S06 Solicitation 36C26223Q1270 Amendment 0002.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 7

6/26/2023

36C262

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

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

To all Offerors/Bidders

36C26223Q1270

06-26-2023

X

X

X 1

The purpose of this Amendment 0002 is to respond to vendors' questions and attach an updated Performance Work Statement.

See subsequent pages for more details.

All other terms and conditions remain unchanged.

CECIL S. NICHOLS

Contracting Officer

VA-VHA-2021-84859FDA

CONTINUATION PAGE

The purpose of this Amendment 0002 is as follows:

I. To respond to vendors’ questions as follows, see responses in red font:

QUESTION 1: Can you please define what you mean by a lease and how that differs from a rental?

Typically a lease is through a third party company with a firm term, no termination option and specific buyout options at the end (FMV or $1 buyout).

A lease normally only includes warranty coverage in year 1 and then the hospital is responsible for the costs of service (repairs, PM, parts and labor) thereafter. A rental is typically directly through the vendor, with a flexible term, renewal options, termination option and no specific buyout option at the end. For a rental, the warranty/service coverage (repairs, PM, parts and labor) is included throughout the term.

ANSWER: The definitions provided for “rental” and “lease” in Question 1 are the accepted definitions for the terms. As such, only a rental offer package will be accepted for this solicitation, not lease offer packages, in correction of what was previously stated in Amendment 0001 for a similar question.

QUESTION 2: For the past performance requirement. Do you need exact customer names and information or can we provide an install base total (number of units) who we provide similar services to? Typically we do not share specific customer names and information with other customers. We want to satisfy this requirement, while respecting the privacy of our customers.

ANSWER: Exact customer names and Point-of-Contact are required, as the intention is to contact them and inquire about their experience with the vendor.

II. To attach the revised Performance Work Statement as follows:

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.

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

TABLE A - RENTAL ITEMS

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

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 & 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 BPA contract structured as a base year including four (4) option years.

3. General Requirements Vendor shall deliver to VASDHS the requested rental equipment listed in the solicitation. 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.

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.

7.28. All equipment must be in new condition, not refurbished or used condition.

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.

END OF AMENDMENT