S02 Fit Testing 36C26026Q0672 0002.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 10

36C260

NCO 20 Network Contracting Office

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

36C260

NCO 20 Network Contracting Office

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

To all Offerors/Bidders

36C26026Q0672

08/14/2026

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 08-14-2026 5PM PDT

See CONTINUATION Page

X 1

Purpose of this amendment is to:

1. B.2 Essential Physical Characteristic is removed and replaced in its entirety.

2. Provision E.1 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (SEP 2023) (DEVIATION OCT 2025) is removed and replaced in its entirety.

3. Provision E.6 52.212-2 Evaluation—Commercial Products and Commercial Services (NOV 2021) (DEVIATION OCT 2025) is removed and replaced in its entirety.

4. Extend the closing date from 07/31/2026 to 08/14/2026 5PM PST See continuation pages.

No other changes to the RFQ.

CONTINUATION PAGE

B.2 ESSENTIAL PHYSICAL CHARACTERISTICS

Contractor shall provide brand name or equal to TSI 8048 PortaCount Respirator Fit Tester

1. The quantitative Respirator Fit Tester shall include a fit-testing protocol with exercises and exercise procedures that shall be in compliance with OSHA and ANSI for tight-fitting respirators.

2. The Respirator Fit Tester shall be able to fit test a wide variety of disposable N95s as well as other respirators. The quantitative respirator fit-tester at a minimum must be capable of fit-testing the following respirators:

a. Full-face elastomeric

b. Half-face elastomeric

c. NIOSH series-100 filtering-facepiece

d. NIOSH series-99 filtering-facepiece

e. NIOSH series-95 filtering-facepiece, including disposable N95s

f. Series FFP1, FFP2, FFP3 respirators

3. The Respirator Fit Tester must have a maximum fit factor of 10,000; and a maximum fit factor of 200 for disposable N95 respirators.

4. The respirator Fit Tester shall complete the test between 2 – 5 minutes.

5. The respirator Fit Tester must have either a built-in screen or an optional onboard touch screen for ease of use.

6. The respirator Fit Tester must have the option to connect to an external tablet or laptop.

7. The respirator Fit Tester must have its own internal memory capability for the storage and retrieval of previously conducted tests, capable of storing at minimum 1000 fit-test results.

8. The respirator Fit Tester needs to be portable for transporting it to various locations with an approximate weight limit of 8 pounds.

9. Carrying case shall be included.

10. The equipment must have bridge software that transfers the FIT testing results to a VA computer using a direct USB connection. Due to strict VA security protocols, the software must be either already TRM approved or capable of getting TRM approved. All patches and software upgrades shall be provided at no additional cost. TRM approval is required prior to the sale of any equipment to WSNC medical centers.

11. A particle generator shall be included.

12. A rechargeable battery shall be included (if the unit has an option for a rechargeable battery).

13. The Fit Tester shall have a one-year minimum warranty.

14. The fit Tester shall come with an initial set of probe refill kits and Isopropyl Alcohol 99.5%, and the contract will have an optional CLINS for re-ordering these supplies.

15. Annual Calibrations shall be an optional CLIN(S).

16. Virtual or video training shall be included.

17. All equipment must be new and unused.

18. Shipping costs shall be included in the price of newly purchased equipment.

B.10 TECHNICAL REFERENCE MODEL (TRM) AND LOCAL WORKSTATION SOFTWARE

REQUIREMENTS

B.10.1 SCOPE OF SOFTWARE WORKSTATION COMPLIANCE

The Contractor shall provide a standalone desktop "bridge" software application (and all necessary hardware/USB connectivity drivers) to interface the fit-testing equipment with local, VA-issued computers. The software component of this procurement is treated as an enterprise endpoint application and is strictly subject to the One-VA Technical Reference Model (TRM) review and approval process.

B.10.2 LIFECYCLE SUPPORT, SECURITY PATCHES, AND ZERO-COST UPGRADES

Mandatory Zero-Cost Support: The Contractor shall provide all necessary software patches, bug fixes, security updates, and vulnerability remediations required to maintain the software in an "Approved" or "Approved with Constraints" status on the One-VA TRM List at no additional cost to the Government for the lifetime of the hardware or contract performance period.

Operating System Compatibility Upgrades: The Contractor shall deliver all minor updates (e.g., version point releases) and major version upgrades (e.g., changes to core software architecture) at zero additional cost to ensure uninterrupted compatibility with VA standard desktop operating systems (including Windows 10, Windows 11 Enterprise, and subsequent enterprise OS migrations).

No Hidden Fees: Under no circumstances shall the Contractor charge the Government any recurring maintenance, re-licensing, subscription, or re-validation fees to deploy these mandatory security or architectural upgrades.

B.10.3 ENDPOINT ENVIRONMENT AND WORKSTATION CONSTRAINTS

No Administrative Privileges: The software must execute completely under a standard, non-privileged, non-administrative VA local user account. The software shall not require local administrator rights to operate, communicate with the fit-testing hardware, or save testing data.

