RFP # 75N93025R00011, Amendment 1 1

Amendment No. 1

RFP # 75N93025R00011,

entitled, "Patient Safety Monitoring in International Laboratories (pSMILE)"

Solicitation Number: 75N93025R00011

Amendment Number: One (1)

Amendment Issue Date: February 19, 2026

Proposal Due Date/Time: Thursday, March 12, 2026 at 3:00 P.M. EST. (Unchanged)

Issued By: Patrick Finn

Contracting Officer

Points of Contact: PRIMARY patrick.finn@nih.gov Patrick Finn, Contracting Officer Phone: 240.669.5401

SECONDARY

robert.corno@nih.gov Robert Corno, Contracting Officer Phone: 240.669.5151

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying this amendment number (Amendment # 1) and the date of the amendment (February 19, 2026) on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The purpose of this Amendment 1 is to provide responses to questions from potential offerors, regarding the solicitation.

The solicitation is amended to provide the following responses to questions received from potential offerors:

mailto:patrick.finn@nih.gov mailto:robert.corno@nih.gov

RFP # 75N93025R00011, Amendment 1 2

Question 1 Section C – Scope - Please confirm the current number of laboratories in scope, their countries/regions, and whether a definitive lab list will be provided to offerors.

Response to Question 1 A definite list of laboratories that are currently supported by pSMILE will be provided to the Offeror upon award. For now, respond to the indicated uniform cost assumptions which can be found in “Attachment 5 – Additional Business Proposal Instructions”.

Question 2 Section C – Scope - What is the anticipated onboarding/offboarding cadence for laboratories during the base and option years (e.g., typical adds/removals per year)?

Response to Question 2 Most of the laboratories currently supported by pSMILE have been overseen for many years.

Onboarding a new laboratory is rare and it may take 4-12 months to onboard, depending on what testing the laboratory is expected to perform reliably in support of specific clinical trials. Off boarding is also rare and does not take any time as services are simply being discontinued.

Question 3 Section B/C – Options - For any “additional laboratories” options, how will the Government exercise options (timing/notice), and must pricing be fully loaded for each option CLIN?

Response to Question 3 For any “additional laboratories” options, the Government will send a notice of intent letter to the contractor that the Government intends to exercise the option. Regarding the second part of your question, please follow the indicated uniform cost assumptions which can be found in “Attachment 5 – Additional Business Proposal Instructions”, each option for increased services to increase the level of effort will be for 1.7 FTEs. A breakout of costs must be provided for each cost category for each option for additional LOE for additional laboratories just as you would for the Base Period and Term Options 1-6.

Question 4 Section C – Deliverables - Please confirm required deliverables (e.g., progress reports cadence, final report) and the expected format/template (Word, PDF, specific forms).

Response to Question 4 Please follow C.2 Reporting Requirements. No specific template for progress reports. RFP indicates the elements that should be included.

Question 5 Section C – Audits - Are laboratory assessments/audits performed by the contractor, RFP # 75N93025R00011, Amendment 1 3

Government, or both? If both, what is the contractor’s expected role during Government-led audits?

Response to Question 5 Laboratory GCLP audits are performed by another contractor (not pSMILE). pSMILE’s role is to resolve the findings. Please see Attachment 3 – Statement of Work.

Question 6 Section C – CAPA - What system/tool is required for CAPA tracking (contractor-provided vs Government-provided), and are there required fields/workflows?

Response to Question 6 CAPA tracking is to be provided by pSMILE, not the government.

Question 7 Section C – Site Visits - Are there minimum annual visit counts/durations per laboratory, and are visits expected to be scheduled with DAIDS coordination?

Response to Question 7 Please see uniform cost assumptions for number and duration of site visits. Scheduling is coordinated with DAIDS.

Question 8 Section C - Proficiency Testing (PT) - Please confirm whether PT panels/providers are Government-furnished or contractor-procured, and who funds PT shipments/customs fees.

