Summary
The Association of Public Health Laboratories (APHL), in cooperation with the Centers for Disease Control and Prevention (CDC) is seeking up to two (2) public health laboratories (PHLs) to provide testing in a flexible, shared services model that enhances Legionella case and outbreak investigation capacity to support CDC, state and local jurisdictions. The selected Legionella Reference Center(s) (LRCs) will provide a variety of testing services related to Legionella outbreak response including clinical and environmental culture, molecular detection (nucleic acid amplification) and next generation sequencing (NGS).
Eligibility
Eligible laboratories include all PHLs with the following capabilities and facilities in place. Specific expectations regarding methodologies to be used by the awardees are outlined in
Appendix A. All applicants are required to agree to the minimum requirements (as outlined in
Appendix B).
- Applicants must meet the following eligibility requirements:
- Currently performing isolation of Legionella species from clinical specimens and environmental samples
- Currently performing nucleic acid amplification testing (NAAT) for Legionella species, Legionella pneumophila (LP) and LP serogroup 1 (LP1) on clinical specimens and isolates in compliance with CLIA requirements
- Currently conducting next generation sequencing on bacterial isolates and ability to have an NGS test for Legionella isolates by July 1, 2025
- Sufficient equipment, laboratory space and workforce capacity for the proposed work described in Appendix A
- Willing to alter or amend existing testing protocols or workflows at the request of APHL and CDC
- Willing to provide technical assistance, training and SOPs to other jurisdictions to improve testing capacity
- Has a Laboratory Information Management System (LIMS) in place to meet clinical testing workflows and reporting requirements
- Ability to provide consultations to submitters around sample collection, sample submission and result interpretation
- Willingness and ability to respond to Freedom of Information Act (FOIA) requests related to Legionella testing
- Ability to contract with APHL or has an existing relationship with a third party that can contract directly with APHL on behalf of the laboratory
Anticipated RFP Schedule
November 18, 2024 – RFP Issued
December 5, 2024 – Informational Teleconference at 2:00 pm ET (optional)
December 13, 2024 EXTENDED TO December 18, 2024– Letter of Intent Due to APHL by 5:00 pm ET
January 17, 2025 – RFP Responses Due to APHL by 5:00 pm ET
February 3, 2025 – Proposal review completed
February 4 – 16, 2025 – As needed, follow-up interviews
February 17, 2025 – Final review completed and awardees selected
Spring 2025 – Establish submission and result reporting processes,
validation of assays and training activities, as needed
July 1, 2025 – Anticipated Contract Start Date
July 2025 – LRC(s) begin accepting samples/specimens/isolates from submitting laboratories
Response Submittal
Confirmation of Intent to Respond
APHL requires that prospective applicants submit a brief email statement to
elizabeth.toure@aphl.org and
infectious.diseases@aphl.org indicating an intent to submit a proposal. APHL must receive this email by no later than
5:00pm ET on December 13, 2024. To allow for appropriate review process planning,
a letter of intent is required for consideration.
Final Response
APHL must receive complete responses by
5:00 pm ET on January 17, 2025. Please see the
Proposal-Required Submissions section for items that must be included in the completed proposal. Applicants should send proposals via email to
elizabeth.toure@aphl.org and infectious.diseases@aphl.org.
APHL will send an email acknowledging the receipt of your application; if you do not receive an acknowledgement within 48 hours, please call Liz Toure at (240) 485-3860 to confirm receipt.
RFP MaterialsThe Official
RFP Document will provide detailed information. APHL will post all RFP-related documents, current schedule information, and answers to submitted questions and clarifications on APHL's procurement site,
www.aphl.org/rfp.
Questions and Answers
Is there a requirement for applicants to be Environmental Legionella Isolation Techniques Evaluation (ELITE) members?
A:There is not a requirement to be an ELITE member at the time of application. However, by July 1, 2025, the LRC environmental testing procedures must either be accredited by a recognized regional, national or international accrediting body according to a nationally or internationally recognized standard (e.g., ISO) or the LRC must be enrolled as a participant of the ELITE Program. See Appendix A: Expectations for the Legionella Reference Center(s) on page 8 of the RFP.
Is there support for laboratories that don’t have their Legionella clinical testing process fully implemented?
A: CDC is happy to provide their protocols for Legionella culture and PCR on clinical specimens to any public health laboratories whether they apply to this RFP or not (email legionellalab@cdc.gov). To be eligible to apply to this RFP, laboratories must currently perform isolation of Legionella species from clinical specimens and perform nucleic acid amplification testing (NAAT) for Legionella species, Legionella pneumophila (LP) and LP serogroup 1 (LP1) on clinical specimens and isolates in compliance with CLIA requirements. See the eligibility requirements on page 3 and in Appendix B of the RFP.
Regarding the mechanism for the LRC to report results to CDC, what mechanism does CDC plan to use/require? For example, is this data transmission expected through one of CDC’s other data exchange mechanisms like AIMS or PHINMS? Or is this a completely separate API that is needed?
A: It would be a separate API. For example, an S3 bucket may be used to store data that can then be transferred to other AWS services or external locations.
Is the CDC Legionella Team integrated with the existing AIMS platform?
A:No, the CDC Legionella is not currently integrated with the AIMS platform. The data transmission to CDC would be a new build that would need to be put in place. The data are intended to be integrated with the CDC NCIRD Legionella database. The CDC Legionella Team can receive the data in many formats including csv, HL7 and others. One option could be to use an S3 bucket, but there are others and CDC will work collaboratively with the selected laboratory to determine an appropriate mechanism.
How quickly would the LRC need to have the data transmission API with CDC up and running?
A:The data transmission to CDC would ideally be up and running as early as possible (July 1, 2025), however CDC is flexible and will work with the selected laboratory to get it set up in a timely manner.