Directory Path Compliance: The software shall not write data, execute files, or create caches within root directories (e.g., C:\) or restricted system folders (e.g., C:\Windows).

All user-specific data, logs, and local databases must be written exclusively to standard, non-privileged paths (e.g., AppData\Local or designated local user profile folders).

Security Software Coexistence: The software and its communication drivers must operate seamlessly alongside VA endpoint security tools (including, but not limited to, Microsoft Defender for Endpoint and McAfee) without requiring security exclusions, disabled host firewalls, or deactivated antivirus scanning.

B.10.4 SECURITY, DATA ENCRYPTION, AND CLOUD RESTRICTIONS

FIPS 140-3 Cryptographic Validation: Because the software processes Personally Identifiable Information (PII) and protected employee health records (names, employee IDs, respiratory mask sizes, and fit-testing results), any local database, cache, or file-level storage utilized by the software must utilize FIPS 140-3 validated encryption algorithms for data-at-rest.

Prohibition of Commercial Cloud Syncing: The software must be capable of operating entirely offline or via local hardwired connections (USB or LAN). Automated over-the-air (OTA) or cloud-initiated software updates are strictly prohibited. All native, commercial vendor cloud synchronization features built into the software or hardware must be fully disabled and restricted unless specifically authorized by a VA FedRAMP Authority to Operate (ATO).

B.10.5 ENTERPRISE PACKAGING AND DOCUMENTATION ARTIFACTS

Offline Deployment Delivery: The Contractor must deliver all patches, firmware updates, and software upgrades as static, self-contained standalone installation files (e.g., signed .msi or .exeformats) to allow the VA IT team to internally test, package, and deploy them using Microsoft Endpoint Configuration Manager (MECM) or other enterprise deployment utilities.

Post-Award Deliverables: An updated Software Bill of Materials (SBOM) must accompany every subsequent patch or version update delivered over the life of the contract.

B.10.6 TECHNICAL REFERENCE MODEL (TRM) COMPLIANCE CONTINGENCY REMEDY

Contingent Acceptance: Final acceptance of the software component and final payment for the integrated hardware solution is strictly contingent upon the software achieving a status of "Approved" or "Approved with Constraints" on the One-VA TRM List.

Failure to Comply and Termination Remedy: If the software is formally rejected by the VA TRM review board, or if an existing TRM approval is revoked due to an unpatched vulnerability, the Contractor shall have forty-five (45) calendar days from the date of notification to provide a remediated, compliant version at no cost to the Government. If the Contractor fails to provide a TRM-approved software solution within this window, the Government reserves the right to terminate the contract for cause at no cost to the Government, and return all unapproved software and associated equipment for a full refund.

B.10.7 TECHNICAL REFERENCE MODEL (TRM) PRE-SCREENING SUBMISSION

REQUIREMNTS

If not already TRM approved, the Offeror shall submit the following technical documentation as part of Volume I (Technical Proposal) to demonstrate compliance with the One-VA TRM requirements. Failure to provide any of the following items with the initial submission shall render the submission non-compliant and ineligible for award:

1. Software Bill of Materials (SBOM): A complete machine-readable SBOM detailing all open-source, commercial, and proprietary components, libraries, and dependencies embedded within the bridge software.

2. Data-Flow Diagram: A detailed architectural diagram illustrating how data moves between the fit-testing equipment, the host workstation, and local directories, including explicit protocol types and port utilization.

3. FIPS 140-3 Validation Documentation: Official National Institute of Standards and Technology (NIST) cryptographic module validation certificates proving that the software utilizes FIPS 140-3 validated encryption for data-at-rest.

4. Driver and Workstation Permissions Profiles: Documentation proving all hardware communication drivers are digitally signed by Microsoft and verifying the software functions seamlessly under a standard, non-privileged VA local user account.

B.11 HOURS/DAYS OF PERFORMANCE

Unless otherwise specified and/or directed by the Contracting Officer (CO) or the Contracting Officer’s Representative (COR), all contract work shall be performed during the hours of 8:00 a.m. to 4:30 p.m. Monday through Friday, except federal holidays.

B.12 FEDERAL HOLIDAYS

The 11 holidays set by law (5 U.S.C. 6103) that are observed by the VA, i.e., New Year’s Day, Birthday of Martin Luther King, Jr., Washington’s Birthday, Memorial Day, Juneteenth National Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day and any other day declared by Executive order to be a federal holiday.

