J and A SAP 13.5 Sterilization IDIQ final redacted_Redacted.pdf

CUI

Control Number: FY25-0168

Controlled by: Defense Health Agency (DHA) Controlled by: HCD-W CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON POC: Shannon.lacom2.civ@health.mil

Source Selection Information - See FAR 2.101 and 3.104-4

1 NOV 2024

Justification and Approval (J&A) Modified for Federal Acquisition Regulation (FAR) 13.501

1. Identification of the Agency and Contracting Activity: This justification for an exception to fair opportunity is executed by the Defense Health Agency (DHA), DHA Contracting Activity (DHACA), Healthcare Contracting Division – West (HCD-W) on behalf of Military Treatment Facilities (MTFs) throughout Japan.

2. Nature and/or Description of Action being Approved: Firm Fixed Price, Single Award, Indefinite Delivery/Indefinite Quantity (IDIQ) Contract. This is an individual J&A Modified for

FAR 13.501.

This is a sole-source award to Konoike, Inc. for an IDIQ contract to provide complete instrument sterilization services, including receipt, processing, and return of all government-owned instrument sets, fully sterilized and ready for immediate use. The contract will cover services tailored to the specific needs of each MTF, ranging from daily service for hospitals to weekly service for smaller clinics, as detailed in the Performance Work Statement (PWS).

3. Description of Supplies/Services: This acquisition covers complete sterile processing services for government-owned dental, medical, and surgical instrument sets at various hospitals and clinics in Japan. Services include receipt, handling, transportation to/from the sterile processing facility, sterilization, packaging, quality assurance (including functional testing during assembly), and sterile delivery. All processing will adhere to Association for the Advancement of Medical Instrumentation (AAMI) standards and/or manufacturer’s Instructions for Use (IFU).

Specific task orders will detail instrument quantities/types, locations, and deadlines.

Vendor Information:

Konoike Medical Co, Ltd.

6-4, Yuraku-Cho 1-Chome Chiyoda-Ku, Tokyo 100-0006, Japan

Control Number:

Source Selection Information - See FAR 2.101 and 3.104-4

3 NOV 2024

6. Efforts to Obtain Competition: The Government published a notice to Contract Opportunities on 31 Mar 2025 under notice number HT941025N0070. The notice closed on 3 Apr 25 at 4 PM.

The government did not receive any capabilities statements. The prior purchase order HT941025P0149, a sole source to Konoike, published a notice of intent to sole source under notice HT941024N0041 from 22 Mar 24 through 30 Mar 24. The government did not receive any responses.

The contract specialist submitted an inquiry to the Healthcare Sterile Processing Association (HSPA) on 3 April 2025. The Healthcare Sterile Processing Association (HSPA) is the recognized expert professional organization for medical tool sterilization. HSPA collaborates with organizations like the CDC and FDA to develop and disseminate best practices for sterile processing. HSPA administers the only nationally recognized certifications for sterile processing professionals - CSP, CIS, and CSDS. HSPA provides training materials, publications, and conferences focused on sterile processing techniques and regulations. Unlike broader healthcare associations, HSPA’s sole focus is sterile processing, allowing for specialized expertise and resource development. These factors position HSPA as a primary source of information and professional development within the field of healthcare sterile processing. The HSPA maintains a list of vendors both inside the United States and Internationally. The HSPA did not have any recommended sources in Japan.

The suggested vendor performed satisfactorily on HT941024P0149 and demonstrated they have the knowledge, facilities and skill set to satisfy this performance work statement. They are uniquely positioned to provide the sterilization transportation and service in a timely manner.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: Despite continuous market research and ongoing posting of notices to Contract Opportunities since 2021, the Government is currently unaware of any other similarly situated company capable of meeting these unique requirements. If other sources become known to the Government for future procurements, a competitive procurement will be considered.

8. Market Research: Market research was conducted for each procurement starting in June 2021 for various purchase orders for this type of service and again in March 2025. Mandatory sources are not capable of providing support. Despite continuous market research and ongoing posting of sole source notices to Contract Opportunities since 2021, the Government is currently unaware of any other similarly situated company capable of meeting these unique requirements.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? Yes. This is considered a new requirement because the procurement will be a three-year single award, pre-priced IDIQ. Previous procurements were short term purchase orders.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

4 NOV 2024

(2) If 9.a.(1) is No, was the action just prior to this one competed? Previous small purchase orders were awarded using sole source procedures under FAR 13.106-1(b).

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed: Not applicable

b. Additional Information: None.

10. Interested Sources: As discussed in paragraphs 6-8 the government is unable to locate any additional sources.

11. Technical Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

5/30/25 LCDR Kelsey Gurney SPD Division Officer United States Naval Hospital (USNH) Yokosuka

12. Requirements Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

5/29/25 Yoko Miike NMRTC (Navy Medicine Readiness & Training Command) Yokosuka Materials Management Department

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

5 NOV 2024

13. Fair and Reasonable Cost Determination: This procurement will utilize simplified acquisition procedures under FAR Subpart 13.5. The services are commercially available and have been previously procured, which establishes current and historical information that will be used as a basis for fair and reasonableness. Certified cost or pricing data will not be required in accordance with FAR 15.403-1(b)(3).

I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

5/30/25 Marcela Cervantes Contracting Officer Healthcare Contracting Division – West (HCD-W) DHA Contracting Activity (DHACA)

14. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

5/30/25 Jillian C. Kaido Attorney, Office of General Counsel Contract Law MTF Support Branch Defense Health Agency

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

6/2/25 Marcela Cervantes Contracting Officer Healthcare Contracting Division – West (HCD-W) DHA Contracting Activity (DHACA)

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

6 NOV 2024

Approval Based on the foregoing justification, I hereby approve the procurement of medical tool sterilization services as a single award IDIQ Contract on a sole source basis pursuant to the authority of 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items), subject to availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

6/4/25 Kelly L. Sherman Competition Advocate for Healthcare Operations DHA Contracting Activity (DHACA)