Conformed Solicitation W81K0023Q0056-0002 ASIP Reagents and Consumables GLWACH 13 June 23.pdf

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Immunohematology (IH)/Immunoassay Reagents and Consumables
Solicitation number
W81K00-23-Q-0056
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This is a solicitation seeking offers for immunohematology and immunoassay reagents and consumables. The contractor shall provide one fully automated immunohematology analyzer, three fully automated immunoassay analyzer systems, training, supplies, reagents, maintenance, and installation support. The contractor must also provide consumables for manual blood typing equipment. Offers are due by 12:00 PM on June 19, 2023. The solicitation involves providing ongoing reagents and support for clinical testing at an Army medical facility on a cost-per-test basis.

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SEE ADDENDUM

(No Collect Calls)

W81K0023Q0056 18-May-2023

b. TELEPHONE NUMBER

254-288-4767

8. OFFER DUE DATE/LOCAL TIME

12:00 PM 21 Jun 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

FREDICINDA D. JONES

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

0011896515

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 HT0805 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

ACH LEONARD WOOD - PA

ACH LEONARD WOOD - PA

4430 MISSOURI AVE

BLDG 310A

FORT LEONARD WOOD MO 65473-8952

TEL: 888- 929-2265 FAX:

FAX:

TEL: 210-221-1110 SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,250

NAICS:

325413

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 OF89

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.

W81K0023Q0056

Section SF 30 - BLOCK 14 CONTINUATION PAGE

QUESTIONS AND ANSWERS

Questions and Answers Solicitation W81K00-23-Q-0056

ASIP Reagents and Consumables GLWACH

1. Question: Immunoassay tests listed in Exhibit A.

Are the Rapid Plasma Reagent (RPR) and the Syphilis Total Antibody mutually exclusive?

Answer: Row 18 Rapid Plasma Reagent (RPR) and Row 19 Syphilis Total Antibody are not mutually exclusive. Syphillis Total Antibody is a treponemal test and RPR is a non-treponemal test.

A vendor should only propose one or the other, correct?

Answer: A vendor should propose a form of treponema testing-one or the other.

2. Question: Immunoassay tests listed in Exhibit A.

Can you confirm that row 13 of Exhibit A is the name of the panel that consists of the tests on lines 14-17?

Answer: Row 13 of Exhibit A Epstein Barr Virus Antibody (EBV), between rows 13-17 it consists of 2 panels- listed below:

Epstien Barr Virus IgG assays -EBV NA IgG antibodies -EBV VCA IgG antibodies -EBV EA-D antibodies

Epstien Bar Virus IgM assays -Viral Capsid Antigen (VCA) IgM antibodies -Infectious Mononucleosis heterophile antibodies

A vendor should propose Epstein Barr Virus (EBV) IgG and Epstein Barr Virus (EBV) IgM testing.

3. Question: Respectfully requesting that the actual annual testing volumes for each Immunohematology and Manual Blood Type testing be provided (as was provided for Immunoassay testing).

Answer: Immunohematology and the Manual Blood Type testing systems are consumables only. The PWS section 2.1 Immunohematology and 2.5 Blood Bank Consumables, Exhibits A, and B lists the quantities of consumables. Refer to revised CLINs extended descriptions, Exhibit A and B.

4. Question: In order to allow for fair competition, our ask is to separate the three disciplines into three different solicitations. Isn’t having different disciplines on one solicitation considered bundling, which I didn’t think the government allowed?

Hematology Blood Bank Immunochemistry

Answer: The Government will not separate the requirement into three separate solicitations.

5. Question: Please confirm if vendors can bid on the Immunohematology line of business only?

Answer: No, vendors cannot submit an offer for Immunohematology Contract Lint Items CLINS only. Please refer to FAR 52.212-1 Addendum. NOTE: This is an "all or none" solicitation. Failure to provide a unit price for any test listed in Exhibit A and B, unless the offeror states "not separately priced" within the attachment, will be construed to mean the offeror is not quoting that test and thus, not eligible for award.

6. Question: Can the solicitation be “unbundled” to separate the immunohematology, immunoassay, and blood bank products into 3 separate categories?

Answer: The Government will not separate the requirement into three separate categories.

