6525--Ensite Cardiac Mapping System

VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 3 of 5

Original Date: 10/12/17

Revision 04 Date: 06/10/20

Description

1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, 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.

2. This is a Brand Name or Equal Request for Quote (RFQ) and the solicitation number is 36C26021Q0450. The Government anticipates awarding a firm-fixed price supply order from this solicitation.

3. This is a solicitation for Ensite Cardiac Mapping System. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-04 effective January 19, 2021.

4. This solicitation is 100% set-aside for Service-Disabled Veteran Owned Businesses (SDVOSB). The associated North American Industrial Classification System (NAICS) code for this procurement is 334510, with a small business size standard of 1250 employees and the PSC is 6525. All interested SDVOSBs must be verified for ownership and control pursuant to 38 CFR 74 and listed in the Vendor Information Pages database, https://www.vip.vetbiz.va.gov);

There is an SBA Non-Manufacturer Rule Class waiver for the NAICS and PSC for this requirement.

All interested companies shall provide quotations,

5. Equipment Needed:

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

0001

1.00

EA

__________________

__________________

Ensite System-01: EnSite X EP Cardiac Mapping System

0002

1.00

EA

__________________

__________________

EX904-UPG: OMW to Assurance Premium Warranty Level Upgrade (Year 1)

0003

1.00

EA

__________________

__________________

EX904: EnSite X Assurance Premium Service/Warranty Plan (2 Years)

0004

1.00

EA

__________________

__________________

CFK3000: EnSiteT Contact Force Module - Included w/ EnSite X EP System

0005

1.00

EA

__________________

__________________

H700494: Ampere Generator Kit - Included w/ EnSite X EP System

0006

1.00

EA

__________________

__________________

H700490: Ampere Remote Control (includes 15m fiber cord) - Included w/ EnSite X EP System

0007

1.00

EA

__________________

__________________

89003: Cool Point Irrigation Pump - Included w/ EnSite X EP System

0008

1.00

EA

__________________

__________________

H700124: WorkMate Claris Recording System 120 with EP-4 Cardiac Stimulator

0009

1.00

EA

__________________

__________________

H700147: WorkMate Unity HL-7 Module

0010

1.00

EA

__________________

__________________

H700144: WorkMate Unity DICOM Module

0011

1.00

EA

__________________

__________________

H700144: WorkMate Unity Review Module Single License (1)

0012

2.00

EA

__________________

__________________

H700180: Fiber Optic Cable - Duplex LC/LC 30m

0013

1.00

EA

__________________

__________________

H701339: Fiber Cord Assembly Remote 30m

0014

2.00

EA

__________________

__________________

H701666: Pressure Alarm Adapter Cable Universal

0015

2.00

EA

__________________

__________________

42-04659-002: Fiber Optic Cable, NavX 100 ft (DWS2)

0016

1.00

EA

__________________

__________________

43-0006-0005: Cable Serial Extension 9M/9F 100'-0 inch

GRAND TOTAL

__________________

6. Salient Characteristics:

Brand Name Item: St. Jude Electrophysiology (EP) Lab System

Ensite X EP Cardiac Mapping System:

Essential/significant physical, functional, or performance characteristics:

Must be capable of displaying the 3-dimensional (3-D) position of conventional and Sensor-Enabled electrophysiology catheters, as well as display cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber

Must be able to provide diagnostic information to the Physician to aid in the treatment of arrhythmias

Must be able to create non-fluoroscopic 3D images of the heart chambers

Must be able to assist with recording the location of ablation lesions as applied by an ablation generator

Must include display workstation, monitors, medical grade isolation transformer:

Minimum 32 GB RAM

Minimum 3.4 GHz dual six-core processors

Minimum equivalent Quadro K2200 Graphics running most current version of operating system software

Must include amplifier subsystem

Must be able to create 3D cardiac chamber models from CT/MR datasets for display on the system

Must be able to incorporate a real time model with a segmented CT or MR model to facilitate navigation within the segmented geometry

Must include software features that integrate the recording system with the EP system to consolidate patient and clinical information and reduce the duplicate steps in the workflow

Must be able to import CT/MR/3D rotational angiography cardiac datasets from the PACS server to the EP system

Must be able to export segmented 3D models back to the PACS server

Must be able to backup the velocity system data to the PACS server

Must allow review of case data from the velocity system or a remote workstation

Must allow the user to create high density maps with any catheter and collect date with no point limit

Must allow for automated lesion marker guidance based on user-defined criteria

Must include Instruction For Use (IFU)

Must include 1-year warranty

Must include an anti-fatigue mat

Must allow for remote access for real time technical support through the secure network

Must include a contact force module that allows contact force data to be viewed on the cardiac mapping system.

Ampere Generator Kit:

Must be designed for improved efficiency and decreased noise interference

Must include user-controlled power or temperature modes for:

Multiple types of ablation catheters

Future irrigated ablation catheters

Must be able to monitor real-time temperature and impedance data on the color LCD screen

Must have presets

Must have a bedside physician control with footswitch to reduce risk

Must be able to select maximum temperature for automatic modulation of power

Must be able to manage procedural needs through user-configured variable power ramp-up

Must be able to control irrigation flow rates

Must be able to control RF delivery with automatic RF shutoff parameters

Must have seamless integration for the EP lab

Must be able to upgrade the software

Must include the generator and footswitch

Specifications:

RF Output Power: 1 to 100 W adjustable in steps of 1 W

Impedance Range: Measures 50 to 300 in steps of 1

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

Must include remote control

Must include one-year warranty

Irrigation Pump:

Must include pump, power cord, pole clamp, connecting cable, tubing set, operator s manual

Must include one-year warranty

EP Recording System

Must be a high-performance electrophysiology recording system for collecting, displaying and storing data from multiple sources withing the lab

Must have fast post-pacing recovery, high sample rates, and low baseline ablation noise so fast and accurate diagnoses can be determined

Must have seamless connections among multiple systems and platforms to increase operator efficiency without sacrificing patient care

Workstation

DVD-RW Drive

Mouse, custom keyboard

Basic image capture system

Network connection to hospital system

Inbound/outbound data interface

Display of signal FFT data

Ablation data interface

Integrated cardiac simulator control software

Amplifier

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

Miscellaneous

(4) 24 high resolution 16:9 aspect ratio widescreen monitors

(1) color printer

12 lead ECG cables

All necessary cables

(1) Anti fatigue mat

Cardiac Simulator

Integrated EP-4 four channel cardiac stimulator

Stimulator touch screen control

Physiological Pressure monitoring

(1) pressure transducer cable (up to 4 pressure channels)

Carts

(1) primary workstation cart 48

(1) bedside slave cart 24

Warranty

Service coverage: initial one-year manufacturer warranty

90-day warranty on cables and batteries

Data Management Module:

Ability to seamlessly store and retrieve patient and procedure data on a PACS, hospital file server or other HL-7 compliant systems within the hospital.

HL-7 Module

Need to be able to query hospital information systems using HL-7 interface for patient demographic data to eliminate manual data entry time and reduce the potential for errors

At the end of the study, must be able to transmit HL-7 encoded reports to the electronic medical records or any HL-7 compliant system

DICOM Module

Must be able to store and retrieve procedure data onto a PACS to reduce time spent saving cases onto external media, such as DVDs, and archiving the external media in accordance with VA Puget Sound policies

Review Module

Must be able to review archived patient data

Extra Cords Optional:

Include extra cords needed for install and maintenance (See items 12-16)

Warranty/Service Plan Upgrade (see items 0002 and 0003) no additional individual module warranties:

Include hardware upgrades and revisions released during the term of service coverage

Include software expansion modules released during the term of service coverage

Include replacement coverage for select normal wear-and-tear items

Include preventive maintenance and corrective maintenance

Up to two years additional coverage

Note: Entire system needs to work with Siemens Cath lab and Siemens Hemodynamic systems at VA Puget Sound HCS.

Complete generic identification Electrophysiology Lab System

Applicable model/make/catalog number

EnSite X EP System (Ensite-System-01)

OMW to Assurance Premium Service Level Upgrade (Year 1) (EX904-UPG) -optional

EnSite X Assurance Premium Service Plan (2 Years) (EX904) - optional

EnSite Contact Force Module (CFK3000)

Ampere Generator Kit (H700494)

Ampere Remote control (includes 15m fiber cord) (H700490)

Cool Point Irrigation Pump (89003)

WorkMate Claris Recording System 120 with EP-4 Cardiac Stimulator (H700124)

WorkMate Unity Module

WorkMate Unity HL-7 Module (H700147)

WorkMate Unity DICOM Module (H700144)

WorkMate Unity Review Module Single License (1) (H700144)

Fiber Optic Cable Duplex LC/LC 30m (H700180)

Fiber Cord Assembly Remote 30m (H701339)

Pressure Alarm Adapter Cable Universal (H701666)

Fiber Optic Cable. NavX 100ft (DWS2) (42-04659-002)

Cable Serial Extension 9M/9F 100 -0inch (43-0006-0005)

Manufacturer name

Abbott Laboratories Inc

6300 Bee Cave Road

Building Two, Suite 100

Austin TX 78746

(end SOW)

7. Place of Delivery

Seattle VA Medical Center

VA Puget Sound Health Care System

1660 S. Columbian Way

Seattle, WA

Postal Code: 98108

Country: UNITED STATES

F.O.B. Destination is the preferred delivery.

