Solicitation --- W81K00-23-Q-0124 -- HPV Reagents and Analyzer Systems.pdf

SEE ADDENDUM

(No Collect Calls)

W81K0023Q0124 11-Jul-2023

b. TELEPHONE NUMBER

210-539-8525

8. OFFER DUE DATE/LOCAL TIME

01:00 PM 25 Jul 2023

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W81K009. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

MEDINA L. WOODSON

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

0 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

0011891382-0001

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED ORX

SMALL BUSINESS

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

3160 MCINDOE BLDG 1103

JBSA FT SAM HOUSTON TX 78234-4504

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE 16. ADMINISTERED BY

SEE SCHEDULE

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFP

FAX:

TEL: 210-221-1110 SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,250

NAICS:

325413

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF78

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

W81K0023Q0124

Section SF 1449 - CONTINUATION SHEET

52.212-4 ADDENDUM

(w) The non-FAR Part 12 and 13 discretionary FAR and DFARS clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 herein for locations where full text can be found.

52.212-1 ADDENDUM

Volume I. Administrative.

All offerors shall provide the following items:

Completed SF 1449: Blocks 12, 17 (to include CAGE code and UEI number), 30A - C Completed SF 30:

Completed Blocks 8, 15A - 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 120 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 shall 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 25 July 2023, 1:00 PM, Central Standard Time (unless extended via amendment). Offers shall be submitted via e-mail to medina.l.woodson.civ@health.mil and cicely.d.simmons-carroll.civ@health.mil. Quotes received after the deadline will be considered untimely and will not be eligible for award.

The deadline for questions is 18 July 2023, 4:00 PM, Central Standard Time (questions submitted after this deadline will not be answered). All questions shall be submitted in writing to Medina.L.Woodson.civ@health.mil and cicely.d.simmons-carroll.civ@health.mil.

The Offeror is responsible for notifying the government of any changes in point of contact (POC) during the acquisition process and the life of the Contract.

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 6 and 7 - Instruments/Equipment and Reagents/Consumables.

Subfactor 1A: Instruments/Equipment and Reagents/Consumables. Offerors shall provide two (2) instruments to be delivered/installed to the Brooke Army Medical Center (4th floor), immunology laboratory (Room 428‐5).

Offerors shall provide all equipment and reagents/consumables to conduct testing for HPV DNA testing, detection, and genotyping. The testing systems shall be FDA‐approved primary screening for cervical carcinoma and shall include testing for the following: HPV High Risk pool plus HPV 16 & 18 Genotype simultaneously eliminating the need to re‐run a sample; as well as a traditional High Risk pool (14 HR Genotypes) with no grey zone or indeterminate results.

Subfactor 1B – SOO - Section 10 - Maintenance and Service.

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. non-availability of parts, etc.) for non-compliance. If the equipment cannot be repaired, a replacement instrument shall be provided within seven (7) days.

Subfactor 1C – SOO - Section 12 - Training.

Subfactor 1C: Training. Equipment setup, LIS connectivity, on-site training, and 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.

Subfactor 1D –SOO – Section 8 - 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 2023, delivery of the equipment would occur on 15 October 2023, with installation on 1 November 2023, 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 2023 or earlier, for at least 1 instrument. 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. Risk Management Framework (RMF) Compliance. In order to ascertain security compliance that is in agreement with Federal, DOD, and DHA directives and policies, Defense Logistics Agency Troop Support DLATS) 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 shall 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.

Factor 3. Interface capability with the Military Health System (MHS) Genesis. The system shall be capable of interfacing with MHS Genesis. The analyzers shall have an interface that is compatible to the current Government Laboratory Information System (LIS) and Military Health System (MHS) Genesis. Each interface shall allow for recognition and interpretation of MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors instrument systems and middleware to each LIS at varying times during the contracted period of performance.

Volume III. Subcontracting Plan.

Factor 4. Subcontracting Plan. The offeror shall submit a Subcontracting Plan with their quote. 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.

Volume IV. Price.

Factor 5. Price. For CLINs X001 – X003 for the base and all option periods, 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. Offerors shall also complete the pricing matrix contained at Attachment B – Pricing Matrix in Excel format and shall provide a price for each CLIN/SubCLIN in the pricing matrix, not to exceed the hundredths decimal point

For CLINs 0003, 1003, 2003, 3003 and 4003 for the RMF Compliance, a unit price shall besubmitted (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.

52.212-2 ADDENDUM

a) Award will be made using the lowest price technically acceptable (LPTA) process in accordance with FAR Parts 12 and 13. Award will be made to the responsible offeror on the basis of the lowest evaluated price of offers meeting or exceeding the acceptability standards for non-cost factors. Award may be made without discussions with offerors (except communications conducted for the purpose of minor clarification). Therefore, each initial offer should contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary. Award will be made on an all or none basis.

Factor 1: Technical Capability. In addition to the overall factor, each subfactor (as listed below) will be evaluated individually.

Subfactor 1A - SOO – Section 6 and 7 - Instruments/Equipment and Reagents/Consumables.

Subfactor 1B – SOO - Section 10 - Maintenance and Service.

Subfactor 1C – SOO - Section 12 - Training.

Subfactor 1D –SOO – Section 8 - Delivery/Installation.

The following adjectival ratings will be used in evaluating the offeror’s Technical Capability:

Acceptable – An Acceptable rating will be assessed on any offeror whose quote clearly meets each aspect of the Statement of Objectives and other requirements listed in the solicitation.

Unacceptable – An Unacceptable rating will be assessed on any offeror that presents a quote that demonstrates any of the following:

a. Failure to meet each aspect of the Statement of Objectives and other requirements of the solicitation.

b. Failure to provide sufficient detail for the Government to determine whether its offer meets the Statement of Objectives and the requirements of this solicitation.

c. Failure to provide all of the tests required in the solicitation (as listed in Table 1) of the statement of objectives.

NOTE: Each subfactor shall be separately addressed in the offeror's quote. An offeror shall be found technically acceptable on each subfactor in order to be eligible for award. If one or more subfactors are found technically unacceptable, the entire factor will be determined unacceptable, and thus not eligible for award.

Factor 2. Risk Management Framework (RMF) Compliance.

Acceptable – Acknowledgement of and demonstrated willingness and ability to comply with the DHA Cybersecurity RMF Requirements, to include by specifically acknowledging Exhibit 1, RMF Timeline, and completion of Exhibit 2, Medical Device Risk Assessment Questionnaire.

Unacceptable – Failure to acknowledge willingness to comply with the DHA requirements, and/or failure to acknowledge Exhibit 1 and complete Exhibit 2.

Factor 3. Interface capability with Military Health System (MHS) Genesis.

Acceptable – Acknowledgement and demonstration of analyzer interface compatibility to the current Government Laboratory Information System (LIS), Military Health System (MHS) Genesis. Each interface allows recognition and interpretation of MHS Genesis generated bar-code labels on all sample tube types. Connectivity between theContractors instrument systems and middleware to each LIS at varying times during the contracted period of performance.

Unacceptable – Analyzer(s) interface not compatible with the MHS Genesis. Interface does not allow recognition and interpretation of MHS Genesis generated bar-code labels on all sample tube types. Connectivity not available between the Contractors instrument systems and middleware to LIS.

Factor 4. Subcontracting Plan. If submitting other than a Commercial Subcontracting Plan that has been approved by a Government Contracting Officer, the offeror's Subcontracting Plan shall be evaluated to determine if its goals are realistic, challenging, and achievable. Failure to provide such a plan, or provide sufficient evidence that no subcontracting opportunities exist, will render the entire offer ineligible for award.

The following adjectival ratings will be used in evaluating the offeror’s Subcontracting Plan:

Acceptable – An Acceptable rating will be assessed on any offeror whose Subcontracting Plan is:

a. Already approved by a Government Contracting Officer; or

b. Determined to be realistic, challenging, and achievable by this requirement's Contracting Officer; or

c. Provides sufficient evidence for this requirement's Contracting Officer to concur that there are no subcontracting opportunities available.

Unacceptable – An Unacceptable rating will be assessed on any offeror whose Subcontracting Plan is:

a. Determined to be other than realistic, challenging, and achievable by this requirement's Contracting Officer; or

b. Failure to provide sufficient evidence for this requirement's Contracting Officer to concur that there are no subcontracting opportunities available.

Factor 5. Price. The Government will evaluate price proposals on the basis of fair and reasonable pricing if and when the proposal has received an Acceptable rating on Factors 1 - 4. The offeror's pricing shall be determined to be fair and reasonable in order to be considered for contract award.

(b) Options. 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. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise 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.

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Job HPV Analyzers - CPT - FY24

FFP

The Contractor shall provide Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Reagents in support of the HPV DNA Amplification/Detection Testing mission for the Department of Pathology and Area Laboratory Services (DPALS), Microbiology Section, Molecular Laboratory at the Brooke Army Medical Center (BAMC) and its surrounding clinics/healthcare network, located at or near Joint Base San Antonio, TX 78234.

The Contractor shall be responsible for furnishing 2 fully automated HPV analyzer system (inclusive of instruments, ancillary equipment, maintenance, services, repairs, training, support, and parts as required in order to maintain the systems in optimal operating condition at no extra cost to the Government).

This cost-per-test price shall include costs covering the Following;

(a) Equipment Use

(b) All reagents, standards, controls, supplies, consumable/disaposable items, parts, accessories and any other items required for the proper operation of the Contractor's equipment this is necessary for the generation of a test result, (c) All necessary maintenance to keep the equipment in good operating condition(this includes both preventive maintenance and emergency repairs) and (d)Training for Government personnel.

Delivery for CLINS 0001 will be from 01 October 2023 to 30 September 2024 with the last order date to be 30 September 2024. Items will be ordered in accordance with the SOO.

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

PURCHASE REQUEST NUMBER: 0011891382-0001

PSC CD: 6505

NET AMT

0002 1 Job Military Health System (MHS) Genesis

FFP

The analyzers must have an interface that is compatible to the current Government Laboratory Information System (LIS), Composite Health Care System (CHCS),and new Government LIS, Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of CHCS and MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance. Location: Department of Pathology and Area Laboratory, Brooke Army Medical Center, Ft Sam Houston, Texas.

FOB: Destination

0003 1 Job RMF Compliance

FFP

The vendor must remain in compliance with current edition of Defense Health Agency Cybersecurity Risk Management Framework (RMF) Requirements (or successor document), to include timelines established in award (see Exhibit 1, RMF Timelines and Exhibit 2, Medical Device Risk Assessment Qestionnaire).

Location: Department of Pathology and Area Laboratory Services (DPALS), Brooke Army Medical Center, Ft Sam Houston Texas.

FOB: Destination

1001 1 Job OPTION HPV Analyzers - CPT - FY25

FFP

The Contractor shall provide Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Reagents in support of the HPV DNA Amplification/Detection Testing mission for the Department of Pathology and Area Laboratory Services (DPALS), Microbiology Section, Molecular Laboratory at the Brooke Army Medical Center (BAMC) and its surrounding clinics/healthcare network, located at or near Joint Base San Antonio, TX 78234.

The Contractor shall be responsible for furnishing 2 fully automated HPV analyzer system (inclusive of instruments, ancillary equipment, maintenance, services, repairs, training, support, and parts as required in order to maintain the systems in optimal operating condition at no extra cost to the Government).

This cost-per-test price shall include costs covering the Following;

(a) Equipment Use

(b) All reagents, standards, controls, supplies, consumable/disaposable items, parts, accessories and any other items required for the proper operation of the Contractor's equipment this is necessary for the generation of a test result, (c) All necessary maintenance to keep the equipment in good operating condition(this includes both preventive maintenance and emergency repairs) and (d)Training for Government personnel.

Delivery for CLINS 1001 will be from 01 October 2024 to 30 September 2025 with the last order date to be 30 September 2025. Items will be ordered in unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

1002 1 Job OPTION Military Health System (MHS) Genesis

FFP

The analyzers must have an interface that is compatible to the current Government Laboratory Information System (LIS), Composite Health Care System (CHCS),and new Government LIS, Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of CHCS and MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance. Location: Department of Pathology and Area Laboratory, Brooke Army Medical Center, Ft Sam Houston, Texas.

