Amendment 0001 doc.pdf

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Attached to
6550--Molecular Diagnostic Tests for SARS-CoV-2 Federal contract opportunity
Solicitation number
36C26224Q0704
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 22

About this file

This document is an amendment to a solicitation for molecular diagnostic tests for SARS-CoV-2. The Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 22 is seeking SARS-CoV-2 assays and SARS-CoV-2/influenza/RSV assays that are compatible with Cepheid GenXpert systems. The assays must be FDA EUA approved for qualitative detection of SARS-CoV-2 and simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus. A minimum of 4080 tests will be provided to VISN22 laboratories on a weekly basis. The amendment provides answers to questions from offerors to clarify quantities in Attachment A and provide Attachment B which lists salient characteristics. Offerors must acknowledge receipt of the amendment by the date and time specified in the solicitation.

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Other files for this federal contract opportunity

Other files attached to 6550--Molecular Diagnostic Tests for SARS-CoV-2, newest first.
File Type Posted
Attachment B-Salient Characteristics.docx DOCX document
Attachment A doc.xlsx XLSX spreadsheet
RFQ.docx DOCX document
SOW.docx DOCX document
36C26224Q0704.docx DOCX document

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Text version

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

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

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, 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.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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

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

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

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

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

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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

1 3

0001 N/A

36C262

Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

To all Offerors/Bidders 36C26224Q0704

03-08-2024 X

See CONTINUATION Page

The following amendment is to answer the questions received during the question period.

Please view below for questions received.

Carlos Magana Contracting Officer x 1

Question: In Attachment A, the quantities mentioned for the three line items are: 2945 EA, 5303 EA and 2000 EA respectively. However, on page 2 of the SOW, it is mentioned that "A minimum allocation of 4080 tests will be provided to VISN22 laboratories on a weekly basis." Please provide clarity around the quantities.

Answer: 4080 tests number is to further explain on a micro level what the VISN testing weekly estimates are. Contracting understands that some kits consist of different tests amounts per kit; this information is to further assist potential offerors on test estimates needed on a weekly basis. Please refer to page 1;

paragraph 8 of the solicitation for further guidance.

Question: The RFQ & Attachment A reference Attachment B (Salient Characteristics) at multiple places.

However, no such attachment is available on the SAM page of this RFQ. Kindly provide clarity if the salient characteristics refer to the specifications in the SOW or if there is a separate attachment for salient characteristics?

Answer: Attachment A references salient characteristics could be located as an Attachment B.

Unfortunately, Attachment B Salient Characteristics was not uploaded by the system. The Attachment is now uploaded and can be viewed. In addition, the information can be found below the Q&As.

Question: I believe that this is only for Cephiad SARS-CoV-2 testing kits or like kits that can be operated on the Cephiad. It that correct? This is not a solicitation for new equipment?

Answer: This solicitation is a requirement for a Brand Name or Equal per FAR 52.211-6. Please view Attachment B-Salient Characteristics. This is solicitation is only for reagents and no equipment.

Question: Is this for the simple purchase of these: [vendor is referencing line items Attachment A].

Answer: This is a Brand Name or equal Solicitation, please review all Attachments for full details.

(end)

Attachment B Salient Characteristics

SARS-CoV-2 Assay and SARS-CoV-2/Influenza/RSV must be 100% compatible with all features, must physically fit without alteration, and not void the preventive maintenance and service or warranty of the current VA-owned and leased Cepheid GenXpert systems:

o GENEXPERT XVI Dx R1 o GENEXPERT XVI Dx R2 o GenXpert Infinity

SARS-CoV-2 Assay must be EUA FDA approved for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab or anterior nasal swab specimen obtained from individuals meeting COVID-19 clinical and/or epidemiological criteria, as well as individuals without symptoms or other reasons to suspect COVID-19 infection.

SARS-CoV-2/Flu/RSV plus must be EUA FDA approved for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A, influenza B, and/or respiratory syncytial virus (RSV) in either nasopharyngeal swab, anterior nasal swab or nasal wash/ aspirate specimens collected from individuals suspected of respiratory viral infection, consistent with COVID-19, by their healthcare provider.

SARS-CoV-2 Assay and SARS-CoV-2/Influenza/RSV must not negatively impact system performance, assay results, safety, and equipment life cycle of the current VA-owned and leased Cepheid GenXpert systems.

Ambient temperature transport system and storage of reagents.

Pricing must include all handling, HAZMAT, dry-ice and shipping fees when applicable.

2024-03-08T15:43:05-0800
Carlos A. Magana 1404156

File details come from the government source that posted it. Updated .