Response to Question 8 PT panels are to be procured by pSMILE. PT panels are “off-the-shelf”, shipped by their provides to the receiving laboratories. Shipping costs are included with the cost of the panels.

Question 9 Section C – Training - Are trainings expected to be delivered in specific languages/time zones and/or require in-country delivery in addition to webinars?

Response to Question 9 Assume training primarily in English. In-country training is folded into visits. Please respond to the Uniform Cost Assumptions.

Question 10 Section C – Data System - Is there an existing DAIDS/Lab data platform the contractor must use, or is the contractor expected to provide/host a system?

Response to Question 10 The existing data system will be given to the successful Offeror. A new incumbent will be expected to host and maintain.

RFP # 75N93025R00011, Amendment 1 4

Question 11 Security – NIST - If the contractor must host/manage systems, is an ATO/FedRAMP authorization required, or is NIST 800-171 alignment sufficient?

Response to Question 11 NIST 800-53 or FedRAMP ATO standards should be followed.

Question 12 Section 508 - Which deliverables must meet Section 508 (documents only vs web portal/application as well)?

Response to Question 12 Per Section C., ARTICLE C.2. REPORTING REQUIREMENTS, All electronic reports submitted must be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at https://www.hhs.gov/web/section- 508/index.html and at: https://www.section508.gov/create/documents , "Create Accessible Documents."

Question 13 Transition - Will there be an incumbent transition period and access to incumbent SOPs/data? If so, what is the planned transition duration?

Response to Question 13 There will be a transition period. Depending on time constraints, the transition period would possibly be 2 months.

Question 14 Key Personnel - Are there mandatory Key Personnel roles/resumes required (and if so, which roles)?

Response to Question 14 Under SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, paragraph 2. INSTRUCTIONS TO OFFERORS, subparagraph b., TECHNICAL PROPOSAL INSTRUCTIONS, item 1.b. 4., Resumes, “Resumes of all key personnel are required. Each must indicate educational background recent experience, specific or technical accomplishments, and a listing of relevant publications”. Generally, the Principal Investigator (PI) is the only key personnel, however, it is up to the offeror to propose what key personnel they feel is necessary.

Question 15 Staffing/FTE - Please confirm how the stated annual FTE level should be mapped (e.g., by labor category) and whether fractional FTEs are acceptable per role.

Response to Question 15 Under SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, RFP # 75N93025R00011, Amendment 1 5 paragraph 1. GENERAL INFORMATION, item d. LEVEL OF EFFORT (Page 59), we have provided suggestions for mapping the LOE for each Labor Category. Fractional FTEs are acceptable per role; however, the total FTE need to match 13.70 FTEs for Base Period and each Term Option Period 1-6, and 1.7 FTEs for each OPTION FOR INCREASED LEVEL OF

EFFORT – INCREASED LEVEL OF EFFORT FOR INCREASED SERVICES (OPTIONS 7-

27). There is also a helpful table, to visually convey how Options 7-27 are delineated per year (page 60-61).

Question 16 Travel - Are there Government restrictions/requirements for international travel approvals, security training, vaccinations, or country clearance processes?

Response to Question 16 Regarding travel restrictions/requirements, it’s expected that the Contractor to be aware of all restrictions and requirements.

Question 17 Customs/Shipping - For shipment of PT panels or supplies, who is responsible for customs brokerage, duties, and in-country logistics?

Response to Question 17 The receiving laboratories are responsible for custom brokerage duties and in-country logistics.

It is possible that the PT panels providers and the shippers they use handle it too. This will not be a cost to pSMILE.

Question 18 Data Rights - Are there specific data rights/ownership expectations for SOPs, training materials, and system artifacts created under the contract?

Response to Question 18 No data right to the contractor. All materials produced under this contract are the property of the government. Tools that the contractor developed to perform its work more efficiently should remain the property of the contractor. The following Data Rights clauses are in the RFP: FAR 52.227-14, Rights in Data – General, Alternate IV and V.

Question 19 Subcontracting Plan - Please confirm whether the Small Business Subcontracting Plan must be submitted via SBCX by the proposal due date and whether it is evaluated as part of the proposal.

