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6515--Delivery of Brand Name Only Hologic Fluent Fluid Management System to the Philadelphia VA Medical Center
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36C24423Q0426
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36C24423Q0426 This is a Request for Quote Solicitation for the purchase of Brand Name Only Hologic Fluent Fluid Management System. The solicitation number is 36C24423Q0426. This is set aside for Small Business firms. The solicitation closes March 13, 2023, at 4:00 pm EST.

All quotes to be emailed to Jason.May2@va.gov as per Instructions to Offerors.

See attached RFQ PROVISIONS.

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

642-23-1-315-0041 36C24423Q0426 03-02-2023 Jason May, Jason.May2@va.gov 412-822-2227 03-13-2023

4:00 PM

EDT

36C244 Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road Pittsburgh

PA

15215-1802 X X Y 339112 1000 Employees N/A X 36C642 Department of Veterans Affairs Philadelphia VA Medical Center 3900 Woodland Avenue Philadelphia

PA

19104-4551 36C244 Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Road Pittsburgh

PA

15215

Austin Payment Center Department of Veterans Affairs PO Box 149971 Austin

TX

78714-9971

(877) 353-9791

(512) 460-5429 See CONTINUATION Page See Continuation Page.

Provisions and Instruction to Offerors are included at Section E (Provisions).

Quoting Firms are required to complete Certificates and Excel Price Cost Schedule at Section D and attached.

See CONTINUATION Page X X Mark Murray Contracting Officer Table of Contents

SECTION A2
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES2
SECTION B - CONTINUATION OF SF 1449 BLOCKS4
B.1 CONTRACT ADMINISTRATION DATA4
B.2 PRICE/COST SCHEDULE5
ITEM INFORMATION5
B.3 DELIVERY SCHEDULE8
SECTION C - CONTRACT CLAUSES9
C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)9
C.2 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)9
C.3 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)9
C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)10
C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)11
C.6 VAAR 852.246-71 REJECTED GOODS (OCT 2018)11
C.7 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)12
C.8 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)12
C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)12
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS16
SECTION E - SOLICITATION PROVISIONS17
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (NOV 2021)17
E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)19
E.3 VAAR 852.273-70 LATE OFFERS (NOV 2021)19
E.4 13.106-2 EVALUATION OF QUOTATION OR OFFERS20
E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)21

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: To Be Determined

b. GOVERNMENT: Contracting Officer 36C10H Department of Veterans Affairs Network Contracting Office 4

1010 Delafield Road Pittsburgh PA 15215-1802

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X]
52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or
[]
52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[X] Upon completion IAW the Statement of Need

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Austin Payment Center https://www.tungsten-network.com/customer-campaigns/veteransaffairs/ ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO
DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1.00
EA
__________________
__________________

FLUENT SYSTEM

LOCAL STOCK NUMBER: FLT-100

1.00
EA
__________________
__________________

OMNI INSTRUMENT TRAY

LOCAL STOCK NUMBER: 60-903

1.00
EA
__________________
__________________

OMNI HYSTEROSCOPY STANDARD SET

LOCAL STOCK NUMBER: 60-250-1

GRAND TOTAL
__________________

Page 1 of Page 1 of Background:

The Hologic Fluent Fluid Management System is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The Fluent Fluid Management System and Disposable Pack is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus while providing drive, control, and suction for hysteroscopic morcellators.

Scope of Work:

The Philadelphia VA Medical Center (PHIVAMC) has a Brand Name Only requirement for a Hologic Fluent Fluid Management System. The system includes one (1) FLT-100 Fluent System, one (1) Omni Instrument Tray and one (1) Omni Hysteroscopy Standard Set. This shall include training of all equipment.

Salient Characteristics of the brand name required Hologic Fluent Fluid Management System:

The Hologic Fluent Fluid Management System removal device is intended for use in visualizing the uterine cavity and performing operative hysteroscopy procedures including use with the MyoSure Tissue Removal Device. The Omni Hysteroscope system includes a base scope with compatible sheaths of varying working channel size. The removable outflow channels are intended to be used to provide a fluid outflow lumen for use with Omni 5.5mm and 6mm Operative Sheaths.

The removable outflow channel includes a sealed entry port to permit the introduction of instrumentation. The reusable rod lens hysteroscope utilizes rod lenses for visualization and fibers for illumination. The hysteroscope includes Omni 5.5mm and 6mm Operative Sheaths to accommodate the respective MyoSure Tissue Removal Device. The operative hysteroscopy system can be combined with a hysteroscopic fluid management system to provide continuous flow hysteroscopy capability.

Salient Characteristics of the brand name required The Omni™ Hysteroscope Standard Set:

60-201 – Omni 3.7mm Diagnostic Sheath 60-200 – Omni Hysteroscope 60-202 – Omni 5.5mm Operative Sheath 40-201 – Omni 5.5mm Outflow Channel 50-201XL – Omni 6mm Outflow Channel 60-203 – Omni 6mm Operative Sheath

Salient Characteristics of the brand name required Hologic Fluent System:

• Dual peristaltic pump technology with integrated suction

• Deficit accuracy within +/- 50mL

• Preset deficits per AAGL guidelines

• System won’t leave setup screen until all components are in place

• System starts warning users at 75% of set deficit limit

• System warns users when supply bag is low and waste bag is full

• Can hang a bag while the system is running

• Deficit set from 100ml-2,500Ml in 50ml increments

• Pressure can be set from 40-120mmHg in 5mmHg increments

• Fluent Disposable Pack (6-Pack) Delivery:

Delivery shall be within thirty (30) days from the time of award. The Hologic Fluent Fluid Management System, one (1) FLT-100 Fluent System, one (1) Omni Instrument Tray and one (1) Omni Hysteroscopy Standard Set and accessories shall be delivered to the Philadelphia VAMC located at 3900 Woodland Avenue, Philadelphia, PA 19104; Attn; Warehouse. BioMedical Engineering will need to perform a safety check and enter the equipment into the system for annual Preventive Maintenance (PM) checks. Placement in the PHIVAMC clinic shall be coordinated through the Point of Contact.

VHA Supplemental Contract Requirements for Combatting COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS- 319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

4. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.

B.3 DELIVERY SCHEDULE

ITEM NUMBER
QUANTITY
DELIVERY DATE

1.00

1.00

1.00

Philadelphia VA Medical Center
Statement of Need
Hologic Fluent Fluid Management System

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Clause)

FAR Number
Title
Date
52.204-13
SYSTEM FOR AWARD MANAGEMENT MAINTENANCE
OCT 2018
52.204-18
COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE
AUG 2020
52.212-4
CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES
DEC 2022
52.232-40
PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS
NOV 2021

C.2 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.3 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

(a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided. This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory.

(b) No counterfeit supplies or equipment/parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

(c) Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(End of Clause)

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

C.6 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

(a) Supplies and equipment. Rejected goods will be held subject to Contractor’s order for not more than 15 days, after which the rejected merchandise will be returned to the Contractor’s address at the Contractor’s risk and expense. Expenses incident to the examination and testing of materials or supplies that have been rejected will be charged to the Contractor.

(b) Perishable supplies. The Contractor shall remove rejected perishable supplies within 48 hours after notice of rejection. Supplies determined to be unfit for human consumption will not be removed without permission of the local health authorities. Supplies not removed within the allowed time may be destroyed. The Department of Veterans Affairs will not be responsible for, nor pay for, products rejected. The Contractor will be liable for costs incident to examination of rejected products.

(End of Clause)

C.7 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

Shipment of deliverable items, other than reports, shall be to:

Department of Veterans Affairs Philadelphia VA Medical Center

3900 Woodland Avenue Philadelphia PA 19104-4551 (End of Clause)

C.8 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation.

(End of Clause) (End of Addendum to 52.212-4)

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[ X ] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[ X ] (8) 52.209–6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) (31 U.S.C. 6101 note).

[ X ] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[ X ] (22) (i) 52.219–28, Post-Award Small Business Program Representation (OCT 2022) (15 U.S.C. 632(a)(2)).

[ X ] (28) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (DEC 2022) (E.O. 13126).

[ X ] (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[ X ] (30)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[ X ] (32)(i) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

[ X ] (35)(i) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627).

[ X ] (44) 52.223–18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

[ X ] (48)(i) 52.225-1, Buy American—Supplies (OCT 2022) (41 U.S.C. chapter 83).

[ X ] (51) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

[ X ] (58) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C. 3332).

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services: NOT APPLICABLE.

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203–13, Contractor Code of Business Ethics and Conduct (NOV 2021) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115–91).

(iv) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115–232).

(v) 52.219–8, Utilization of Small Business Concerns (OCT 2022) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219–8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(vii) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

(viii) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

(ix) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

(x) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

(xiii)(A) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627).

