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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 21, 2018 FBO #6146
DOCUMENT

65 -- CryoConsole - Attachment

Notice Date

9/19/2018
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN17 Network Contracting Activity;7400 Merton Minter Blvd. (10N17/90C);San Antonio TX 78229
 

ZIP Code

78229
 

Solicitation Number

36C25718U0073
 

Response Due

9/20/2018
 

Archive Date

10/5/2018
 

Point of Contact

Michael J Tusinger
 

E-Mail Address

8-5040<br
 

Small Business Set-Aside

Service-Disabled Veteran-Owned Small Business
 

Description

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; quotations are being requested, and a written solicitation document will not be issued This a brand Name or equal solicitation / request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-95. This solicitation is issued as a service disabled Veteran-owned small business set-aside. The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1250. The evaluation of offers received in response to the solicitation will be based on lowest price only. The North Texas VA Medical Center is seeking to purchase a brand name or equal Cryoconsole system. Please quote items below - 106A3 1 CRYOCONSOLE 1 EA 2037a 2 AUTO CONNECTION BOX 2 EA 104FS 3 FOOTSWITCH 1 EA 2035W 4 ECG CABLE 2 EA 1035CW 5 WHITE SCAVENENGING HOSE 6.0M/20FT 1 EA 103N2 6 N2O REFRIGERANT TANK (FULL) 4 EA 1038N 7 NORTH AMERICAN POWER CORD 1 EA 1036W 8 WRENCH 1 EA NONE 9 CRYOCONSOLE OPERATOR'S MANUAL FOR REF 106A3 1 EA 2AF284 10 ARTIC FRONT ADVANCE CRYOALATION CATHETER 30 EA 4FC12 11 FLEXCATH ADVANCE 12 STEERABLE SHEATH 30 EA 990063-0220 12 ACHIEVE MAPPING CATHETER 30 EA 203CX 13 COAXIAL UMBILICAL 30 EA 990066 14 ACHEVE CABLE 10 EA 2035U 15 ELECTRICAL UMBILICAL 30 EA Statement of Work (SOW) General: Contractor shall provide a catheter ablation to treat atrial fibrillation that builds on the industry s first cryoballoon system indicated to treat drug refractory (resistant) recurrent symptomatic paroxysmal atrial fibrillation (PAF), a serious heart rhythm disorder. The Arctic Front Advance Cryoballoon utilizes coolant to freeze and ablate the tissue, rather than creating lesions with radiofrequency or heated energy with a point-by-point catheter. The freezing helps the balloon maintain contact with the heart tissue during the procedure. Justification: System needed to reduce radiation exposure and improve procedure times for electrophysiology procedures. The Arctic Front Advance Cryoballoon utilizes coolant to freeze and ablate the tissue, rather than creating lesions with radiofrequency or heated energy with a point-by-point catheter. The freezing helps the balloon maintain contact with the heart tissue during the procedure. Physician and Patient Benefits A leading advancement from currently available ablation tools, the Arctic Front Advance Cryoballoon provides a more straightforward approach to pulmonary vein isolation than a point-by-point catheter. The procedure is proven safe and effective in isolating the pulmonary veins to stop AF in patients who have previously failed drug treatment. About the Medtronic Arctic Front Advance CryoAblation Catheter System The Arctic Front Advance Cryoballoon System and its predecessor have been used to treat more than 70,000 patients in approximately 700 centers across 40 countries. The technologies currently offered include: · The Arctic Front Advance Cryoballoon, which inflates and fills with coolant to ablate the tissue where the pulmonary veins enter the left atrium; · The FlexCath Advance Steerable Sheath, which helps deliver and position the cryocatheter in the left atrium; · The Achieve ® Mapping Catheter, an intra-cardiac electrophysiology recording catheter used to assess pulmonary vein isolation when treating paroxysmal atrial fibrillation; · The Freezor ® MAX Cardiac CryoAblation Catheter, which is a single-point catheter used to provide additional ablations, as needed; and · The CryoConsole, which houses the coolant, electrical and mechanical components that run the catheters during a cryoablation procedure. Atrial Fibrillation Overview and Statistics · Atrial fibrillation is a quivering or rapid heart rhythm in the upper chambers (atria) of the heart. · AF causes inefficient pumping of the heart and can lead to other rhythm problems as well as chronic fatigue, difficulty breathing and heart failure. · AF is the most common heart arrhythmia affecting more than 3 million Americans and 7 million people worldwide.1 · Half of all diagnosed AF patients fail drug therapy.2 · Untreated AF patients have a five times higher risk of stroke. Hours of Performance: Work shall occur Monday Friday during normal duty hours unless authorized by Cardiology. Check in Requirements: The Vendor Rep must report to the Biomedical Engineering Department to obtain a badge and sign in with the Biomedical Engineering Service before work begins. Upon completion of work, the Rep must report to the Biomedical Engineering Service to sign out. Period of Performance: Period of performance shall be done in a reasonable time frame (no longer than one 90 days after receipt of order) unless unseen circumstances arise which need to be discussed with Biomed representative. Place of Performance: Dallas VA Medical Center at 4500 S. Lancaster Rd. Dallas TX 75216. Documentation: Contractor shall furnish a detailed field service report upon completion of work to Cardiology Staff. Payment will not be processed until a properly completed service report is received. The service report shall contain, at a minimum, the following information: Date and time of contractor s arrival on station Type, model and serial number (s) of all equipment on which maintenance was performed Total time spent performing maintenance and travel time Detailed narrative description of the services required Copies of all test reports Complete list of parts replaced Date and time the repair was completed Cost Estimate of all labor(including travel), parts/supplies, and shipping charges The service report shall itemize every item in the specification. Each item shall state the "as found" condition or values, the "calibrated to" or "adjusted to" values, the factory design tolerances, and a complete description of all work performed concerning the items Contracting Officer Technical Representatives: All work coordination shall be made through the Purchasing agent. The Contractor shall be provided a copy of the letter of delegation authorizing the purchasing agent at the commencement of the term of the contract. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer. Information technology security requirements: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. The contractor shall comply with all Federal laws and regulations the VA has developed when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor. The information made available to the contractor by VA for the performance of this contract will be used only for the purposes of performance under this contract. The certification and accreditation requirements do not apply to this requirement and a security accreditation package is not required. SECURITY STATEMENT: The CO and the Contractor will assure that- No other information except what is in this contract will be shared with the contractor in any follow up communication. Biomedical Engineering shall perform virus scans on all removable media prior to use on VA medical equipment. This includes all types of removable media, including media (e.g., USB devices, CDs, dongles, etc.) that has been issued by VA, media not issued by VA, and media brought in by vendors or independent service organizations. Within accordance of VA Directive 6500, Information Security Program, September 2007 Sensitive VA information is contained within the systems covered by this contract. The Vendor will not transfer any VA information to a location outside the VA and only to VA locations determined by the VA System Administrator. The information in these systems may be covered by the Privacy Act 1974 which contains criminal penalties of abuse of information. During onsite service, the Vendor shall be chaperoned by VA Personnel. However, the vendor shall not be issued a UserID/Password. Non-volatile memory devices, working or non-working, shall NOT be removed from the VA facility until the ISO has certified that the data has been destroyed. For magnetic devices and media, the data destruction will be by degaussing. Other forms of cleansing will be used for non-magnetic media. The vendor will not have remote access to complete the repair(s) and preventive maintenance. The vendor shall sign a Business Associate Agreement with the VA. The COR is responsible for the actions of the vendor during the repair. Because the Vendor is chaperoned, the vendor does not need to take VA Privacy or Information Security training. A background investigation is not required. The Vendor and all VA employees are required to immediately report any security violations to the Information Security Officer (214-857-0512). No other security statements are required. RECORDS MANAGMENENT STATEMENT: All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTXHCS) and must be returned to VANTXHCS at the end of the contract or destroyed in accordance to the VHA Record Control Schedule (RCS)10-1. 1. Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C 552a); 36 CFR Part 1222 and Part 1228. 2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it is determines to be in the public interest. 3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. 4. Contractor shall not retain, use, sell or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. 5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identified in the RCS 10-1. 6. The Government Agency owns the rights to all data/records produced as part of this contract. 7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. 8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. 9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. 10. Contractor is required to obtain the Contracting Officer s approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (or any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and propriety information. Safety Requirements: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer Representative shall notify the Contractor of any safety issues and the action necessary to correct these issues. Such notice, when served to the Contractor or his representative at the work site shall be deemed sufficient for the corrective actions to be taken. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work, and hold the Contractor in default. Gray Market (a) Gray market items are Original Equipment Manufacturer s (OEM) 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) Vendor 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.   Delivery shall be provided no later than 30 days after receipt of order/award of contract. Specify delivery terms: FOB Destination. The contractor shall deliver all CLINs to 4500 S. Lancaster Rd., Dallas, TX 75216. 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: FAR 52.212-1, Instructions to Offerors Commercial Items (JAN 2017) FAR 52.212-2, Evaluation-Commercial Items (JAN 1999) FAR 52.212-3, Offerors Representations and Certifications Commercial Items (NOV 2017) Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov 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: FAR 52.212-4, Contract Terms and Conditions Commercial Items [insert date of clause] [Insert a statement regarding any addenda to FAR 52.212-4] - 852.203-70 Commercial Advertising (JAN 2008) - 852.211-73 Brand Name or Equal (JAN 2008) - 852.219-11 VA Notice of Total Veteran Owned Small Business Set-Aside (JUL 2016) - 852.232-72 Electronic Submission of Payment Requests (NOV 2012) - 852.273-72 Alternative Evaluation (JAN 2003) - 852.246-71 Inspection (JAN 2008) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders [insert date of clause] The following subparagraphs of FAR 52.212-5 are applicable: - 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards - 52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment - 52.222-3 Convict Labor - 52.222-19 Child Labor Cooperation with Authorities and Remedies - 52.222-21 Prohibition of Segregated Facilities - 52.222-26 Equal Opportunity - 52.222-36 Affirmative Action for Workers with Disabilities - 52.222-41 Service Contract Labor Standards - 52.222-50 Combating Trafficking in Persons (MAR 2015) - 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving - 52.225-3 Buy American-Free Trade Agreements-Israeli Trade Act, Alternate II (MAY 2014) This is a combined synopsis/solicitation for commercial items as defined herein.    The government intends to award a contract as the result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. The Government will award a firm-fixed-price contract resulting from this RFQ to the responsible offeror whose quote represents the lowest price acceptable for the government. Quotations shall be received no later than 3:00PM EST on September 21, 2018. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f) and will not be evaluated. Quotations shall be submitted via email to Sevie Sarabia at severino.sarabia@va.gov
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VASTHCS/VASTHCS/36C25718U0073/listing.html)
 

Document(s)

Attachment
 

File Name: 36C25718U0073 36C25718U0073.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4600096&FileName=36C25718U0073-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4600096&FileName=36C25718U0073-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN05096250-W 20180921/180919231026-950fe760027ebba55a6c3f35e8eec57c (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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