36C244-20-AP-3453 DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: 36C244-20-AP-3453 Contracting Activity: Department of Veterans Affairs, VISN 4, James E. Van Zandt VA Medical Center, 2907 Pleasant Valley Blvd., Altoona, PA 16602. Purchase Request (2237) Number 503- 20-3-225-0152 Nature and/or Description of the Action Being Processed: The James E. Van Zandt VA Medical Center has a new brand name requirement for one (1) Smith & Nephew Endoscopic Arthroscope system to expand the Medical centers scope of care and to complete endoscopic surgical procedures. The 660HD-E Image Management System is designed to capture high resolution intraoperative still images, and video clips, using the camera system, front panel, optional keyboard or optional footswitch. Images, video clips, audio clips, procedure data and patient information are captured and stored in a patient record. Patient records can be edited and stored on transportable media or printed. Patient records can also be exported to an Ethernet network for long-term archival, retrieval or printing. With native 3840 x 2160 resolution, the LENS 4K system provides detailed images with four times as many pixels as HD and over 1 billion colors (10 bit) creating impressive color reproduction, image clarity and enhanced depth of field. The Dyonics Power II Control System takes powered resection to a new level. It combines the most aggressive arthroscopic soft tissue resection mode and powerful torque for efficient bone resection with proven Dyonics shaver handpieces and blades. Soft-tissue resection rates of the 4.5mm Dyonics Incisor Plus Platinum Blade and 4.5mm Dyonics Synovator Platinum Blade were found to be significantly higher than the 4.0mm Arthrex Torpedo Blade1. Similarly, the proportion of blades that clogged, was significantly lower than the Torpedo Blade. The Werewolf Coblation System can be used on a range of joint tissue types to provide Coblation technology across a range of different settings. The Werewolf Coblation system with Flow IQ technology is the first and only platform to automatically optimize both energy delivery and saline flow, setting a new standard of performance, versatility, and confidence in arthroscopic resection. All instruments and accessories must be Smith and Nephew which connects with the VA Paradigm Independent Communication Interface Standardization (PICIS) Clinical Solutions software system already in place. Description of Supplies/Services Required to Meet the Agency s Needs: Estimated total cost is ITEM CODE VENDOR DESCRIPTION UNIT QTY 722010 29 SMITH & NEPHEW ENDO KIT, U.S., DYONICS POWER II EA 2 722002 08 SMITH & NEPHEW ENDO KIT, U.S., DYONICS 25 EA 2 721101 0 SMITH & NEPHEW ENDO CONTROL UNIT, DYONICS 25 EA 2 721101 SMITH & NEPHEW LEVELERT II, FLUID LEVEL SENSOR EA 2 Page 1 of 7 1 ENDO 722008 91 SMITH & NEPHEW ENDO DYONICS 25 WIRELESS REMOTE EA 2 722901 05 SMITH & NEPHEW ENDO WEREWOLF RF 20000 CONTROLLER EA 2 722900 57 SMITH & NEPHEW ENDO WEREWOLF POWER CORD/MANUAL - US ENGLISH EA 2 12310 SMITH & NEPHEW ENDO HOLDER, LEG EA 2 722043 53 SMITH & NEPHEW ENDO MENISCAL POST EA 2 722052 11 SMITH & NEPHEW ENDO LENS 4K CCU US WIFI VERSON EA 1 722050 59 SMITH & NEPHEW ENDO LENS 4K CCU WIFI VERSION EA 2 722052 25 SMITH & NEPHEW ENDO KIT US LENS 4K CCU WIFI VERSION 1/EA 2 722050 58 SMITH & NEPHEW ENDO LENS 4K A/C CAMERA HEAD EA 4 722053 45 SMITH & NEPHEW ENDO KIT, US, LENS 4K A/C CAMERA HEAD 1/EA 4 722049 24 SMITH & NEPHEW ENDO UNIVERSAL LIGHT GUIDE ORANGE 5MM X10 FT EA 4 2147 SMITH & NEPHEW ENDO DYONICS/WOLF SOURCE VERSITIP .. EA 4 2146 SMITH & NEPHEW ENDO DYONICS/WOLF INSTR VERSITIP * MADE IN INDONESIA. EA 4 722050 11 SMITH & NEPHEW ENDO UHD 4K FLAT PANEL DISPLAY LCD SONY 31" EA 4 722029 59 SMITH & NEPHEW ENDO VAS, HD, AC, 4MM X 30 DEG EA 4 722029 58 SMITH & NEPHEW ENDO 4MM X 70DEG., HD VAS, REF 72200089 EA 2 722003 15 SMITH & NEPHEW ENDO COUPLER, 19.5MM, 5:4 AUTOCLAVABLE, HD EA 4 4144 SMITH & NEPHEW ENDO ENDOSCOPE,ECTRA 4.0X30DEG EA 4 722024 28 SMITH & NEPHEW ENDO MULTI-PURPOSE STERILIZATION TRAY EA 4 10001 SMITH & NEPHEW ENDO PROBE,STRAIGHT EA 4 720486 9 SMITH & NEPHEW ENDO HEAVY HOOK PROBE W/ HANDLE EA 4 3801 SMITH & NEPHEW ENDO SWITCHING STICK EA 4 4356 SMITH & NEPHEW ENDO OBTURATOR, INTEL 4MM A'SP FOR EA 4 722008 29 SMITH & NEPHEW ENDO CANN, H.F.,DGNST, 6MM, RTBL, DBL VLV EA 4 722008 31 SMITH & NEPHEW ENDO IRR. EXT'R, HIGH FLOW, DOUBLE VALVE EA 4 Page 2 of 7 1992 SMITH & NEPHEW ENDO OBTURATOR,4.5MM EA 4 1995 SMITH & NEPHEW ENDO TROCAR,4.5MM EA 4 3673 SMITH & NEPHEW ENDO 4.5MM OPERATIVE CANNULA EA 8 2209 SMITH & NEPHEW ENDO OBTURATOR,5.5MM EA 4 722022 10 SMITH & NEPHEW ENDO HIP REPAIR MICROFRACTURE PICK, 60 DEG EA. 2 720470 8 SMITH & NEPHEW ENDO CANNULA,OPERATIVE 5.5MM FINGERPOST EA 8 720486 4 SMITH & NEPHEW ENDO INFUSION ADAPTER,W/STOPCOCK EA 4 720486 5 SMITH & NEPHEW ENDO OBTURATOR,3MM EA 4 720486 3 SMITH & NEPHEW ENDO CANNULA,OUTFLOW,3MM EA 4 12044 SMITH & NEPHEW ENDO PCH,BSKT,DCKLING,STR EA 4 12045 SMITH & NEPHEW ENDO PCH,BSKT,DCKLING,UPBTR EA 4 12048 SMITH & NEPHEW ENDO PCH,BSKT,DCKLING,UPSWPT EA 5 11024 SMITH & NEPHEW ENDO GRSPR,ALGTR,MAX EA 5 10912 SMITH & NEPHEW ENDO PCH,BSKT,RTRY,90D,2.2MM,L,LP EA 1 10913 SMITH & NEPHEW ENDO PCH,BSKT,RTRY,90D,2.2MM RT.LP EA 1 12059 SMITH & NEPHEW ENDO PCH,STNGRY,L EA 1 12058 SMITH & NEPHEW ENDO PCH,STNGRY,R EA 1 12014 SMITH & NEPHEW ENDO PCH,BSKT,DCKBL,UPBTR,1.5MM EA 1 12013 SMITH & NEPHEW ENDO PCH,BSKT,DCKBL,STR,1.5MM EA 1 12012 SMITH & NEPHEW ENDO PCH,BSKT,SCP,STR,3.4MM EA 1 12046 SMITH & NEPHEW ENDO PCH,BSKT,DCKLING,CRVD,L EA 1 12047 SMITH & NEPHEW ENDO PCH,BSKT,DCKLING,CRVD,R EA 1 12036 SMITH & NEPHEW ENDO PCH,SCSR,STR EA 1 12051 SMITH & NEPHEW ENDO PCH,BSKT,NRWLN,UPBTR EA 1 12201 SMITH & NEPHEW ENDO PCH,PSTR,UPBTR EA 1 11022 SMITH & NEPHEW ENDO GRSPR,FRCP,LOOSEBODY,PTBLL EA 1 Page 3 of 7 722014 38 SMITH & NEPHEW ENDO CABLE, SDI/HDTV RG-59 BNC, 25 FEET EA 2 722046 68 SMITH & NEPHEW ENDO IMAGE MANAGEMENT SYSTEM 660HD-E EA 2 722050 13 SMITH & NEPHEW ENDO EPSON XP - 630 INKJET PRINTER EA 2 722021 19 SMITH & NEPHEW ENDO HIP REPAIR MICROFRACTURE PICK,30 DEG EA.. 2 722021 20 SMITH & NEPHEW ENDO MICROFRACTURE PICK,HIP, 45DEGREES EA 2 722025 83 SMITH & NEPHEW ENDO OPEN CURETTE, 4.5MM,XL EA. 2 722025 84 SMITH & NEPHEW ENDO OPEN CURETTE, 6MM,REVERSE CUT,XL EA. 2 720221 0 SMITH & NEPHEW ENDO TROCAR,5.5MM EA 4 722007 47 SMITH & NEPHEW ENDO CART, PROCEDURE, W. ISOL. TRANSFORMER EA 2 722021 62 SMITH & NEPHEW ENDO CROSS SPECIALTY CART W/ BOOM AND TRANSFORMER EA 2 722032 03 SMITH & NEPHEW ENDO CART, LCD MONITOR EA 2 720473 7 SMITH & NEPHEW ENDO STERI-TRAY, 3' X 9',4.0MM SCOPE EA 14 722030 13 SMITH & NEPHEW ENDO 4.5 INCISOR PLUS ELITE BLADE PLAT SERIES 6/BX ** 3 721100 5 SMITH & NEPHEW ENDO DYONICS 25 INFLOW/OUTFLOW TUBE SET (3) 3/BX 6 722900 37 SMITH & NEPHEW ENDO WEREWOLF FLOW 50 COBLATION WAND EA 2 722900 38 SMITH & NEPHEW ENDO WEREWOLF FLOW 90 COBLATI EA 2 722007 29 SMITH & NEPHEW ENDO DYONICS 5.5MM ELITE STONECUTTER BURR 6/BX ** 1 722050 34 SMITH & NEPHEW ENDO CARTRIDGE EPSON INK BLACK EA 2 722050 35 SMITH & NEPHEW ENDO CARTRIDGE EPSON INK YELLOW EA 2 722050 36 SMITH & NEPHEW ENDO CARTRDIGE EPSON INK YELLOW EA 2 722050 37 SMITH & NEPHEW ENDO CARTRDIGE EPSON INK MAGENTA EA 2 722051 05 SMITH & NEPHEW ENDO CARTRIDGE EPSON INK PHOTO BLACK 1/EA 2 721053 3 SMITH & NEPHEW ENDO PAPER,HP PREM GLOSSY, 50 SHEETS Q1785A EA 2 Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. ร‚ยง 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below: Page 4 of 7 ( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest Demonstration that the Contractor s Unique Qualifications and Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The unique qualifications of the Smith and Nephew system are the proprietary design of the blades and the system s software. The blades improve visualization, reduce instrument exchanges, and can limit the amount of operative bleeding by simultaneously resecting and coagulating soft tissue. Some of the arthroscope system s components had to be ordered by The James E. Van Zandt VA Medical Center from the mandatory Strategic Acquisition Center contract (36C10G19D0070) which consists of a Smith & Nephew DII controller (a wireless foot pedal), a Smith & Nephew Motor drive, and a Smith & Nephew hand control. It is vital to have the same instruments to complete the major system purchased. The Smith & Nephew endoscopic system can connect with the highly specialized PICIS Clinical Solutions software already in place at the James E. Van Zandt VA Medical Center. PICIS is a global provider of clinical information solutions that automate the entire preoperative experience with one contiguous patient record, from preop to intraop and anesthesia through post anesthesia care. The PICIS focuses and specializes in the integrated suite of solutions in life-critical areas of the hospital where the patients are the most vulnerable, the care process is the most complex, and an increasing majority of hospital costs and potential revenue are concentrated. The software enables rapid, sustained delivery of clinical documentation, and financial and operational results. From department performance to patient case costing, hospitals benefit from the ability to interact with the data needed to help clinicians improve patient care, engagement and hospital revenue goals. All the surgeons are currently trained, have experience with Smith & Nephew equipment, PICIS software in their practices and will not need trained on the new request for equipment. Smith & Nephew is the only corporation capable of providing the supplies and services described in Section III above. This will ensure patient safety and emergency response time eliminating substantial duplication of cost to the government preventing unacceptable delays in fulfilling the VA requirement to the standard of care for our Veterans. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: RFI # 36C24420Q0791 was posted July 8, 2020 and closed July 10, 2020 and the Vendor Information Page, General Service Administration, Federal Procurement Data System, data bases were searched. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: In comparison to the competitors item cost list and the IGCE, the prices are considered fair and reasonable. Award 36C24120N0884 on Jul 29, 2020 for Surgical Appliance And Supplies Manufacturing with Sizewise Rentals LLC with an action Obligation of $317,373.46 considers this fair and reasonable. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The Contract Specialist used the Veteran Information Pages, Strategic Acquisition Center, National Acquisition Center, Federal Procurement Data System, and General Service Administration search engines. Request For Information number 36C24420Q0791 was posted to GSA on July 8, 2020 and closed July 10, 2020 no vendors are able to provide the brand name request from an existing schedule. One Page 5 of 7 WOSB Metro Medical Equipment and Supply and two SDVOSB s- SpecOps Medical Supply, LLC and TrillaMed responded. However, these companies stated these items are not on their contracts but are open market. TrillaMed is unable to provide the brand name Smith and Nephew required. A mandatory SAC Contract had been found to contain 3 Smith & Nephew items out of the 69 items to be ordered on the mandatory list. RFQ 36C24420Q0903 posted July 31, 2020 to August 7, 2020 to obtain quotes to fulfill the requirement for the remaining 66 items. The resulting solicitation will be competed unrestricted utilizing FAR Part 13 Simplified Acquisition Procedures and is expected to result in a firm-fixed-price contract award for the brand name Smith & Nephew requirement. Any Other Facts Supporting the Use of Other than Full and Open Competition: Brand Name in accordance with Federal Acquisition Regulations (FAR) 11.105 (a) (1) The particular brand name, product, or feature is essential to the Government's requirements, and market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency's needs. This requirement will be solicited in accordance with FAR 13.5 Simplified Acquisition Procedures. There is not individual or class waivers to the Non-Manufacturing Rule under 339113/6515 for the Arthoscope system therefore this requirement cannot be set-aside and will be solicited unrestricted for the brand name Smith and Nephew system. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Metro Medical Equipment and SpecOps Medical Supply, LLC supply Smith and Nephew instruments. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The Philadelphia VA Medical Center is currently acquiring components of Arthroscope system through an Ordering Officer off of the mandatory VA Strategic Acquisition Center contract. One way the agency may remove barriers to competition is to include the entire Arthroscope system under the mandatory Strategic Acquisition Center contract in the future or to remove the components of the Arthroscope system from the mandatory schedule to allow for full and open competition of the entire system. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. Page 6 of 7 36(244-20-AP-3453 a. I c rtify that the foregoing Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: CjuosntitfricaacttiionngisOaffciccuerraoter aDnedsicgonmepel estCeetrottihfiecabteisotno(frmeqyukinroewd)le: dge and belief. NCO 4 Contracting Specialist NCO 4 Contracting Officer b. One Level Above the Contracting Officer (Required over SAT but not exceeding $co7m00pKet)i:tiIocne.rtify the justification meets requirements for other than full and open NCO 4 Acting Branch Chief Commodities 2 Page 7 of 7

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