MODIFICATION
65 -- Allograft Bone Spacers that will be used in transforaminal Posterior Lumbar Interbody Fusion (PLIF) procedures - Solicitation 1
- Notice Date
- 1/10/2017
- Notice Type
- Modification/Amendment
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Center San Diego, Bldg 1, 34800 Bob Wilson Drive, San Diego, California, 92134-5000, United States
- ZIP Code
- 92134-5000
- Solicitation Number
- N0025917Q0063
- Archive Date
- 2/4/2017
- Point of Contact
- Christopher J. Jennen, Phone: 6195328100
- E-Mail Address
-
Christopher.J.Jennen.CIV@mail.mil
(Christopher.J.Jennen.CIV@mail.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- RFQ in word format This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the information in FAR Subpart 12.6, using Simplified Acquisition Procedures for commercial items found at FAR 13, as supplemented with the additional information included in this notice. This announcement constitutes the only solicitation; a written solicitation will not be issued. The Request for Quotation (RFQ) number is N0025917Q0063. The North American Industry Classification System (NAICS) code is 339113 and the Small Business Standard is 750. This is a small business set-aside solicitation. The proposed contract is 100% set aside for small business concerns. The Small Business Office concurs with the set-aside determination. This COMBINED SYNOPSIS/SOLICITATION documents and incorporates provisions and clauses in effect through FAC 2005-92 and DFARS Publication Notice 20161104. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: https://www.acquisition.gov/far/ and http://www.acq.osd.mil/dpap/dars/dfarspgi/current/index.html. PAPER COPIES OF THIS SOLICITATION WILL NOT BE AVAILABLE. This combined synopsis/solicitation SHALL be posted on FEDBIZOPPS. The Naval Medical Center San Diego (NMCSD) has a requirement for Allograft Bone Spacers that will be used in Anterior Cervical Disc Fusion (ACDF) procedures. The spacers to be used are specific to the individual patient's medical needs and will be selected by the NMCSD attending physician who has the responsibility for determining the product and size for the patient. This base contract period will be from 01 February 2017 - 30 September 2017, with a one year option period. This solicitation uses a Brand Name or Equal Description of the product required. This permits prospective contractors to offer products other than those specifically referenced by brand name. Provide information required by FAR 52.211-6 when submitting offers for brand name or equal products. The Naval Medical Center requests to purchase bone spacer allografts to support our surgeons during surgical procedures. NMCSD requests responses from qualified sources capable of providing: Items Needed: All item descriptions and part numbers listed below shall be comparable to the Musculoskeletal Transplant Foundation, Inc. (MTF) part numbers. Allograft bone spacers used in ACDF procedures of several different sizes listed consist of the initial stock on CLIN 0001 that will be shipped to the Government as follows: ITEM Description (Freeze-Dried) QTY. 17405 Cortico-Cancaellous ACF Spacer, Lordotic:5mm(H)x 12.5mm(L)x 15mm(W) 6 17406 Cortico-Cancaellous ACF Spacer, Lordotic:6mm(H)x 12.5mm(L)x 15mm(W) 8 17407 Cortico-Cancaellous ACF Spacer, Lordotic:7mm(H)x 12.5mm(L)x 15mm(W) 8 17408 Cortico-Cancaellous ACF Spacer, Lordotic:8mm(H)x 12.5mm(L)x 15mm(W) 8 17409 Cortico-Cancaellous ACF Spacer, Lordotic:9mm(H)x 12.5mm(L)x 15mm(W) 6 17410 Cortico-Cancaellous ACF Spacer, Lordotic:10mm(H)x 12.5mm(L)x 15mm(W) 6 17411 Cortico-Cancaellous ACF Spacer, Lordotic:11mm(H)x 12.5mm(L)x 15mm(W) 4 17412 Cortico-Cancaellous ACF Spacer, Lordotic:12mm(H)x 12.5mm(L)x 15mm(W) 2 CLIN Description Qty Unit Price Period of Performance: 01 February 2017 - 30 September 2017 0001: Allograft Bone Spacer initial stock (table above) 48 ea $ 0002: Allograft Bone Spacer (bill as used) 23 ea $ 0003: Shipping charges 01 Lot$ Period of Performance: 01 October 2017 - 30 September 2018 1001: Allograft Bone Spacer (bill as used) 23 ea $ 1002: Shipping charges 01 Lot$ Total Price $ Delivery must be from 01 February 2017 - 30 September 2017; Delivery Location is 34800 Bob Wilson Drive San Diego, CA 92134. Responsibility and Inspection: unless otherwise specified in the order, the supplier is responsible for the performance of all inspection requirements and quality control. The following FAR provisions and clauses are applicable to this procurement: 52.204-7 System for Award Management 52.204-13 System for Award Management Maintenance 52.204-16 Commercial and Government Entity Code Reporting 52.204-17 Ownership or Control of Offeror 52.204-18 Commercial and Government Entity Code Maintenance 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law 52.211-6 BRAND NAME OR EQUAL 52.212-1 Instructions to Offerors - Commercial Items 52.212-3 and its ALT I, Offeror Representations and Certifications - Commercial Items; 52.212-4 Contract Terms and Conditions - Commercial Items 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial 52.233-3 Protest After Award (Aug 1996) (31 U.S.C. 3553) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004) (Pub.L. 108-77, 108-78 (19 U.S.C. 3805 note)) 52.204-10 Sub Contracting 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, S Suspended, or Proposed for Debarment 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations 52.219-28 Post Award Small Business Program Representation 52-222-3 Convict Labor 52.222-19 Child Labor 52.222-21 Prohibition of Segregated Facilities 52.222-26 Equal Opportunity 52.222-36 Affirmative Action for Workers with Disabilities 52.222.50 Human trafficking 52.223-18 Contractor Policy to Ban Text Messaging While Driving 52.225-13 Restrictions on Certain Foreign Purchases 52.232-33 Payment by Electronic Funds Transfer 52.217-5 Evaluation of Options 52.217-8 Option to Extend Services 52.217-9 Option to Extend the Term of the Contract 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-Representation 52.232-18 Availability of Funds 52.247-34 F.O.B. DESTINATION 52.252-1, Solicitation Provisions Incorporated by Reference Quoters are reminded to include a completed copy of 52.212-3 and it's ALT I with quotes. All clauses shall be incorporated by reference in the order. Additional contract terms and conditions applicable to this procurement are: 252.203-7000 Requirements Relating To Compensation of Former DoD Officials 252.203-7001 Prohibition on Persons Convicted of Fraud or Other Defense-Contract-Related Felonies DEC 2008 252.203-7002 Requirements to Inform Employees of Whistleblower Rights 252.203-7005 Representation Relating To Compensation of Former DoD Officials 252.204-7000 Disclosure of Information 252.204-7003 Control of Government Personnel Work Product 252.204-7008 Compliance with Safeguarding Covered Defense Information Controls 252.204-7009 Limitations on the Use or Disclosure of Third-Party Contractor Information 252.204.7011 Alternative Line Item Structure 252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting. 252.204-7013, Limitations on the Use or Disclosure of Information by Litigation Support Offerors 252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support 252.211-7003 ITEM UNIQUE IDENTIFICATION AND VALUATION 252.223-7008 Prohibition of Hexavalent Chromium 252.225-7001 Buy American And Balance Of Payments Program-- Basic 252.225-7002 Qualifying Country Sources As Subcontractors 252.225-7048 Export-Controlled Items JUN 2013 252.232-7003 Electronic Submission of Payment Requests and Receiving Reports 252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS 252.232-7010 Levies on Contract Payments 252.237-7024 Notice of Continuation of Essential Contractor Services 252.239-7018 Supply Chain Risk 252.244-7000 Subcontracts for Commercial Items 252.203-7994 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements-Representation. 252.203-7995 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements. This announcement will close at 0600am PST on 20 January 2017. Contact Christopher J. Jennen who can be reached at 619-532-8100 or email Christopher.j.jennen.civ@navy.mil. Oral communications are not acceptable in response to this notice. All responsible sources may submit a quote which shall be considered by the agency. Offerors must be registered in the System for Award Management (SAM) database to be considered for award. Registration is free and can be completed on-line at http://www.sam.gov/. All quotes shall include price(s), FOB point, a point of contact, name and phone number, GSA contract number if applicable, business size, and payment terms. Quotes will not be accepted by facsimile. Each response must clearly indicate the capability of the Offeror to meet all specifications and requirements. If you are interested, and are capable of providing the sought out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) indicates the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hub zone, Woman Owned Small Business (WOSB), Large Business, etc.)? (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer or distributor of the items being referenced above (or equivalent product/solution)? (4) If you're a small business and you are an authorized distributor/reseller for the items identified above (or equivalent product/solution), do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (5) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract type and number. (6) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (7) Please provide general pricing for your products/solutions for market research purposes. (8) Please submit your capabilities in regards to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? All information received in response to this RFQ that is marked as proprietary will be handled accordingly. Responders are solely responsible for all expenses associated with responding to this RFQ. ******* End of Combined Synopsis/Solicitation ******** STATEMENT OF REQUIREMENTS 1.0 Introduction: The purpose of this contract is to provide allograft spacers as detailed below to the Director of Surgical Services (DSS), Main Operating Room (MOR) at Naval Medical Center San Diego (NMCSD). NMCSD requires a brand name or equal allograft spacer equivalent to the brand provided by Musculoskeletal Transplant Foundation, Inc. (MTF) described in paragraph 4.0. The facility addresses is as follows: Naval Medical Center San Diego 34800 Bob Wilson Drive Building 1, 4th floor Main Operating Room San Diego, CA 92134-5000 2.0 Background: This requirement is for the contractor to provide allograft spacers to NMCSD, MOR department. The term Products as used herein shall mean all allograft bone spacers listed at paragraph 4.0 and will be shipped via a certified delivery courier for human tissue to the Government's premises (or within the customer's control). The Government is responsible for storing the product to use as indicated by the product's labeling. Once used, NMCSD is invoiced at the agreed upon price for the product, and the unused stock will be then shipped back to the Contractor. All allograft bone spacers offered shall be state-of-the-art products. "State-of-the-art" is defined as the most recently designed product which is announced for marketing purposes, available, maintained and supported in accordance with requirements specified in the solicitation. Components and products with a manufacturer's planned obsolescence within the first year of contract award are not acceptable. 3.0 Scope of Work: The objective of this order is to provide products that are required for transforaminal Posterior Lumbar Interbody Fusion (PLIF) procedures to be performed at NMCSD, MOR. Attending physician at NMCSD will have the responsibility for determining the product(s) that will be utilized from the product sizes listed within the purchase order. NMCSD attending physician decides which products best meet the needs of the facility taking into account the physician's medical determination as to which products will best meet the needs of the patient. If a determination is made that a patients circumstance warrants use of a product that is unavailable from the Contractor's awarded product line, the Medical Center will be free to use another contract or if needed, a non-contract source to meet the particular need of the patient. 3.1 At implementation of award, an initial stock on the specified CLIN will be provided as stated in CLIN 0001 for use in a secured location as determined by DSS within the MOR. The stock list will be verified by the vendor's representative and a designee(s) of NMCSD. 3.1.1 The Government will be responsible for all expenses incidental to the safekeeping and use of the inventory items and shall furnish proper storage and security for all items(s) supplied hereunder. 3.1.2 The initial order on CLIN 0001 will be placed immediately after contract award. Initial inventory shall be placed at NMCSD within 15 calendar days after receipt of the purchase order. 3.2 The contractor shall replace products on a one for one basis as they are used to replenish NMCSD's initial stock and shall be invoiced against CLIN 0002 as the products are properly ordered and delivered. Contractor shall not provide more product than is available on CLIN 0002. 3.3 Contractor shall be responsible for restocking the products within 03 days after products are ordered 3.4 Contractor shall conduct a joint inventory with a Government representative at the initial stocking, and once a month thereafter. 4.0 Product Requirement: Contractor shall supply products, on-site support and FOB destination delivery. Contractor shall state product warranty against defects in material or workmanship for evaluation purposes. (_____________________ years) 4.1 Products provided shall meet the following salient characteristics: 4.1.1 Shall be FDA Approved/Certified 4.1.2 Shall have On-site representative support available; locally based representative highly desired but not mandatory 4.1.3 Manufacturer shall have a minimum of 25 years' experience providing product to medical facilities within the United States. 4.1.4 On-site representative support shall be available between 0600 - 1800 PST, Monday through Friday, according to NMCSD's surgery schedule requirements. 4.1.5 On-site representative shall have a minimum of 12 months' experience supporting ACDF procedures. 4.1.6 Companies may be subject to end-user/surgeon approval for patient safety purposes, and may require a hands-on evaluation/comparison. 4.1.7 Each product must feature: i. Chamfer on the distal end to help facilitate implant insertion. ii. Pyramidal teeth on the superior and inferior surfaces to minimize migration and resist expulsion. iii. Precise machine instrument slot that ensures a secure fit between the implant and implant holder. iv. Surfaces shall be demineralized with exposed proteins that are inherent to bone growth, which is necessary for fusion and the implants incorporation of implant with vertebral bodies. v. Shall have a larger central lumen which accommodates osteobiologic material packing and fusion through the implant. SPACER COMPONENTS: ITEM Description (Freeze-Dried) 17405 Cortico-Cancaellous ACF Spacer, Lordotic:5mm(H)x 12.5mm(L)x 15mm(W) 17406 Cortico-Cancaellous ACF Spacer, Lordotic:6mm(H)x 12.5mm(L)x 15mm(W) 17407 Cortico-Cancaellous ACF Spacer, Lordotic:7mm(H)x 12.5mm(L)x 15mm(W) 17408 Cortico-Cancaellous ACF Spacer, Lordotic:8mm(H)x 12.5mm(L)x 15mm(W) 17409 Cortico-Cancaellous ACF Spacer, Lordotic:9mm(H)x 12.5mm(L)x 15mm(W) 17410 Cortico-Cancaellous ACF Spacer, Lordotic:10mm(H)x 12.5mm(L)x 15mm(W) 17411 Cortico-Cancaellous ACF Spacer, Lordotic:11mm(H)x 12.5mm(L)x 15mm(W) 17412 Cortico-Cancaellous ACF Spacer, Lordotic:12mm(H)x 12.5mm(L)x 15mm(W) 5.0 Contract Type: Firm Fixed Price (FFP) 6.0 Administration Points of contact are listed in this section as follows: 6.1 DSS / Surgical Cases POC: Todd Wentz, LT USN, (619) 251-9103 Kellie Haney, LT USN, (619) 453-6391 Tracy Robinson, DSS Supply, (619) 532-8863 6.2 Contractor; once you have entered invoice in Wide Area Work Flow (WAWF) please contact the below listed WAWF Acceptor: WAWF Acceptor/ PAYMENT QUESTIONS PLS CONTACT: Tracy Robinson Telephone Number: (619) 532-8863 E-Mail Address: tracy.m.robinson18.civ@mail.mil 6.3 CONTRACT QUESTIONS Christopher J. Jennen Contract Specialist Material Management Department Phone: 619-532-8100 Email: christopher.j.jennen.civ@mail.mil 6.4 Contract Support NOTICE: NAVY USE OF SUPPORT CONTRACTOR FOR CONTRACT CLOSEOUT FUNCTIONS NMCSD uses a private contractor in support of the contract closeout process. 6.4.1 The contract closeout process includes activities such as processing de-obligation modifications, obtaining contractor and requiring activity concurrence, preparing the DD-Form 1594 (Contract Completion Statement), and preparing closed files for archiving. Support contractors may perform additional administrative duties, including filing and processing simple administrative modifications. Performing these functions require the contractor employees to have access to the contract file. Therefore, information you provide to the Government or information already in the possession of the Government may be viewed by these support contractors in the course of performing contract close-out functions. The information that may be made available to the contractor may include pricing and technical proposals and performance information. The agency has signed Non-Disclosure Agreements with each support contractor employee and has required the contractor to provide a Conflict of interest Mitigation Plan to ensure these employees are firewalled from all business development activity. By acknowledging receipt and acceptance of this award, the offeror and its subcontractors consent to access of their business sensitive/confidential or proprietary data by the Government's support contractor personnel in order to perform close out services. 7.0 Period of Performance The base contract period for this purchase order will be from: 01 February 2017 - 30 September 2017; with a unilateral one-year option period that may be exercised by NMCSD.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N00259/N0025917Q0063/listing.html)
- Place of Performance
- Address: Naval Medical Center San Diego, 34800 Bob Wilson Drive, Building 1, 4th floor, Main Operating Room, San Diego, California, 92134-5000, United States
- Zip Code: 92134-5000
- Zip Code: 92134-5000
- Record
- SN04368037-W 20170112/170110234450-6f4335631dc011156080d25d1fa2479f (fbodaily.com)
- Source
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