Atch 1 FAR 13.5 Sole Source Justification - Over SAT_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >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: 36C244-22-AP-6509

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Lebanon VA Medical Center 1700 S.

Lincoln Ave. Lebanon, PA 17042-7529. PR: 595-23-1-480-0007

2. Nature and/or Description of the Action Being Processed: The procurement is for one (1) P/N

91.0021 Leica BOND-PRIME Processing Module 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. The action being reviewed and approved will be awarded as a new contract and the type of contract planned will be a Firm-Fixed-Price.

3. Descr : The Lebanon VAMC has a new brand name request for one (1) P/N 91.0021 Leica BOND-PRIME Processing Module. The BOND- PRIME staining platform delivers high productivity, featuring Universal Access, and can seamlessly adapt to your incoming workflow demands whether it be batch, continuous, single slide or STAT cases, or a combination of all the above.

Coupled with the ability to produce high-quality, crisp, clean staining with an average IHC TAT of 90 minutes, the BOND-PRIME staining platform lets you transcend expectations for quality, timeliness, and diagnostic productivity.

Line Item Part No. Description Qty 0001 91.0021 BOND-PRIME Processing Module 1 0002 49.0644.A BOND System Control Kit (7.0/W10 IoT) 1 0003 91.1701 BOND-PRIME PM Add Kit-US 1 0004 8120973 NXT 1500 VA Line Conditioned On Line UPS 1

The estimated value of the proposed action is $

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

Effective Date: 02/01/2022 Page 2 of 5

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

5.

the Use of the Authority Cited Above (applicability of authority): BOND-PRIME Processing Module is peculiar to one manufacturer, Leica Microsystems Inc. (Original Equipment Manufacturer) (Large Business). The Lebanon VA Laboratory has been using Leica BOND stainers for many years and finds them to be the most reliable. The Leica BOND stainers also provide the quickest processing times supporting VA requirements for timely results reporting and patient care. Maintaining a standard of continuity, quality, and dependability in our laboratory department is paramount to providing the quality of care required for veterans. This continuity will also result in laboratory personnel using the Leica stainers they have been trained with and have become comfortable using. To go to another slide stainer would jeopardize the standard of timely results our physicians have come to expect and the standards to which the VA is held regarding timely results preventing dangerous delays, timely diagnosis, and lifesaving patient care.

Accordingly, Leica Microsystems Inc. is the only firm capable of providing the supplies and services duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought synopsis (36C24422Q1295) was issued from 09-23-2022 to 09-30-2022 for the delivery order of one (1) P/N 91.0021 BOND-PRIME Processing Module. This effort produced one (1) response: Government Scientific Source, Inc. (Small Business).

The Contract Specialist (CS) contacted the OEM to verify authorized resellers. The OEM responded by verifying one (1) vendor Government Scientific Source, Inc. (Small Business) is the only authorized reseller available.

The results of the screening process and rationale follow: Government Scientific Source, Inc. (Small Business) is determined acceptable based on the vendor being an Authorized Distributor of the required items as demonstrated by their Authorized Distribution Letter.

Under the authority of 10 USC 2304(c)(1) it is this survey of the marketplace that confirms our assumptions regarding the capability of industry to meet our needs.

As a result of the above market research and adhering to the Non-Manufacturer Rule, an Unrestricted solicitation will be posted to the Open Market.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be considered fair and reasonable. This determination is based on the following:

1. A comparison of Proposed Prices with Prices Found Reasonable on Previous Purchases (FAR 13.106-3(a)(2)(ii).

Effective Date: 02/01/2022 Page 3 of 5

2. A comparison to the Independent Government Cost Estimate (IGCE) (FAR 13.106-3(a)(2)(vi).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The results of market research conducted pursuant to FAR Part 10, VAAR Part 810 and PPM 2016-05 (REVISED AUG 2019) are as follow:

A Sources Sought synopsis (36C24422Q1295) was issued from 09-23-2022 to 09-30-2022 for the delivery order of one (1) P/N 91.0021 BOND-PRIME Processing Module. This effort produced one (1) response: Government Scientific Source, Inc. (Small Business).

The Contract Specialist (CS) contacted the OEM to verify authorized resellers. The OEM responded by verifying one (1) vendor Government Scientific Source, Inc. (Small Business) is the only authorized reseller available.

BOND-

Small Business Search found zero (0) vendors.

eLibrary, Interagency Contract Directory Portal, Defense Logistics Agency Troop Support ECAT Medical Electronic Catalog, National Acquisition Center Catalog Search Tool (CCST), and VA Supply Chain Medical Catalog found zero (0) vendors.

The Federal Procurement Data System-Next Generation was used for market research for an examination of the acquisition history and experience with the marketplace under previous acquisitions for the same items.

System-Next Generation found one (1) vendor: Government Scientific Source, Inc. (Small Business).

This Brand Name Justification is in accordance with 11.105(a)(1) Items Peculiar to One Manufacturer. This justification shall be posted to Contracting Opportunities with the solicitation in accordance with 11.105 (3).

This Brand Name requirement will be solicited in accordance with FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented for restricting competition on this non-manufacturer rule database found one (1) waiver.

Per PPM 2016-05, Implementation of the Veterans First Contracting Program as a Result of the U.S.

Supreme Court Decision: §8127 is mandatory, not discretionary and its text requires the Department to apply the Rule of Two to all contracting determinations. In order to meet the VA Rule of Two, the CS reviewed the Vendor Information Pages (VIP) database in accordance with VAAR Class Deviation 810.001-70 to determine if two or more service-disabled veteran-owned businesses (SDVOSBs) and veteran-owned small businesses (VOSBs), in NAICS code 334516, are listed as verified in the VIP database. Per VAAR 810.002, a keyword search of North American Industry Classification System

Portal, and SBA Dynamic Small Business Search identified zero (0) vendors.

Effective Date: 02/01/2022 Page 4 of 5

There are no BAA/TAA/Exceptions to BAA (See FAR 25) needed for this procurement.

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis 36C24422Q1295 of the proposed acquisition, advising the industry of the pending acquisition and soliciting inquiries from interested parties. Market Research has determined the authority of only one (or a limited number of) responsible sources Leica Microsystems Inc. (Original Equipment Manufacturer) (Large Business) and Government Scientific Source (Small Business) are the only entities that can fill customer needs based on Brand Name requirements.

Based on the above Market Research and the Non-Manufacturer Rule, the CS anticipates a Brand Name Unrestricted Solicitation on the Open Market.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Leica Biosystems (Original Equipment Manufacturer) (Large Business) is the only manufacturer of the BOND-PRIME Processing Module therefore this will be posted as other than full and open competition. Full and open competition is not being used due to one (1) vendor being able to provide this Brand Name Only requirement. When other exceptions from the requirement to obtain full-and-open competition are relied upon, market research is limited to an examination of the acquisition history and experience with the marketplace under previous acquisitions for the same or similar items. In all instances, a current check of VIP was performed and identified zero (0) vendors.

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

Firm 1: Leica Microsystems Inc. (Large Business)

14008 Collections Center Drive Chicago, IL 60693 Jennifer Grill jennifer.grill@leicabiosystems.com 847-236-3009

Firm 2: Government Scientific Source, Inc. (Small Business) 12351 Sunrise Valley Dr Reston, VA 20191 Annette Cheltenham acheltenham@govsci.com 703-362-2821

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 actions will be taken to foster competition for future acquisitions of the supplies being acquired.

Only one (1) manufacturer is able to fulfill this Brand Name Only requirement.

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.