36C10G21R0010.docx

Contract Opportunity Combined Synopsis/Solicitation Notice

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* = Required Field Contract Opportunity Combined Synopsis/Solicitation Notice Follow-On (BPA) for Electrophysiology Catheters 22408-2697 36C10G21R0010 07-12-2021

12:00PM

EASTERN TIME, NEW YORK, USA

N 339112 U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 Brian Shepard | Brian.Shepard@va.gov Brian.Shepard@va.gov Gwennifer.Epps@va.gov Gwennifer Epps | Contract Specialist Gwennifer.Epps@va.gov

TBD

https://www.va.gov/opal/sac/index.asp To learn more about SAC and its mission, please click here The Department of Veterans Affairs (VA) Veterans Health Administration (VHA) Electrophysiology Integrated Product Team (IPT) has identified the need to purchase Electrophysiology (EP) Catheters and products. Electrophysiology is a medical branch related to the study of electrical activity within the body. Catheters are slim, bendable tubes used in medical procedures or in ablation of cardiac tissues responsible for heart arrhythmia disorders.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 36C10G21R0010 issued as a request for proposal (RFP). The North American Industry Classification System (NAICS) code for this acquisition is 339112, (Surgical and Medical Manufacturing) with a small business size standard of 1,000 employees. The Product Service Code (PCS) number is 6515, Medical and Surgical Instruments, Equipment, and Supplies. The blanket purchase agreement, (BPA) will be for a 60-month ordering period. As a clinical need for support of the Veterans Health Administration (VHA) Clinicians nationwide as identified by the Prosthetic & Sensory Aids Services (PSAS) Program Office, the Strategic Acquisition Center (SAC), U.S. Department of Veterans Affairs (DVA) intends to negotiate, a non-competitive follow-on, Blanket Purchase Agreement (BPA), Brand-Name or Equal to Biosense Webster, 33 Technology Drive, Irvine, CA 92618 for the procurement of Biosense Webster Electrophysiology (EP) Catheters. Biosense Webster is the global leader in the science of diagnosing and treating heart rhythm disorders. Biosense Webster is part of the Johnson & Johnson Family of Companies. Biosense Webster is the sole source for all Biosense Webster disposable products and does not authorize the sale of these disposable products through any third-party distributors.

This acquisition being solicited under Federal Acquisition Regulation (FAR) Part 12, Acquisition of Commercial Items and FAR Part 13, Simplified Acquisition Procedures. The statutory authority permitting other than full and open competition is FAR 11.105(a)(1), and (FAR) Subpart 6.302-1(c). The particular brand name, product, or feature is essential to the Government’s requirements, and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency’s needs. Only one award will be made as a result of this solicitation. There are no existing compatibility requirements and the Contractor shall ensure that all Biosense Webster EP Catheters offered are the most recently designed components. If upgrades of the Biosense Webster EP Catheters become available after extension or subsequent BPA Order, the technical program office and the Contracting Officer will conduct additional market research to determine if there are other sources available that can provide the required services.

Vendors must be registered in the System for Award Management (SAM) database https://www.sam.gov/SAM/ The Contractor shall furnish all necessary equipment, supplies, and materials to provide Biosense Webster EP Catheters and products to VA Medical Centers (VAMCs) in the continental United States and Puerto Rico. For standard delivery, the Contractor shall provide the requested items within 3 calendar days. The vendor must have the capability to receive payment upon delivery utilizing the Government Purchase Card (GPC).

Offers are to be received by email to: Gwennifer Epps, Gwennifer.Epps@va.gov Contract Specialist, and copy Brian Shepard, Brian.Shepard@va.gov, Contracting Officer, no later than 12:00 P.M. Eastern Standard Time (EST) on July 12, 2021. Electronic copies of proposal may be submitted; Facsimile proposals will NOT be accepted. Electronic offers are acceptable for this acquisition if received by date and time specified. The offeror is responsible for ensuring that the contract specialist has received the offer before the deadline for receipt of offers, and the Government will not be responsible for delays or failures of either the contractor’s email system or the Government’s email system. The physical work site location is the Strategic Acquisition Center (SAC), U.S. Department of Veterans Affairs, 10300 Spotsylvania Avenue, Suite 400 Fredericksburg, VA 22408, but due to the on-going COVID-19 pandemic only email submission is required. The VA SAC Contract Specialist will respond to ensure that all offerors have had the proposals received by the SAC Contracting Team.

BLANKET PURCHASE AGREEMENT (BPA) TERMS & CONDITIONS

THE FOLLOWING TERMS AND CONDITIONS ARE MANDATORY:

1. DESCRIPTION OF AGREEMENT:

Electrophysiology is a medical branch related to the study of electrical activity within the heart. These catheters are slim, bendable or deflectable multi-electrode wires used in recording intra-cardiac electrical signals or in ablation of cardiac tissues responsible for heart rhythm disorders. In addition, sheaths are tubes that are used to direct the catheters to specific areas in the heart and connectors linking the catheters to monitoring or ablation systems. Cardiac ablation is a popular procedure in which physicians guide EP catheters through blood vessels into the heart to destroy diseased tissue. The EP Catheters and products are used for diagnostic testing and treatment for both invasive (intra-cardiac) and non-invasive procedures and are a critical part of cardiac patient care. These items will be used in invasive cardiac electrophysiology laboratories and other procedural suites in the Veterans Health Administration for invasive electrophysiology and arrhythmia ablation procedures.

The Contractor shall ensure that any product provided under this BPA is approved in accordance with the pre-market notification process under the Food and Drug Administration (FDA) 510K Program and labeled accordingly.

The BPA, including product, prices, and other terms and conditions, is public information and is releasable under the Freedom of Information Act (FOIA). Procurement related information, including negotiations, shall be treated as confidential and shall not be disclosed except as required by applicable laws and regulations.

The BPA holder shall provide written notice to the Department of Veterans Affairs, Strategic Acquisition Center (SAC) BPA Administrator, of any changes, specifically to any items on this resultant BPA. Changes include, but are not limited to, price increases and decreases, product deletions, new technological refreshes to its product lines or of new product introductions, and/or change in vendor company information including contract administrator, company name, address and phone number. All orders placed against this BPA are subject to the terms and conditions and contained herein and all clauses and provisions in full text or incorporated by reference herein.

2. PERIOD OF AGREEMENT:

This BPA shall be established for a period of up to thirty (30) months from the effective date of the BPA and will remain in effect for the 30 months or until it is terminated in accordance with the terms of this BPA, whichever is earlier. In accordance with FAR 13.303-6(b)(1), the Contracting Officer shall conduct an annual review of the established BPA. Upon completion of the annual review, a determination will be made whether or not it is in the best interest of the Government to continue with performance of the BPA. The maximum BPA ordering period is 30 months.

3. EXTENT OF OBLIGATION:

The Government is obligated only to the extent of authorized purchases actually made under the resultant BPA. This BPA does not obligate any funds, nor is the Government obligated to make any purchases under this BPA. The Government does not guarantee any volume of purchases through a BPA. The terms and conditions included in this BPA apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this BPA and the BPA Holder’s invoice, the provisions of this BPA will take precedence.

4. PURCHASE LIMITATION:

Ordering Officials may place orders against this agreement in excess of the simplified acquisition threshold (SAT) up to $7.0 million per Simplified Procedures for Certain Commercial Items under FAR Subpart 13.5.

In accordance with FAR Subpart 13.303-5(c), the existence of a BPA does not justify purchasing from only one source or avoiding small business set-asides. FAR 13.303-5(d) requires that for a particular purchase greater than the micro-purchase threshold, and there is an insufficient number of BPAs to ensure maximum practicable competition, the contracting officer shall—

(1) Solicit quotations from other sources (see 13.105) and make the purchase as appropriate; and

(2) Establish additional BPAs to facilitate future purchases if --

(i) Recurring requirements for the same or similar supplies or services seem likely;

(ii) Qualified sources are willing to accept BPAs; and

(iii) It is otherwise practical to do so.

5. BPA EFFECTIVE DATE:

The BPA is effective on a date that is agreed to by both the successful Offeror and the Government or 30 days after the date signed by the Government, or sooner upon mutual agreement.

6. AS214 PRODUCT MODIFICATION, REMOVAL OR RECALL (JAN 2008)

If any product awarded under this solicitation requires modification, is removed or recalled by the contractor or manufacturer due to defects in the product or potential dangers to patients, or if any required modification, removal or recall is suggested or mandated by a regulatory or official agency, the following steps will immediately be taken by the contractor or manufacturer:

a. Notify the Contracting Officer, VA Strategic Acquisition Center, 10300 Spotsylvania Avenue, Suite 400 Fredericksburg, VA 22408, in writing, within 48 hours or the next calendar day after a weekend or holiday. The notification shall include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from customers, and the contract number assigned as a result of an award on this solicitation.

(2) Reasons for modifications, removal or recall.

(3) Necessary instructions for return for credit, replacement or corrective action.

b. A copy of the notification in a. above shall be provided to:

c. Provide the information in (a) above to all agencies and VA Facilities who purchased the product.

Contract Specialist, Gwennifer Epps (Gwennifer.Epps@va.gov) or whoever is listed at that time, shall be provided a copy of the notification in b above, and a list of all agencies and/or VA facilities notified.

7. RETURNED UNITS

In the event a procedure is cancelled, or an item is otherwise not needed, The Offeror shall accept unopened and undamaged EP Catheter packages in salable condition returned with prior authorization.

TBD PRODUCT RETURN POLICY

Effective Date: TBD Authorization:

A Return Goods Authorization number must be obtained prior to returning Vendor products. To request return authorization, contact Vendor Customer Service at 800-729-9010 (toll-free in the Continental U.S.). Please be prepared to provide the following information:

• Catalog number, quantity, and lot or serial number of each item you wish to return.

• Reason for return.

Once an authorization number is acquired, products should be returned to Vendor within 30 days, in proper protective packaging, with freight/postage prepaid.

Return Product Conditions:

All products must be in their original shipped condition, as determined by Vendor, for return credit consideration. If any of the following conditions exist, the product(s) will not be considered for credit:

• Product is not in the original sealed package or other Vendor standard packaging.

• Markings or stickers have been added on the outside label of the Vendor product packaging.

• Product packaging is defaced in any manner.

• Packaging is opened.

• Product has been used.

• Product has been damaged.

• Product was purchased on a “special order” or “made-to-order” basis.

• Product is returned without a Return Goods Authorization.

• Product was held by the customer for more than 180 days.

Credit will be given only after the product has been received and inspected.

Credit Policy for Unused Products in their Original Shipped Condition:

Full credit:

Product returned within 90 days from the date of purchase (determined by the invoice date).

75% credit:

Product returned between 91-120 days from the date of invoice.

50% credit:

Product returned between 121-180 days from the date of invoice.

No credit will be given for products returned after 180 days from the date of invoice.

Product Complaints:

This policy does not address product complaints. All product complaints should be handled by calling the Clinical and Technical Support Center at 866-473-7823.

Hardware-related Returns:

This policy does not apply to hardware returns.

8. INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE BPA:

The Contractor shall accept orders against this BPA only from the Contracting Officer Representative, (COR) or Contracting Officer up to their warrant authority.

9. DISTRIBUTION:

a. Direct Orders:

The Contractor shall accept all items ordered under the resultant BPA for delivery within the continental United States, including Alaska, Hawaii, Puerto Rico and all other U.S. territories, within the time frame specified in this BPA. Contractors shall bill the individual ordering facilities directly. Ordering facilities are responsible for remitting payment in accordance with the Prompt Payment Clause.

Government Participants – The Contractor shall provide delivery of United States Food and Drug Administration (FDA) approved EP Catheters as specified in the BPA. When an Order is placed against the BPA, the BPA holder shall ship directly to the applicable Veterans Affairs Medical Center (VAMC) set forth in the Order at the prices awarded herein and under the terms and conditions set forth in the BPA. Shipments to the VA facility shall commence upon receipt of a delivery order/purchase order signed by a person with purchasing authority on behalf of a VAMC; but in no event shall delivery exceed 3 calendar days after receipt of order for CONUS orders and 10 business days for OCONUS orders. Individuals at VAMCs shall issue delivery orders to the contractor which shall indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures.

10. NOTIFICATION OF SUBSTITUTED AND BACK-ORDERED ITEMS

The Contractor shall notify the Ordering Office point of contact within one (1) business day for non-emergency Orders and within four (4) hours of an emergency Order placed via phone if any parts/materials cannot be delivered in accordance with the individual BPA Order delivery requirements. The Contractor shall notify the Ordering Office point of contact within one (1) business day for non-emergency Orders and within four (4) hours of an emergency order placed via fax or email if any parts/materials cannot be delivered in accordance with the individual BPA Order delivery requirements. To ensure that the correct Biosense Webster EP Catheter items are shipped, the Contractor shall not substitute items without prior approval by Ordering Official. Instances where the Contractor cannot meet the Government’s requirement(s), the Contractor shall notify the Ordering Office of the shortest delivery period available. If the Contractor’s shortest delivery period is not acceptable to the Government, the Government reserves the right to procure the item(s) from other sources.

11. PRODUCT REFRESH:

The Contractor shall provide improved items within the awarded product line as appropriate new industry technologies emerge and obsolete items are replaced. By mutual agreement the Government Contracting Officer and the Contractor, the Contractor shall add the new or improved items to the BPA. The revised product listing shall be in writing and approved by both parties.

Further, the Contractor shall ensure that all Biosense Webster EP Catheters and products offered are state-of-the-art. "State-of-the-art" is defined as the most recently designed components approved by the FDA and are announced for marketing purposes. All improved or enhanced products shall be provided with the standard industry warranty.

The Contractor shall ensure that all new products are approved in accordance with the pre-market notification under the Food and Drug Administration (FDA) 510K process and labeled appropriately for Biosense Webster EP Catheter Studies.

The Contractor shall provide the Contracting Officer the following information as items become obsolete:

New products replacing awarded items and released to the market during the period of performance shall be offered to the Government at a discounted price. The Government reserves the right to not accept the new products. The Contractor shall continue to supply the Contracted item(s) as originally identified.

12. ORDERING METHOD:

Orders will be placed against this BPA via Electronic Data Interchange (EDI), via facsimile, in writing, by phone, or through an individual authorized to purchase (Purchase Card). Each individual BPA Order will describe the tasks, services and deliverables required.

13. ORIGINAL EQUIPMENT MAUFACTURER GOODS:

Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment such that OEM warranty and service are provided and maintained by the OEM. All warranties associated with the equipment shall be in accordance with the OEM terms and conditions.

The Contractor shall provide only new equipment and new parts for the required products described herein. ABSOLUTELY NO “GRAY MARKET GOODS” shall be provided under any Delivery Order. Gray Market Goods are defined as genuine branded goods sold outside of an authorized sales-territory (or by non-authorized dealers in an authorized territory) at prices lower than being charged in authorized sales territories (or by authorized dealers). All Equipment must be covered by the manufacturer's warranty.

14. DELIVERY:

All orders shall be delivered Free On Board, (FOB) destination in accordance with FAR 52.247-34 to any VAMC (which may include outpatient facilities) within the Continental United States (CONUS) and all U.S. Territories to include delivery to Alaska, Hawaii, and Puerto Rico. The delivery time offered for all orders placed against the resultant BPA shall not exceed 10 calendar days After Receipt of Order (ARO). In some cases, the product may be required on an emergency basis and must be delivered within 24 hours after receipt of the order(s).

Delivery Requirements – All deliveries shall be made Free On Board, (FOB) destination. Upon delivery of equipment, VA shall thoroughly inspect the equipment. After the inspection has been performed, the ordering VA medical facility shall issue a written notice of acceptance or rejection.

Emergency Turnaround-When identified on the individual order, the Contractor shall provide emergency shipping service for the requested item(s) within 24 hours after receiving the Emergency Order Request. The Contractor shall notify the Ordering POC of any additional charges or insurance for emergency orders, prior to shipping and it shall not exceed $250.00.

Package Marking -The Contractor shall ensure the addressee information for any delivered item includes the Ordering Office point of contact(s) information on the outside packaging to ensure delivery to the correct location and correct person.

15. DELIVERY TICKETS:

At a minimum, delivery tickets or sales slips must contain the following information, if provided by the Ordering office and must accompany all deliveries under this BPA, unless otherwise agreed to:

Name of the contractor Contract Number BPA Number Model Number or National Stock Number (NSN) Date of purchase Purchase Order Number Itemized list of supplies or services furnished Quantity, unit price, and extension of each item less applicable discounts (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided that the invoice is itemized to show the information) Date of delivery and shipment

16. PURCHASE CARD:

(a) Definitions.

“Government wide commercial purchase card” means a uniquely numbered credit card issued by a contractor under GSA’s Government wide Contract for Fleet, Travel, and Purchase Card Services to named individual Government employees or entities to pay for official Government purchases.

“Oral order” means an order placed orally either in person or by telephone, which is paid for by Government wide commercial purchase card.

(b) The Contractor shall accept payments for oral or written delivery orders made using the Government wide commercial purchase card in the amount of $10,000.00 or less.

(c) The Contractor shall not process a transaction for payment through the purchase card clearinghouse until the purchased supplies have been shipped or services performed. Unless the cardholder requests correction or replacement of a defective or faulty item in accordance with other contract requirements, the Contractor shall immediately credit a cardholder’s account for items returned as defective or faulty.

17. INVOICES:

An itemized invoice shall be submitted to the VA billing address listed on each delivery order. The requirements of a proper invoice for direct orders are as specified in the BPA. The itemized invoice shall identify the delivery ticket or packing list, ship-to-address of supplies, the BPA number, and the delivery/purchase order number assigned by and provided by the individual facility at the time of ordering.

18. CONTRACT ADMINISTRATION:

The SAC Contracting Officer will: (1) issue the BPA; and (2) provide overall management and oversight of the BPA and any resulting modifications to the BPA. Each BPA Order shall have a COR assigned who will coordinate with the Contracting Officer. Any individual who has ordering/contracting authority, on behalf of VA (as authorized below), to place delivery/purchase orders, may use this BPA in accordance with Section 10, Ordering Method of B.2 BPA Terms and Conditions.

The Contracting Officer’s Representative (COR) will be responsible for inspection and acceptance of all deliverables, as appropriate, to determine the contractor’s adherence to prescribed performance and quality of products as outlined within the BPA. The COR will be designated/delegated at the ordering level by the Contracting Officer. Payments will be made upon delivery of the items ordered based upon verification that supplies were satisfactorily acceptable in accordance with the Inspection and Acceptance Clause incorporated under the BPA. In accordance with FAR 13.303-6(b)(1), the Contracting Officer shall conduct an annual review of the established BPA.

19. BPA MODIFICATION IMPLEMENTATION:

The effective date for all product additions, deletions, and price changes is as follows:

If the modification is signed by the Contracting Officer between the 9th and 23rd of the month, the effective date is the 1st day of the following month.

If the modification is signed by the Contracting Officer between the 24th and 8th of the following month, the effective date is the 15th of the latter month.

The Contracting Officer will determine the effective date for all other changes.

20. CANCELLATION:

Either party may terminate this agreement at any time upon 90 days prior written notice to the other party. The cancellation will take effect 90 calendar days after the other party receives the notice of cancellation.

This BPA ordering period expires thirty (30) months after award of BPA, including any extensions, whichever is earlier. The BPA Holder must immediately notify, in writing, the responsible VA SAC Contracting Officer if the BPA is no longer in force.

21. UNIVERSAL PRODUCT NUMBERS (UPNs):

The Supplier that receives a BPA shall utilize Universal Product Numbers as product identifiers and UPN bar code compliant labels on all packaging sizes down to the unit of measure, as they become available from manufacturers of medical and surgical supplies.

A UPN uniquely identifies healthcare products. It is derived from either the HIBCC-LIC or UCC/EAN bar code labeling data structures. The HIBCC-LIIC format is variable in length, alpha-numeric and consists of manufacturer LIC assigned by HIBCC, the labeler’s products or catalog number, and the package level (or inventory unit) indicator.

The UCC/EAN format is fixed length, all numeric and consists of the UCC/EAN assigned manufacturer number (company prefix), numeric item number, a package level (or inventory unit) indicator, and a calculated check character.

When available, the contractor shall use UPNs as the key product unit identifier in its electronic product catalogs, order-processing systems, all product recalls, business documents, and reports called for under the terms of the contract.

22. ADDITIONAL OFFEROR’S INFORMATION: (Please Complete)

Payment Terms: ____________________ (As stated in your BPA) Delivery: ____________________ (Shall not exceed 3 Business Days ARO in accordance with Section 10 of this document) Emergency Delivery Terms: _________________________________________ (Please reiterate, as stated in your BPA) Emergency Order Contact Person: _______________________________ Phone: _______________________________ Is your company EDI capable? Yes__________ No__________ (If yes, please provide registration number) ___________________________________ Company website: _______________________________________________________

JJBW PRICE LIST - ATTACHMENT D

All quantities listed are for informational and evaluation purposes only and do not obligate the Government to purchase such quantity nor does the Government guarantee any volume of purchases through this BPA. The estimated quantities are based upon FY2020 historical information. Provide all types and sizes available in commercial product line.

Contract Period: 30 Months POP Begin: Effective Date of Award POP End: TBD

PRODUCT DESCRIPTION

Standardization of Electrophysiology (EP) Catheters ensures continuity of care from one Department of Veterans Affairs (VA) hospital to another across the United States and Puerto Rico. It also provides uniformity and quality products at lower-than-current market prices.

This acquisition will provide Biosense Webster EP Catheters to more than 160 VA Medical Centers (VAMC) for clinical use throughout the VA community.

Intended Use: These items will be used in invasive cardiac electrophysiology laboratories and other procedural suites in the Veterans Health Administration for invasive electrophysiology and arrhythmia ablation procedures:

Product Description

Diagnostic electrophysiology catheters: Multi-pole, non-deflectable or multiple deflectable

Ablation catheters: multi-pole non-irrigated radiofrequency, multiple irrigated radio frequency, or cryoablation catheters

Intracardiac Ultrasound imaging catheters

Electrophysiology introducer sheaths: non-deflectable or deflectable

Trans-septal catheterization needles

3D mapping electrodes and patches

3D mapping catheters (equipment specific)

Biosense Webster Electrophysiology (EP) Catheters Minimum Requirements Intended Use: These items will be used in invasive cardiac electrophysiology laboratories and other procedural suites in the Veterans Health Administration for invasive electrophysiology and arrhythmia ablation procedures.

MTR#

Method of Evaluation

1. The Biosense Webster EP Catheters shall have appropriate FDA clearance.

CFR - Title 21--Food and Drugs, Chapter I--Food and Drug Administration, Department of Health and Human Services, Subchapter H--Medical Devices, Part 814 – Premarket Approval of Medical Devices Literature Review

1. Cardiac Electrophysiology diagnostic catheters

1. Ablation catheters: multi-pole non-irrigated radiofrequency, multiple irrigated radiofrequency, or cryoablation catheters.

1. Intracardiac Ultrasound imaging catheters

1. 3D mapping catheters Literature Review

1. Electrophysiology introducer sheaths: non-deflectable or deflectable

1. Trans-septal catheterization needles

1. 3D mapping electrodes and patches Literature Review

1. The Offeror shall provide a Product Listing of all items relating to Electrophysiology Catheters provided by their company.

1. The Offeror shall ensure that all products provided are new and free from defect.

1. The Offeror shall ensure that the products are properly packaged to maintain the item’s integrity (e.g., sterilization)

1. The Offeror shall clearly identify the item and the expected shelf-life on the outside of the packaging.

Literature Review

The Contractor shall provide a commercial warranty to industry standards for all products under this effort.

Literature Review

The Offeror shall comply with all environmental federal, state, and local laws and regulations; and policies, instructions, and plans.

Literature Review

1. In the event a procedure is cancelled, or an item is otherwise not needed,

1. The Offeror shall accept unopened and undamaged EP Catheter packages in salable condition returned for full credit to the Government.

1. The Offeror shall accept returned products for full credit to the Government -life has reached expiration for unopened and undamaged products. Unused products shall be returned to the Contractor, to the shelf within 90 calendar days after receipt of invoice by the Ordering Official.

Literature Review

BIOSENSE ADDITIONAL MINIMUM REQUIREMENTS AND UNIQUE ATTRIBUTES

The Biosense Webster EP catheters integrate with and enable the use of the Biosense Webster CARTO® 3 System, a capital equipment mapping system. Many Electrophysiology programs within VA Medical Centers currently utilize Biosense Webster’s CARTO® 3 System to map, diagnose and treat cardiac arrhythmia patients which is only possible in conjunction with the Biosense Webster EP Catheters. Biosense Webster EP Catheters are exclusive to Biosense Webster. EP catheters from other manufacturers in the marketplace do not integrate with the CARTO® 3 capital equipment to facilitate navigation or therapy delivery.

The CARTO® 3 System uses current and magnetic based technologies which integrate with a broad portfolio of diagnostic, ultrasound and therapeutic products, as well as related accessories. Much like a Global Positioning System (GPS), the CARTO® 3 System technology relies on proprietary Biosense Webster disposable catheters which are equipped with internal navigation sensors. These internal navigation sensors provide the specialized capabilities of enabling real-time navigation, ensuring +1mm of location accuracy in maps and integrating 3D ultrasound images. These capabilities make it possible for Electrophysiologists to utilize the CARTO® 3 System to generate 3D cardiac maps from which they can diagnosis a myriad of cardiac arrhythmias and deliver immediate therapy.

Use of the CARTO® 3 System is not possible without Biosense Webster disposable products. Disposable products of other Original Equipment Manufacturers (OEMs) are not functional for cardiac navigation, map generation, ultrasound image integration or therapy delivery with Biosense Webster’s CARTO® 3 System. Additionally, the proprietary Biosense Webster catheters with navigation sensors enable visualization of the expanded portfolio of non-sensor based Biosense Webster products through the hybrid current and magnetic framework of the CARTO® 3 System. Through Biosense Webster’s Connection of Choice™ functionality, use of the non-sensor based Biosense Webster products with the CARTO® 3 System ensures a seamless interface and more efficient set-up process as compared to other items available in the market from other OEMs.

Biosense Webster EP Catheters are clinically tested and proven to support favorable results in repeated medical procedures throughout VHA enterprise. The availability of these products for stock and issue verses open market buys increase VHA’s ability to provide patient care by having products on-hand.

Furthermore, the Patient Interface Unit (PIU) of Biosense Webster EP catheters can be interfaced through the PIU, (see page 36 off attached UG-500-007H_00ACARTO 3 System v7p2_IFU_EN). However, as a warning the system (including its peripheral components) is intended for use by healthcare professionals only, otherwise, the system (including its peripheral components) might cause radio interference or might disrupt the operation of nearby equipment. Only Biosense Webster navigation catheters that are equipped with magnetic sensors can be used for mapping. Also, Biosense Webster documents diagnostic catheters are all only compatible and suitable for use with the CARTO 3 System. Moreover, there are standard diagnostic catheters, Biosense Webster catheters without the Auto ID technology or diagnostic catheters from other manufacturers that can also be used with the CARTO 3 System, but they will not be automatically recognized by those systems.

Lastly, for magnetic-based location accuracy and mapping of the CARTO 3 System, Biosense Webster has an important sensor-based catheter, (see page 63 of the IFU). The catheters are equipped with a passive Biosense Webster location sensor. The sensor provides real-time information that is used for calculating catheter location, based on the magnetic fields generated by the Location Pad.

CONTRACT CLAUSES – that apply to this acquisition:

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 52.212-4, Contract Terms and Conditions; (FEB 2018) FAR 52.212-5, Contract terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items; (JAN 2021) Under paragraph b, the following clauses are incorporated: 52.203-6, Restrictions on Subcontractor Sales to the Government with Alternate I; (JUN 2020) 52.203-13, Contractor Code of Business ethics and Conduct; (JUN 2020) 52.204-10, Reporting Executive Compensation and First Tier Subcontract Awards; (JUN 2020) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment; (JUN 2020) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters; (OCT 2018) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns; (MAR 2020) 52.219-8, Utilization of Small Business Concerns; (OCT 2018) 52.219-9, Small Business Subcontracting Plan; (JUN 2020) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting; (APR 2018) 52.219-28, Post Award Small Business Program Representation; (NOV 2020) 52.222-3, Convict Labor; (JUN 2003) 52.222-19, Child Labor - Cooperation with Authorities and Remedies; (JAN 2020) 52.222-21, Prohibition of Segregated Facilities; (APR 2015) 52.222-26, Equal Opportunity; (SEP 2016) 52.222-35, Equal Opportunity for Veterans; (JUN 2020) 52.222-36, Equal Opportunity for Workers with Disabilities; (JUN 2020) 52.222-37, Employment Reports on Veterans; (JUN 2020) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act; (DEC 2010) 52.222-41, Service Contract Labor Standards; (AUG 2018) 52.222-50, Combating Trafficking in Persons; (OCT 2020) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving; (JUN 2020) 52.225-1, Buy American Act—Supplies; (JAN 20201) 52.225-5, Trade Agreements; (OCT 2019) 52.225-13, Restrictions on Certain Foreign Purchases; (FEB 2021) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management; (OCT 2018) 52.232-34, Payment by Electronic Funds Transfer – Other than System for Award Management; (JUL 2013) 52.232-36, Payment by Third Party; (MAY 2014) FEDERAL ACQUISITION REGULATIONS (FAR) PROVISIONS AND CLAUSES: CLAUSES INCORPORATED BY REFERENCE:

52.202-1, Definitions; (JUN 2020)

52.203-7, Anti-Kickback Procedures; (JUN 2020)

52.203-13, Contractor Code of Business Ethics and Conduct; (JUN 2020)

52.203-17, Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistle Blower Rights; (JUN 2020)

52.204-4, Printed of Copied Double-Sided on Recycled Paper; (MAY 2011)

52.204-13, System For Award Management Maintenance; (OCT 2018)

52.211-6, Brand Name or Equal; (AUG 1999)

52.212-4, Contract Terms and Conditions – Commercial Items; (OCT 2018)

52.227-14, Rights In Data – General; (MAY 2014)

52.232-18, Availability of Funds; (APR 1984)

52.232-35, Designation of Office for Government Receipt of Electronic Funds Transfer Information; (JUL 2013)

52.232-39, Unenforceability of Unauthorized Obligations; (JUN 2013)

52.232-40, Providing Accelerated Payment to Small Business Subcontractors; (DEC 2013)

52.233-1, Disputes; (MAY 2014)

52.233-3, Protest After Award; (AUG 1996)

52.233-4, Applicable Law For Breach of Contract Claim (OCT 2004)

MANDATORY WRITTEN DISCLOSURES

Mandatory written disclosures required by FAR clause 52.203-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OIG Hotline at http://www.va.gov/oig/contacts/hotline.asp and clicking on "FAR clause 52.203-13 Reporting." If you experience difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

SAC 18-01 SAC SERVICE LEVEL AGREEMENT FEE AND SUBMISSION OF QUARTERLY SALES REPORTS; OPEN MARKET (JANUARY 2016)

a. Service Level Agreement Fee.

The Service Level Agreement (SLA) fee is established by the Supply Fund Board and is provided as a means of reimbursement for customary acquisition-related services necessary to obtain contractor services and/or supplies as required. The SLA is reimbursed to the SAC based on rates established by the supply fund board and are recouped based on a percentage of total quarterly sales. The Supply Fund Board may change the percentage at any time, but typically not more than once per year. Upon a change in the SLA, the Contracting Officer (CO) shall issue a unilateral modification to apply the change to CLIN prices based upon the SLA rate change. The SAC will provide reasonable notice prior to the effective date of the change.

In order to facilitate SLA reimbursement, offerors must include (imbed) the SLA fee into their prices; therefore, the fee will be reflected in the total amount charged and transparent to ordering activities.

The current SLA which applies to this contract action is 3.0%. This SLA Fee shall be imbedded in the awarded contract/agreement price(s) and offers submitted in response to this solicitation shall include this SLA Fee in the price of every line item offered.

b. Quarterly Sales Reports.

The Contractor shall report all contract sales under this contract and submit collected SLAs as follows:

(1) The Contractor shall accurately report the dollar value, in U.S. dollars and rounded to the nearest whole dollar, of all sales made under this contract by calendar quarter (January 1–March 31, April 1–June 30, July 1–September 30, and October 1–December 31). Reported sales must include all sales made to all authorized contract or agreement users, whether shipped directly to the users or through Prime Vendor contractors. The report shall reflect sales by contract line item and shall segment sales by the Department of Veterans Affairs (VA) and Other Government Agencies (OGA). The reported contract sales shall include the SLA Fee and each quarterly report shall show the total SLA Fee amount collected on the reported sales. The Contractor shall maintain a consistent accounting method of sales reporting, based on the Contractor’s established commercial accounting practice. The Contractor shall consistently use only one of the following acceptable points at which sales may be reported-—

i. Receipt of order;

ii. Shipment or delivery, as applicable;

iii. Issuance of an invoice; or

iv. Payment.

(2) Sales under this contract/agreement shall be reported to the SAC within 60 calendar days following the completion of each reporting quarter. The Contractor shall continue to furnish quarterly reports, including “zero” sales, through physical completion of the last outstanding order of the contract/agreement.

(3) The sales report signed by an authorized representative of the contractor shall be emailed to the appropriate individual(s) listed in the terms and conditions of the contract or agreement.

c. SLA Remittance

The Contractor shall remit the SLA fee to the SAC in U.S. dollars within 60 calendar days after the end of the reporting quarter and final payment shall be remitted within 60 days after physical completion of the last outstanding task order or delivery order of the contract.

The SLA Fee amount collected and due shall be paid electronically. To ensure that the payment is credited properly, the contractor shall electronically transmit the SLA fee at www.pay.gov (VA Strategic Acquisition Center (SAC)); specific instructions in Attachment 3 – PAY.gov Vendor Submittal Instructions).

The Government reserves the right to inspect, without further notice, such records of the Contractor as pertinent to sales under any contract or agreements resulting from this solicitation. Failure to remit the full amount of the SLA within 60 calendar days after the end of the applicable reporting period constitutes a contract debt to the United States Government under the terms of Federal Acquisition Regulation (FAR) Subpart 32.6. The Government may exercise all rights under the Debt Collection Improvement Act of 1996, including withholding or setting off payments and interest on the debt (see FAR clause 52.232-17, Interest). Should the Contractor fail to submit the required sales reports, falsify them, or fail to timely pay the SLA, the Government shall have, in addition to the rights and remedies described in this clause, all other rights and remedies permitted by Federal law and statutes.

(End of Clause)

Solicitation Provisions:

52.204-7, System for Award Management; (Oct 2018) 52.209-2, Prohibitions on contracting with inverted domestic corporations’ representation; (NOV 2015) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment; (JUN 2020) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters; (OCT 2018) 52.212-1, Instructions to Offerors- Commercial Items; (JUN 2020) 52.212-2, Evaluation-Commercial Items; (OCT 2014) 52.212-3, Offeror Representations and Certifications-Commercial Items; (FEB 2021) 52.216-1, Type of Contract (1984); The Government contemplates award of a Blanket Purchase Agreement resulting from this solicitation 52.233-2, Service of Protest; (SEP 2006)

VA ACQUISITION REGULATION, (VAAR) - CLAUSES APPLICABLE TO THIS ACQUISTION:

852.203-70, Commercial Advertising 852.203-71, Display of Department of Veterans Affairs Hotline Poster 852.232-72, Electronic Submission of Payment Requests 852.242-71, Administrative Contracting Officer 852.246-70, Guarantee 852.246-71, Inspection Solicitation provisions or clauses incorporated by reference 852.211-72, Technical Industry Standards 852.233-70, Protest content/alternative dispute resolution 852.233-71, Alternate protest procedure 852.270-1, Representatives of Contracting Officers 852.273-74, Award Without Exchanges Information concerning clauses and provision incorporated by reference may be obtained at http://farsite.hill.af.mil. Contract clauses and provisions cited in this solicitation may be accessed electronically at these addresses: http://www.arnet.gov/far/ and http://www.va.gov/oamm/acquisitions/ars/policyreg/vaar/vaar852.htm

ATTACHMENT A

Authorized Med/Surg Prime Vendors (Distributors) Cardinal Health 200, LLC 3651 Birchwood Drive Waukegan, IL 60085 Contact: James Leonowitz Tel: (847) 785-4895 Contract: 36C10G20D0025

DUNS# 961027315

Coverage: CO, UT, NM, AZ, CA, OR, ID, NV, WA, HI, AL, Guam (Geographic Areas 16 through 19)

Concordance Healthcare Solutions LLC 85 Shaffer Park Dr Tiffin, OH 44883 Contact: Jaysen Stevenson Tel: (605) 679-7456 Contract: 36C10G20D0028

DUNS# 080220245

Coverage: KY, TN, OH, IN, IL, WI, MN, MI, MO, IA, KS, NE, ND, SD, MT, WY (Geographic Areas 8 through 13)

Medline Industries, Inc.

3 Lakes Drive Northbrook, IL 60093 Contact: Chris Powers Tel: (224) 931-7611 Contract: 36C10G20D0029

DUNS# 025460908

Coverage: AL, GA, SC, AR, LA, MI, OK, TX (Geographic Areas 6, 14, and 15)

Medline Industries, Inc.

3 Lakes Drive Northbrook, IL 60093 Contact: Chris Powers Tel: (224) 931-7611 Contract: 36C10G19D0036

DUNS# 025460908

Coverage: Puerto Rico (Geographic Area 21)

ATTACHMENT B

CONTRACT ADMINISTRATION DATA

1. CONTRACT ADMINISTRATION: The Contractor shall contact the Contracting Officer on all matters pertaining to administration. Only the Contracting Officer is authorized to make commitments or issue changes that will affect the price, quantity or delivery terms of the contract. The following individuals will handle all contract administration matters:

a. CONTRACTOR: TBD

b. GOVERNMENT: Contracting Officer 0010G Brian Shepard Office of Acquisition Operations Strategic Acquisition Center (SAC) A4 U.S. Department of Veterans Affairs 10300 Spotsylvania Ave Fredericksburg VA 22408 202- 341-8393

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

1. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [X] To the Strategic Acquisition Center-Fredericksburg as set forth in section 4.

b. Semi-Annually [ ]

c. Other [X] Upon Inspection/Acceptance as set forth on Individual BPA Order

4. GOVERNMENT INVOICE PROCEDURES: All Invoices from the Contractor will be mailed to the individual ordering facilities for payment. The BPA order issuing address will serve as the invoicing address for tracking payment purposes. The ordering shall be decentralized.

If…