36C24726Q0066.docx

Special Notice Special Notice

GENERAL INFORMATION

VETERANS HEALTH ADMINISTRATION

Network Contracting Office (NCO) 7 2957 CLAIRMONT ROAD NE, Suite 1200 Atlanta GA 30329

POINT OF CONTACT*

Contract Speaclist Jessica Cummings Jessica.Cummings3@va.gov

(803) 776-4000 x7801

ADDITIONAL INFORMATION

AGENCY’S URL

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AGENCY CONTACT’S EMAIL ADDRESS

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DESCRIPTION

The Department of Veterans Affairs Network Contracting Office 7 Acquisition Plan Action ID:

544-26-1-045-0010

Department of Veterans Affairs (VA), Network Contracting Office (NCO 7), Columbia VA Health Care System, intends to award a sole source procurement to:

Stryker Sales LLC.

1941 STRYKER WAY

PORTAGE, MI 49002-97

This procurement will be made under the authority of FAR 13.106-1(b), “Soliciting from a Single Source.”

This requirement is for a firm-fixed price service contract for the Stryker TGS ENT Navigation System, encompassing Preventive and Corrective Maintenance as well as software support for the covered items. Covered items include the Electromagnetic Navigation Unit, Field Generator, Field Generator Mounting Arm, Patient Tracker, Registration Pointer, and Scopis ENT Software. This system is owned by the Columbia VA Health Care System, Columbia, SC.

The NAICS Code of 811210-Electronic and Precision Equipment Repair and Maintenance with a size standard of $34 million. A Limited Sources Justification has been prepared.

Place of Performance:

WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, SC 29209

This notice of intent is not a request for competitive proposals. It is not a solicitation or request for offers. No solicitation package is available. A determination not to compete is solely within the discretion of the Government. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses must be received no later than 12:00 pm EST on Tuesday, October 17, 2025. No telephone inquiries or emails with questions will be accepted. Responses may be emailed to Jessica.Cummings3@va.gov

Disclaimer:

This Notice of Intent to Sole Source is issued solely for information and planning purposes. It does not constitute a solicitation or a commitment by the Government. A solicitation will not be issued. The Government will not reimburse costs incurred by the any party that responds to this notice.

Statement of Work

Maintenance and Service for TGS Navigator

1. REQUIREMENT:

This requirement is for a firm-fixed price service contract for the Stryker TGS ENT Navigation System, encompassing Preventive and Corrective Maintenance as well as software support for the covered items. Covered items include the Electromagnetic Navigation Unit, Field Generator, Field Generator Mounting Arm, Patient Tracker, Registration Pointer, and Scopis ENT Software. This system is owned by the Columbia VA Health Care System, Columbia, SC. Specific models and serial numbers are listed in the performance requirements below.

2. BACKGROUND:

The CVAHCS Medical Center is a 216-bed facility, encompassing acute medical, surgical, psychiatric, and long-term care. The hospital is located in Columbia, South Carolina and provides primary, secondary, and some tertiary care. Annually, the Medical Center serves approximately 56,116 patients. Satellite outpatient clinics are located in Anderson, Greenville, Florence, Orangeburg, Rock Hill, Sumter, and Spartanburg, South Carolina.

The Stryker TGS ENT Navigation System is critical for ensuring precise and accurate navigation during ENT surgical procedures. Maintaining optimal performance and reliability of this system is paramount to patient safety and surgical outcomes.

3. PERIOD OF PERFORMANCE:

This is a requirement for manufacturer recommended preventive maintenance services and repair service coverage. This requirement is for Base year and three (3) renewal options. The Period of performance shall be as follows:

Work is to be performed by the contractor during normal hours and must be accomplished during the allotted timeframe. Hospital business hours are Monday through Friday, 8:00AM – 5:00PM EST except Federal holidays. If extended hours are required to complete work the contractor must notify the COR/ACOR and the owning department prior to scheduling the work.

4. PLACE OF PERFORMANCE:

WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, SC 29209

Please schedule with COR/ACOR prior to any service visits.

Federal Holidays

Juneteenth Day June 19th

5. PERFORMANCE REQUIREMENTS:

A. A Contracting Officer Representative (COR) and/or Alternate Contracting Officer Representative (ACOR) shall be assigned to this procurement and written notification shall be provided to the Contractor after award.

a. Scheduling of work performance shall be arranged through the designated COR/ACOR assigned.

B. The contractor will be responsible for the following specific requirements:

a. Provide preventive and corrective maintenance services for the Stryker TGS ENT Navigation System, covering the following items:

i. Electromagnetic Navigation Unit

ii. Field Generator

iii. Field Generator Mounting Arm

iv. Patient Tracker

v. Registration Pointer

vi. Scopis ENT Software

b. Ensure all preventive maintenance services are conducted at manufacturer’s recommended frequency and corrective maintenance services are performed as needed.

c. Services and parts to restore damaged equipment to its normal operating condition.

d. Any and all replacement parts must be Original Equipment Manufacturer (OEM) supplied parts.

e. All software and firmware updates required or recommended by the manufacturer, including proprietary operating system software enhancements.

f. Performance verification will be required at the conclusion of every preventive maintenance and emergency repair event. This verification procedure shall include performance testing for accuracy and precision of the system.

g. Each maintenance will include inspection for internal and/or external causes of mechanical, electrical, of software-related system failures.

C. Contractor shall provide all personnel, parts, tools, test equipment, service manuals, computer software and necessary upgrades/patches/firmware changes, applications support and schematics necessary to effect repairs and preventive maintenance procedures on the listed equipment. Due to the operations requirements of the hemodialysis section, work cannot be performed during normal hours and must be accomplished during working hours, 8:00am – 5:00 PM EST Monday through Friday except federal holidays, unless otherwise scheduled with the COR / ACOR. The following equipment shall be covered under this contract:

D. The Contractor’s service representative (CSR) shall contact the COR/ACOR to schedule an inspection or prior to responding to a service call.

a. CSR shall acknowledge receipt of a service call within 2 hours and shall arrive on the premises to effect repairs within 24 hours.

b. CSR shall provide, upon request, suitable loaners for contracted equipment that shall be out of service for more than 48 hours.

i. Equipment repaired by the CSR or loaned to the Medical Center by the contractor shall be calibrated and safety tested by the CSR before being placed into service.

ii. CSR shall not deviate from this protocol without the prior approval of designated COR.

E. The contractor’s service representative shall present the field service report to a representative of COR/ACOR for an authorized signature, leaving one legible copy for inclusion in the individual equipment’s Historical Maintenance Record. Contractor shall also provide COR/ACOR with a legible copy of the calibration reports including numerical values of measurements taken within 5 business days.

F. Preventive maintenance shall include, but not be limited to the following:

a. Electrical safety testing

b. Lubrication

c. Adjustments

d. Calibration

e. Testing and replacement of faulty parts and parts which are likely to fail at no additional charge

f. Returning the instruments or equipment to the operating conditions specified by the manufacturer, NFPA 99 and VA MP-3 guidelines.

G. The contractor shall be responsible for providing and applying any and all recommended manufacturer’s software updates, upgrades, and patches during the execution of this contract. Timing and device availability shall be coordinated with COR/ACOR.

EXPERIENCE/CERTIFICATION

All work shall be performed by competent, experienced personnel qualified to work on the specified equipment in accordance with good manufacturing practices. Prior to award Contractor shall provide factory training certificates/competencies for all technicians assigned to service the specified equipment, in accordance with JCAHO standards. Technicians assigned to provide services to the equipment shall provide evidence of OEM training in the form of factory training certificates that are within their expiration date. These OEM certifications shall clearly identify the technicians’ name, the training center, and the equipment the technician was trained to service. Technicians shall provide certifications that indicate they were trained on all items / equipment listed as to be covered under this contract. Such certificates/competencies are to be submitted to COR/ACOR within 30 days from date of contract award. Failure to provide required documentation shall result in non-payment of invoices for this service.

Per ISO 9001, contractor shall list all the test equipment that had been used along with the details on the service report during any service associated with the medical equipment to include, but not limited to:

· Test equipment name

· Equipment Calibration due date

· Model

· Serial number

· Manufacturer

REPORTS:

The Contractor’s Service Representative shall present a Field Service Report to the designated COR for an authorized signature, leaving one legible copy for inclusion in the individual Equipment’s Historical Maintenance Record.

Contractor shall provide the designated COR with a legible copy of the Calibration Reports including numerical values of measurements taken within five (5) business days.

A copy of the Preventive Maintenance Inspection procedure (including Qualitative and Quantitative tests) used by the Contractor Service Representative for each item listed on the contract, shall be made available upon request.

SAFETY:

Contractor shall ensure all tools and equipment are secured at all times.

· Tools and equipment must be removed from open areas or stored in secured location during breaks, lunch, and/or at the end of each work day.

· All debris must be removed from the facility upon completion of service each day.

Operation of the equipment for testing, servicing, or any other purpose shall be done only in secured areas designated by the COR/ACOR and away from the general patient population.

Contractor shall ensure proper signage and/or blockage of service area is provided and clearly visible to ensure patient/employee safety is adhered to.

Smoking is not permitted within the facilities at any time. All smoking shall be conducted in designated smoking areas only.

6. INVOICES:

a. Payment shall be made monthly in arrears, invoices shall be prepared by the Contractor, and submitted through Tungsten Network (formerly known as OB10) http://www.tungsten-network.com/us/en/. A properly prepared invoice shall contain:

· Invoice Number and Date

· Contractor’s Name and Address

· Accurate Purchase Order Number

· Supply or Service provided

· Period Supply or Service Provided

· Total Amount Due

b. Please begin submitting your electronic invoices through the Tungsten Network for payment processing, free of charge.

c. If you have questions about the e-invoicing program or Tungsten Network, contact information is as follows:

· Tungsten e-Invoice Setup Information: 1-877-489-6135

· Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

· FSC e-Invoice Contact Information: 1-877-353-9791

· FSC e-invoice email: vafsccshd@va.gov

d. Web Address: HTTP://WWW.FSC.VA.GOV/EINVOICE.ASP

7. TERMINATION FOR CONVENIENCE: In accordance with FAR 52.212-4 (l) The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience.

8. RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS:

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

h. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

i. No disposition of documents shall be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

RECORDS MANAGEMENT AND CONTRACT SECURITY

1. A. Contractor shall comply with VA Handbook 6300.1 Records Management Procedures and VA Handbook 6500.6 Contract Security. Both can be found at:

https://www.va.gov/vapubs/search_action.cfm?dType=2 **Note: This link is the complete list of VA Handbooks and are in sequential order.

**Instructions for accessing VA Handbooks at link listed above:

· • Click on link above and once it is opened, please scroll down on the left side until you get to VA Handbook 6300.1.

· • Once there, go to the PDF Format Column and click on PDF.

· • VA Handbook 6300.1 will then ask you to open or save the document.

B. Please follow the same instructions listed above for accessing VA Handbook 6500.6.

· All contractor employees working on this requirement are required to complete mandatory annual training entitled, “VA Privacy and Information Security Awareness” and “HIPPA Training” prior to providing service for each year of the contract with copies sent to the COR for each and available for audit as requested. The course numbers are VA10203 and VA 10176. You must select that you are a contractor. Contractor employees are to self-enroll into TMS via the link: https://www.tms.va.gov/learning/user/SelfRegistrationUserSelection.do

· A VA employee will escort the contractor when contractor is required to enter/work in sensitive areas.

B9. IDENTIFICATION, SMOKING AND VA REGULATIONS

The Contractor's FSE shall wear visible identification always while on the premises of the Columbia VA Medical Center. Contractor shall contact the Contracting Officer’s Representative (COR) upon contract award, to receive instructions on how to obtain a VA Identification Badge during the performance of this contract. Columbia VA Medical Center is a smoke free campus which includes both tobacco and e-cigarettes; tickets can be issued by Police Services. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court. Photography or Video on medical center premises is strictly prohibited. Additionally, pursuant to 38 CFR 1.218(b) (23) Use of recording devices of any kind to record patients or employees is strictly prohibited.

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