Sole Source Justification for Expert AFM Consultation.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 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 University of Washington

b. Procurement Request (PR) Number (if available): 000HCJDB-2024-84632

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

a. Proposed Vendor: University of Washington

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-

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-

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-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-

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 the University of Washington has more than 4 years of experience conducting AFM case classification at CDC.

In addition, the neurologist has advanced training and experience in treating a spectrum of inflammatory neurological disorders including AFM. The neurologist is well equipped to provide expert 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 the University of Washington 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 we prepare for a possible outbreak of AFM this summer, any other potential provider may compromise the consistency, accuracy, and timeliness of the AFM surveillance.

There are no known neurologists who are not already included on the panel other than through the University of Washington 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 who are not already on the panel other than through the University of Washington that have the depth of experience with this type of review of spinal and brain MRIs and surveillance classification for novel illness like AFM.

3. Program Office efforts to seek potential offerors:

Market research this highly specialized field of study. When the University of Washington joined the CDC AFM neurology panel, the university was already part of the Enhanced Surveillance for New Vaccine Preventable Diseases: AFM Surveillance (through the New Vaccine Surveillance Network) and a member of the AFM Working Group (a multidisciplinary group of experts that helped establish diagnostic criteria and management for AFM). Other than the neurologists currently on the panel, there are no known institutions like the University of Washington that has a child neurologist that specializes in inflammatory neurologic disorders that can carry out this type of MRI review for a novel disease and provide continuity of AFM case classification. All other known sources are already part of the CDC AFM neurology panel.

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.