P03 JnA 36C259-25-AP-1451 GE CardioDay Muse 623.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 5 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C259-25-AP-1451

3DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C259-25-AP-1451

JOFOC: FY 25 – NCO 19 - 1704

1. Contracting Activity:

Department of Veterans Affairs Network Contracting Office 19, 1011 Honor Heights Drive Muskogee, OK 74401

Organizational Activity:

Department of Veterans Affairs Eastern Oklahoma VA Health Care System 1101 Honor Heights Drive Muskogee, OK 74401

2237: 623-25-2-091-0020

2. Nature and/or Description of the Action Being Processed: This procurement is for an annual service to support, calibrate, maintain, install, remote hook up, and monitor the GE Health Care MUSE and Cardio Day System. GE Health Care is the only approved vendor that is able to perform this service in person and remotely through an already approved agreement and IT port with the Information and Technology Department of the Eastern Oklahoma VA Health Care System. The Eastern Oklahoma VA Medical Center (VAMC) in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501. Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require justification using the format of FAR 6.303-2. The extended software warranty for all proprietary software components of the GE Health Care MUSE and Cardio Day Holter System to ensure they perform in substantial compliance with documentation.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Eastern Oklahoma Veterans Affairs Healthcare System (EOVAHCS) requires comprehensive maintenance and repair services to include hardware /software support services, software upgrades and annual preventive maintenance/calibration coverage for the GE Health Care MUSE and Cardio Day System. The Cardio Day Holter system is required to work seamlessly with GE Healthcare MUSE (transferring to MUSE nX, once installed), VISTA, and GE Healthcare SEER Light Holter recorders. Server software must be Microsoft Windows 2012R2 and thin client workstation software compatible with Microsoft Windows

10. Service and Software agreement will cover software errors, technical support and clinical applications support, software updates and database maintenance, and remote diagnostics

VHAPG Part 806.3 OFOC Page 2 of 5 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C259-25-AP-1451 services when available. GE supplied a sole source letter indicating that GE Medical Systems Information Technologies (a “GE Healthcare” business) is the sole manufacturer and the sole licensed provider of equipment, parts, service, and software for the MUSE Resting EKG Equipment. GE Healthcare maintains certain proprietary service technologies relating to the equipment. GE is the OEM vendor to perform said OEM task at the Oklahoma Veterans Affairs Healthcare System (EOVAHCS).

The total cost of the five-year contract (NOT including possible -8) is $265,740.00 with periods of performance:

Base: 08/01/2025 – 07/30/2026 at a cost of $53,148.00 OY#1: 08/01/2026 – 07/30/2027 at a cost of $53,148.00 OY#2: 08/01/2027 – 07/30/2028 at a cost of $53,148.00 OY#3: 08/01/2028 – 07/30/2029 at a cost of $53,148.00 OY#4: 08/01/2029 – 07/30/2030 at a cost of $53,148.00

Total cost of $265,740.00

The total estimated value of this contract is $265,740.00, If exercised for up to 6 months the FAR 52.217-8 option will be exercised at the same rates as those in effect under the contract at the time the contract is extended.

4. Statutory Authority Permitting Other than Full and Open Competition: Due to the critical parts of the equipment involved and the network communication which only the OEM has with EOVAHCS approved by IT, only one responsible source will satisfy this requirement. The certified OEM has access to the parts and also provides qualified technicians to keep the GE Health Care MUSE and Cardio Day system and components functioning properly.

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Applicable authority of this sole source acquisition is FAR 13.5 “Only One Reasonable Source and No Other Supplies or Services Will Satisfy Agency Requirements” as a proprietary letter has been provided from GE Health Care stating they are the only authorized

VHAPG Part 806.3 OFOC Page 3 of 5

Acquisition ID#: 36C259-25-AP-1451 service technicians for this highly technical medical equipment. Which includes the Monitoring System and also includes hardware and software components. This is a follow on contract for the existing equipment that was put in place at the Eastern Oklahoma VA Health Care System. Therefore, this service plan is critical for the equipment to continue to function as purchased. Accordingly, GE Health Care is the only firm capable of providing these services described above.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Limited Market Research was conducted. A proprietary letter was provided by GE Health Care. The proprietary letter states only the current vendor and manufacturer of this equipment, GE Health Care, can repair, update software and provide parts or software/hardware as needed and indicated in the Performance Work Statement. GE Health Care does not offer or sale any parts or software/hardware upgrades to any third-party company.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The suggested pricing is based upon the previous contract currently in service at the Jack C Montgomery VAMC and set to expire at the start of this contract. The same cost per year in the existing contract is the same cost per base year and each option year, priced at $53,148.00. The anticipated cost for the Base plus 4 Option Year contract at $265,740.00 is considered fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A check of the VETCERT system for registered SDVOSB and VOSB companies was executed and identified the following; when the NAICS code 811210 for electronic and precision equipment repair and maintenance was used there were 320 matching profiles identified. When using the Dynamic Small Business Search (DSBS) using the same NAICS with the key word MUSE, there were 0 matching profiles identified. When a search of DSBS was conducted for any Small Business using NAICS 811210, there were 14 matching profiles and when a keyword entry of MUSE was input with the same NAICS there were 0 matching profiles identified.

GE has provided a proprietary letter which states they do not have any authorized third-party firms for servicing or maintaining the OEM Cardioday or MUSE equipment, nor does GE sell this equipment to any other third party for installation or service. Their proprietary letter also states that use of non-GE parts may invalidate the limited manufacturer warranty, and it will invalidate the software communication and instructions provided in the device’s instructions for use.

A search was conducted finding GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC (GEMS-IT) UEI# V4ZDCG4KSEX8, is registered in SAM.gov and is a Large Business under NAICS 811210 “Electronic and Precision Equipment Repair and Maintenance”. Based on my Market Research and confirmation of the Proprietary Letter provided by GEMS-IT, the Contracting Officer has determined that the rule of two cannot be met and this is a sole source acquisition to a large business, GEMS-IT.

VHAPG Part 806.3 OFOC Page 4 of 5

Acquisition ID#: 36C259-25-AP-1451

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: No other facts supporting the use of Other than Full and Open Competition are identified at this time.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: GE

MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC (GEMS-IT) UEI#

V4ZDCG4KSEX8

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any

Barriers to Competition before Making subsequent acquisitions for the supplies or services required: No actions are planned at this time. The suggested vendor is the only source for the warranty, service and support through their full-service agreement. Sole source from GEMS-IT is required for the duration of this contract due to proprietary reasons related to this equipment.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Victoria Smith Date Biomedical Engineer Jack C. Montgomery VAMC

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Mitchael Purdom Date Contracting Officer Network Contracting Office 19 (NCO19) VHA Regional Procurement Office West (RPOW)

7/7/25VICTORIA

SMITH

Digitally signed by VICTORIA

SMITH

Date: 2025.07.07 11:45:38 -05'00'

VHAPG Part 806.3 OFOC Page 5 of 5

Acquisition ID#: 36C259-25-AP-1451

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Jeffery Farley Date Branch Chief, Services 3 Network Contracting Office 19 (NCO19) VHA Regional Procurement Office West (RPOW)