Description
Background The Division of AIDS (DAIDS) in the National Institute of Allergy and Infectious Diseases (NIAID) supports a global research portfolio to advance biological knowledge of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), its related co-infections, and its co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” DAIDS develops and supports the infrastructure and biomedical research needed to: 1) reduce HIV incidence 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) develop interventions to treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) foster partnerships with scientific and community stakeholders to develop and implement effective interventions. NIAID supports four HIV/AIDS clinical trial networks as part of its HIV clinical research enterprise. High quality test results support the safety of study participants and the reliability of study results. DAIDS employs a variety of Laboratory Quality Assurance oversight contractual resources to monitor and enhance the ability of laboratories to accurately and reliably perform trial-specified clinical laboratory testing (https://www.niaid.nih.gov/research/daids-clinical-research-policies-standard-procedures). 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 current contract supports approximately 150 laboratories in 18 countries. The current contract has been held by Johns Hopkins University, Baltimore, Maryland since its inception in 2004. The current contract is held under contract number 75N93020C00001. The period of performance of the current contract is November 15, 2019 through November 14, 2026. Purpose and Objectives The purpose of this contract for Patient Safety Monitoring in International Laboratories (SMILE) is to enhance the ability of mostly non-U.S. laboratories participating in NIAID-funded and collaborative clinical trials to perform study-specified tests in accordance with good clinical laboratory practices (GCLP) and produce reliable test results. SMILE activities also support 1) comparability between multi-site trial data obtained in licensed U.S. laboratories and data obtained in non-U.S. ones, 2) sponsor accountability to regulatory organizations (e.g., FDA, EMA) for investigational new drug (IND)/registrational studies, and 3) harmonized approach in laboratory operations and sponsor oversight. Project Requirements Offerors should have the qualifications, experience and capability to perform this requirement. Specifically, the Contractor will be responsible for the following: The objective of this contract is provide to mostly non-U.S. laboratories (Labs) a comprehensive and uniform approach to support and evaluate initial and on-going capability and readiness to carry out NIAID-funded and collaborative clinical trial protocols (Protocols) by (1) supporting and monitoring compliance with good clinical laboratory practice (GCLP) standards, (2) supporting and monitoring the quality and reliability of Protocol-specified laboratory test results, (3) providing Labs with various means of assistance, guidance and training to improve the quality of laboratory operations, and (4) hosting and maintaining the existing electronic data management system. Options to increase level of effort, to support unanticipated increases in demand related to oversight of additional Labs, are also within the scope of the contract. Specifically, the contractor shall: 1. Review annual GCLP audit reports from all Labs, capture findings/deficiencies in the form of an action plan, provide guidance for the resolution of deficiencies, review Labs’ standard operating procedures (SOPs), track completion of Labs’ corrective actions, and post to a web-based document repository. 2. Support method verification/validations performed by Labs by reviewing validation reports and, as needed, provide validation materials. 3. Determine the ability of Labs to accurately and reliably perform protocol-specified tests (e.g., chemistry, hematology, pregnancy, HIV and TB diagnosis). This will be accomplished by: a. Purchasing and arranging shipment of appropriate Proficiency Testing (PT) panels which include unknown (blinded) samples provided by an external source b. Monitoring and grading PT results c. Guiding Labs in the investigation of root causes to prevent future failures d. Assisting Labs to correct identified deficiencies 4. Provide guidance and training to Labs to achieve GCLP and test proficiency via email and phone communications, interactive web conferences, presentations at investigator meetings and regional training events, and visits of various durations to Labs as needed. 5. Maintain a 508 and FISMA-compliant web-based information repository that includes password-protected Lab-specific documents such as records of resolution of each Lab's GCLP audit findings and performance in PT panels, as well as an open-access resource library that includes guidance documents and SOPs for various laboratory procedures. Examples of resource documents include a checklist and guidance for moving a Lab to a new location, and instructions for validating instruments. The Contractor will provide each participating Lab with controlled access to its own documents and provide NIAID and Network lab managers with controlled access to all documents. 6. Provide overall program management for the integration and coordination of all contract activities, including systems used to track activities and to keep multiple activities on time and budget. 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 7 years, beginning on or about February 15, 2027. The performance requirement will be the delivery of 13.70 full time equivalents (FTEs) per year for the base period (Year 1) and option periods 1-6 (Year 2 through Year 7). Please note that the number of FTEs is exclusive of consultant effort. 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 1 through 6 to Extend the Term of the Contract: The Government may exercise options to extend the period of the contract beyond the base period (Year 1), annually, for a total contract period of up to 7 years. The scope and types of activities as outlined for Year 1 of the contract would be continued for each succeeding annual contract period up to 7 total years. The percentage of effort includes the effort of subcontracts but excludes the effort of consultants. Options 7 - 27 to Increased Level of Effort for Additional Labs : 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. During the period of the contract, it may be necessary to incorporate additional Labs to support NIAID clinical trials. Such an increase would require an increase in the Contractor's effort 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 15 Labs. If the Government elects to exercise this Option, the Contractor shall provide an additional 1.7 Full Time Equivalents (FTEs). One Option for adding new Labs may be exercised once per year during any year of the contract, beginning with year 2 of the contract, to a total of 21 options during the life of the contract, as follows: Year 2 (Option 7), Year 3 (Options 8 & 9), Year 4 (Options 10, 11, 12), Year 5 (Options 13, 14, 15, 16), Year 6 (Options 17, 18, 19, 20, 21), and Year 7 (Options 22, 23, 24, 25, 26, 27). The period of performance of an Option for Increased Level of Effort will not exceed the term of the Option year in which the Option is exercised. Other important considerations NIAID may authorize, at any time during the contract period of performance, independent audits of the Contractor’s performance with respect to the functions specified in the Statement of Work, including review of Contractor processes, procedures and operations at the Contractor’s site. NIAID shall notify the Contractor of plans for independent audits at least five (5) business days in advance of the scheduled audit. For remote audits or those conducted at Contractor facilities, the Contractor shall ensure that appropriate staff and all necessary information and documentation are available. For-cause audits may be performed at any time and without advance notice to the Contractor in instances of suspected non-performance and/or non-compliance with Federal and/or country-specific regulatory requirements. The SMILE contract will require staff with knowledge and experience in clinical laboratory testing, principles of proficiency testing assessment and GCLP. The SMILE contract will require advanced programmer capabilities to create and maintain electronic systems to support direct PT data capture from PT providers, provision of PT data to User Groups, query capabilities, and automated workflow processes. ISO 9001:2015 certification for SMILE contract operations is recommended to support the establishment, maintenance, and continual improvement of contract quality management systems. Any responsible offeror may submit a proposal, which will be considered by the Agency. This RFP will be available electronically, on/about January 26, 2026 , and may be accessed through SAM http://sam.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 online via the NIH’s electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website (https://ecps.nih.gov) and then click on "How to Submit."