Section SF 1449 - CONTINUATION SHEET

52.212-4 ADDENDUM

(v) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL 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

This requirement will be procured using FAR Part 12 Acquisition of Commercial Products and Commercial Services and FAR Part 13 Simplified Acquisition Procedures. The Government will make an award to the offeror's quote that conforms to the Request for Quote (RFQ) and proposed price is determined fair and reasonable.

QUOTES PREPARATION INSTRUCTIONS: Quotes shall be submitted in three individual electronic volumes:

Volume I. Administrative Volume II. Technical Volume II. Price

Each subfactor under Volume II shall be separately tabbed and addressed in sufficient detail so the government may evaluate each subfactor independently.

Electronic (e-mail) is the only method of submission for quotes; paper or printed copies will not be accepted.

Files larger than 20MB may need to be transmitted in separate emails.

The Contracting Officer and Contract Specialist are sole points of contact for this solicitation.

Responsibility Determination: The Contracting Officer is required to make a determination of responsibility

IAW FAR 9.1.

Volume I Administrative: Offerors shall provide the following:

a. Summary or title page identifying the offeror, address, phone, UIE number, CAGE Code, Point of Contact

(POC) information for the authorized individuals authorized to negotiate with the Government on behalf of the Offeror, and the solicitation number. The Offeror is responsible for notifying the contracting office of any POC changes.

b. The offeror shall include a copy of the completed SF 1449, with the signature in block 30a, name and title of signer in block 30b, and date signed in block 30c. Signature shall be from an authorized individual authorized to negotiate on behalf of the company. Include the name of the offeror, address, phone number, and CAGE Code in Block 17a.

c. For all solicitation amendments, if applicable: Completed and signed SF 30: Blocks 8, 15A - C

d. Provide statement that the offeror will hold its quote firm for at least 90 calendar days from the offer due date, subject to any changes that may occur as a result of discussions (if applicable).

e. All offerors must be registered in the System for Award Management (SAM) with the appropriate NAICS Code prior to award and shall not have any Active Exclusions listed within SAM.GOV to be eligible for award. Lack of registration shall make an offeror ineligible for award.

f. Completed provisions, as listed in the solicitation. Alternately, complete all provisions in SAM and provide confirmation of completion and accuracy with offer.

g. The offeror shall submit a completed copy of FAR 52.212-3, Representations and Certifications - Commercial Items. If the offeror has completed the Online Representations and Certifications Application (ORCA) at https://www.sam.gov the offeror shall indicate such on the FAR clause.

h. Questions regarding this solicitation are to be submitted electronically to the Contract Specialist by 24 May 2023 at 10:00 a.m. CST to fredicinda.d.jones.civ@health.mil; answers to all questions will be provided via an amendment to the solicitation and posted to https://sam.gov no later than 31 May

2023 3:00 PM CST.

i. Offers are due by the date and time identified on Page 1 Block 8 of the SF1449(Unless extended via solicitation amendment). Offers shall be submitted via e-mail to fredicinda.d.jones.civ@health.mil. Quotes received after the deadline will be considered untimely and will not be eligible for award. When submitting your offer via email please annotate the subject line as “Quote for W81K00-23-Q-0056”.

Volume II Technical: The technical volume shall be addressed in sufficient written detail for the Government to determine if the offeror understands the technical requirements listed in the following subfactors.

a. Subfactor 1-Equipment/Reagents/Consumables: Offeror shall provide equipment, reagent, and consumables that conform to the salient physical, functional, performance characteristics, and quantities as specified in the Special Terms and Conditions and Exhibits A and B. Offeror’s system must be able to run all of the required tests listed in the Special Terms and Conditions.

b. Subfactor 2- ATO/RMF Compliance – Provide documentation of Authority to Operate/Risk Management Framework (ATO/RMF) compliance. Offeror shall be in compliance with Authority to Operate/Risk Management Framework (ATO/RMF) upon submission of offer. Any updates to the equipment after receipt of an approved ATO shall be approved by the Defense Health Agency's Cybersecurity Team in accordance with the Exhibit C.

c. Subfactor 3- Offeror must be able to provide Maintenance (unscheduled and preventive) and telephonic assistance in accordance with Special Terms and Conditions.

d. Subfactor 4- Offeror must be able to provide Training in accordance with Special Terms and Conditions.

e. Subfactor 5- Offer must be able to ensure delivery/reconfiguration of analyzers to General Leonard Wood Army Community Hospital (GLWACH), Fort Leonard Wood, MO, 65473 no later than 1 August 2023 for correlation and validation for a 1 October 2023 start date.

Include a timeline identifying critical points in the delivery/installation phase in accordance with the Special Terms and Conditions.

The offer shall include the proposed equipment layout, the layout shall include all equipment to run the mandatory test, all the equipment shall fit within the designated laboratory space.

Quotes without the layout information and pricing for all mandatory tests will not be considered for award. All equipment shall fit in the designated laboratory space. Please see Special Terms and Conditions para 2.3.14 Lab Layout and Exhibits A and B.

Volume III Pricing:

a. Offeror shall submit Exhibits A and B with all pricing in excel format to be eligible for award.

b. The offeror shall submit proposed pricing for all Contract Line-Item numbers (CLINs) and subCLINs identified in the Request for Quote SF1449. Include the unit price and the total extended price for each CLIN and option year CLIN. The prices shall be in whole dollar amounts to the second decimal place (i.e., $0.00) only.

* Must provide pricing for all mandatory test and future test on Exhibit A and B. Shall transpose Grand total/Net Amount from Exhibit A and B to Standard Form 1449 (SF 1449) subCLINs identified for each

Option year for mandatory testing.

If the SF 1449 is not completed in accordance with Volume I of FAR Provision 52.212-1 Addendum or all line items for the base year and all option years are not completed the offer will be considered non-complaint and will not be evaluated or eligible for award.

NOTE: This is an "all or none" solicitation. Failure to provide a unit price for any test listed in Exhibit A and B, unless the offeror states "not separately priced" within the attachment, will be construed to mean the offeror is not quoting that test and thus, not eligible for award.

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

END OF ADDENDUM TO 52.212-1

52.212-2 ADDENDUM

Paragraph (a) is hereby replaced with the following:

Award will be made using the Lowest Price Technically Acceptable (LPTA). The Government will award a contract resulting from this solicitation to the responsible offeror whose quote meets all technical evaluation factors and whose price has been determined fair and reasonable. Award will be made to the responsible offeror on the basis of the lowest evaluated price of offer 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 using the LPTA source selection process. The government will initially list offers from lowest to highest price. The government will evaluate the lowest priced offer first. If that offer is determined technically unacceptable, the government will evaluate the next lowest priced offer and continue in that manner until an offer is rated Technically Acceptable. If an offer is rated Technically Unacceptable, the Government will not evaluate any other subfactors. USING THIS PROCEDURE, THE GOVERNMENT MIGHT NOT EVALUATE ALL OFFERS.

Award will be made on an all or none basis.

The criteria for Evaluation of offerors are provided below.

Volume II Technical Evaluation: The technical volume shall be addressed in sufficient written detail for the Government to determine if the offeror understands the technical requirements listed in the following subfactors.

Failure to provide a response in sufficient detail for each factor below shall result in an offeror receiving a rating of unacceptable. Each subfactor will be evaluated using the criteria stated in Table 1 below. Each factor must be found technically acceptable in order to be eligible for award.

a. Subfactor 1-Equipment/Reagents/Consumables: Offeror shall provide equipment, reagent, and consumables that conform to the salient physical, functional, performance characteristics, and quantities as specified in the Special Terms and Conditions and Exhibits. Offeror’s system must be able to run all of the required tests listed in the Special Terms and Conditions.

*Failure to provide a price for all test, unless the offeror states "not separately priced" within the offer, will be construed to mean the offeror cannot provide the test. Any offer that fails to price all required testing, unless the test is identified as "not separately priced", will not be evaluated further and will be ineligible for award.

b. Subfactor 2- ATO/RMF Compliance –Offeror shall be in compliance with Authority to Operate/Risk Management Framework (ATO/RMF) upon submission of offer. The Contracting Officer will evaluate the technical offer to determine whether the Offeror provided documentary proof from a DOD organization that the Offeror are in compliance with Authority to Operate/Risk Management Framework (ATO/RMF) for the proposed equipment that will access the DOD informational technology system.

c. Subfactor 3- Offeror must be able to provide Maintenance (unscheduled and preventive) and telephonic assistance in accordance with Special Terms and Conditions.

d. Subfactor 4- Offeror must be able to provide Training in accordance with Special Terms and Conditions.

e. Subfactor 5- Delivery/reconfiguration of analyzers to General Leonard Wood Army Community Hospital (GLWACH), Fort Leonard Wood, MO, 65473 no later than 1 August 2023 for correlation and validation for a 1 October 2023 start date.

