JA_OVER_SAT - Cardiac Monitoring SIG.pdf

Attachment 7: Request for Sole Source Justification Format >SAT Acq Plan # 36C241-23-AP-4042

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 01 Effective Date: 04/01/23

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C241-23-AP-4042

1. Contracting Activity: Department of Veterans Affairs, VISN 1, NCO 1 on behalf of Connecticut

Medical Center. The Purchase request (2237) number is 689-23-4-7922-0136.

2. Nature and/or Description of the Action Being Processed: This contract is for a firm-fixed price for the cardiac monitoring services of real-time 30-day monitoring, and 24- or 48-hour holter monitors. The estimated cost value amount is $2,224,750.00. The award will start on 10/1/2023 for 1 base year and 4 option years.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The contractor will provide devices/ monitors at VA Connecticut Healthcare System. The vendor shall provide cardiac holter and real-time 30-day monitor services, an electronic device which monitors the patient’s heart rhythm. The vendor shall provide the devices to VA Connecticut Health Care system for patients needing diagnosis of cardiac arrhythmias. This device shall monitor and allow transmission of the patient’s heart rhythm to the patient’s designated physician to review the official report and data. The vendor shall provide notification to the physician on pre-defined criteria.

4. Statutory Authority Permitting Other than Full and Open Competition:

(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): Many of the cardiology patients are also patients at Yale university, as well as a majority of VA CT Healthcare System cardiologist doctors being affiliated with Yale university. Yale and the VAMC CT Healthcare system use the vendor Irhythm system for cardiology care. Having the same proprietary brand name, the Preventice program, will ensure compatibility and continuity of care for our cardiology veteran patients and Yale University, along with superior diagnostic results that were severely lacking on the prior cardiac monitoring contract. Boston Scientific acquired Preventice Solutions, a company that designed mobile heart solutions and remote monitoring for patients with cardiac issues.

One of the most critical criteria the cardiology department requests is that the vendor notifies the cardiologists for is Atrial Fibrillation. Boston Scientific has proprietary BeatLogic to help ensure the most accurate information is received. “Preventice has over a decade of experience as a trusted service and technology partner providing monitoring for millions of patients, supporting thousands of practices nationwide and leveraging its proprietary BeatLogic deep learning platform. In May 2020, Preventice was the first to publish in the Heart Rhythm Journal and show that BeatLogic outperformed the leading gold standard algorithms on Afib in the MIT Atrial Fibrillation Database (AFDB) library and MIT Ventricular Ectopic Beats (VEB) classification”

VHAPG Part 806.3 OFOC Page 2 of 4

Effective Date: 04/01/23

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Significant efforts were made to solicit to as many sources as possible, but after conducting market research (see paragraph 8), it was determined that this requirement will be sole source due to proprietary Preventice system. Used Sam.gov database to filter the following companies that meet our needs: The below did not match our requirements:

a. JLS Medical Products Group, LLC

b. Medical Device Depot, Inc.

c. Mercy Medical Equipment Company

d. Sustainment Technologies, LLC

e. TrillaMed, LLC

f. Veterans Healthcare Supply Solutions, Inc

Three sources were sought to meet the proven services provided by Preventice Solutions.

Biotel refused to send price quote. Instead, preferred to speak directly to contracting officer.

Rhythmedix has no proven track record and could not provide the services. Preventice solutions has proven performance history, an example being the St. Louis VAMC. Intelli-heart, which is the current contract vendor, has had unsatisfactory performance and customer service that has harmed the health of Veterans.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This requirement will be deemed fair and reasonable based on the previous contract 36C24120P0610 and the IGCE. The previous contract was awarded for $1,621,300.00 for 1 base year and 4 option years. At present, the IGCE is significantly higher than the previous contract price, but the incumbent vendor’s performance not satisfactory and endangering the lives of veterans utilizing the service. The incumbent’s price reflects this substandard performance. Further research of the Award decision form (S19) from the previous contract 36C24120P0610 shows another vendors pricing, which is similar in price at $2,027,400.00.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted. A VIP search using NAICS 621999 and PSC Q502 revealed 14 potential SDVOSB/VOSB vendors. All 14 were emailed to inquire if they had the capability to meet this requirement. At this time, no SDVOSB/VOSB vendors responded to my inquiry to meet this requirement. An SBA DSBS search using NAICS 621999 and criteria cardiac resulted in 3 potential SB vendors. All 3 SB vendors were emailed to inquire if they had the capability to meet this requirement. At this time, no SB vendors responded to my inquiry to show interest or the capability to meet this requirement. The Rule of Two could not be met for this requirement for SDVOSB/VOSB vendors. An RFI was issued on 7/10/2023 and no responses were received. A search on contract opportunities using criteria cardiac monitoring services revealed only supply requirements and no services. The intra-contract directory using criteria cardiac monitoring revealed none found. An FPDS-NG search using criteria cardiac monitoring revealed Cardionet, LLC (LB), RMX Monitoring, LLC (SB Inactive in SAM), Cardio Labs, Inc (SB), Medicomp, Inc (SB), Intelli-Heart Services, Inc (SB), Precision Monitoring, LLC, (SB). The customer recommended Boston Scientific Corporation (LB). A Source Sought notice for Cardiac monitoring services with brand name Preventice was issued on 7/10/2023, which resulted in no responses. The manufacturer, Boston Scientific Corporation, was contacted to inquire if they had any authorized distributors that provide this service, they stated there were no authorized distributors and were the only vendor that provided the services, due to Preventice cardiac monitors/holters being proprietary property. The manufacturer also stated they have E-CAT contract SPE2DE-21-D-7020 in place, that provides significantly better pricing then originally received from Boston Scientific.

VHAPG Part 806.3 OFOC Page 3 of 4 Revision: 01 Effective Date: 04/01/23

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

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: An RFI was issued and resulted in no responses.

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 previous contract completed a sources sought notice for SDVOSB potential vendors and did not receive any responses. The previous contract was then solicited with a SB set-aside and received 2 quotes. The contract was then awarded to the incumbent, in which the performance was not satisfactory and put veterans health at risk. Due to the previous contracts attempt to solicit for SDVOSB and SB vendors, and the unsatisfactory performance, it would be in the governments best interest to sole source this requirement to large business, Boston Scientific Corporation, since the previous contract attempted competition that resulted in unsatisfactory performance.

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.

Peter DiGrazia Date

COR

VA CT Healthcare System

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.

Tara Dossiema Date Contracting Officer

NCO 1

07/24/2023

07/24/2023TARA DOSSIEMA

Digitally signed by TARA

DOSSIEMA

Date: 2023.07.24 12:20:15 -04'00'

VHAPG Part 806.3 OFOC Page 4 of 4

Effective Date: 04/01/23

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.

Cory Dionne Date Branch Chief

NCO 1

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $75 million) or approve ($750K to $75 million) for other than full and open competition.

Joseph P. Maletta Executive Director, Acquisition Date VHA Head of Contracting Activity (HCA)

Cory J. Dionne 210760 Digitally signed by Cory J. Dionne 210760 Date: 2023.07.24 12:26:56 -04'00'

JOSEPH

MALETTA

Digitally signed by JOSEPH

MALETTA

Date: 2023.07.26 16:05:45 -04'00'