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, as supplemented with the additional information included in this notice. 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 FEDBIZOPPS.

Naval Medical Center San Diego (NMCSD) has a requirement for two (2) procedures
1.) Lumbar Disc Arthroplasty L4-L5 and
2.) Anterior Lumbar Interbody Fusion (ALIF) L5-S1.
The required implants are needed to treat a patient's specific anatomical need as determined by their physician's medical determination. The RFQ number is N0025917Q0016. This solicitation documents and incorporates provisions and clauses in effect through FAC 2005-91 and DFARS Publication Notice 20160923. 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. The NAICS code is 339113 and the Small Business Standard is 750. This is a competitive, unrestricted action. The Small Business Office concurs with the set-aside determination.

The Naval Medical Center San Diego (NMCSD) requests responses from qualified sources capable of providing:
CLIN 0001: Instrumentation for L4/5 Replacement and L5/S1 ALIF
The surgical team identified the following instrumentation: one (1) interbody divide, 12 degree, sterile and four (4) locking screws, fine tip, Titanium, 25mm, a polyethylene inlay, one (1) inferior endplate, and one (1) superior endplate. These items have been determined to provide the best patient outcome by providing both immediate and maximum stability to the patient and preventing blackout. The instrumentation must meet the following specifications in order to be determined as technically acceptable:
1.) Comprehensive compliance program for the procedures
2.) Four-way retracting frame protecting patient's key vessels and hold patient's anatomy away from the site of operation
3.) Implants must be a PEEK implant to support bone growth
4.) Stand-alone without back-up posterior lumbar rods and screws
5.) Must prevent back-out by utilizing titanium screws that lock into a titanium faceplate.

Delivery must be on or before November 08, 2016; 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
52.204-19 Incorporation by Reference of Representations and Certifications
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
52.209-10 Prohibition on Contracting with Inverted Domestic Corporations
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
52.219-28 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
52.239-1 Privacy or Security Safeguards
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
252.203-7998 Prohibition on Contracting With Entities That Require Certain Internal Confidentiality Agreements- Representation (Deviation 2015-O0010)
252.203-7999 Prohibition on Contracting With Entities That Require Certain Internal Confidentiality Agreements (Deviation 2015-O0010)
252.204-7000 Disclosure of Information
252.204-7003 Control of Government Personnel Work Product
252.204-7004 Alt A, System for Award Management
252.204-7007 Alternate A, Annual Representations and Certifications
252.204-7008 Compliance with Safeguarding Covered Defense Information Controls
252.204-7009 Limitations on the Use or Disclosure of Third-Party Contractor Information
252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting.
252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support
252.211-7003 ITEM UNIQUE IDENTIFICATION AND VALUATION
252.211-7008 Use of Government-Assigned Serial Numbers
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
252.232-7010 Levies on Contract Payments
252.239-7018 Supply Chain Risk
252.244-7000 Subcontracts for Commercial Items
252.232-7003 Electronic Submission of Payment Requests And Receiving Reports
252.232-7010 Levies On Contract Payments
252.237-7010 Prohibition on Interrogation of Detainees by Contractor Personnel
252.244-7000 Subcontracts for Commercial Items
252.247-7023 Transportation of Supplies by Sea
This announcement will close at 06:00am PST on October 25, 2016. Contact Christopher Jennen who can be reached at 619-532-8100 or email [email protected]. Oral communications are not acceptable in response to this notice. All responsible sources may submit a quote which shall be considered by the agency.

Procedures in FAR 13.106 are applicable to this procurement. While price will be a significant factor in the evaluation of offers, the final contract award will be based on a combination of factors: technically acceptable low bids and past performance in relation to the best patient outcome.

System for Award Management (SAM). Quoters must be registered in the 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, 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.

******* End of Combined Synopsis/Solicitation ********

Bid Protests Not Available