Solicitation Amendment W81K0026QA0050001 SF 30.pdf

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

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:

(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 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.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

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 (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

Previous edition unusable STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

Addendum to 52.212-1, Instructions to Offerors - Commercial Products and Commercial Services

Miscellaneous text in this section has been modified to:

Volume I - Administrative.

All offerors shall provide the following items:

Completed SF 1449: Blocks 12, 17 (to include CAGE code and Unique Entity ID Number), 30A - C Completed SF 30: Blocks 5A - C (for all amendments issued, if any) Point of Contact Information (Name, Telephone Number, Fax Number, and Email) Statement that the offeror will hold its quote firm for at least 90 days from the due date for receipt of quotes, subject to any changes that may occur as a result of discussions (if applicable). Completed provisions, as listed in the solicitation. Alternately, complete all provisions in SAM and provide confirmation of completion and accuracy with offer.

Potential contractors must be registered in the System for Award Management (SAM) to be eligible for award. The SAM website is http://www.sam.gov. Offers are due by (unless 14 August 2025,12:00 PM, Central Standard Time extended via amendment). Offers shall be submitted via e-mail to andcolleen.m.rye.civ@health.mil

Quotes received after the deadline will be considered salameya.paulouskaya2.civ@health.mil.

untimely and will not be eligible for award.

The deadline for questions is (questions submitted after 30 July 2025, 10 AM, Central Standard Time this deadline will not be answered). All questions must be submitted in writing to colleen.m.rye.

.civ@health.mil and salameya.paulouskaya2.civ@health.mil Electronic submissions with files larger than 20MB will need to be submitted in separate emails. All emails, regardless of the size, need to be received by the Government server, by the stated date and time.

It is the offeror's responsibility to ensure the Government receives the entire quote.

Volume II - Technical Capability Factor 1. Technical Capability. Offerors shall demonstrate how their proposed items comply with the Government's Statement of Objectives via the submission of a written capability statement, product literature, or other materials.

Each of the following shall be addressed:

Subfactor 1A - SOO - Section 7 and 11 - Instruments/Equipment and Reagents/Consumables.

Subfactor 1A: Offerors shall provide all instruments/equipment necessary to conduct testing as per workload data table on the testing identified.

The instrument/equipment provided will be utilized for BAMC's viral loads and high-risk HPV assay needs. In addition, the instrument /equipment must include an automated component that facilitates ease of sample preparation and seamless input of data via barcode scanning. A printer to produce hard copy patients reports and other reports generated shall also be provided. As indicated in the FDA safety alert communication, assays that use free capture streptavidin/biotin in their assay architecture have been demonstrated to show interference with can lead to misdiagnosis and medical error. We require that the assays must not use free- capture streptavidin/biotin in the assay architecture to minimize the risk of interference from ingested biotin. See Statement of Objectives for additional details.

Subfactor 1B - SOO - Section 8 - Maintenance and Service.

W81K0026QA0050001

Subfactor 1B Service and Maintenance. Offerors shall provide a full-service plan to include the recommended unscheduled and preventive maintenance service for their instrument/equipment period.

Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer's maintenance manuals), and hotline telephone service, in order to assist customer in troubleshooting problems. Offerors shall respond to telephonic requests for unscheduled repair Service Engineer/technician shall be on-site within 24 hours of initial notification for routine /emergency failures. If the equipment is out of service for longer than 72 hours (from the time-of service technician's arrival on site), the contractor shall notify the government point of contact on duty, in writing, as to the reason(s) (i.e., nonavailability of parts, etc.) for non-compliance. If the equipment cannot be repaired, a replacement instrument shall be provided within seven (7) days. See Statement of Objectives for additional details.

Subfactor 1C - SOO - Section 12 - Training.

1C: Training. Offerors will provide initial operator training to all technicians assigned to the US Government site (BAMC Department of Pathology Microbiology staff), as well as annual refresher training, as needed to ensure adequate use competency during times of personnel turnover. See Statement of Objectives for additional details.

Subfactor 1D -SOO - Section 10 - Delivery/Installation.

Subfactor 1D: Delivery/Installation/Verification. Indicate what facility modifications are necessary for the delivery/installation of equipment. Include a timeline identifying critical points in the delivery /installation/verification phase that aims at avoiding or minimizing interruption of in-house testing, expense associated with send-out of samples to reference laboratory for testing, and impact to patient care, wherein Day 0 = Notice of Award. For example, if the offeror is notified that they are awarded the contract on 1 October 2026, delivery of the equipment would occur on 15 October 2026, with installation on 1 November 2026, the timeline would be: Day 0 = Notification of Award; Day 15 = Delivery of equipment; Day 31 = Installation. Expected day of installation completion is 1 November 2026 or earlier.

Method verification studies shall be completed by vendor personnel within six (6) weeks or less after contract award to ensure that equipment is fully operational.

Factor 2. Interface capability with the Military Health System (MHS) Genesis. The equipment must be able to connect to the MHS Genesis and must come with an un-interruptible power supply capable of providing power for at least 45 to 60 minutes. All equipment and supplies must be approved by the FDA.

This requirement is needed NLT 1 October 2025. All detailed information regarding delivery and installation is provided in the SOO.

