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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 13, 2015 FBO #5042
DOCUMENT

65 -- 501-16-1-5909-0005 Edwards Lifescience- Annuloplasty Rings Consignment Agreement - Amendment to extend response date to 09/18/2015 due to no response. - Attachment

Notice Date

9/11/2015
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN/18PHX;4135 S. Power Rd;Mesa, AZ 85212
 

ZIP Code

85212
 

Solicitation Number

VA25815Q0680
 

Response Due

9/18/2015
 

Archive Date

9/28/2015
 

Point of Contact

Melissa Harding, Contracts Specialist
 

Small Business Set-Aside

N/A
 

Description

This is an amendment to 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; quotes are being requested and a written solicitation will not be issued. The solicitation number is VA258-15-Q-0680 and is being issued as request for quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83 (Effective 7/02/15). This acquisition is UNRESTRICTED and the associated NAICS code is 339112 and small business size standard is 500 employees. This synopsis/solicitation is being amended to extend the offer due date due to no responses received on initial posting. The Government anticipates awarding a five (5) year firm-fixed price consignment agreement. This RFQ closes on September 18, 2015 at 1:00 PM EST. Quotes must be received on or before the closing date and time of this RFQ. All responding vendors must be registered in System for Award Management (SAM - https://www.sam.gov) in order to receive an award. The Veterans Integrated Service Network 18 (VISN 18) has a requirement for brand-name or equal FDA approved Annuloplasty Rings brand name or equal to Edwards Lifescience Physio Annuloplasty Rings. Contractor shall furnish all supplies listed in below, Supplies/Services and Prices/Costs on a Consignment Basis to the New Mexico VA Health Care System (NMVAHCS), the Phoenix VA Health Care System (PVAHCS) and the Southern Arizona VA Health Care System (SAVAHCS), in accordance with the terms and conditions of a consignment agreement. Items as listed shall be placed at the designated VA Medical Centers (VAMC's), stocked in a secured area agreed upon by the Contractor and Contracting Officer's Representative (COR) and as described by the product labeling, at no expense to the Government. The prices proposed shall not exceed the established Medicare prices applicable to the geographic area subject to this solicitation and at the time of performance. Payment for items furnished under the agreement is applicable only when such items are used (implanted) or the package is opened by the VA. Contractor(s) shall agree to accept the Government Purchase Card as the preferred method of payment. Consignment Agreement - An agreement for a specified period of time during which the Contractor provides an item to the Government, reimbursement for which is made only if and when the Government makes use of the item. Unused items are returned to the Contractor at the end of the effective period of the agreement without reimbursement or other expense to the Government. The Government assumes no liability for any item(s) assigned to VISN 18 on a consignment basis until a requirement for the item exists and a purchase or delivery order is placed against the agreement. Title for the consigned items shall remain with the contractor until the items are used. The proposed contract period is for five (5) years to begin at the start of fiscal year 2016. Based on the anticipated volume of orders to be issued over the life of the contract, potential offerors are encouraged to provide additional discounts and price reductions from their current pricing schedules. ? This request is written with the specification of BRAND NAME OR EQUAL to the currently used items at the participating VAMC's. If any interested potential offerors can meet the below specifications BRAND NAME OR EQUAL to the currently used items, please respond to this solicitation with enough information to demonstrate that these specifications can be met. The Edwards Physio Annuloplasty Ring is made of layers of Elgiloy and plastic strips and has a sewing ring margin that consists of a layer of silicone rubber covered by a polyester knit fabric. The rings are provided on holders, sterile and nonpyrogenic in plastic trays. For resterilization by steam, the rings must be removed from the original package and transferred to a suitable container. The reusable handle is provided non-sterile and may be sterilized by steam. This ring offers the security of a proven design based on forty years of experience in mitral valve reconstruction. Integrating fifteen years of new learning about mitral valve anatomy and physiology, the next generation Edwards Physio Annuloplasty Ring helps surgeons repair without limits. Salient Characteristics include: oGlobal shape optimization: evolves from the native D-shape to a more circular shape to accommodate the pathological changes in mitral annular dimensions. oDouble saddle configuration: maximizes the distribution of stress across the reconstructed mitral valve oDesigned by surgeons to improve the implant experience. oTrue sewing cuff design offers a 40% improvement in sewing margin. oAn easy-to-access, single-cut removal offers quick ring detachment from the holder. oAngled holder improves visualization and line-of-sight to the mitral valve. oWindows on the holder permit direct visualization of the repaired coaptation line. oProven design offers remodeling with flexibility. oBased on over 100,000 implants of the Edwards Physio Annuloplasty Ring oClinical efficacy demonstrated by 7,000 published patient-years oSingle-piece sizer designed to optimize ease of use oExtended length handle provides optimal access in MIS or