Attach 09 JandA_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 6

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C244-22-AP-5609

1. Contracting Activity:

Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road Pittsburgh, PA 15215-1802

Purchase Request (VA2237): 642-22-3-315-0255 | Delivery, Installation, and Training for GE Cardiolab Upgrade | Philadelphia VA Medical Center (PVAMC), 3900 Woodland Avenue, Philadelphia, PA 19104- 4551 | Contracting Agency: Network Contracting Office 4

2. Nature and/or Description of the Action Being Approved:

CMC Veterans Affairs Medical Center requires the CardioLab System by GE Healthcare. The GE CardioLab System is used for diagnostic and therapeutic cardiac electrophysiology procedures for diagnosing and treating abnormal cardiac arrhythmias. When connected to the patient, the system provides continuous cardiac ECG and invasive pressure monitoring, using 128 total ECG recording channels, configurable, to monitor and record all aspects of diagnostic electrophysiology and radiofrequency ablation procedures. This system enables the end-users to record from multiple electrocardiogram channels to diagnose and treat cardiac arrhythmias and record/document findings. This upgrade will enhance the operator’s ability to diagnose various cardiac arrhythmias and determine/document success of procedural intervention and provide a clinical documentation that transfers to the patient chart when completed.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The estimated value of the proposed action is

The GE Cardiolab Altix BT21 System is used for diagnostic and therapeutic electrophysiology procedures for diagnosing and treating patients with aberrant heart rhythms that are too fast or too slow. The system, when connected to the patient, provides continuous monitoring, recording of invasive pressures, and a 128 channel, configurable electrocardiogram analysis that allows the operator to pinpoint the specific site of the rhythm abnormality, treat the aberrant rhythm and re-check the site of treatment to ensure the therapeutic intervention worked all while providing cardiac electrophysiologic recordings of finding and site-specific treatment for clinical documentation. It also comes with a hemodynamic package that allows the clinical team to provide continuous invasive and non-invasive monitoring during the procedure. This request is for an upgrade to the latest software and hardware refresh and to bring the system to a Microsoft Supported Operating System and current technology. Medical Center HL7 interfaces already exist for this and are transferrable to refreshed technology. End user familiarity is tantamount to patient safety, technology is interchangeable with existing Medical Center monitoring framework.

Effective Date: 02/01/2022 Page 3 of 6

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S. Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. Check the specific VAAR clause used below:

Item # Description/Part Number* Qty Price Extended Amount

INW Server PowerEdge R640 Server (210-AKWU)ProSupport Mission Critical: 4-Hour 7x24 On-Site Service with Emergency Dispatch, 3 Years (813-9259) ProSupport Mission Critical: 7x24 HW / SW Technical Support and Assistance, 3 Years (813-9265) Intel Xeon Gold 5222 3.8G, 4C/8T, 10.4GT/s, 16.5M Cache, Turbo, HT (105W) DDR4-2933 (338-BSGI) Intel Xeon Gold 5222 3.8G, 4C/8T, 10.4GT/s, 16.5M Cache, Turbo, HT (105W) DDR4-2933 (338-BSGI)

(8) 8GB RDIMM, 3200MT/s, Single Rank (370-AEVO)

(2) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT)

(6) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT) Windows Server 2019 Standard,16CORE,FI,No Med, No CAL, Multi Language (634-BSFE)

(2) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT) (6)1 2TB 10K RPM SAS ISE 12Gbps 512n 2.5in Hot-plug Hard Drive

(400-ASHI)/ 2064856-056

33 Integration/ INTEGRATION 1

CardioLab Production Server PowerEdge R740 Server (210-AKXJ) ProSupport Mission Critical: 4-Hour 7x24 On-Site Service with Emergency Dispatch, 3 Years (813-9123) ProSupport Mission Critical: 7x24 HW / SW Technical Support and Assistance, 3 Years (813-9129) Intel Xeon Gold 5222 3.8G, 4C/8T, 10.4GT/s, 16.5M Cache, Turbo, HT (105W) DDR4-2933 (338-BSGI) Intel Xeon Gold 5222 3.8G, 4C/8T, 10.4GT/s, 16.5M Cache, Turbo, HT (105W) DDR4-2933 (338-BSGI)

(8) 8GB RDIMM, 3200MT/s, Single Rank (370-AEVO)

(2) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT)

(6) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT) Windows Server 2019 Standard,16CORE,FI,No Med, No CAL, Multi Language (634-BSFE)

35 Integration/ INTEGRATION 1

CardioLab Test Server PowerEdge R740 Server (210-AKXJ) ProSupport Mission Critical: 4-Hour 7x24 On-Site Service with Emergency Dispatch, 3 Years (813-9123) ProSupport Mission Critical: 7x24 HW / SW Technical Support and Assistance, 3 Years (813-9129)/ 2064856-058 Intel Xeon Gold 5222 3.8G, 4C/8T, 10.4GT/s, 16.5M Cache, Turbo, HT (105W) DDR4-2933 (338-BSGI) Intel Xeon Gold 5222 3.8G, 4C/8T, 10.4GT/s, 16.5M Cache, Turbo, HT (105W) DDR4-2933 (338-BSGI)

(8) 8GB RDIMM, 3200MT/s, Single Rank (370-AEVO)

(2) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT)

(6) 480GB SSD SATA Mix Use 6Gbps 512 2.5in Hot-plug AG Drive, 3 DWPD, (400-AZUT) Windows Server 2019 Standard,16CORE,FI,No Med, No CAL, Multi Language (634-BSFE)/ 2064856-058

37 Integration/ INTEGRATION 1 37 -$

$ TOTAL

Effective Date: 02/01/2022 Page 4 of 6

( X ) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business;

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

The upgrade materials and software are proprietary to the GE CardioLab and require licensed GE trained maintenance personnel.

