Alinity M Consumables JA rev 1-SIGNED.pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 4 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C246-21-AP-0312

1. Contracting Activity: Department of Veterans Affairs, VISN 06, Durham VA Medical Center, NCO 06/RPO East, PR # 558-21-1-2173-0010

2. Nature and/or Description of the Action Being Processed: This procurement is for a new contract, sole source Firm-Fixed-Price (FFP), base plus 4 year Indefinite Delivery Contract (IDC) requirements contract with yearly delivery orders against the IDC. This action is in support of COVID-19 PCR testing.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The proposed action is to provide reagents and consumables for the Alinity M system manufactured by Abbott Laboratories.

The consumables will allow the Alinity M to test for SARS-COV-2 (COVID-19), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human immunodeficiency virus (HIV)-1, and sexually transmitted infections.

The period of performance is 5 years. Base Year $197,820.20, Option Year (OY) 1 $197,820.20, OY2 $197,820.20, OY3 $197,820.20, OY4 $197,820.20 = Grand Total is $989,101.00. The total estimated value of the proposed action is $989,101.00 (inclusive of options). Delivery periods are as follows:

Base Year 12/1/2020 thru 11/30/2021, OY1 12/1/2021 thru 11/30/2022, OY2 12/1/2022 thru 11/30/2023, OY3 12/1/2023 thru 11/30/2024, OY4 12/1/2024 thru 11/30/2025.

Estimated quantities for 1 year:

PRODUCT

List Number Product Description Price (Kit) Volume (Kit) Annual Spend

HCV IVD

08N50-095 ALNTY M HCV AMP KIT US $5,764.00 10 $57,640.00

08N50-085 ALNTY M HCV CTL KIT US $978.00 22 $21,516.00

08N50-075 ALNTY M HCV CAL KIT US $1,200.00 2 $2,400.00

HCV Subtotal: $81,556.00

HIV IVD

08N45-095 ALNTY M HIV-1 AMP KIT US $5,016.00 8 $40,128.00

08N45-085 ALNTY M HIV-1 CTL KIT US $950.00 22 $20,900.00

08N45-075 ALNTY M HIV-1 CAL KIT US $1,200.00 2 $2,400.00

HIV Subtotal $63,428.00

HBV IVD

08N47-095 ALNTY M HBV AMP Kit $6,144.00 1 $6,144.00 08N47-085 ALNTY M HBV CTRL Kit $1,200.00 2 $2,400.00 08N47-075 ALNTY M HBV CAL Kit $1,200.00 2 $2,400.00

HBV IVD $10,944.00

SARS-CoV2 EUA*

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 4 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

09N78-095 Alinity m SARS-CoV-2 AMP Kit $5,568.00 2 $11,136.00 08N45-085 Alinity m SARS-CoV-2 CTRLKit $950.00 1 $950.00

SARS-CoV2 EUA* $12,086.00 Alinity Sample Preparation & Consumables

09N12-001 ALNTY M SAMPLE PREP KIT $400.00 12 $4,800.00

09N20-001 ALNTY M LYSIS SOLUTION $400.00 12 $4,800.00

09N20-003 ALNTY M DILUENT SOLUTION $780.64 3 $2,341.92

09N20-004 ALNTY M VAPOR BARRIER S $400.00 1 $400.00

09N26-001 ALNTY M PIPETTE TIPS 50 $1,713.60 2 $3,427.20

09N26-002 ALNTY M PIPETTE TIPS 10 $1,316.76 2 $2,633.52

09N26-010 ALNTY M INTEGR REACTION UNIT $500.00 20 $10,000.00

09N26-012 ALNTY M WASTE BOX $466.37 1 $466.37

09N26-020 ALNTY M IRU WASTE CONTAINER $937.19 1 $937.19

Disposables Subtotal: $29,806.20 Annual Customer Purchase Commitment: $197,820.20

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 Abbott Alinity M system can only utilize Abbott Alinity M reagents and consumables in order to perform the desired tests for HBV, HCV, HIV-1, and SARS-CoV-2. Correspondence and sole source letter received from Abbott show that they are the sole source for the consumables for their proprietary Alinity M system and they have no partnerships with small business to provide the requested items. The property is deemed to be available only from the original source and shall be procured through other than competitive procedures.

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

$197,820.20

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 4 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

Market research was conducted, details of which are in the market research section, paragraph 8 of this document. None of these efforts have yielded additional potential sources. There is no competition anticipated for this procurement.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Price reasonableness will be based off of the Independent Government Cost Estimate.

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. VA Vendor Information Pages (VIP) database was searched and found no potential SD/VOSB potential vendors.

Correspondence was sent to vendor Abbott (Large Business) on if they had partnerships with any small business for the distribution of consumables for their proprietary system Alinity M. Abbott responded all consumables for the Alinity are only available thru Abbott. GSA library, GSA advantage, NAC, SAC, ECAT, FPDS, and Beta SAM were all searched and found no mandatory or existing contracts to utilize. The procurement history for the Alinity M consumables show Abbott as the only source able to provide the product. Additionally, Abbott does not provide subcontracting opportunities for the consumables being procured as all procured consumables need to be ordered through Abbott.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Intent to sole source notice was posted to www.Beta.SAM.gov on 10/29/2020 and closed on 11/5/2020, with no responses.

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: The Contract Specialist and acquisition team will continue to conduct market research in order to overcome any barriers to competition.

PM Part 813.5 SAP for Certain Commercial Items Page 4 of 4 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

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.

John Summers Date Contracting Officer NCO 6/RPO East

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.

Keeshia Newman Date NCO/PCO 06 Division Chief

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($700K to $7 million (or $13.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Joseph P. Maletta Date Executive Director, RPO East Head of Contracting Activity (HCA)

John J. Summers 405995

Digitally signed by John J.

Summers 405995 Date: 2020.11.10 09:53:49 -05'00'

KEESHIA R

NEWMAN

254911

Digitally signed by

KEESHIA R

NEWMAN 254911

Date: 2020.11.10 10:43:18 -05'00'