PRE-SOLICITATION NOTICE: NIAID Virology Quality Assurance (VQA) Program, NIAID-DAIDS-NIHAI201700103

Notice Number: NOT-AI-18-035

Key Dates
Release Date: April 27, 2018

Related Announcements
None

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), is seeking proposals from qualified offerors to provide a comprehensive quality assessment program for virologic assays for HIV, and other viral pathogens.  

The current contract is held by Rush University Medical Center, Chicago, Illinois, under contract number HHSN272201200023C.  The period of performance of the current contract is September 21, 2012 through September 20, 2019.

The purpose of the NIAID Virology Quality Assurance (VQA) program is to provide a comprehensive quality assessment program for virologic assays for HIV, and other viral pathogens, performed on samples from subjects enrolled in NIAID-sponsored multisite clinical studies. The VQA program ensures the validity and inter- and intra-laboratory comparability of virologic laboratory data obtained from NIAID-supported clinical trials and HIV natural history studies by providing laboratories with proficiency testing panels and real-time assay run controls and analyzing proficiency panel and assay run data from each laboratory. The VQA program also implements standards of performance for existing and state-of-the-art new virologic assays, develops and tests biostatistical methods relating to the assays, and acquires, tests, stores and dispenses quality control materials and reagents. Thus, the VQA program is critical to the scientific integrity of on-going and future studies concerning HIV diagnosis, disease progression, assessment of treatments, vaccine efficacy and other preventive measures. The VQA has been in operation since 1988 and has developed and standardized quality control procedures for approximately 25 virologic assays used in NIAID-sponsored clinical trials.

The Contractor shall: 1) implement standards of performance for existing and newly developed virologic assays for HIV and HIV related pathogens (including  HCV, HBV, CMV, HSV, HPV, and KSHV) to assess the ability of laboratories performing virologic testing for NIAID-sponsored clinical trials (Labs) to successfully perform the assays; 2) conduct studies on the evaluation, standardization and application of new and existing virologic and biostatistical methodologies for HIV and other viral coinfections; 3) acquire, characterize, store, document and disburse quality control materials and reagents required for this program, including biohazardous materials and infectious agents; and 4) maintain a document library that supports the VQA program; 5) obtain ISO/IEC 17043 certification for Proficiency Testing Providers within one year of the contract and maintain the certification throughout the life of the contract (see http://www.a2la.org); 6) Provide administrative and technical support to support meetings and teleconferences as well as the dissemination of data; and 7) provide initial and final transition of the contract.  

The Contractor shall serve laboratories associated with current and future NIAID-sponsored clinical trial networks and collaborating study groups. Currently, the contract serves approximately 110 laboratories, with 55 international laboratories in 22 countries.  

The Government anticipates a potential need to increase the level of effort by exercising Options for the following additional support: 1) to expand the number of laboratories serviced by the Program during the period of the contract; 2) for similar services that address viral disease agents other than HIV and HIV related pathogens; and 3) to add a CLIA certified lab for late stage validation of assays for clinical testing.  
 

Anticipated Period of Performance

It is anticipated that one cost reimbursement, term/level of effort, type contact will be awarded.  The period of performance will be for one-year (Base Period) plus six (6) one-year options to extend the term of the contract that may be exercised by the Government unilaterally, for a total possible period of performance of seven (7) years, beginning approximately June 21, 2019.  The requirement will be the delivery of 9.80 full time equivalents (FTEs) per year, including consultant and subcontractor effort, for the Base Period (Year 1) and 9.80 FTEs per year, including consultant and subcontractor effort, for Options 1-6 (Years 2-7).  

In addition, the Government may exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract.  Options for increased services may include:

Options for Increased Level of Effort for Additional Labs: During the period of the contract it may be necessary to incorporate additional Labs to support new NIAID supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. Each option of this type will implement work commensurate with the addition of 5 Labs. These options may be exercised during Years 2 through 7. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 0.20 FTE during the first year, including consultant and subcontractor effort. If the options for these Laboratories are exercised in any year after the first year, 0.10 FTE per year, including consultant and subcontractor effort, will be needed in subsequent years. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Option year in which the Option is exercised. 

Options for Increased Level of Effort for Additional Expertise: During the period of the contract it may be necessary to develop a quality assessment program for assays associated with viral disease agents other than HIV and HIV-related pathogens that were not anticipated at the time of contract award, and that would directly support high priority NIAID research programs. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 3.65 FTE, including consultant and subcontractor effort, for each option exercised. One option may be exercised per year in years 2 through 7. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of Option year in which the Option is exercised.  

Options for Increased Level of Effort for the Addition of CLIA Certified Labs: During the period of the contract, it may become necessary to use new and novel virologic assays in clinical trials where results will be used for clinical decisions within the trial.  This will necessitate the use of a CLIA certified laboratory for late stage validation of the assay and for clinical testing.  If necessary, this will be provided through the exercise of options to this contract.  Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.0 FTE, including consultant and subcontractor effort, for each option exercised.  One option may be exercised per year in years 2 through 7.  The period of performance of an Option for increased level of effort for this purpose will not exceed the term of Option year in which the Option is exercised.  

Any responsible offeror may submit a proposal which will be considered by the Agency.  This RFP will be available electronically on/about May 2, 2018 and may be accessed through FedBizOpps (http://www.fedbizopps.gov/).  This notice does not commit the Government to award a contract.  No collect calls will be accepted.  No facsimile transmissions will be accepted.

For this solicitation, the NIAID requires proposals to be submitted via the NIAID electronic Contract Proposal Submission (eCPS) website. 

For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."

Inquiries

Please direct all inquiries to:

Rosemary Gomes
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5374
Email: rosemary.gomes@nih.gov  

Michelle L. Scala
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5156
Email: mscala@niaid.nih.gov