Timeline identifies critical points in the delivery/installation phase in accordance with the Special Terms and Conditions.

Proposed equipment layout shall include all equipment to run the mandatory test, all the equipment shall fit within the designated laboratory space. Quotes without the layout information and pricing for all mandatory tests will not be considered for award. All equipment shall fit in the designated laboratory space.

Note: A rating of acceptable must be achieved on all technical subfactors in order to receive an acceptable rating for the overall Technical Factor.

Technical Ratings Rating Description Acceptable Offer clearly meets the minimum requirements in accordance with the solicitation.

Unacceptable Offer does not meet the minimum requirement in accordance with the solicitation.

An unacceptable rating will be assessed if offeror fails to submit verifiable proof of RMF/ATO accreditation and certification in accordance with Defense Health Agency guidelines.

An unacceptable rating will be assessed if offeror fails to provide pricing for all required testing.

Volume III Price Evaluation: All offers will initially be reviewed to determine whether each offer contains the required pricing for each test. Any offer that fails to price all required testing, unless the test is identified as "not separately priced", will not be evaluated further and will be ineligible for award.

Failure to provide a price for all test, unless the offeror specifically identified as "not separately priced" within the offer, will be construed to mean the offeror cannot provide the test.

a. Award will be made to the offer submitting the lowest overall price of those offerors that are evaluated as technically acceptable.

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. In addition, given that FAR Clause 52.217-9, Option to Extend the Term of the Contract, provides that the Government may require continued performance/delivery of any supplies within the limits and at the rates specified in the contract (i.e., the rates in effect when the Option to Extend the Term of the Contract clause is exercised), for purposes of evaluating this option, the contracting officer will consider the prices submitted for each CLIN, since those would be the binding prices should this option be exercised.

Evaluation of this option shall not obligate the Government to exercise the option.

c. Price will be evaluated using various price analysis techniques and procedures IAW FAR 13.5

(Acquisition not exceeding $7.5M) including, but not limited to, comparison of proposed price received in response to the solicitation. Evaluation of price will include a determination that the price is fair and reasonable.

d. 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.

END OF ADDENDUM TO 52.212-2

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

Immunohematology & Immunoassay Reagents

FFP

Immunohematology (Consumables) & Immunoassay Reagents (CPT): All costs associated with the Cost-Per-Test shall be included in the price for the Cost-Per- Test. Please see Special Terms and Conditions for details of the requirement.

Leasing the necessary equipment/analyzers (one (1) fully automated integrated platform, discrete random access immunohematology analyzer system) (three (3) fully automated integrated platform, discrete random access immunoassay analyzer system), training, supplies, reagents, training, maintenance (unscheduled & preventative), telephonic assistance, and installation, based on Cost-Per-Test with no additional cost to the Government. See FAR 52.212-1 Addendum for Instructions to Offers and FAR 52.212-2 Addendum for Evaluation of Commercial Items. POP: 1 October 2023 to 30 September 2024. Reagents will be ordered as needed by a Government Ordering Officer who will be appointed upon award.

Subject to availability of FY24 Funds.

NET AMT

0001AA 1 Job ImmunoAssay Reagents

FFP

ImmunoAssay Reagents (CPT), see attached ImmunoAssy/Hematology Reagents list (Exhibit A) for a complete list of mandatory estimated tests based on Cost-Per- Test and Consumables required Quantities. Use Exhibit "A" to annotate pricing of Each Cost-Per-Test and Consumables unit price.

FOB: Destination

PURCHASE REQUEST NUMBER: 0011896515

PSC CD: 6505

0001AB 1 Job ImmunoHematology Reagents

FFP

ImmunoHematology Reagents (Consumbales), see attached ImmunoAssy/Hematology Reagents list (Exhibit A) for a complete list of mandatory estimated tests based on Cost-Per-Test and Consumables required Quantities. Use Exhibit "A" to annotate pricing of Each Cost-Per-Test and Consumables unit price.