FOB: Destination

1003 1 Job OPTION RMF Compliance

FFP

The vendor must remain in compliance with current edition of Defense Health Agency Cybersecurity Risk Management Framework (RMF) Requirements (or successor document), to include timelines established in award (see Exhibit 1, RMF Timelines and Exhibit 2, Medical Device Risk Assessment Qestionnaire).

Location: Department of Pathology and Area Laboratory Services (DPALS), Brooke Army Medical Center, Ft Sam Houston Texas.

FOB: Destination

2001 1 Job OPTION HPV Analyzers - CPT - FY26

FFP

The Contractor shall provide Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Reagents in support of the HPV DNA Amplification/Detection Testing mission for the Department of Pathology and Area Laboratory Services (DPALS), Microbiology Section, Molecular Laboratory at the Brooke Army Medical Center (BAMC) and its surrounding clinics/healthcare network, located at or near Joint Base San Antonio, TX 78234.

The Contractor shall be responsible for furnishing 2 fully automated HPV analyzer system (inclusive of instruments, ancillary equipment, maintenance, services, repairs, training, support, and parts as required in order to maintain the systems in optimal operating condition at no extra cost to the Government).

This cost-per-test price shall include costs covering the Following;

(a) Equipment Use

(b) All reagents, standards, controls, supplies, consumable/disaposable items, parts, accessories and any other items required for the proper operation of the Contractor's equipment this is necessary for the generation of a test result, (c) All necessary maintenance to keep the equipment in good operating condition(this includes both preventive maintenance and emergency repairs) and (d)Training for Government personnel.

Delivery for CLINS 2001 will be from 01 October 2025 to 30 September 2026 with the last order date to be 30 September 2026. Items will be ordered in unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

2002 1 Job OPTION Military Health System (MHS) Genesis

FFP

The analyzers must have an interface that is compatible to the current Government Laboratory Information System (LIS), Composite Health Care System (CHCS),and new Government LIS, Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of CHCS and MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance. Location: Department of Pathology and Area Laboratory, Brooke Army Medical Center, Ft Sam Houston, Texas.

FOB: Destination

2003 1 Job OPTION RMF Compliance

FFP

The vendor must remain in compliance with current edition of Defense Health Agency Cybersecurity Risk Management Framework (RMF) Requirements (or successor document), to include timelines established in award (see Exhibit 1, RMF Timelines and Exhibit 2, Medical Device Risk Assessment Qestionnaire).

Location: Department of Pathology and Area Laboratory Services (DPALS), Brooke Army Medical Center, Ft Sam Houston Texas.

FOB: Destination

3001 1 Job OPTION HPV Analyzers - CPT - FY27

FFP

The Contractor shall provide Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Reagents in support of the HPV DNA Amplification/Detection Testing mission for the Department of Pathology and Area Laboratory Services (DPALS), Microbiology Section, Molecular Laboratory at the Brooke Army Medical Center (BAMC) and its surrounding clinics/healthcare network, located at or near Joint Base San Antonio, TX 78234.

The Contractor shall be responsible for furnishing 2 fully automated HPV analyzer system (inclusive of instruments, ancillary equipment, maintenance, services, repairs, training, support, and parts as required in order to maintain the systems in optimal operating condition at no extra cost to the Government).

This cost-per-test price shall include costs covering the Following;

(a) Equipment Use

(b) All reagents, standards, controls, supplies, consumable/disaposable items, parts, accessories and any other items required for the proper operation of the Contractor's equipment this is necessary for the generation of a test result, (c) All necessary maintenance to keep the equipment in good operating condition(this includes both preventive maintenance and emergency repairs) and (d)Training for Government personnel.

Delivery for CLINS 3001 will be from 01 October 2026 to 30 September 2027 with the last order date to be 30 September 2027. Items will be ordered in unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

3002 1 Job OPTION Military Health System (MHS) Genesis

FFP

The analyzers must have an interface that is compatible to the current Government Laboratory Information System (LIS), Composite Health Care System (CHCS),and new Government LIS, Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of CHCS and MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance. Location: Department of Pathology and Area Laboratory, Brooke Army Medical Center, Ft Sam Houston, Texas.

