Statement of Work - Smoke Evacuators and Electrosurgical Generators.docx

STATEMENT OF WORK (SOW)

Veterans Health Administration (VHA) Eastern Oklahoma VA Health Care System (EOVAHCS) Provision Electrosurgical Unit and Smoke Evacuator At the new Tulsa VA Medical Center

GENERAL

PURPOSE / OBJECTIVE:

Eastern Oklahoma VA Health Care System (EOVAHCS) requires a contractor to provide and deliver two (2) Medtronic AEX Generator with plasmablades and four (4) electrosurgical units with carts for high-frequency electrical current to cut, coagulate (seal blood vessels), and destroy tissue during surgical procedures. Contractor is also to provide and deliver five (5) Medtronic RapidVac smoke evacuators that capture and filter the smoke generated during laser and electrosurgical procedures, protecting healthcare personnel and patients from potentially harmful gases, bioaerosols and other particles within the smoke plume. These units are needed to provide vessel sealing and protection to patients, as needed, in the operating rooms.

The Purpose, to include provision of products and manuals must be accomplished by the Contractor by the Delivery Times at the Locations, in accordance with this SOW, in a cost-effective, efficient, and safe manner, while contributing the VA Mission.

BACKGROUND: The Eastern Oklahoma VA Health Care System (EOVAHCS) is renovating a non- medical existing facility to be the new Tulsa VA Medical Center (VAMC).

LOCATION:

Product Delivery: Jack C Montgomery VA Medical Center, 1011 Honor Heights Drive, Muskogee, OK 74401. Each delivery package must be MARKED FOR: PKG #115 & PO#” (list PO# from Award).

DELIVERY TIMES (PERFORMANCE PERIOD): The VA requires the Contractor to deliver the products no earlier than September 1, 2025.

The Contractor shall furnish all contract oversight, management, Technically Trained Personnel, OEM authorizations to support provision of OEM products, applicable licenses, uniforms, equipment, tools, materials, supplies, storage, insurances, shipping and delivery costs, and transportations necessary to provide the products for EOVAHCS in accordance with this SOW. Any services associated with this product are considered non- personal services. The Contractor, its employees, agents, and subcontractors shall not be considered VA employees for any purpose of fulfilling the SOW and shall be considered employees of the Contractor.

Contractor must provide products and perform in a professional manner and quality as recognized by commercial industry standards as good to excellent. Contractor must provide to the COR and CO, and maintain for the life of the contract, written certification from the Original Equipment Manufacturer (OEM) that authorizes the Contractor to provide and assemble the products, as detailed in the Contractor’s quote and identified in this SOW.

SCOPE: EOVAHCS requires a contractor to provide products that meet or exceeds the physical, functional, and performance of the listed salient characteristics in the following sections. The equipment features are essential to the technical requirements to meet the VA’s needs. The VA’s needs assessment identified the type of products and components listed below as a suitable solution to fill the gap. However, these are only used as a guide and the VA’s basic, salient characteristics and critical minimum requirements define the type of product that is needed to ensure the Purpose of this SOW is satisfied. OEM part numbers/references, in the salient characteristics section, are used as a basis of design and are provided as a means to convey the minimum standard characteristics.

PHYSICAL CHARACTERISTICS: Contractor must provide two (2) Medtronic AEX Generator with plasmablades, four (4) electrosurgical units with carts and five (5) Medtronic RapidVac smoke evacuators and associated components that meet or exceed the critical minimum requirements as well as the specifications in this SOW.

CRITICAL MINIMUM REQUIREMENTS

Contractor must provide the following critical minimum requirements:

Medtronic AEX Generator with plasmablades

a. Soft tissue dissection device that uses brief, precise pulses of radiofrequency (RF) energy to cut and coagulate soft tissue. Unit will be capable of being utilized for General, Plastic and Reconstruction, ENT, Gynecologic, Orthopedic, Arthroscopic, Spinal and Neurological procedures.

b. System will include:

i. Generator will include: touchscreen interface, four (4) memory settings, must be lightweight with rapid startup and priming.

ii. Plasma Blades: All plasma blades will include ergonomic handles.

· 3.0S Blade

· 4.0 Blade

iii. Manuals: Two (2) copies each maintenance and operator manuals.

c. Power Requirements: 120V, 60Hz

d. Quantity: 2

2) Electrosurgical units - Valleylab FT10 w/Universal Generator Cart

a. Dual output electrosurgical unit. Solid state power source with foot switch jacks, monopolar and bipolar outputs, and four independent modes of operation.

b. Used in the operating room or surgicenter as an alternative to the scalpel for cutting tissue.

c. Must be capable of an average sealing/fusion cycle time of 1–4 seconds.5,‡ LigaSure™ devices to minimize thermal spread to surrounding tissue.

d. Must be a plug-and-play system with automatic device detection and power setting.

e. System should be an isolated output with natural convection and fan for cooling.

f. Unit will include the following connector terminals: 1 standard monopolar with UFP, 1 advanced monopolar, 1 bipolar, and 1 LigaSure™/bipolar receptacle.

g. Unit must be capable of operating a duty cycle of 25%, defined as 10 seconds active and 30 seconds inactive, in any mode for a period of 4 hours.

h. Unit must include: ethernet connection, bipolar cable compensation, touch screen and ES (soft coag) settings.

i. Must include Universal Generator Cart: Constructed of aluminum with insulated nylon casters.

j. Must include:

i. Cautery Pencil Reference: E2516- 1 box of 50

ii. Grounding Pad Reference: E7507 - 1 box of 50

iii. Cautery Pencil with Smoke Evacuation Tubing Reference: CVLP2000 - 1 box of 20

iv. 10' Smoke Evacuation Tubing Reference: E3810 - 1 box of 20

v. Ligasure Small Jaw Open Sealer/Divider Reference: LF1212A - 1 Case of 6

vi. Ligasure Impact Curved, Large Jaw, Sealer/Divider Nano-Coated Reference:

LF4418 - 1 Case of 6

vii. Ligasure Blunt Tip Sealer/Divider Nano-Coated Reference: LF1837 - 1 Case of 6

viii. Bipolar Forceps Reusable Cord Reference: E0020V - 1 box of 1

ix. Monopolar Reusable Cord (Laporoscopic) Reference: AB5005 - 1 box of 1

k. Power Requirements: 120V, 60Hz

l. Quantity: 4

3) Medtronic RapidVac Smoke Evacuator

a. Filtration system used in conjunction with laser operations to remove surgical laser plume. The unit includes a pneumatic foot switch, disposable 0.12 micron HEPA primary filters, a secondary 0.12 micron ULPA/carbon filter, disposable funnels, reducer fittings and connector hoses.

b. This unit must be fully compatible with ESU and in no way negate the ESU or associated components warranties.

c. Evacuator Dimensions:

i. 8” high x 14” wide x 18 ¾” deep

ii. 20.3 cm high x 35.5 cm wide x 47.6 cm deep

d. Weight: 20 pounds (9 kg)

e. ULPA Filter Efficiency: The ULPA filter is 99.9995% efficient on a 0.12μm particle size, but it can capture smaller and larger particles at equal or greater efficiency.

f. Voltage operating range: 100-132 VAC, 50/60 Hz; current: 10 amps, maximum

g. Certifications and Markings: UL, CE, cUL

h. Quantity: 5 These devices must be compatible with the following accessories and must not negate warranty of equipment:

IMF: 2694 Description: Cautery Pencil Reference: E2516 IMF: 4424 Description: Grounding Pad Reference: E7507 IMF: 21829 Description: Cautery Pencil with Smoke Evacuation Tubing Reference: CVLA2000 IMF: 17987 Description: Smoke Evacuation Tubing Reference: USUSEA3710 IMF: 5792 Description: Small Ligasure Reference: LF1212A IMF: 16968 Description: Large Ligasure Reference: LF4418 IMF: 17443 Description: Laparoscopic Ligasure Reference: LF1837 IMF: 17934 Description: Bi-Polar Reusable Cord Reference: E0020V IMF: 20157 Description: Mono-Polar Reusable Cord (Laparoscopic) Reference: 26006M IMF: 26018 Description: TUR Mono-Polar Reusable Cord 8mm Plug Reference: 277KB

OTHER REQUIREMENTS:

Contractor is required to provide the following requirements as part of the product. Equipment must be serviceable throughout lifecycle of equipment.

SPECIFICATIONS (including SALIENT CHARACTERISTICS) Contractor must provide products that meet or exceed the specifications in this table.

EA

40-405-1

AEX Generator

case of 6

QUALITY

Conformance Standards Refer to section on Safety and Compliance in this SOW.

