Justification and Approval_36C256-22-AP-0274.pdf

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C256-22-AP-0274

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 16 Michael E. DeBakey VA Medical Center (MEDVAMC) 2002 Holcombe Boulevard Houston, TX 77030

PR#: 580-22-1-255-005

2. Nature and/or Description of the Action Being Processed: This procurement is conducted under FAR 13.5, Simplified Procedures for the Certain Commercial Items. The MEDVAMC requires Preventive Maintenance and Inspection (PMI) Service for Government-Owned GE MacLab Hemodynamic Monitoring System. This requirement will be awarded as a new contract action utilizing a Firm Fixed Price type contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Contractor shall furnish all labor, materials, parts, equipment, tools, supervision, transportation, and trained/certified Field Service Engineers (FSE) required to service and perform preventative maintenance and emergency repairs for all GE MacLab Hemodynamic Monitoring Systems.

Additionally, the contractor shall provide Original Equipment Manufacturer (OEM) replacement parts, upgrades, and software support during life cycle of this contract. These parts, upgrades and software support is proprietary to GE Medical Systems Information Technologies, INC., (GEMSIT) as they are the sole source provider for this equipment.

The Period of Performance (POP) for this requirement is estimated to be a Base Period of February 15, 2022 through February 14, 2023 ($123,723.00) plus 4 (four) 1 (one) year option periods, to be exercised at the government’s discretion. The total estimated award amount is $618,615.00.

Base Year (February 15, 2022 – February 14, 2023): $123,723.00 Option Year 1 (February 15, 2023 - February 14, 2024): $123,723.00 Option Year 2 (February 15, 2024 - February 14, 2025): $123,723.00 Option Year 3 (February 15, 2025 - February 14, 2026): $123,723.00 Option Year 4 (February 15, 2026 - February 14, 2027): $123,723.00

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 4

Revision 03 Date: 02/11/2021

( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): GEMSIT, as the manufacturer of the GE MacLab Hemodynamic Monitoring System, has certified there are no third parties that are authorized to maintain, repair, or provide parts for GE MacLab Hemodynamic Monitoring Systems.

Any deviation from using authorized vendors for maintenance will jeopardize Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) accreditation and would potentially harm the patient or cause death.

GEMSIT is the sole designer, developer, distributor and OEM of the equipment/systems in which this contract shall cover. Additionally, GEMSIT is the only contractor with the requisite knowledge, experience and software that can meet the government requirements on a timely basis. GEMSIT possesses the legal rights to their proprietary software and equipment. As such, only OEM parts and GEMSIT trained/certified technicians are authorized to work on their equipment. Utilizing non-OEM parts on any of these systems will void the equipment. Failure to use OEM parts and GEMSIT trained/certified technicians could result in a significant risk to patients, whereby negatively impacting patient care and potentially lead to catastrophic conditions.

Awarding a contract for these services to any vendor besides GEMSIT, would create significant disruption in services to the VA mission. Accordingly, GEMSIT is the only company capable of providing the necessary parts and services described in section III above without the Veterans Health Administration experiencing unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: While GEMSIT has authorized SDVOSB distributors, these distributors are not authorized to establish service agreements, this was confirmed by the Contract Specialist with communication with GEMSIT Regional Service Sales Representative Karla Jaeke which further verified there were no third party vendors authorized to provide GEMSIT proprietary parts or perform maintenance and repair services for these systems. Additionally, the Contract Specialist (CS), as identified in paragraph 8 below, conducted Market Research to determine the availability of sources for the proposed requirement. The results of the Market Research show that GEMSIT (OEM) is the only source for the required services, and that there are no equivalent service providers within the commercial marketplace that can fulfil the VA’s requirement with the system in place.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Services being procured, while specialized and specific, are anticipated to be in line with historical data, prior project awards and the Independent Government Cost Estimate (IGCE). By utilizing the previous contracts awarded along with the IGCE, the government compared this to the cost of services to be provided by GEMSIT and deemed the prices to be fair and reasonable.

