IHS1526435_SSJ under FAR subpart 8.4 (CO Signed).pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES

PUBLIC HEALTH SERVICE

Division of Acquisition Management Phoenix Area Indian Health Service Two Renaissance Square 40 North Central Avenue Phoenix, Arizona 85004

[Last updated 11/28/2025.]

Sole Source Justification (SSJ) 1 RFO - FAR 8.401 & GSAM/R 538.7104-3(b)(1)(ii) 2

1. Acquisition Title: PIMC - Sterilization Equipment PM and Repair Services 4 Division: IHS 5 Contracting Activity: PIMC 6 Author: Minkyu Kim, Contract Specialist 7

2. Nature and/or Description of the Action being Approved: The Phoenix Indian Medical 9 Center (PIMC) requests a 36F79721D0237 with the contractor listed in the table below. This 10 acquisition is conducted under the Federal Supply Schedule (FSS) Program using the ordering 11 procedures established by the General Services Administration found in the General Services 12 Acquisition Manual/Regulation (GSAM/R) at subpart 538.71. The Government projects award 13 for June 2026 using fiscal year 2026 funds. 14

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Contractor: Getinge USA Sales, 1 Geoffrey Way, Wayne, NJ 07470 Schedule Contract Number: 36F79721D0237 Performance Period

Dates/Duration Unit Price/CLIN (3% Escalation rate used for illustration purposes only; actual escalation rates may vary)

Multiplier Total

Base Period 12 months $62,611.08 1 $62,611.08 Option Period 1 12 months $65,934.84 1 $65,934.84 Option Period 2 12 months $68,540.04 1 $68,540.04 Option Period 3 12 months $70,300.92 1 $70,300.92 Option Period 4 12 months $71,079.12 1 $71,079.12 Option to Extend Services per FAR Clause 52.217-8

6 months $35,539.56 1 $35,539.56

Estimated Total Dollar Value: $338,466.00 Original Contract Value: $446,500.00 New Contract Value: $338,466.00

3. Description of Supplies and/or Services: 21 PIMC requires preventive maintenance and repair services for Government-owned Getinge 22 sterilization and related equipment supporting critical clinical and infection control operations. 23 Equipment includes Getinge sterilizers, washer/disinfectors, ultrasonic cleaners, reverse osmosis 24 systems, water savers, and electric boilers. 25 Services include all labor, tools, parts, proprietary software access, and materials necessary to 26 perform scheduled preventive maintenance and corrective repairs. 27 The equipment is proprietary to Getinge and requires OEM-certified technicians, proprietary 28 diagnostic tools, and access to password-protected systems that are periodically updated and 29 controlled exclusively by the manufacturer. Only OEM parts and authorized service are 30 acceptable to ensure compliance with CMS standards and safe operation. 31 Period of Performance: 33 Base Year: 06/08/2026 – 06/07/2027 34 Option Year 1: 06/08/2027 – 06/07/2028 35 Option Year 2: 06/08/2028 – 06/07/2029 36 Option Year 3: 06/08/2029 – 06/07/2030 37 Option Year 4: 06/08/2030 – 06/07/2031 38

4. Authority Cited and Rationale: Authority of the FSS Program, Title III of the Federal Property 40 and Administrative Services Act of 1949 (41 U.S.C. 251, et seq.); Title 40 U.S.C. 501, Services for 41 Executive Agencies, as implemented at RFO - FAR 8.401 and GSAM/R 538.7104-3(b)(1). 42

b. GSAM/R 538.7104-3(b)(1)(ii)- Only one source is capable of providing the products, services, 44 or solution required at the level of quality required because the products, services, or solutions 45 are unique or highly specialized. 46 Only one source is capable of providing the required services at the level of quality required 48 because the services are unique and highly specialized. 49 Getinge USA Sales is the original equipment manufacturer (OEM) of the sterilization and related 51 equipment installed at PIMC. The equipment is proprietary and requires OEM-certified 52 technicians, proprietary diagnostic tools, and access to manufacturer-controlled software and 53 passwords that are periodically updated and not available to third-party vendors. 54 The Government previously awarded a contract to a non-OEM vendor, which was unsuccessful. 56 That effort demonstrated that third-party contractors lack the ability to fully service the 57 equipment due to restricted access to proprietary systems and reliance on Getinge for technical 58 support, parts, and system access. 59 Additionally, the equipment requires passwords that are periodically changed by Getinge, 61 preventing third-party vendors from independently performing required maintenance and 62 repairs. Use of a third-party vendor would necessitate coordination with Getinge, resulting in 63 significant delays. 64

Because this equipment is critical to sterilization, infection control, and patient care, any delay 66 in maintenance or repair presents an unacceptable risk to clinical operations. While prior direct 67 performance by Getinge included periodic delays, those delays were significantly less severe 68 than those experienced or anticipated under third-party servicing arrangements. 69 Market research confirmed that no other FSS contract holders possess the OEM authorization, 71 proprietary access, and technical capability required to perform the full scope of services. 72 Accordingly, Getinge USA Sales is the only source capable of meeting the Government’s 73 requirement. 74

5. Market Research: Market research was conducted in accordance with FAR Part 10 and 76 included review of GSA eBuy, SAM.gov, and other procurement databases under NAICS 811210 77 and PSC J065. No other schedule holders were identified that could meet the requirement. 78 A Sources Sought notice was posted on SAM.gov and restricted to IEE/ISBEE vendors. No 80 capable vendors responded. Two small businesses expressed interest but did not demonstrate 81 OEM certification, proprietary access, or full capability. 82 Market research confirmed that Getinge maintains exclusive control over proprietary service 84 tools, parts, and password-protected systems, preventing third-party servicing without OEM 85 involvement. 86

