RFI 75D301-24-R-72876 - CDC OLSS Surge Testing Partnership Mechanisms.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service Centers for Disease Control and Prevention (CDC)

REQUEST FOR INFORMATION (RFI) NO. 75D301-24-R-72876

Mechanisms for Public-Private Partnerships to Support Surge Testing During Public Health Emergency Responses

Issue Date: Tuesday, Oct. 10, 2023 Questions Due By: Wednesday, Oct. 18, 2023 at 5:00pm ET Responses Due By: Friday, Nov. 3, 2023 at 5:00pm ET

TARGET AUDIENCE: Diagnostic Testing Services Industry (Private Sector Clinical Laboratories)

This is a Request for Information (RFI). It is not a solicitation for proposals, proposal abstracts, or quotations.

Release of this information should not be construed as a commitment to procure items discussed or to incur costs for which reimbursement would be required or sought.

As permitted by Federal Acquisition Regulation (FAR) Part 10, and in accordance with FAR 52.215-3, this is a market research tool being utilized for informational and planning purposes only. Responses will assist the Government in the development of its acquisition strategy, informing potential support requirements to be defined and released at a later date, and in the assessment of the capabilities, capacities, and technical methods, processes, and practices available and being utilized in the current marketplace for related topics.

I. BACKGROUND

To improve the efficiency and accuracy of lab testing during and out of a public health emergency (PHE), the Centers for Disease Control and Prevention (CDC) aims to enhance laboratory quality, safety, and science by improving key laboratory processes and coordination between internal and external partners. Depending on the type and scale of an outbreak or PHE, laboratory testing could be performed entirely at CDC, expanded to include public health laboratories (PHL), or enhanced by partnering with private sector clinical laboratories to achieve widespread national capacity.

Engagement with the clinical laboratory community has been used for surge testing support in different capacities for three (3) recent PHE responses: the Zika response utilized regional clinical laboratories; the Mpox response utilized a set of commercial clinical laboratories with nationwide reach; and the COVID response utilized broad nationwide testing in commercial and hospital clinical laboratories and many non-traditional testing sites, such as pharmacies. These recent experiences have proven that engaging with private sector laboratories significantly increases the nation’s resources and diagnostic capacity beyond what is available between CDC and the PHL system. Commercial laboratories leverage sophisticated, nationwide logistical operations that can move specimens from anywhere in the United States to a site with expertise and/or capacity, and can accession and process large volumes of tests performed on high-throughput instrumentation.

Additionally, there are other laboratories, such as those affiliated with academic medical centers, that have specialized expertise, high containment facilities, and unique capabilities that may be useful depending on the emergency.

In learning from previous PHE responses, CDC would like to better prepare for future responses by enhancing the state of readiness for high-volume diagnostic testing. To do this, CDC would like to partner with private sector laboratories that have the capability, scalability (i.e., capacity), and willingness to collaborate with CDC to

RFI 75D301-24-R-72876 Page 2 of 4 develop and rapidly scale-up testing when a pathogen of concern emerges, even before a PHE would be declared. Such a formalized collaboration, once established, would ensure that mechanisms are in place before a PHE exists to facilitate coordination between the federal government (CDC) and private partners, thereby accelerating the implementation of private-sector surge diagnostic testing ideally to tamp down an outbreak before it becomes a widespread emergency and certainly during a PHE.

II. PURPOSE

The purpose of this Request for Information (RFI) is to ascertain the level of interest and capacities of private sector clinical laboratories for coordinating with the CDC to establish pre-event collaborations. Responses to this RFI may be used to inform potential pre-event agreements and strategies that can be used to support activities for these public-private partnerships.

III. OBJECTIVE

The primary objective of this RFI is to understand the type of support, cost, and resources needed for private sector laboratories to provide test development and surge diagnostic testing support prior to and during a PHE, as well as to determine what method, such as formal agreements via Memorandums of Understanding (MOUs), contracts, or otherwise, would be best to execute this arrangement with private sector laboratories to meet response needs depending on the type and scale of the emergency.

IV. REQUIREMENTS

CDC seeks information from organizations about their capability, proven experience, and capacity to develop and implement solutions to enable pre-positioned partnerships between private sector laboratories and public health and federal laboratories for enhancing surge diagnostic testing capacity in the event of a PHE.

The agency asks for a summary response of no more than 10 pages, with three sections: (1) cover page; (2) approach; and (3) business information.

Section 1: Cover Page

Respondents are asked to provide a Cover Page that contains the following information:

a. Company Name

b. Company Address

c. Unique Entity Identification Number

d. Point of Contact information (email addresses, phone numbers, and mailing address)

e. Type of company under North American Industry Classification System (NAICS), as validated via the SAM. Additional information on NAICS codes can be found at www.sba.gov. Any potential government contractor must be registered on the SAM located at http://www.sam.gov/index.asp

f. Identification as a large or small business. If small, indicate any additional classification.

g. Identification of services on any Federal Supply Schedules, if any, and the relevant schedule numbers.

