Statement of Work.pdf

STATEMENT OF WORK (SOW)

Veterans’ Health Administration (VHA)

Eastern Oklahoma VA Health Care System (EOVAHCS)

Surgical Scopes lease at the new Tulsa VA Medical Center and Scope Maintenance Throughout All of Eastern Oklahoma

GENERAL: This is a non-personal equipment lease and comprehensive service agreement contract to provide surgical scopes and accompanying equipment to the Eastern Oklahoma VA Health Care System (EOVAHCS).

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). The facility requires new scopes for procedures to be performed. There currently are no scopes in this facility. This requirement is in support of a Brand Name or Equal requirement.

LOCATION:

Tulsa VAMC Lease Scopes, Loaners exchange service & Streamconnect

Muskogee VAMC Loaner exchange services, & Streamconnect upgrade.

DELIVERY TIMES (PERFORMANCE PERIOD): The VA requires the Contractor to deliver the products no later than 100 days post contract award. The base period of performance for this contract shall begin on September 1st, 2026, unless otherwise specified, and shall expire on August 31st, 2027.

PURPOSE / OBJECTIVE:

Eastern Oklahoma VA Health Care System (EOVAHCS) requires a Contractor to provide full leasing, preventative maintenance, and repair services for scopes for surgical use. The objective of this scope of work is to define the requirements, responsibilities, and expectations involved in the acquisition and use of Urology ENT equipment.

The goal is to ensure the safe, effective, and standardized deployment of Urology ENT. This scope supports the following key objectives:

Qualifications of Contractor:

For a contract of this size, scope and complexity, the successful 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.

The Contractor shall have the ability to repair/service the equipment per the Original Equipment Manufacturers (OEM) specifications in order to not void the leased equipment’s warranty. The Contractor shall provide full preventative maintenance and repair service coverage for all contracted equipment. The preventative maintenance and repair services shall be completed by OEM certified service personnel. The contractor shall submit equipment service reports to the Contracting Officer’s Representative (COR), confirming completion of said repair/maintenance service that was provided. Contract performance shall be monitored using this report, indicating the timeliness of the repair, the completion of the services provided, and shall act as a guide for confirming that the repaired equipment is operational.

Brand Name of Products, to include make and model numbers:

VA requires Brand Name or Equal selection.

SCOPE:

EOVAHCS requires a contractor to provide products that meet or exceed 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’ sections are used as a basis of design and are provided to convey the minimum standard characteristics.

CRITICAL MINIMUM REQUIREMENTS

Contractor must provide the following critical minimum requirements as part of the product needed.

Salient Characteristics for Urology/ENT and Video leasing Requirements:

Must have the following minimum salient characteristics on all items

Saphira Urology Blue Light System:

Blue Light Cystoscopy with Cysview (BLCC) High-Definition Camera Head:

• Must be compatible and interchangeable with existing KARL STORZ Saphira BLCC video system.

• Must be compatible with Saphira Image1 S Camera Connect Unit

• Must be one piece pendulum design without modular adapters in high-definition format

• Must have focus knob with 16mm focal length

• Must have (3) programmable user control buttons

• Must be 16 x 9 image format with 60 Hz image refresh rate

Power LED Saphira D-Light PDD Light Source:

• Must be compatible and interchangeable with existing KARL STORZ Saphira BLCC video system.

• Must be Dual LED light source for both white light and blue light

• Must include dual white light and PDD blue light mode ability with excitation filter mounted on the fly wheel

• Must include simple switchover between white light and PDD fluorescence excitation light in the selected operating mode via camera head or foot switch

• Must include 3 separate operating modes for various photosensitizers and fields of application

• Must include operating time of 30,000 hours

• Must include Type CF applied part according to IEC 60601-1

• Must include integrated SCB (Storz Communication Bus) module for controlling the entire system from camera head

• Specifications: Lamp type: LED

• Color temperature: 6000 K (white light)

• Light intensity adjustment: Continuously adjustable

• Dimensions: 305 mm x 120 mm x 370 mm (w x h x d)

• Weight: approx. 7.4 kg

• Certified to: IEC 601-1, protection class 1/CF

UROLOGY

Sinus Sets

• RHINOFORCE STRAIGHT NASAL SCISSORS

• 0º, 30º, 70º TELESCOPE, 4MM X 18CM AUTOCLAVABLE

• 0º, 30º, 70º TELESCOPE, 2.7MM X 18CM

• CONTAINER SYSTEM FOR 4 TELESCOPES, STEAM/STERRAD,

• LIGHT CABLE

• RHINOFORCE NASAL SCISSORS

• BLAKESLEY RHINOFORCE STRGHT NASAL FRCPS THRU CUT,TISSUE SPARING, in multiple angles

• MONTGOMERY-YOUNGS RHINOFORCE CLIP APPLICATOR, W/SUCTION, STRAIGHT, Left and right

• TAKAHASHI STRAIGHT ETHMOID FORCEPS

• BLAKESLEY RHINOFORCE NASAL FORCEPS

• STAMMBERGER ANTRUM PUNCH

• DOUBLE-ENDED FREER ELEVATOR

• FREER SUCTION ELEVATOR

• DOUBLE-ENDED COTTLE ELEVATOR,

• FRAZIER SUCTION TUBE WITH CALIBRATIONS MARKED

• V.EICKEN CURVED ANTRUM CANNULA

• SHARP POINTED SICKLE KNIFE

• MAXILLARY SINUS OBLONG ANTRUM CURETTE

• KUHN-BOLGER FRONTAL SINUS CURETTE, AND SEEKER

• HAJEK-KOFLER SPHENOID PUNCH

• KUHN-BOLGER GIRAFFE FORCEPS

• KUHN FRONTAL FRONTAL SINUS FORCEPS

• KERRISON PUNCH

• BIPOLAR HIGH FREQUENCY CORD

• FRAZIER SUCTION

Panendoscopy Sets

• ROBERTS-JESBERG OVAL ESOPHAGOSCOPE

• ESOPHAGOSCOPE HANDLE

• SCHNIDT FORCEPS WITH SERRATIONS

• INSERTABLE SUCTION TUBE

• GOTTINGEN LARYNGOSCOPE HOLDER WITH WHEEL

• SUPPORT ROD FOR LARYNGOSCOPY HOLDER

• OPERATING LARYNGOSCOPE

• FIBER OPTIC LIGHT

• FORCEPS

Flexible Scopes

• VIDEO RHINO-LARYNGOSCOPE

• SEALED CONTAINER SYSTEM FOR VIDEOENDOSCOPES

Weerda Diverticuloscope Sets

• WEERDA DISTENDING DIVERTICULOSCOPE

• FIBER OPTIC LIGHT CARRIER

• SEALED CONTAINER SYSTEM

• GRASPING FORCEPS AND SUCTION TUBES

• TELESCOPE FOR BRONCHOSCOPY, ESOPHAGOSCOPY

• HOLINGER-BENJAMIN DIVERTICULOSCOPE SLENDER

• FIBER OPTIC LIGHT CARRIER

• SEALED CONTAINER SYSTEM FOR TELESCOPES

Peel Pack Items

• OPTICAL BIOPSY FORCEPS AND STONE CRUSHING FORCEPS

• MONOPOLAR COAGULATING BALL ELECTRODE

• CONNECTOR WITH TUBE AND LOCKING DEVICE

Flexible Cystoscopes

• FLEXIBLE VIDEO CYSTOSCOPE

• SEALED CONTAINER SYSTEM FOR FLEXIBLE VIDEOENDOSCOPES

• VIDEO-URETERO-RENOSCOPE

Perc Neph Short

• 6º TELESCOPE

• GRASPING FORCEPS

• OPERATING SHEATHS

• CONTAINER SYSTEM

Perc Neph Long

• GRASPING FORCEPS

• PERC NEPH TELESCOPE

• HOLLOW OBTURATOR AND FASCIAL DIALATOR

• CONTINUOUS SUCTION OPERATING SHEATH

• LUER-LOCK CONNECTOR WITH STOPCOCK

• CONTAINER SYSTEM

Semi-Rigid Scopes

• SEMI-RIGID URETERO-RENOSCOPE

• RIGID SCOPES TRAY

• STERILIZATION / STORAGE TRAY

Rigid Cystoscopes

• TELESCOPE, AUTOCLAVABLE, 0º, 70º, 12º

• CONTAINER SYSTEM FOR TELESCOPES, STEAM/STERRAD,

Cysto Sets

• TELESCOPE BRIDGE

• CYSTO-URETHROSCOPE SHEATH SET

• LUER-LOCK CONNECTOR WITH STOPCOCK

• TWO LAYER STERILIZATION CONTAINER SYSTEM

Generator

• CART FOR ESU

• TWO-PEDAL FOOTSWITCH WITH BUTTON W/HF GENERATOR

• HIGH-END UNIT AND MAINS POWER CORD

DVIU

• WORKING ELEMENT WITH SPRING ACTION AND MOVABLE THUMB SUPPORT

• TELESCOPE BRIDGE

• SACHSE URETHROTOME SHEATH

• OBTURATOR FOR SACHSE URETHROTOME SHEATH

• STERILIZATION/STORAGE TRAY

Resection o RESECTOSCOPE SHEATH WITH OBLIQUE BEAK AND OBTURATOR o DEFLECTING OBTURATOR FOR RESECTOSCOPE SHEATHS o WORKING ELEMENT WITH SPRING ACTION AND MOVABLE THUMB SUPPORT o CONNECTOR WITH TUBE ELLIK EVACUATOR o LUER-LOCK CONNECTOR WITH STOPCOCK o VIDEO URETERO-RENOSCOPE o 30°, 70°, PDD TELESCOPE WITH ENLARGED, AUTOCLAVABLE

VIDEO

32" 4K/3D MONITOR

SURGICAL PROCEDURE OPERATING SYSTEM WITH SOFTWARE LICENSE AND UPGRADES;

AND REQUIRED MODULES FOR PROCEDURE SPECIFIC CONNECTIONS; WITH KEYBOARDS

AND ADAPTERS

INSUFFLATOR ENDOFLATOR

MEDICAL GRADE PRINTER

"SLIM DESIGN SURGICAL CART W/OPEN SIDES KIT WITH CO2 TANK HOLDER XUSM0008"

LED LIGHT SOURCE

VARIABLE HEIGHT SECONDARY MONITOR STAND

TRANSMITTER + RECEIVER

CONTAINER SYSTEM, CAMERA HEADS

CAMERA HEAD

LIGHT CABLE, AUTOCLAVABLE

ENT

Sialendoscopy

• SIALENDOSCOPY TELESCOPE SEMI-RIGID

• FORCEPS, BOUGIE, SCISSORS AND SALIVARY INSTRUMENTS TRY

• SALIVARY DUCT PROBE, DILATOR, AND EXTRACTOR

Laryngoscopy

• OPERATING LARYNGOSCOPE

• SEALED CONTAINER SYSTEM FOR TELESCOPES FOR STEAM/STERRAD

• 0º, 0º TELESCOPE, F/BRONCHOSCOPY, ESOPHAGOSCOPY, AUTOCLAVE

• LIGHT CABLE

• 30º TELESCOPE, AUTOCLAVABLE, FOR ENT

• FIBER OPTIC LIGHT CARRIER

• SUCTION TUBE FOR LARYNGOSCOPE

• BENJAMIN SLIMLINE OPERATING LARYNGOSCOPE AND CANNULA

• ANTERIOR COMMISSURE, LARYNGOSCOPE

• STERILIZATION/STORAGE TRAY WITH TWO LEVELS

• FORCEPS, SCISSORS, ACCESSORIES HOLDER, PROTECTORS AND SUCTION TUBES

• SEALED CONTAINER SYSTEM FOR LAP SCOPES

• PHONOSURGERY STERILIZATION TRAY

Items to be purchased in the Base year of the contract:

Tulsa VAMC

• StreamConnect® - StreamConnect Server

• StreamConnect® - Video On Demand (Operating Room)

• StreamConnect® - EMR Connectivity

Muskogee VAMC

• Muskogee Streamconnect Migration - Muskogee

Qualifications of Contractor OEM-Trained Technicians: For a contract of this size, scope and complexity, the successful 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.

