Solicitation Amendment W81K0023Q0056-0001 ASIP Reagents and Consumables GLWACH 31 May 23.pdf

W40M USA HCA

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: FREDICINDA D. JONES

36000 DARNELL LOOP

FORT HOOD TX 76544

0011896515

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to:

A. Provide answ ers to the questions submitted by industry. Exhibits A, B, and CLINs Extended descriptions have been revised.

B. This ends the question and answ er period.

C. All other solicitation terms and conditions remain the same.

See SUMMARY OF CHANGES

1. CONTRACT ID CODE PAGE OF PAGES

1 7

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

16C. DATE SIGNED

BY 31-May-2023

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

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

8. NAME AND ADDRESS OF CONTRACTOR (No., Street , County, State and Zip Code) X W81K0023Q0056

X 9B. DATED (SEE ITEM 11)

18-May-2023

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

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

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

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

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

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

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

CONTRACT ORDER NO. IN ITEM 10A.

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

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

D. OTHER (Specify type of modification and authority)

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

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

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

31-May-2023

CODE

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

3160 MCINDOE BLDG 1103

JBSA FT SAM HOUSTON TX 78234-4504

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K0023Q0056

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

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

SOLICITATION/CONTRACT FORM

The 'issued by' organization has changed from

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

FT SAM HOUSTON TX 78234-0000

to

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

3160 MCINDOE BLDG 1103

JBSA FT SAM HOUSTON TX 78234-4504

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

Immunohematology & Immunoassay Reagents: 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.

To:

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.

SUBCLIN 0001AA

ImmunoAssay Reagents, see attached ImmunoAssy/Hematology Reagents list for a complete list of mandatory tests based on Cost-Per-Test. See Exhibit "A" for estimated Cost-Per-Test quantities. Use Exhibit "A" to annotate pricing of Each Cost-Per-Test.

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.

SUBCLIN 0001AB

ImmunoHematology Reagents, see attached ImmunoAssy/Hematology Reagents list for a complete list of mandatory tests based on Cost-Per-Test. See Exhibit "A" for estimated Cost-Per-Test quantities. Use Exhibit "A" to annotate pricing of Each Cost-Per-Test.

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.

CLIN 1001

Immunohematology & Immunoassay Reagents and Manual Blood Type Testing Consumables: 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.

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.

SUBCLIN 1001AA

ImmunoAssay Reagents, see attached ImmunoAssy/Hematology Reagents list for a complete list of mandatory tests based on Cost-Per-Test. See Exhibit "A" for estimated Cost-Per-Test quantities. Use Exhibit "A" to annotate pricing

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

SUBCLIN 1001AB

ImmunoHematology Reagents, see attached ImmunoAssy/Hematology Reagents list for a complete list of mandatory tests based on Cost-Per-Test. See Exhibit "A" for estimated Cost-Per-Test quantities. Use Exhibit "A" to

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.

CLIN 2001

Immunohematology & Immunoassay Reagents and Manual Blood Type Testing Consumables: 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.

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.

SUBCLIN 2001AA

ImmunoAssay Reagents, see attached ImmunoAssy/Hematology Reagents list for a complete list of mandatory tests based on Cost-Per-Test. See Exhibit "A" for estimated Cost-Per-Test quantities. Use Exhibit "A" to annotate pricing

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

SUBCLIN 2001AB

ImmunoHematology Reagents, see attached ImmunoAssy/Hematology Reagents list for a complete list of mandatory tests based on Cost-Per-Test. See Exhibit "A" for estimated Cost-Per-Test quantities. Use Exhibit "A" to

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.

(End of Summary of Changes)