Attachment 1 Sole Source Justification Over SAT redact_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Last Updated: 02/01/22

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C263-22-AP-3704

1. Contracting Activity: Department of Veterans Affairs, VISN 23, Medical Center Laboratories

(indicated below) has a requirement for reference laboratory testing for Nodify Lung Nodule Risk Assessment composed of CDT and XL2 testing.

VISN 23 laboratories:

1. Fargo VA Health Care System; Fargo, ND

2. VA Black Hills Health Care System, Hot Springs, SD

3. VA Black Hills Health Care System, Fort Meade, SD

4. VA Nebraska-Western Iowa Health Care System, Omaha, NE

5. St. Cloud VA Healthcare System, St. Cloud, MN

6. Sioux Falls VA Health Care System, Sioux Falls, SD

7. Iowa City VA Health Care System, Iowa City, IA

8. Minneapolis VA Health Care System, Minneapolis, MN

9. VA Central Iowa Health Care System, Des Moines, IA

2. Nature and/or Description of the Action Being Processed: This procurement is for Nodify Lung

Nodule Risk Assessment composed of CDT and XL2 testing. The estimated period of performance is date of award through five years. The request is for an new contract firm-fixed price IDIQ.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Nodify Lung Nodule Risk Assessment is a blood-based biomarker in patients with pulmonary nodules. Using a blood-based antibody assay, one can determine the likelihood of a pulmonary nodule to be malignant or benign therefore re-classifying risk in order to improve management and avoid unnecessary procedures and/or delay in diagnosis. Incorporating this blood test will benefit improving risk stratification on patients with lung nodules and potentially avoiding procedures complications and/or delay in treatment.

Item # Qty Price Extended

Amount 0001 50 0002 50

1001 50 1002 50

2001 50 2002 50

3001 50 3002 50

4001 50 4002 50

NODIFY LUNG XL2 CPT 0080U Option Year One

NODIFY LUNG CDT CPT 81599 Option Year Four NODIFY LUNG XL2 CPT 0080U Option Year Four SUBTOTAL (Products)

NODIFY LUNG CDT CPT 81599 Option Year Two NODIFY LUNG XL2 CPT 0080U Option Year Two

NODIFY LUNG CDT CPT 81599 Option Year Three NODIFY LUNG XL2 CPT 0080U Option Year Three

Description/Part Number* NODIFY LUNG CDT CPT 81599 Base Year NODIFY LUNG XL2 CPT 0080U Base Year

NODIFY LUNG CDT CPT 81599 Option Year One

Last Updated: 02/01/22

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):

Biodesix owns the patent for the highly specialized tests requested, does not have any affiliation with larger labs that have VISN 23 contracts and therefore cannot be sent through them, and does not have any authorized resellers.

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

Market research supports Biodesix INC is the only vendor capable of providing this service. An intent to sole source notice 36C26322Q0717 was issued publicly on sam.gov from 7/5/22-7/25/22. No other sources expressed interest or capability to provide for this requirement. These tests are proprietary to Biodesix INC.

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

Reasonable:

Biodesix INC has been awarded 9 actions from 2015-2022. This provides a history of pricing. Prices will be determined fair and reasonable per FAR 13.106-3(a)(2)(ii) Based on Comparison of Proposed Prices with Prices Found Reasonable on Previous Purchases.

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

Market Research Was Not Conducted:

Market research supports Biodesix INC is the only vendor capable of providing this service. An intent to sole source notice 36C26322Q0717 was issued publicly on sam.gov from 7/5/22-7/25/22. No other sources expressed interest or capability to provide for this requirement. These tests are proprietary to Biodesix INC. See market research report for more detail.

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

Last Updated: 02/01/22

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

a. Biodesix

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 VA will continue to monitor the market to identify changes and opportunities to compete future requirements.

12. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Joshua Imdacha Date Contracting Officer NCO 23 Contracting Office

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.

Chara Collins Date NCO23 HCT2 Branch Chief NCO 23 Contracting Office

Joshua I.

Imdacha 1447737

Digitally signed by Joshua I. Imdacha 1447737 Date: 2022.07.29 10:51:29 -05'00'

Chara L. Collins 663925

Digitally signed by Chara L.

Collins 663925 Date: 2022.07.29 13:45:09 -05'00'