FOB: Destination

Immunohema/assay Reagents & Manual Tests

FFP

Immunohematology (Consumables) & Immunoassay Reagents (CPT): All costs associated with the Cost-Per-Test shall be included in the price for the Cost-Per- Test. Please see Special Terms and Conditions for details of the requirement.

Leasing the necessary equipment/analyzers (one (1) fully automated integrated platform, discrete random access immunohematology analyzer system) (three (3) fully automated integrated platform, discrete random access immunoassay analyzer system), training, supplies, reagents, training, maintenance (unscheduled & preventative), telephonic assistance, and installation, based on Cost-Per-Test with no additional cost to the Government.

Consumables for the manual blood type testing machines (IH Incubator L and IH Centrifuge L). Please see Special Terms and Conditions for details of the requirement (Table 5).

See FAR 52.212-1 Addendum for Instructions to Offers and FAR 52.212-2 Addendum for Evaluation of Commercial Items. POP: 1 October 2024 to 30 September 2025. Reagents will be ordered as needed by a Government Ordering Officer who will be appointed upon award. Subject to availability of FY25 Funds.

1001AA 1 Job OPTION ImmunoAssay Reagents

FFP

ImmunoAssay Reagents (CPT), see attached ImmunoAssy/Hematology Reagents list (Exhibit A) for a complete list of mandatory estimated tests based on Cost-Per- Test and Consumables required Quantities. Use Exhibit "A" to annotate pricing of Each Cost-Per-Test and Consumables unit price.

FOB: Destination

1001AB 1 Job OPTION ImmunoHematology Reagents

FFP

ImmunoHematology Reagents (Consumbales), see attached ImmunoAssy/Hematology Reagents list (Exhibit A) for a complete list of mandatory estimated tests based on Cost-Per-Test and Consumables required Quantities. Use Exhibit "A" to annotate pricing of Each Cost-Per-Test and Consumables unit price.

FOB: Destination

1001AC 1 Job OPTION Blood Bank Consumables

FFP

Blood Bank Consumables, see attached Manual Blood Type Testing Consumables List for a complete list of mandatory consumables. See Exhibit "B" for estimated consumables quantities. Use Exhibit "B" to annotate pricing of Each consumable.

FOB: Destination

Immunohema/assay Reagents & Manual Tests

FFP

IImmunohematology (Consumables) & Immunoassay Reagents (CPT): All costs associated with the Cost-Per-Test shall be included in the price for the Cost-Per- Test. Please see Special Terms and Conditions for details of the requirement.

Leasing the necessary equipment/analyzers (one (1) fully automated integrated platform, discrete random access immunohematology analyzer system) (three (3) fully automated integrated platform, discrete random access immunoassay analyzer system), training, supplies, reagents, training, maintenance (unscheduled & preventative), telephonic assistance, and installation, based on Cost-Per-Test with no additional cost to the Government.

Consumables for the manual blood type testing machines (IH Incubator L and IH Centrifuge L). Please see Special Terms and Conditions for details of the requirement (Table 5).

See FAR 52.212-1 Addendum for Instructions to Offers and FAR 52.212-2 Addendum for Evaluation of Commercial Items. POP: 1 October 2025 to 30 September 2026. Reagents will be ordered as needed by a Government Ordering Officer who will be appointed upon award. Subject to availability of FY26 Funds.

2001AA 1 Job OPTION ImmunoAssay Reagents

FFP

ImmunoAssay Reagents (CPT), see attached ImmunoAssy/Hematology Reagents list (Exhibit A) for a complete list of mandatory estimated tests based on Cost-Per- Test and Consumables required Quantities. Use Exhibit "A" to annotate pricing of Each Cost-Per-Test and Consumables unit price.

FOB: Destination

2001AB 1 Job OPTION ImmunoHematology Analyzer

FFP

ImmunoHematology Reagents (Consumbales), see attached ImmunoAssy/Hematology Reagents list (Exhibit A) for a complete list of mandatory estimated tests based on Cost-Per-Test and Consumables required Quantities. Use Exhibit "A" to annotate pricing of Each Cost-Per-Test and Consumables unit price.

