Notice Number: NOT-AI-18-035
Key Dates
Release Date: April 27, 2018
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).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