S02 - ATTACHMENT 2 - SOW NEUROMUSCULAR MONITORS - BRAND NAME OR EQUAL TO SENZIME IAW SOW - 05-07-2025.pdf

STATEMENT OF WORK (SOW)

1. Contract Title. Senzime TetraGraph Neuromuscular Monitors

2. Background.

The Washington DC VA Medical Center requires fourteen Senzime Tetragraph Neuromuscular Monitors for the Anesthesia department to quantitatively monitor neuromuscular blockade levels during surgery. This is a relatively new technology and will align with new 2023 guidelines from the American Society of Anesthesiologists (ASA). Current practice does not allow for quantitative monitoring of the Train-Of-Four Ratio (TOFR), which allows anesthesiologists to measure the extent of neuromuscular blockade remaining in a patient’s body. This acquisition will increase patient safety and prevent adverse events by ensuring the accuracy of reversal medication given to the patient at the end of a procedure. If the reversal dose is not adequate, there is a higher risk of adverse events postoperatively such as oxygen desaturation/hypoxemia, muscle weakness, respiratory failure, aspiration, and reintubation.

3. Scope of Work. The procurement shall include all parts, materials, labor, software/licenses, resources, and training required to implement and utilize the equipment/system to their fullest capacity. All items must be covered by manufacturer’s warranty and procured through a manufacturer-approved distribution channel. Distributers and resellers must be able to document ability to provide items through manufacturer-approved distribution channels upon request.

4. Specifications.

4.1 Equipment

Line-Item Description Quantity

SEN-2015 – TetraGraph Next Gens 14

SEN-2012 – TetraSens Adult EZClick Sensor (20/BOX) 1

4.2 Required Features

• Must include five (5) modes of operation: TOF Interval, Automatic stimulus setup, TOF Ratio & TOF Count, Post-tetanic Count (PTC), and Single Twitch (ST).

o TOF Interval must be 20 sec – 60 mins.

o Automatic stimulus setup must allow for automatic detection of maximal current and supramaximal current 20% above maximal current.

o TOF Ratio & TOF Count must provide 4 pulses of 200 or 300 μs duration at 2 Hz repeated at user selected frequency of 20 s, 1 min, 5 min, 15 min, or 60 min.

o PTC must consist of a set of 250 pulses fixed at 50 mA, 200 μs;

followed by up to 20 ST pulses at 1Hz.

o ST must include a pulse of 200 or 300 μs duration at 0.1 Hz

• Battery must align with the following characteristics:

o Must allow for 8 hours of continuous operation with a fully charged battery.

o Charger must be EN 60601-1 power supply 5V DC USB connection o Battery must be a rechargeable Lithium battery, Varta Easy-Pack standard battery.

o Cord length must be 3 m.

• Accuracy of measurement for TOFR is ±10% of full scale compared to theoretical value.

• Must allow at least six stimulation current options between 10-60 mA.

• Must show a bar of four pulse amplitudes and percentage, trend of successive TOFR values.

• Graphics include muscle action potential display of waveforms, TOF count, integer, & trend, and the number of post-tetanic ST responses.

• Unit must be no larger than 18 x 10 x 3.5 cm.

• Input power ratings of 100 -240 V ~, 50 to 60 Hz, 160-80 mA and output power ratings of 5 V DC, 1400 mA.

5. Specific Tasks.

5.1 Delivery.

i. All equipment shall be delivered to:

Washington DC VA Medical Center 50 Irving St NW Washington, DC 20422 ATTN: VHAWAS Equipment Committee

ii. Contract VA Purchase Order (PO) number shall be included with delivery information (e.g., packing slip).

Note: PO number starts with station code 688 followed by a letter and 5 digits (e.g., 688A12345)

iii. Delivery Hours: The Warehouse is open to receive deliveries Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding holidays.

iv. Contractor shall coordinate delivery with the on-site Point of Contact (POC) and provide shipment tracking information.

v. Contractor shall verify delivery date and time with the on-site POC at least 3 business days prior to scheduled delivery.

vi. Delivery is required within 90 days from award of the contract.

5.2 On Site Procedures.

i. COVID-19 Screening: All persons entering the facility shall be subject to screening for COVID-19 per the current CDC (Center for Disease Control) guidelines.

ii. Mask Requirement: All contractors shall wear masks while indoors.

iii. Contract personnel are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government Officials.

iv. Time spent on site shall be for a period sufficient to complete the work set forth in the statement of work.

v. On site visits shall be scheduled in advance with the designated on-site POC.

vi. Contractor shall check in and out with Biomedical Engineering prior to visiting the worksite for each day of work.

vii. The VA campus is non-smoking. Contractor personnel are required to comply with this policy.

viii. Parking: it is the responsibility of the Contractor to park in the appropriate designated parking areas.

ix. Contractor personnel’s tool bags are subject to inspection.

