36C25025Q0031 0001.docx

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) 539-25-1-556-0002 36C250 Department of Veterans Affairs Network Contracting Office 10 8888 Keystone Crossing Suite 325 Indianapolis

IN

46240 36C250 Department of Veterans Affairs Network Contracting Office 10 8888 Keystone Crossing Suite 325 Indianapolis

IN

46240 To all Offerors/Bidders

36C25025Q0031 10-09-2024

X X X

See CONTINUATION Page The purpose of this solicitation amendment is to provide responses to questions from industry.

All questions and answers are listed in the continuation pages (page 2 and 3.)

Josh Kovar Contracting Officer

CONTINUATION PAGE

The purpose of this solicitation amendment is to provide answers to questions from industry.

Questions are listed below, and the corresponding responses are below each question in red.

1. We would like to know if this a brand new contract OR if there is (was) an incumbent performing these services.

a. There was a pilot program for a limited number of facilities that was previously awarded (36C25022P1056). However, this is considered a new contract due to the increased participation, and several changes to the Statement of Work.

2. Please clarify what documentation is needed for certification of device.

a. VA Directive requires Proof of quality checks and the device must be FDA-approved for CLIA-waived testing.

3. Are rechargeable batteries required for the devices, or will VA accept regular batteries if recommended by manufacturer?

a. Rechargeable batteries are highly preferred.

4. Please clarify what is meant by supplies required for quality control. Would this be the code chips that come in every box of strips?

a. This depends on what the quality control process entails. The quality control process should be the internal process used to ensure that the meter and strips work appropriately. Vendor must describe their quality process and if other supplies are needed to perform this process (i.e., code chips, liquid controls, etc.), these must be provided to the Veteran.

5. VAMC required quality control testing, if regularly scheduled maintenance intervals are deemed too infrequent – please clarify what VAMC would need in this situation.

a. If the VA requires that additional quality controls be performed, the vendor will provide the supplies to perform the testing. Additional quality controls would be performed for troubleshooting purposes. Frequency of testing depends on the meter specifications.

6. RE: Results communication: Can you please clarify which method is preferred? Test results should be sent via encrypted email, fax, and/or phone; All test results outside of specified parameters will be communicated to the facility via a phone call to the facility POC in addition to the email and fax.

a. Please refer to the solicitation, page 7 (paragraph – Results Communication) - INR results shall be transmitted from the device to the vendor via Bluetooth or some type of automatic downloading capabilities. This is the preferred method, however, patient may self-report via an online portal system or phone call to the vendor is acceptable if downloading/Bluetooth is not available.

b. The phone call is in addition to the routine communication method if the results are outside the specified parameters.

c.

7. Please clarify what SaaS approval is.

a. Software as a Service – A VA information security requirement.

b. VA Office of Information Technology, Privacy, and Security will review the system to determine the risk and provide approval or additional steps needed to be compliant.

8. RE: Billing – If the veteran does not test within the calendar month, how should we invoice for that veteran?

a. The VA should be billed per month for each active Veteran enrolled in the program. The monthly price should be all-inclusive of supplies and testing.

9. RE: Billing – Does the VA expect an invoice for the meter and supplies?

a. The monthly price should be all-inclusive of supplies and testing.

10. What are your expectations for quality control outside of manufacturer guidelines?

a. Please refer to the Quality Control section of the solicitation. The quality controls must meet FDA and CLIA-approved requirements.

11. RFP states – The vendor shall have a system in place to provide summary reports or information in an organized fashion of any quality control completed should it be needed for audits, governing body reviews, VA lab requirements, etc. – Please clarify what is needed to meet this requirement.

a. Please refer to the Quality Control section of the solicitation. The quality controls must meet FDA and CLIA-approved requirements.

12. Please define what the Government’s Quality Control Program is and the requirements of the quality assurance plan.

a. Vendor must be able to provide documentation in an organized fashion of the quality controls conducted.

13. What formula is required for unity price and estimated amount on CLINs 0001, 1001, 2001, 3001, and 4001 if unit is 1 yr?

a. CLINs 0001, 1001, 2001, 3001, and 4001 will be the total of all of the SLINs for the year, and you are not required to enter those amounts. Our system will automatically total the SLINs and place the total in the designated CLIN. It is possible the “highlights” didn’t come through Contract Opportunities, but we did not highlight the CLINs in our original because we do not require an entry. Additionally, the entries in the SLINs Unit Price should be price per patient per month.

14. Decision factors – The Evaluation – Commercial Products & Commercial Services’ section on page 63 references a price schedule .xls attachment. The preparation instructions do not reference a spreadsheet attachment or that vendor must create the price proposal in xls format. There isn’t anything in SAM either. Can VA provide the Price Schedule.xls attachment or clarify that it is just the Price/Cost Schedule in section B3 that needs to be completed?

a. Reference to the xls document was in error. Please complete the Price/Cost Schedule in section B3 and include with your submission.