​The Association of Public Health Laboratories (APHL), in cooperation with the US Centers for Disease Control and Prevention (CDC) Division of Tuberculosis Elimination (DTBE), is seeking to recompete the National Public Health Laboratory (PHL) Drug Susceptibility Testing (DST) Reference Center for Mycobacterium tuberculosis (MTBC) for PHLs with low to moderate incidences of TB. APHL is seeking to identify one (1) state or local public health laboratory to serve as the Reference center. This Reference center will serve as an extension of the CDC DTBE Laboratory Branch and provide services that are complementary to those at CDC. Services provided by the Reference center for PHLs with lower volumes of drug susceptibility testing (DST) (<50 isolates per year) will include:   

  1. first-line DST
  2. second-line DST
  3. molecular detection of drug resistance.

Anticipated RFP Schedule

September 30, 2019 – RFP Issued
October 10, 2019 – Informational Teleconference (Q&A)  
October 18, 2019 – Letter of Intent Due to APHL (see below)
November 15, 2019 – RFP Responses Due
December 6, 2019 – Proposal review completed
December 9-13, 2019  – If needed, follow-up interviews and updated proposals due
December 20, 2019 – Final review completed and awardees selected
Spring 2020 – Harmonization, Validations and other Pre-Planning (as needed)
July 1, 2020 – First year contract awarded

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 must receive this email by no later than 5:00pm EST on October 18, 2019. 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 EST on November 15, 2019. Please see Proposal-Required Submissions section for items that must be included in the completed proposal.  Applicants may send proposals via email to Anne.Gaynor@aphl.org

APHL will send an email acknowledging the receipt of your application; if you do not receive an acknowledgement within 48 hours, please email the RFP point of contact above to confirm receipt.

Additional Information and Deadlines for Application Submission

Applicants must direct all questions to Anne Gaynor (anne.gaynor@aphl.org). APHL will post questions received from interested PHLs, together with the answers provided by APHL or CDC staff to APHL’s procurement website associated with the specific RFP (www.aphl.org/rfp).

To allow for appropriate review process planning, a letter of intent is required for consideration. Applicants should submit letters by email to Anne Gaynor at APHL (anne.gaynor@aphl.org) no later than 5:00 pm EST on Friday, October 18, 2019.

Applications are due to Anne Gaynor at APHL (anne.gaynor@aphl.org) by close of business (5:00pm ET) November 15, 2019. APHL will send an email acknowledging the receipt of your application. If you do not receive an acknowledgement within two (2) business days, call 240-485-2739 to confirm receipt.

APHL will hold an optional teleconference on Thursday October 10, 2019 at 2:00pm 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, or please contact anne.gaynor@aphl.org or infectious.diseases@aphl.org no later than 12:00pm ET on Wednesday October 9, 2019 to receive the calendar invitation.

Join Zoom Meeting
https://aphl.zoom.us/j/130625862
Call-in Information
1-646-876-9923 OR 1-669-900-6833
Meeting ID: 130 625 862

Materials

The National PHL Drug Susceptibility Testing (DST) Reference Center for Mycobacterium tuberculosis (MTBC) RFP provides detailed information in regards to this request, please read it in its entirety. Additionally, feel free to contact Anne Gaynor at Anne.Gaynor@aphl.org with any questions.

Supplemental documents

The Public Health Need for ETOR Poster
Electronic Test Order & Result Data Flow Lab Web Portal OverviewLIMSConnect Overview
LIMSConnect Informational Overview
iConnect Lab Web Portal v8 Architecture

Questions and Answers

Is a letter of intent required to submit an application?

A: Yes, A letter of intent must be submitted by Friday October 18, 2019 to be eligible to submit a complete application. It is a requirement of the RFP. Applicants that do not submit a letter of intent will not be eligible to submit an application.

As the current reference center are we required to have a letter of support from our IT department indicating that we can connect to the AIMS LabWeb Portal environment using LIMSConnect?

A: A letter of support from IT is required from all applicants and should indicate that they support one of the mechanisms outlined in the RFP for Electronic Test Order and Resulting. As the current reference center, maintaining the current connection would be sufficient. There are added benefits of connecting using the LIMSConnect solution so we encourage laboratories and IT departments to give consideration to this connection.

Can you clarify what is meant by item 13 in the Eligibility criteria “Ability to perform and report results from laboratory developed tests or research use only assays”?

A: Yes. There may be assays or reagents that are laboratory developed tests or sold by the manufacturer as research only that we would want the selected awardee to potentially be able to adopt and use for testing, following appropriate validation and verification studies.

In the award section an approximate specimen volume is given, but is there a minimum specimen volume or number of tests that can be used to help calculate an appropriate budget?

A: There is not a minimum volume of testing guaranteed. However, over the last three years of operation the testing volume has remained steady and over 250 tests per year. The budget should be prepared to offer testing at that level.

If a laboratory does not currently perform the full panel of testing for one of the minimum testing panels (first-line DST, second-line DST, or molecular detection of drug resistance) are they still eligible to apply?

A: Yes, if the laboratory currently does not offer some aspect of the outlined minimum panels the application should clearly address the gap and how the applicant would plan to bring on the full minimum testing panels (timeline and any validation/verification studies) by the start of the project term (or close to the start term of the project).

On page 10, question 4 one of the items requests the applicant to provide the turnaround time for second-line DST, how should this be calculated?

A: The applicant can stratify the turnaround time to address the turnaround time from specimen receipt to reporting results for second-line DST when the sample is sent directly for that test method and/or they can report the turnaround time from when drug resistance was found (FL-DST or molecular detection of drug resistance) to reporting of results for second-line DST results.

How many submitting sites are there currently for this reference center?

A: There are 17 submitting PHLs currently.

Our laboratory currently reports CRE through the AIMS platform within the Reporting Portal for ARLN—are these the same capabilities that are needed for the TB RFP or will additional elements be needed (i.e., LIMSConnect Solution)?

A: The ARLN Reporting portal is a simple mechanism to send AR data to CDC programs either through a .csv upload or through HL7 messaging, much like the Flu messages that PHLs send to CDC through APHL’s PHLIP, it is uni-directional and does not support the needs of the DST Reference Center.  

Additional capabilities will be necessary to meet the Electronic Test Order and Result (ETOR) requirement found in the RFP.  The laboratory must already have a system in place to support electronic bi-directional communication with submitters- either through a web-based portal or through HL7 messaging, and have the ability to  expand or leverage their current ETOR solution to support the DST reference center workflow) OR 

The laboratory may choose to adopt the Lab Web Portal (LWP) solution to meet this requirement.  LWP is a web based “Software as a Service” that allows the lab to capture test orders, manage communications, publish test results, and allows submitting laboratory to download their own reports.  LWP is hosted on AIMS; the support and maintenance of LWP along with the expertise to support the laboratory during implementation, is provided directly to APHL through CDC.  However, If the lab selects to use LabWeb Portal, the state would need:

  1. the support and guidance of the lab team to: 
    1. provide lab specific information to configure LWP 
    2. participate in system testing and provide “dummy data” to support test case development 
    3. Approve and register submitters and manage those user permissions locally 
  2. the support and guidance of the informatics or IT team and the potential support of their LIMS vendor to review the architecture, approve of LWP’s LIMSConnect service, and assist in the needed deployment of the service.  The LIMSConnect service must run locally to enable a connection to the LWP system on AIMS, it allows submitters and laboratories to get real time access to the status of specimens and allows for additional functionality to support the lab workflow, such as batch ordering and reporting.