COMBINED SYNOPSIS/SOLICITATION General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24418Q9794 Current Response Date: Thursday, September 13, 2018 Product or Service Code: 6515 Set Aside (SDVOSB/VOSB): SDVOSB NAICS Code: 339112 Contracting Office Address Department of Veterans Affairs Lebanon VA Medical Center 1700 South Lincoln Avenue Lebanon, PA 17046 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 solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-95. The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1000 employees. The Lebanon VA Medical Center is seeking to purchase, BRAND NAME, Arhtrex instruments. All interested companies shall provide quotation(s) for the following: Supplies Line Item Description Quantity Unit Price Total Price 0001 ACL Kit (Listing in Statement of Need) 1 EA Delivery shall be provided no later than 30 calendar days after receipt of order/award of contract. Delivery terms FOB destination and must be coordinated with facility Point-of-Contact (POC), prior to delivery. The contractor shall deliver line item(s) 0001 to Lebanon VAMC, 1700 South Lincoln Avenue, Lebanon, PA 17042. Delivery Location Address: Department of Veterans Affairs Lebanon VA Medical Center Lebanon, PA Postal Code: 17042 Country: UNITED STATES Award shall be made to the quoter whose quotation offers the best value to the government, considering technical capability, past performance, and price. The government will evaluate information based on the following evaluation criteria: "(1) price, (2) past performance, and (3) technical capability factor "meeting or exceeding the requirement Quoters must provide a copy of the authorized distributor letter to verify that they are an authorized distributor. 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) Addendum: (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 to 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. 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. and its quote if it has not been completed on SAM.gov. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Items (Jan 2017) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (Nov 2017) The following subparagraphs of FAR 52.212-5 are applicable: 52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (Oct 2016) 52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) 52.219-27 Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f) 52.219-28 Post Award Small Business Program Representation (Jul 2013) 52.222-3 Convict Labor (Jun 2003) (E.O. 11755) 52.222-19 Child Labor--Cooperation with Authorities and Remedies (Oct 2016) (E.O. 13126) 52.222-21 Prohibition of Segregated Facilities (APR 2015) 52.222-26 Equal Opportunity (Sep 2016) (E.O. 11246) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) 52.222-50 Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513) 52.225-3 Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L.) 52.225-13 Restrictions on Certain Foreign Purchases (Jun 2008) 52.232-34 Payment by Electronic Funds Transfer--Other than System for Award Management (Jul 2013) (31 U.S.C. 3332) Additional Clauses: 52.202-1 Definitions (Nov 2013) 52.203-7 Anti-kickback Procedures (May 2014) 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (Apr 2014) 52.214-21 Descriptive Literature (Apr 2002) 52.232-25 Prompt Payment (Jan 2017) 852.203-70 Commercial Advertising (Jan 2008) 852-219-10 VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (Jul 2016) 852.246-70 Guarantee (Jan 2008) 852.246-71 Inspection (Jan 2008) 852.203-70 Commercial Advertising (Jan 2008) 852.246-71 Inspection (Jan 2008) All quoters shall submit the following: One (1) copy and must provide a certificate or a letter from the manufacturer, stating that they are a certified reseller. All quotations shall be sent to the Contract Specialist via e-mail, at [email protected]. This is an open-market combined synopsis/solicitation for, BRAND NAME, Arhtrex instruments as defined herein.  The government intends to award a purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoter shall list exception(s) and rationale for the exception(s). Submission shall be received not later than 4:00 P.M. EST, Thursday, September 13, 2018. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Only e-mailed quotes will be accepted. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contract Specialist, Daniel Johnson, at [email protected]. Point of Contact Daniel Johnson Contract Specialist 717-304-9166 [email protected] STATEMENT OF NEED SURGICAL INSTURMENT KITS General Equipment Name: 65 Surgical Instruments Description and Salient Characteristics: The Lebanon VA Medical Center (VAMC) has a requirement for Arthrex brand name surgical instrument kits. These instrument kits are used for anterior cruciate ligament (ACL) surgeries performed at the Lebanon VAMC. These instruments are needed as redundancy requirement due to Sterile Processing Service s (SPS) new sterilization policy that prohibits flash sterilization. All instruments and accessories must be compatible with Arthrex brand equipment currently in use. The Lebanon VAMC uses Arthrex implants, and requires Arthrex brand instruments to assure compatibility with the prosthetic devices that are used. The instrument set shall be brand new and in original packaging. Sterilization and processing instructions are required upon delivery. All products are manufactured by Arthrex Inc. Required instruments for each surgical instrument kit includes: Kit 1: ACL Kit Arthrex ACL KIT 1 Code for ordering entire system listed below # Item Quantity # 1 INSTRUMENT KIT (Arthrex ACLKit) Includes the following: 1 AR-1900C 1 EA ACL TOOLBOX INSTRUMENT CASE 2 AR-1510HR 1 EA SIDE RELEASE FLIPCUTTER HANDLE 3 AR-1510T 1 EA TIBIAL FLIPCUTTER GUIDE 4 AR-1510FR 1 EA 6-9MM RIGHT FEMORAL FLIPCUTTER GUIDE 5 AR-1510FL 1 EA 6-9MM LEFT FEMORAL FLIPCUTTER GUDE 6 AR-1510FS-7 1 EA 7MM OFFSET RATCHETING BULLET 7 AR-1204F-24I 1 EA 2.4MM FLIPCUTTER INSERT 8 AR-1250F 6 EA 3.5MM DRILL PIN 9 AR-1208L 1 EA DRILL, 8MM CANNULATED 10 AR-1209L 1 EA DRILL, 9MM CANNULATED 11 AR-1214L 1 EA DRILL, 10MM CANNULATED 12 AR-1217L 1 EA DRILL, 11MM CANNULATED 13 AR-1245L 1 EA PARALLEL CHEATER GUIDE 14 AR-1282 1 EA DOUBLE-SIDED RASP 15 AR-4130 1 EA BALL RASP, MENISCUS 16 AR-12540 1 EA CRAB CLAW SUTURE GRASPER 17 AR-1415 1 EA YELLOWCHUCK HANDLE 18 AR-1830 1 EA NOTCHPLASTY OSTEOTOME 19 AR-1999 1 EA RATCHETING SCREWDRIVERHANDLE 20 AR-1998 1 EA 3.5MMCANNULATEDHEX, QUICK CONNECT 21 AR-1996CD-1 1 EA BIOCOMPOSITE DRIVER TIP, QUICK CONNECT 22 AR-1377C-07 1 EA 7MM PENCIL DILATOR 23 AR-11791 1 EA 2-0 UP-CURVESUTURE-CUTTER 24 AR-1217S 1 EA DRILL SLEEVE, 11MM CANNULATED 25 AR-12990 1 EA KNEE SCORPION 26 AR-1204LX 1 EA DRILL, 4MM CANNULATED      AR-2950DS  1 EA GRAFTPRO, MASTER SET Items in GRAFTPRO, MASTER SET: 27  AR-1886   GRAFT SIZING BLOCK 28  AR-2950AP   ADJUSTMENT POST, GRAFTPRO 29  AR-2950BH   RETROBUTTON HOLDER, GRAFTPRO 30  AR-2950D   GRAFTPRO, GRAFT PREP BOARD 31  AR-2950DC   GRAFTPRO GRAFT PREP INSTRUMENT CASE 32  AR-2950GH   GRAFTLINK HOLDER, GRAFTPRO 33  AR-2950GT   GRAFTLINKTENSIONER, GRAFTPRO 34  AR-2950SC   SOFT TISSUE CLAMP, GRAFTPRO   AR-1886-S 1 EA GRAFTTUBE SET    Items in GRAFTTUBE SET:   35  AR-1886-001   GRAFT TUBE FLANGE 36  AR-1886-050   GRAFT TUBE 5MM 37  AR-1886-055   GRAFT TUBE 5.5MM 38  AR-1886-060   GRAFT TUBE 6MM 39  AR-1886-065   GRAFT TUBE 6.5MM 40  AR-1886-070   GRAFT TUBE 7MM 41  AR-1886-075   GRAFT TUBE 7.5MM 42  AR-1886-080   GRAFT TUBE 8MM 43  AR-1886-085   GRAFT TUBE 8.5MM 44  AR-1886-090   GRAFT TUBE 9MM 45  AR-1886-095   GRAFT TUBE 9.5MM 46  AR-1886-100   GRAFT TUBE 10MM 47  AR-1886-105   GRAFT TUBE 10.5MM 48  AR-1886-110   GRAFT TUBE 11MM 49  AR-1886-115   GRAFT TUBE 11.5MM 50  AR-1886-120   GRAFT TUBE 12MM 51  AR-1886-125   GRAFT TUBE 12.5MM 52  AR-1886-130   GRAFT TUBE 13MM 53  AR-1886C-01   GRAFT TUBE TRAY Delivery: Estimated date of delivery: with delivery 30 days after award date Ship to: Lebanon VA Medical Center 1700 S. Lincoln Ave. Lebanon, PA 17042 DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID:__ REDACTED __ Contracting Activity: Department of Veterans Affairs, VISN 4, Lebanon Medical Center Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The proposed action is a BRAND NAME, firm-fixed price contract for Arthrex ACL Instrument Kits used for anterior cruciate ligament (ACL) surgeries performed. The Lebanon VA Medical Center (VAMC) has a BRAND NAME requirement for Arthrex surgical instrument kits. These instrument kits are used for anterior cruciate ligament (ACL) surgeries performed at the Lebanon VAMC. REDACTED. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: These instruments are needed as redundancy requirement due to Sterile Processing Service s (SPS) new sterilization policy that prohibits flash sterilization. The instruments and accessories must be compatible with Arthrex brand equipment currently in use. The Lebanon VAMC uses Arthrex implants, and requires Arthrex brand instruments to assure compatibility with the prosthetic devices that are used. This instrumentation is required for surgeons who perform surgeries using the preferred All-Inside Allograft GraftLink ACL technique. The grafts are specific to each patient, and the instrumentation allows for a more anatomic placement of the ACL than traditional ACL techniques. It also minimizes the size of the required incisions, allows for earlier return to activities. Description of market research conducted and results or statement why it was not conducted: Initial market research conducted by Procurement Liaison: Communication with the Manufacturer about Distributors; Informal Quotes; Verify SAM Registration This is a new requirement, therefore Agency Inventories and Excess from Other Agencies is N/A. DLA is the wholesale source. We do not have an agreement with DLA, therefore that source is N/A. An initial search was conducted on Unicor and AbilityOne, using the following keywords: surgical, kit, ACL, medical. Though some of these keywords resulted in some products, none related to the essential needs of the procurement. Another search was conducted on GSA and the NAC, using the following keywords: Arthrex, surgical, Kits, Instrument Kit. Though some of these keywords resulted in some products, none related to the essential needs of the procurement. A Sources Sought Notification was posted onto FedBizOpps (FBO.gov), seeking any SDVOSB or VOSB that could provide the Arthrex ACL Kits. During the lifetime of the notification, there were REDACTED SDVOSB/VOSB/SB response to the posted notification. To further seek out any SDVOSBs, and fulfill the Veterans Benefit Act of 2003 (15 U.S.C. 657f), the manufacturer, Arthrex, was contacted to see if they had any authorized Service Disabled Veteran Owned Small Businesses (SDVOSBs) or Veteran Owned Small Businesses (VOSBs) that are authorized resellers/distributors. REDACTED. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ____________________________ ________________________ REDACTED Date NCO 4 ____________________________ ________________________ REDACTED Date NCO 4

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