Redacted_SSJ_Roche_Hurlston_03APR17_modified_02MAY17_Redacted.pdf

Rev. 1/6/14

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN

MARKET OR GSA) UNDER $150,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

Center for Global Health Roybal 1600 Clifton Road NE. Mailstop D-69 Centers for Disease Control and Prevention Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Procurement and Grants Office Acquisition Branch 4

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Reagents and consumables for use on the Roche COBAS Ampliprep COBAS Taqman 48

b. Procurement Request (PR) Number (if available): Click here to enter text.

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: Roche Diagnostics, 9115 Hague Rd, Indianapolis, IN 46256

b. Estimated Procurement Amount: $

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number: Click here to enter text.

D. Justification:

1. The justification for this non-competitive action is:

☒ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency

☐ Exclusive licensing agreements/Proprietary data

☒ Brand name required

☐ Industrial mobilization

☐ Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

☐ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency

☐ Only One Source

☐ Logical Follow Up

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

Only Roche Diagnostics can provide reagents compatible with the Roche COBAS Ampliprep COBAS Taqman 48. If another vendor was selected with a non-compatible system, testing and training, directly fulfilling branch and division support for PEPFAR early infant diagnosis and viral load scale-up would not be able to be conducted using the Roche COBAS Ampliprep COBAS Taqman 48 (CAP/CTM). The Roche CAP/CTM is one of the most widely used molecular testing platforms for HIV-1 viral load and early infant diagnosis in PEPFAR-supported laboratories globally. We are the only US laboratory performing this testing for PEPFAR-supported countries. The Roche CAP/CTM is the reference method for the World Health Organization Prequalification of in Vitro Diagnostics (Viral Load and Early Infant Diagnosis). The supplies and consumables needed for this year will support viral load and early infant diagnosis testing and training for PEPFAR-supported countries and World Health Organization Evaluations. If another vendor was selected with a non-compatible system, which would not allow testing and training using the current Roche CAP/CTM, the laboratory would not be able to adequately support PEPFAR-laboratories and the World Health Organization with the Roche CAP/CTM system and the PEPFAR mission.

b. What other products/services were considered and why did they not meet the need?

No other products were considered as only Roche reagents and consumable are compatible with the Roche COBAS Ampliprep COBAS Taqman 48.

3. Program Office efforts to seek potential offerors:

Roche COBAS HIV-1 VL kits and HIV-1 Qualitative kits, reagents, and consumables are available through Roche Diagnostics only.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Timothy Barnes.

Contracting Officer Signature:

Certification Date: Click here to enter a date.

05/4/2017