ASSEMBLY AND TRAINING:

Contractor must provide any product assembly and training as part of this contract. Delivery, assembly, and training must be coordinated with the local COR.

Contractor shall provide certified in-service training for all shifts of direct patient care, nurses, surgical service staff, physicians, and Biomedical (BESS) staff, in units where products will be used, at no additional cost to the Government, for any equipment new to this facility.

This training shall include hands-on product use and be extensive enough to prepare participants to train others.

Dates to be coordinated with facility and COR.

Training and support to be ongoing for users.

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.

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.

INSPECTION: All items and accessories shall be inspected after assembly (If applicable). Each resultant inspection shall be documented and provided to the COR within 7 days of assembly along with any inspection documentation or checklists required by the manufacturer. Any changes in inspection requirements during the period of assembly will be communicated to the Contractor immediately.

Inspection and Acceptance of Products and Services: The Government reserves the right to inspect and test services in accordance with this SOW and the Contract. The only individual authorized to officially accept services is COR. While inspection of services may be delegated by the COR and shared responsibility with departmental management staff, the COR is ultimately the only authorized individual to approve and accept services 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. Manufacturer’s warranty must begin on 1st Patient Day, which is currently scheduled for August 1st, 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.”

New Year’s Day January 1st

Martin Luther King’s Birthday Third Monday in January

President’s Day Last Monday in February

Memorial Day Last Monday in May

Juneteenth June 19th

Independence Day July 4th

Labor Day First Monday in September

Columbus Day Second Monday in October

Veteran’s Day November 11th

Thanksgiving Day Fourth Thursday in November

Christmas Day December 25th

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 guidelines and legislation, as well as VA Health Care System Directives and guidelines, relating to chemicals and usage of chemicals, to include pesticides;

c) 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);

d) local and state environmental laws as well as Environmental Protection Agency (EPA) regulations, Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), involving pesticide use and other pest control procedures;

REGULATORY REQUIRMENTS: Environmental Protection Agency (EPA) 40 CFR.

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

b. Department of Transportation (DOT) 49 CFR.

c. Occupational Safety and Health Administration (OSHA)

d. VHA DIRECTIVE 7708 Pollution Prevention Program

e. 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.

Contractor Point of Contact (POC) The Contractor shall specify an individual who shall serve as a single point of contact for all contract issues (POC). Contractor must provide the COR and Contracting Office with the POC contact details, including business phone number or cell phone number and email, as a minimum:

a) Within 5 business days of contract award,

b) Within 5 business days after renewal or extension of services in accordance with, and if permitted by applicable FAR clause, and

c) Within 5 business days prior to a change in the POC by the Contractor.

The POC must be easily accessible by phone and return COR calls within 48 hours of a voice message left by the COR.

Contracting Officer’s Representative (COR) Upon contract commencement, the Contracting Officer will notify the Contractor in writing as to the COR assigned to this contract, and upon reassignment of a new COR, as applicable. Contractor shall only respond to requests for changes, new products or service, from the COR or the CO. If any product or services is requested from any source, other than the COR or the CO, the Contractor is to advise the individual of this requirement and refuse to respond. Any billing resulting from unauthorized service will not be paid by the government. The COR will evaluate the contractor’s performance through review of the Contractor’s Quality Control Procedures in accordance with this contract and SOW.

Authority of the COR The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract. In the event the Contractor affects any changes at the direction of any person other than the Contracting Officer, the changes will be considered to have been made without authority, and no adjustment will be made in the contract price or schedule to cover any increase in costs incurred as a result thereof. The Contracting Officer shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract, and/or modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer. Any invoicing or charges resulting from unauthorized service will not be paid by the government.

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.

SECURITY:

Contract Personnel Security

Contractor must check in and out with COR when entering the VA and must be escorted while on VA premises.

Security requirements

Reference:

VA HANDBOOK 6500.6 APPENDIX B

VA HANDBOOK 6500.6 APPENDIX C

The C&A requirements do not apply, and Security Accreditation Package is not required.