S02 - ATTACHMENT 2 - STATEMENT OF WORK - BRAND NAME OR EQUAL TO NATUS IAW SOW - COMPREHENSIVE VESTIBULAR TESTING SYSTEM.pdf

B.2 STATEMENT OF WORK

STATEMENT OF WORK

COMPREHENSIVE VESTIBULAR TESTING SYSTEM

VA MARYLAND HEALTH CARE SYSTEM

BALTIMORE, MD

1. PURPOSE:

The VA Maryland Health Care System is seeking to procure one (1) comprehensive vestibular testing system in order to treat veteran patients at the Baltimore VA Medical Center. The current testing system utilized at the Baltimore VA is no longer in service and has reached its end of life, making this an emergency procurement. If this replacement is not purchased, we will have to continue cancelling patients and will not be able to serve our veterans. This will result in our veteran patients not receiving proper care and will have to travel to another hospital for proper care. The primary function of a vestibular testing system is to perform a series of non-invasive diagnostic procedures to assess the function of the vestibular system within the inner ear. With these systems, we are able to diagnose balance and dizziness disorders by monitoring the brain, eyes, and muscles to maintain balance and spatial awareness. This procurement will account for the vestibular system, the associated software, a TV, installation, and if deemed necessary an air caloric. An air caloric is critical for vestibular testing by evaluating the function of the lateral semicircular canals to determine the degree of vestibular responsiveness. The current air caloric system is not compatible with all vestibular systems available on the market and will soon be reaching its end of life in 2028. Key criteria include system size, portability and test protocols.

2. SCOPE:

2.1. The contractor shall deliver and install the system with all specified salient characteristics. Only new equipment will be accepted.

2.2. The contractor shall provide shipping, transport, installation, and all equipment necessary to meet the requirements and capabilities listed within the scope.

2.3. The contractor shall deliver the system to the Baltimore VA Medical center.

2.4. The assembly and validation of the system must be performed by a vendor service trained representative.

2.5. The contractor is responsible for identifying any missing parts or components not included in the order for the vestibular testing system to be successfully installed and validated to their full potential.

2.6. The contractor shall include accessories and consumables that have been detailed in the provided quotes.

2.7. SALIENT CHARACTERISTICS: Please note, all items listed below must be technically equivalent to or exceed the ICS Dizcovery System, AirCal, and Duet system.

2.7.1. One (1) Vestibular Testing System (ICS Dizcovery System)

2.7.1.1. Manufacturer: Natus

2.7.1.2. Model: ICS Dizcovery System

2.7.1.2.1. System must have an operating system that has at least 64 bits and works on widows 10 pro and above.

2.7.1.2.2. System must have a memory of at least 8 gb, and a disk space of at least 250 gb.

2.7.1.2.3. System monitors must have a screen resolution of at least 1600 x 900 at 100% dpi.

2.7.1.2.4. System goggles must include at least two small cameras for patient eye movement records.

2.7.1.2.5. System goggles must have fixation leds for caloric testing.

2.7.1.2.6. System goggles must shield the light emitted on the leds from the patient.

2.7.1.2.7. System goggles must include indicator lights, one on each side of the goggles.

2.7.1.2.8. System goggles must include disposable foam cushions.

2.7.1.2.9. System goggles must have an eye movement resolution of at least 0.22 degrees.

2.7.1.2.10. System goggles must be no larger than 6.8 in x 7.3 in x 4.8 in

(lxwxh).

2.7.1.2.11. System goggles must have color-coded nystagmus beats.

2.7.1.2.12. System goggle wavelength must be at least 650 nm (+20 nm)

2.7.1.2.13. System goggles must weigh no more than 395g.

2.7.1.2.14. System goggle sampling rate must be at least 60 fps.

2.7.1.2.15. System top mount goggles must have an eye movement resolution of at least 0.3 degrees.

2.7.1.2.16. System top mount goggles must weigh no more than 345g with the cover.

2.7.1.2.17. System must include a remote control.

2.7.2. One (1) AirCal System (1079 AirCal Caloric Stimulator)

2.7.2.1. Manufacturer: Natus

2.7.2.2. Model: 1079 AirCal Caloric Stimulator

2.7.2.2.1. System must have a recording window of at least 150 ms.

2.7.2.2.2. System must have the capability to monitor vemp within the abr system.

2.7.2.2.3. System tests should include, but not limited to, ecochg, abr, mlr, and llr/cae.

2.7.2.2.4. System PC should be no larger than 15 x 12.6 x 2.2 inches.

2.7.2.2.5. System weight should be no larger than 5.5 lbs. Excluding accessories.

2.7.2.2.6. System must be able to mask white noise, and a noise level up to

125 db.