FOB: Destination

2001AC 1 Job OPTION Blood Bank Consumables

FFP

Blood Bank Consumables, see attached Manual Blood Type Testing Consumables List for a complete list of mandatory consumables. See Exhibit "B" for estimated consumables quantities. Use Exhibit "B" to annotate pricing of Each consumable.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 N/A N/A N/A N/A 0001AA Destination Government Destination Government

0001AB Destination Government Destination Government 1001 N/A N/A N/A N/A 1001AA Destination Government Destination Government 1001AB Destination Government Destination Government 1001AC Destination Government Destination Government 2001 N/A N/A N/A N/A 2001AA Destination Government Destination Government 2001AB Destination Government Destination Government 2001AC Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 N/A N/A N/A N/A

0001AA 30-SEP-2024 1 ACH LEONARD WOOD - PA

ACH LEONARD WOOD - PA

4430 MISSOURI AVE

BLDG 310A

FORT LEONARD WOOD MO 65473-8952

888- 929-2265

HT0805

0001AB 30-SEP-2024 1 (SAME AS PREVIOUS LOCATION)

1001 N/A N/A N/A N/A

1001AA 30-SEP-2025 1 ACH LEONARD WOOD - PA

ACH LEONARD WOOD - PA

4430 MISSOURI AVE

BLDG 310A

FORT LEONARD WOOD MO 65473-8952

888- 929-2265

1001AB 30-SEP-2025 1 (SAME AS PREVIOUS LOCATION)

1001AC 30-SEP-2025 1 (SAME AS PREVIOUS LOCATION)

2001 N/A N/A N/A N/A

2001AA 30-SEP-2026 1 ACH LEONARD WOOD - PA

ACH LEONARD WOOD - PA

4430 MISSOURI AVE

BLDG 310A

FORT LEONARD WOOD MO 65473-8952

888- 929-2265

2001AB 30-SEP-2026 1 (SAME AS PREVIOUS LOCATION)

2001AC 30-SEP-2026 1 (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984 52.203-11 Certification And Disclosure Regarding Payments To

Influence Certain Federal Transactions

SEP 2007

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

MAY 2011

52.204-7 System for Award Management OCT 2018 52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011 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 52.209-7 Information Regarding Responsibility Matters OCT 2018 52.212-4 Contract Terms and Conditions--Commercial Products and

Commercial Services

DEC 2022

52.222-25 Affirmative Action Compliance APR 1984 52.223-22 Public Disclosure of Greenhouse Gas Emissions and

Reduction Goals -- Representation.

DEC 2016

52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-- Representation and Certifications.

JUN 2020

52.229-11 Tax on Certain Foreign Procurements--Notice and Representation

JUN 2020

52.232-18 Availability Of Funds APR 1984 52.242-13 Bankruptcy JUL 1995 52.246-16 Responsibility For Supplies APR 1984 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 252.203-7005 Representation Relating to Compensation of Former DoD

Officials

SEP 2022

252.204-7000 Disclosure Of Information OCT 2016 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7004 Antiterrorism Awareness Training for Contractors JAN 2023 252.204-7006 Billing Instructions OCT 2005 252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

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

252.204-7019 Notice of NIST SP 800-171 DoD Assessment Requirements MAR 2022 252.204-7020 NIST SP 800-171 DoD Assessment Requirements JAN 2023 252.205-7000 Provision Of Information To Cooperative Agreement Holders DEC 1991 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

252.215-7008 Only One Offer DEC 2022 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 252.225-7048 Export-Controlled Items JUN 2013 252.225-7052 Restriction on the Acquisition of Certain Magnets, Tantalum, and Tungsten.

JAN 2023

252.225-7055 Representation Regarding Business Operations with the Maduro Regime

MAY 2022

252.225-7056 Prohibition Regarding Business Operations with the Maduro Regime

JAN 2023

252.225-7059 Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous Region - Certification

DEC 2022

252.225-7060 Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous Region

JAN 2023

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 252.232-7017 Accelerating Payments to Small Business Subcontractors--

Prohibition on Fees and Consideration

JAN 2023

252.243-7001 Pricing Of Contract Modifications DEC 1991 252.243-7002 Requests for Equitable Adjustment DEC 2022

CLAUSES INCORPORATED BY FULL TEXT

52.204-20 Predecessor of Offeror (AUG 2020)

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

Commercial and Government Entity (CAGE) code means--

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity by unique location; or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term “successor” does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

(b) The Offeror represents that it [____] is or [____] is not a successor to a predecessor that held a Federal contract or grant within the last three years.

