SOLICITATION NOTICE
65 -- Heart Valves
- Notice Date
- 1/8/2009
- Notice Type
- Modification/Amendment
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 1681 Nelson St, FT Detrick, Maryland, 21702-9203
- ZIP Code
- 21702-9203
- Solicitation Number
- N662645-09-R-0020
- Response Due
- 1/14/2009 8:00:00 AM
- Archive Date
- 1/29/2009
- Point of Contact
- Tameka N Davis,, Phone: 301-619-1677, Shannon Lertora,, Phone: (301) 619-0287
- E-Mail Address
-
tameka.davis@med.navy.mil, shannon.lertora@med.navy.mil
- Small Business Set-Aside
- N/A
- Description
- This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the information in FAR Subpart 12.6, using Simplified Acquisition Procedures under the test program for commercial items found at FAR 13.5, as supplemented with the additional information included in this notice. The resultant contract will be a firm fixed price Indefinite Delivery/Indefinite Quantity contract in accordance with FAR 16.5. This announcement constitutes the only solicitation; a written solicitation will not be issued. PAPER COPIES OF THIS SOLICITATION WILL NOT BE AVAILABLE. This combined synopsis/solicitation SHALL be posted on both FEDBIZOPPS and the Naval Medical Logistics Command website. The RFQ number is N62645-09-R-0020 This solicitation documents and incorporates provisions and clauses in effect through FAC 2005-27 and DFARS Change Notice 2008-1124. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: www.arnet.gov/far and http://www.acq.osd.mil/dpap/dars/dfars/index.htm. The NAICS code is 334510 and the Small Business Standard is 500 employees. This is a competitive, unrestricted action. The Naval Medical Logistics Command requests responses from qualified sources capable of providing the supplies in the chart labeled Schedule A below: Schedule AConsignment / Quantity Estimated Annual Usage CLIN 0001 Stented Porcine Bioprosthetic Aortic Valve 1 of each available size 2 CLIN 0002 Stented Porcine Bioprosthetic Mitral Valve 1 of each available size 1 CLIN 0003 Mechanical Bi-leaflet Aortic Valve 1 of each available size 4 CLIN 0004 Mechanical Bi-leaflet Mitral Valve 1 of each available size 2 CLIN 0005 Mechanical Bi-leaflet Aortic Valve conduit one of each available size 5 DESCRIPTION/SPECIFICATIONS/WORK STATEMENT 1. Contractor shall provide the required heart valves as listed in Schedule A on a consignment basis, with the vendor stocking one each of the full range of adult sizes for the above five products in a secure location at the Naval Medical Center San Diego. The vendor will be responsible for providing a full range of the products in Schedule A, removing any stock before its expiration date and replacing expired valves with current valves at no additional cost to the government. The government will notify the contractor when a valve is removed from inventory. The vendor is responsible for restocking the implanted item within 48 hours after notification. The stock list will be verified by the vendor's representative and a designee(s) of the hospital. The vendor will provide a sterilizable sizing set for valve implantation. Unexpired, unused items at the conclusion of the contract will be returned to the contractor. The Government will be responsible for all expenses incidental to the safekeeping and use of the consigned items and shall furnish proper storage and security for all item(s) supplied hereunder. 2.The offeror must be able to provide porcine bioprosthetic aortic valves size 19mm and up and porcine bioprosthetic mitral valves size 25mm and up. 3. The contractor will conduct a joint inventory with a Government representative at the initial stocking of the shelves, and once a month thereafter. Yearly calls/delivery orders will be issued, stated in terms of estimated usage per year. Billing for actual usage shall be done at the end of each month for supplies used in the preceding month. 4. An initial consignment inventory to be placed at the NMCSD will be based on the consignment levels listed on Schedule A above. However, this level may be changed upon mutual agreement between the Contractor and NMCSD. The initial call/delivery order will be placed immediately after contract award. Initial consignment inventory shall be placed at the NMCSD within 10 calendar days after receipt of the first delivery/call order. A complete listing of model and/or part numbers will be provided to the Contracting Officer upon delivery of the initial inventory. 5. All Transportation charges will be borne by the Contractor for all orders placed against this contract/consignment agreement. The Contractor will replace defective products at no cost to the Government, unless the defect is caused by Government misuse of the products. 6.All equipment and accessories shall be new from the manufacturer. Used or refurbished equipment, or equipment obtained from a third party shall not be accepted. 7.As required by FAR 13.303, “Blanket Purchase Agreements (BPAs)” there is no minimum guaranteed amount for the contract/consignment agreement. 