SSJ - CDC - AFM Cases - post to betasam.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: The Children’s Hospital of Philadelphia /AFM Case Classification

b. Procurement Request (PR) Number (if available): 00HCVGED-2021-53742

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

a. Proposed Vendor: Children’s Hospital of Philadelphia

b. Estimated Procurement Amount: $233,990.00

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?

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 pediatric 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 pediatric neurologist at Children’s Hospital of Philadelphia has more than 4 years of experience conducting AFM case classification at CDC. The neurologist has reviewed 4 years’ worth of MRIs and has demonstrated the capability and experience to conduct review for this type of rare neurological disease. In addition, the neurologist has advanced training and experience in treating the full spectrum of neurological disorders including AFM. Children’s Hospital of Philadelphia is well equipped to provide expert consultation on AFM surveillance, neurologic diagnoses, and support physicians’ education to increase AFM recognition and reporting.

Rev. 5/14/19

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

Alternatives to Children’s Hospital of Philadelphia as an offeror include other academic centers with an interest in AFM, however none have the experience that Children’s Hospital of Philadelphia has in this type of in-depth review of spinal and brain MRIs for novel illness like AFM. Also, none have subject matter experts that have experience in AFM clinician outreach and education.

3. Program Office efforts to seek potential offerors:

Market research was not conducted for other potential vendors because this type of work is highly specialized. Although other institutions may be able to initiate a project like this, none of the other institutions were found to have the necessary similar experience and capabilities to carry out this type of MRI review for a novel disease.

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.