(c) If the Offeror has indicated “is” in paragraph (b) of this provision, enter the following information for all predecessors that held a Federal contract or grant within the last three years (if more than one predecessor, list in reverse chronological order):

Predecessor CAGE code: ____ (or mark “Unknown”).

Predecessor legal name: ____.

(Do not use a “doing business as” name).

(End of provision)

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.

52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES--REPRESENTATION (OCT

2020)

(a) Definitions. As used in this provision, “covered telecommunications equipment or services” and "reasonable inquiry" have the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) 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”.

(c) Representations.

(1) The Offeror represents that it [ ___ ] does, [ ___ ] 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.

(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 any equipment, system, or service that uses covered telecommunications equipment or services.

52.209-2 PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC CORPORATIONS--

REPRESENTATION (NOV 2015)

(a) Definitions. Inverted domestic corporation and subsidiary have the meaning given in the clause of this contract entitled Prohibition on Contracting with Inverted Domestic Corporations (52.209-10).

(b) Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in accordance with the procedures at 9.108-4.

(c) Representation. The Offeror represents that--

(1) It [ ___ ] is, [ ___ ] is not an inverted domestic corporation; and

(2) It [ ___ ] is, [ ___ ] is not a subsidiary of an inverted domestic corporation.

52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS (AUG 2020)

(a)(1) The Offeror certifies, to the best of its knowledge and belief, that-

(i) The Offeror and/or any of its Principals-

(A) Are ( ) are not ( ) presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency;

(B) Have ( ) have not ( ), within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State, or local) contract or subcontract; violation of Federal or State antitrust statutes relating to the submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property (if offeror checks “have”, the offeror shall also see 52.209-7, if included in this solicitation); and

(C) Are ( ) are not ( ) presently indicted for, or otherwise criminally or civilly charged by a governmental entity with, commission of any of the offenses enumerated in paragraph (a)(1)(i)(B) of this provision;

and

(D) Have , have not , within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds the threshold at 9.104-5(a)(2) for which the liability remains unsatisfied.

(1) Federal taxes are considered delinquent if both of the following criteria apply:

(i) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted.

(ii) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded.

(2) Examples. (i) The taxpayer has received a statutory notice of deficiency, under I.R.C. Sec. 6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(ii) The IRS has filed a notice of Federal tax lien with respect to an assessed tax liability, and the taxpayer has been issued a notice under I.R.C. Sec. 6320 entitling the taxpayer to request a hearing with the IRS Office of Appeals contesting the lien filing, and to further appeal to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(iii) The taxpayer has entered into an installment agreement pursuant to I.R.C. Sec. 6159. The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment.

(iv) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. 362 (the Bankruptcy Code).

(ii) The Offeror has ( ) has not ( ), within a three-year period preceding this offer, had one or more contracts terminated for default by any Federal agency.

(2) Principal, for the purposes of this certification, means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager;

head of a division or business segment; and similar positions).

(b) The Offeror shall provide immediate written notice to the Contracting Officer if, at any time prior to contract award, the Offeror learns that its certification was erroneous when submitted or has become erroneous by reason of changed circumstances.

(c) A certification that any of the items in paragraph (a) of this provision exists will not necessarily result in withholding of an award under this solicitation. However, the certification will be considered in connection with a determination of the Offeror's responsibility. Failure of the Offeror to furnish a certification or provide such additional information as requested by the Contracting Officer may render the Offeror nonresponsible.

(d) Nothing contained in the foregoing shall be construed to require establishment of a system of records in order to render, in good faith, the certification required by paragraph (a) of this provision. The knowledge and information of an Offeror is not required to exceed that which is normally possessed by a prudent person in the ordinary course of business dealings.

(e) The certification in paragraph (a) of this provision is a material representation of fact upon which reliance was placed when making award. If it is later determined that the Offeror knowingly rendered an erroneous certification, in addition to other remedies available to the Government,…

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