B.13 SECURITY REQUIREMENTS

1. The following C&A requirements apply to this requirement.

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data

- General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (DEVIATION OCT 2025)

(a) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. As a minimum, offers shall include—

(1) The solicitation number;

(2) The name, address, telephone number of the Offeror;

(3) The Offeror’s Unique Entity Identifier (UEI) and, if applicable, Electronic Funds Transfer (EFT) indicator;

(4) Information necessary to evaluate the factors contained in the provision at 52.212-2 or as described in the solicitation;

(5) Responses to provisions that require Offeror completion of information, representations, and certifications (other than those collected via the System for Award Management (SAM));

and

(6) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and any solicitation amendments.

Specific Instructions Volume I:

Provide your quote to robin.wilson3@va.gov by the due date and time expressed on the Standard Form 1449 (SF1449) in block 8. The deadline for questions is stated on the SF1449 in block 20. All questions shall be submitted in writing, verbal questions will not be answered. Late quotes will not be considered. The quote must be received by the due date/time shown.

Quote Submission Requirements: Vendors are required to include the following information with their quote submissions, consisting of three parts:

Part 1: Price

(1) Offerors shall complete Price/Cost Schedule for the listed items in order to be considered for award.

Part 2: Technical

(1) Capability statement detailing offeror’s ability to meet the "brand name or equal to" requirements of the Essential Physical Characteristics. The capability statement shall be clear, logical and reflect the understanding of the Government’s.

(2) Capability Statement demonstrating vendor's understanding of Part B of the Essential Physical Characteristics.

(3) Information required by B.10.7. The submission information detailed in B.10.7 is to demonstrate compliance with the VA Technical Reference Model (TRM) requirements. If the software being quoted is already TRM-approved, proof of approval (through screenshots of the VA TRM website or otherwise) shall fulfill this part of the submission requirement. Failure to provide this information may result in the quote being rendered ineligible for award.

Part 3: Relevant Experience/Past Performance

(1) Will be evaluated on how well the offeror has performed similar work and meeting similar performance standards in the past (size and scope). Specifically, this evaluation will focus on the vendors ability to support a wide variety of medical centers, ordering across a large geographic area, management of a large schedule of items or inventory, ability to provide highly technical medical products, and ability to meet high volume ordering deliveries. Additionally, quotes will be evaluated to determine the likelihood of best meeting the VA requirements in magnitude; meaning type products and ordering, as well as the scope and coverage.

(2) Offerors shall demonstrate a minimum of three (3) years’ experience installing and delivering Respirator Fit Testing Equipment, Supplies, and Annual Calibrations.in VAMCs throughout a large geographical area. Furthermore, offerors shall provide evidence of any current or past government contracts of similar scope/complexity (if applicable).

(3) Offerors shall also provide a list of contracts that they have performed in the last 3 years that have had CPARS completed.

FAILURE TO FOLLOW INSTRUCTIONS OR TO INCLUDE ANY OF THE ABOVE

REQUESTED INFORMATION MAY RESULT IN AN OFFER BEING FOUND

UNACCEPTABLE.

(b) Period for acceptance of offers. The Offeror agrees to hold the prices in its offer firm for 60 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(c) Late submissions, modifications, revisions, and withdrawals of offers.

(1) Offerors are responsible for submitting offers and any modifications or revisions to the Government office designated in the solicitation by the time specified in the solicitation.

(2) Any offer, modification, or revision received after the time specified for receipt of offers is “late” and will not be considered unless it is received before award is made and the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition. However, a late modification of an otherwise successful offer that makes its terms more favorable to the Government will be considered at any time it is received and may be accepted.

(3) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(4) Offerors may withdraw their offers by written notice to the Government received at any time before award.

(d) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with Offerors. Therefore, the Offeror’s initial offer should contain the Offeror’s best terms. However, the Government reserves the right to conduct discussions, if necessary. The Government may reject any or all offers if such action is in the public interest, accept other than the lowest offer, and waive informalities and minor irregularities in offers received.

(e) Debriefings. If a postaward debriefing is given to requesting Offerors, the Government will disclose the following information, if applicable:

(1) The agency’s evaluation of the significant weak or deficient factors in the debriefed Offeror’s offer.

(2) The overall evaluated cost or price and technical rating of the successful Offeror and the debriefed Offeror and past performance information on the debriefed Offeror.

(3) The overall ranking of all Offerors when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award.

(5) For acquisitions of commercial products, the make and model of the product to be delivered by the successful Offeror.

(6) Reasonable responses to relevant questions posed by the debriefed Offeror as to whether the agency followed source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities.

(End of Provision)

E.6 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021) (DEVIATION OCT 2025)

a) Evaluation factors. The Government may award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. First the source selection team will evaluate the brand name or equal product proposed, to determine if any “equal to” products will meet the needs of the requirement per section B of this document. Then, all quotes, that meet the brand name or equal requirement, the following factors will be used to evaluate offers:

(1) Price

(2) Technical

(3) Past performance/ Relevant experience

(b) Options (if applicable). The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. The evaluation of options does not obligate the Government to exercise the option(s).

(c) Notice of award. A written notice of award or acceptance of an offer furnished to the successful Offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)