S02 36C26223Q1270 Surgical Navigation and Imaging System Lease.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

664-23-2-151-0013

36C26223Q1270 06-22-2023

Kim, Dyne 562-766-2231 06-27-2023

1:00 PM PDT

36C262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

X

339113

750 Employees

N/A

X

36C664

Department of Veterans Affairs VA San Diego Healthcare System

3350 La Jolla Village Drive San Diego AZ 92161-0002

36C262

Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

Department of Veterans Affairs Financial Services Center

See CONTINUATION Page

This is the solicitation for Surgical Navigation and Imaging System Lease.

COR: To Be Determined (TBD)

SEE SECTION E.5 - ADDENDUM INSTRUCTIONS TO OFFERORS - FOR

FULL INSTRUCTIONS ON HOW TO PROPERLY SUBMIT YOUR OFFER.

See CONTINUATION Page

X X

X 1

CECIL S. NICHOLS VA-VHA-2021-84859FDA

Contracting Officer

36C26223Q1270

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PERFORMANCE WORK STATEMENT

1. Introduction

2. Background

3. General Requirements

3.1 TABLE A – ITEMS LIST

4. Period of Performance

5. Mandatory Tasks

6. Vendor Responsibilities:

7. Salient Characteristics

8. Warranty

9. Delivery

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 TERMS AND CONDITIONS

B.5 ADMINISTRATIVE DATA

B.6 PRICING DATA

B.7 OPTION TO EXTEND THE TERM OF THE BPA

B.8 GENERAL SERVICES ORDERS

B.9 NONPERSONAL SERVICES

B.10 AUTHORIZED LIMITS

B.11 OBLIGATION OF FUNDS

B.12 PERIOD OF PERFORMANCE

B.13 AUTHORIZED INDIVIDUALS

B.14 ORDER FORMAT

B.15 AUTHORIZED REPRESENTATIVES

B.16 FEDERAL HOLIDAYS

B.17 PROHIBITED ACTIVITIES

B.18 INVOICES

B.19 PRECEDENCE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (DEC 2022)

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 WAGE DETERMINATION RATE SCA 2015-5635 REV #21

D.2 SALIENT CHARACTERISTICS SHEET

D.3 EXPERIENCE NARRATIVE SHEET

D.4 PAST PERFORMANCE SHEET

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.211-6 BRAND NAME OR EQUAL (AUG 1999)

E.8 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C262

Network Contracting Office 22 4811 Airport Plaza Drive, Suite 600 Long Beach CA 90815

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

5. INVOICES: Invoices shall be submitted in arrears in accordance with 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012) upon acceptance of items.

a. In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with OB10 e-Invoicing network, for submissions of all electronic invoices to VA. OB10 electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with OB10 by submitting an email to VA.Registration@ob10.com or calling 1-877-752-0900 option 2 for Enrollment.

b. For assistance setting up e-Invoice, the below information is provided:

mailto:VA.Registration@ob10.com

OB10 e-Invoice Setup Information: 1-877-489-6135 OB10 e-Invoice email: VA.Registration@ob10.com <http://VA.Registration@ob10.com/> FSC e-Invoice Contact Information: 1-877-353-9791 FSC e-invoice email: vafsccshd@va.gov <http://va.gov/

c. FACSIMILE, E-MAIL, AND SCANNED DOCUMENTS ARE NOT ACCEPTABLE

FORMS OF SUBMISSION FOR PAYMENT REQUESTS.

d. All invoices shall reference the Contractor’s name and address, customer name, contract number, appropriate obligation/funding order number, description of services provided, quantity, unit price, and total invoice amount (any additional info). Invoices shall also include any payment discount terms.

f. For questions regarding invoice receipt or payment, please call VAFSC directly at 1- 877-353-9791 or email vafsccshd@va.gov.

6. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

mailto:VA.Registration@ob10.com http://ob10.com/ mailto:vafsccshd@va.gov http://va.gov/ mailto:vafsccshd@va.gov

B.2 PERFORMANCE WORK STATEMENT

FOR VA SAN DIEGO HEALTHCARE SYSTEM (VASDHS)

1. Introduction The purpose of this performance work statement (PWS) is to outline the tasks and responsibilities of a rental service agreement of all products listed below in Table A.

2. Background The VASDHS is part of the Desert Pacific Healthcare Network – Veterans Integrated Services Network (VISN 22), and is one of the most diversified tertiary health care providers in the VA.

We are a teaching hospital, providing a full range of patient services, with state-of-the-art technology as well as education and research. Rental of a brain-and-spine navigation and imaging system for surgical cases in the operating room (OR) is being sought due to the frequency of procedures/usage of these systems through a Blank Purchase Agreement (BPA) structured as a base year with four (4) option years.

3. General Requirements Vendor shall deliver to VASDHS the requested rental equipment listed in Table A. Case coverage will also be provided for surgeries in which a Medtronic clinical specialist will be present on an as needed basis for scheduled and unscheduled emergent/urgent Operating room procedures which require spine navigation.

The units for this requirement listed in Table A shall be used for cranial surgeries in conjunction with case coverage, but mostly it will be used for spinal surgeries, which does not require case coverage.

3.1 TABLE A – ITEMS LIST

The following items should be available upon request by facility in any combination as required by the facility:

Item Number

Item Description QTY

1 Imaging Equipment BASE UNIT 1

2 Imaging Equipment SYSTEM NAVIGATION INTERFACE 1

3 Imaging Equipment MULTIPLE FIELD OF VIEW 1

4 Imaging Equipment ADVANCED VIEWING 1

5 Imaging Equipment ISOCENTER POINT ROTATION MECHANISM 1

6 Imaging Equipment COLLIMATED AXIAL 3D 1

7 Imaging Equipment HIGH DEFINITION 3D – HD3D 1

8 Imaging Equipment 2D LONG FILM 1

9 Imaging Equipment STEREOTAXY 1

10 Surgical Navigation System - New 1

11 Surgical Navigation Electromagnetic (EM) KIT CRANIAL ACCESSORIES 1

12 Surgical Navigation SPINE SOFTWARE 1

13 Basic Spine Referencing 2

14 PERCUTANEOUS PIN UPGRADE SET 2

15 Spinal System Awl-Tip Taps 2

16 Spinal System Taps 2

17 Spinal System 5.5/6.0 DRIVERS 1

18 NAVIGATION INSTRUMENT SET 2

19 Surgical Navigation UNIVERSAL DRILL GUIDE 2

20 Surgical Navigation CRANIAL SOFTWARE 1

21 Surgical Navigation 3D SOFTWARE 1

22 CRANIAL INSTRUMENT SET 2

23 Precision Applicator KIT 1

24 Guide Assembly Aiming Probe for Cranial Biopsy Procedures 1

25 MICROSCOPE PROBE 1

26 Surgical Navigation MERGE SOFTWARE 1

4. Period of Performance

4.1. Period of Performance for the Blanket Purchase Agreement (BPA) is as follows for the base and option years:

4.1.1. Base year: 07/01/2023 – 06/30/2024

4.1.2. Option Year 1: 07/01/2024 – 06/30/2025

4.1.3. Option Year 2: 07/01/2025 – 06/30/2026

4.1.4. Option Year 3: 07/01/2026 – 06/30/2027

4.1.5. Option Year 4: 07/01/2027 – 06/30/2028

5. Mandatory Tasks

5.1. Each rental must come with a specific set of trays, as noted in the price/cost schedule, tailored for the specific type of surgery requested.

5.2. The delivery must be made timely as to not disrupt a planned surgical case.

6. Vendor Responsibilities:

6.1. VASDHS equipment Staff training will be conducted in-person annually by Vendor

Professional Staff on use of the equipment listed for OR purposes as part of the rental service.

6.2. Vendor shall be responsible for all liability actions or suits when the vendor is at fault or negligent in the performance period.

7. Salient Characteristics

7.1. Item 1: Imaging Equipment BASE UNIT

7.1.1. Include Multidimensional Surgical Imaging System – with two-dimensional (2D) Fluoroscopy Mode, Multi-plane 2D Fluoroscopy Mode (M-2D), and 3D Mode (3D).

2D Long Film Scan (2D) is optional.

7.2. Item 2: Imaging Equipment SYSTEM NAVIGATION INTERFACE

7.2.1. Include iso-centric rotation relative to the lateral image in fluoroscopy mode with rotation around the vertical axis while keeping the anatomy of interest in the imaging field

7.3. Item 3: Imaging Equipment MULTIPLE FIELD OF VIEW

7.3.1. Support 3D volumetric imaging in multiple fields of views, capable of improving visualization for large anatomical regions and supporting imaging high contrast landmarks of stereotactic localizers

7.4. Item 4: Imaging Equipment ADVANCED VIEWING

7.4.1. Include an image processor and user interface that display the images produced, displaying patient exam data and images on high definition, flat panel monitor displays for increased precision in aid to surgeon for optimal safety.

