Sole source Doc Panther System signed.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

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:

NCHHSTP/DVH

Roybal Bldg 18, Room 3-123, MS H18-3 Centers for Disease Control and Prevention Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch Click here to enter text.

C. Identification of Requirement:

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

a. Sole source acquisition of: Hologic Panther for the Laboratory Branch, Division of Viral Hepatitis

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

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

a. Proposed Vendor: Hologic, Inc, 250 Campus Drive Marlborough, MA 01752 T: 508-

263-2900

b. Estimated Procurement Amount: $130,000

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:

Rev. 5/14/19

☒ 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

☐ Brand name required

2. Other facts supporting sole source procurement:

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

The Panther system is a fully automated sample to result analyzer for quantitation of hepatitis B and hepatitis C nucleic acids. It has one of the smallest footprints of any comparable analyzers that quantitate hepatitis B and C nucleic acids on the market.

It also has the lowest limit of detection of any of the comparable FDA approved assays on the market. The Panther has random and continuous access to permit STAT processing and the ability to sample from multiple primary sample tubes.

Additionally the random and continuous access permits the Panther to run different assays simultaneously, a feature not permitted on other FDA approved platforms.

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

Roche COBAS 6800 was considered, however the price of the instrument was not within the program’s budget and the laboratory space cannot accommodate the footprint. The only other FDA approved platform for HBV and HCV viral load on the market is Abbott m2000 which also has a footprint that is too large for the laboratory space planned for the equipment.

3. Program Office efforts to seek potential offerors:

Rev. 5/14/19

Abbott and Roche were both considered, however space constraint and cost were prohibitive.

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.

Center/Institute/Office COR/Program Official Name/Title: NCHHSTP/DVH/COR/Sumathi Ramachandran

Center/Institute/Office COR/Program Official Signature:

Certification Date: June 10, 2020

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: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.