Rework or Remedy Rework or Remedy is defined as replacing a product or performing the service again until the Purpose of this SOW is achieved in full. This involves less than Satisfactory Products or Service by the Contractor and as noted by the COR. Rework or Remedy occurs at no additional cost to the Government. Payment will be withheld until all replacement products are received or services are performed to the Satisfactory level in accordance with this SOW and as documented by the COR.

DELIVERY:

Delivery and receipt of the proposed items are anticipated to be directed to the location identified in this SOW. Confirmation of delivery location will be provided by the VA COR post- award. Delivery must be coordinated with VA COR before any delivery attempts. Any item that has not been coordinated will be turned away and any additional charges will be the responsibility of the sender/transportation company.

Contractor is responsible for offloading the equipment from the truck, moving the equipment to the correct delivery location in the space, uncrating or unboxing the equipment, and removing all trash. Equipment paperwork and warranty information must be handed to the VA receiving staff, as advised by the COR.

Contractor must provide product and manuals as part of this contract. Delivery must be coordinated with the local COR.

Manuals: Contractor shall provide electronic, digital copies of the user manuals and repair manuals for each different product under this order or contract, at no additional cost to the government.

INSPECTION: All equipment shall be tested after installation. Each resultant inspection shall be documented and provided to the COR within 7 days of installation along with any inspection documentation or checklists required by the manufacturer. Any changes in inspection requirements during the period of installation will be communicated to the Contractor immediately.

Inspection and Acceptance of Products: The Government reserves the right to inspect and test products in accordance with this SOW and the Contract. The only individual authorized to officially accept products is the COR. While inspection of products may be delegated by the COR and a shared responsibility with departmental management staff, the COR is ultimately the only authorized individual to approve and accept products on behalf of the VA.

WARRANTY OF EQUIPMENT: Contractor must provide a warranty per the Specifications in this SOW. The warranty must meet or exceed standard manufacturer industry warranty terms. The government does not accept an extended warranty, which requires advance payment. The manufacturer’s warranty must begin on 1st Patient Day, anticipated for early 2026.

STANDARD BUSINESS HOURS AND FEDERAL HOLIDAYS

Hours: Normal duty hours are 8:00 a.m. through 5:00 p.m. CST, Monday through Friday, not including federal holidays. Whenever contact with a facility is required outside of normal duty hours, the Contractor shall coordinate these times with the designated COR.

In accordance with 5 U.S.C. 6103, Executive Order 11582, and Public Law 94-97, the following national holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays.”

In addition to the days designated as holidays, the Government observes the following days:

· Any other day designated by Federal Statute

· Any other day designated by Executive Order

· Any other day designated by the President of the United States to be a Federal holiday.

SAFETY AND COMPLIANCE

The Contractor must perform services and ensure equipment functions in accordance with:

a) local, state, and federal Occupational Safety and Health guidelines and legislation, to include Occupational Safety and Health Administration (OSHA), the American National Standards Institute (ANSI) safety guidelines;

b) local, state, and federal Fire and Safety legislation and guidelines, to include VA Health Care System directives and legislation on Fire and Safety, as well as the latest published edition of NFPA-99 (Health Care Facilities Code);

REGULATORY REQUIRMENTS:

a. Environmental Protection Agency (EPA) 40 CFR.

b. Food and Drug Administration (FDA) Quality System Regulation as stated in 21 CFR Part 820

c. Department of Transportation (DOT) 49 CFR.

d. Occupational Safety and Health Administration (OSHA)

e. VHA DIRECTIVE 7708 Pollution Prevention Program

f. VHA Directive 7707 Green Environmental Management Systems (GEMS)

Medical Center Policies Each VA Medical Center has policies that are updated from time to time. The COR can provide more detailed information to the contractor of these upon commencement of the contract and throughout the term of the contract, as needed, especially policies regarding, parking, possession of weapons, cell phone use and photography as well as smoking on VA property. Violations of such policies may result in individual fines or citation answerable in the United States (Federal) District Court.

Contractor shall abide by all rules and regulations set forth by VA Tulsa due to Coronavirus (COVID-19) and have their own personal protective equipment (PPE) in use for the time they are on grounds of the new Tulsa VA Medical Center.

LIABILITIES AND INSURANCES

Protection from Damage Contractor shall provide all labor, materials, and equipment necessary for protection of VAMC personnel, furnishings, equipment and buildings from damage, and shall replace or repair any damage due to work performed under this contract equal to its original construction and finish.

Liability Insurance Contractor must provide the COR and the CO with written confirmation that Contractor has adequate insurance protection against negligent work and other forms of liability.

END OF STATEMENT OF WORK