36A77620Q0261-014.docx

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36A77620Q0261 ATTACHMENT 1 -Final SOW Rev. 2 -Omaha Pkg. 52 - Spine Instruments -4-27-20.docx

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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
116
U0086-A
CLAMP, SINGLE STANDARD
117
U0086-A
CLAMP, SINGLE SHORT
118
U0086-A
REFERENCE ELBOW, TITANIUM
119
U0086-A
INST 960-559 PLANAR PASSIVE BALL 1.5MM
120
U0086-A
DILATOR 9733817 NAVIGATED
121
U0086-A
TRACKER 9733816 DILATOR
122
U0086-A
DRIVER, T HANDLE
123
U0086-A
SPINE REFERENCING TRAY
124
U0086-A
TOOLS CD
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
129
U0086-A
Awl-Tip Tap 5.5 mm
130
U0086-A
Awl-Tip Tap 6.5 mm
131
U0086-A
Awl-Tip Tap 7.5 mm
132
U0086-A
Small Tissue Protector
133
U0086-A
Large Tissue Protector
134
U0086-A
Percutaneous Tray
135
U0086-A
Taps Module
136
U0086-A
INSERTER, CAPSTONE and CLYDESDALE SET (includes the following)
9734836
2
137
U0086-A
1 Navigated Inserter for Capstone and Clydesdale Implants
138
U0086-A
Rotating tracker on Inserter
139
U0086-A
Slap Hammer compatible with navigated and non-navigated trials
140
U0086-A
NAVLOCK NAVIGATION INSTRUMENT SET
9734833
2
141
U0086-A
NavLock Gray Tracker 9734590
142
U0086-A
NavLock Orange Tracker 9734683
143
U0086-A
NavLock Violet Tracker 9734682
144
U0086-A
NavLock Green Tracker 9734734
145
U0086-A
NavLock Container 9734692
146
U0086-A
Ratcheting Small Straight Handle (2 each) 9733734
147
U0086-A
Awl Tip 9734678
148
U0086-A
Lumbar Probe 9734679
149
U0086-A
Thoracic Probe Tip 9734680
150
U0086-A
CAPSTONE TRIALS SET (TLIF/PLIF) (includes the following)
9734834
2
151
U0086-A
4 Navigated Capstone Trails:
152
U0086-A
8x26mm
153
U0086-A
10x26mm
154
U0086-A
12.26mm
155
U0086-A
14.26mm
156
U0086-A
Slap Hammer compatibility
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

2.3.1The 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.
2.3.2Actual delivery dates will be confirmed by the VA upon award.
2.3.3Post-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, mark.stockstell@va.gov, Colin Beal at (402) 930-7775, colin.beal@va.gov, Dan Thompson at (785) 477-2820, dan.thompson@sme-solutions.com, and Robert Stonerook at (706) 304-7194, Robert.stonerook@sme-solutions.co.

☒ 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

2.4.2The 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.
2.4.32.4.3 Due to COVID19 concerns the delivery of items identified in this document may take place during adjusted business hours which are defined as: 1:00 PM-5:00 PM Central Standard Time, Monday through Friday, and excluding Federal Holidays. Confirmation of delivery time and location will be provided post-award
2.4.4Delivery 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.
2.4.5Labeling 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

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

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) image2.png

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