P09_STATEMENT OF WORK NuTrace Laser and Marking_2026.docx

STATEMENT OF WORK

VA Connecticut Sterile Processing Service NuTrace Laser and Marking

1. PURPOSE: To establish a contract for a NuTrace Laser marking device, scanners, marking service and maintenance. Obtaining this equipment and service will allow for traceability of reusable medical devices (RMD), enhance reprocessing workflows and efficiency, eliminate wasted time and effort during set assembly, support compliance with industry standards and regulatory requirements, and ultimately facilitate safe and effective Veteran care at VA Connecticut Healthcare System (VACHS).

The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to perform the following:

· Installation and implementation of a fully functional NuTrace NUX-20 laser unit and associated accessories, including a 1-year maintenance service period post installation.

· Training of 2 VA staff in Laser Safety and operation of the NuTrace NUX-20 laser unit, to include all safety accessories required.

· Laser marking of up to 35,000 instruments at 800 instruments per day minimum

2. EQUIPMENT and SERVICES The following equipment and services shall be provided and installed by the Contractor in the space determined by the Government. All equipment installed by the Contractor shall be FDA approved for use, in new condition, and fully operational in accordance with manufacturer literature specifications. A minimum of two (2) copies of any associated operational and/or service manuals shall be provided for all equipment listed below as applicable.

The Contractor shall provide all tools and equipment necessary to properly and safely perform the services set forth within this statement of work. This shall include, but is not limited, to all Personal Protective Equipment (PPE) and Laser safety equipment to safely operate the laser etcher required for the work to be completed in a safe manner. The Contractor shall provide any equipment necessary for proper infection control measures during installation.

"The A&A requirements do not apply and a Security Accreditation Package is not required”

3. SALIENT CHARACTERISTICS

The Contractor shall provide a fully functional system that meets the following characteristics:

· NuTrace NUX-20 NG laser unit.

· Computer/Laptop with the most recent Windows operating system and supporting accessories

· Fumex Fume/Odor extractor equipment

· FA1-M-NuTrace Select & Mark templates. Different laser configurations for different instrument materials included GS1 Codes.

· Safety glasses to operate the laser

· Electropolishing Unit with proprietary solution Ratero

· Laser must produce a data matrix that is CensiTrac compatible and be capable of marking devices of various materials including titanium, anodized titanium, anodized aluminum, stainless steel, plastics, brass, ceramic and more.

· Warranty starting on date of set up not date of delivery.

· Installation includes unpacking, making all connections and adjustments prior to training staff. Installation includes any cable, data cables or other electronic wiring outside of electrical utility at the West Haven VA Medical Center.

· NuTrace R+ Scanners

· Capable of reading a 2D Data Matrix in < 0.5 seconds per instrument, irrelevant of instrument contrast, instrument material or position of the code

· Capable of reading a 2D Matrix as small as .010 X.010mm (4mils).

· Stainless steel body housing able to be cleaned with hospital disinfectants.

· Warranty starting on date of set up not date of delivery.

· Installation includes unpacking, making all connections and adjustments prior to training staff. Installation includes any cable, data cables or other electronic wiring outside of electrical utility at the West Haven VA Medical Center.

· Laser Start Up Training

· Laser Institute of America or equivalent certification of 2 VA staff.

· Up to 32 hours of training Online and On-site.

· Marking of sample instruments of various materials including stainless steel, aluminum, titanium, and plastic.

· Data entry/Editing – Existing instruments already marked will be reviewed for accurate description and unnecessary duplicates will be eliminated.

· Laser Etching

· Unique Device Identifier (UDI) application of up to 35000 instruments at 800 instruments per day minimum, instruments of various materials.

· Data entry/Editing – Existing instruments already marked will be reviewed for accurate description and unnecessary duplicates will be eliminated.

· Any marks not being picked up and read by scanners will be removed and reapplied.

· Commissioning of marked instruments in CensiTrac instrument tracking system.

· Count sheet revisions – as directed by and agreed to by VA SPS Leadership, we will edit and make necessary count sheet changes.

· Contractor shall make recommendations for surgical instrument replacement which may be pertinent to meet the scope of surgical tray completion.

· Instruments will not be altered, changed or tampered in any way that results in non-compliance with manufacturers original design specifications or ANSI-AAMI ST-79.

· Contractor must communicate and collaborate with VACHS SPS staff on how to best schedule instrument marking to minimize OR downtime, prevent case delays, and support efficiency in the Sterile Processing department.

· Laser Service Maintenance contract for a period of 1 year from the date of set up, not date of delivery, inclusive of:

· Any Preventative Maintenance recommended in manufacturers instruction for use

· Mechanical repairs as needed

· On-location specialist for 3 days per year

· Any costs associated with the shipping or use of a loaner laser device

4. PLACE OF PERFORMANCE

Department of Veterans Affairs VA Connecticut Healthcare System Sterile Processing Services (SPS) 950 Campbell Avenue West Haven, CT 06516-2770

5. INSTALLATION

1. The Contractor shall provide all labor, materials, tools, equipment etc. to prepare for and safely complete the installation of the equipment in the space determined by the Government.

1. Project implementation meetings, if necessary, shall be coordinated with the COR.

1. Installation and implementation dates are to be coordinated in advance with the Contractor and the COR.

1. All employees of the Contractor and subcontractors shall comply with VA security management program and obtain the permission of the VA police, be identified by project and employer, and restricted from unauthorized access.

1. Before work is performed and during the entire performance period when work is being conducted the contractor shall ensure they possess or obtain the necessary credentials/badges needed to enter/exit the facility to include obtaining access to needed and specific site areas where instruments are located. Coordination and check-in with the VA police and other appropriate security personnel may be required. Contractor shall coordinate with the COR, other authorized representative, or the Contracting Officer if assistance is needed.

1. Contractors must comply with all applicable VA, HIPAA, and OSHA regulations.

1. All installation personnel shall be trained by the manufacturer on how to properly install the equipment. Resumes and certifications shall be submitted for review upon request by the Government.

1. All installation personnel shall be trained by the manufacturer on safe and proper Personal Protective Equipment (PPE) usage and general infection control regulations and requirements relevant to the work outlined in the Scope of Work.

1. The Contractor shall communicate to the Government the estimated downtime required to complete full installation and testing of NuTrace Laser. If the Contractor is unable to install the equipment to its normal operational state within 24 hours the Contractor shall compensate the Government for the downtime by extending the warranty service in a period equivalent to the downtime of the equipment.

1. The Contractor shall be responsible for the safe removal and disposal of all trade-in equipment as applicable.

1. The Contractor shall be responsible for the safe removal and disposal of all packing materials and related waste generated during installation.

6. TRAINING

The Contractor shall provide a comprehensive onsite training program for the VACHS operating personnel on use of all equipment provided or installed. This training program shall include at the minimum the following sessions: (i) Technical Training, (ii) Operational Training, (iii) Administrative Training, and (iv) Hardware and Software Troubleshooting. Training shall occur onsite during normal business hours, 7:30am-4:00pm, Monday through Friday, with alternate hours as needed and mutually agreed upon. Competency assessments shall be provided with the training. Onsite training is to be scheduled in advance with the VACHS through the COR.

The Contractor shall provide onsite general overview technical training for Clinical Engineering personnel as requested. Training shall include a technical overview of the mechanics, electronics, and general operations of the system. Training shall cover detailed instruction regarding the preventative maintenance, troubleshooting, and general maintenance of the equipment.

Training service will also include:

• UDI Application- Surgical instruments will be marked with a unique device identifier on instruments of various material including titanium, anodized titanium, anodized aluminum, stainless steel, plastics, brass, ceramic and more.

• Data entry/Editing – Existing instruments already marked will be reviewed for accurate description and unnecessary duplicates will be eliminated. Any marks not being picked up and read by Tenth Medical Group scanners will be removed and reapplied using our approved Class I laser. We are certified by the OEM on using this technology and can also provide necessary training to end users for sustainability.

• Count sheet revisions - as directed by and agreed to by VACHS Leadership, we will edit and make necessary count sheet changes to help eliminate tray picking errors.

• Identify all missing instruments needed to make sets complete, finding replacements as available, then marking them and entering them into the system.

• Quality Assurance- each device that has been laser marked will also be individually examined.

7. INSPECTION AND ACCEPTANCE

1. The Contractor shall conduct a joint inspection with the COR upon delivery of equipment and again after installation/startup

1. Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s).

1. The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer.

8. WARRANTY

1. The contractor shall provide an 18-month manufacturer’s warranty on all parts and labor.

1. The warranty shall include all travel and shipping costs associated with any warranty repair.

1. Laser Service Maintenance for a period of 1 year from the date of set up, not date of delivery as previously described.

9. TASK FREQUENCY AND INSTRUCTIONS

The work set forth in the Scope of Work shall be completed in a single visit, be it a single day or multiple days as required for appropriate completion. All work is to be scheduled in advance with the COR.

Equipment delivery shall not precede installation by more than 20 days. Installation and implementation must be immediately followed by clinical user training including “go live” support. Implementation and integration with VA Systems shall not exceed 90 days from date of award.

10. SPECIAL WORK REQUIREMENTS

The Contractor shall comply with all Infection Control Risk Assessment requirements deemed appropriate by the VACHS during all portions of the work set forth in the Scope of Work.

The Contractor must comply with security, privacy, and safety issues in accordance with VA standards, policies, and directives set forth at all times while providing the work outlined in the Scope of Work.

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

The Contractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

11. PROPERTY DAMAGE

The contractor shall take all necessary precautions to prevent damage to any government property. 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. Any damaged material 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.