6. Procurement history: 89

a. Contractor: LE3 LLC 91 Contract or Order Number: 75H71225P00078 92 Award Date and Period of Performance: 05/01/2025, 07/01/2025 to 06/30/2030 93 Value (including all options): $446,500 94 Competitive Status: Total Small Business Set-Aside 95 Authority formerly relied upon if Not Competed: 96

b. Contractor: GETINGE USA SALES LLC 98 Contract or Order Number: V797P-4452B/75H71220F80018 99 Award Date and Period of Performance: 01/29/2020, 01/20/2020 to 12/31/2034 100 Value (including all options): $293,615 101 Competitive Status: Full and Open 102 Authority formerly relied upon if Not Competed: 103

7. Actions to Foster Competition for Future, Similar Requirements: The Government will 106 continue to monitor the marketplace for vendors capable of providing OEM-authorized servicing 107 of Getinge equipment. However, due to proprietary restrictions, competition is not currently 108 practicable. If alternative servicing solutions or equipment replacement options become 109 available, future requirements will be competed to the maximum extent practicable. 110

8. Additional Information or Other Facts: This equipment supports sterilization and infection 112 control operations serving approximately 140,000 patients. Delays in servicing could result in 113 equipment downtime, canceled procedures, and increased risk to patient safety. 114 Prior experience demonstrated that third-party servicing is ineffective and results in 115 unacceptable delays due to reliance on Getinge for proprietary access. Direct OEM support 116 minimizes downtime and ensures continuity of patient care. 117

9. Technical or Requirements Program Management Certification: I certify that the supporting 119 data under my cognizance which are included in the justification are accurate and complete to 120 the best of my knowledge and belief. 121

X Right-Click "Signature Setup" Supervisory Biomedical Eng

Zachary Navarro Supervisory Biomedical Engineer Signature & Date:

10. Best Value Determination: As the contracting officer, I hereby determine that the 123 anticipated price to the Government for this contract action represents the best value for the 124 Government. 125 The proposed pricing was evaluated against the contractor’s GSA Federal Supply Schedule rates, 127 which have been determined fair and reasonable by GSA in accordance with FAR 8.404(d). The 128 Government will seek and consider any available GSA schedule discounts prior to award. 129 Additionally, the Independent Government Cost Estimate (IGCE) and historical pricing from prior 130 contracts for similar services were reviewed and found to be consistent with the proposed 131 pricing. 132 Market research confirmed that no other GSA schedule contractors are capable of providing 134 OEM-certified services with access to proprietary systems required for this equipment. Although 135 competition is limited, the use of the GSA Schedule ensures pricing transparency and pre-136 negotiated ceiling rates. 137 Award to Getinge USA Sales represents the best value because it ensures access to OEM-139 certified technicians, proprietary tools, and system controls necessary to maintain equipment 140 performance and compliance with healthcare standards. Attempting to obtain lower-priced 141 services through non-OEM vendors has previously resulted in performance issues and delays, 142 which ultimately increased operational risk and reduced overall value to the Government. 143 Accordingly, the combination of fair and reasonable pricing under the GSA Schedule, alignment 145 with historical costs, and the contractor’s unique technical capability supports the 146 determination that this acquisition represents the best value to the Government. 147

11. Contracting Officer (CO) Certification and Approval: I hereby certify that this justification is 150 accurate and complete to the best of my knowledge. [Always required; CO approval authority is 151 limited to $900 thousand.] 152

Joshua Pearlman Contracting Officer Signature & Date:

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(The following Reviews and Approvals will ordinarily begin on a separate page at the end of the 186 justification to allow minor, administrative changes to be made during the review process; 187 delete any individual reviews/approvals not applicable.) 188

ELEVATED REVIEWS & APPROVALS 190

12. Insert Division Advocate for Competition (AfC) Review and Approval: I reviewed this 192 justification and find that it adequately supports a sole source acquisition. [Division AfC 193 approval authority is limited to $20 million.] 194

Typed Name Title Signature & Date:

13. Insert Division Head of the Contracting Activity (HCA) Review and Approval: I reviewed 197 this justification and find that it adequately supports a sole source acquisition. [HCA approval 198 authority is limited to $90 million.] 199

Head of the Contracting Activity Signature & Date:

14. HHS Office of General Counsel Review and Concurrence: I reviewed this justification and 202 concur that it adequately supports a sole source acquisition. [Mandatory when SPE approval is 203 required, unless otherwise waived in writing by the SPE.] 204

Title Signature & Date:

15. HHS Advocate for Competition (AfC) Review and Concurrence: I reviewed this justification 208 and concur that it adequately supports a sole source acquisition. [Mandatory when SPE 209 approval is required.] 210

HHS Advocate for Competition Signature & Date:

FINAL APPROVAL 215

16. HHS Senior Procurement Executive Approval: Based on the foregoing, I hereby approve 217 this sole source justification pursuant to the authority of 41 U.S.C. 251, et seq. and 40 U.S.C. 218

501. [Required if the total award value (including all options and FAR 52.217-8 value, as 219 applicable) exceeds $90 million.] 220

HHS Senior Procurement Executive Signature & Date: