W9114F22Q0054-0001_RFQ_Amendment.pdf

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

POC: HENNING MAYER-GOLDSTEIN

CMR 402

APO AE 09180

0011787644

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 do the follow ing:

a. Remove the w ord “Fusion” from Contract Line Item Number (CLIN) descriptions.

b. Adjusted the list of items to be included in CLIN 0001 and 0002 and added required quantities along w ith manufacturer’s item numbers.

c. Changed CLIN 0003 quantity and item description based on question and answ er.

d. Publicize the Question received from Industry along w ith the appropriate Answ er from the Government. See 'Summary of Changes' for details.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 6

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

16C. DATE SIGNED

BY 01-Jun-2022

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 W9114F22Q0054

X 9B. DATED (SEE ITEM 11)

25-May-2022

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-2022

CODE

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

CMR 402

APO AE 09180

W9114F 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W9114F

FACILITY CODECODE

EMAIL:TEL:

W9114F22Q0054

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

The Contractor shall provide reagents compatible for use with the Hologic Panther Fusion Analyzer. Reagents must be capable of in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the Hologic Panther Fusion System. Test kits shall be for 8,500 tests.

**************************************************************** * See Addendum to 52.212-1 for Instructions to Offerors. * * Brand Name or Equal to the below listed Hologic supplies ***************************************************************** Including the following at no additional cost: Aptima Combo 2 Kit (250 Pack) Aptima Combo 2 Kit (100 Pack) Tecan 1000 microliter Filtered Tips (960 Tips) Aptima Urine Collection Tubes (100 Pack) Aptima Unisex Swab Collection Kit (50 Per Kit) Aptima Urine Collection Kit (50 Per Kit) Aptima Multitest Swab Specimen Collection Kit (50 Pack) Run Kit Panther (for 5000 Tests) Multi-Tube Unit (MTU) Kit Panther Waste Bag Panther Waste Cover Aptima Universal Fluids Kit, As Commercial shipping included to the following address at no additional cost: Landstuhl Regional Medical Center (LRMC) Building 3738, 66849 Landstuhl, Germany

To:

The Contractor shall provide reagents compatible for use with the Hologic Panther Analyzer. Reagents must be capable of in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the Hologic Panther System. Test kits shall be for 8,500 tests.

**************************************************************** * See Addendum to 52.212-1 for Instructions to Offerors. * * Brand Name or Equal to the below listed Hologic supplies ***************************************************************** Including the following at no additional cost: 34 Each PRD-05571 Aptima Combo 2 Kit (250 Pack) 17 Each 104772-02 Multi- Tube Unit (MTU) Kit 1 Each 902731 Panther Waste Bag 1 Each 504405 Panther Waste Cover 9 Each 903031 Tecan 1000 microliter Filtered Tips (960 Tips) 9 Each 303001 Aptima Universal Fluids Kit, As 34 Each CL0041 Spare Caps, Amp/Enz/Probe (100/bag)/P.R.S.(CL0045)DIAG. 34 Each 501604 Spare Caps, 100TK TCR/Select (100/bag)/PP, 60mL, TCR APTIMA 2x50 170 Each PRD-03546 Aptima Multitest Swab Specimen Collection Kit (50 Pack) 5 Each 303085 Advanced Cleaning Solution 60 Each 301110 Aptima Combo 2 Controls Kit 9 Each 303013 Aptima Auto Detect Kit Commercial shipping included to the following address at no additional cost: Landstuhl Regional Medical Center (LRMC) Building 3738, 66849 Landstuhl, Germany

CLIN 0002

The Contractor shall provide reagents compatible for use with the Hologic Panther Fusion Analyzer. Reagents must be capable of conducting nucleic acid extraction of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal, oropharyngeal swab specimens, nasopharyngeal washes/aspirates or nasal aspirates, anterior nasal and mid-turbinate nasal swab from individuals who meet COVID-19 clinical and/or epidemiological criteria in accordance with CDC guidelines. Test kits shall be for 20,000 tests.

**************************************************************** * See Addendum to 52.212-1 for Instructions to Offerors. * * Brand Name or Equal to the below listed Hologic supplies ***************************************************************** Including the following at no additional cost: Aptima SARS-CoV-2 Assay, (250-T), CE/IVD Aptima SARS-CoV-2 Assay Controls, CE/IVD - 1 POS/NEG CE/IVD Multi-Tube Unit (MTU) Kit Panther Waste Bag Panther Waste Cover Aptima Universal Fluids Kit, As Advanced Cleaning Solution (255 ml) Spare Caps, 100TK TCR/Select (100/bag) Aptima Specimen Aliquot Tubes, Secundary Tubes (100 Pack) Caps For Specimen Aliquot Tubes (100 Pack) Spare Caps, 250TK TCR/Sel. (100/bag) Spare Caps, Amp/Enz/Probe (100/bag) Spare Caps, Enz (100/bag) Aptima Specimen Lysis Tubes, SARS-CoV-2 (100 Pack) Replacement non-penetrable caps Tecan 1000 microliter Filtered Tips (960 Tips)

The Contractor shall provide reagents compatible for use with the Hologic Panther Analyzer. Reagents must be capable of conducting nucleic acid extraction of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal, oropharyngeal swab specimens, nasopharyngeal washes/aspirates or nasal aspirates, anterior nasal and mid-turbinate nasal swab from individuals who meet COVID-19 clinical and/or epidemiological criteria in accordance with CDC guidelines. Test kits shall be for 20,000 tests.