Response to Question 19 Please read Article H.11 SUBCONTRACTING PROVISIONS, paragraph b. Subcontracting Reports. Yes, the Small Business Subcontracting Plan (SBSP) must be submitted via the SBCX

RFP # 75N93025R00011, Amendment 1 6 by the proposal due date. An offeror’s SBSP must be determined to be acceptable, by the Contracting Officer, prior to the contract award.

Question 20 Proposal Submission - Please confirm the official proposal submission method (e.g., NIH eCPS) and whether email submissions are allowed under any circumstances.

Response to Question 20 Please read “Attachment 1 – Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website”. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Proposals submitted by facsimile or e-mail will not be accepted.

Question 21 Page Limits - Please confirm page limits and formatting rules for the Technical Volume (and whether resumes/org charts count toward the limit).

Response to Question 21 Please read “Attachment 1 – Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website” for the formatting rules. Page limitation on Technical Proposal shall not exceed 175 pages. Total page count does not include title and back page; table of contents; section dividers that do not contain information other than title of Section. Each Curriculum Vitae (CV) shall not exceed 3 pages. Pages exceeding limitations will be removed from the proposal and will not be considered.

Question 22 Evaluation - Please clarify the relative weighting (or importance) of technical approach vs staffing vs past performance.

Response to Question 22 Please read SECTION M – EVALUATION FACTORS FOR AWARD of this solicitation, beginning on page 96. This will provide the relative weighting (or importance) of each evaluation factor for award.

Question 23 Invoicing - Please confirm invoicing structure expectations (monthly), and whether supporting documentation is prohibited unless requested.

Response to Question 23 Invoices shall be submitted monthly. Supporting documentation is required. Please read

ARTICLE B.4 ADVANCE UNDERSTANDINGS; ARTICLE G.3. INVOICE

SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL

https://ecps.nih.gov/

RFP # 75N93025R00011, Amendment 1 7

REPORT; and Attachment 16: Invoice/Financing Request and Contract Financial Reporting Instructions – Cost Reimbursement, NIH(RC)-4.

Question 24 COR/Interfaces - Please confirm primary Government stakeholders (COR, technical leads) and expected cadence for status meetings/reviews.

Response to Question 24 Please read SOW for language on Meetings and Teleconferences. These meetings will be on an as needed basis unless specified in the SOW. Regarding costing purposes, please see Uniform Cost Assumptions for “Meetings”.

Question 25 Section L / Attachment 5 (Business Proposal Instructions) — Pricing / Cost Workbook - Does the Government have an Independent Government Cost Estimate (IGCE) and/or an anticipated funding profile, ceiling, or not-to-exceed (NTE) constraint for the base period and each option year/CLIN that offerors should consider when structuring pricing?

Response to Question 25 Please read the RFP it its entirety and follow the uniform cost assumptions for costing purposes.

Question 26 Government Furnished Property/data - Will any Government-furnished information, tools, or systems be provided at award (e.g., incumbent datasets, historical PT results, lab rosters, system documentation), and in what format?

Response to Question 26 There is no Government Furnished Property for this contract. However, as mentioned above, in response to Question 10 - Data System, the existing data system will be given to the successful Offeror. A new incumbent will be expected to host and maintain.

Question 27 Deliverable templates - Will the Government provide templates for the tri-annual progress report, final report, and monthly failure summary, or should the contractor propose formats?

Response to Question 27 Please read Article C.2. REPORTING REQUIREMENTS, which explain what these reports shall include for the cover page prepared in accordance with the following format and information which must be provided.

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Question 28 Is the salary verification needed at submission and can be supplied at contracting? Our research administration is asking since this is no longer a requirement for other contracts, report, final report, and monthly failure summary, or should the contractor propose formats?

Response to Question 28

Please include salary verification. It could be in the form of pay stubs or a document from payroll/HR with their names and salaries or hourly rates.

END OF AMENDMENT NO. 1, RFP No. 75N93025R00011