Notice of Intent to Sole Source UT Southwestern/CDC Acute Flaccid Myelitis Data

The Centers for Disease Control and Prevention intends to award a sole source firm fixed price purchase order to

University of Texas Southwestern (UT Southwestern) for a surveillance pilot program to conduct regional case finding

for patients with acute flaccid myelitis (AFM) in a more timely manner than the current existing surveillance system to

promote rapid collection of laboratory specimens and data.

CDC will contract with UT Southwestern to provide a study coordinator and research nurse who will receive

information about suspected AFM patients through a network of providers and families. From experience conducting

the CAPTURE study (2013-2018), UTSW noted a significant value to partnering with the Siegel Rare Neuroimmune

Diseases Association (SRNA) (5) including the dedicated AFM parent working group. Often these families are the first to

hear about AFM cases via email, Facebook and other social media platforms. The project will improve case

identification in Texas, Louisiana, Arkansas and Oklahoma (approximately 20 hospitals) by working with the SRNA to

assist with patient identification within 24 hours of contact and by working directly with our regional hospital

partners. Once a patient is identified, the nurse will travel to the hospital to collect medical information, radiology

images, and biological specimens. Medical information and specimens will be sent to CDC for analysis. Data and

specimens will be collected on behalf of CDC and subject to CDC oversight and IRB. This project will include solutions

for 4 of the major barriers to AFM studies, specifically, early case identification, case reporting to public health, acute

specimen collection, and prompt data collection. Using a regional, on-site approach to collect this surveillance data

and specimens should reduce the amount of time from the start of symptoms to notification of the patient to CDC.

The contractor will be responsible for developing a provider network, interfacing with the local health departments,

travel expenses and supplies for specimen collection and transport. Time for notification from onset of limb weakness

in a patient to CDC notification will reduce by 40%, from 18 days to 10 days or less. The contractor shall perform the

following tasks:

A. Case identification

• Make direct connections to hospitalist and pediatric neurology colleagues at each of the major pediatric facilities

(>150 beds) in the region.

• In the first 4 months of the contract schedule lunch and learn programs to educate each facility on the signs and

symptoms of AFM, recommended testing, and the need to contact public health officials.

• Offer a clinical consultation line for clinicians with suspected cases of AFM and utilize the consultation line to help

increase contacts from regional pediatric facilities.

B. Case reporting

• Upon hearing about cases, the study team will connect clinicians with local public health authorities to ensure

appropriate case reporting occurs to the health department.

C. Specimen collection

• Work with the regional centers during the networking phase of the study to ensure appropriate clinical and public

health specimens (nasopharyngeal, cerebrospinal fluid, stool, and blood-based specimens such as serum and

peripheral blood mononuclear cells) are collected appropriately and within 10 days of limb weakness onset and

shipped to public health officials.

• If necessary, a research staff member will travel to the hospital for further specimen collection, processing and

shipping for storage.

D. Data collection

• Ensure the AFM patient summary form is completed and appropriate medical records have been collected.

• Ensure all documents are submitted to the respective health department as part of AFM surveillance.

UT Southwestern has almost 10 years of experience in specimen biobanking and enrolling remote patients into

longitudinal studies for the purposes of collecting information on rare diseases where patients may have to be

enrolled across a wide geographical area. They have been funded for a remote study of Neuromyelitis Optica for over

7 years, which has utilized a nurse who travels across the US enrolling patients, collecting samples and collecting data

for longitudinal research of this rare condition. This type of data collection for rare illnesses is unique to UT

Southwestern and they have spent 10 years testing and perfecting procedures specific to rare conditions. This

institution has more experience than any other academic center in the U.S. with respect to this unique situation of

rare and widely scattered patient enrollment.

This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one

source under the authority of FAR 13.106-1(b) (SAP) and 10 U.S.C. 2304(c)(1). Interested persons may identify their

interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for

competitive quotations; however, all quotations/responses received within five (5) days of the issuance of this notice

will be considered by the government. A determination by the government not to compete this proposed contract

based upon responses to this notice is solely within the discretion of the government. Information received will

normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any

quotation/response should be emailed to Contract Specialist at pyx9@cdc.gov by COB 03-17-2020.