7.5. Item 5: Imaging Equipment ISOCENTER POINT ROTATION MECHANISM

7.5.1. Have ability to robotically position and rotate the gantry around isocenter point.

7.6. Item 6: Imaging Equipment COLLIMATED AXIAL 3D

7.6.1. Have collimated 3D scanning capability

7.7. Item 7: Imaging Equipment HIGH DEFINITION 3D – HD3D

7.7.1. Provides image quality through acquisition of images at a rate of at least 20 frames per second, capturing at least 700 projections.

7.8. Item 8: Imaging Equipment 2D LONG FILM

7.8.1. Assess intraoperative positioning and corrections of coronal and sagittal long films with lengths of a minimum of 35 cm.

7.9. Item 9: Imaging Equipment STEREOTAXY

7.9.1. Stereotaxy mode supporting high definition 3D (HD3D) volumetric imaging of high contrast landmarks of stereotactic localizers for cranial procedures.

7.10. Item 10: Surgical Navigation System - New

7.10.1. Visualization and surgical navigation of every segment in the spine

7.11. Item 11: Surgical Navigation Electromagnetic (EM) KIT CRANIAL ACCESSORIES

7.11.1. Latest EM (electromagnetic) side emitter with large tracking volume, supporting tumor resection, biopsy, and catheter placement procedures with support for auto-registration with imaging system

7.12. Item 12: Surgical Navigation SPINE SOFTWARE

7.12.1. Equipment software allowing for customization of procedure settings for each surgeon and auto-registration with imaging system.

7.13. Item 13: Basic Spine Referencing

7.13.1. Basic spine referencing, including frame (spine air), multiple sized clamps, reference elbow (titanium), at least one dilator, and spine referencing tray

7.14. Item 14: PERCUTANEOUS PIN UPGRADE SET

7.14.1. Adapter for percutaneous pin and percutaneous pin delivery tools

7.15. Item 15: Spinal System Awl-Tip Taps

7.15.1. Awl-tips ranging from 4.5 to 7.5 mm, as well as small and large tissue protectors, and percutaneous tray

7.16. Item 16: Spinal System Taps

7.16.1. Cannulated solera taps ranging from 4.5 to 6.5 mm

7.17. Item 17: Spinal System 5.5/6.0 DRIVERS

7.17.1. Solera 5.5/6.0 drivers, including cannulated (MAS and FAS/SAS) and non-cannulated (MAS and RMAS)

7.18. Item 18: NAVIGATION INSTRUMENT SET

7.18.1. Navigation instrument set, including Trackers (Gray, Orange, Violet, and Green), Container, at least 2 ratcheting small straight handles, awl tip, lumbar probe, and thoracic probe tip

7.19. Item 19: Surgical Navigation UNIVERSAL DRILL GUIDE

7.19.1. Universal drill guide

7.20. Item 20: Surgical Navigation CRANIAL SOFTWARE

7.20.1. Cranial software supporting tumor resection, biopsy, and catheter placement procedures at minimum

7.21. Item 21: Surgical Navigation 3D SOFTWARE

7.21.1. 3D software enabling automatic and semi-automatic segmentation of structures such as tumor, cortex, bone; allowing for advanced visualization of structures and seamless import of tractography objects; and providing additional color maps for anatomic visualization

7.22. Item 22: CRANIAL INSTRUMENT SET

7.22.1. Cranial instrument set including at least 2 wireless, autoclavable probes for intra-operative use and reference frames with integrated touchpad control

7.23. Item 23: Precision Applicator KIT

7.23.1. Ability to identify locations of fiducial markers on the patient to be used in trace registration.

7.24. Item 24: Guide Assembly Aiming Probe for Cranial Biopsy Procedures

7.24.1. Probe to aim the guide assembly along a planned surgical trajectory on cranial biopsy procedures.

7.25. Item 25: MICROSCOPE PROBE

7.25.1. Scope probe with compact bayonet pointer for use when space is limited (for example, when a microscope is used in the surgical field)

7.26. Item 26: Surgical Navigation MERGE SOFTWARE

7.26.1. Advanced image correlation algorithms and tools that provide automatic and manual image fusion of different imaging modalities such as MRI (magnetic resonance imaging is diagnostic imaging to visualize soft tissue structures such as the brain and organs), CT (computed tomography provides X-ray images to produces cross sectional slice images of the inside of the body), imaging device (which uses X-ray to produce 3D and 2D images in the operating room), fMRI (functional magnetic resonance imaging which provides a means by which to measure and map brain activity noninvasively and safely), and PET scans(positron emission tomography is a diagnostic scan that helps reveal metabolic or biochemical function of specific tissues such as the brain, for example).

7.27. Compatible with facility owned Stryker/Berchtold Operon D860 surgical tables currently in use at station.

8. Warranty

8.1 Vendor shall provide properly functioning equipment and products within useful life cycle, and immediately replace any equipment utilized by the VASDHS that ceases to function due to manufacturer defect, or all other discrepancies not caused by VASDHS staff at no additional cost.

9. Delivery

9.1. Vendor shall be responsible to deliver the rental equipment (and any supply products for each case as applicable) to the location designated by the VA COR and shall be responsible to retrieve the system upon completion of the contract without material damage to facility.

9.2. Vendor shall not conduct any work that will break the flooring, break walls or electrical or plumbing work to the Sterile Processing Services Decontamination or Preparation Area. The rental items are not intended to be attached to the facility and it is not permanent to the structure.

9.3. Vendor shall not damage any flooring, electrical, walls to the Emergency department designated location while making delivery for rental purposes.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

MINIMUM

QUANTITY

MAXIMUM

QUANTITY

DESCRIPTION OF

SUPPLIES/SERVICES

ESTIMATED

QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 10

10.00 EA ____________ ________

Case Coverage for Cranial Surgeries

Fee per Rental Equipment (Table A) and Services (Technician) – per cranial surgery. This line item is charged to the government per cranial surgery every time rental items and or/services are ordered for cranial surgeries.

Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: W065 - Lease or Rental of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

12.00 MO ____________ ________

1 12 Rental Fee for Unlimited Use

This includes Navigation Units (Table A: Item #1 and #10) and Rental Equipment included in Table A, respective of particular surgical procedure (spinal or cranial).

Contract Period: Base POP Begin:

POP End:

PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

1001 1 10

Fee per Rental Equipment (Table A) and Services (Technician) – per cranial surgery. This line item is charged to the government per cranial surgery every time rental items and or/services are ordered for cranial surgeries.

Contract Period: Option 1 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

This includes Navigation Units (Table A: Item #1 and #10) and Rental Equipment included in Table A, respective of particular surgical procedure (spinal or cranial).

Contract Period: Option 1 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

2001 1 10

Fee per Rental Equipment (Table A) and Services (Technician) – per cranial surgery. This line item is charged to the government per cranial surgery every time rental items and or/services are ordered for cranial surgeries.

Contract Period: Option 2 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

This includes Navigation Units (Table A: Item #1 and #10) and Rental Equipment included in Table A, respective of particular surgical procedure (spinal or cranial).

Contract Period: Option 2 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

3001 1 10

Fee per Rental Equipment (Table A) and Services (Technician) – per cranial surgery. This line item is charged to the government per cranial surgery every time rental items and or/services are ordered for cranial surgeries.

Contract Period: Option 3 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

3002 1 12

Rental Fee for Unlimited Use

This includes Navigation Units (Table A: Item #1 and #10) and Rental Equipment included in Table A, respective of particular surgical procedure (spinal or cranial).

Contract Period: Option 3 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

4001 1 10

Fee per Rental Equipment (Table A) and Services (Technician) – per cranial surgery. This line item is charged to the government per cranial surgery every time rental items and or/services are ordered for cranial surgeries.

Contract Period: Option 4 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

4002 1 12

Rental Fee for Unlimited Use

This includes Navigation Units (Table A: Item #1 and #10) and Rental Equipment included in Table A, respective of particular surgical procedure (spinal or cranial).

Contract Period: Option 4 POP Begin:

POP End:

PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

GRAND

TOTAL

B.4 TERMS AND CONDITIONS

The Contractor agrees to the following terms of a Blanket Purchase Agreement (BPA) EXCLUSIVELY WITH the Department of Veterans Affairs:

B.5 ADMINISTRATIVE DATA

A Blanket Purchase Agreement (BPA) is hereby established between and the Department of Veterans Affairs under the following terms and conditions incorporated in this BPA:

Primary Point of Contact:

Alternate Point of Contact:

SAM UEI NUMBER:

Cognizant Office (Include complete address):

Network Contracting Office 22

4811 Airport Plaza Drive, Suite 600

Long Beach CA 90815

B.6 PRICING DATA

1. The prices included on the BPA list (or applicable "discounted" rates submitted in a proposal response to an RFQ resulting in award) that are in effect on the effective date of an order shall govern that order's basic performance period. With regard to any option years, which are later exercised, the proposed option year rates as incorporated into the order award are in effect until such time, if applicable, that the contractor has been authorized a rate increase culminating from a negotiation with the Contracting Officer.

2. The BPA holder can voluntarily reduce offered prices at any time by giving 24-hour advance notice (by facsimile or electronic-mail) to the Department of Veterans Affairs/Contracting Officer.

This BPA also allows for additional discounts if a "large order" is placed at one time. An advanced notice is not required for discounts offered for only an individual order. Whether an order is large enough to warrant such a discount is subject to the discretion of the BPA holder.

3. The BPA holder may also increase BPA prices at any time. Any BPA price increase shall not take effect until the Department of Veterans Affairs Contracting Officer receives written notification (U.S. mail, facsimile, or electronic-mail). Any order already issued shall not be affected by any change to BPA pricing. The prices offered under this BPA will undergo annual review by the Department of Veterans Affairs Contracting Officer.

B.7 OPTION TO EXTEND THE TERM OF THE BPA

a. The Government may extend the term of this BPA by written notice to the Contractor at any time prior to the expiration of the BPA, provided that the Government shall give the Contractor a preliminary written notice of its intent to extend at least 30 days before the BPA expires. The preliminary notice does not commit the Government to an extension.

b. If the Government exercises this option, the extended BPA shall be considered to include this option provision.

B.8 GENERAL SERVICES ORDERS

a. The BPA holder shall furnish all the necessary qualified personnel, materials, facilities and management resources to furnish the services set forth in the Statement of Objectives (SOO) or the Performance Work Statement (PWS) within the terms specified and at the price(s) stated.

b. It is understood and agreed that the BPA holder shall provide Fixed-Price proposals when requested by the Contracting Officer (CO). The contractor's proposal shall be priced using labor rates and labor categories here in provided. The CO will issue Fixed Priced Orders upon completion of negotiations of contractor proposals.

B.9 NONPERSONAL SERVICES

a. In performance of this contract, the BPA holder will provide services as required by program offices to support management of their overall mission. This will be based upon the order's Performance Work Statement for the specific effort. Orders will be formally issued to the BPA holder as opposed to individual BPA holder employees.

b. The services required under the Agreement constitute professional and management services within the definition provided by FAR 37.201. Under this Agreement the Government will obtain professional services, which are essential to the Department of Veterans Affairs mission but not otherwise available within Department of Veterans Affairs.

c. The Government will neither supervise BPA holder employees nor control the method by which the BPA holder performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual BPA holder employees.

It shall be the responsibility of the BPA holder to manage their employees and to guard against any actions that are of the nature of personal services, or give the perception of personal services. If the BPA holder feels that any actions constitute, or are perceived to constitute personal services, it shall be the BPA holder's further responsibility to notify the Contracting Officer immediately.

d. These services shall not be used to perform work of a policy/ decision making or management nature. All decisions relative to programs supported by BPA holders will be the sole responsibility of the Government. Support services will not be ordered to circumvent personnel ceilings, pay limitations, or competitive employment procedures.

B.10 AUTHORIZED LIMITS

The Government estimates, but does not guarantee, that individual BPA Orders placed against this Agreement may reach 10 cases per Order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the Agreement is set at 10 cases per year over the period covered by the Agreement; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with Order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary. Authorization for individual orders above the stated order and/or Ceiling Limits must be coordinated through the Contracting Officer before larger valued orders can be issued and prior to commencement of work. All unauthorized work, regardless of amount, will be processed through the ratification process.

B.11 OBLIGATION OF FUNDS

This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by the Contracting Officer.

B.12 PERIOD OF PERFORMANCE

This BPA expires on 06-30-2024 or such later ending date as determined by the exercise of any option.

B.13 AUTHORIZED INDIVIDUALS

Individuals Authorized to Place Orders:

DVA authorizes the following entities to place orders:

ALL Network Contracting Office (NCO) 22 Contracting Officers

B.14 ORDER FORMAT

Orders will be placed against this BPA via e-mail, Electronic Data Interchange (EDI), FAX, or in hardcopy format. Each individual BPA Order will describe the tasks, services and deliverables required.

B.15 AUTHORIZED REPRESENTATIVES

The primary Contracting Officer (CO) for this Agreement is:

CECIL S. NICHOLS

Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive, Suite 600 Long Beach, CA 90815 cecil.nichols@va.gov

The Primary Contracting Officer's Representative (COR) for projects under this Agreement is:

JOAN LAKIN

Department of Veterans Affairs VA San Diego Healthcare System 3350 La Jolla Village Drive San Diego, CA 92161 joan.lakin@va.gov

The Secondary Contracting Officer's Representative (COR) for projects under this Agreement is:

The Primary and/or Secondary COR will be responsible for technical monitoring of the contractor's performance and deliveries. The COR and the Contractor's Representative shall work together to ensure that all contractual requirements are being met. The COR will interpret specifications or technical portions of the work. The COR is not authorized to perform, formally or informally, any of the following actions:

(1) Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change this contract;

(2) Waive or agree to modification of the delivery schedule;

(3) Make any final decision on any contract matter subject to the Disputes Clause;

(4) Terminate, for any reason, the contractor's right to proceed;

(5) Obligate in any way, the payment of money by the Government. Only a warranted Contracting Officer is authorized to obligate funds on this or any other contract action.

The contractor shall immediately notify the Contracting Officer in writing if the COR has taken an action (or fails to take action) or issues directions (written or oral) that the contractor considers to exceed the above limitations.

The contractor shall provide the Contracting Officer information copies of all correspondence to the COR.

mailto:cecil.nichols@va.gov mailto:joan.lakin@va.gov

B.16 FEDERAL HOLIDAYS

Unless specifically authorized in writing by the Contracting Officer, no services will be provided and no charges will be incurred and/or billed to any order on this contract on any of the Federal Holidays listed below.

New Year’s Day Labor Day Martin Luther King, Jr. Day Columbus Day President’s Day Veterans Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

B.17 PROHIBITED ACTIVITIES

The BPA holder shall not perform tasks under any resultant order which involve the following:

(a) preparation of any statement of requirements, objectives, or needs to be procured by the Government for services, whether to be acquired by future orders under the program, or by any other contract action at Department of Veterans Affairs;

(b) evaluation of the qualifications of a potential source or any proposal for a contract or order by the Government for services or any other supplies or services;

(c) formulation of "best value" criteria, acquisition plans, solicitations or strategies for the purchase of -like services;

(d) preparation of documentation for future orders for services.

B.18 INVOICES

a. Inspection and acceptance shall be accomplished as follows: The Government, for all services furnished under any resulting order, hereby designates the COR in the program office as the point of final inspection and acceptance. The BPA holder will submit each invoice electronically in a monthly basis (see section B.1) and e-mail all back-up data (delivery tickets), to the Contracting Officer Representative (COR) for review and signature. The invoice will include all Case Coverage Rental Services (Line Items 0001, 1001, 2001, 3001 or 4001) for that particular month and the monthly rental fee ((Line Items 0002, 1002, 2002, 3002 or 4002).

When the COR receives an accurate and complete invoice, he/she will certify the invoice within five (5) working days. If the invoice is incomplete or inaccurate, the COR will notify the BPA holder and return the unsigned electronic invoice to the BPA holder for correction. Monthly payment for each order will be accomplished by monthly invoice electronic submission followed by monthly certification by the COR.

b. An itemized invoice shall be submitted to the CO at least monthly or upon expiration of this BPA, whichever occurs first, for all deliveries made during a billing period and for which payment has not been received. Copies of delivery tickets shall support these invoices.

"Approved-for-payment" invoices will be submitted electronically specified on each individual order issued under this BPA.

B.19 PRECEDENCE

The Terms and conditions included in this BPA apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this BPA and the Contractor's invoice, the provisions of this BPA will take precedence.

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 4701 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/ http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

FAR

Number

Title Date

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

MAY 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.237-2 PROTECTION OF GOVERNMENT BUILDINGS,

EQUIPMENT, AND VEGETATION

APR 1984

852.203-70 COMMERCIAL ADVERTISING MAY 2018

852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS

OCT 2019

852.215-71 EVALUATION FACTOR COMMITMENTS OCT 2019

(End of Clause)

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (MAR 2023)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware,…