Section 2: Approach

Respondents are asked to describe end-to-end solutions for private sector partnerships with the PHL system and/or CDC to provide surge diagnostic testing support in the event of a PHE. As part of this section, respondents should address the following:

a. Describe what would be your organization’s approach to preparing to support test development and surge testing capacity, in collaboration with the CDC, to be leveraged when a pathogen of concern

RFI 75D301-24-R-72876 Page 3 of 4 emerges that may become a PHE. Please consider providing details on the following and adding any other information you believe the CDC should recognize about your organization’s expertise and capacity, such as:

i. Time frames necessary to develop tests for a new pathogen of concern, assuming CDC can or cannot provide to your organization clinical or contrived samples containing the pathogen.

ii. Lead time to move from test development to ramping up capacity to 10,000 tests per week and beyond, while maintaining your capacity to continue to serve patients testing needs for other healthcare concerns.

iii. The geographic coverage for testing that your organization has in place now, including information on logistical mechanisms used to ensure rapid turnaround times of 2 days or less within that geographic area.

iv. Your organization’s expertise in infectious disease testing—immunoassay, molecular, etc.— and optimizing tests for improved throughput and performance.

v. Your processes for ensuring appropriate biosafety.

vi. Your workforce, supply, logistical, and other potential costs and constraints that would challenge a rapid test development and response effort. (e.g., partnership costs, inventory, staff retention, appointment availability, automated reporting to submitter and public health, forecasting demand, etc.).

vii. Existing relationships with local, state, territorial and/or tribal public health laboratories and agencies (e.g., department of health) in areas where you operate.

b. Describe preferred type of agreements (e.g., MOU, contract, other) that could be established with CDC in advance of a PHE to expedite emergency response efforts and enable a more efficient scale up for surge testing. Please include any liability issues, constraints, and/or concerns to be considered.

c. Provide any additional suggestions for improving partnerships between public and private laboratories.

d. Provide testimonial(s) or proof of successful past performance of these capabilities, including volume of tests processed.

Section 3: Business and Pricing Model Considerations

Respondents are asked to provide the following information:

a. To establish a warm-base1 test development and surge capacity agreement, describe your organization’s requirements for what you would consider a feasible minimum capacity level kept warm to sustain preparedness to rapidly develop and expand testing.

b. Describe coding, coverage, test payment, and other anticipated funding needs for long-term sustainability of surge testing support.

c. Describe the preferred mechanism for partnership (e.g., MOU, grant, contract).

1 The term “warm base” is derived from usage by the U.S. Armed Forces, U.S. Congress, and various federal agencies to reflect the minimum resources, personnel, or capacity to maintain workload and manufacturing readiness for greater responsiveness during an emergency. Warm base for the purposes of this RFI can be defined as the minimum sustainable level of testing to maintain preparedness for rapid response to a future PHE.

(See Dept. of Health & Serv., Public Health Supply Chain and Industrial Base One-Year Report in Response to EO 14017 (2022), https://aspr.hhs.gov/MCM/IBx/2022Report/Pages/default.aspx. See also Margaret Browne, Warm Base, U.S. Army (May 29, 2008), https://www.army.mil/article/9500/warm_base. See also Joanne S. Eglovitch, Budget Law calls for Barda and FDA to Establish “Warm Base” Manufacturing, Regulatory Focus (Jan. 16, 2023), https://www.raps.org/News-and-Articles/News-Articles/2023/1/Budget-law-calls-for-BARDA-and-FDA-to-establish-wa.)

https://aspr.hhs.gov/MCM/IBx/2022Report/Pages/default.aspx https://www.army.mil/article/9500/warm_base https://www.raps.org/News-and-Articles/News-Articles/2023/1/Budget-law-calls-for-BARDA-and-FDA-to-establish-wa https://www.raps.org/News-and-Articles/News-Articles/2023/1/Budget-law-calls-for-BARDA-and-FDA-to-establish-wa

RFI 75D301-24-R-72876 Page 4 of 4

V. INSTRUCTIONS FOR SUBMISSION

Phase Medium & Format Delivery Due Date

Questions Question and Answer Excel Template provided below in “Attachments”

Via e-mail to QST7@cdc.gov

Oct. 18, 2023 (Weds.)

by 5:00pm ET

RFI Response Submission

Summary format following the flow of Part IV above

• 10 page limit (not including

Cover Page)

Via e-mail to QST7@cdc.gov

Nov. 3, 2023 (Fri.)

by 5:00pm ET

Q&A Instructions

Questions about this RFI must be sent via e-mail to Liz Cole-Greenblatt at QST7@cdc.gov by 5:00pm ET on Wednesday, October 18, 2023. Questions should be sent in the excel sheet Questions & Answer Template provided as an attachment to this RFI.

Final Response Instructions

Respondents shall submit a summary response of no more than ten (10) pages with the information requested above in, “IV. Requirements.” The Cover Page will not count toward the maximum page limit. Page formatting, font type, point-size, and line spacing are left to the respondent’s discretion, but preferably no less than 8-point font. All written text, illustrations, graphs, tables, other graphics, etc. of the submission must be easily readable.

Respondents shall provide only the most pertinent information, data, and materials necessary to adequately convey the information sought and a declaration of capability in line with this RFI. Proprietary information, if any, should be minimized and marked as proprietary. All responses will be kept strictly confidential and only for US Government use.

Please submit your final responses to this RFI via e-mail to Liz Cole-Greenblatt at QST7@cdc.gov by 5:00pm ET on Friday, November 3, 2023. Only e-mailed responses will be accepted. Late responses will not be accepted.

mailto:QST7@cdc.gov mailto:QST7@cdc.gov mailto:QST7@cdc.gov mailto:QST7@cdc.gov