FOB: Destination

3003 1 Job OPTION RMF Compliance

FFP

The vendor must remain in compliance with current edition of Defense Health Agency Cybersecurity Risk Management Framework (RMF) Requirements (or successor document), to include timelines established in award (see Exhibit 1, RMF Timelines and Exhibit 2, Medical Device Risk Assessment Qestionnaire).

Location: Department of Pathology and Area Laboratory Services (DPALS), Brooke Army Medical Center, Ft Sam Houston Texas.

FOB: Destination

4001 1 Job OPTION HPV Analyzers - CPT - FY28

FFP

The Contractor shall provide Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Reagents in support of the HPV DNA Amplification/Detection Testing mission for the Department of Pathology and Area Laboratory Services (DPALS), Microbiology Section, Molecular Laboratory at the Brooke Army Medical Center (BAMC) and its surrounding clinics/healthcare network, located at or near Joint Base San Antonio, TX 78234.

The Contractor shall be responsible for furnishing 2 fully automated HPV analyzer system (inclusive of instruments, ancillary equipment, maintenance, services, repairs, training, support, and parts as required in order to maintain the systems in optimal operating condition at no extra cost to the Government).

This cost-per-test price shall include costs covering the Following;

(a) Equipment Use

(b) All reagents, standards, controls, supplies, consumable/disaposable items, parts, accessories and any other items required for the proper operation of the Contractor's equipment this is necessary for the generation of a test result, (c) All necessary maintenance to keep the equipment in good operating condition(this includes both preventive maintenance and emergency repairs) and (d)Training for Government personnel.

Delivery for CLINS 4001 will be from 01 October 2027 to 30 September 2028 with the last order date to be 30 September 2028. Items will be ordered in accordance with the SOO.

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

4002 1 Job OPTION Military Health System (MHS) Genesis

FFP

The analyzers must have an interface that is compatible to the current Government Laboratory Information System (LIS), Composite Health Care System (CHCS),and new Government LIS, Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of CHCS and MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance. Location: Department of Pathology and Area Laboratory, Brooke Army Medical Center, Ft Sam Houston, Texas.

FOB: Destination

4003 1 Job OPTION RMF Compliance

FFP

The vendor must remain in compliance with current edition of Defense Health Agency Cybersecurity Risk Management Framework (RMF) Requirements (or successor document), to include timelines established in award (see Exhibit 1, RMF Timelines and Exhibit 2, Medical Device Risk Assessment Qestionnaire).

Location: Department of Pathology and Area Laboratory Services (DPALS), Brooke Army Medical Center, Ft Sam Houston Texas.

FOB: Destination

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

0002 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

0003 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

1001 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

1002 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

1003 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

2001 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

2002 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

2003 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

3001 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

3002 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

3003 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

4001 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

4002 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

4003 Destination Government AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX

78234-6200

Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 30-SEP-2024 1 AMC BAMC FSH - MM

AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX 78234-6200

FOB: Destination

HT0852

0002 30-SEP-2024 1 AMC BAMC FSH - MM

AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX 78234-6200

210-916-4141

0003 30-SEP-2024 1 (SAME AS PREVIOUS LOCATION)

1001 30-SEP-2025 1 AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX 78234-6200

1002 30-SEP-2025 1 AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX 78234-6200

210-916-4141

1003 30-SEP-2025 1 (SAME AS PREVIOUS LOCATION)

2001 30-SEP-2026 1 AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX 78234-6200

2002 30-SEP-2026 1 AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX 78234-6200

210-916-4141

2003 30-SEP-2026 1 (SAME AS PREVIOUS LOCATION)

3001 30-SEP-2027 1 AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX 78234-6200

3002 30-SEP-2027 1 AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX 78234-6200

210-916-4141

3003 30-SEP-2027 1 (SAME AS PREVIOUS LOCATION)

4001 30-SEP-2028 1 AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX 78234-6200

4002 30-SEP-2028 1 AMC BAMC FSH - MM

3551 ROGER BROOKE DR

BLDG 3600

JBSA FT SAM HOUSTON TX 78234-6200

210-916-4141

4003 30-SEP-2028 1 (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984 52.203-6 Alt I Restrictions On Subcontractor Sales To The Government