Original Equipment Manufacturer has designated that TrillaMed is their “turnkey” solution for GE Cardiolab upgrades.

NCO4 shall proceed with a sole source award to SDVOSB Vendor, TrillaMed based on 38 U.S.C.

8127(c) and that this SDVOSB concern has been determined to be a responsible source with respect to performance. NCO4 has determined that the business meets eligibility requirements in VAAR 819.7003.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies:

NCO4 released an Intent to Sole Source Notice to TrillaMed LLC on Systems for Award Management (SAM) Contract Opportunities (CO), 07-27-2022. No vendors responded. NCO4 will publish Combined Synopsis Solicitation to SAM CO during solicitation along with this J&A (redacted).

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

Reasonable:

Based on Market Research, NCO4 anticipates that only one response will be received from TrillaMed, LLC. and will based on a Fair and Reasonable decision in comparison to Market Research (Historical Pricing) and comparison of the proposed price with prices found reasonable on previous purchases in accordance with FAR 13.106-3(a)(2)(i) and (ii).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

As presented by the CVAMC Customer in original acquisition package. Requirement was further validated by the CVAMC Equipment Committee.

DVA Vendor Information Page (VIP) database. NCO4 searched the VIP database (08-13-2022) using NAICS Code 334510 and search terms “Cardiolab”. Search yielded no results. GE Healthcare affirmed that the Vendor they have selected as the sole source firm for this procurement is TrillaMed, LLC, an SDVOSB firm. NCO4 confirmed TrillaMed’s VIP certification. As this is GE Specific equipment requiring GE licensed support, the authorization regarding what vendors are certified rests with the OEM.

Vendor Information Page (VIP) database. NCO4 searched the VIP database (08-13-2022) using NAICS Code 334510 and search terms “Cardiolab”. Search yielded no results. GE Healthcare affirmed that the Vendor they have selected as the sole source firm for this procurement is TrillaMed, LLC, an SDVOSB firm. NCO4 confirmed TrillaMed’s VIP certification.

System for Award Management (SAM). NCO4 validated that the Vendor TrillaMed maintains an active SAM accounts (expires: 08-14-2023) with no active exclusions (08-23-2022).

Effective Date: 02/01/2022 Page 5 of 6

VA National Acquisition Center (NAC), High Tech Medical Equipment (HTME) Contract.

NCO4 acknowledges that GE Healthcare maintains a Department of Veterans Affairs, National Acquisition Center Contract that would encompass this requirement (VA797H-17-D-0024, SPE2D1- 17-D-0015). OEM Representative, reports that TrillaMed is GE Healthcare’s lead for “turnkey” solutions (01-18-2022 email correspondence).

further offers that TrillaMed can supply “[a]ll of the necessary server components and hardware, along with the invasive upgrades” (01-18-2022). The Federal Procurement Data System (FPDS) further supports the GE Healthcare TrillaMed arrangement (08-18-2022). Search term “Combolab Altix” yielded 4 contract actions out of 9. The two Vendors awarded these actions were either General Electric or TrillaMed.

General Services Administration (GSA) Advantage. NCO4 searched GSA Advantage (08-21- 2022) using the search terms “GE Combolab” and “Cardiolab”. The search yielded no results.

System for Award Management (SAM) Contract Opportunities (CO). NCO4 posted an Intent to Sole Source Notice on 08-08-2022 on SAM Contract Opportunities for this requirement. No Vendors responded.

Small Business Administration (SBA) Dynamic Small Business Search (DSBS) database. NCO searched the DSBS (08-13-2022) using NAICS Code 334510 and search term “Cardiolab”. Search yielded no results.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None.

NCO4 shall proceed with a sole source award to SDVOSB Vendor, TrillaMed based on 38 U.S.C.

8127(c) and that this SDVOSB concern has been determined to be a responsible source with respect to performance. NCO4 has determined that the business meets eligibility requirements in VAAR 819.7003.

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

TrillaMed, LLC, 30100 Telegraph Road, Suite 366, Bingham Farms, MI 48025

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 if there are changes in the marketplace that would enable future actions to be competed.

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.

Nurse Manager Cardiology

CMCVAMC

Program Manager

Effective Date: 02/01/2022 Page 6 of 6

13. 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.

Mark E. Murray Date Contracting Officer Commodities 2, NCO4

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding

$750K): I certify the justification meets requirements for other than full and open competition.

Gregory Wizar Date Branch Chief

Commodities 2, NCO4

Gregory M. Wizar 1398639

Digitally signed by Gregory M.

Wizar 1398639 Date: 2022.08.24 14:24:25 -04'00'

MARK E. MURRAY

1083666

Digitally signed by MARK E.

MURRAY 1083666

Date: 2022.08.23 14:35:17 -04'00'