(B) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-54, Employment Eligibility Verification (MAY 2022) (E. O. 12989).

(xvii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022).

(xviii) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706).

(xix)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

(B) Alternate I (JAN 2017) of 52.224-3.

(xx) 52.225–26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

(xxi) 52.226–6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) (46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

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SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

See attached document: 004 Attachment Index.

See attached document: Attach 01 Price Cost Scehdule--.

See attached document: Attach 02 52.225-2 BUY AMERICAN CERTIFICATE.

See attached document: Attach 03 52.225-18 PLACE OF MANUFACTURE.

See attached document: Attach 04 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING--CERTIFICATE.

See attached document: Attch 5 SSJ Hologic Fluent Fluid Management System _Redacted.

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SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (NOV 2021)

The following FAR and Veterans Affairs Acquisition Regulation (VAAR) apply to this acquisition:

52.212-1 Instructions to Offerors -- Commercial Items (SEP 2021) applies to this acquisition.

Addenda to 52.212-1:

Reference word “offer”: delete “offer” and insert “quote” in its place.

Reference word “offeror”: delete “offeror” and insert “vendor” in its place.

Reference paragraph (c) period for acceptance of quotes: delete “30 calendar days” and insert “60 calendar days” in its place.

The following paragraphs are hereby deleted from this provision: (d) product samples, (e) multiple offers, and (h) multiple awards.

Quote Submission Instructions:

Vendors should review RFQ and are ultimately responsible for ensuring that their quotes fully comply with submission requirements for this RFQ. Each quote shall clearly demonstrate that the Vendor understands both the general and specific technical requirements of the Statement of Need. Failure to explain Vendor’s ability to meet all requirements may result in the Vendor's quote not being considered. Along with their quote and documentation of understanding the vendor must submit the documentation of certification to work on the subject equipment. Clarity and completeness of quotes are of the utmost importance. Therefore, quotes must be organized in a practical, clear, and concise manner.

Quotes shall be sent electronically via e-mail. All quotes shall include one (1) separate copy of each of the items listed below. Submission of a quote that does not contain all items requested below may result in elimination from consideration of award. Offerors must submit each item of quote in a separate electronic attachment clearly identified as described below. No price information shall be included in the technical or past performance section. Offerors are responsible for including sufficient details to permit a complete and accurate evaluation of each quote.

Attachment 1

1. Completed Schedule of Supplies and Services (Attachment 01 (Price Cost Schedule-Excel Document) to this solicitation). Completed CLIN price information in the Schedule of Supplies/Services. *Vendors must use the CLINs specified in the Schedule of Supplies/Services. It is not permissible for offerors to use offeror created CLINs or SUBCLINs. The Vendor is required to provide all CLIN pricing, including Delivery Dates. The Vendor shall provide all the Items listed in the Pricing Schedule listed in this Request for Quotation. The Vendor is required to provide the Data Value Spreadsheet in order to be considered responsive.

2. Completed certifications and representations located at FAR 52.212-3, or an indication that said certifications and representations are current and located in the SAM database.

3. Signed Certifications that may be included as Addenda to FAR 52.212-1. (Attachments Numbers 2 and 3).

4. Signed acknowledgements of amendments (SF30). Applicable only if any amendments are issued against this solicitation.

5. The Vendor must be an Authorized Distributor of the required items as demonstrated by their Authorized Distribution Letter.

6. Provide manufacturer’s warranty information for each product listed with the Contract Line Items Numbers for all provided equipment so that the manufacturer’s warranty can be put in place. The contractor will be responsible for providing continuity of all warranties and will ensure transfer of all warranties to VA is completed.

Attachment 2 Vendors shall provide a narrative (including any descriptive literature and/or certifications) which demonstrates the offeror’s ability to meet the technical credentials and capability stated in the Statement of Need (SON). The narrative shall not exceed twenty (20) pages and address requirements stated in the SON.

The Government may utilize the Federal Past Performance Information Retrieval System (PPIRS), the Contractor Performance Assessment Reporting System (CPARS), responses from the Performance Risk Assessment Questionnaire, data submitted by the vendor, and any other information available to determine the quality and relevance of the vendor’s past performance.

Prospective Vendors are warned against contacting any DVA personnel outside the Procurement Department prior to award of a Contract resulting from this solicitation. If such contact occurs and is found to be prejudicial to competing Vendors, the Vendor making such contact may be excluded from award consideration.

