P03 - Attachment 1 FAR 13.5 Sole Source Justification - Over SAT Signed BC.pdf

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

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257-24-AP-2071 JOFOC Log Number: FY24-NCO-17-2043

1. Contracting Activity: Department of Veterans Affairs, VISN 17, VA North Texas VA Health Care

System (NTVAHCS), 4500 South Lancaster Road, Dallas, TX 75216, NCO 17, Pathology and Laboratory Medicine Service.

PR IFCAP Number: 549-24-4-057-0028

2. Nature and/or Description of the Action Being Processed: This procurement is to obtain a new firm fixed price contract for base plus four option years technology license that includes service, support, and maintenance updates for the RALS Web3 computer software interface for the Instrumentation Laboratory Hemochron Signature Elite, Instrumentation Laboratory AVOXimeter 4000, Roche Accu- Chek Inform II, and the Siemens Clinitek Status analyzers. The RALS data management system allows the ability to capture and review the quality control and patient results electronically on a continued and expeditious basis during inspections. RALS improves the process of getting patient results to the electronic patient record without delay enabling the caregiver to treat the patient in a timely manner. This data management system also allows for device and operator management.

The RALS interface enhances the laboratory’s ability to identify patient identification errors in a timely manner. This data management system will capture data and generate reports which will enable the laboratory to meet the requirements of regulatory agencies (VA, The Joint Commission and CLIA). The inability of ancillary testing coordinators to review and retrieve results electronically creates a great amount of inefficiency, while also adding to the amount of time dedicated visiting each site to download results and update analyzer information. This contract will replace the current contract 36C25719P1041 which ends 7/6/2024.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This action is to obtain data management software system for the following analyzers: Instrumentation Laboratory Hemochron Signature Elite, Instrumentation Laboratory AVOXimeter 4000, Roche Accu-Chek Inform II, and the Siemens Clinitek Status. These analyzers are used at the point-of-care for patient testing to measure low and high activated clotting time, oximetry, glucose, and urine results. The new contract will replace the current contract 36C25719P1041 which ends 7/6/2024. Period of Performance will be base plus four option years 07/07/2024-07/06/2029. The estimated amount for the base year is $61,653.00 and $277,438.50 for the base year plus four option years.

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

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( ) 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

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

a. Only One Responsible Source (FAR 6.302-1) – This is follow-on contract for the RALS interface which enhances the laboratory’s ability to identify patient identification errors in a timely manner continued development or production. Any delays in implementing this highly specialized software would be unacceptable due to the need for fulfilling the North Texas Health Care System’s requirements. As such, adverse patient outcomes would be unavoidable.

The requirement must be capable of the following unique qualifications:

• Is vendor neutral which eliminates the need for device-specific data managers. This allows for a centralized system for managing patient and quality control data from several point-of-care devices.

• Interfaces the following analyzers to the VistA/CPRS LIS systems: Instrumentation Laboratory (IL) Hemochron Signature Elite and AVOXimeter 4000, Roche Accu-Chek Inform II, Abbott i-Stat, Siemens Clinitek Status.

• Direct to Device connectivity- (Does not require a device specific data managers/drivers)

• Is capable of “Manual Test Entry” for accepting urine pregnancy test results.

• Minimizes search time using smart filters and allows for easy review and retrieval of data.

• Provides multiple levels of authority to ensure security.

• Uses HL7 result interface, ADT (admit, discharge, transfer) in-hospital patient verification and

PPI (positive patient identification).

• Has web remote access capabilities.

• Captures patient results, quality control, linearity, operators, certifications, and device configurations electronically.

• Allows the ability to manage, update, review and troubleshoot device issues remotely.

• Provides free upgrades at no cost to the medical center.

• Provides technical support 24 hours a day, seven days a week.

• Has national VPN access.

• Features at-a-glance device management status (whether a device has downloaded)

• Allows the ability to access flagged results that require review prior to upload to the LIS.

• Allows direct-to-device interfacing for uploading or updating device operators and provides operator certification management.