**************************************************************** * See Addendum to 52.212-1 for Instructions to Offerors. * * Brand Name or Equal to the below listed Hologic supplies ***************************************************************** Including the following at no additional cost: 80 Each PRD-06419 Aptima SARS-CoV-2 Assay, (250-T), CE/IVD 40 Each 104772-02 Multi-Tube Unit (MTU) Kit 2 Each 902731 Panther Waste Bag 2 Each 504405 Panther Waste Cover 42 Each 903031 Tecan 1000 microliter Filtered Tips (960 Tips) 20 Each 303001 Aptima Universal Fluids Kit, As 32 Each PRD-06420 Aptima SARS-CoV-2 Assay Controls, CE/IVD - 1 POS/NEG CE/IVD 23 Each 303085 Advanced Cleaning Solution 20 Each 303013 Aptima Auto Detect Kit

CLIN 0003

The Contractor shall provide Specimen Lysis Tubes inclusive of Specimen Transport Medium (STM), compatible for use with the Hologic Panther Fusion Analyzer.

The Contractor shall provide Specimen Lysis Tubes inclusive of Specimen Transport Medium (STM), compatible for use with the Hologic Panther Analyzer. Specimen Lysis Tubes shall be for a minimum of 20,000 tests.

**************************************************************** * See Addendum to 52.212-1 for Instructions to Offerors. * * Brand Name or Equal to the below listed Hologic supplies ***************************************************************** Shall be either one of the following Specimen Lysis Tubes: 17 Each PRD-06660 Hologic Specimen Lysis Tubes, SARS-CoV-2 (1200 Pack) (PREFERRED) 200 Each PRD-04339 Fusion Specimen Lysis Tube, 100/Bag (ALTERNATE) The pricing detail quantity has decreased by 183.00 from 200.00 to 17.00.

DELIVERIES AND PERFORMANCE

The following Delivery Schedule Item has been deleted from CLIN 0003:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

15-SEP-2022 50 LANDSTUHL REGIONAL MEDICAL

CENTER

BLDG 3738 DR. HITZELBERGER STR.

LANDSTUHL, 66849

GERMANY

FOB: Destination

WK4FW0

CAGE

15-JUL-2022 50 LANDSTUHL REGIONAL MEDICAL

CENTER

BLDG 3738 DR. HITZELBERGER STR.

LANDSTUHL, 66849

GERMANY

15-AUG-2022 50 LANDSTUHL REGIONAL MEDICAL

CENTER

BLDG 3738 DR. HITZELBERGER STR.

LANDSTUHL, 66849

GERMANY

15-JUN-2022 50 LANDSTUHL REGIONAL MEDICAL

CENTER

BLDG 3738 DR. HITZELBERGER STR.

LANDSTUHL, 66849

GERMANY

The following Delivery Schedule item has been added to CLIN 0003:

CAGE

15-SEP-2022 4 LANDSTUHL REGIONAL MEDICAL

CENTER

BLDG 3738 DR. HITZELBERGER STR.

LANDSTUHL, 66849

GERMANY

15-AUG-2022 4 LANDSTUHL REGIONAL MEDICAL

CENTER

BLDG 3738 DR. HITZELBERGER STR.

LANDSTUHL, 66849

GERMANY

15-JUL-2022 4 LANDSTUHL REGIONAL MEDICAL

CENTER

BLDG 3738 DR. HITZELBERGER STR.

LANDSTUHL, 66849

GERMANY

15-JUN-2022 5 LANDSTUHL REGIONAL MEDICAL

CENTER

BLDG 3738 DR. HITZELBERGER STR.

LANDSTUHL, 66849

GERMANY

The following have been added by full text:

QUESTIONS AND ANSWERS

Question: We received a question regarding line item CLIN 0003 Specimen Lysis Tubes from the manufacturer.

Could you please advise what is exactly requested by 200 x Specimen Lysis Tubes inclusive of Specimen Transport Medium (STM), compatible for use with the Hologic Panther Fusion Analyzer?

Both of the products could be meant by the description:

Component Quantity Description Cat. No.

Panther Fusion Specimen Lysis Tube

Each

1 tube containing 0.71 mL of Specimen Transport Media (STM) with penetrable cap

PRD-04339

Hologic Specimen Lysis Tube

Each

1 tube containing 0.71 mL of Specimen Transport Media (STM) with a solid cap

PRD-06554

Please advise which one is requested.

Answer: The Government prefers PRD-06660 but can also use PRD-04339. Since the Government does not use the Hologic Panther Fusion, there is no need to be compatible with it.

(End of Questions and Answers)

(End of Summary of Changes)