Factor 3. Risk Management Framework (RMF) Compliance. In order to ascertain security compliance that is in agreement with Federal, DOD, and DHA directives and policies requires the vendor to complete the attached Medical Device Risk Assessment Questionnaire. The Defense Health Agency's Cybersecurity Risk Management Framework (RMF) Requirements dated 5 January 2022, and any local supplements, outline what requirements must be met in order for a contractor's equipment to be connected to the network. The offeror shall certify that they are able to meet the timelines listed in Exhibit 1, RMF Deliverables, and complete Exhibit 2, Medical Device Risk Assessment Questionnaire and return as part of their offer.

Volume III. Price.

Factor 4. Price.

For CLINs 0001 for the base, a unit price shall be submitted for each line item (i.e., per kit), as well as the extended price (i.e., unit price multiplied by quantity). For those CLINs that contain multiple items (i.

e., Consumables and Controls), submit a unit price for each item and an estimated quantity for each, that would be required to process the estimated annual number of tests. For CLINs 0002 and 0003 for the RMF Compliance and MHS Genesis Compliance, a unit price shall be submitted (or the offeror may elect to "Not Separately Price" (NSP) this line item) that will ensure the offeror maintains compliance with the Defense Health Agency's

RMF standards. (m) The non-FAR Part 12 discretionary FAR and DFARS provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

Volume IV. Subcontracting Plan

Subcontracting Plan Subcontracting Plan - The offeror shall submit a Subcontracting Plan with their proposal. If the offeror already has a current Commercial Subcontracting Plan approved by a Government Contracting Officer, that plan (along with corresponding approval) is sufficient for submission. If the offeror does not believe any subcontracting opportunities exist, an explanation with supporting documentation shall be submitted.

ACWS TRANSITION INFORMATION

1. Army Contract Writing System (ACWS) Transition Information for Offerors

a. The Army Contracting Enterprise (ACE) is in the process of deploying a new contract writing software to Army contracting offices worldwide. Known as the Army Contract Writing System (ACWS), this modern software will soon replace the legacy Army contract writing systems.

b. During this transition period, Offerors are hereby advised: The Contracting Office may use any combination of contract writing systems to create and release documents related to this solicitation (e.g.

solicitation amendments and awards, if any). Due to this:

I. This solicitation may contain different offer submission instructions than other solicitations released by the same Contracting Office (e.g. requiring offer submission via the PIEE Solicitation Module vs. e-mail). Offerors should review all offer submission instructions contained in the solicitation documents and direct any questions or concerns to the Contract Specialist or Contracting Officer.

II. If the Contracting Office switches contract writing systems prior to award, documents you receive from the Contracting Officer or view on SAM.gov or other forums may appear noticeably different than the initial solicitation or previous solicitations or awards from the same Contracting Office. This is normal and expected.

III. A change between contract writing systems may cause important information concerning solicitation response (amendments) or accepted terms (awards) to take on different formatting or appear in different parts of later documents issued. Offerors shall review all documents carefully to locate this important information and direct any questions or concerns to the Contract Specialist or Contracting Officer.

2. The Government does not intend to use the transition between contract writing systems to effect any changes to solicitation or award terms and conditions without accompanying document narratives explicitly stating such changes are deliberate and desired. While the Contract Specialist and Contracting Officer will take care to minimize or eliminate any inadvertent changes when adapting to the new contract writing software, you, as the Offeror, may still be the first to spot such errors. Therefore, Offerors shall:

I. Notify the Contracting Officer immediately if any observed changes, removals, or additions affect your award eligibility, violate or alter existing quote/proposal terms, or could affect Contract performance post award.

II. from the Contracting Office throughout the Solicitation and Award process.

III. Contact the Contracting Officer listed on the first page of the solicitation or solicitation amendment for guidance if you notice or suspect any inadvertent change has occurred between document issuances.

3. The Contracting Officer will correct problems affecting award documents (if any) via bilateral modification, at no cost to the Contractor. Any such modification will reconcile the award with the latest version of this solicitation reflecting deliberate action by the Contracting Officer (e.g. the first issuance if no amendments, or the latest amendment with accompanying narratives), inclusive of any documented pre-award negotiations or accepted supplemental offer terms

4. In the unlikely event that a network disruption, contract writing system error, or financial system error threatens timely award of the requirement set forth in this solicitation, the Contracting Officer:

I. May elect to use alternative mechanisms to obligate fund sand allow work or deliveries to legally begin to the benefit of, and with legal protection for, both parties.

II. Will incorporate the latest version of this Solicitation into such mechanisms to serve as a framework for contract execution until any such system problems are resolved.

III. Will ensure any action taken does not conflict with the stated offer evaluation and award methodology of this requirement.

IV. Will issue a complete, properly formatted award that accurately reflects this requirement and all applicable terms and conditions once systems return to normal.

MEDICAL READINESS CONTR OFFICE WEST, 3160 MCINDOE BLDG1103

JBSA FT SAM HOUSTON, TX 78234-4504

UNITED STATES

COLLEEN RYE, EMAIL: COLLEEN.M.RYE.CIV@HEALTH.MIL TELEPHONE: 210-539-8662

AdminBy:

SCD: PAS: