36C24923Q0397-Solicitation-CardioEPSystem.pdf

Combined Synopsis/Solicitation Notice

SUBJECT* 621-23-3-091-0172 - Brand Name or Equal to Ensite X EP System and Accessories

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 37129

SOLICITATION NUMBER* 36C24923Q0397

RESPONSE DATE/TIME/ZONE 9/12/2023, 12:00pm, Eastern Time

ARCHIVE 60 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE SDVOSBC

PRODUCT SERVICE CODE* 6515

NAICS CODE* 334510

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 400 Murfreesboro TN 37129

POINT OF CONTACT*

Contract Specialist Sascha Hertslet sascha.hertslet@va.gov 615-225-6664 cc: douglas.huddy@va.gov

PLACE OF PERFORMANCE

ADDRESS Department of Veterans Affairs (VA) James H. Quillen VA Medical Center Lamont St & Veterans Way Bldg. 205 Warehouse Mountain Home TN

POSTAL CODE 37684

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Description This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart (FAR)

12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as a request for quotes (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04 dated 6/30/2023 and VA Acquisition Regulation (VAAR) Update 2008-36.

This solicitation is 100% set-aside for Service-Disabled Veteran-Owned small businesses (SDVOSB). All SDVOSBs must be SBA-certified at time of submission of offer and before award. https://veterans.certify.sba.gov/

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing with a small business size standard of 1250 employees.

The FSC/PSC is 6525.

The Government will award a single firm-fixed price (FFP) contract to the responsive and responsible offeror whose offer, conforming to the synopsis/solicitation, will be most advantageous -i.e. Best Value- to the Government as determined by the solicitation evaluation criteria.

VA Network Contracting Office (NCO) 9, located at 1639 Medical Center Parkway, Murfreesboro, TN, 37129 is seeking to purchase the services described below.

Any questions or concerns regarding this solicitation should be forwarded via email to sascha.hertslet@va.gov no later than 3:00pm, (ET), Friday, 9/8/2023, to give the Government an opportunity to respond and consider whether to extend the solicitation period.

Submit final offers electronically via email only, no later than 12:00pm, Eastern Time, 9/12/2023 to the sascha.hertslet@va.gov, cc: douglas.huddy@va.gov with subject line stating 36C24923Q0397-Solicitation-RFQ-[contractor name]

Contract terms are firm-fixed price, in English only, and in US Dollars rounded to the nearest hundredth position.

All interested companies must provide quotations for the following:

https://www.acquisition.gov/far/part-12#FAR_Subpart_12_6 https://www.acquisition.gov/far/part-12#FAR_Subpart_12_6 https://veterans.certify.sba.gov/ mailto:sascha.hertslet@va.gov mailto:sascha.hertslet@va.gov mailto:douglas.huddy@va.gov

Price/Cost Schedule: (Brand Name or Equal)

As a Brand Name or Equal requirement, the salient characteristics identified describe the minimum physical, functional, or performance, characteristics that “equal" products must meet. Responses to this RFQ need not be the brand name item identified. See FAR 52.211-6, incorporated in this RFQ, for the response requirements for equal products.

VENDOR RESPONSE FOR EACH LINE ITEM MUST INCLUDE:

Make, model, warranty coverage details, contents of packaged item (what is included and excluded), and place of manufacture.

Item Number

Qty Description [Salient Characteristics]

Unit Price

0001 1

EA

EnSite X ElectroPhysiological (EP) System [A catheter navigation and mapping system capable of displaying the 3-dimensional (3-D) position of conventional and Sensor-Enabled™ (or Equal) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these 3-D maps are based on the anatomy of the patient’s own cardiac chamber.

The intended clinical benefit is to provide diagnostic information to the physician to aid in the treatment of arrhythmias.

System has the following components:

1. EP System Amplifier Cart [Accepts signals from:

-Various electrode connections (i.e. EP system, ECG, etc.)

- 20 pin and 80 pin Catheter Input Modules for connection of standard diagnostic catheters;

- Magnetic tracking Field Frame that generates the magnetic tracking field during an EP System procedure., and -Four (4) Patient Reference Sensors: one anterior (PRS-A) and three posterior (PRS-P) sensors with cables. The devices accept signals from catheters and electrodes attached to the patient and pass these signals to the EP Amplifier. The EP amplifier converts these signals to a digital format and sends them to the DWS for processing and display.

-Medical Grade Isolation Transformer. When using the Amplifier Cart, the system components connected to line power through the isolation transformer. Only components on the Amplifier Cart should be connected to this isolation transformer.

2. Display Work Station (DWS) Cart (latest version) [Consists of the workstation (computer), monitors, medical grade isolation transformer, and optional printer.

-The workstation contains the system software displaying data from the EP Amplifier. Attached to the workstation are a keyboard and mouse for user input.

-Monitors are used to display patient information. One monitor is placed near the workstation and keyboard for system operation.

-Medical Grade Isolation Transformer. All system components on the DWS cart are connected to line power through the isolation transformer. Only components of the DWS should be connected to this isolation transformer. ]

Vendor Response: ________________________

0002 1

Advanced Mapping Software License [A set of mapping features that introduces the following new functionality:

Omnipolar Technology (OT) Near Field Detection Algorithm – A new detection method placing the detection time at the peak frequency (sharpest point) of the signal.

Peak Frequency maps – A new map type based on the peak frequency (sharpness) of the map point signal.

Emphasis maps – A new map visualization tool where areas of interest are emphasized on the map by darkening areas on the map that do not meet user-defined criteria.

Includes:

1. OT License Features:

-Omnipolar waveforms – A calculated waveform of the optimal bipole (maximum voltage) independent of catheter orientation. Omnipolar waveforms are calculated from the bipoles of triangular three-electrode groupings, or cliques, on the HD Grid Mapping Catheter.

-Activation Vectors – A mapping feature where arrows representing activation direction, calculated from OT waveforms, are overlaid on the map.

2. Wave Speed License Features:

-Wave Speed maps – A new map type showing the apparent speed at which the depolarization wave travel through the cardiac tissue. ]

Vendor Response: _______________________________

0003 1

EnSite Contact Force Module [Allows contact force data to be viewed on the EP Cardiac Mapping System. Key benefits include an intuitive display of contact force data, easier set-up and an enhanced workflow.]

0004 1

Ampere RF Generator Kit [Increased efficiency and control *Designed for improved efficiency and decreased noise interference *User controlled Power or Temperature modes *New Power Control mode for steerable, deflectable, irrigated catheters used to treat atrial flutter by finding the source of the rhythm disturbance and ablating small areas of the heart tissue.

Easy to use standard options *Monitor real-time temperature and impedance data on the color LCD screen *Power, temperature, impedance and duration push-button controls *Increased lab efficiency through user presets *Easy bedside physician control with included Footswitch Solutions designed to reduce risk *Select maximum temperature for automatic modulation of power with the built-in overload protection.

*Manage procedural needs through user-configured variable Power Ramp-Up *Control irrigation flow rates with the Auto Flow feature *Enhanced control of RF delivery with Automatic RF shutoff parameters

- For example, auto-shut off is adjustable for impedance that changes by more than 10 ohms over 5 seconds Seamless integration for the EP Lab *Ampere RF generator integrates with the EP System, EP Recording System, Irrigation Pump and all other standard and irrigated ablation catheters. The Ampere software is also upgradable via USB connection.

Includes generator and footswitch with 2.5 m cable.

Specifications *RF Output Power: 1 to 100 W adjustable in steps of 1 W *Impedance Range: Measures 50 Ω to 300 Ω in steps of 1 Ω *Target Temperature: 15° C to 80° C adjustable in steps of 1° C *RF Delivery Time: 1 to 999 seconds adjustable in steps of 1 second *Control Modes: Temperature; Power *Energy Delivery Modes: Independent; Sequential;

Simultaneous

*Operating Parameters: Values are digitally displayed on the Ampere™ Generator front panel **Supply Voltage: 100-240 VAC, 50/60 Hz *Safety Class: Class I; Type CF according to IEC 60601-1]

0005 1

Ampere Remote Control (includes 15m fiber cord) [RF Ampere Generator remote control]

0006 1

Cool Point Irrigation Pump [ A peristaltic pump meant for the process of irrigation through irrigated ablation catheters, to build up a unique two-way connection. The Irrigation Pump is also a part of the Cardiac Ablation Generator. Device features means to prevent infusion of air, and provide indication either visually, orally, digitally, etc. when an occlusion occurs.]

0007 1

SensiTherm Multi Esophageal System Monitor [Is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms.]

0008 1

Medinbox Mobile Configuration [An integrated audio/visual live collaboration system for EP labs that facilitates live engagement and collaboration for procedural support, service support, and/or community engagement for EP procedures. The system can integrate multiple overhead screens; including but not limited to fluoroscopy, ICE, electro-anatomical mapping, and EP recording, and combines it with a live audio and video feed into a single remote-accessed and capable of remote-controlled two-way communication display via commonly used business conferencing software.]

0009 1

SensiTherm Cable Holder [Cable holder for

0010 1

SensiTherm Mapping System Adapter Cable

0011 1

WorkMate Claris Recording System 120 with EP-4 Cardiac Stimulator

[High-performance electrophysiology recording system for collecting, displaying and storing data from multiple sources within the electrophysiology (EP) lab.

Essential Features:

*Ease of use and set-up *Seamless connections among multiple IT systems and platforms *Accurate, instantaneous, dynamic, and conditioned signal response for ECG displays and recording.

TECHNICAL DESCRIPTION

Advanced Display Workstation DVD-RW Drive Mouse, Custom Keyboard Basic Image Capture System (2 Black & White

Inputs) Network Connection to Hospital System Inbound/Outbound Data Interface o Allows the EP Recording System to connect to an external data source, archival of signals to a hospital file server

Display of Signal FFT Data Ablation Data Interface (RF & Cryo) Integrated cardiac stimulator control software

Amplifier with controlled signal generation technology Up to 448 Channel Display capability 120 Intracardiac Electrode Inputs 4 Analog Input Channels 4 Analog Output Channels 4 Physiologic Input Channels 12 Surface ECG Channels Catheter Interface Module(s)

Miscellaneous

(4) 24” High Resolution 16:9 aspect ratio

Widescreen Monitors

(1) Color Printer

(1) 12-Lead ECG Cable Cables

(1) Anti Fatigue Mat

Cardiac Stimulator Integrated EP-4 Four Channel Cardiac Stimulator Stimulator Touch Screen Control

Physiologic Pressure Monitoring

(1) Pressure Transducer Cable (Up to 4 pressure

Channels) Carts

(1) Primary Workstation Cart - 48"

(1) Bedside Slave Cart - 24"]

0012 1

WorkMate Scribe Module [Mobile/Cart-type Nurses’ EP Workstation for Efficient and Comprehensive Patient Data Management allows a secondary user to simultaneously monitor the patient’s vital signs, record patient monitoring and charting information, and perform signal analysis—all independent of the primary EP lab workstation] Enhanced Lab Staff Efficiency

Enter patient data via the mobile nurses EP workstation during the procedure at the same time as the primary EP lab workstation operator without the need for an additional centralized IT server.

Monitor and chart patient data remotely Seamlessly exchange procedure data, including EP signals, with the primary EP lab workstation during the case.

Enable the physician and staff to enter procedure data concurrently for speed and efficiency, reducing post-procedure data entry, improving lab turnover and providing faster case throughput.

Track medications, dosage, log times and quantities used during the procedure for maintenance of a unified chronological log.

Chart patient care notes and enter ACT and sedation information at specific user-defined intervals at the patient’s bedside for ease and convenience.

0013 1

ViewMate Ultrasound System [A fully-featured imaging platform. Optimized for a 64-element phased array intra-cardiac echo (ICE) visualization, the system is compatible with ICE catheters. The imaging platform uses a software-driven approach to acoustic data acquisition and image formation.] Consists of:

Software:

o Modes: 2D/B, M, Color Doppler (CD), Power Doppler, Pulse Wave (PW), Continuous Wave (CW), AUX CW o Auto Operation which can equalize image gain and optimize sound speed compensation o Total Recall Imaging (TRI)- enabling retrospective processing o Cardiac calculations packages o Configurable cybersecurity options o DICOM networking – includes Verify, Store, Print, and Basic Modality Worklist Query service classes

Hardware:

o 19” color, high resolution LCD display mounted on articulating arm o OLED display for customizable mode menus o Interface Module for ICE o Rechargeable battery allows up to 1.5 hours of operation without plugging into AC power o Connect up to 3 transducers simultaneously o Multifunction USB port, Wireless ready o Minimum 120 GB Hard Drive Storage o HDMI/DVI digital video output

Accessories:

o Customized, durable baskets to carry supplies o 3-Lead ECG connection o Operator’s manual and quick reference guide o

0014 1

L8-3 Linear Transducer [Linear Array (8-3 MHz) transducer designed for peripheral vascular imaging. The transducer offers ten frequencies including three frequencies for 2D and M- Mode, two for Tissue Harmonics, one for Compound Harmonics, and two each for Color/Power and PW Doppler]

0015 1

P4-1C Trans-thoracic Transducer [Phased Array (4-1 MHz) transducer designed to address Adult Echocardiography, Trans-cranial and Abdominal Vascular Imaging. The transducer offers fourteen frequencies within 2D and M-Mode, Tissue Harmonics, Color/Power, PW Doppler, Compound Harmonics, and Compound Imaging. Up to 30 cm penetration.]

0016 1

Multi-System Discount

0017 1

JB

INSTALLATION SERVICE

State if it is included or not included in the above product purchase and what is covered for this service.

Delivery Schedule: [Contractor required response] Give an estimate time from order placement to delivery of items to the Government (i.e. 30 days ARO, 4-6 weeks, etc.)

Freight on Board: Destination.

Place of Performance/Place of Delivery:

James H. Quillen VA Medical Center Corner of Lamont Street and Veterans Way c/o Warehouse Bldg. 205

Mountain Home, TN 37684

Basis for Award:

Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on the decision factors given below resulting in a Contracting Officer decision for the quote most favorable – i.e. Best Value- to the Government.

FAR 52.212-3, “Offerors Representations and Certifications– Commercial Items” (Nov 2021)

Note: Offerors must complete annual representations and certifications online in the System for Award Management (SAM) in accordance with FAR 52.212-3. If paragraph (b)(2) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

FAR 52.212-4, “Contract Terms and Conditions–Commercial Products and Commercial Services” (Dec 2022)

Addendum to FAR 52.212-4 – Show FAR clauses followed by VAAR clauses in numeric order. List all clauses incorporated by reference in numeric order under 52.252- 2 (see below):

FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998) http://www.acquisition.gov/far/index.html (FAR) and http://www.va.gov/oal/library/vaar/index.asp (VAAR) https://sam.gov/content/home https://www.acquisition.gov/far/part-52#FAR_52_212_3 http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/index.asp

• FAR 52.204-13 System for Award Management Maintenance (Oct 2018)

• FAR 52.204-18 Commercial and Government Entity Code Maintenance

(Aug 2020)

• FAR 52.204-25 Prohibition on Contracting for Certain

Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

(End of Clause)

VAAR 852.203-70 Commercial Advertising (May 2018) The Contractor shall not refer 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)

VAAR 852.211-70 Equipment Operation and Maintenance Manuals (Nov 2018)

The Contractor shall follow standard commercial practices to furnish manual(s), handbook(s) or brochure(s) containing operation, installation, and maintenance instructions, including pictures or illustrations, schematics, and complete repair/test guides, as necessary, for technical medical equipment and devices, and/or other technical and mechanical equipment provided per CLIN(s) # 1 – 5 .

The manuals, handbooks or brochures shall be provided in hard copy, soft copy or with electronic access instructions, consistent with standard industry practices for the equipment or device. Where applicable, the manuals, handbooks or brochures will include electrical data and connection diagrams for all utilities. The documentation shall also contain a complete list of all replaceable parts showing part number, name, and quantity required.

(End of clause)

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)

VAAR 852.219-73 VA Notice of Total Set-Aside for Certified Service-Disabled Veteran-Owned Small Business (Jan 2023)

(a) Definition. For the Department of Veterans Affairs, “Service-disabled Veteran-owned small business concern or SDVOSB”:

(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 or eligible surviving spouses (see VAAR 802.101, Surviving Spouse definition);

(ii) The management and daily business operations of which are controlled by one or more service-disabled Veterans (or eligible surviving spouses) or, in the case of a service-disabled Veteran with permanent and severe disability, the spouse or permanent caregiver of such Veteran;

(iii) The business meets Federal small business size standards for the applicable North American Industry Classification System (NAICS) code identified in the solicitation document;

(iv) The business has been certified for ownership and control pursuant to 38 U.S.C. 8127, 13 CFR 128, and is listed as certified in the SBA certification database at https://veterans.certify.sba.gov/; and

(v) The business agrees to comply with VAAR subpart 819.70 and Small Business Administration (SBA) regulations regarding small business size, government contracting, and the Veteran Small Business Certification Program at 13 CFR parts 121, 125, and 128.

(2) The term “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).

(3) The term “small business concern” has the meaning given that term under section 3 of the Small Business Act (15 U.S.C. 632).

(4) The term “small business concern owned and controlled by Veterans with service- connected disabilities” has the meaning given the term “small business https://www.va.gov/oal/library/vaar/vaar802.asp#802101 https://veterans.certify.sba.gov/ https://www.va.gov/oal/library/vaar/vaar819.asp#81970 concern owned and controlled by service-disabled veterans” under section 3(q)(2) of the Small Business Act (15 U.S.C. 632(q)(2)).

(5) The term "SDVOSB participant” or certified SDVOSB means a small business that has been certified in the SBA Veteran Small Business Certification Program and listed in the SBA certification database (see 13 CFR 128.102).

(b) General. In order for a concern to submit an offer and be eligible for the award of an SDVOSB set-aside or sole source contract, the concern must qualify as a small business concern under the size standard corresponding to the NAICS code assigned to the contract and be listed as an SDVOSB participant in the SBA certification database as set forth in 13 CFR 128.

(1) Offers received from entities that are not certified SDVOSBs and listed in the SBA certification database at the time of offer shall not be considered.

(2) Any award resulting from this solicitation shall be made to a certified SDVOSB listed in the SBA certification database who is eligible at the time of submission of offer(s) and at the time of award.

(3) The requirements in this clause apply to any contract, order or subcontract where the firm receives a benefit or preference from its designation as an SDVOSB, including set-asides, sole source awards, and evaluation preferences.

(c) Representation. Pursuant to 38 U.S.C. 8127(e), only certified SDVOSBs listed in the SBA certification database are considered eligible to receive award of a resulting contract. By submitting an offer, the prospective contractor represents that it is an eligible and certified SDVOSB as defined in this clause, 13 CFR 121, 125, and 128, and VAAR subpart 819.70.

(d) Agreement/LOS certification. When awarded a contract action, including orders under multiple-award contracts, an SDVOSB agrees that in the performance of the contract, the SDVOSB shall comply with requirements in VAAR subpart

819.70 and SBA regulations on small business size, and government contracting programs at 13 CFR part 121 and part 125, including the non-manufacturer rule and limitations on subcontracting (LOS) requirements in 13 CFR 121.406(b) and 13 CFR

125.6. For the purpose of limitations on subcontracting, only certified SDVOSBs listed in the SBA certification database (including independent contractors) shall be considered eligible and/or “similarly situated” (i.e., a firm that has the same small business program status as the prime contractor). An otherwise eligible firm further agrees to comply with the required (LOS) certification requirements in this solicitation (see 852.219-75 or 852.219- 76 as applicable). These requirements are summarized as follows:

(1) Services. In the case of a contract for services (except construction), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance to firms that are not certified SDVOSBs listed in the SBA certification database (excluding direct costs to the https://www.va.gov/oal/library/vaar/vaar819.asp#81970 https://www.va.gov/oal/library/vaar/vaar819.asp#81970 https://www.va.gov/oal/library/vaar/vaar819.asp#81970 https://www.va.gov/oal/library/vaar/vaar819.asp#81970 https://www.va.gov/oal/library/vaar/vaar852.asp#85221975 https://www.va.gov/oal/library/vaar/vaar852.asp#85221976 https://www.va.gov/oal/library/vaar/vaar852.asp#85221976 extent they are not the principal purpose of the acquisition and the SDVOSB/VOSB does not provide the service, such as airline travel, cloud computing services, or mass media purchases). When a contract includes both services and supplies, the 50 percent limitation shall apply only to the service portion of the contract.

(2) Supplies/products. (i) In the case of a contract for supplies or products (other than from a non-manufacturer of such supplies), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not certified SDVOSBs listed in the SBA certification database. When a contract includes both supply and services, the 50 percent limitation shall apply only to the supply portion of the contract.

(ii) In the case of a contract for supplies from a non-manufacturer, the SDVOSB prime contractor will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) has been granted.

Refer to 13 CFR 125.6(a)(2)(ii) for guidance pertaining to multiple item procurements.

(3) General construction. In the case of a contract for general construction, the SDVOSB prime contractor will not pay more than 85% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not certified SDVOSBs listed in the SBA certification database.

(4) Special trade construction contractors. In the case of a contract for special trade contractors, no more than 75% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, may be paid to firms that are not certified SDVOSBs listed in the SBA certification database.

(5) Subcontracting. An SDVOSB subcontractor must meet the NAICS size standard assigned by the prime contractor and be certified and listed in the SBA certification database to count as similarly situated. Any work that a first tier VIP-listed SDVOSB subcontractor further subcontracts will count towards the percent of subcontract amount that cannot be exceeded. For supply or construction contracts, the cost of materials is excluded and not considered to be subcontracted. When a contract includes both services and supplies, the 50 percent limitation shall apply only to the portion of the contract with the preponderance of the expenditure upon which the assigned NAICS is based. For information and more specific requirements, refer to 13 CFR 125.6.

(e) Required limitations on subcontracting compliance measurement period. An SDVOSB shall comply with the limitations on subcontracting as follows:

[Contracting Officer check as appropriate.]

By the end of the base term of the contract or order, and then by the end of each subsequent option period; or

X_ By the end of the performance period for each order issued under the contract.

(f) Joint ventures. A joint venture may be considered eligible as an SDVOSB if the joint venture 13 CFR 128.402 and the managing joint venture partner makes the representations under paragraph (c) of this clause. A joint venture agrees that, in the performance of the contract, the applicable percentage specified in paragraph (d) of this clause will be performed by the aggregate of the joint venture participants.

(g) Precedence. The VA Veterans First Contracting Program, as defined in VAAR 802.101, subpart 819.70, and this clause, takes precedence over any inconsistencies between the requirements of the SBA Veteran Small Business Certification Program, and the VA Veterans First Contracting Program.

(h) Misrepresentation. Pursuant to 38 USC 8127(g), any business concern, including all its principals, that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB status is subject to debarment from contracting with the Department for a period of not less than five years (see VAAR 809.406-2 Causes for Debarment).

(End of clause)

VAAR 852.219-76 VA Notice of Limitations of Subcontracting – Certificate of Compliance for Supplies and Products (Jan 2023) (Deviation)

(a) Pursuant to 38 U.S.C. 8127(l)(2), the offeror certifies that—

(1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows: [Offeror check the appropriate box]

(i) [ ] In the case of a contract for supplies or products (other than from a non-manufacturer of such supplies), it will not pay more than 50% of the amount paid by the government to it to firms that are not certified SDVOSBs listed in the SBA certification database as set forth in 852.219-73 or certified VOSBs listed in the SBA certification database as set forth in 852.219-74. Any work that a similarly situated certified SDBOSB/VOSB subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(ii) [ ] In the case of a contract for supplies from a nonmanufacturer, it will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) is granted. The offeror understands that, as provided in 13 CFR 121.406(b)(7), such a waiver has no effect on requirements external to the Small Business Act, such as the Buy American Act or the Trade Agreements Act.

(2) Manufacturer or nonmanufacturer representation and certification. [Offeror fill-in— check each applicable box below. The offeror must select the applicable provision below, identifying itself as either a manufacturer or nonmanufacturer]:

https://www.va.gov/oal/library/vaar/vaar802.asp#802101 https://www.va.gov/oal/library/vaar/vaar802.asp#802101 https://www.va.gov/oal/library/vaar/vaar819.asp#81970 https://www.va.gov/oal/library/vaar/vaar809.asp#8094062 https://www.va.gov/oal/library/vaar/vaar809.asp#8094062 https://www.va.gov/oal/library/vaar/vaar852.asp#85221973 https://www.va.gov/oal/library/vaar/vaar852.asp#85221974

(i) [ ] Manufacturer or producer. The offeror certifies that it is the manufacturer or producer of the end item being procured, and the end item is manufactured or produced in the United States, in accordance with paragraph (a)(1)(i).

(ii) [ ] Nonmanufacturer. The offeror certifies that it qualifies as a nonmanufacturer in accordance with the requirements of 13 CFR 121.406(b) and paragraph (a)(1)(ii). The offeror further certifies it meets each element below as required in order to qualify as a nonmanufacturer. [Offeror fill-in—check each box below.]

[ ] The offeror certifies that it does not exceed 500 employees (or 150 employees for the Information Technology Value Added Reseller exception to NAICS code 541519, which is found at 13 CFR 121.201, footnote 18).

[ ] The offeror certifies that it is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied.

[ ] The offeror certifies that it will take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice.

(iii) Removed.

(3) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution.

(4) If VA determines that an SDVOSB/VOSB awarded a contract pursuant to 38

U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following:

(i) Referral to the VA Suspension and Debarment Committee;

(ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and

(iii) Prosecution for violating 18 U.S.C. 1001.

(b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract or to determine whether the offeror qualifies as a manufacturer or nonmanufacturer in compliance with the limitations on subcontracting requirement. Contracting officers may, at their discretion, require the contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the contracting officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed.

(c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance.

The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate.

(d) Offeror completed certification/fill-in required. The formal certification must be completed, signed, and returned with the offeror’s bid, quotation, or proposal. The

Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award.

Certification:

I hereby certify that if awarded the contract, [insert name of offeror] will comply with the limitations on subcontracting specified in this clause and in the resultant contract. I further certify that I am authorized to execute this certification on behalf of [insert name of offeror].

Printed Name of Signee:

Printed Title of Signee:

Signature:

Date:

Company Name and Address:

(End of clause)

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, e-mail, 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 https://www.acquisition.gov/far/part-32#FAR_32_001 https://www.va.gov/oal/library/vaar/vaar852.asp#85223272c https://www.acquisition.gov/far/part-32#FAR_32_001

(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 below, 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)

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 shall be furnished to the Contractor.

(End of clause) https://www.va.gov/oal/library/vaar/vaar852.asp#85223272e https://www.acquisition.gov/far/part-32#FAR_32_905

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)

VAAR 852.247-72 Marking Deliverables (Oct 2018)

(a) The Government’s contract number shall be placed on or adjacent to all exterior mailing or shipping labels of deliverable items called for by the contract.

(b) Mark deliverables, except reports, for: Mullins, John "Kevin", Medical

Physicist, Radiation Safety

(End of clause)

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)

FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” (Mar 2023)

The following subparagraphs of FAR 52.212-5 are applicable:

(b) (8) 52.209-6, Protecting the Government’s Interest when Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Nov 2021)

(10) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (FEB 2016)

(19) 52.219-14, Limitations on Subcontracting (OCT 2022) (15 U.S.C. 637s).

(21) 52.219.27, Notice of Service-Disabled Veteran-Owned Small Business Set- Aside (OCT 2022) (15 U.S.C.632(a)(2))

(22)(i) 52.219-28, Post Award Small Business Program Rerepresentation (MAR 2023) (15 U.S.C 632(a)(2))

(26) 52.219-33, Nonmanufacturer Rule (SEP 2021) (15 U.S.C.637(a)(17))

(27) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

(35)(i) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C.

chapter 78 and E.O. 13627).

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

(48)(i) 52.225-1, Buy American-Supplies (OCT 2022) (41 U.S.C. Chapter 83)

(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).

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

(60) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

(End of Clause)

PROVISIONS/CLAUSES:

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions and clauses apply to this acquisition:

• FAR 52.204-7 System for Award Management (Oct 2018)

• FAR 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020)

• FAR 52.211-6 Brand Name or Equal (Aug 1999)

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—

COMMERCIAL ITEMS

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 version of http://acquisition.gov/comp/far/index.html

FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR.

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

FAR 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)

• FAR 52.204-7 System for Award Management (OCT 2018)

• FAR 52.204-16 Commercial and Government Entity Code Reporting (AUG

2020)

• FAR 52.204-24 Representation Regarding Certain

Telecommunications and Video Surveillance Services or Equipment

(NOV 2021)

• FAR 52.204-26 Covered Telecommunications Equipment or Services- Representation (Oct 2020)

Addendum to FAR 52.212-1(b) Submission of Offers:

All quoters must also submit the following:

(1) Authorized distributor letter from the Original Equipment Manufacturer (OEM)

– See VAAR 852.212-71 Gray Market and Counterfeit Items (Feb 2023)

(2) Must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters must list exception(s) and rationale for the exception(s), if any. Failure to include either statement is grounds for rejection of the offer.

(3) Quote must show place of manufacture for all items to ensure compliance with Buy American Act.

(4) Roll Shipping & Handling and/or Freight charges into unit price and commented in the description box to the affected line item. No separate line item for this service.

(5) Submit “equal” items in accordance with FAR 52.211-6 Brand Name or Equal instructions.

(6) Complete VAAR 852.219-76 VA Notice of Limitations of Subcontracting – Certificate of Compliance for Supplies and Products (Jan 2023) (Deviation)

Addendum to FAR 52.212-1(b)(8):

The Offeror must 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 must complete only paragraphs (c) through (v)) of this provision.

(7) Submit completed “FAR_Reps&Certs-ConfirmationStatement.docx”

(End of Addendum to 52.212-1)

52.212-1 Instructions to Offerors – Commercial Products and Commercial Services (Mar 2023)

(a) North American Industry Classification System (NAICS) code and small business size standard are stated in the combined synopsis/solicitation.

(b) Submission of quotations. Submit quotations to the office specified in this solicitation at or before the exact time specified in this solicitation.

Quotations may be submitted on letterhead stationery, or as otherwise specified in the solicitation. As a minimum, quotations must show-

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of quotations;

(3) The name, address, and telephone number of the quoter;

(4) A technical description of the items being quoted in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) “Remit to” address, if different than mailing address;

(8) A completed copy of the representations and certifications at FAR 52.212-

3 (see FAR 52.212-3( b ) for those representations and certifications that the quoter must complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the quotation is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Quotations that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

https://www.sam.gov/

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples must be submitted at or prior to the time specified for receipt of quotations.

Unless otherwise specified in this solicitation, these samples must be submitted at no expense to the Government, and returned at the sender’s request and expense, unless they are destroyed during testing.

(e) Multiple quotations. Quoters are encouraged to submit multiple quotations presenting alternative terms and conditions or commercial items for satisfying the requirements of this solicitation. Each quotation submitted will be evaluated separately.

(f) Late submissions

(1) Quoters are responsible for submitting quotations to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that quotations are due.

(2) Any quotation received at the Government office designated in the solicitation after the exact time specified for receipt of quotations is late and will not be considered unless it is received before purchase order issuance and the Contracting Officer determines that accepting the late quotation would not unduly delay the acquisition.

(3) If an emergency or unanticipated event interrupts normal Government processes so that quotations cannot be received at the Government office designated for receipt of quotations by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of quotations will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(g) Issuance of purchase order. Quotations should contain the quoter’s best technical and price terms. The Contracting Officer may reject any or all quotations. The Contracting Officer may issue a purchase order to other than the quoter with the lowest priced quotation.