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 spread-plate culture, molecular detection (real-time PCR) 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 an Environmental Legionella Isolation Techniques Evaluation (ELITE) Program member laboratory for isolation
Legionella from environmental specimens
- Currently perform real-time PCR on bacterial isolates in compliance with CLIA requirements
- Currently conducting next generation sequencing on bacterial isolates
- In possession of the major equipment and space required to conduct the
Legionella testing 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 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
October 10, 2022 – RFP Issued
October 27, 2022 – Informational Teleconference at 2:00 pm ET (optional)
November 11, 2022 – Letter of Intent Due to APHL by 5:00 pm ET *NOTE: THIS DEADLINE HAS BEEN EXTENDED FROM THE ORIGINAL DATE (NOVEMBER 4)
November 18, 2022 –
RFP Responses Due to APHL by 5:00 pm ET
December 9, 2022 – Proposal review completed
December 12 – 15, 2022 – As needed, follow-up interviews
December 16, 2022 – Final review completed and awardees selected
February 6, 2023 – Anticipated Contract Start Date
Spring 2023 – Establish submission and result reporting processes, validation of assays and training activities, as needed
April 1, 2023 – LRC(s) begin accepting samples/specimens/isolates from submitting laboratories
APHL will communicate any modification to this anticipated schedule on APHL's procurement website (www.aphl.org/rfp) and via an email blast to the PHLs.
Informational Teleconference
APHL will hold an optional teleconference on Thursday, October 27, 2022 at 2:00 pm ET. The purpose of this call will be to provide a brief overview of the project and to allow potential applicants to ask CDC and APHL questions. Please come with questions prepared.
Teleconference call-in information is below. Please contact
elizabeth.toure@aphl.org or
infectious.diseases@aphl.org no later than 12:00 pm ET on Monday, October 24, 2022 if you would like to be sent the calendar invitation.
Join Zoom Meeting
https://aphl.zoom.us/j/87046244056?pwd=UDRnVUpMajRWVzNjaEJaTlFvU2piZz09
Call-in Information
+13017158592 US (Washington DC)
Meeting ID: 870 4624 4056
+13126266799 US (Chicago)
Passcode: 821830
Response Submittal
Confirmation of Intent to Respond
APHL requires that prospective applicants submit a brief email statement indicating an intent to submit a proposal. APHL has extended the deadline to submit a letter of intent. The new deadline by which APHL must receive this email is by 5:00pm ET on November 11, 2022. 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 November 18, 2022. 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.
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.
Materials
The official RFP document will provide detailed information in regards to this request, please read it in its entirety.
Questions and Answers
Our laboratory is currently working to achieve ELITE certification before the end of the year. Would a lack of being currently ELITE certified disqualify us from this opportunity?
A: In order to be considered, applicants should be an ELITE program member by the time that final applications are due (November 18).
After a lab is accepted and can begin testing in April 2023, what is the timeframe for this project?
A: The terms of the project are listed in the full
RFP document (page 4). The initial project term will be through June 30, 2023. The potential for annual renewals (with each additional funding year running from July 1 to June 30) may be considered by APHL based on availability of funds and performance of the awardee(s) for a maximum of two additional years (through June 2025).
Will protocols be available for PCR and whole genome sequencing?
A: Yes, CDC can provide some protocols if needed.
If we are not currently an ELITE member, but were in the past, can we still apply?
A: Being a current ELITE member is a requirement to apply. You must have ELITE member status at the time that you submit your final application. Note: This is a correction to a verbal response provided on the informational teleconference.
What will the reporting requirements be for reporting results to the submitter or CDC?
A: The reference center will receive personally identifiable information from the submitter and will report results back to the submitter. The reference center will also send de-identified results to CDC.
What will the reference center report?
A: The reference center will report whether legionella was recovered from culture or what the PCR result was. Reporting for WGS will be determined in collaboration with CDC and the reference center.
Who pays for shipping samples to the reference center?
A: The submitter will pay for shipping, so this does not need to be included in the proposed budget.
Can you give us an approximate sample/specimen number or capacity we need to be able to manage to be able to plan costs?
A: This information can be found on page 6 in the RFP. The budget may be estimated based on an anticipated quarterly volume of 10 clinical specimens, 10 clinical isolates and 40 environmental samples, assuming 25% of environmental samples are positive for Legionella.
The RFP mentions providing support for environmental investigation. Do we need to have this capability, and should we budget for this epi support?