Questions regarding this solicitation are due by 03/09/2023. No questions will be answered following this date. Questions received after this time may not be considered for review. Questions shall be submitted to jason.may2@va.gov. Prospective Vendors are asked to submit their questions grouped by solicitation section and make reference to the particular paragraph in that section. The Subject Line for questions shall state ‘Hologic Fluent Fluid Management System – Questions’. Responses to all inquiries/questions will be posted to System for Award Management Contract Opportunities (CO) as an Amendment. Vendors shall be responsible for monitoring SAM CO for the agency’s responses. No information concerning this solicitation shall be provided in response to telephone calls.

Submission of your response shall be received not later than 16:00 ET on 03/13/2023 at jason.may2@va.gov in order to be considered for award.

Late submissions shall be treated in accordance with the solicitation provision at VAAR 852.273-70.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.

The following provisions apply and are incorporated by reference and full text:

(End of Provision) ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Provision)

FAR Number
Title
Date
52.204-7
SYSTEM FOR AWARD MANAGEMENT
OCT 2018
52.204-16
COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING
AUG 2020
52.229-11
TAX ON CERTAIN FOREIGN PROCUREMENTS—NOTICE AND REPRESENTATION
JUN 2020

E.3 VAAR 852.273-70 LATE OFFERS (NOV 2021)

This provision replaces paragraph (f) of FAR provision 52.212–1, Instructions to Offerors—Commercial Items. Offers or modifications of offers received after the time set forth in a request for quotations or request for proposals may be considered, at the discretion of the Contracting Officer, if determined to be in the best interest of the Government. Late bids submitted in response to an invitation for bid (IFB) will not be considered.

(End of Provision) (End of Addendum to 52.212-1)

E.4 13.106-2 EVALUATION OF QUOTATION OR OFFERS

The Government intends to award one purchase order as a result of this Request for Quote to the responsible offeror whose quote conforms to the solicitation requirements and will be most advantageous to the Government, price, technical capability of the items offered to meet the Government requirement, and past performance considered.

The Government is not limited to the Past Performance Record information provided above, but reserves the right to independently seek past performance information through open market contracts, government systems, and other government agencies.

The Contracting Officer does anticipate adequate price competition for this RFQ. Should that not happen, the Contracting Officer may need to ask for Data Other than Certified Cost and Price Data to assist with the determination of price reasonableness.

Vendors are advised that submitting an unrealistically low price may be grounds for eliminating a quote from competition. This could be on the basis that the vendor does not understand the requirement or has made an incautious quote.

Award for this requirement will be made to the vendor who proposes the Lowest Price Technically Acceptable quote to the Government. To be Technically Acceptable, the vendor must be an authorized reseller of the required items as demonstrated by their Authorized Distributor Letter. A review will be conducted. The Department of Veteran’s Affairs (DVA) will award to the vendor proposing the best value to the Government, price and other factors considered.

The evaluation matrix is as follows:

1. Authorized Distributor Letter.

2. A completed Pricing Schedule.

3. A Delivery Date no more than 30 calendar days ARO.

4. CLIN Data Value Spreadsheet included.

The DVA will evaluate quotes for award purposes by adding the total price of all Base and Option amounts for each CLIN. Evaluation of options will not obligate the DVA to exercise the option(s).

At the time of evaluation, all quotes will be evaluated to determine the Lowest Priced Quote. At that time, only the Lowest Priced Quote will be forwarded on for Technical Evaluation. If the lowest price quote is found to NOT be technically acceptable, the next lowest priced quote will be forwarded on for technical acceptability. This process will continue until the lowest priced, technically acceptable quote is identified.

All optional services must be priced in order for the proposal to be evaluated.

The DVA may reject a quote as non-responsive if it is materially unbalanced. A quote is unbalanced when it is based on prices significantly less for some work and significantly overstated for other work, or the prices do not reflect market value.

(End of Provision) E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022) The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision— Covered telecommunications equipment or services has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR 127, and the concern is identified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Reasonable inquiry has the meaning provided in the clause 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

Service-disabled veteran-owned small business concern—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

Small business concern—

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in its field of operation, and qualified as a small business under the criteria in 13 CFR part 121 and size standards in this solicitation.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

Small disadvantaged business concern, consistent with 13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by—

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

Subsidiary means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term “successor” does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

Veteran-owned small business concern means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

Women-owned business concern means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

Women-owned small business concern means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned…

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