VA Nebraska-Western Iowa Healthcare System Initial Outfitting, Transition & Activation Statement of Work Omaha Pkg. 52 Spinal Instrument Sets April 27, 2020 Rev. 2.1 VA Nebraska-Western Iowa Healthcare System 4101 Woolworth Avenue Omaha, NE 68105 Ambulatory Care Center Project INTRODUCTION Veteran Affairs Nebraska-Western Iowa Healthcare System (VANWIHS) has a requirement to purchase JSNs U0086, & U0086-A Spinal Instrument Sets with an authorized vendor to supply and deliver the item(s) identified in Table 1 below. This is in support of a brand name or equal (JSN U0086) and Brand Name Only (JSN U0086-A). See salient characteristics below. This requirement is in support of the activation of VA Nebraska-Western Iowa Healthcare System Ambulatory Care Center. The new Ambulatory Care Center has the need for Spinal Instrument Sets for surgical use in the new Operating Rooms. Medtronic is the basis for design. Table 1 Package Items Summary (*The basis of design brand s part numbers referenced in the brand name or equal portion of the table (JSN U0086) are for reference only; they are not to indicate the brand name is required. Item descriptions may also vary based on the brand being offered and should not be construed as a brand name requirement.) Item # JSN Item Description Part # (For Reference*) Qty Micro Endoscopic Spinal Set (Brand Name or Equal) 1 U0086 CASE 185-064 CD HORIZON BASELID STEAM 185-064 2 2 U0086 CASE 9560693 STRT Bl POLAR FORCEP SPOOL 9560693 2 3 U0086 OUTER CASE, INSTRUMENTS 9569790 2 4 U0086 INSTRUMENT TRAY 1 9569791 2 5 U0086 INSTRUMENT TRAY 2 9569792 2 6 U0086 INSTRUMENT TRAY 3 9569793 2 7 U0086 INSTRUMENTTRAY 4 9569794 2 8 U0086 INSTRUMENT TRAY 2 (NESTED) 9569795 2 9 U0086 INSTRUMENT9560534 SUCKER #10 9560534 2 10 U0086 INSTRUMENT 9560535 SUCKER #8 9560535 2 11 U0086 INSTRUMENT 9560561 SUCTION RETRACTOR 9560561 2 12 U0086 INSTRUMENT 9560573 BIPOLAR CABLE US CON 9560573 2 13 U0086 INSTRUMENT 9560691 MICRO SCISSORS 9560691 2 14 U0086 4MM PITUITARY RONGEUR 9569525 2 15 U0086 4MM PITUITARY, RING HANDLE 9569536 2 16 U0086 SUCKER, #12 9569559 2 17 U0086 WIDE SUCTION RETRACTOR 9569560 2 18 U0086 2MM UPBITING PITUITARY 9569564 2 19 U0086 2MM MICROPITUITARY 9569565 2 20 U0086 2MM PITUITARY WITH TOOTH 9569566 2 21 U0086 2MM UPBITING MICROPITUITARY 9569567 2 22 U0086 CURVED SCISSORS 9569568 2 23 U0086 2MM DOWNBITING PITUITARY 9569569 2 24 U0086 4MM UPBITING PITUITARY 9569570 2 25 U0086 ANGLED BIPOLAR FORCEP, US CON 9569571 2 26 U0086 STRAIGHT BIPOLAR FORCP, US CON 9569572 2 27 U0086 ANGLED BIPOLAR, US-SHORT/FINE 9569574 2 28 U0086 BAYONETED KERRISON, 1MM, 40 9569600 2 29 U0086 BAYONETED KERRISON, 1MM, 90 9569601 2 30 U0086 BAYONETED KERRISON, 2MM, 40 9569602 2 31 U0086 BAYONETEDKERRISON, 2MM, 90 9569603 2 32 U0086 BAYONETED KERRISON, 3MM, 40 9569604 2 33 U0086 BAYONETED KERRISON, 3MM, 90 9569605 2 34 U0086 BAYONETED KERRISON, 4MM, 40 9569606 2 35 U0086 BAYONETED KERRISON, 4MM, 90 9569607 2 36 U0086 BAYONETED KERRISON, 5MM, 40 9569608 2 37 U0086 BAYONETED KERRISON, 5MM. 90 9569609 2 38 U0086 BAYONETED CURETTE, 5.2MM. STR 9569620 2 39 U0086 BAYONETED CURETTE, 3.6MM, STR 9569621 2 40 U0086 BAYONETED CURETTE. 18MM. STR 9569623 2 41 U0086 BAYONETED CURETTE, 5.2MM, ANG 9569624 2 42 U0086 BAYONETED CURETTE, 3.6MM, ANG 9569625 2 43 U0086 BAYONETED CURETTE, 1.8MM, ANG 9569627 2 44 U0086 BAYONETED CURETTE, 5.2MM, REV 9569628 2 45 U0086 BAYONETED CURETTE, 3.6MM. REV 9569629 2 46 U0086 BAYONETED CURETTE, 1.8MM, REV 9569631 2 47 U0086 MICROBAYONETED NERVE HOOK, STR 9569638 2 48 U0086 BAYONET PENFIELD #7, PUSH/PULL 9569639 2 49 U0086 BAYON WOODSEN, PROBE 9569640 2 50 U0086 BAYON BALL PROBE, SHORT RT 9569641 2 51 U0086 BAYON BALL PROBE, SHORT STR 9569642 2 52 U0086 BAYON BALL PROBE, SHORT LT 9569643 2 53 U0086 BAYON BALL PROBE, LONG RT 9569644 2 54 U0086 BAYON BALL PROBE, LONG STR 9569645 2 55 U0086 BAYON BALL PROBE, LONG LT 9569646 2 56 U0086 BAYONET PENFIELD #2, PUSH/PULL 9569647 2 57 U0086 INSTRUMENT 9569649 BYNT PNFLD 4 PSH PULL 9569649 2 58 U0086 BAYON NERVE HOOK. RT 9569651 2 59 U0086 BAYON NERVE HOOK, STR 9569652 2 60 U0086 BAYON NERVE HOOK, LT 9569653 2 61 U0086 BAYON DISSECTOR, RT 9569654 2 62 U0086 BAYON DISSECTOR, STR 9569655 2 63 U0086 BAYON DISSECTOR, LT 9569656 2 64 U0086 MICROBAYONETED NERVE HOOK, LT 9569688 2 65 U0086 MICROBAYONETED NERVE HOOK, RT 9569689 2 66 U0086 SHORT/FINER STR BIPOLAR, FORCE 9569690 2 67 U0086 NERVE ROOT RETRACTOR 9569954 2 68 U0086 CASE 185-064 CD HORIZON BASELID STEAM 185-064 2 69 U0086 DILATORS TRAY, RIGID 9569529 2 70 U0086 OUTER CASE, FLEX ARM 9569530 2 71 U0086 CASES 9569532 METRX FLEX ARM TRAY RIGID 9569532 2 72 U0086 INSTRUMENT 955 519 MED GUIDEWIRE 955-519 2 73 U0086 INSTRUMENT 9560420 METRX DILATOR 5 3MM 9560420 2 74 U0086 INSTRUMENT 9560421 METRX DILATOR 9 4MM 9560421 2 75 U0086 INSTRUMENT 9560429 METRX DILATOR 18 8 MM 9560429 2 76 U0086 INSTRUMENT 9560430 METRX DILATOR 20 8 MM 9560430 2 77 U0086 INSTRUMENT 9560431 METRX DILATOR 22 8MM 9560431 2 78 U0086 INSTRUMENT 9560432 METRX DILATOR 24 8MM 9560432 2 79 U0086 INSTRUMENT 9561426 METRX DILATOR 12 8MM 9561426 2 80 U0086 INSTRUMENT 9561427 METRX DILATOR 14 6MM 9561427 2 81 U0086 INSTRUMENT 9561428 METRX DILATOR 16 8MM 9561428 2 82 U0086 INSTRUMENT 9561523 BED RAIL CLAMP 9561523 2 83 U0086 INSTRUMENT 9561524 FLEXIBLE ARM 9561524 2 84 U0086 INSTRUMENT 9561525 SELF RETAINING NERVE ROOT RETRACTOR 9561525 2 85 U0086 INSTRUMENT 9561526 SELF RETAINING NERVE ROOT POST 9561526 2 86 U0086 CASE 185-064 CD HORIZON BASELID STEAM 185--064 2 87 U0086 TUBE CADDY, 18MM 9569687 2 88 U0086 TUBE CADDY, 22MM 9569737 2 89 U0086 TUBE CADDY, 26MM 9569757 2 90 U0086 OUTER CASE, NON DISP TUBES 9569796 2 91 U0086 TUBE TRAY 1 9569797 2 92 U0086 TUBE TRAY 2 9569798 2 93 U0086 18MM X 3CM COATED/ANGLED TUBE 9569680 2 94 U0086 18MM X 4CM COATED/ANGLED TUBE 9569681 2 95 U0086 18MM X 5CM COATED/ANGLED TUBE 9569682 2 96 U0086 18MM X 6CM COATED/ANGLED TUBE 9569683 2 97 U0086 18MM X 7CM COATED/ANGLED TUBE 9569684 2 98 U0086 18MM X 8CM COATED/ANGLED TUBE 9569685 2 99 U0086 18MM X 9CM COATED/ANGLED TUBE 9569686 2 100 U0086 TUBE 9569730 22MM X 3CM COATED 9569730 2 101 U0086 TUBE 9569731 COATED 22MMX4CM 9569731 2 102 U0086 TUBE 9569732 22MM X 5CM COATED 9569732 2 103 U0086 TUBE 9569733 22MM X 6CM COATED 9569733 2 104 U0086 TUBE 9569734 22MM X 7CM COATED 9569734 2 105 U0086 TUBE 9569735 22MM X 8CM COATED 9569735 2 106 U0086 TUBE 9569736 22MM X 9CM COATED 9569736 2 107 U0086 TUBE 9569750 COATED 26MM X 3CM 9569750 2 108 U0086 TUBE 9569751 COATED 26MM X 4CM 9569751 2 109 U0086 TUBE 9569752 COATED 26MMX5CM 9569752 2 110 U0086 TUBE 9569753 COATED 26MM X 6CM 9569753 2 111 U0086 TUBE 9569754 26MM X 7CM COATED 9569754 2 112 U0086 TUBE 9569755 26MM X 8CM COATED 9569755 2 113 U0086 TUBE 9569756 26MM X 9CM COATED 9569756 2 Spine Referencing and Navigation Sets (Brand Name Only) 114 U0086-A Basic Spine Referencing (includes the following) 9735500 2 115 U0086-A FRAME, SPINE AIR    2 116 U0086-A CLAMP, SINGLE STANDARD    2 117 U0086-A CLAMP, SINGLE SHORT    2 118 U0086-A REFERENCE ELBOW, TITANIUM    2 119 U0086-A INST 960-559 PLANAR PASSIVE BALL 1.5MM  2 120 U0086-A DILATOR 9733817 NAVIGATED  2 121 U0086-A TRACKER 9733816 DILATOR  2 122 U0086-A DRIVER, T HANDLE    2 123 U0086-A SPINE REFERENCING TRAY    2 124 U0086-A TOOLS CD    2 125 U0086-A PERCUTANEOUS PIN UPGRADE 9734501 2 126 U0086-A DRIVER NAV2024 SOLERA 4.75 STANDARD MAS NAV2024K 2 127 U0086-A CD HORIZON SOLERA Awl-Tip Taps (includes the following) 9735465 2 128 U0086-A Awl-Tip Tap 4.5 mm  2 129 U0086-A Awl-Tip Tap 5.5 mm    2 130 U0086-A Awl-Tip Tap 6.5 mm    2 131 U0086-A Awl-Tip Tap 7.5 mm    2 132 U0086-A Small Tissue Protector    2 133 U0086-A Large Tissue Protector    2 134 U0086-A Percutaneous Tray    2 135 U0086-A Taps Module    2 136 U0086-A INSERTER, CAPSTONE and CLYDESDALE SET (includes the following) 9734836 2 137 U0086-A 1 Navigated Inserter for Capstone and Clydesdale Implants    2 138 U0086-A Rotating tracker on Inserter    2 139 U0086-A Slap Hammer compatible with navigated and non-navigated trials    2 140 U0086-A NAVLOCK NAVIGATION INSTRUMENT SET 9734833 2 141 U0086-A NavLock Gray Tracker 9734590    2 142 U0086-A NavLock Orange Tracker 9734683    2 143 U0086-A NavLock Violet Tracker 9734682    2 144 U0086-A NavLock Green Tracker 9734734    2 145 U0086-A NavLock Container 9734692    2 146 U0086-A Ratcheting Small Straight Handle (2 each) 9733734    2 147 U0086-A Awl Tip 9734678    2 148 U0086-A Lumbar Probe 9734679    2 149 U0086-A Thoracic Probe Tip 9734680    2 150 U0086-A CAPSTONE TRIALS SET (TLIF/PLIF) (includes the following) 9734834 2 151 U0086-A 4 Navigated Capstone Trails:    2 152 U0086-A 8x26mm    2 153 U0086-A 10x26mm    2 154 U0086-A 12.26mm    2 155 U0086-A 14.26mm    2 156 U0086-A Slap Hammer compatibility    2 157 U0086-A HANDLE 9734410 RATCHETING EGG 9734410 2 Additional Item Requirements For all Spinal Instrument Sets the vendor shall provide user manuals that describe proper use, care, and cleaning for users of the equipment. In addition, the vendor shall provide service manuals that include theory of operation, maintenance requirements, repair information, schematics, part lists, and troubleshooting information in electronic format for use by the VA Biomedical Engineering Department. Date of manufacture shall not be greater than two (2) years before the purchase order date. The equipment shall not be used or refurbished and shall have the latest manufacturer s software/hardware updates installed. Any batteries provided with the unit shall not be manufactured more than 12 months before the purchase order issue date. GENERAL CONDITIONS Site Address The address of the VA Nebraska-Western Iowa Healthcare System Ambulatory Care Clinic is provided below. 4101 Woolworth Avenue Omaha, NE 68105 Delivery Schedule Items shall be delivered no earlier than the estimated delivery start date and no later than the delivery end date listed in Table 2 below. Building Name Building # & Letter Acronym Est. Delivery Start Date Est. Delivery End Date Ambulatory Care Center 4101 30 MAY 2020 Table 2 Anticipated Building Outfitting Schedule Schedule and Order Management 2.3.1 The above delivery schedule is based upon the current construction schedule due to the nature of activation efforts and construction. Timelines and dates may vary and shift. Delivery dates shall be flexible. The delivery of items for installation are dependent upon the completion of applicable areas within the building. If there is a delay, the Contractor may be required to adjust the delivery date at no cost to the Government. The Contractor will coordinate with the on-site POC s before delivery. 2.3.2 Actual delivery dates will be confirmed by the VA upon award. 2.3.3 Post-award, the vendor shall coordinate delivery identified in this document with the VANWIHS prior to beginning any work (See Section 2.4). Once the dates have been confirmed, modifications to the schedule are subject to written approval by the CO, COR, and the vendor only. Delivery and Receiving NOTE: Due to the COVID19 situation, masks are required to be worn by all individuals when in common areas on VA property. Any individuals who needs to enter the building for installation &/or training will be required to be screened by the site staff prior to entry. Please allow time for this in your schedule. 2.4.1 Delivery and receipt of the proposed items is anticipated to be directed to the location identified below. Confirmation of delivery location will be provided post-award. To coordinate delivery, contact Government POC Mark Stockstell at (402) 995-5847, [email protected], Colin Beal at (402) 930-7775, [email protected], Dan Thompson at (785) 477-2820, [email protected], and Robert Stonerook at (706) 304-7194, [email protected]. VANWIHS Omaha VA Ambulatory Care Clinic (Direct Delivery to address detailed in paragraph 2.1.1) Special Note: There is no loading dock available at this location. All delivery vehicles must be equipped with a Tommy Gate type lift to facilitate unloading to ground level. IOT&A Contractor-Provided Warehouse Local to the VANWIHS SME Solutions Warehouse: Attn: SME Solutions-VA Project, Gratton Warehouse Co. 11005 E Circle Omaha, NE 68137 2.4.2 The vendor is required to define the need for a staging area to accommodate item delivery, if needed. Post-award, this information will be confirmed with the vendor. 2.4.3 The delivery of items identified in this document may take place during normal business hours which are defined as: 8:15 AM to 3:00 PM Central Standard Time, Monday through Friday, and excluding Federal Holidays. Due to COVID19 concerns, some deliveries may be required to be done after business hours. Confirmation of delivery time and location will be provided post-award. 2.4.4 Delivery trucks will not be permitted to remain at the Door entrance. Trucks shall be unloaded, moved, and then brought back to the entrance if required to haul out any waste, tools, or excess materials. 2.4.5 Labeling of delivered items shall include the VA facilities contract number and VA purchase order number for identification and reference upon receipt of product. Clean Up and Disposal 2.6.1 There are no dumpsters available for vendor use. 2.6.2 The removal of waste and/or excess material shall be conducted through the front door. Assembly and Installation Required (Yes No ) 2.7.5 The vendor shall protect all finished spaces and surfaces as required from delivery damage. The vendor shall use covering and protection to the extent necessary to prevent damage to finished spaces. Any damage occurred during delivery is the responsibility of the vendor. The vendor will be responsible for paying for and repairing any damage or noted deficiencies to finished spaces and surfaces that occur as a result of the vendor s (or associated sub-contractors) Delivery. 3.0 DELIVERABLES 3.1.1 VA Nebraska-Western Iowa Healthcare System U0086 4101 Woolworth Avenue Omaha, NE 68105 Finish Sample Required if Checked Manufacturer Certified Installation Required if Checked BMET Training Required if Checked End User Training Required if Checked JSN Nomenclature: JSN U0086 Micro Endoscopic Spinal Instrument Set Medtronic METRxII System is the basis for design. /Brand Name or Equal See Table 1 above at Section 1 Salient Characteristics: All instruments must be made of surgical grade stainless steel, unless otherwise specified All instruments are required to be key dotted so that they are compatible with the Censitrac Instrument Tracking System currently installed in the facility. (if service is available) 3.1.2 VA Nebraska-Western Iowa Healthcare System U0086A 4101 Woolworth Avenue Omaha, NE 68105 Finish Sample Required if Checked Manufacturer Certified Installation Required if Checked BMET Training Required if Checked End User Training Required if Checked JSN Nomenclature: JSN U0086-A Spine Referencing and Navigation Sets Medtronic METRxII System Basic Spine Set is the basis for design. /Brand Name Only See Table 1 above at Section 1 Salient Characteristics: All instruments must be made of surgical grade stainless steel, unless otherwise specified All instruments are required to be key dotted so that they are compatible with the Censitrac Instrument Tracking System currently installed in the facility. (if service is available)

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