A: CDC will take the lead on epidemiology support, but the reference center is welcome to participate if they want. It is not necessary to submit a budget for epidemiology support. In the future, if the reference center is interested and able, they may be able to provide some of their own epidemiology support.
How will geography play into the selection of the reference center(s)? Will there be two from different geographic locations?
A: Geographic location is not very important as samples will be shipped from all locations; more importantly is whether the laboratory is the right fit.
Is the intent in this cycle to only award one reference center, with a possibility of two?
A: Yes, there will only be one reference center initially. As we gain a better understanding of the demand and volume of testing and if demand is high, we may add a second reference center if funding is available. The second reference center would be chosen from the second highest score from this RFP process; we will not recompete the RFP for a second reference center.
Will CDC help with the validation process for reference center?
A: Yes, CDC can help with panels or other resources for validation.
How do we account for personnel time in our budget?
A: Information on how to prepare your budget is found on page 6 of the RFP. The per specimen/sample/isolate budget should include the cost of test reagents, ancillary reagents, staff time, fringe/overhead and any other charges.
Will there be another RFP in the next fiscal year to bring on additional lab(s)? If so, roughly when?
A: We do not plan to have another RFP in the next fiscal year. If there is a need to add a second reference center (and if funding is available), the second reference center would be chosen from the second highest score from this RFP process; we will not recompete the RFP for a second reference center.
We stopped participating in the ELITE PT program several years ago. If we sign up and participate in the February event and April ELITE events, would we be eligible to be a Reference Center for this RFP or does our current inactive member status disqualify us from this cycle?
A: Applicants must be current ELITE program members - ELITE program members have correctly identified Legionella in two consecutive panels of the Environmental Legionella Isolation Techniques Evaluation Program and have received documentation for passing the proficiency test. Eligible applicants must already have passed the ELITE proficiency test at the time of application.
If our laboratory has the capability to report results to our clients via our web portal and to the CDC and health department via ELR do we still need to provide results via the secure ftp, fax, and email mechanisms?
A: Your existing system should be fine as long as all the submitters are able to use your web portal. In the future, the LRC will be required to comply with data modernization standards of practice.
Question 3 is asking to enter personnel from specimen accessioning through each methodology and reporting. Do you want us to enter the personnel that will be doing the routine ~60 specimens testing and validation experiment, or do you want us to enter everybody, including personnel that will be able to help in case of large outbreaks and surge?
A: For question 3, please include the people who would routinely be involved in Legionella testing. In question 4 you can describe how you would approach staffing to accommodate unpredictable testing volumes and include personnel that are cross trained to support work during periods of increased testing demand.
For budgeting reagents and labor, should it be just based on ~60 specimens per quarter? Will there be independent funding in case of surge or large outbreak?
A: For budgeting, you can base it on ~60 specimens per quarter (approximately 10 clinical specimens, 10 clinical isolates and 40 environmental samples, assuming 25% of environmental samples are positive for Legionella). There is not additional funding for larger outbreaks; APHL and CDC will work with the LRC to monitor the test request volume and accept or reject testing requests according to the availability of resources (and other factors).
We would be interested in receiving panels/specimens from CDC for multiplex PCR validation. What would the panel consist of?
A: CDC does not have a standard validation panel. However, they can put something together depending on your needs. CDC is able to share isolate panels with a collection of 5-10 Legionella isolates of different species and serogroups. If you have access to remnants of clinical specimens of the appropriate type, you could spike these with the isolates that CDC can share. A material transfer agreement (MTA) would need to be in place.
Which parts of the application are included in the 10 page response limit?
A: The ten page response limit is for the whole application package (Appendix B, responses to appendix C, budgets, and letter of IT support) except the biosketch. The biosketch is the only part of the application that is not included in the ten page limit.
In the workforce table (Q3) – What are you looking for in the “cross-training” column? Are you asking for what other testing they are cross-trained in or could be cross-trained in, or something else?
A: In the Q3 table for cross-training we are looking for what other testing they are already cross-trained in.
For the response does Appendix C need to have the questions included, if so does that count towards the max pages?
A: Please include the question number and subject to help the reviewers (ie. Q1. Testing environment); the whole question does not need to be written out.
Is there a particular font, size or spacing that is preferred for the application?
A: The responses to Appendix C should be double spaced. There is no requirement on the font; just make sure it is easy to read.
Is the $100,000 budget only related to startup costs? Should the entire budget be no more than $165,000?
A: That’s correct. The initial award will be for up to $165,000. In your budget proposal, you can budget for up to $100,000 in startup costs.