFlCERS CERTIFICATION

I certify that this Justification is accurate and complete to the best. of my knowledge and belief. The

Contracting Officer's signature below also represents approval of the J&A.

DANIELS.TIMOTHY Digitallysignedby

DANIELS.TIMOTHY.A.1092817713

.A.1092817713 Date: 2025.04.2909:04:02-04'00'

Contracting Officer

Naval Medical Research 'ommand

Michael . Tiller, CAPT,