P03_ FAR 13.5 Sole Source Justification - Over SAT - SAM.docx

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-23-AP-1688

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 21 on behalf of VISN 21, VA Northern California Healthcare System (VANCHCS).

2237 # 612-23-2-111-0119

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

The VA Northern California Healthcare System has a requirement for Remote Automated Laboratory Systems (RALS) software technology. The purpose for obtaining the 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.

The contractor shall provide RALS software licensing and interface for Point of Care testing connectivity software that is used to post patient test results to the electronic patient record (Vista/CPRS). This software allows the end user to monitor tests done at the point of care and to meet numerous accreditation requirements for laboratory tests performed throughout the VA Northern California Healthcare System located at 10535 Hospital Way Mather, CA 95655.

Software must be compatible with the following existing equipment: Roche Accuchek Inform II (80 meters) , the Abbott iSTAT (4 meters), the Siemens EPOC (9 meters) , Signature Elite Hemochron (3 meters), Avox 1000E (2 meters) and the VA’s LIS and electronic patient record system (Vista/CPRS). The software must have the capability to add more instruments as the need arises. The Technology License includes service, support, updates and hardware maintenance. The supply of Alere’s Informatics RALS Web3 for the use by the VANCHCS is governed by the terms and conditions of the Alere’s Informatics RALS Software System and Support Master Agreement.

The RRC service uses PC serial or Universal Serial Bus (USB) ports to communicate with a local Point-of-Care (POC) instrument or device on the one side, and the PC Ethernet port on the other side to link the device via the network to a remote RALS server. Data collected by this technology is stored on the user`s local drive until it is uploaded to a patient`s chart through, either unidirectional or bi-directional, Laboratory Information System (LIS). The procurement will include the following: 4 connections for i-STAT meters, 80 connections for Accucheck meters, 9 connections for the Siemens EPOC analyzers, 3 connections to the Signature Hemochron analyzers, and 2 connections to the Avox analyzers, data management for all devices, patient results, operators, consumables and reports from a single-system solution, results Interface-LIS HL7 Un-Solicited Results and ADT Interface (admit, discharge, transfer)-ADT In-Hospital Patient Verification.

The point of care testing program is required to have the oversight by the Ancillary Testing Coordinator by Joint Commission and VA Handbook 1106.1. The point of care program is a large program with over 900 participants. We need software that has the capabilities to monitor quality control and patient results. The software is important for the compliance program. Training for all personnel operating the data management system.

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

The VA Northern California Healthcare System has a requirement for Remote Automated Laboratory Systems (RALS) software technology. Base plus four (4) options years for the following items:

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

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

VANCHCS has the RALs system installed and the VA has purchased upgrades in preparation for the Cerner install coming up at all VA locations. VANCHCS currently has 74 Accuchecks, 4 iSTATS and 8 EPOCs installed. This procurement is to maintain the current connections and increase the number of connections and add new types of analyzers onto the contract. The new analyzers, Hemochrom and Avox are being added to ensure compliance with The Joint Commission (TJC) requirements of what information/data has to transfer to the patient account in CPRS.

The required software must be compatible with the following existing equipment: Roche Accuchek Inform II (80 meters) , the Abbott iSTAT (4 meters), the Siemens EPOC (9 meters) , Signature Elite Hemochron (3 meters), Avox 1000E (2 meters) and the VA’s LIS and electronic patient record system (VistA/CPRS). The software must have the capability to add more instruments as the need arises. The Technology License includes service, support, updates and hardware maintenance. The supply of Alere’s Informatics RALS Web3 for the use by the VANCHCS is governed by the terms and conditions of the Alere’s Informatics RALS Software System and Support Master Agreement. Abbott rapid Diagnostics Informatics, Inc’s (ARDx) RALS Software Technology is the only software that is compatible with the above equipment.

Accordingly, Abbott rapid Diagnostics Informatics, Inc’s (ARDx) is the only firm capable of providing the supplies described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

5. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Sources Sought Synopsis: Sources Sought Notice under 36C26123Q0408 was posted on Contract Opportunities from 3/1/2023-3/6/2023. The sources sought notice included the line items descriptions and quantities, and the draft statement of work (SOW). No responses were received as a result of the sources sought published notice.

Other Actions: The Contracting Officer sent an email to the manufacture of the RALS Software, asking if they have authorized resellers and/or if the software is available on an existing contract. ARDx confirmed the supplies are not on GSA or other existing contract and that they do not have any authorized resellers of the software. RALS Software is proprietary to ARDx.

Additionally, a search on GSA Advantage! for the RALS software yielded zero results.

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The Contracting Officer will determine price fair and reasonableness by comparing to existing/previous contract prices of the same supplies.

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

The Contracting Officer reviewed the market research history for the previous contract 36C26121P1043. The previous contract was sole sourced to ARDx for the same/similar requirement. It was determined that the RALS Software was proprietary to the OEM and only available on the open market.

The Contracting Officer sent an email to the OEM of the RALS Software, ARDx, asking if they have authorized resellers and/or if the software is available on an existing contract. ARDx confirmed the supplies are not on GSA or other existing contract and that they do not have any authorized resellers of the software. RALS Software is proprietary to ARDx.

The Contracting Officer posted a sources sought with the draft statement of work (SOW) to Contract Opportunities on 3/1/2023 with a close date of 3/6/2023, no responses received as a result of the sources sought notice.

The Contracting Officer conducted a search on Veteran Small Business Certification (VETCERT) for NAICS 513210, which yielded 701 results. However, this software is proprietary to the large business manufacturer.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

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

There are not other facts.

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

Abbott Rapid Diagnostics Informatics, Inc. (ARDx) 2000 Holiday Drive Charlottesville, VA 22901

10. 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 station and Contracting will continue market research for future requirements.

11. 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.

Effective Date: 02/01/2022 Page 1 of 9