SMILE_Sources Sought Notice.pdf

SOURCES SOUGHT NOTICE

Agency/Office Department of Health and Human Services, National Institutes of Health

Contracting Office Location Office of Acquisition & Logistics Management (OALM) 6701 Rockledge Drive, Bethesda, Maryland

Type Research & Development Sources Sought

Solicitation Number

HHS–NIH–NIAID–RDSS–26–75N93026R00010

Title

PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (SMILE)

Classification Code A – Research and Development

NAICS Code 541715 – Research and Development in the Physical, Engineering and Life Sciences (except Nanotechnology and Biotechnology)

Response Date March 6, 2026, 3PM Local Time

Primary Point of Contact Patrick Finn, Contracting Officer patrick.finn@nih.gov 240-669-5401

Secondary Point of Contact Robert Corno, Contracting Officer robert.corno@nih.gov 240-669-5151

Introduction/Synopsis This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources including small and small disadvantaged businesses to perform a potential R&D requirement.

Background The Division of AIDS (DAIDS), National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), project is for work related to the contract below:

“Patient Safety Monitoring in International Laboratories (SMILE)”, Johns Hopkins University, School of Medicine (Contract 75N93020C00001)

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 mailto:patrick.finn@nih.gov mailto:robert.corno@nih.gov 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 practices 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 current contract was awarded to Johns Hopkins University, Baltimore, MD, under Contract No.

75N93020C00001, on November 15, 2019, for a period of seven years. 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).

This current contract was awarded on a competitive basis for a seven-year period from November 15, 2019 through November 14, 2026. A term type/level of effort contract was awarded for the delivery of 13.70 Full Time Equivalents (FTEs) per year for Years 1-7, the work is with mostly non- U.S. laboratories (Labs) to provide a comprehensive and uniform approach to evaluate initial and on-going capability and readiness to carry out NIAID-funded clinical trial protocols (Protocols) by

(1) monitoring compliance with good clinical laboratory practice standards, (2) 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, in order to support unanticipated increases in demand, related to support of additional labs and in support of additional data sources and document library services, are also within the scope of the contract.

The total value of the contract is $28,283,334 and includes options for extension of the term for a total performance period of 7 years and options for increases in the level of effort for additional labs.

This Sources Sough Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the NIAID.

Performance Requirement and Anticipated Period of Performance A term/level of effort type contract is anticipated. The performance requirement will be for the delivery of 6.85 FTEs during the period November 15, 2026 through May 14, 2027. An option to extend services for a 6 month period (from May 15, 2027 through November 14, 2027) is also anticipated, for a total possible 13.70 FTEs for 12 months (two 6-month option periods).

Purpose and Objectives The purpose of this Research and Development (R&D) Sources Sought Notice is to discern whether or not there are other contractors, including small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a https://www.niaid.nih.gov/research/hivaids-clinical-trials-networks contract on the basis of responses received nor otherwise pay for the preparation of any information submitted.

As a result of this R&D Sources Sought Notice, the NIAID may issue a Request for Proposals (RFP) if it deemed necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME.

However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Sources Sought Notice or the NIAID’s use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement.

The objective of this acquisition is to continue to provide a comprehensive and uniform approach to evaluate initial and on-going capability and readiness to carry out NIAID-funded clinical trial protocols (Protocols) by (1) monitoring compliance with good clinical laboratory practice standards,

(2) 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.

Other important considerations:

The Respondent will be expected to maintain and host the existing computerized data management system and enhance it when necessary.

Project Requirements The Contractor shall provide evidence as to the capability to perform this requirement, with particular attention to 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 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.

4. 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).

The prospective contractor must have a Principal Investigator and staff with the experience and expertise to carry out a project of this size and complexity, must understand cultural sensitivity issues relevant to resource-constrained countries, and must have the flexibility to address emerging needs and expansion.

Personnel/Management: Interested parties must demonstrate adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity.

Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity

Capability Statement/Information Sought Capability Statements that are submitted in response to this announcement should clearly convey information regarding the respondent’s capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information.

Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company’s experience and ability to perform this effort that includes the following:

(1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work.

Each response should include the following Business Information:

a. Unique Entity ID number

b. Company Name

c. Company Address

d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses

e. Current GSA Schedule appropriate to this Sources Sought

f. Do you have a Government-approved accounting system? If so, please identify the agency that approved the system.

g. Type of Company (i.e., large business, non-profit, educational institution, small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/

Responses must be submitted no later than 3:00 PM (Local Time), March 6, 2026. Capability statements will not be returned and will not be accepted after the due date. These statements should be submitted electronically (via e-mail) to Patrick Finn, Contracting Officer, at patrick.finn@nih.gov. These statements should be submitted in Adobe Portable Document Format (PDF); however, capability statements in Microsoft Word will also be accepted. The e-mail subject line must specify HHS–NIH–NIAID–RDSS–26–75N93026R00010. Facsimile responses will not be accepted.

Common Cut-off Date:

Electronically submitted, tailored capability statements are due not later than 3:00 PM (E.S.T.), on March 6, 2026. CAPABILITY STATEMENTS WILL NOT BE RETURNED AND WILL NOT BE

ACCEPTED AFTER THE DUE DATE.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a Presolicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses:

Contracting Officer: Patrick Finn Email Address: patrick.finn@nih.gov

Contracting Officer: Robert Corno Email Address: robert.corno@nih.gov

Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.

mailto:robert.corno@nih.gov