JA - AMA VIDAS Lease 36C257-21-AP-0607.pdf

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 5 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

Acquisition Plan Action ID: 36C257-21-AP-0607 RPOW JOFOC Tracking Number: 2021-01-20T12:11:05

1. Contracting Activity:

Department of Veterans Affairs, VISN 17, Amarillo VA Healthcare System (AVAHCS), Pathology and Laboratory Medical Services (P&LMS) at 6010 Amarillo Blvd. West, Amarillo, TX 79106. Contracting Activity: Network Contracting Office 17. Purchase Request Number: 504-21-2-044-0064.

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

This procurement is for the lease of a Biomerieux VIDAS 3 and reagents for the testing of infectious diseases in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from FAR part 6, but still require a justificiation using the format of FAR 6.303-2. A new contract will be awarded as a Firm Fixed-Price contract with a base plus four (4) option years will be awarded for the VIDAS 3 lease and reagents.

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

The lease of a VIDAS 3 Analyzer, reagents, and services for the AVAHCS P&LMS to perform critical care and infectious disease testing, to include tests for secondary infectious diseases associated with COVID-19. Currently, the P&LMS is utilizing the Biomerieux Mini VIDAS, and is seeking to upgrade to a VIDAS 3. All of the supplies currently in use on the Mini VIDAS are compatible with the VIDAS 3.

The upgrade to the VIDAS 3 requires no new reference ranges, testing builds, and no extensive training on the new analyzer. The VIDAS 3 is also currently utilized at the South Texas and Central Texas Veterans Healthcare Systems. The procurement of the VIDAS 3 for the AVAHCS coincides with compliance of VHA Directive 1761(2), Supply Chain Inventory Management, furthering the standardization of infectious disease analyzers and reagents within VISN 17.

The table below contains the items required by the AVAHCS P&LMS:

Description Quanity Estimated Annual Value

Procalcitonin 30450-01 3000 units/ 50 boxes/ 60 tests/ box $54,000.00 Measles IgG 30219 120 units/ 2 boxes $403.20 Mumps IgG 30218 120 units/ 2 boxes $423.60 Rubella IgG 30226 120 units/ 2 boxes $496.80 Varicella IgG 30217 120 units/ 2 boxes $410.40 H.pylori 30192-01 120 units/ 2 boxes $806.40 Vidas Assay Dilution cup X44 412500 176.0 cups/ 10.5 boxes/ 44 cups/ box $66.88 Sample tip Vida x 2304 412501 6912/ 3 boxes/ 2304 tips $622.08 Clean Lliner VIDAS X 50 412502 50 units / 1 box /50 per box $32.00 VIDAS 3 Empty vials 415368 3 units $0.87 Utility Cart 27217 1 unit $0.00 Vilink remote Acces Software 4700027 1 unit $0.00 Warranty Enhance-Vidas 3 Analyzer WE- 4702895 2 units $0.00

Vidas 3 analyzer 4702895 1 unit $0.00 Total Estimated Annual Cost $57,262.23

ACCORDANCE WITH FAR 13.5

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 5 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

The total estimated value, including options years and option to extend services, is $314,942.27.

The anticipated period of performance, including option years, is 3/20/2021-3/19/2026.

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

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

The VIDAS 3 analyzer, reagents, and incidental maintenance services are proprietary to Biomerieux, Inc. The VIDAS 3 is a highly specialized system used to test for highly infectious diseases such as measules, mumps, rubella, varicella, and sepsis, a secondary condition as a result of COVID-19. The VIDAS 3 allows for multiple assay protocols to be run at the same time, starting at the same or different times. The manual processes for the analyzer are efficient, taking approximately two (2) minutes per sample by personally with varying levels of training. The analyzer’s pipettor action, calibration, and on-board dilution are automated, decreasing the processing time of samples. The VIDAS 3 provides on-demand results; batching is not required to achieve operational efficiency.

Accordingly, Biomerieux, Inc., is the only firm capable of providing the supplies in services described in Section III above without the AVAHCS experiencing substantial duplication of cost that cannot be recovered through competition and unacceptable delays in fulfilling its requirements. If the requirement is open to competition, there is the potential of an undue delay as there will be a need for validation and parallel studies to determine if there is “equal” items that can provide the same testing within the same range as required by the AVAHCS P&LMS. Additionaly, competing this requirement could cause a break in in-house testing, preventing the diagnosis of highly infectious diseases of veteran patients, and potentially exposing other veterans and facility employees to acquire the disease(s).

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. The results of this effort to determine if the VA Rule of Two could be met as well as finding other potential vendors capable of providing the required supplies and services are described in Section VIII below.

