501-17-3-119-0182 ABQ CARTO 3 SYSTEM (VA-17-119179)
Added: Aug 24, 2017 6:13 pm STATEMENT OF WORK (SOW) as of 27/Nov/2016 1. Contracting Officer s Representative (COR). Name: Roman Wynnyckyj Section: Medicine Service Cardiology Section Address: 1501 San Pedro Drive SE, Albuquerque, NM 87108 Phone Number: (505) 767-6003 Fax Number: (505) 256-2803 E-Mail Address: Roman.Wynnyckyj@va.gov 2. Contract Title. BRAND NAME ONLY The VA is seeking to replace our current Cath Lab Cardiac Mapping system with a CARTO 3 System. 3. Background. Our current Cardiac Mapping system is a St. Jude ENSITE Velosity system that past its end of life two years ago. The current system uses an old platform and does not have any available updates or upgrades. We are living on borrowed time, as the unit can malfunction or cease working at any time. 4. Scope. Cardiac Mapping Systems are used by our Electrophysiologist Cardiologists to map the electro-conductivity of the heart. This allows for precise placement of ablation catheters that are able to cauterize aberrant electronic impulses that can cause arrhythmias and stop the heart from beating. Clearly, the more precise and accurate the system, the better the outcome for our Veteran patients. Our current system is outdated, past its useful life and has no available updates or upgrades. The system we are seeking is more accurate, has better placement, is safer, decreases our fluoroscopy time and uses less expensive supply costs. This system will be housed in our Cardiology Cath Lab and will be used on inpatient and outpatients to map and/or ablate aberrant electronic impulses. 5. Specific Tasks. The replacement system needs include: Allow for the selection, visualization and management of ablation parameters Work with ThermoCool SmartTouch Irrigated Ablation Catheters Allow for importation of pre-acquired MRI and CT images direct from scanners or from radiology workstations and provide a semi-automated image segmentation. Allow for catheter icon registration to pre-acquired MRI and CT images. Allow for the integration of real time intra-cardiac echo in an integrated and a side-by-side manner on the system screen. Be compatible with Biosense Webster SoundStar 10F and 8F and GE and Siemans 10F and 8F AcuNav catheters. Enable automatic detection of CFAE (Complex Fractional Atrial Electrogram) sites by analyzing individual signals from endocardial locations. Insure the analysis is based on a series of advanced user defined parameters applied to the acquired signals. Insure the analysis provides a consistent method to quantify and characterize complex fractional signals. Provide rapid acquisition of mapping points based on physician standards. Capability to continuously acquire MEM points, indicators of tissue proximity of MEM-enabled catheters, advanced electrogram annotation algorithms, and advanced map integrity algorithms. Provide detailed electrogram recording and review for the duration of each case with the ability to add points from any time in the case to a map. Be able to review catheter placement for any acquired point and edit maps with data from review tools. Allow the user to automate pace mapping for ventricular tachycardia cases and integrate the results into the system s maps. Access catheter position stability, time at location and range of movement. Evaluate temperature and time. Focus users on ablation strategy. Evaluate ablation parameters during and after ablation. Customize parameters by procedure type. Control influencing factors associated with user input. Evaluate specific parameters to determine adequacy and gaps. Display essential data at each application to assess progress. Increase safety at high-risk anatomical locations. Index and visualize parameters of RF lesion formation. Indicate when minimum and maximum time RF delivery has been maintained. System quote should include appropriate workstations, carts and training for BioMed and cardiology staff. 6. Performance Monitoring System performance will be monitored by our BioMed staff, our Cardiology Cath Lab Cardiologists, Cardiology staff, and COR. 7. Security Requirements Although this system is capable interfacing with our CPRS/VISTA system, our intent is to use it as a stand-alone system for mapping electrical conductivity and /or ablating aberrant nodes in the heart. We will use printed reports or CDs rather than direct input into CPRS/VISTA. Please see 6550 and 6500.6 for details of this system. The C&A requirements do not apply, and that a Security Accreditation Package is not required 8. Other Pertinent Information or Special Considerations. Quoted price includes training for all appropriate staff. a. Identification of Possible Follow-on Work. No follow-on work identified at this time. b. Identification of Potential Conflicts of Interest (COI). No known conflicts of interest have been identified at this time. c. Identification of Non-Disclosure Requirements. N/A d. Packaging, Packing and Shipping Instructions. N/A e. Inspection and Acceptance Criteria. Acceptance of the equipment identified in this requirement will be performed by our Warehouse, BioMed and Cardiology staff. 10. Risk Control Risk using this equipment is reduced as the amount of radiation exposure with Fluoroscopy is reduced. 11. Place of Performance. Use of the requested equipment will be limited to the NMVAHCS in Albuquerque, NM 87108. VA25817Q0806 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 22
8/24/17, 6:13 PM BIOSENSE WEBSTER CARTO 3 SYSTEM
Added: Sep 01, 2017 12:01 pm STATEMENT OF WORK (SOW) as of 27/Nov/2016 1. Contracting Officer s Representative (COR). Name: Roman Wynnyckyj Section: Medicine Service Cardiology Section Address: 1501 San Pedro Drive SE, Albuquerque, NM 87108 Phone Number: (505) 767-6003 Fax Number: (505) 256-2803 E-Mail Address: Roman.Wynnyckyj@va.gov 2. Contract Title. We are requesting to replace our current Cath Lab Cardiac Mapping system with a CARTO 3 System. 3. Background. Our current Cardiac Mapping system is a St. Jude ENSITE Velosity system that past its end of life two years ago. The current system uses an old platform and does not have any available updates or upgrades. We are living on borrowed time, as the unit can malfunction or cease working at any time. 4. Scope. Cardiac Mapping Systems are used by our Electrophysiologist Cardiologists to map the electro-conductivity of the heart. This allows for precise placement of ablation catheters that are able to cauterize aberrant electronic impulses that can cause arrhythmias and stop the heart from beating. Clearly, the more precise and accurate the system, the better the outcome for our Veteran patients. Our current system is outdated, past its useful life and has no available updates or upgrades. The system we are seeking is more accurate, has better placement, is safer, decreases our fluoroscopy time and uses less expensive supply costs. This system will be housed in our Cardiology Cath Lab and will be used on inpatient and outpatients to map and/or ablate aberrant electronic impulses. 5. Specific Tasks. The replacement system needs include: Allow for the selection, visualization and management of ablation parameters Work with ThermoCool SmartTouch Irrigated Ablation Catheters Allow for importation of pre-acquired MRI and CT images direct from scanners or from radiology workstations and provide a semi-automated image segmentation. Allow for catheter icon registration to pre-acquired MRI and CT images. Allow for the integration of real time intra-cardiac echo in an integrated and a side-by-side manner on the system screen. Be compatible with Biosense Webster SoundStar 10F and 8F and GE and Siemans 10F and 8F AcuNav catheters. Enable automatic detection of CFAE (Complex Fractional Atrial Electrogram) sites by analyzing individual signals from endocardial locations. Insure the analysis is based on a series of advanced user defined parameters applied to the acquired signals. Insure the analysis provides a consistent method to quantify and characterize complex fractional signals. Provide rapid acquisition of mapping points based on physician standards. Capability to continuously acquire MEM points, indicators of tissue proximity of MEM-enabled catheters, advanced electrogram annotation algorithms, and advanced map integrity algorithms. Provide detailed electrogram recording and review for the duration of each case with the ability to add points from any time in the case to a map. Be able to review catheter placement for any acquired point and edit maps with data from review tools. Allow the user to automate pace mapping for ventricular tachycardia cases and integrate the results into the system s maps. Access catheter position stability, time at location and range of movement. Evaluate temperature and time. Focus users on ablation strategy. Evaluate ablation parameters during and after ablation. Customize parameters by procedure type. Control influencing factors associated with user input. Evaluate specific parameters to determine adequacy and gaps. Display essential data at each application to assess progress. Increase safety at high-risk anatomical locations. Index and visualize parameters of RF lesion formation. Indicate when minimum and maximum time RF delivery has been maintained. System quote should include appropriate workstations, carts and training for BioMed and cardiology staff. 6. Performance Monitoring System performance will be monitored by our BioMed staff, our Cardiology Cath Lab Cardiologists, Cardiology staff, and COR. 7. Security Requirements Although this system is capable interfacing with our CPRS/VISTA system, our intent is to use it as a stand-alone system for mapping electrical conductivity and /or ablating aberrant nodes in the heart. We will use printed reports or CDs rather than direct input into CPRS/VISTA. Please see 6550 and 6500.6 for details of this system. The C&A requirements do not apply, and that a Security Accreditation Package is not required 8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). This requirement is for equipment not services. 9. Other Pertinent Information or Special Considerations. Quoted price includes training for all appropriate staff. a. Identification of Possible Follow-on Work. No follow-on work identified at this time. b. Identification of Potential Conflicts of Interest (COI). No known conflicts of interest have been identified at this time. c. Identification of Non-Disclosure Requirements. N/A d. Packaging, Packing and Shipping Instructions. N/A e. Inspection and Acceptance Criteria. Acceptance of the equipment identified in this requirement will be performed by our Warehouse, BioMed and Cardiology staff. 10. Risk Control Risk using this equipment is reduced as the amount of radiation exposure with Fluoroscopy is reduced. 11. Place of Performance. Use of the requested equipment will be limited to the NMVAHCS in Albuquerque, NM 87108. VA25817Q0806 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 22
9/1/17, 12:01 PM 501-17-3-119-0182 ABQ CARTO 3 SYSTEM (VA-17-119179)
Added: Sep 19, 2017 11:56 am VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >$150K OFOC SOP Revision 06 Page 2 of 2 Original Date: 03/22/11 Revision 06 Date: 08/30/2017 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>$150K) Acquisition Plan Action ID: VA258-17-AP-4718 CARTO 3 SYSTEM (VA-17-119179) Contracting Activity: Department of Veterans Affairs, VISN 22, New Mexico VA Medical Center, Purchase Request# 501-17-3-119-0182. Nature and/or Description of the Action Being Processed: The NAICS code for this requirement 334510 is within the SBA Class Waiver list for Non-Manufacturers. The requirement is for the purchase of a system that maps the electrical conductivity of the heart and is capable of ablating any misfiring areas of the heart that are able to create dysrhythmias that can affect the functioning of the heart and even stop the heart from beating. FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for a BIOSENSE WEBSTER CARTO 3 SYSTEM in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. Description of Supplies/Services Required to Meet the Agency s Needs: The estimated value of the proposed action is over the SAT teshold. This is a one-time purchase of NX equipment. Statutory Authority Permitting Other than Full and Open Competition: ( XX) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; - BRAND NAME ONLY ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2). Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): There are only two vendors that manufacture this type of equipment (Biosense Webster and St. Jude Medical Inc). The Biosense Webster CARTO 3 Unit meets all of the requirements of the NMVAHCS Cardiology Unit. The St. Jude Medical product does not meet the needs of the NMVAHCS and uses older technology, requires use of multiple patches to trace the conductivity of the heart and requires more supply utilization. Additionally the Biosense system requires less radiation exposure when using fluoroscopy, it has better catheter placement and accuracy which increases safety to the patient. The current system in the NMVAHCS Cardiology Unit has been past its useful life for 2 (two) years. These and other features are proprietary and are not offered by any other manufacturer and therefore, this is a BRAND NAME ONLY requirement for the Biosense Webster (OEM) product from distributors authorized by the OEM only. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Sources Sought Synopsis: If a sources sought synopsis was issued on 8-24-2017, BRAND NAME ONLY. Only one response was received from the SDVOSB Geo-Med LLC offering it as open-market although they have numerous SAC BPAs and GSA contracts. The requirement does exceed the SAT teshold and pursuant to FAR 5.301(b)(6)(ii) the government would be significantly harmed if these requirements are not purchased in the brand name requested. Accordingly, since the requirement exceeds the SAT teshold the sole source justification will be posted. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be determined fair and reasonable and provides the basis for this determination. The prices will be evaluated based upon the IGCE and negotiation of any possible discounts. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Discuss any market research conducted pursuant to FAR Part 10 and is documented in the contract file. No other distributors for the BIOSENSE products were identified and the NAICS 334510 was identified as NMR SBA Class waiver (also uploaded to the eCMS contract file.) Upon the ONLY response to the Sources Sought notice for the Brand Name BIOSENSE WEBSTER BRAND NAME ONLY requirement as the only item that can meet the needs of the NMVAHCS Cardiology Unit and to ensure patient safety. Geo-Med LLC provided certification from the OEM that they are authorized distributor for the BIOSENSE products in the Sources Sought response. Only authorized SDVOSB OEM distributors will be acceptable. Any Other Facts Supporting the Use of Other than Full and Open Competition: Future requirements will also post Sources Sought seeking any other SDVOSB sources for competition. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Only one source responded to the sources sought notice. VA25817Q0806 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 22
9/19/17, 11:56 AM