External Quality Assurance Program Oversight Laboratory

Added: Mar 21, 2016 12:23 pm Modified: Apr 05, 2016 11:49 amTrack Changes

PRESOLICITATION NOTICE

 

EXTERNAL QUALITY ASSURANCE PROGRAM

OVERSIGHT LABORATORY (EQAPOL)

RFP No. NIAID-DAIDS-NIHAI2015055

 

Type of Requirement

      New Requirement

      Follow-on (Contract No.:HHSN272201000045C)

      Other (specify):________________

 

Place of Performance

      Place of performance is unknown at this time

      Place of performance is known.  Address or general location:__________________

 

Recompetition

Duke Human Vaccine Institute

Duke University Medical Center
Durham, NC 27710

 

Contracting Office Address

Office of Acquisitions

National Institute of Allergy and Infectious Diseases

National Institute of Health

Department of Health and Human Services

5601 Fishers Lane, Room 3D10, MSC 9821

Bethesda, MD 20892-9821

 

Primary Point of Contact

Lorna Finn

Contract Specialist

Email:  Lorna.finn@nih.gov

Telephone:  240-669-5153

 

Secondary Point of Contact

John Manouelian

Contracting Officer

Email:  manouelj@mail.nih.gov

Telephone:  240-669-5152

 

The NAICS Code is 541712 with a size standard of 500 employees.

 

Presolicitation Notice Information

 

Introduction

The mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is to increase basic knowledge of the pathogenesis and transmission of the human immunodeficiency virus (HIV), support the development of therapies for HIV infection and its complications, and support the development of vaccines and other prevention strategies.  Reliable laboratory data are essential to the clinical evaluation of candidate HIV vaccine platforms and immunogens.  Data from multiple laboratories performing assays in support of single or multiple vaccine candidate trials must be accurate and reproducible.  The purpose of the External Quality Assurance Program Oversight Laboratory (EQAPOL) is to provide confidence that individual laboratories generate reliable data to support vaccine immunogen advancement. EQAPOL supports these efforts by participating in the development and availability of validated assays, providing common and well-characterized reagents and Standard Operating Procedures (SOPs), and providing External Quality Assurance (EQA) programs to measure and monitor laboratory performance.

 

The current contract, awarded in 2010, established proficiency testing programs serving over 60 laboratories in more than 40 sites worldwide and provided a panel of fully characterized viruses from early acute HIV infections to develop new assays and validate assay platforms. The contract also established a peripheral blood mononuclear cell (PBMC) bank and an EQA reagent repository of characterized material that supports EQAPOL proficiency testing programs and are made available to NIAID-supported investigators.

 

The current contract (number HHSN272201000045C) was awarded to Duke Human Vaccine Institute, Duke University Medical Center, on September 30, 2010, for a total period of seven years.

 

Purpose

The purpose of the new contract will be to support existing activities, develop new assays, and provide assistance in the standardization, validation, and development of new proficiency testing programs. The contract will continue to make materials available to NIAID-sponsored domestic and international investigators.  Options will be included to extend the contract for up to six years beyond the base year, to increase level of effort for unanticipated increases in demand, and to develop/implement a new EQA program. Requirement changes from previous EQAPOL competition include an EQA Program for Multiplex/Array, EQA of Mucosal Specimens, and an option for HIV Incidence Assays. 

 

Project Requirements

Offerors should have the qualifications, experience and capability to perform this requirement.  Specifically, the Contractor will be responsible for the following:

 

1.      Maintain and expand a peripheral blood mono-nuclear cell (PBMC) bank and EQA reagent repository;

 

2.      Design, set up, manage and coordinate an interferon-gamma (IFNγ) ELISpot proficiency program for NIAID supported research laboratories to provide an unbiased assessment of data quality from participating laboratories;

 

3.      Design, set up, manage and coordinate a flow cytometry intracellular cytokine staining (ICS) program;

 

4.     Design, set up, manage and coordinate a Luminex cytokine assay EQA program;

 

5.      Participate in assay development and validation for mucosal immune factors and assist in development of an EQA program to assess collection, storage, and testing parameters of mucosal specimens for host pathogens (microbiota) or anti-vaccine immune responses;

 

6.      Support the development of antibody characterization assays and EQA programs;

 

7.     Establish and characterize unique clade-specific HIV virus panels;

 

8.      Operate and maintain a central web database for contract-related activities;

 

9.      Coordinate optimization efforts for new assays and advise on assay validation, regulatory, compliance, and statistical issues;

 

10  Plan and conduct contract-related meetings and teleconferences; and
 

11  Conduct initial and final transition. 

 

Anticipated Period of Performance

It is anticipated that one (1) cost reimbursement, level-of-effort (term) type contract will be awarded.  The period of performance will be for one (1) year (Base Period), plus six (6) one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about June 30, 2017.  The requirement will be for the delivery of 16.82 full time equivalents (FTEs) per year for the Base Period (Year 1) and 16.82 FTEs per year for Options 1-6 (Years 2-7).

 

In addition to the functions and services to be provided for the Base period, the Government may exercise options for an increased level of effort to support the following:  (1) unanticipated increases in demand for such things as proficiency testing in areas such as ELISpot EQA program, Flow Cytometry-based assays and/or to expand the panel of characterized HIV isolates and other viral isolates that may be required to respond to emerging needs or public health emergencies; and (2) development/implementation of an EQA program for HIV incidence assays.

 

These Options are defined as follows:

 

Options for Increased Level of Effort for Unanticipated Increases in Demand (Options 7 - 34):  The Government may exercise options for increased level of effort that may result from unanticipated increases in demand for such things as proficiency testing in areas within the scope of activities supported by the base requirements of the contract, which include:  ELISpot EQA program, Flow-Cytometry-based assays, and/or to expand the panel of characterized HIV isolates and other viral isolates may be required in order to respond to emerging needs or public health emergencies.  Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.0 full time equivalent (FTE) for each option exercised.  These options may be exercised four times per performance year during Years 1 through 7.  The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Base Period or Option year in which the Option is exercised.

 

Options for Increased Level of Effort - Develop/Implement an EQA Program for HIV Incidence Assays (Options 35 - 41): The Government may exercise options for increased level of effort for the development/ implementation of an EQA program for HIV incidence assays.  Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 2.0 FTEs for each option exercised.  It is anticipated that only one option will be exercised per performance year.  The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Base Period or 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 April 5, 2016, and may be accessed through FedBizOpps http://www.fedbizopps.gov/ and the NIAID Office of Acquisitions (OA) Home Page at http://www.niaid.nih.gov/contract.  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 its electronic Contract Proposal Submission system (eCPS).  Submission of proposals by facsimile or e-mail is not acceptable.

 

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