APHL seeks to identify and select one state or local public health laboratory that will perform hepatitis C virus (HCV) nucleic acid testing (NAT) in a regional shared service model.
The recommended testing algorithm for diagnosis of current HCV infection comes from the
2013 Guidance. All persons who test positive for an HCV antibody (anti-HCV) test should receive a HCV nucleic acid test (NAT) to detect HCV RNA.
To determine the best approach to assist laboratories in expanding access to HCV NAT in a cost effective and timely manner, APHL is seeking proposals for test sharing models that would provide HCV NAT on qualified specimens (anti-HCV positive) to PHLs in neighboring jurisdictions.
Proposals will be evaluated based on the laboratory's existing capability and facilities and applicants must have:
- Established capacity for diagnostic HCV NAT; and
- Established capacity for providing testing for outside PHLs including data transfer and specimen receipt and processing; and
- Sufficient equipment, laboratory space and workforce capacity for the proposed workload
March 20, 2017 – RFP Issued
April 15, 2017 – Letter of Intent Due to APHL (see RFP)
May 15, 2017 – RFP Responses Due
June 2, 2017 – Proposal review completed
June 5-16, 2017 – If needed, follow-up interviews and updated proposals due
June 21, 2017 – Final review completed and awardees selected
June 30, 2017 – Draft contracts submitted to APHL Legal Dept. for final internal review
Any modification to this anticipated schedule will be posted here (www.aphl.org/rfp) and via an email blast to the public health laboratories (PHLs).
Request for Proposal Materials
Expansion of Hepatitis C Virus (HCV) Nucleic Acid Testing (NAT) RFP provides details on how to complete this RFP. The RFP contains a copy of the scoring criteria that will be used for evaluation of proposals in Appendix C. The details for expectations for HCV NAT testing are contained in Appendix A.
"On page five (5) of the RFP, under section "Post-Evaluation Procedures," the following updates the first sentence of paragraph."
The selected laboratory will be notified by APHL staff within ten business days of the completion of the evaluation and the name of the recipient will be posted to APHL’s procurement website, www.aphl.org/rfp on the same day.
Questions and Answers
Is this a federal grant and if so is there a CFDA number? Who is the funder?
A: The funding is by the Centers for Disease Control and Prevention of DHHS Cooperative Agreement Number 1U60OE000103 through the Association of Public Health Laboratories. The CFDA No. is 93.322.
Is an HCV Viral Load assay (which does not have a diagnostic claim) an acceptable method for this application?
A: Yes, with the caveat that the appropriate validation/verifications have been performed to meet the needs of your regulatory body to use the test "off-label for diagnostic purposes AND that the sites you will be partnering are aware of and approve of the method being used for HCV NAT testing.
Is the applicant required to create the region or will APHL be involved in that process?
A: Each applicant should establish their own partners/collaborators that will participate in this pilot project
Do the partner/collaborating jurisdictions need to be physical neighbors?
A: No, any public health laboratories in the United States that are interested in partnering with the applicant are acceptable for the application