8.Contractor shall remove all unused supplies at contract expiration. Regulatory Requirements: All valves shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The base Period of performance is estimated to be 01 February 2009-30 September 2009. Three, one year option periods will also be included. The dates of the Option periods are as follows: October 1, 2009 - September 30, 2010 (Option 1) October 1, 2010- September 30, 2011 (Option 2) October 1, 2011- September 30, 2012 (Option 3) The Government intends to award a firm fixed price, Blanket Purchase Agreement resulting from this solicitation to the responsible, single offeror whose offer is the Best Value, price and other factors considered. Technical Factors A-F will be evaluated individually on a pass/fail basis. If an offeror’s technical proposal is judged to have failed any one of the Factors A-F the firm’s offer will receive no further consideration for award. If two or more offerors’ technical proposals are judged to have passed all Factors A –F (Minimum Technical Qualifications), then they will be ranked against all other offerors passing the minimum qualifications using Enhancing Technical Factor G. Offerors passing the Minimum Technical Qualifications will subsequently be evaluated on Past Performance and Price. The technical and past performance factors below, combined are more important than price, and are listed in descending order of importance. Past Performance is more important than price However, price may become a critical factor in the event that two or more offerors are determined to be essentially equal following the evaluation of technical and past performance factors. Evaluation of price will be based on the offeror’s total price. Minimum Technical Qualifications: a. Contractor shall manufacture all of the required valves b.Contractor shall replace valves that are near expiration c.Contractor shall replace used valves within 48 hours d. The offeror shall provide porcine bioprosthetic aortic valves size 19mm and up e. The offeror shall provide porcine bioprosthetic mitral valves size 25mm and up. f. All valves shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The Factor identified below will be the evaluation factor used to evaluate all offers passing all Minimal Technical Qualifications A-F Enhancing Technical Factor to be used in a Contract Award Decision: g) Product Performance- This evaluation may include stroke rate, early failures, ease of implementation. Government reserves the right to obtain information for use in the evaluation of product performance from any and all sources including sources outside of the Government. Past Performance Evaluation Factors The offeror shall submit, as part of its quote, information on previously performed contracts or on-going contracts that are similar to the item description in the solicitation performed for Federal, State or local Governments, and for commercial firms. Information shall be provided on either 1) all such contracts within the past three years, or 2) the last three such contracts performed, whichever is fewer, and shall be limited to the name and address of the organization for which the product was supplied and services were performed and the number (phone, fax or Internet) of a contact for each contract listed. The offeror should not describe past performance history in the quote. The information should include, however, discussion of any major problems encountered on the contracts listed and the corrective actions taken to resolve them. The information may also include a description of any quality awards earned by the offeror. The Government reserves the right to obtain information for use in the evaluation of past performance from any and all sources including sources outside of the Government. Offerors lacking relevant past performance history will not be evaluated favorably or unfavorably on past performance. However, the quote of a company with no relevant past performance history, while not rated favorably or unfavorably for past performance, may not represent the most advantageous quote to the Government and thus, may be an unsuccessful quote when compared to the responses of other offerors. The offeror should provide the information requested above for past performance evaluation, or affirmatively state that it possesses no relevant directly related or similar past performance. The assessment of the offeror’s past performance will be used as a means of evaluating the relative capability of the responder and other competitors to successfully meet the requirements of the RFQ. The Government will give greater consideration to the contracts that the Government feels are most relevant to the RFQ. Price Evaluation Factor (i)Completeness. The offeror has submitted a total price, completed all required representations and certifications, and acknowledgement of any amendments. (ii) Reasonableness. The Government's determination that the proposed price is fair and reasonable based on price analysis. The offeror’s initial proposal shall contain the offeror’s best terms from a price and technical standpoint. The Government intends to evaluate offers and award a contract without discussions, but reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government reserves the right to award to other than the lowest priced offeror if the Government determines that a price premium is warranted in order to achieve best value. The Government reserves the right to award to other than the highest rated offeror. The Government reserves the right to make no award as a result of this solicitation. INSTRUCTIONS TO OFFERORS: Offerors are required to submit their proposals in two separate volumes as follows: Volume I – Technical and Past Performance Proposal: This volume shall contain the Offer’s Technical Qualifications and Past Performance information. This portion of the proposal to include all data and information required for technical evaluation and should describe how the offeror meets or exceeds the technical qualifications; the proposal should also list the valve sizes available. The technical proposal shall not include any pricing information. Two copies of Volume I shall be submitted. Volume II – Business Proposal: This volume shall include the complete pricing for each valve for the base year and each option period. Offerors shall include a list of available valve sizes. One copy of Volume II shall be submitted. The completion and submission of the above items will constitute a proposal and will indicate the offeror’s unconditional assent to the terms and conditions of this combined synopsis and solicitation and any attachments hereto. Objections to any terms and conditions of this solicitation will constitute a deficiency, which will make the offer unacceptable. Offerors shall provide sufficient technical documentation (including but not limited to: product literature, specifications) to allow for thorough evaluation of proposal. Additionally, the vendor shall fully explain their ability to meet the requirements above. Proposal shall specify the Total Price. Adequate competition is anticipated for this acquisition. The government anticipates award of a Firm Fixed Price Indefinite Delivery/Indefinite Quantity Contract. Offerors shall submit firm-fixed pricing for all above requirements. Include commercial price lists and if applicable, any Federal Supply Schedule (FSS) numbers, a point of contact, name and phone number, business size, payment terms, and pricing. Include any applicable discounts to the Government. Each response must clearly indicate the capability of the offeror to meet all specifications and requirements. OTHER ADMINISTRATIVE INSTRUCTIONS: Central Contractor Registration (CCR): Offerors shall be registered in the CCR database to be considered for award. Registration is free and can be completed on-line at http://www.ccr.gov; provide DUNS number; Cage Code and TIN. Online Representations and Certifications Application (ORCA) The Federal Acquisition Regulation (FAR) requires the use of the Online Representations and Certifications Application (ORCA) in Federal solicitations as a part of the quote submission process. ORCA is a web-based system that centralizes and standardizes the collection, storage and viewing of many of the FAR required representations and certifications previously found in solicitations. With ORCA, you now have the ability to enter and maintain your representation and certification information, at your convenience, via the Internet at http://orca.bpn.gov. In addition, rather than receiving and reviewing paper submissions, government contracting officials can access ORCA and review your information online as a part of the quote evaluation process. You will no longer have to submit representations and certifications completed in ORCA with each offer. Instead, a solicitation will contain a provision that will allow you to either certify that all of your representations and certifications in ORCA are current, complete and accurate as of the date of your signature, or list any changes. Additionally, FAR clause: 52.204-3 TAXPAYER IDENTIFICATION (OCT 1998), is included and is a required part of the quote submission process to ensure that the government is informed of your company Taxpayer Identification number. Also, DFARS clause 252.247-7022 REPRESENTATION OF EXTENT OF TRANSPORTATION BY SEA (AUG 1992), is a required part of the quote submission process and is included for offeror’s to acknowledge whether transportation of supplies by sea is anticipated under the resultant contract. To prepare for this requirement and to register in ORCA, you will need to have two items: an active Central Contractor Registration (CCR) record and a Marketing Partner Identification Number (MPIN) identified in that CCR record. Your Data Universal Numbering System (DUNS) number and MPIN act as your company's ID and password into ORCA. (Visit www.ccr.gov for more information on creating and entering your MPIN). The basic information provided in your CCR record is used to pre-populate a number of fields in ORCA. Vendors are reminded to protect their MPIN from unauthorized use. NOTE: Any Contractor who is not registered in CCR will NOT get paid. Once in ORCA you will be asked to review pertinent information pre-populated from CCR, provide a point of contact, and answer a questionnaire that contains up to 26 questions. The questionnaire is to help you gather information you need for the clauses. The questionnaire is not the official version. Be sure to read the provisions carefully. The answers you provide are then automatically entered into the actual FAR provisions. You are required to review your information, as inserted, in context of the full-text provisions for accuracy; acknowledge three additional read-only provisions; and click a time/date stamp before final submission. You will need to review and/or update your ORCA record when necessary, but at least annually in order to maintain its active status. Detailed information regarding ORCA, how to submit your record, and whom to call for assistance can be found on ORCA's homepage at http://orca.bpn.gov under "Help." The following Online Representations and Certifications Application (ORCA) must be submitted with an offeror’s proposal. Online Representations and Certifications Application (ORCA) I certify that all of the representations and certifications completed in ORCA are current, complete and accurate as of the date below for Solicitation Offer and Award for RFQ # N62645-09-T-0020 _________________________________ __________ SignatureDate _________________________________ Title _________________________________ Organization OR I certify that all of the representations and certifications completed in ORCA are current, complete and accurate as of the date of my signature provided on the SF33, Solicitation Offer and Award for RFQ # N62645-09-R-0020 with the exception of the following: (list any changes) _________________________________ __________ SignatureDate _________________________________ Title _________________________________ Organization FAR Provisions & Clauses: Offerors are reminded to include a completed copy of 52.212-3 with RFQ response. All clauses shall be incorporated by reference in each delivery/call order. The following FAR provision and clauses are applicable to this procurement: FAR 52.212-1, Instructions to Offerors---Commercial Items FAR 52.212-3 Offeror Representations and Certifications-Commercial Items; FAR 52.212-4, Contract Terms and Conditions---Commercial Items; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items. In compliance with said clause, the following FAR clauses apply: 52.219-8, Utilization of Small Business Concerns; 52.216-18 Ordering 52.222-3, Convict Labor; 52.222-19 Child Labor 52.222-21 Prohibition of Segregated Facilities 52.222-26, Equal Opportunity; 52.222-35, Affirmative Action for Special Disabled and Vietnam Era Veterans; 52.222-36, Affirmative Action for Handicapped Workers with disabilities; 52.225-1 Buy American Act, Supplies 52.225-3 Buy American Act, -Free Trade Agreements 52.225-13 Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). FAR 52.216-18 Ordering FAR 52.217-9 Option to Extend the term of the contract (a) The Government may extend the term of this contract by written notice to the Contractor within 7 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years. FAR 52.203-6 Restrictions of Subcontractor Sales to the government FAR 52.203-6 Alt I Restrictions of Subcontractor Sales to the government (Sept 2006) Alt I FAR 52.246-2 Inspection of Supplies FAR 52.252-1 Solicitation Provisions Incorporated by Reference FAR 52.252-2 Clauses Incorporated by reference DFARS 252.212-7000, Offeror Representations and Certification-Commercial Items; DFARS 252.212-7001, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders---Commercial Items, In compliance with said clause, following additional DFARS clauses apply: 52.203-3, Gratuities 252.225-7001, Buy American Act and Balance of Payment Program; 252.225-7012, Preference for Certain Domestic Commodities, 252.225-7021, Trade Agreements; 252.227-7015, Technical Data—Commercial Items; 252.232-7003, Electronic Submission of Payment Requests; 252.243-7002, Requests for Equitable Adjustment; 252.247-7024, Notification of Transportation of Supplies by Sea. DFARS 252.225-7000, Buy American Act-Balance of Payments Program Certificate. DFARS 252.243-7001, Pricing of Contract Modifications DFARS 252.246-7000, Material Inspection and Receiving Report DFARS 252.225-7002, Qualifying Country Sources as Subcontractors Proposals are due by 8:00pm Eastern Time on 14 January 2009. Proposals shall be submitted by email only as a MS Word, MS Excel or Adobe PDF attachment to: tameka.davis@med.navy.mil. Any questions shall be addressed to tameka.davis@med.navy.mil by email only NLT 12 January 2009. No phone calls accepted. All responsible sources may submit a proposal, which shall be considered by the agency.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=f763d1fd3dfa857fe4db555c5029af1b&tab=core&_cview=1)
- Place of Performance
- Address: San Diego, California, San Diego, California, 92134, United States
- Zip Code: 92134
- Zip Code: 92134
- Record
- SN01729595-W 20090110/090108220238-f763d1fd3dfa857fe4db555c5029af1b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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