Abbott Rapid Diagnostics Informatics, Inc. (Abbott) is the only firm capable of providing the needed services. They provided a proprietary letter dated June 25, 2024, as described in Section 3 above.

Additionally, no other vendor can meet the required time frame and would cause a break in continuity of services should award be delayed.

https://www.acquisition.gov/far/part-6#FAR_6_302_1

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6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted in accordance with FAR Part 10 and VAAR part 810 to determine if there are SDVOSBs, VOSBs, and small businesses that can provide the required services. Abbott is the incumbent vendor and can continue to provide the RALS system.

Siemens Healthineers LTD (Siemens) could potentially meet the needs of the government by implementing a new data management system called UniPOC. This information was presented to the Contracting Officer’s Representative (COR), and they stated this system does not provide for manual entry for urine drug screen and customer service is limited. Also, Siemens stated would not be able to implement this system by the need date of July 7, 2024. This would cause a disruption in services and would not be in the best interest of the government.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer has anticipated the proposed prices will be fair and reasonable. The prices of these services will be compared to prices of other NCO 17 procurements for RALS services.

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 through VetCert, FPDS, SAM.gov, GSA Global Supply, and a Sources Sought Notice published on SAM.gov.

• A search of the VetCert database using NAICS Code 541512 resulted 4,767 vendors. None are able to perform the needed services due to the proprietary nature of this requirement.

• A search of FPDS only found two businesses in the last 18 months that provides RALS. See below:

1. Abbott Rapid Diagnostic Informatics, Inc (large business)

2. Alere Informatics (small business) has been acquired by Abbott Rapid Diagnostics.

• A search of SAM.gov for RALS System found several notices of intent to Sole Source to Abbott, the most recent being on June 21, 2024. Other notice numbers found are 36C25624Q1003, W81K02-24-Q-0046 and 36C25624Q1003.

• A search of SBA’s Dynamic Small Business Search (DSBS) using NAICS Code 541512 and keyword “RALS Informatics” resulted in no businesses that could provide this requirement.

• A search of GSA Global Supply for RALS System Informatics resulted in (0) zero vendors were able to provide this requirement.

Sources Sought Notice number 36C25724Q0391 was posted from 04/28/2024 - 05/12/2024.

Responses were received from two vendors: Abbott and Siemens. As stated in Section 6 above, Abbott is the incumbent vendor and can continue to provide the RALS system. Siemens could potentially meet the needs of the government by implementing a new data management system called UniPOC. This information was presented to the Contracting Officer’s Representative (COR), and they stated this system does not provide for manual entry for urine drug screen and customer service is limited. Also, Siemens stated would not be able to implement this system by the need date of July 7, 2024. This would cause a disruption in services and would not be in the best interest of the government.

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

The software license agreement ensures continuity of services for this medical center utilizing the server that is already in place. The term of this license agreement shall commence as of the license effective date and shall remain in effect as long as the STS is licensed hereunder. The term of each license granted shall remain in effect for the duration of the purchase order. The Technology License includes service, support, updates, and hardware maintenance. The supply of RALS-RALS Web3 for use by the customer is governed by the terms and conditions of the RALS Software System and Support Master Agreement.

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

Firm 1: Abbott Rapid Diagnostics Informatics

2000 Holiday Drive Charlottesville, VA 22901 (Large Business) POC: Cody Moubray Email: cody.moubray@abbott.com Phone: 1-434-326-8790

Firm 2: Siemens Healthineers (Large Business) 14 Seocho-Daero 74-Gil, Seocho-Gu Seoul, South Korea 03737 POC: Lisa Vitry, MT (ASCP) Email: lisa.vitry@siemens-healthineers.com Phone: 1-720-327-3148

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:

For future acquisitions, an extensive review of possible vendors will be conducted to ensure the best value to the government.

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.

William J. Scott, EdD, MS, MLS (ASCP)CM Asst. Laboratory Manager/Education Coordinator North Texas Veterans Health Care System mailto:cody.moubray@abbott.com mailto:lisa.vitry@siemens-healthineers.com

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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.

Robyn Nussbaum Contracting Officer Network Contracting Office 17

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.

James C. Easley Branch Chief

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