Justification and Approval (JA) NHP Off-site Sterilization Service CO signed Final REDACTED.pdf

Control Number: FY26-0816

Controlled by: Defense Health Agency (DHA) Controlled by: HCD-S CUI Category: Source Selection Limited Dissemination Control: FED Only POC: Marcus H. Mattingly

1 OCT 2024

Justification and Approval (J&A) for Other than Full and Open Competition Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) Parts 6 and 12

Implemented by Class Deviation 2026-O0017, Revision 1

1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA), DHA Contracting Activity (DHACA), Healthcare Contracting Division (HCD) - South

2. Nature and/or Description of Action being Approved: This Justification and Approval is to establish a new base (~2 months) plus three (3) one year options, firm-fixed price contract, with Steris Corporation (Cage:0NWN1) to provide off-site sterilization and maintenance of surgical medical instruments in support of the Naval Hospital Pensacola (NHP), Sterile Processing Department (SPD).

3. Description of Supplies/Services and Estimated Value: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision to provide sterilization, tracking, pick-up, and delivery for with a 72 hour turnaround for approximately 150 medical surgical instrumentation trays and peel packs per week in accordance with the Performance Work Statement (PWS).

Period Period of Performance Estimated Value Type of Funding Base Period 9/15/26 – 09/30/26 O&M Option Period 1 10/01/26 – 09/30/27 O&M Option Period 2 10/01/27 – 09/30/28 O&M Option Period 3 10/01/28 – 09/30/29 O&M Option Period 4 N/A

FAR 52.217-8 N/A

Total

4. Statutory Authority Permitting Other Than Full and Open Competition: 41 USC 1901

5. Rationale Justifying Use of Authority Cited: Naval Hospital Pensacola requests the use of a single source justification IAW 12.102 to procure off-site sterilization and maintenance of surgical medical instruments to STERIS Corporation. These are commercial services that are

OCT 2024

common in the marketplace; however, STERIS is the only company that can meet the Government’s requirement.

Naval Hospital Pensacola’s (NHP) Sterile Processing Department (SPD) has not been operational due to deficient water quality. In order to support NHP operating rooms, off-site sterilization processing is required. The Government’s requirement is for sterilization processing and logistics service of 150 trays, on a weekly basis, with an approximate 72-hour turnover time.

STERIS is the only company that can meet this time requirement with the personnel, vehicles, equipment, tools, materials, and processing facility to provide off-site sterile processing and instrument maintenance.

6. Efforts to Obtain Competition: Efforts to obtain competition was accomplished for this action by utilizing commercial and Government databases to locate sources of sterilization services that would support the need of the Government as follows:

a. UNICOR: a search of potential sources under the FPI Schedule of Products and Services using keyword: ‘sterilization’ has revealed 0 matches.

b. Ability One Procurement List: a search was conducted under procurement list, using keyword ‘sterilization’ which revealed no evidence that Ability One can provide these services.

c. GSA Multiple Award Schedule: a search of the Schedules was conducted, using the keyword ‘sterilization’ with no matching records found.

d. SBA Small Business Search: a search of potential sources under NAICS code 561910 resulted in zero results.

e. Government contacted three (3) local hospitals: HCA West Florida Hospital, Ascension Sacred Heart Hospital and Baptist Hospital. All three (3) hospitals do not have the capability to support NHP’s offsite sterilization requirements. The local hospitals that were contacted confirmed they provide their own internal, on-site sterilization services.

f. Request for Information (RFI), Sources Sought: A RFI was posted on SAM.gov on 5 June 2026 for seven (7) days. No responses were received for this RFI.

g. A Notice of Intent to Sole Source (pre-solicitation notice) will be posted on the Government’s Point of Entry (POE) website IAW RFO 5.101.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: The MTF located at Naval Hospital Pensacola, Florida will continue to evaluate other service provider capabilities through continuing market research. Additionally, if the Government's requirement changes in the future, the intent of the Government is to issue a full and open competitive solicitation in order to provide the greatest amount of competition as practicable.

Continued efforts in this regard will ensure that Government is receiving the best value at a fair and reasonable price by ensuring the Government utilizes the most efficient and economical means possible. The Government will issue a Notice of Intent to Sole Source, to include the justification to sole source this action, on the Government Point of Entry website, Contract Opportunities, to encourage small business participation and foster competition.

8. Market Research: Market research was conducted utilizing Sam.gov, FPDS-NG.gov, GSA Advantage and other Government/commercial sources in order to locate alternative sources to support the services required at the level and quality required by the Government. A Request for Information - Sources sought (RFI-SS) was posted on the Government Point of Entry, Sam.gov, on 5 June 2026 with a closing date of 13 June 2026. The search was available for businesses of all size standards that are capable of providing the Government’s requirement. One response was received from BHPE LLC, but the firm did not include any documentation for the Government to review and was found unresponsive to the posting. After conducting a thorough analysis, it is evident that STERIS is the only company that can fulfill the Government’s need.

STERIS has the capabilities to meet the requirements which are not available by any other company.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? Yes

(2) If 9.a.(1) is No, was the action just prior to this one competed? Not Applicable.

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

b. Additional Information: N/A

10. Interested Sources: No other sources were located or expressed an interest in this acquisition.

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.

Director of Surgical Services Navy Medical Readiness Training Center (NMRTC)

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.

Director of Surgical Services Navy Medical Readiness Training Center (NMRTC)

13. Legal Review:

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

Office of General Counsel Contract Law MTF Support Branch

14. Contracting Officer Determination of Fair and Reasonable Pricing and Certification of Accuracy and Completion.

Fair and Reasonable Cost Determination:

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

Basis for Determination: It is anticipated that the price will be determined fair and reasonable based on price analysis techniques as annotated under FAR Subpart 12.204. The Government will not require certified cost and pricing data in accordance with FAR Subpart 15.403-2, which states in relevant part that “any acquisition for an item that meets the commercial definition in FAR Subpart 2.101 is exempt from the requirement for certified cost or pricing data.

Contracting Officer Certification:

I certify this justification is accurate and complete to the best of my knowledge and belief.

Marcus H. Mattingly Contracting Officer

DHACA HCD-S

Approval Based on the foregoing justification, I hereby approve the procurement of Off-Site Sterilization Processing ($ ) on an other than full and open competition basis pursuant to the authority of RFO 12.201-1, Simplified procedures, subject to availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

Marcus H. Mattingly Contracting Officer

DHACA HCD-S