P03 - JA_OVER_SAT - 36C257-23-AP-0148 - BC Signed.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257-23-AP-0148

RPOW JOFOC Log Number: 2023-01-11T13:44:13

1. Contracting Activity: Networking Contracting Office 17, Requesting Office: Central Texas Veterans Health Care System (CTVHCS), Olin E. Teague VA Medical Center. Purchase Request Number: 674-23-3-034-0031

2. Nature and/or Description of the Action Being Processed: NCO 17 intends to enter into a sole source contract with Abbott Rapid Diagnostics Informatics, Inc. for the RALS Point of Care (POC) Interface. The proposed contract action will be awarded as a new Firm-Fixed price contract action.

The contract will consist of a Base + four (4) Option years. Base period of performance: 7/1/2023 – 6/30/2024.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The purpose for obtaining the Remote Automated Laboratory Systems (RALS) software technology is to connect multiple devices to one data manager. The RALS software enables review and release of patient results to the LIS directly from each unit. It allows the ability to manage, update, review and troubleshoot quality control results, operator, and device issues remotely. CTVHCS uses RALS Web3 for our Roche glucose meters and the RALS interface for other point of care instruments (Siemens Healthineers 6 Clinitek Status Connect Module, Abbott i-STAT, Accriva Diagnostics Avoximeter 100E Meter, RALS Equiz Operators, BinaxNOW COVID-19 MTE Package and Annual License and the Nova StatSensor LAC). The software license agreement ensures a continuity of services for the CTVHCS utilizing the same server which is part of this contract. The term of this license agreement shall commence as of the license effective date and shall remain in effect if the STS is licensed hereunder.

The term of each license granted hereunder shall remain in effect for duration of the contract. The Technology License includes service, support, updates, and hardware maintenance. The supply of RALS-Freedom for the use by Customer is governed by the terms and conditions of the RALS Software Technology System License Agreement. This is also for a full-service warranty and maintenance agreement for the interface and software technology for RALS. There may be other components that Abbott Alere RALS offers that may be added to this requirement in a future time frame. The total estimated cost of this procurement, including options, is $361,653.

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

Effective Date: 02/01/2022 Page 2 of 3

( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

( ) 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): CTVHCS has been using using RALS interface for point of care testing since 2012. We need continuity of this service since these are utilized throughout CTVHCS to include all the community based outpatient clinics (CBOCs) and they are validated and currently being used for the point of care program.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Abbott Rapid Diagnostics Informatics, Inc. provided a proprietary letter for the RALS system services. A search in FPDS for RALS software identified numerous VA contracts all being performed by Abbott Rapid Diagnostics Informatics, Inc within the past five years (36C26322P0711 & 36C25718P1533). A Notice of Intent to Sole Source (36C25723Q0211) was posted in FBO for (10) days and resulted in (0) responses.

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

Reasonable: Previously awarded contracts from Abbott Rapid Diagnostics Informatics, Inc. such as 36C25718P1533 (NCO 17) and 36C26322P0711 (NCO 23) were priced at $203,081.00 and $309,232.00 for RALS software system. Based on these prices the Contracting Officer has determined that the anticipated proposal prices will be fair and reasonable.

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

Market Research Was Not Conducted: VetBiz results showed a total of 2725 vendors for NAICS code 541512, but Alere RALS Interface and no other vendors can third party this interface service.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Web searches showed that the only company that provided Alere RALS Interface is Abbott Rapid Diagnostics Informatics, Inc. The RALS Alere interface is needed for all the CBOCS for point of care testing.

Abbott Rapid Diagnostics Informatics, Inc. has a current Business Associate Agreement (BAA) with the VA.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None

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: Market research will be conducted at the exercise of each option and for the subsequent requirements to see if there has been any changes in the market place.

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

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.

Debra King Date Chief Technologist

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.

Vance Wayne Farrell Date Contracting Officer

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.

Michael J. Tusinger Date Branch Chief, Lab Support Team

Networking Contracting Office 17 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx