Attachment 1 - SOW.doc

STATEMENT OF WORK (SOW)

as of 6/01/2026

1. Contract Title:

· Test, Measurement, and Diagnostic Equipment (TMDE) Calibration contract

2. Period of Performance:

· Period of performance will be a Base Year + 4 Option Year contract

3. Background:

· The George E. Wahlen VAMC needs this calibration contract to be put in place to ensure we comply with TJC requirements, ensuring our test equipment is certified and able to be used on medical devices to safely and accurately pass preventative maintenance inspections on equipment. Per TJC we cannot certify our own TMDE and need vendors with certified and calibrated equipment to ensure our devices are still accurate or make them accurate again.

4. Scope:

· The contractor shall provide calibration services to the list of equipment found below in Table. All services shall be provided in accordance with the specifications, terms and conditions contained herein. Some equipment must be sent/taken to the vendor’s facility for calibration, as indicated by an asterisk(*) at the beginning of the Model number. FSEs will notify Biomedical Engineering staff prior to removing/shipping any equipment.

· process requirement for the old item will be assigned to the new equipment and the list updated. The updated list will then be forwarded to the vendor.

Table A: Equipment models, EEs, serials, and locations that must be included in this agreement.

DM9510120

78980048

15160155

2122717

8974011

114K16109

114K16122

42530654WS

42530655WS

800396-108264

9547015

I419455

062507KWS01

36410042

71462604

13980160

88590217

73215175NNFC1225B

E1-18131509

90422

MNXN00075

J1340

062807KWS06

5. Specific Tasks:

5.1 Task 1 – Calibration:

· The vendor shall provide Calibration services within the month of June. This will include and required parts, system verification, alignment, and adjustments for the equipment listed in Table A. This is provided by the vendor at no additional customer cost than what is agreed upon in this contract.

5.1.1: Subtask 1 – Inspection and Calibration specifications:

· The vendor shall inspect and calibrate the Equipment listed in Table A in accordance with OEM policies and procedures for performing preventative maintenance in effect at the time the Services are performed.

6. Definitions/Acronyms:

· Biomedical Engineering - Supervisor or COR designee

· CO - Contracting Officer.

· COR - Contracting Officer's Representative.

· CM – Corrective Maintenance. Maintenance tasks that are undertaken to identify, isolate and repair a fault to restore equipment, a machine or a system to an operational condition so it can perform its intended function. Services may include troubleshooting, disassembly, adjustment, repair, part replacement, realignment, and operational verification to manufacturers or VA’s performance specifications, whichever is most rigorous.

· FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Outpatient Clinic premises.

· ESR - Vendor Engineering Service Report. Documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

· Acceptance Signature - VAMC employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR.

· Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR.

· NFPA - National Fire Protection Association.

· CDRH - Center for Devices and Radiological Health.

· VAMC - Department of Veterans Affairs Medical Center

· OEM - Original Equipment Manufacturer

7. Performance Monitoring:

· Performance monitoring will be conducted by the COR and subsequent necessary Biomed staff to certify that work was done in accordance with this contract. This work will be conducted via two ways.

· Vendor will need to report to Biomed any time they come on site to check in. This may include obtaining appropriate contractor ID badges from Police. This ensures we are aware of you on site and performing work. For more information on this monitoring step see section 9.5 Reporting Requirements

· Service Reports will be asked to be given by the vendor to list all work completed during the reporting period, as well as work scheduled for the upcoming period. This will ensure that timely progress is made by the vendor. Please see section 8.3 Service Report documentation.

8. Other Pertinent Information or Special Considerations:

8.1 Service Report Requirements:

· The documentation must be provided in a timely manner. Documentation delivery is not to exceed 72 hours post service. This documentation will include equipment downtime and detailed descriptions of the preventative maintenance procedures performed, including replaced parts and prices required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

· Name of Contractor

· Name of FSE who performed services.

· Contractor Service ESR Number/Log Number.

· Date, Time (starting and ending), Hours-On-Site for service call.

· VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours.

· Description of Problem Reported by COR/User.

· Identification of Equipment to be serviced to include the following: Equipment ID # or EE#/MX#/Nuvolo# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers.

· Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services), including Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action.

· Total Cost to be billed.

· Signatures from the following:

· FSE performing services described.

· VA Employee who witnessed service described.

· Equipment downtime calculated in accordance with Conformance Standards.

8.2 Service Manuals:

· The VAMC shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation, (such as operational and service manuals, schematics, and parts list), which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request.

8.3 Reporting Requirements:

· The contractor shall report to Biomedical Engineering to "check-in" upon arrival and prior to performance of work under this contract. This check-in is mandatory and can be accomplished in person or by phone contact. Prior to arrival, please follow the below instructions:

· VA SLC Campus Map which details the location of the patient parking garage and main medical center entrance.

· On the scheduled service date please call 801-582-1565 x1005 when you’re 30 minutes from the medical center.

· Please park your vehicle in the patient parking garage on the bottom level.

· Please re-call call 801-582-1565 x1005 once your vehicle is parked and then proceed to the medical center lobby.

a. The intended Biomedical Staff member will meet you in the main lobby to check in and take you to the equipment to be serviced.

· When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s). The FSE shall be required to check out with the Biomedical Engineering Department (location to be specified at time of contract award) and submit the ESR(s) to the COR. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature." If the COR is unavailable, a signed accepted copy of the ESR will be sent to the COR within 5 business days of work completion.

· Failure to comply, either in whole or in part, with either the notification or ESR requirements will be deemed significant non-compliance with the contract and may be justification for termination of the contract.

8.4 Condition of Equipment:

· The contractor accepts responsibility for the equipment described in Section B, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract.

8.5 Competency of Personnel Servicing Equipment:

· Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

· "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment identified in Section B. For field experience, the FSE(s) shall have a minimum of two years of experience, with respect to preventive maintenance on equipment identified in Section B.

· The FSE(s) shall be authorized by the contractor to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the contractor services at the VAMC. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VAMC equipment. The CO and/or the COR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAMC equipment.

8.6 Test Equipment:

· Prior to commencement of work on this contract, the contractor shall make available if requested a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to a national standard.

8.7 Identification, Parking, Smoking, Cellular Phone use and VA Regulations:

· The contractor's FSE shall wear visible identification at all times while on the premises of the VAMC. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VAMC will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

9. Risk Control:

9.1 Conformance Standards:

· Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment should be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

9.2 Reporting Required Services Beyond the Contract Scope:

· The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

9.3 Compliance with OSHA Bloodborne Pathogens Standard:

· The contractor shall comply with the Federal OSHA Bloodborne Pathogens Standard. The contractor shall:

· Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

· Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens.

· Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

· Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract

10. Place of Performance:

NOTE: Work at the Government site shall not be conducted on Federal holidays or weekends, unless otherwise instructed by the Contracting Officer.

· VA Salt Lake City Healthcare System

500 Foothill Drive

Salt Lake City, UT 84148

11. Delivery Schedule:

One Copy to COR

AT TIME OF CALIBRATION (JUNE)

12. Security Requirements:

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

END OF SOW