Reference # Award/Estimate Comments FA442720C0019 $166,549.96 per year GE MacLab Maintenance Service 36C26219R0103 $210,411.00 per year GE MacLab Maintenance Service VA26214C1075 $224,505.13 per year GE MacLab Maintenance Service 36C25920C0169 $134,255.00 per year GE MacLab Maintenance Service

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 4

Revision 03 Date: 02/11/2021

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A query of the Vendor Information Page (VIP) resulted in 0 results when searched using Keyword “ GE MacLab”. VIP was also queried using NAICS 811219 and identified 285 SDVOSBs and 58 VOSBs in the market who has the requisite 811219 NAICS code associated to perform Electronic and Precision Equipment Repair and Maintenance Services. In addition, Notice of Intent (NOI) 36C25622Q0210 was posted to sam.gov on December 15, 2021 through December 23, 2021 as a Notice of Intent to award Sole Source Contract to GEMSIT to provide all labor, tools, material, parts, equipment, supervision, software maintenance, license, certification, transportation, management, and personnel required to perform yearly preventive maintenance and services for GE MACLAB Hemodynamic Monitoring System equipment at the Michael E. DeBakey VA Medical Center (MEDVAMC). NOI 36C25622Q0210 was sent to Ability One, three SDVOSBs (Mountain States Biomedical Services Inc, Stertek, L.L.C. and Electra-Med Corporation) and three VOSBs (Rush Hour Biomedical Services LLC, RTL Sterilizer and Biomedical Services LLC and Medical Equipment Specialists Company) which resulted with no response received. The only response received from the NOI was from the OEM, GEMSIT. Contract Specialist searched General Service Administration (GSA) Advantage website under search term “GE MacLab” which returned with 0 (zero) results. Contract Specialist searched the Small Business Association Dynamic Small Business search website at https:// web.sba.gov under keyword “ GE MacLab”. The search resulted in no results found.

Additional Market Research was conducted by reviewing FPDS. Results of this review revealed that the VA Eastern Colorado Health Care System in Denver recently awarded contract 36C25920C0169 for the same services, GE MacLab Maintenance Service to GEMSIT, as identified in Paragraph 7 above.

Based on the information received as a result of this Market Research, it has been determined that this requirement does not meet the VA Rule of Two; as there are not 2 (two) or more SDVSOBs/VOSBs concerns capable of providing these services due to the proprietary nature of the

OEM, GEMSIT.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: GEMSIT, as the OEM of these systems has certified that there are no third-party entities authorized to perform the required contractual services.

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

Name:GE Healthcare Systems Address: 9900 Innovation Dr Wauwatosa, Wisconsin 53226-4856 POC Name/eMail: Karla Jaeke/karla.jaeke@ge.com POC Phone: (608) 628-8942

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: The Government will continue to conduct Market Research to ascertain whether there are any changes in the commercial marketplace which would enable future actions to be competed. This Market Research will ensure potential providers are not overlooked for possible competition. Based, on the current construct, it is recommended a Base plus 4-year option period be approved and awarded to the OEM, GEMSIT.

OFOC SOP Revision 11 Page 4 of 4 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

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.

Name Lujain Elnihum Date Title Staff Biomedical Engineer Michael E. DeBakey VA Medical Center (MEDVAMC)

13. Prepared by:

Albert Kelly Contract Specialist Network Contracting Office (NCO) 16

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

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

Anthony Marion Date Contracting Officer Network Contracting Office (NCO) 16

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.

Le Kisha A. Douglas Date Branch Chief, DIV III Services B

Network Contracting Office (NCO) 16

Albert Kelly 1641018

Digitally signed by Albert Kelly 1641018 Date: 2021.12.29 10:13:44 -06'00'

LUJAIN ELNIHUM 3500714 Digitally signed by LUJAIN ELNIHUM 3500714 Date: 2022.01.04 07:39:08 -06'00'

Anthony C Marion 131115

Digitally signed by Anthony C Marion 131115 Date: 2022.01.04 11:25:17 -06'00'

Le Kisha A Douglas 157307

Digitally signed by Le Kisha A Douglas 157307 Date: 2022.01.11 10:54:38 -06'00'