traditional procedures oErgonomic grip enhances sizer handling Remodeling o Preserves natural 3:4 ratio between the anteroposterior diameter and transverse diameter during systole o Restores anatomical size & shape to provide optimal orifice area Progressive Posterior Flexibility o Variable flexibility is created by the movement of Elgiloy* bands separated by plastic bands o Allows for physiologic contractility of the mitral valve annulus during systole o Minimizes stresses on sutures Anatomical Conformance o Kidney shaped ring conforms to the configuration of the normal mitral annulus o Anterior saddle shape adapts to aortic root and conforms to annulus' anterior fibrous segment o Increased anteroposterior dimension better accommodates requirements of degenerative and ischemic valvular repair Enhanced Ease of Use - Handle/Holder o Increases ease-of-use and operative efficiency o Assists in visual orientation for ring placement o Stabilizes ring during suturing o Allows for individualized holding preferences ITEM NUMBERDESCRIPTION OF SUPPLIES/SERVICESQUANTITYUNITUNIT PRICEAMOUNT CLIN 0001Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 24MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to -Edwards Lifescience Part Number CE 4450-24MM36.00EA____________________________________ CLIN 0002Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 26MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-26MM36.00EA____________________________________ CLIN 0003Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 28MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-28MM36.00SE____________________________________ CLIN 0004Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 30MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-30MM36.00EA____________________________________ CLIN 0005Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 32MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-32MM36.00EA____________________________________ CLIN 0006Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 34MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-34MM36.00EA____________________________________ CLIN 0007Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 36MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-36MM36.00EA____________________________________ CLIN 0008Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 38MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-38MM36.00EA____________________________________ CLIN 0009Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 Physio Tricuspid Annuloplasty System 24T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T24MM36.00EA_____________________________________ CLIN 0010Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 Physio Tricuspid Annuloplasty System 26T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T26MM36.00EA_____________________________________ CLIN 0011Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 Physio Tricuspid Annuloplasty System 28T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T28MM36.00EA_____________________________________ CLIN 0012Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 Physio Tricuspid Annuloplasty System 30T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T30MM36.00EA_____________________________________ CLIN 0013Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 Physio Tricuspid Annuloplasty System 32T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T32MM36.00EA_____________________________________ CLIN 0014Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 Physio Tricuspid Annuloplasty System 34T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T34MM36.00EA_____________________________________ CLIN 0015Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 Physio Tricuspid Annuloplasty System 36T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T36MM36.00EA_____________________________________ CLIN 0016Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 28MM RIGID MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4400-28MM36.00EA_____________________________________ CLIN 0017Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 30MM RIGID MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4400-30MM 36.00EA_____________________________________ CLIN 0018Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 32MM RIGID MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4400-32MM 36.00EA____________________________________ CLIN 0019Contract Period: Base POP Begin: 10-01-2015 POP End: 09-30-2016 34MM RIGID MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4400-34MM 36.00EA_____________________________________ CLIN 0020Contract Period: Option Year One POP Begin: 10-01-2016 POP End: 09-30-2017 List Grand Total of Items contained in CLINS 1-19 for Option Year Pricing1.00EA____________________________________ CLIN 0021Contract Period: Option Year Two POP Begin: 10-01-2017 POP End: 09-30-2018 List Grand Total of Items contained in CLINS 1-19 for Option Year Pricing1.00EA______________________________________ CLIN 0022Contract Period: Option Year Three POP Begin: 10-01-2018 POP End: 09-30-2019 List Grand Total of Items contained in CLINS 1-19 for Option Year Pricing1.00EA______________________________________ CLIN 0023Contract Period: Option Year Four POP Begin: 10-01-2019 POP End: 09-30-2020 List Grand Total of Items contained in CLINS 1-19 for Option Year Pricing1.00EA____________________________________ GRAND TOTAL__________________ Interested offerors: All questions must be in writing and submitted one calendar day prior to the closing date of the solicitation to enable the Buyer to respond. Questions not received within this timeframe may not be considered. The Government reserves the right to not answer questions not meeting this timeline if doing so would result in an amendment requiring an extension of the solicitation and to extend would not be in the best interest of the Government. The selected Offeror(s) must comply with the following commercial item terms and conditions, which are incorporated herein by reference: (FAR CLAUSES) 52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS; ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS- Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The following clauses are incorporated into 52.212-4 as an addendum to this contract: 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/oamm/oa/ars/policyreg/vaar/index.cfm 52.204-9 Contractor Access to Government Facilities 52.216-18 Ordering 52.216-19 Order Limitations 52.216-22 Indefinite Quantity 52.217-8 Option to Extend Services - temporary extension 52.217-9 Option to Extend the Term of the Contract 52.232-37 Multiple Payment Arrangements 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (VAAR CLAUSES) 852.203-70 Commercial Advertising 852.211-73 Brand Name or Equal 852.232-72 Electronic Submission of Payment Requests 852.246-71 Inspection 852.232-72 Electronic invoice 852.246-70 Guarantee 852.246-71 Inspection (End of Addendum to 52.212-4) 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders. 52.212-1 Instructions to Offerors-Commercial Items Offeror must complete and return the Price/Cost Schedule (for all line items) electronically to Melissa.Harding2@va.gov. Offeror submitting an equal item must include product literature and documentation for an equal determination based on the following salient characteristics: FDA approved items, specified sizes in Price/Cost Schedule, consignment agreement with all items at facility must start 10/1/2015, reimbursement for which is made only if and when the Government makes use of the item, and unused items are returned to the Contractor at the end of the effective period of the agreement without reimbursement or other expense to the Government. (ADDENDUM TO 52.212-1) 52.252-1 Solicitation Provisions Incorporated by Reference: http://www.acqusition.gov/far/index.htms http://www.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm (FAR PROVISIONS) 52.209-5 Certification Regarding Responsibility Matters 52.211-6 Brand Name or Equal 52.216-27 Single or Multiple Awards 52.225-18 Place of Manufacture (VAAR PROVISIONS) 852.211-72 Technical Industry Standards 852.252-70 Solicitation Provisions or Clauses Incorporated by Reference 852.270-1 Representatives of Contracting Officers 852.273-74 Award Without Exchanges (End of Addendum 52.212-1) 52.212-2 Evaluation-Commercial Items The provision at 52.212-2, Evaluation -- Commercial Items -Lowest Price Technically Acceptable. This is a competitive Request for Quote (RFQ) that represents the best value to the Government conducted under FAR Part 15, Lowest Price Technically Acceptable (LPTA) source selection process. An Award will be made based on the lowest priced quote meeting or exceeding the salient characteristics for non-cost factors. 52.212-2 Addendum includes the following to paragraph (a): The Government will evaluate each quote strictly in accordance with its contents. A quote that is unrealistic in terms of technical quality or price will be deemed reflective of an inherent lack of technical competence or indicative of failure to comprehend the complexity and risks of the contractual requirements. Such quotes may be determined unacceptable. Award will be made to the lowest-price, technically-acceptable offeror. Award will be made to the offeror that presents the quote that possesses all of the following characteristics: (1) meets the acceptability standards, (2) conforms to the solicitation, (3) determined acceptable to the Government, (4) is from a responsible (as defined in Federal Acquisition Regulation Part 9) offeror, and (5) has the lowest price of those offerors meeting the first four characteristics listed here. Except for communications conducted for the purpose of minor clarification, the Government intends to evaluate quotes and award a contract without discussions. Therefore, each initial offer shall contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the Contracting Officer to be necessary The factors are listed in descending order of importance. TECHNICAL ACCEPTABILITY AND PRICE: 1. Technical acceptability: Technical acceptability of the items offered to meet the Government's requirement. Salient characteristics: FDA approved items, specified in Price/Cost Schedule 'Brand Name or Equal to" the Edwards Lifescience items, consignment agreement with all items at facility must start 10/1/2015, reimbursement for which is made only if and when the Government makes use of the item, and unused items are returned to the Contractor at the end of the effective period of the agreement without reimbursement or other expense to the Government. 2. Price: Prices will be evaluated for fair and reasonableness. Offeror shall provide all items in the Price/Cost Schedule, "Brand Name or Equal to" Edwards Lifescience listed surgical implants. (End of 52.212-2 Addendum) FAR 52.212-3 Offeror Representations and Certifications- Commercial Items
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25815Q0680/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-15-Q-0680 VA258-15-Q-0680_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2312523&FileName=VA258-15-Q-0680-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2312523&FileName=VA258-15-Q-0680-001.docx

 

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

Record

SN03881947-W 20150913/150911235327-e2ac78d79333f7ff19d665d21feef31c (fbodaily.com)
 

Source

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

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