S02 - ATTACHMENT 3 - STATEMENT OF WORK - LAPAROSCOPIC SYSTEM FOR BECKLEY VAMC - 06-11-2025.pdf

B.2 STATEMENT OF WORK

STATEMENT OF WORK (SOW)

BECKLEY LAPAROSCOPIC SYSTEM

“BRAND NAME OR EQUAL TO STRYKER IAW SOW”

A. GENERAL:

Scope of Services:

The purpose of this requirement is to replace the failing laparoscopic towers for the

Operating Rooms at the Beckley VA Medical Center. The requirement includes the cameras, controllers, carts, light sources, device controllers, transmitters, receivers, displays, insufflators, printers, and more for the three systems. The procurement shall include all parts, materials, labor, software/licenses, and travel to complete the full installation/configuration of the systems.

Location: 200 Veterans Ave, Beckley, WV 25801

Performance Period: Requested delivery within 90 days of award

B. WORK HOURS:

a. Hours of Operation: Normal business hours are Monday through Friday, 8:00 a.m. 4:00 p.m., excluding holidays. Should the Contractor require work afterhours, the Contractor shall arrange in advance with the Contracting Officer’s Representative (COR).

b. Delivery Hours: The Warehouse is open to receive deliveries Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding holidays.

c. National Holidays: The holidays observed by the Federal Government are:

New Year’s Day, Martin Luther King Day, President’s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day and any other day specifically declared by the President of the United States to be a national holiday.

Contractor may work on holidays with prior communication and coordination.

C. SPECIFICATIONS:

a. Technical Requirements

i. The procurement is for a brand name or equal solution for three comprehensive surgical video tower systems to be utilized during laparoscopic, sinuscopic, and arthroscopic cases.

ii. The Stryker brand name components include:

Description/Part Number* Qty

1788010000 PKG 1788 Camera Control Unit CCU 3

220240300 PKG L12 LED LIGHT SOURCE WITH AIM 3

0240099110K FLAT PANEL ROLL STAND KIT 1

240200412 Connected OR Hub Base System with Device Control and SDP1000 Printer

240031065 Pkg SYNK 4K Wireless Transmitter 3

240031075 Pkg SYNK 4K Wireless Receiver 3

240031311 32IN 4K OLED Surgical Display with OLED Display

Cover Kit

1788610122

PKG 1788 4K CAMERA HEAD WITH INTEGRATED

COUPLER

233050400

FG SAFELIGHT FIBER OPTIC CABLE WITH

ADVANCED IMAGING MODALITY 5 MM

0502-103-010 PRECISION IDEAL EYES 10MM 0° HD AC LPSC 6

0502-103-030 PRECISION IDEAL EYES 10MM 30° HD AC LPSC 6

0502-503-010 PRECISION IDEAL EYES 5.5 0° HD ACL LAP30 6

0502-503-030 PRECISION IDEAL EYE 5.5 30° HD ACL LAP30 6

240-099-155 Connected OR Cart 120 V 3

620050001

PNEUMOCLEAR CO2 CONDITIONING

INSUFFLATOR KIT BOTTLE GAS

0502-444-030 PRECISION IE 4K EYPC ASC ATCL4X30°140SLK 8

0502-444-070 PRECISION IE 4K EYPC ASC ATCL4X70°140SLK 3

0502-127-030

HD 2.7MMX30° ARTHROSCOPE SPEEDLOCK

A/C

747031530 PKG. PUMP CANNULA 5.8MM W 1 ROTATING ST 11

747031510

PKG. PENCIL OBTURATOR 5.8MM PUMP

CANNULA

0343-331-430

PKG. 4.0MM SINGLE ROTATING STOPCOCK -

WITH HOLES

0343-331-410 PKG. OBTURATOR 4.0MM PENCIL TIP 1

0502-655-010 Precision S 4K Sinuscope, Autoclavable, 4mm x 0°, 180mm Â

0502-654-045 PRECISION S 4K SINUSCOPE, ACLV,4X45°,155 3

0502-654-070 PRECISION S 4K SINUSCOPE, ACLV,4X70°,155 3

0502652010K 0502652010 Sinuscope and 0502752010 Sheath Kit 3

0502652030K 0502652030 Sinuscope and 0502752030 Sheath Kit 3

233032105

ENDOSCOPE AND CAMERA STERILIZATION

TRAY

233032108 PKG LAPAROSCOPE STERILIZATION TRAY 10

233032116 ENDOSCOPE AND HARDWARE SET TRAY 12

iii. The systems shall be able to perform the video visualization function for all laparoscopic, sinuscopic, and arthroscopic cases at the Beckley VAMC.

iv. The three systems shall be on towers/carts to allow for mobility in the operating room.

v. The system shall have advanced visualization/quality.

vi. The system shall have the ability for visualizing perfusion during open surgery.

vii. The systems shall include 2, 32inch, 4K, OLED displays. One located on the scope tower and the other to be located on an existing equipment boom.

viii. The systems’ insufflators are preferred to have integrated heating, humidification, and smoke evacuation.

ix. The system shall offer a means to export captured images off the device to be later scanned and manually uploaded into the VA EMR.

x. The provided boom mounted monitors shall be able to connect to the existing Steris video integration system for displaying video/images in the ORs via a hardwired connection (i.e. HDMI).

xi. Contractor shall provide two copies of the operating and service manuals.

xii. Scope Requirements

1. Laparoscopes

Diameter, mm

Working

Length, mm

Direction of view, degrees

Field of View, degrees Definition Cleaning Quantity

10 330 0 75 HD Autoclavable 5

10 330 30 75 HD Autoclavable 5

5 300 0 75 HD Autoclavable 5

5 300 30 75 HD Autoclavable 5

2. Arthroscopes mm

Working

Length, mm

Direction of view, degrees Lock Type Definition Cleaning Quantity

4 140 mm 0 deg Speedlock 4K Autoclavable 8

4 140 mm 70 deg Speedlock 4K Autoclavable 3

3. Sinuscopes mm

Working

Length, mm

Direction of view, degrees

Field of

View, degrees

Definition Cleaning Quantity

4 180 0 105 4K Autoclavable 3

4 155 45 105 4K Autoclavable 3

4 155 70 105 4K Autoclavable 3

3.1 170 0 80 4K Autoclavable 3

3.1 170 30 80 4K Autoclavable 3

xiii. Networking Requirements.

1. Connection to the VA network is NOT a requirement.

2. If the proposed solution requires a VA network connection to operate, the vendor will be required to complete the VA’s required documentation.

a. Should the manufacturer of the equipment not have an approved Enterprise Risk Analysis completed, this will be required in order to fully install the system on the network.

b. Only OEM-supported operating systems shall be provided

c. Following purchase, the VA will provide specific network information for the configuration of the system.

d. If remote support is required, the Contractor must have a completed MOU/ISA.

xiv. Cleaning/Sterilization Requirements.

1. The Contractor shall provide cleaning/sterilization instructions

(Instructions for Use – IFU) for the Government to determine the ability of the facility to properly process the equipment.

b. Delivery Requirements

i. Delivery is required 90 days from award of the contract.

ii. Large deliveries are to be coordinated in advance with the COR to ensure necessary planning takes place.

iii. Contractor is to provide the COR with shipment tracking information.

c. Installation Requirements

i. Full installation of the system shall be included as a part of this contract. This will include, but not be limited to:

1. Assembly and configuration of scope towers

2. Mounting of monitors on existing equipment booms. Contractor shall provide new mounting brackets if existing bracket cannot support the new monitors. Contractor to utilize existing power present in the boom.

ii. All parts, materials, tools, labor, and travel to complete the installation shall be included as a part of this contract.

iii. Contractor is required to complete all configuration for the system to be usable.

iv. Contractor shall provide validation that the system is fully functional upon completion of the installation/implementation.

v. Patient Health Information

1. The Contractor shall safeguard patient health information.

2. The Contractor shall report to the Biomedical Engineering Department any issues with disclosed or unsecure patient health information.

vi. Contractor shall not remove any hard-drives or storage systems containing sensitive or patient health information.

d. Training Requirements

i. Contract shall include training for the end-users in the operation of the system.

1. Training shall be on the function and use of the device, in addition to any software/applications.

2. Training shall be on-site for one day.

ii. Contract shall include training for the technical professionals (Biomedical Equipment Support Specialists)

1. Training shall cover the maintenance, troubleshooting, and repair of the system.

2. Training shall be on-site for one day.

e. Contractor Requirements

i. All Contractor personnel performing installation services of the equipment shall have factory training and experience in the implementation of the equipment.

ii. Contractor shall provide copies of training certificates for the Contractor personnel performing work on-site upon the request of the Government.

f. Warranty Information

i. The equipment shall have a warranty of 1 year from the full installation/acceptance of the equipment.

ii. Warranty support shall include repair of the system

iii. Warranty support shall include all parts, materials, labor, and travel to complete the repair or maintenance.

iv. Requests for warranty support shall be made to the telephone support number provided by the Contractor.

v. Warranty support requests shall be responded to within 2 days.

vi. Contractor shall perform any available system updates during the warranty period at the discretion of Biomedical Engineering.

vii. Contractor shall provide a copy of the service report, complete with test data, to the contract COR within five working days after completion of any services.

viii. Service reports shall include identifying information about the equipment, all services provided during the service visit, any issues found during the visit, the technician/engineer names of the personnel performing work, and the date service was provided.

ix. On-Site Procedures

1. Contractor personnel arriving on-site to perform work shall report to the Biomedical Engineering Department.

2. Contractor personnel shall sign in using the department’s vendor sign in sheet, filling out all required information.

3. Contractor personnel’s tool bags are subject to inspection by the Biomedical Engineering department upon arrival and upon departure.

4. Contractor personnel shall sign out upon completion of visit.

5. Prior to departure, Contractor personnel are required to, at a minimum, verbally report any issues with the equipment to the

Biomedical Engineering department, especially noting if the system is still down or not fully repaired.

6. The VA campus is non-smoking. Contractor personnel are required to comply with this policy.

7. Parking. It is the responsibility of the Contractor to park in the appropriate designated parking areas.

g. Safety and Security

i. Contractor shall follow all Occupational Safety and Health

Administration (OSHA) laws and regulations. The Contractor is responsible for reporting any hazards they come across to their point of contact.

ii. Contractor shall follow all local procedures concerning infection control. Should the Contractor be unsure of the requirements, the COR can provide the specific information and procedures.

iii. Contractor personnel shall wear visible identification at all times while on VA property. Contract personnel are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials.

iv. Property Damage

1. The contractor shall take all necessary precautions to prevent damage to any Government property.

2. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken.

3. Any damaged material (i.e., trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the Government, upon approval of the Contracting Officer.

D. QUALITY ASSURANCE

a. End-users, Biomedical Engineering, and/or the contract COR shall perform system verification tests to ensure the system is fully functional.

b. Issues with the quality of the Contractor’s work will be communicated through the Contracting Officer to the Contractor point of contact for resolution.

c. Documentation with be completed in the Government systems.

EVALUATION FACTORS

LAPAROSCOPIC SYSTEM - BECKLEY VA MEDICAL CENTER

Volume I - Technical Capability

The offeror shall provide technical information regarding its proposed laparoscopic system solution as described in the Statement of Work with technical information required to include the following:

• Ability to provide all of the required components of the laparoscopic system, clearly noting any deviations from the items, dimensions, features, etc. for any parts

• Demonstrate the camera system visualization quality

• Demonstrate the ability for visualizing perfusion during open surgery

• Provide information on the surgical monitor size and quality

• Explain the fluorescence imaging capabilities and quality

• Provide information on the insufflator’s features

• Confirm ability to connect to existing Steris video integration system

• Provide the Instructions for Use (IFU) or Cleaning Instructions for reprocessed/reused parts

Volume II – Price

Price - The offeror shall complete the pricing schedule provided in the above: Price/Cost

Schedule.

Volume III – Past Performance

The offeror shall submit three (3) past performance references that are recent and relevant which focuses on experience within the last five (5) years in hospital settings that are comparable in size as the Beckley VA Medical Center. References shall include the contract number for the project, a brief description, and a point of contact to include an email address. The information shall be provided in 5 pages or less.

Past Performance- Acceptable or Unacceptable Rating

The Government shall make an objective assessment of the Offeror's current/past performance. It will conduct a performance acceptable assessment based on aspects of offeror's past performance that are recent and relevant which focuses on experience within the last 5 years in the hospital settings that are comparable in size as VA Capitol

Health Care Network (VISN 5) or larger which contain Operating Rooms, PACUs and other critical care areas. They have to be relevant, similar in complexity, and magnitude requirements of solicitation. Performance that are not recent, relevant, similar in complexity or magnitude will be evaluated with unacceptable performance in this area.

Volume IV – Must Complete the Trade Agreement Certificate.

Must complete the Trade Agreement Certificate completely to mention all the line-items on this certificate.

Volume V – Must provide an OEM Authorized Distributor Letter from the manufacturer

Must provide the OEM from the manufacturer, if no OEM letter from the manufacturer is supplied. The vendor will be considered non-responsive, and the vendor will be dis-qualified at the time request for official quote (RFQ) will close.