S02 RFQ Amendment 36C26024Q0628 0001.pdf

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. NUMBER 3. 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

36C260

Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

36C260

Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

To all Offerors/Bidders

36C26024Q0628

06-14-2024

X

X one (1)

a. The purpose of this modification is to answer questions.

b. See continuation page (B.1) for all questions and answers.

c. All other terms and conditions remain in full force and effect.

Jennifer Robles Contracting Officer

VA-VHA-RPOW-2023-0015

B.1 CONTINUATION PAGE

1. QUESTION: Will the pickup for the Stem cells be from the VA hospital ?

ANSWER: No, the pickup will not be at the VA hospital. All pick ups will be at:

Fred Hutch Cancer Center Cellular Therapy Lab 1100 Eastlake Ave East Seattle, WA 98109

2. QUESTION: How frequent is the pickup from the location?

ANSWER: The frequency can be as little as weekly or as much as monthly.

3. QUESTION: Do you required frequent return of stored stem cell to your facility?

ANSWER: Yes, we need frequent returns (at least weekly).

4. QUESTION: This section mentions "(2) Technical or Quality: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government’s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation." However, there is no instructions to quoters section in the solicitation. Can the government either revise this section to either delete reference to the instructions to quoters section or provide the instructions to quoters section?

ANSWER: The instructions to quoters can be found starting on page 46, titled “E.1 52.212-1 Instruction to Offereors”

5. QUESTION: The SOW specifically calls out that All freight transportation, shipping, and material handling costs associated with this solicitation for the cryopreserved/cryo-stored HSCs/cellular products, including the pre-conditioned liquid nitrogen cryo-shippers with bag holders or racks will be an expense incurred by the Vendor and not the responsibility of the VA Puget Sound .

Then the SOW continues with the following: This will include shipments from the VA Puget Sound’s local apheresis and cellular therapy laboratory in Seattle, WA, after initial Veteran HSCs/cellular product cryopreservation/freezing, and again when the HSCs/cellular product is requested for HSCT infusion . Further in the SOW, there is a statement that Costs associated with Transportation, Shipping, material handling, and project management will also be detailed .

There is also a price line in section B.2 regarding a unit price for the initial transportation of cell products, but no line item for shipment of HSC to the clinical site for administering to the patient. Please clarify if the VA is expecting to see a price for both the initial transportation to the repository from the clinical apheresis site as well as the transportation to the clinical site for administering of the HSC when needed or does the VA expect to have all Transportation/shipping be provided by the vendor and not as a separate charge to the VA for these activities?

ANSWER: The VA Is expecting to see a price for both the initial transportation to the repository from the clinical apheresis site as well as the transportation to the clinical site for administering of the HSC when needed.

6. QUESTION: Does the Government expect separate volumes for Technical and Business?

ANSWER: The volumes are stated in the statement of work.

7. QUESTION: Please provide the VA Directives and Handbook 0710, Personnel Suitability and Security Program regarding information and information system security so that we can review the requirements?

ANSWER: VA Directives and Handobook 0710 can be found at https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8110.

8. QUESTION: Please provide the VA's sanitization requirements for media sanitization as well as the requirements for media storage systems.

ANSWER: See Attachment “6500.1”.

9. QUESTION: Please provide the VA configuration guidelines for firewall and web services as well as a listing of the VA-approved encryption tools.

ANSWER: See Attachment “Firewall configuration”.

10. QUESTION: Please provide a copy of 6500.2 Handbook, Management of Security and Privacy Incidents.

ANSWER: 6500.2 Handbook can be found at https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1449&FType=2

11. QUESTION: The RFQ specifies that the vendor have a turn around time of 24-72 hours from notification of the need of a delivery of HSCs/cellular products to the VA. Does the government anticipate or require weekend delivery of HSCs/cellular products to the transplant team?

ANSWER: Yes, weekend deliveries will be needed.

See attached document: 6500.1.

See attached document: Firewall configeration.

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8110 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1449&FType=2

B.1 CONTINUATION PAGE