5.3 Installation/Implementation.

i. Installation/Implementation will be completed by personnel certified and knowledgeable with the designated equipment/system.

ii. Installation shall be completed within the period of performance.

iii. Contractor shall be responsible for any Personal Protection Equipment

(PPE) required when performing work on site.

iv. Contractor shall submit all removable media to be used on a VA system to Biomedical Engineering for scanning with anti-virus software prior to use.

v. In the case turn-in, exchange, repair, or replacement of equipment containing hard drives used by the VA, the hard drives shall be removed from the equipment and remain in possession of the VA (this includes loaned or rented equipment).

vi. 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 (i.e., trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) 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.

5.4 Training.

i. Contractor shall be responsible for providing training to clinical staff/users.

ii. Training is to be scheduled in advance with the designated on-site

POC.

iii. Education shall be provided prior to and/or at time of installation.

iv. Education professional shall be certified to provide instruction on the designated equipment/system.

v. Education curriculum must include operations and set-up, user maintenance, safety, and user troubleshooting tips.

5.5 Inspection and Acceptance.

i. Contractor shall conduct a joint inspection with the on-site POC upon completion of installation.

ii. In the event deficiencies are identified, the contractor shall provide the date when the identified deficiencies will be addressed if not addressed on the date of installation. The Contractor shall conduct a joint inspection with the on-site POC after addressing all deficiencies. All deficiencies identified in the joint inspections shall be corrected by the Contractor prior to Government acceptance of the item. Any disputes shall be resolved by the Contracting Officer.

5.6 Deliverables.

The Contractor shall provide the below documentation for the proposed equipment to VHAWASEquipmentRequests@va.gov within 10 business days of work completion:

i. Service report.

ii. Warranty information.

iii. Electronic copy of the Operators Manual.

iv. Electronic copies of the complete technical service manuals, including troubleshooting guides, necessary diagnostic software and equipment information, schematic diagrams, and parts lists.

6. Hours of Operation.

DC VAMC’s normal business hours are Monday-Friday, 8:00 am to 4:30 pm, excluding observed Federal holidays:

New Year’s Day Labor Day

Martin Luther King’s Birthday Columbus Day

President’s Day Veteran’s Day

Memorial Day Thanksgiving Day

Juneteenth Christmas Day

Independence Day Any other national holiday as declared by the President of the United States

7. Period of Performance. Delivery within 60 days from contract award.

mailto:VHAWASEquipmentRequests@va.gov

8. Invoicing.

Contractor shall submit a consolidated invoice monthly in arrears of the month for which services are being billed. One all-inclusive monthly invoice shall be provided, which shall contain an invoice number, contract number, obligations order number, and an itemized list of services provided. An acceptable master (all-inclusive) itemized list of services shall be agreed to between the Contractor and the COR prior to submission of the first invoice.

All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

VA’s Electronic Invoice Presentment and Payment System (IPPS) – The VA Financial Services Center (FSC) uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website to begin submitting electronic invoices, free of charge:

http://www.tungsten-network.com/US/en/veterans-affairs/.

More information on the VA FSC is available at:

http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

To begin submitting your electronic invoices to the VA FSC for payment processing, free of charge, please contact Tungsten at the below phone number or email address:

Tungsten e-Invoice Setup Information: 1-877-489-6135 Tungsten e-Invoice Email: VA.Registration@Tungsten-

Network.com

If you have a question about the e-invoicing program or Tungsten, please contact the FSC at the below phone number email address.

FSC e-Invoice Contact Information: 1-877-353-9791 FSC e-Invoice Email: vafsccshd@va.gov

9. Contract Type.

Firm-Fixed Priced Contract

10. Evaluation Factors.

i. Brand Name or Equal to Senzime IAW SOW.

ii. OEM Distributor/Authorization Letter from the manufacturer is required for all responses, if no OEM letter is supplied the vendor will be considered non-responsive and the vendor will be considered dis-qualified at the time RFI will close.

iii. Delivery Lead Times.

iv. Price.

http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.fsc.va.gov/einvoice.asp mailto:VA.Registration@Tungsten-Network.com mailto:VA.Registration@Tungsten-Network.com mailto:vafsccshd@va.gov