36C24825Q0021 0004.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

None

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

To all Offerors/Bidders

36C24825Q0021

12-26-2024

X

X X

See CONTINUATION Page

X 1

The purpose of this Amendment is to answer questions. As a result;

a. Answers to participant questions are referenced beginning on page 2.

b. The question and answer period is hereby closed. No further questions shall be accepted.

c. Offers are due NLT 03/05/2025 at 3:00 PM EST.

36C24825Q0021 0004

CONTINUATION PAGE

QUESTIONS AND ANSWERS

Q1. The manufacturer name on many of the components in the packs has “Transfer” listed, which is not a valid manufacturer. Now that we have a new requirement to submit images and salient characteristics, which we have not had to do before with other VA’s, it appears that the incumbent may have an advantage. They are the current supplier, so images and info are at their fingertips.

A1. Reference Amendment 0003.

Q2. We are respectfully asking for an extension, in order to continue gathering all of the information as required, in addition to the correct manufacturers name on each of the components.

A2. The offer due date has been EXTENDED to 03/05/2025 at 3:00 PM EST in Amendment 0003.

Q3. [X] (34)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246) is checked. Does this need to be removed?

A3. There will be no change to outlined specifics in this section.

Q4. Custom Surgical Packs are made up of unique components per the requirement of the facility staff that are compiled for large and small manufacturers. As this RFQ is an SDVOSB set aside, and there are no SDVOSB manufacturers in the country that can manufacturer all the components contained in the Orlando packs, why is the NMR not checked?

A4. Reference Answer 1 from Amendment 0001 dated 01/28/2025.

Q5. NAICS 339112 is for Surgical and Medical Instrument Medical Manufacturing. Custom Surgical Packs do not fit in this NAICS code as this is more for COTS items. We’d suggest changing to 339113 Surgical Appliance & Supply Manufacturing which better defines the manufacturing of a custom surgical pack. This NACIS code also allows for the NMR to be used as there are no small businesses that can manufacture all the components needed in the BOMs.

A5. See Question 4. There are also no applicable nonmanufacturer waivers for NAICS 339113 as of 02/20/2025. The Contracting Officer decision is to maintain using NAICS code 339112.

Q6. Putting the burden on contractors to find small businesses that manufacture the components needed in a CUSTOM pack is not standard business practice or an acceptable means to fill the requirement for FAR 552.225-1 and FAR 552.225-2. Had market research been done on locating COTS items by the VA prior to the RFQ being published, this would have been determined. Please explain, in detail, the rationale for contractors to have to provide small business manufacturers when the VA requires components in the BOMs that are not manufactured by small business and/or not made domestically.

A6. The Prescription at FAR 25.1101 details the criteria for inserting FAR 52.225-1. If domestic end products cannot be furnished, is the responsibility of the Contractor to specify and disclose all foreign end products under FAR 52.225-2 Buy American Certificate.

Q7. The Medical Device Single Audit Program (MDSAP) is designed for manufacturers that market products in multiple participating countries (U.S., Canada, Brazil, Australia, and Japan).

MDSAP certification is not applicable to companies that manufacture in the US and only market in the US. Since the Orlando VAMC is located in the United States, the MDSAP requirement does not

36C24825Q0021 0004 apply and should be removed from this RFQ. Please explain the reasoning it would be kept on and not removed without just referencing the SOW.

A7. The Medical Device Single Audit Program (MDSAP) requirement does not apply and is hereby removed from the solicitation.

Q8. In which volume are the BOMs to be inserted, if anywhere, and in what format will be allowed in order to fit and be readable in a Word or PDF document?

A8. In accordance with Section VII of the Statement of Work, BOMs are only included in the event of a change to any of the packs. Changed packs shall include a hard copy of the BOM inside the packaging.

Formatting shall be at the discretion of the Contractor.

Please refer to Addendum to FAR 52.212-1 Instruction to Offerors for instructions on format.