STATEMENT OF WORK NATUS 2.pdf

STATEMENT OF WORK

SECTION C - DESCRIPTION/SPECIFICATIONS

FOR SERVICE OF MEDICAL EQUIPMENT

El Paso VAMC is requesting a full service/maintenance of all our Natus systems. The services requested would allow the Neurology Department and Sleep Clinic to facilitate patient care more efficiently without the possibility of turning away or referring patients out due to broken/faulty equipment. The services needed is to include all items listed below.

S/N PERIOD DATE

1 BASE YEAR

2 OPTION YEAR 1

3 OPTION YEAR 2

4 OPTION YEAR 3

5 OPTION YEAR 4

6 SECTIONS 52.217-8 AND 52.217-9 INCLUDED

EEG System

Natus Base Unit SN:16862209907, Natus Brain Monitor SN:21911164777, 120V Isolation

Transformer for Quantum System SN:2240056, IP PTZ ErgoJust Video Extension

SN:IPECHDVEM002800, NATUS PHOTIC STIM, NATUS PHOTIC STIM KIT

SN:10440S11954, NeuroWorks Acquisition Software SN:32844, NeuroWorks Review Software

SN:32844, NeuroWorks/SleepWorks Acquisition Software SN:32843, NeuroWorks/SleepWorks

Data Server Software SN:33459, Tablet PC Trex SN:12292505353, Trex HD Headbox

SN:19245090861, XLTEK EEG/PSG DELL OPTIPLEX SN:1RWKKQ3, XLTEK EEG/PSG

DELL OPTIPLEX SN:7PWKKQ3.

EMG System

2015 Visual Stim SN:6269, 2015 Visual Stim with LCD Monitor SN:IV234310M, 24”Display

SN:ETBBL0038904U, EDX 8 channel Amplifier SN:C220808078, EDX Base Unit

SN:C230425013, EDX US/Canada + Base Unit SN:RZ233452M, EDX Window 10 Desktop

SN:2LY7XP3, EMG USB Control Panel SN:C220706197, ELTEK EEG/PSG DELL

OPTIPLEX SN:GP0L3Q3.

PSG/SLEEPWORKS System

Embletta MPR PG- SN: EBMPG-C1010664, EBMPG-C1010560, EBMPG-C1010772, EBMPG-C1009760, EBMPG-C1009761, EBMPG-C1009780, EBMPG-C1011018, EBMPG-

C1011099, EBMPG-C1011393, EBMPG-C1011505, EBMPG-C1011506, EBMPG-C1011507,

EBMPG-C1011508, EBMPG-C1011509, EBMPG-C1011511, EBMPG-C1011513, EBMPG-

C1011514, EBMPG-C1011515, EBMPG-C1011517, EBMPG-C1011518, EBMPG-C1011519,

EBMPG-C1011524, EBMPG-C1011525, EBMPG-C1011527, EBMPG-C1011528, EBMPG-

C1011529, EBMPG-C1011530, EBMPG-C1011531, EBMPG-C1011532, EBMPG-C1011533,

EBMPG-C1011534, EBMPG-C1011535, EBMPG-C1011536, EBMPG-C1011537, EBMPG-

C1011539, EBMPG-C1011541, EBMPG-C1011543, EBMPG-C1011552, EBMPG-C1010487,

EBMPG-C1011753, EBMPG-C1011754, EBMPG-C1011761, EBMPG-C1011763, EBMPG-

C1011781, EBMPG-C1011782, EBMPG-C1011796, EBMPG-C1011798, EBMPG-C1011783,

EBMPG-C1011805, EBMPG-C1011826.

FHD IP PTZ Tile Kit- SN: 022638M001622, 022638M001624, 022638M001626, 022638M001628, 022638M001629, 022638M001630.

Pulse Oximeters- SN: 505866512, 505866533, 505873192, 505873232, 505873237, 505873248, 505866497, 505873242, 505853795, 505866568, 505873730, 505873926, 505873972, 505874023, 505874052, 505874067, 505874080, 505874319, 505874421, 505874460, 505874477, 505874488, 505874374, 505874398, 505874212, 505874221, 505874241, 505874245, 505874250, 505874272, 505893590, 505893591, 505893596, 505893610, 505893611, 505893639, 505893661, 505893672, 505893677, 505893679, 505893694, 505893702, 505873229, 505866562, 505866535, 505874521, 505874540, 505957875, 505958099, 505958120.

Natus Base Unit- SN: 16862200443, 16862200442, 16862200440, 16862200441, 16862200444, 16862200445.

Natus Embla NDx Breakout- SN: 21919132115, 21919132116, 21919132117, 21919132118, 21919132119, 21919132120, 21919132129.

NeuroWorks/SleepWorks 9.x 1-User (HL7) License- SN: 33729, 33730.

SleepWorks 9.x Embletta Software License (Embletta Only)- SN: 33758, 33759, 33760, 33761, 33762, 33763, 33764, 33765, 33766, 33767, 33768, 33769, 33770, 33771, 33772, 33773, 33774, 33775, 33776, 33777, 33778, 33779, 33780, 33731, 33732, 33733, 33734, 33735, 33736, 33737, 33738, 33740, 33741, 33742, 33743, 33744, 33745, 33746, 33747, 33748, 33749, 33750, 33751, 33752, 33753, 33754, 33755, 33756, 33757.

SleepWorks 9.x Acquisition Software with Spike- SN: 33723, 33724, 33725, 33726, 33727, 33728.

Upgrade NeuroWorks/SleepWorks 9.x Data Server Software SN: 33782.

Upgrade SleepWorks 9.x Review Software NON-Natus PC SN: 33781.

XactTrace Pre-sized Belts Snap Sensors, Abdomen and XactTrace Snap Sensors Pre-sized Belts, Thorax

XLTEK EEG/PSG DELL OPTIPLEX- SN: 1Y3L3Q3, 3GBL3Q3, 8L9NKQ3, CL9NKQ3,

FVZKKQ3, HX3L3Q3.

Prem Intercom System w/ Recording

II. DEFINITIONS/ACRONYMS:

A. Biomedical Engineer - Supervisor or designee.

B. CO - Contracting Officer

C. COR - Contracting Officer's Representative

D. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

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

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

G. Acceptance Signature - VA employee who is authorized to sign-off on the ESR which indicates that the Emergency Repair has been accomplished or in a pending status.

H. Authorization Signature – COR’s signature; indicates acceptance of work status as stated in

ESR.

I. OEM – Original Equipment Manufacturer

J. VA - Department of Veterans Affairs

K. ELPVAHCS – El Paso VA Health Care System

III. CONFORMANCE STANDARDS:

A. Contractor shall ensure that the equipment functions in conformance with the latest published edition of the applicable standards, such as: NFPA-99, UL, OSHA, JCAHO, VA, etc. and the

“Manufacturer's Performance Standards/ specifications” as used when the equipment was originally procured and that any upgrades/updates shall meet or exceed the stated standards/specifications.

B. Contractor shall comply with the Privacy Act of 1974 and the agency rules and regulations issued under the Act.

C. Contractor shall comply with Health Insurance Portability and Accountability Act of 1996

(HIPAA) and the agency rules and regulations issued under the Act surrounding access, protection and confidentiality of personal health information and individually identifiable information.

D. The Certification and Accreditation (C&A) requirements do not apply and a Security

Accreditation Package is not required.

IV. HOURS OF COVERAGE:

A. Vendor shall provide telephone support 24 hours a day, 7 days a week.

B. Vendor shall provide unscheduled maintenance Mondays - Fridays, 8:00 AM-6:00 PM local site time for NATUS Systems, Mondays - excluding Federal Holidays.

C. Vendor shall provide planned maintenance scheduled at a mutually agreeable time Mondays

- Fridays, 8:00 AM-6:00 PM local site time for NATUES Systems, excluding Federal

Holidays.

D. COR or designated alternate shall provide reasonable access to the equipment, reasonable working space, and a reasonable safe, hazard-free operating environment for contractor’s employees and representatives providing services hereunder during hours of coverage.

E. Federal Holidays observed by the ELPVAHCS are:

New Years' Day Labor Day

Martin Luther King Day Columbus Day

Presidents' Day Veterans' Day

Memorial Day Thanksgiving Day

Independence Day Christmas Day

V. UNSCHEDULED MAINTENANCE (Repair Service):

A. Contractor shall maintain the equipment in accordance with NATUS and OEM recommended frequencies and hardware specifications as set forth in the service manuals.

Vendor shall make reasonable efforts provide on-site support within twenty-four hours, during covered days, upon notification by Customer.

B. The CO or COR has the authority to approve/request a service call from the

Contractor.

B. Coverage includes on-site support (4-hour On-Site Response), service parts (ordered by noon, same day delivery), hardware updates, software, software updates, labor, travel, remote service, safety checks, planned maintenance, and quality assurance.

C. Contractor shall provide telephone support per Section C, IV, Hours of Coverage.

D. When the Contractor leaves on-site location where maintenance services are being performed, the site shall be left in a clean, neat, and orderly condition ensuring the hospital/clinic staff and patients are not subjected to any safety hazards, including but not limited to expose wiring, open circuit panels, or tripping hazards.

E. The COR shall be informed personally or in writing of the equipment status prior to the Contractor leaving the work site.

F. The Contractor is not responsible for the maintenance of equipment listed when damage resulted from act of God or when services from other than the Contractor’s personnel have been performed. The Contractor is not responsible for the maintenance of equipment listed when damage results from Government neglect, misuse, abuse, liquid spills, unauthorized attachments, or alterations to factory settings of the unit.

VI. SCHEDULED MAINTENANCE:

A. The Contractor shall perform PM/Calibration Services to ensure that equipment listed in the schedule performs in accordance with Section C, III, Conformance Standards. Such maintenance shall be performed at mutually agreed times during PM Coverage Hours. All exceptions to the PM schedule shall be arranged and approved in advance with the COR.

B. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). Any charges for parts, services, manuals, tools, software, or travel required to successfully complete scheduled

PM/Calibration are included within this contract, unless specifically stated in writing.

C. The contractor shall provide written description of Preventive Maintenance Inspections

(PMI). This description shall include an itemized list of the procedures performed. PM services shall include, but need not be limited to, the following:

1. Cleaning of equipment.

2. Calibrating and lubricating the equipment.

3. Performing remedial maintenance of non-emergent nature.

4. Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn.

5. Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying.

6. Inspecting and replacing, where indicated, all mechanical components.

7. Returning the equipment to the operating condition.

8. Providing documentation of services performed.

VII. PARTS:

A. The Contractor has ready access, no more than three (3) business days, to all parts, including unique and/or high mortality replacement parts. Contractor is not responsible for delays beyond the contractor’s reasonable control.

B. The contract shall include all parts except, if applicable, those parts specifically listed as being excluded. The contractor shall use new or rebuilt parts which meet or exceed OEM standards for equivalent quality and reliability as a new part. Used parts or those removed from another system shall not be installed without specific approval by the CO or the COR.

C. The contractor shall not modify the system to facilitate replacement parts that are not identical to the part being replaced unless such modification was developed, approved and released by the OEM.

D. The following items are excluded from coverage: user-replaceable expendable parts/supplies and parts replaced for cosmetic reasons. Pulse Oximetry sensors shall be limited to one direct exchange at no cost per contract year. The Contractor shall also list any additional excluded parts under the service contract.

E. Any hardware, such as a hard drive, which contained patient information, shall be sanitized in accordance with National Security Agency standards by ELPVAHCS staff prior to being removed from the ELPVAHCS.

VIII. SERVICE MANUALS/TOOLS/EQUIPMENT:

A. The ELPVAHCS shall not provide tools, (test) equipment, service manuals, or service diagnostic software to the contractor. Contractor shall obtain, have on file, and make available to its FSE 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.

B. Contractor shall provide the COR two (2) copies of all documentation that pertains to any hardware, software, or firmware upgrade or repair.

IX. DOCUMENTATION/REPORTS:

The documentation shall include detailed descriptions of the maintenance procedures performed, including replaced parts. In addition, each ESR shall, at a minimum, document the following data legibly and in complete detail:

A. Name of contractor and contract number.

B. Name of FSE who performed services.

C. Contractor service ESR number/log number.

D. Description of problem reported by COR.

E. Identification of equipment serviced.

F. Itemized description of service performed, with parts and part numbers.

G. Itemized costs of any approved billable parts and services, if applicable.

X. REPORTING REQUIREMENTS:

The Contractor shall report his arrival in person or by telephone to Biomedical

Engineering. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall check out with Biomedical Engineering and submit the ESR(s) to the COR. If the COR is unavailable, a copy of the ESR shall be sent to the

COR after the work for review.

Contact Information:

ELPVAHCS Biomedical Contact Person(s): Chief Biomedical Engineering or designee.

Location (Building/Room Number): Building 1 Rooms A100

Telephone Number & Extension(s): 915-564-7099

Fax: 915-564-7807

Contractor Service Department: 800-633-7237-586-3647

XI. ADDITIONAL CHARGES:

Additional charges shall be approved by the COR before service is started. There shall be no additional charge for time spent at the site (during, or after the normal hours of coverage) for delivery of parts.

XII. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

The Contractor shall immediately, but no later than 24 (twenty-four) 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.

XII. CONDITION OF EQUIPMENT:

The Contractor accepts responsibility for the equipment described in Section I, "as is" condition. Failure to inspect the equipment prior to contract award shall not relieve the

Contractor from performance of the requirements of this contract.

XIV. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

A. Contractor shall have an established business with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who shall serve as the backup.

B. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed an OEM certified training program for the equipment identified in Part I of this section.

C. The FSEs shall be authorized by the Contractor to perform the maintenance services.

All work shall be performed by "Fully Qualified" competent FSEs. The CO may authenticate the training requirements, request training certificates, or credentials from the Contractor at any time for any personnel who are servicing any

ELPVAHCS equipment. The CO specifically reserves the right to reject any of the

Contractor's personnel and refuse them permission to work on the ELPVAHCS equipment.

D. If subcontractor(s) are used, they shall be approved by the CO; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

XV. TEST EQUIPMENT:

A. The Contractor shall provide the ELPVAHCS, upon request, a copy of the current calibration certification of all test equipment which is to be used by the Contractor on

ELPVAHCS's equipment when requested by the ELPVAHCS. Test equipment calibration shall be traceable to a national standard.

B. The Contractor shall present any removable media (i.e. USB or DVD/CD device) required for performing the work to Biomed to be scanned with an anti-virus program running current virus definitions.

XVI. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:

The Contractor's FSEs shall wear visible identification at all times while in the building of the ELPVAHCS. It is the responsibility of the Contractor to park in the appropriate designated parking areas. The ELPVAHCS shall not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the ELPVAHCS. 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.

XVII. CONTRACT TIME PERIOD:

A. Contract enactment shall be from October 1, 2024 to September 30, 2025 for the

Base year on the NATUS Systems outlined.

B. Contract has the option of four (4) years and one (1) year extension.

C. Contract may be canceled at any time with a thirty (30) day written notice.

XVIII. QUALITY ASSURANCE SURVEILANCE PLAN (QASP):

COR shall use surveillance methods listed below in the administration of this QASP.

A. DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

1. COR shall periodically review major aspects of the SOW to include response time, quality of services provided, and equipment uptime.

2. COR shall utilize direct observations both from the COR, as well as those of the using department or section to ensure a full 360-degree review of the level of service provided.

B. PERIODIC INSPECTION. (Evaluates outcomes on a periodic basis. Inspections shall be unscheduled, as required.)

1. COR shall routinely inspect service records supplied by vendor with using service to ensure quality of service and positive customer interaction.

2. COR shall periodically monitor interaction of vendor with using service to ensure services are provided timely, efficiently, and meet the customer’s needs.

C. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the patient to identify deficiencies. Complaints are then investigated and validated.)

1. COR shall routinely engage customers in discussions regarding services rendered, and ensure that all communications from the vendor are professional.

2. COR shall review customer complaints regarding system maintenance, downtime, and general communication with vendor, to ensure vendor is aware of any situations where a high-quality of service may have been compromised.

XVIV. NARA Records Management Language for Contracts

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. El Paso Veteran Affairs Health Care System (EPVAHCS) 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 EPVAHCS 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 EPVAHCS. 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 EPVAHCS 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 EPVAHCS 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 EPVAHCS policy.

8. The Contractor shall not create or maintain any records containing any non-public EPVAHCS 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 EPVAHCS 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 EPVAHCS 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, Talent Management

System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.