6515--Omaha ACC FY20-52 Spine Instruments

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, 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

2.4.2 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)