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

The following solicitation provisions apply to this acquisition:

8. FAR 52.212-1, Instructions to Offerors Commercial Items , applies to this acquisition and the following clauses and instructions are added as addenda:

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL

52.204-7

Solicitation Provisions Incorporated by Reference (FEB 1998)

52.204-16

Commercial and Government Entity Code Reporting (AUG 2020)

(a) Gray market items are Original Equipment Manufacturers (OEM Stryker) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable.

(b) Offeror shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

(c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

(d) Any award made as a result of this solicitation will be made on an All or Nothing Basis.

(e) Offerors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contactors, the offeror making such contact may be excluded from award considerations.

(f) All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below.

(g) All information shall be confined to the appropriate file. The offeror shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote.

(End of Addendum to 52.212-1)

9. FAR 52.212-2, Evaluation-Commercial Items , applies to this acquisition. the following factors shall be used to evaluate offers:

(a) Technical Compliance Meet or exceed the Salient characteristics.

(b) Price

(c) Proof of Meeting the Special Standards of Responsibility:

The Offeror must be a verified SDVOSB (Vetbiz).

The Offeror must provide proof of being an authorized distributor of the manufacturer.

When combined adherence to technical requirements and meeting special standards are more important than price.

10. Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer if has not been completed on SAM.gov.

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

11. FAR 52.212-4, Contract Terms and Conditions Commercial Items (OCT 2018)

ADDENDUM to FAR 52.212-4 The following clauses are included as a part of the addendum:

52.203-17

Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (JUN 2020)

52.204-4

Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (MAY 2011)

52.204-13

System for Award Management Maintenance (OCT 2018)

52.204-18

Commercial and Government Entity Code Maintenance (AUG 2020)

52.232-40

Providing Accelerated Payments to Small Business Subcontractors (DEC 2013)

852.212-72

Gray Market and Counterfeit Items (MAR 2020) (DEVIATION)

852.212-70, Provisions and Clauses Applicable to VA Acquisition of Commercial Items (APR 2020). The following clauses are incorporated by this clause:

852.203-70

Commercial Advertising

852.219-10

852.219-10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.

852.219-74

Limitations on Subcontracting Monitoring and Compliance (JUL 2018)

852.232-72

Electronic Submission of Payment Requests.

12. The following subparagraphs of FAR 52.212-5 are applicable:

FAR 52.212-5 applies to this acquisition with the following FAR clauses incorporated by reference;

52.204-10

Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note)

52.209-6

Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (JUN 2020) (31 U.S.C. 6101 note)

52.219-28

Post Award Small Business Program Representation (MAY 2020) (15 U.S.C 632(a)(2))

52.222-3

Convict Labor (JUN 2003) (E.O. 11755)

52.222-19

Child Labor Cooperation with Authorities and Remedies (JAN 2020) (E.O. 13126)

52.222-21

Prohibition of Segregated Facilities (APR 2015)

52.222-26

Equal Opportunity (SEP 2016) (E.O. 11246)

52.222-35

Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212)

52.222-36

Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793)

52.222-37

Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212)

52.222-50

Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627)

52.223-18

Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513)

52.225-3

Buy American--Free Trade Agreements--Israeli Trade Act (MAY 2014)

52.225-13

Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury)

52.232-33

Payment by Electronic Funds Transfer System for Award Management (Jul 2018) (31 U.S.C. 3332)

13. There are no additional contract requirements, terms or conditions.

14. The Defense Priorities and Allocations System (DPAS) ratings are NOT APPLICABLE.

15. Quotes must be emailed to robert.hamilton8@va.gov and received no later than 10:00 AM EST on 04/05/2021. Quotes may be submitted on this document or the vendor s own form.

No late quotations will be accepted. The Government intends to make award without discussions.

16. For information regarding the solicitation, please contact Robert Hamilton at Robert.hamilton8@va.gov.