Lexington Audiology SOW.pdf

Lexington VA Health Care System FY26

Statement of Work: Service Contract on Audiology Equipment

I. Equipment

Equipment to be serviced/maintained includes:

Equipment EE S/N Month Due Location Comments

Booth 19385 109858-

D223 April Bowling

Booth 19386 109858-

D224 April Bowling AUDIOSTAR PRO 83918 GS0064177 April Bowling AUDIOSTAR PRO 84728 GS0070477 April Bowling Titan 81595 0943372 April Bowling Verifit 111518 C6896 May Sousley Titan 106250 1011243 May Sousley EyeSeeCam 111615 1040972 May Sousley VisualEyes 111598 1041269 May Sousley Air FX 111538 1039602 May Sousley Eclipse 118731 1007485 May Sousley Eclipse 118732 1019886 May Sousley Binocular Goggles 84473 16255072 May Sousley Included with VisualEyes Binocular Goggles 84474 16289227 May Sousley Included with VisualEyes BerTec 117974 S055400 January Sousley Voyageur 117975 S055305 May Sousley Included with Bertec Verifit 2 111514 C6892 May Sousley Titan 111534 1040283 May Sousley Verifit 2 111517 C6895 May Sousley Titan 111526 1041326 May Sousley Verifit 2 111516 C6894 May Sousley Titan 111528 1040302 May Sousley Verifit 2 111520 C6898 May Sousley Titan 111532 1040340 May Sousley Titan 111531 1041325 May Sousley Titan 111533 1041321 May Sousley AUDIOSTAR PRO 114672 GS0098021 May Sousley AUDIOSTAR PRO 114670 GS0098022 May Sousley AUDIOSTAR PRO 118733 GS0098711 May Sousley Titan 111529 1040346 May Sousley Titan 111527 1040293 May Sousley Verifit 2 84159 C2577 May Sousley Verifit 2 111519 C6897 May Sousley

Titan 83584 947680 May Sousley Titan 81594 943359 May Sousley Verifit 2 84157 C2575 May Sousley AUDIOSTAR PRO 90316 GS0076986 August Berea Booth 104374 HC-57005 May Sousley Booth 104372 HC-57004 May Sousley Booth 104373 HC-57003 May Sousley Booth 104371 HC-57002 May Sousley AUDIOSTAR PRO 114671 GS0098722 May Sousley Titan 111530 1040279 May Sousley Verifit 111515 C6893 May Sousley Titan 74962 0919350 August Berea FreeFit 105941 422668 August Hazard Madsen Zodiac 105940 1916216 August Hazard Madsen Astera2 71663 432683 August Hazard Titan 106252 1018145 August Somerset AUDIOSTAR PRO 111535 GS0109280 August Somerset Eclipse 108406 1000899 August Somerset Verifit 2 85005 C2687 August Somerset Eclipse 108407 100090 August Berea Madsen Astera2 75944 996061 August Berea Titan 106251 1012980 August Berea FreeFit 74581 953433 August Berea Booth 101368 HC-53549 August Berea Verifit 2 84156 C2574 August Berea

AIR FX 83861

AIR1-30-

1027 August Somerset VisualEyes 83854 P5890-3 August Somerset Tinnometer 93400 TINSB006B1 May Sousley Titan 85078 0958528 August Somerset Booth 90330 HC-55779 August Somerset

Equipment is located at:

Bowling Campus, 1101 Veterans Drive, Lexington, KY 40502 Sousley Campus, 2250 Leestown Road, Lexington, KY 40511 Berea Campus, 209 Pauline Drive, Berea, KY 40403 Hazard Campus, 160 Nautilus Drive, Hazard, KY 41701 Somerset Campus, 300 Medpark Drive, Somerset, KY 42503

Period of performance is as follows:

• Base Year: 10/1/2025-9/30/2026

• Option Year 1: 10/1/2026-9/30/2027

• Option Year 2: 10/1/2027-9/30/2028

• Option Year 3: 10/1/2028-9/30/2029

• Option Year 4: 10/1/2029-9/30/2030

II. Scope of Services

Routine calibrations for audiology equipment. Any repairs or unscheduled service require prior approval and applicable charges.

Calibrations shall be completed per the following schedule based on location and equipment type:

Bowling Campus – April Sousley Campus – May Berea Clinic – August Hazard Clinic – August Somerset Clinic – August

• Analyzers: Physio: Middle Ear o Frequency: annual o Procedure: immittance calibration

• Audiometers o Frequency: annual o Procedure: audiometer calibration, secondary phone calibration, hi-frequency phone calibration

• Electronystagmographs, Videonystagmographs, Irrigators: Medical/Surgical o Frequency: annual o Procedure: engineering calibration

• Testers: Hearing Aid o Frequency: annual o Procedure: H.A./probe analyzer calibration

• Tinnometers o Frequency: annual o Procedure: hi-frequency phone calibration

• Recorders: Physio: Evoked Potential o Frequency: annual o Procedure: ABR calibration

All charges for parts, services, manuals, tools, or software required to successfully complete scheduled services are included within this contract. The Medical Center shall not provide any parts, manuals, tools, or software to the Contractor, and all equipment documentation, including operator and service manuals, parts lists, and schematics shall be readily provided to the Contracting Officer (CO) upon request.

All replacement parts furnished shall be new original equipment manufacturer (OEM). The Contractor shall not modify the system to facilitate replacement parts which are not identical to the part being replaced, unless such modification was developed, approved, and released by the OEM. Any used or replaced parts shall remain the property of this Medical Center unless released to the Contractor by the Contracting Officer’s Representative (COR).

Any charges outside the scope of this contract, including unscheduled service or repairs, must be approved by the COR prior to performing service.

III. Conformance Standards and Condition of Equipment

The Contractor shall ensure that the equipment functions in conformance with manufacturer specifications and the latest published editions of NFPA-99 and OSHA. This includes performance standards and specifications used when the equipment was procured and any upgrades/updates thereafter. Test equipment shall be within manufacturer specifications and calibrated at required intervals. Calibrations shall be traceable to a national standard. Any test equipment calibration certificates shall be provided to the CO and COR upon request.

The Contractor accepts responsibility for the equipment described above 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.

The Contractor shall immediately, but not 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 above equipment which the Contractor considers out of scope under the terms of this contract. The Contractor shall furnish the CO and COR with a written cost estimate of the necessary repairs.

IV. Hours of Coverage

Normal hours of coverage are Monday-Friday, 8:00am to 4:30pm (EST), excluding national holidays recognized by the Department of Veterans Affairs. All services will be performed during normal hours of coverage unless requested and approved by the COR. Observed holidays include:

New Year’s Day Labor Day Martin Luther King Day Columbus Day President’s Day Veterans Drive Memorial Day Thanksgiving Day Juneteenth Christmas Day

Independence Day

Work performed outside the normal hours of coverage at the request of the COR will be billed at the Contractor’s applicable rate. Work performance outside the normal hours of coverage at the request of the Contractor will be considered normal hours. There shall be no additional charge for time spent on-site during or after normal hours of coverage awaiting the arrival of additional FSE, finishing any maintenance services, and/or delivery of parts.

V. Scheduled Maintenance

All preventative maintenance (PM) and/or calibration services shall be completed in accordance with Manufacturer’s requirements and recommendations. A PM inspection shall include, at a minimum, the following:

• Cleaning and calibration of equipment

• Review of operating system and software application diagnostics and correction

• Remedial maintenance and lubrication

• Inspection and testing of all system components, hardware, electrical wiring and cables, and peripherals

• Replacement of all worn and fault components, hardware, electrical wiring and cables and peripherals, including any of the above which are likely to become worn, faulty, or fail

• Returning the equipment to Manufacturer operational condition, as defined in Conformance Standards.

• Providing electronic documentation of all services performed to the end user, COR, and Biomedical Engineering

VI. Unscheduled Maintenance

Parts and repairs are to be approved prior to service and are billed accordingly. All repair services shall be completed in accordance with Manufacturer’s requirements and recommendations, as well as the Conformance Standards. The Contractor shall provide full service of diagnosis and remediation to maintain the equipment in operational condition. The Contractor’s FSE must respond with a phone call within (1) hour of service notice and with on-site services within (1) business day. Repair services may consist of troubleshooting, replacing failed components, calibration, cleaning, adjustments, and in situations of severe malfunctions that cannot be repaired, replacement of the unit. All services performed shall be electronically documented and provided to the end user, COR, and Biomedical Engineering.

The Contractor must show satisfactory evidence to the VA that efforts and manpower are progressing to troubleshoot failure and identify a solution in a timely manner. If the Contractor fails to meet the on-site response time to begin performing work, or if downtime exceeds 16 consecutive hours after on-site arrival by the FSE, the VA reserves the right to obtain repair services from another source at the Contractor’s expense. The decision to exercise the alternative repair will reside exclusively with the CO.

VII. Sign-In and Documentation:

During normal hours of coverage, the Contractor, shall enter their signature on the sign-in sheet and receive a temporary ID badge in the Engineering Office, Room D232, second floor of the Main Building. Upon departure, the Contractor shall sign-out on the same sheet, return the ID badge, and leave any hard-copy documentation in D234. During non-normal hours, the Contractor shall sign-in with the Police Service, C101 Main Building, upon arrival and departure.

The ID badge must always be displayed while on the premises of the Medical Center. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the Police Service. The Medical Center will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the Medical Center. 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.

Documentation shall include detailed descriptions of the scheduled and unscheduled maintenance procedures performed. Documentation shall be submitted within three (3) business days of the maintenance performed. Procedures used for PM inspections shall be submitted with each report. The Contractor shall, at a minimum, thoroughly record the following items:

• Name of Contractor

• Name of FSE who performed the service

• Date and time during which services were rendered

• VA PO#(s) associated with the services

• Description of problem reported

• Identification of equipment to be serviced, including model number, serial number, and any other identifying information

• Itemized description of services performed (including costs of items to be billed)

• Total cost to be billed

• Signatures of FSE and VA employee who witnessed service

VIII. Competency of Personnel Service Equipment

The Contractor shall have an established business with a full-time staff, including a fully qualified FSE and backup fully qualified FSE. Fully qualified is based upon training and field experience. All personnel servicing equipment under this contract must have been factory trained by the OEM and have completed a minimum of (2) years of field work. The FSEs shall be authorized by the Contractor and OEM to perform services on the above equipment. Training documentation and related certifications shall be provided to the CO and COR upon request.

The CO and COR reserve the right to reject any personnel and refuse them permission to work on the above equipment.

IX. Security and Privacy of VA Sensitive Information

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

All media (hard drives, DVD’s, Floppies, etc.) that contains sensitive data must be surrendered to the Medical Center (Biomedical Engineering) and may not leave VA property.

All Contractor-owned media (USB drives, DVD’s, CD’s, Floppy disk) that is to be inserted into a medical device must be scanned by Biomedical Engineering prior to being placed in the medical device.

Records Management

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the

Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. Lexington VA Health Care System and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation.

Records may not be removed from the legal custody of Lexington VA Health Care System or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity.

Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Lexington VA Health Care System. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the

Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Lexington VA Health Care System control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle].

Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Lexington VA Health Care System guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Lexington VA Health Care System policy.

8. The Contractor shall not create or maintain any records containing any non-public Lexington VA Health Care System information that are not specifically tied to or authorized by the contract.

9. The 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 from public disclosure by an exemption to the Freedom of Information Act.

10. The Lexington VA Health Care System owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Lexington VA Health Care System shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.