Sole Source Justification - 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:

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases Roybal Bldg 24/5213/MS H24-5 Centers for Disease Control and Prevention Atlanta, GA 30329

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: AFM Case Classification at the Emory University

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

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

a. Proposed Vendor: Emory University

b. Estimated Procurement Amount: $240,477.31

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:

Acute flaccid myelitis (AFM) is a serious neurologic illness with unknown etiology that results in paralysis of the arms or legs. After the first outbreak of AFM in 2014 CDC began standardized surveillance in the

United States to characterize the disease burden and explore potential etiologies and epidemiologic associations. CDC is seeking additional clinical support to provide expert consultation and evaluation of

AFM cases, including classification of cases and expertise in determining risk factors and potential etiologies. The neurologist will provide expert neurologic consultation for AFM case classification and augment the neurology panel for outbreak response efforts. AFM case classification involves an in-depth review of spinal and brain MRIs and other medical documents including MRI reports and neurology consult notes. The neurologist at Emory University has more than 4 years of experience conducting AFM case classification at CDC.

In addition, the neurologist has advanced training and experience in treating the full spectrum of neurological disorders including AFM. The neurologist is well equipped to provide expert consultation on

Rev. 5/14/19

AFM Surveillance, neurologic diagnoses, and physicians’ education to increase AFM recognition and reporting. It is very important to maintain neurologist capacity and to maintain consistency and accuracy in case review. The neurologist's institutional memory and understanding of AFM is exclusive among neurologists since the neurologist at Emory University has been part of the AFM neurology panel since 2018. Understanding the clinical nuances of AFM and developing expertise in surveillance and outbreak response for this rare condition requires time. As part of CDC’s priorities for strengthening readiness to respond to outbreaks, any other potential provider outside the current neurology panel may compromise the consistency and accuracy of the AFM surveillance.

There are no known neurologists other than through Emory University with the ability to provide these services.

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

There are other academic centers with an interest in AFM, however there are no known neurologists other than through the Emory University that have experience with this type of in-depth review of spinal and brain MRIs for novel illnesses like

AFM.

3. Program Office efforts to seek potential offerors:

Market research was conducted by leveraging the CDC’s intimate technical knowledge of this highly specialized field of study. There are no known institutions like Emory University that have a neurologist that can carry out this type of MRI review for a novel disease and provide continuity of AFM case classification.

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: Halle Getachew

Center/Institute/Office COR/Program Official Signature:

Certification Date: Click here to enter a 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.