Attach 05--P03 36C244-21-AP-2482_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: 36C244-21-AP-2482

1. Contracting Activity:

Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road Pittsburgh, PA 15215-1802

Purchase Request (VA2237): 595-21-4-024-0038 | Abbott ID Now COVID-19 Assay Kits | Lebanon VA Medical Center (LVAMC), 1700 South Lincoln Avenue, Lebanon, PA 17042-7829 | Contracting Agency:

Network Contracting Office 4

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

In accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR

13.501 Special Documentation Requirements, this Justification and Approval (J&A) is being issued to document the award of a firm-fixed-price (FFP) contract for Abbott ID Now COVID-19 Assay Kits. This award will be made on an Unrestricted, Brand Name Only solicitation in the Open Market. The assays are intended to aid in the diagnosis or ruling out of COVID-19.

These assay kits have been previously procured via a VA National Contract for the COVID-19 National Emergency. The supplies provided by this National Contract are only available through 09-30-2021 contingent on available inventory. These items are anticipated to become available via Federal Supply Schedule in the near future, but no date of award has been given. NCO4 has consulted the NAC Contracting Officer to check the status of the negotiations between the vendor and the VA National Acquisition Center (NAC). These were ongoing and not expected to be completed by September 30, 2021. Assay kits that this requirement will include are listed below.

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

The estimated value of the proposed supplies:

Lebanon VA Medical Center (LVAMC) has a Monthly Recurring requirement for delivery service of Abbott ID NOW COVID-19 Assay Kits, the assays are intended to aid in the diagnosis or ruling out of patients’ COVID-19 status.

REQUIREMENTS:

Abbott ID NOW COVID-19

• Manufacturer- Abbott Rapid DX (no substitutes)

• Product Number: 190-000

• Kit size-24 pouches with reagents per kit

• Quantity-Delivery of 30 kits each month

• Expiration dates shall be no less than 6 months from delivery date.

• One lot number of product is requested per shipment.

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

Revision 03 Date: 02/11/2021

This will be a 1year contract for 30 kits, each kit including 24 pouches with reagents per kit, at the price of per test, per kit.

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 testing materials are proprietary and not compatible with other instruments. Customer reports that Changing instrumentation would require a month-long validation and retraining of employees. The kits are patented and sold exclusively through Abbott Rapid Dx or their resellers.

Considering that LVAMC requires these assay kits to support an existing inventory of instrumentation for the testing of COVID-19, the duty station requires a contract in place from which to procure. This follow on contract will minimize disruption in lab testing for LVAMC. This justification will enable LVAMC to meet this requirement without exceeding the minimum time necessary and prevent a lapse in availability of critical testing materials currently provided by the strategic contract awarded by the SAC.

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

NCO4 has reviewed the following databases and took the following actions to determine vendors operating in the In-Vitro Diagnostic Substance Manuafacturing. At present, only Abbott Rapid DX, Original Equipment Manufacturer (OEM), manufactures and maintains this product and the authority to determine authorized distributors.

Small Business Administration (SBA) Dynamic Small Business Search (SBDS) Database.

NCO4 conducted a search of the SBA SBDS Database using NAICS Code 325413 and search terms “ID NOW COV” and “Abbott”. The first search yielded no results and the second produced the firm, As there is only one vendor, the “Rule of Two” does not apply.

Further review of the firm demonstrates that while they maintain Abbott Products in their inventory, listing for this particular item is not included on their catalog. In correspondence with the OEM, this firm is not an authorized distributor. Purchasing from a non-authorized distributor runs counter to VHA Policy regarding Gray Market distributors (VHAPM Part 813.106‐1/2).

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

Revision 03 Date: 02/11/2021

System for Award (SAM) Contract Opportunities (CO) Intent to Sole Source Notice. NCO4 released an Intent to Sole Source Notice on SAM CO on 01-14-2021. Five vendors replied but did not provide the necessary information or proof of capability to meet the requirement as stated in the notice.

These vendors were:.

First, provided an FDA data sheet for the product they were selling but did not address the Abbott ID NOW system (01-17-2021).

Second, provided only questions regarding the facility but did not address the Abbott ID NOW system (01-18-2021).

Third, briefly addressed antibody finger stick test but did not address the Abbott ID NOW system (01-22-2021).

Fourth, expressed interest but provided no information regarding their capability to meet the Abbot ID NOW requirement (01-27-2021).

Fifth, provided that the Original Equipment Manufacturer (OEM) Abbott was “taking all business direct” which was further confirmed by the OEM via separate correspondence (01/28/2021).

Original Equipment Manufacturer (OEM). NCO4 contacted the OEM, Abbott Rapid Diagnostics (Large) (06-28-2021). The National Government Accounts lead reports that while the firm maintains authorized distributors (Large) and (Large) and notes that the firms (Large) and (Large) have access, there are currently no firms that fall under the Small Business Administration’s socio-economic categories.

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

Reasonable:

Based on Market Research, NCO4 anticipates that more than one response will be received and will base the Fair and Reasonable decision on competitive quotes. Should only one quote be received NCO4 will evaluate in comparison to Market Research (Historical Pricing) and comparison of the proposed price with prices found reasonable on previous purchases in accordance with FAR 13.106-3(a)(2)(i) and (ii).

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

Market Research Was Not Conducted:

Se Section 6 for a complete listing of the Market Research conducted for this requirement.

As a result of the above Market Research, a Brand Name Only, Request for Quotation will be issued as a Combined Synopsis/Solicitation in the Open Market. The only anticipated responses will be from the OEM Abbott Rapid DX (Large) or the OEM’s authorized distributors (also Large).

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

This requirememt will be solicited on SAM Contract Opportunities as an Unrestricted, Brand Name Only, Combined Synopsis Solicitation in order to ensure Government transparency.

The CO has reviewed the considerations of the above‐referenced guidance in terms of the context of the subject procurement and has determined that it is in the best interest of the Government to purchase the item from the OEM or the OEM’s authorized distributors to preserve and guarantee the manufacturer’s warranty and servicing components.