CEPHEID _ JNA _ IDIQ - LVP signed.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Acquisition Title: Indefinite Delivery Indefinite Quantity IDIQ, Cepheid Molecular Laboratory Analyzer Reagents

Agency: IHS

Acquisition Year: 2022

Author: Daniel Otis

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): Cepheid

Street Address: 904 Caribbean DR

City, State, Zip: Sunnyvale, California 94089-1189

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 $ 6,000,000.00

The Portland Area Indian Health Service (PAIHS) Office in Portland, Oregon, oversees the delivery of health care to approximately 150,000 Native American users in the tristate area of Oregon, Washington, and Idaho. The clinical laboratory services provided throughout the Area include molecular diagnostic testing via a standardized platform acquired from Cepheid. This procurement is for Cepheid testing supplies for all federal Portland Area Laboratories to ensure continuous quality testing and reporting is achieved for the entirety of the Area patient population. This IDIQ will be for a Base plus four option years spanning 9/1/2022 - 8/31/2027. The volume of reagents is unknown and or will fluctuate and th most appropriate procurement vehicle will be an IDIQ.

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 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

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.

3304(a)(1)

In addition, the availability of FDA EUA analyzers and testing kits/reagents is extremely limited due to increased world-wide demand resulting from the COVID-19 pandemic. Sourcing from approved resellers and other distribution channels is not effective in receiving a reliable allocation of equipment and supplies as they become available. To our knowledge, Cepheid, who manufactures and sells the required laboratory equipment and testing kits etc., is the only vendor capable of fulfilling this Area-wide requirement and the associated estimated ordering volumes. Utilization of an approved vendor or sourcing from the manufacturer also ensures that the equipment’s warranty is maintained. This effort is similar to the following national awards pursued by other Federal customers: W81K0420D0008 (Department of Defense); and 36C77620D0002 (Veterans Affairs).

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2)

N/A

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5)

N/A

Other (See FAR Subpart 6.3 for additional authority):

In addition FAR 6.302-1(ii), 6.302-1(ii)(A) and 6.302-1(ii)(B) further outlines; Supplies may be deemed to be available only from the original source in the case of a follow-on contract for the continued development or production of a major system or highly specialized equipment, including major components thereof, when it is likely that award to any other source would result in- (A) Substantial duplication of cost to the Government that is not expected to be recovered through competition; or (B) Unacceptable delays in fulfilling the agency’s requirements.

5. Bridge Contracts:

N/A

6. Actions to Increase Competition:

Competition was not applicable to this procurement, however PAO DOA published a Sources Sought on GPE SAM.GOV for 10 days to allow for any additional competition responses. Additionally PAO will post a Special notice for 10 days to allow for any potential contractors to respond to the intent to Sole Source to Cepheid and oppose the Sole Source classification and Sole source documentation provided by Cepheid.

7. Market Research:

Market research was conducted at the Head Quarters Agency Level and subsequently Cepheid was determined Sole Source.

Additionally PAO DOA has conducted are own market research to determine that no other contractors are capable, reliable and able to provide the volumes and or services to maintain deliver at an acceptable level without risk to equipment service and cost to the government. A source Sources Sought notice and Solicitation was post previously for a continuation of Cepheid services for Cepheid Equipment currently operating at all service units with in PAO; No source responded or were determined certified to distribute or service Cepheid products.

8. Procurement History:

Purchase order or contract number: 75H70420D00001(IHS Agency IDIQ), W81K0420D0008 (Department of Defense); and 36C

Was action competed? Yes No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

FAR 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

9. Additional Information to support the justification

N/A

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.

Program Manager

Name: Karla Mankoff

Position Title: Area Lab Consultant

Email address: Karla.Mankoff@ihs.gov

Phone: 503-414-5590

Program Manager Supervisor (or one level above Program Manager)

Name: Lynn Van Pelt

Position Title: Area Dental Chief

Email address: Lynn.VanPelt@ihs.gov

Signature

Date:

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 (Required for proposed contract not to exceed $700,000 (value calculated including all options)): 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.

Name: Phone:

Signature: Date:

13. Legal Review:

14. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million value calculated including all options):

I have reviewed this justification and find that it adequately supports other than full and open competition.

8/5/2022

11.

Lynn C. Van Pelt -S Digitally signed by Lynn C. Van Pelt -S Date: 2022.08.05 13:12:22 -07'00'

Elida Monroe -S

Digitally signed by Elida Monroe -S Date: 2022.08.05 13:19:25 -07'00'

Name: Phone:

Signature: Date:

15. Office of Small and Disadvantaged Business Utilization I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Phone:

Signature: Date:

16. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million value calculated including all options):

Name: Phone:

Signature: Date:

HHS Senior Procurement Executive (SPE) Approval Based on the foregoing justification, I hereby approve the procurement of (state supplies/services being procured) on an other than full and open competition basis pursuant to the authority of (state the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304), as implemented by FAR 6.301), subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date:

Jonathan S.

Ferguson -S9

Digitally signed by Jonathan S. Ferguson -S9 Date: 2022.08.05 16:29:42 -04'00' ktruesdale Typewritten Text 240-994-0732 ktruesdale Typewritten Text 8-8-2022 ktruesdale Typewritten Text Kenneth G. Truesdale