P03 PM_Part813.5_Atch1_FAR13.5_JA_OVER_SATs_Redacted.pdf

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:36C261-21-AP-4270

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional

Procurement Office West, Network Contracting Office 21, McClellan, CA 95652-1012 on behalf of VA Sierra Pacific Network (VISN 21), VA Las Vegas Medical Center.

2237: 593-22-1-968-0011

2. Nature and/or Description of the Action Being Processed: This procurement is for a sole source to Roche Diagnostic Corporation for a clinical laboratory immunohistochemistry (IHC) and an in-situ hybridization (ISH) analyzer that is a continuous, automated slide staining system for analysis, data review, and reporting of IHC/ISH test results. The estimated value of the sole source is for a one (1) year base period of performance, and three (3) one (1) year option periods.

When the quote received from the vendor on 11/30/21 was sent to the VA Las Vegas Medical Center for evaluation, and since the procurement packet was submitted to Contracting in June 2021, the (Cost per test): Per test ICH/ISH cost per test all-inclusive of instrumentation, reagents, consumables requirements of the Medical Center changed, some tests were added and removed.

Option Year three (3) is added to get better pricing from the vendor.

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 the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This contract will be a four year contract, one (1) year base period of performance, and three (3) one (1) year option periods for automated IHC/ ISH slide staining system (Cost per test): Per test ICH/ISH cost per test all-inclusive of instrumentation, reagents, consumables, service, and training.

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

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 4

Revision 03 Date: 02/11/2021

( ) 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):

Roche Diagnostics’ BenchMark ULTRA system is the only automated IHC/ ISH slide staining system that will fit in the “footprint” or space that’s available in the current lab, is compatible with the configuration of the utilities, and is already validated. Due to the current lab’s electrical and plumbing systems, the facility is unable to install any new equipment until construction is completed to correct any operational infrastructure deficiencies. If this analyzer were not procured, there would be a cost associated with sending lab specimens outside the lab for testing if the Roche Diagnostics equipment were not put into place with a degradation of patient care due to the increased wait times for lab results.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Roche Diagnostics’ BenchMark ULTRA system is the only automated IHC/ ISH slide staining system that will fit in the “footprint” or space that’s available in the current lab, is compatible with the configuration of the utilities, and is already validated. Within fourteen days of award, an award notice with the Justification and Approval will be posted to betaSAM. The requirement will be synopsized to contract opportunities with a notice of intent to sole source to Roche. The synopsis will include the statement found in FAR 5.207(c)(16)(ii).

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated unit rates can be found fair and reasonable based on comparison to previous contracts awarded for Automated IHC/ ISH slide staining system (Cost per test).

Vendor gives better pricing to a four contract than a three year contract.

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

Market Research Was Not Conducted:

Market research efforts also include FPDS, Contract Opportunities, VA NAC Catalog, and SAM. A VIP search utilizing NAICS code 325413 and keyword “Roche” returned zero (0) results.

A query utilizing the contractor’s name, “Roche” on the VA NAC catalog brought up no results. An FPDS query revealed that there are no current existing contract that this facility is able to utilize. A query was made on Contract Opportunities utilizing keywords “Roche Benchmark”. It appears that Roche Diagnostics, who is the sole manufacturer and sole distributor. Due to the justification for a single source procurement (See #5), SAM was queried for DUNS: 001824663 Roche Diagnostics Corporation. They are currently active and have no exclusions.

Roche equipment is small enough to fit into the limited space at the station. The station partner has reviewed other manufacturer's equipment and Roche is only one for its size and operates the way the station prefers.

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 4

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: Roche Diagnostics Corp. 9115 Hague Rd. Indianapolis, IN 46256

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:

No other vendor is able to service the VA Southern Nevada Healthcare System (VASNHCS) Las Vegas for automated IHC/ ISH slide staining system for now. If this analyzer were not procured, there would be a cost associated with sending lab specimens outside the lab for testing if the Roche Diagnostics equipment were not put into place with a degradation of patient care due to the increased wait times for lab results.

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.

Berneithia Sibert Date Administrative Officer VHA VA Las Vegas Medical Center

BERNEITHIA

SIBERT

Digitally signed by

BERNEITHIA SIBERT

Date: 2021.12.16 14:02:06 -08'00'

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

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.

Mandy L. Thompson Date Contracting Officer Network Contracting Office (NCO) 21

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.

Felicia A DeMita Date Division II Chief Network Contracting Office (NCO) 21

Mandy L. Thompson 130808

Digitally signed by Mandy L. Thompson 130808 Date: 2021.12.17 12:04:17 -08'00'

Felicia A. Demita 668653 Digitally signed by Felicia A.

Demita 668653 Date: 2021.12.17 14:30:46 -08'00'