Notice Number: NOT-AI-18-059
Key Dates
Release Date: September 06, 2018
None
Issued by
National Institute of Allergy and Infectious Diseases (NIAID)
Purpose
The Division of AIDS (DAIDS) supports a global research portfolio to advance biological knowledge of HIV/AIDS, its related co-infections, and co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” the division develops and supports the infrastructure and biomedical research needed to: 1) halt the spread of HIV through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) partner with scientific and community stakeholders to efficiently implement effective interventions.
NIAID places the highest priority on ensuring the safety and optimal management of individuals who participate in its clinical trials and on obtaining reliable laboratory-based data critical for the meaningful interpretation of study findings. Equally important is the safety of those who perform the laboratory testing.
NIAID aims to achieve comparability between U.S. (licensed labs) and non-U.S. generated study results. The purpose of this contract for Patient Safety Monitoring in International Laboratories (SMILE) is to enhance the ability of current and future mostly non-U.S. laboratories participating in NIAID-supported clinical trials to perform tests in accordance with good clinical laboratory practice standards and produce reliable test results. SMILE will continue to serve current and future NIAID-sponsored clinical trial networks and collaborating study groups (User Groups), as well as individual grantees conducting clinical research.
The purpose of this contract is to provide a comprehensive and uniform approach to evaluate initial and on-going laboratory capability and readiness to carry out NIAID-funded clinical trial protocols by: (1) monitoring laboratories’ compliance with good clinical laboratory practice standards, (2) monitoring the quality and reliability of Protocol-specified laboratory test results, (3) providing laboratories with various means of assistance, guidance and training to address and prevent recurrence of deficiencies in compliance with good clinical laboratory performance standards and/or proficiency testing, and (4) hosting and maintaining the existing electronic data management system.
The current Patient Safety Monitoring in International Laboratories (SMILE) contract was awarded to Johns Hopkins University, Baltimore, MD on November 15, 2012, for a period of seven years (includes all term options). Currently, SMILE supports approximately 170 non-U.S. laboratories in 15 countries. SMILE will continue to support laboratories that are part of current and future NIAID-sponsored clinical trial networks (https://www.niaid.nih.gov/research/hivaids-clinical-trials-networks).
The Government anticipates a potential need to: (1) expand the number of laboratories serviced by SMILE during the course of the contract, and (2) enhance existing computer software systems in order to accommodate documents, similar to those managed by SMILE, received from other NIAID laboratory-supporting contracts. Increases in effort for these services would be implemented through the exercise of contract options, at the discretion of the Government.
Project Requirements:
Offerors should have the qualifications, experience and capability to perform this requirement. Specifically, the Contractor will be responsible for the following:
1. Reviewing laboratory audit reports to identify deficiencies in good clinical laboratory practices and providing laboratories with guidance for corrective action.
2. Monitoring laboratories ability to accurately and reliably perform Protocol-specified tests used to diagnose viral, fungal, bacterial and parasitic infections, hematology and blood chemistry assays, liver function tests, and drug resistance assays. The contractor must have experience in reviewing and interpreting proficiency testing reports from providers such as the College of American Pathologists.
3. Providing assistance, guidance and training on procedures and Standard Operating Procedures related to laboratory qualify management, instrument and test validation, specimen management, data management, equipment maintenance, personnel safety, test QA/QC. The contractor must have experience with creating and utilizing training tools and must have staff able to travel to various laboratories outside the U.S. to provide training.
Maintaining and hosting an existing SMILE computerized data management system and document library to track and make available documents in support of activities performed under the contract. Further enhancement of the system may be necessary. The contractor must have the ability to maintain the computerized system security documentation as required by OMB Circular A-130, Appendix III and the Federal Information Security Management Act (FISMA).
Anticipated Period of Performance
It is anticipated that one (1) cost reimbursement, level-of-effort (term) type contact 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 August 15, 2019. The requirement will be the delivery of 13.7 full time equivalents (FTEs) for the base period (Year 1) and 13.7 FTEs per year for Options 1-6 (Years 2-7). The number of FTEs includes the effort of subcontractors but does not include the effort of consultants.
In addition, to the functions and services to be provided for the Base period, the Government may exercise quantity Option(s) for additional level of effort, in order to accommodate unanticipated increases in demand. These Options are defined as follows:
Options 7 through 27: Increased Level of Effort for Additional Labs:
During the course of the contract, it may be necessary to incorporate additional Labs to support new NIAID 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 10 Labs, and the Option will be maintained for the life of the contract. If the Government elects to exercise this Option, the Contractor shall provide an additional 1.10 FTEs. The number of FTEs includes the effort of subcontractors but does not include the effort of consultants. One Option for adding new Labs may be exercised once per year during any year of the contract, beginning with Year 2, for a total of 21 Options during the life of the contract, as follows: Year 2 (Option 7), Year 3 (Options 8 and 9), Year 4 (Options 10, 11, and 12), Year 5 (Options 13, 14, 15, and 16), Year 6 (Options 17, 18, 19, 20, and 21), and Year 7 (Options 22, 23, 24, 25, 26, and 7). 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 28 through 34: Increased Level of Effort for Additional Electronic Data Management System and Document Library Services:
During the course of the contract, it may be necessary to incorporate additional Labs to support new NIAID 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 10 Labs, and the Option will be maintained for the life of the contract. If the Government elects to exercise this Option, the Contractor shall provide an additional 1.10 FTEs. The number of FTEs includes the effort of subcontractors but does not include the effort of consultants. One Option for adding new Labs may be exercised once per year during any year of the contract, beginning with Year 2, for a total of 21 Options during the life of the contract, as follows: Year 2 (Option 7), Year 3 (Options 8 and 9), Year 4 (Options 10, 11, and 12,Year 5 (Options 13, 14, 15, and 16), Year 6 (Options 17, 18, 19, 20, and 21), and Year 7(Options 22, 23, 24, 25, 26, and 27). 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.
Any responsible offeror may submit a proposal, which will be considered by the Agency. This RFP will be available, electronically, on/about September 14, 2018, and may be accessed through the FedBizOpps website at: https://www.fbo.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 at https://ecps.nih.gov and then click on "How to Submit." Submission of proposals by facsimile or e-mail is not acceptable.Inquiries
Please direct all inquiries to:
Patrick Finn
National Institute of Allergy & Infectious Diseases
Telephone: 240-669-5401
Email: patrick.finn@nih.gov
John R. Manouelian
National Institute of Allergy & Infectious Diseases
Telephone: 240-669-5152
Email: manouelj@niaid.nih.gov
and Human Services (HHS)