(JUN 2020) -- Alternate I

NOV 2021

52.203-12 Limitation On Payments To Influence Certain Federal Transactions

JUN 2020

52.203-17 Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights

JUN 2020

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

MAY 2011

52.204-7 System for Award Management OCT 2018 52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards

JUN 2020

52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities

NOV 2021

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment

NOV 2021

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

NOV 2021

52.212-2 Evaluation - Commercial Items NOV 2021 52.212-4 Contract Terms and Conditions--Commercial Products and

Commercial Services

DEC 2022

52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns

OCT 2022

52.219-9 Small Business Subcontracting Plan OCT 2022 52.219-16 Liquidated Damages-Subcontracting Plan SEP 2021 52.222-3 Convict Labor JUN 2003 52.222-19 Child Labor -- Cooperation with Authorities and Remedies DEC 2022 52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-26 Equal Opportunity SEP 2016 52.222-35 Equal Opportunity for Veterans JUN 2020 52.222-37 Employment Reports on Veterans JUN 2020 52.222-50 Combating Trafficking in Persons NOV 2021 52.223-5 Pollution Prevention and Right-to-Know Information MAY 2011 52.223-18 Encouraging Contractor Policies To Ban Text Messaging

While Driving

JUN 2020

52.225-13 Restrictions on Certain Foreign Purchases FEB 2021 52.228-5 Insurance - Work On A Government Installation JAN 1997 52.232-18 Availability Of Funds APR 1984 52.232-33 Payment by Electronic Funds Transfer--System for Award

Management

OCT 2018

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.237-2 Protection Of Government Buildings, Equipment, And

Vegetation

APR 1984

52.242-5 Payments to Small Business Subcontractors JAN 2017 52.242-13 Bankruptcy JUL 1995 52.246-16 Responsibility For Supplies APR 1984 52.247-34 F.O.B. Destination NOV 1991 252.201-7000 Contracting Officer's Representative DEC 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights DEC 2022 252.204-7000 Disclosure Of Information OCT 2016 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7015 Notice of Authorized Disclosure of Information for Litigation

Support

JAN 2023

252.204-7016 Covered Defense Telecommunications Equipment or Services -- Representation

DEC 2019

252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services -- Representation

MAY 2021

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services

JAN 2023

252.209-7004 Subcontracting With Firms That Are Owned or Controlled By The Government of a Country that is a State Sponsor of Terrorism

MAY 2019

252.219-7003 Small Business Subcontracting Plan (DOD Contracts) DEC 2019 252.223-7006 Prohibition On Storage, Treatment, and Disposal of Toxic or

Hazardous Materials

SEP 2014

252.223-7008 Prohibition of Hexavalent Chromium JAN 2023 252.225-7002 Qualifying Country Sources As Subcontractors MAR 2022 252.225-7012 Preference For Certain Domestic Commodities APR 2022 252.225-7013 Duty-Free Entry--Basic DEC 2022 252.225-7021 Trade Agreements--Basic JAN 2023 252.225-7048 Export-Controlled Items JUN 2013

252.226-7001 Utilization of Indian Organizations, Indian-Owned Economic Enterprises, and Native Hawaiian Small Business Concerns

JAN 2023

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006 252.243-7001 Pricing Of Contract Modifications DEC 1991 252.243-7002 Requests for Equitable Adjustment DEC 2022

CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services-- Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services."

(d) Representations. The Offeror represents that--

(1) It [ ___ ] will, [ ___ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of provision)

52.204-27 PROHIBITION ON A BYTEDANCE COVERED APPLICATION (JUN 2023)

(a) Definitions. As used in this clause--

Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Information technology, as defined in 40 U.S.C. 11101(6)--

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use-

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a Federal contract.

(b) Prohibition. Section 102 of Division R of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328), the No TikTok on Government Devices Act, and its implementing guidance under Office of Management and Budget (OMB) Memorandum M-23-13, dated February 27, 2023, "No TikTok on Government Devices" Implementation

Guidance, collectively prohibit the presence or use of a covered application on executive agency information technology, including certain equipment used by Federal contractors. The Contractor is prohibited from having or using a covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor's employees; however, this prohibition does not apply if the Contracting Officer provides written notification to the Contractor that an…