ACCORDANCE WITH FAR 13.5

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 5

A Sources Sought Notice, 36C25721Q0327, was posted on 1/13/2021 and closed on 1/19/2021. The Notice described the need for the lease of a VIDAS 3 and the purchase of associated reagents for a base plus four (4) option year contract for the period of 3/20/2021-3/19/2026. No responses were received in response to this Notice.

Other actions considered were to post a solicitation unrestricted on to the open market. However, market research and the Sources Sought Notice did not show any other potential vendors capable of providing the required supplies and services at a fair and reasonable price.

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

The CO anticipates that the cost will be considered fair and reasonable. The pricing of leasing the VIDAS 3 analyzer, reagents, and incidental services was compared to the cost of purchasing the analyzer, reagents and supplies. The cost of purchasing the reagents is based upon current GSA Federal Supply Schedule pricing. For the base period, the cost of leasing the equipment and purchasing reagents and incidental services is $29,845.44 (or a percent change in cost of 52.2%) less than purchase of the VIDAS 3 and its reagents. The cost difference for leasing each option year is $8,728.00 (percent change in cost 15.2%) less than purchasing reagents and incidental 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 pursuant to FAR part 10, VAAR 810.001-70, and VA PPM 2016-05.

The VIP database was searched using NAICS Code 532490 and keywords “biomerieix” and “vidas.”

Neither search yielded any SDVOSBs or VOSBs.

GSA was searched and schedule 532490L (Laboratory Maintenance, Repair, Leasing and Warranties) was found. The schedule contains 42 vendors: 28 small businesses and 14 large businesses. The catalogs of the vendors on the schedule were searched; none of the vendors had products manufactured by Biomerieux, Inc., on their schedules.

The DSBS database was searched using NAICS Code 532490 and keyword “vidas” and yielded no results.

According to FPDS, there are no recent leasing purchases of the VIDAS 3 equipment and purchase of supplies and incidental services. The most recent contracts in FPDS are for the purchase of equipment, reagents, and maintenance/ repair services. A general Internet search was conducted and resulted in only one vendor, Biomerieux, Inc.

Currently, there are two active contracts for facilities in VISN 17 relating to the purchase of Vidas 3 supplies (South Texas Veterans Healthcare System and Central Texas Veterans Healthcare System).

Each contract was for the purchase of reagents, and supplies. The contract for the Central Texas VA, 36C25719F0217, was for the purchase of the Vidas 3, reagents, and annual maintenance. The South Texas VA contract, 36C25719F0048, is only for the reagents. Both contracts were awarded to Biomerieux, Inc., as sole source contracts using FAR 13.5 procedures.

ACCORDANCE WITH FAR 13.5

PM Part 813.5 SAP for Certain Commercial Items Page 4 of 5

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

The Vidas 3 analyzer utilizes reagents that are compatible with the current Mini Vidas analyzer, but is able to meet the increased need for testing of highly infectious diseases, particularly the Procalcitonin test which is used with patients that have tested positive for COVID-19 to determine if the patient has sepsis. If the P&LMS at the AVAHCS were unable to obtain the equipment lease and services, the laboratory would have to send out tests instead of conducting them in-house, potentially increasing the likelihood of patients spreading highly infectious diseases as a delay in test results would occur.

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

Biomerieux, Inc.

100 Rodolphe St.

Durham, NC 27712 Consuelo Wagner 919-620-3363 consuelo.wagner@biomerieux.com

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:

Critical Care and Infectious disease testing are growing at a rapid pace. Manufacturers are constantly putting new products out in the market. The AVAHCS P&LMS is actively searching for better technology to serve the veterans. However, currently, it is in the best interest of the Government to seek a CPRR contract with Biomerieux, Inc.

ACCORDANCE WITH FAR 13.5

PM Part 813.5 SAP for Certain Commercial Items Page 5 of 5

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.

Brenda Brock Date Laboratory Manager

P&LMS, AVAHCS

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.

Isela Loveless Date Contracting Officer

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Michael J. Tusinger Date Branch Chief, Services III

Network Contracting Office 17

1-25-2021

Brenda J.

Brock 177750

Digitally signed by Brenda J. Brock 177750 Date: 2021.01.25 11:13:50 -06'00'

Isela P. Loveless 1565206

Digitally signed by Isela P. Loveless 1565206 Date: 2021.01.27 13:01:03 -06'00'

Michael J.

Tusinger 410059

Digitally signed by Michael J. Tusinger 410059 Date: 2021.01.28 08:55:25 -06'00'