A13. J and A for Sole Source SAM.gov-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:

NCIRD/DBD/MPDL

Roybal Campus Buidling 24, MS H24-6 Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch

C. Identification of Requirement:

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

a. Sole source acquisition of: Purchase of 4680 deidentified nasopharyngeal specimens (selected weekly at random; 20 Bordetella pertussis positive, 20 positive for other Bordetella, 5 negative) in original collection containers labeled with a study ID. Samples will be stored frozen (-70C) and shipped on dry ice overnight once a quarter.

b. Procurement Request (PR) Number (if available): 00378

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

a. Proposed Vendor: Labcorp

b. Estimated Procurement Amount:

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

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

Rev. 5/14/19

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 ☐ Brand name required

2. Other facts supporting sole source procurement:

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

Labcorp possesses residual nasopharyngeal specimens from diagnostic testing submitted from across the US public health jurisdiction, a random selection of which can be used as representative inputs for pertussis pathogen genomic surveillance.

Labcorp performs the majority of diagnostic testing in many regions and thus maintains unique access to the needed sample materials. Additionally, their repository also includes negative specimens from suspected infection that can serve as valuable controls for laboratory assays. Labcorp maintains a system for specimen collection and testing that broadly covers the general US population. Labcorp has the required infrastructure to meet the Meningitis, Pertussis and Diphtheria Laboratory’s (MPDL) requirements in a timely manner.

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

There is an existing purchase order for a similar project with Quest Diagnostics;

however, their service region is not comprehensive enough to satisfy the needs of the laboratory. Labcorp is the other large diagnostic testing provider in the country and their service region is complementary to that of Quest Diagnostics such that together they provide a sufficient nationwide coverage for the needs of the laboratory.

Rev. 5/14/19

3. Program Office efforts to seek potential offerors:

Market research was performed via a Google search to identify nationwide medical diagnostic laboratories: Quest Diagnostics and Labcorp were the only two with the required coverage for the project. This Bordetella pertussis genomic surveillance project is a special study and Labcorp uniquely possess the necessary specimens and existing legal agreement with CDC for the project. The project requires random specimen selection from across the general US population, which is covered by the reach of Labcorp’s diagnostic testing services. All specimens will be residuals from clinical submissions from suspected pertussis cases and tested by Labcorp.

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:

Center/Institute/Office COR/Program Official Signature

Certification Date:

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.