JA - Spotfire Test kits and QC-PIHC.pdf

Justification and Approval for Other Than Full and Open Competition

Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $20 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Subpart 13.5), Federal Supply Schedule orders (FAR 8.4), or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 for guidance.

Do not include these instructions in the final document or contract file.

***Contact your Acquisition Department for any questions you may have.

https://acquisition.gov/far/current/html/Subpart%2013_5.htm https://acquisition.gov/far/current/html/Subpart%2013_5.htm https://acquisition.gov/far/current/html/Subpart%208_4.html https://acquisition.gov/far/current/html/Subpart%2015_5.html#wp1095225 https://acquisition.gov/far/current/html/Subpart%206_3.html

Justification and Approval for Other Than Full and Open Competition

1. Agency/Contracting Activity:

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number-

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s):

Street Address:

City, State, Zip:

Phone:

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C. 253(c)(1)

FAR 6.302-2: Unusal and compelling urgency, 41 U.S.C 253(c)(2)

4. Authority and Rationale: Identify the statutory authority, FAR title, and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 253(c)(5)

Other (See FAR Subpart 6.3 for additional authority):

5. Bridge Contracts:

6. Actions to Increase Competition:

possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new

7. Market Research:

8. Procurement History:

Previous Purchase Order(s) or Contract(s): Yes No

If “Yes”, for each purchase order or contract provide:

Purchase order or contract number:

Was action competed? Yes No

Program Manager

Name:

Position Title:

Email address:

Phone:

(No signature required)

Program Manager Supervisor (or one level above Program Manager)

Name:

Position Title:

Email address:

Signature:

11. Fair and Reasonable Price Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

12. Contracting Officer’s Approval: I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Signature:

Typed Name:

Title:

Date:

9. Additional Information to support the justification.

10.Technical / Requirements Certification: By my signature below, I certify that the supporting data under my review which is included in this J&A is accurate and complete.

The Biomerieux VC-SPOTFIRE is the only FDA approved CLIA Waived supplier that can perform a combo test that will differentiate SARS-CoV-2, flu, RSV and rhinovirus using one sample collection. It is also the only supplier with a 15 respiratory target test kit that is FDA approved and CLIA Waived. Due to the increase in respiratory diseases in our patient population, this combo test is required and necessary for direct patient care.

As vendors become available or other similar tests are developed and approved, the Government will seek competition from the those sources.

-Roche Cobas Liat System has a combo Flu and COVID test that does not include RSV.

-Luminex provides a respiratory panel that is not CLIA Waived.

-Quidel Corporation provides a FLU and SARS combo that does not include RSV -Abbott ID NOW COVID-19 2.0 has individual COVID test. Must test for each test individually with multiple samples.

The only instrument on the market that provides this capability using only one patient sample is the Biomerieux VC-SPOTFIRE. The one sample method reduces patient discomfort as well as provides a better quality of sampling. This analyzer and tests panels are CLIA Waived which allows for a more flexible QC program which decreases tech time providing a more efficient and effective laboratory program.

This analyzer is FDA approved for all the tests above.

The only other option is to send patient samples to reference lab which has a turn around time of at least 48 hours. This delays appropriate treatment.

Text1: DHHS/IHS/Pawnee IHC