2.7.2.2.7. System level must be between the range of 20 – 140 db pespl.

2.7.2.2.8. System tone burst frequency must include, but not limited to, the following: 250, 500, 750, 1000, 1500, 2000, 3000, and 4000 hz.

2.7.2.2.9. System tone burst stimulation time must reach up to 780 ms.

2.7.2.2.10. System stimulus rate must function within the range: 0.1 – 200 per second.

2.7.2.2.11. System must include the option of a mobile cart.

2.7.3. One (1) ABR testing system (DUET 2)

2.7.3.1. Manufacturer: Intelligent Hearing Systems

2.7.3.2. Model: DUET 2

2.7.3.2.1. System Must Be Able to Cool Air Down To At Least 20 Degrees C.

2.7.3.2.2. System Must Be Able to Heat Air Up To 50 Degrees C.

2.7.3.2.3. System Must Have an Air Flow Stability Within + 0.5 L/Min.

2.7.3.2.4. System Must Have a Self-Containing Cooling Ability.

2.7.3.2.5. Systems Must Be Able to Integrate with The VNG System.

2.7.3.2.6. System Must Have Accuracy Of At Least + 0.4 Degrees C.

2.7.3.2.7. System Weight Must Be No Greater Than 18 Lbs.

2.7.3.2.8. System Must Have a Quiet Setting That Reaches At Least 49 Db.

2.7.3.2.9. System Must Be Able To Reach 50 Degrees C From 40 Degrees

C In 3 Minutes or Less.

2.7.3.2.10. System Air Flow Rate Must Have a Range Of At Least 4-10 L/Min.

2.7.3.2.11. System Must Have Otoscope Speculums Of At Least 2.75mm and

4.25mm In a Single Use.

2.7.3.2.12. System Must Have the Ability to Deliver Audible and Visual Cues

During Testing.

2.7.3.2.13. System Size Must Be No Greater Than 13.5 In X 12 In X 4in

(Wxdxh).

2.7.4. Accessories

2.8. IMPLEMENTATION AND INSTALLATION

2.8.1. Installation and validation shall be included in the procurement cost and shall include but not limited to:

2.8.1.1. Assembly of devices and validation.

2.8.1.2. All materials required to assemble the vestibular testing system shall be provided by the contractor.

2.8.2. The contractor will deliver the following quantities of the vestibular testing system and accessories, based on the proposed quote provided during market research, to the addresses below:

2.8.2.1. Baltimore VA Medical Center, 10 North Green Street, Baltimore, MD 21201

2.8.2.1.1. (8-04-16400) 1091, ICS Dizcovery System

2.8.2.1.2. (8-49-98401) License, ICS Dizcovery Pro Plus

2.8.2.1.3. (045657) 1091, ICS Dizcovery Universal Face Cushion (Qty 40)

2.8.2.1.4. (045653) 1091, ICS DIZCOVERY CRADLE

2.8.2.1.5. (8-04-13310) 1079 AirCal Caloric Stimulator (Standard length -

3m), US only

2.8.2.1.6. Notebook Computer Minimum Specifications: Windows 32- or 64-bit Computer with 4GB RAM

2.8.2.1.7. (M011007A) DUET 2 Channel AEP base Unit.

2.8.2.1.8. (M811000) Smart EP Software - required for EP operation

2.8.2.1.9. (M015302) ER3C Insert Earphones (300 ohms)

2.8.2.1.10. (M015053) DD45-300 Headphones (300 ohms)

2.8.2.1.11. (M014404) Bone Vibrator (B-81) (Bone, Cable and Adult

Headband)

2.8.2.1.12. (M010332) DUET 5 Electrode Leads Patient Cable

2.8.2.1.13. (M999000) Compact cart for the HIS Duet EP system

2.8.2.1.14. "(M998606) 120V Isolation Transformer

2.8.2.1.15. Compact 500 Watts (for Mobile Cart)"

2.8.2.1.16. (M998701) Printer - B&W Laser.

2.8.2.1.17. (025311) AUD TRAINING-1/2 DAY

2.8.2.1.18. (M998451) SYSTEM ON-SITE TRAINING - ONE DAY (US ONLY)

2.8.2.1.19. Accessories.

2.8.3. The vendor will assemble all quantities of the vestibular testing system and etc.

2.9. TRAINING

2.9.1. The contractor shall provide onsite training for all VAMHCS staff that require training.

2.10. DELIVERY

2.10.1. The contractor shall deliver necessary equipment to the Baltimore facility as required in the quantities specified above.

2.10.2. The contractor must give VAMHCS staff 3 weeks’ notice of shipment and delivery of the vestibular testing system and accessories.

2.10.3. The contractor shall deliver equipment and all items required for installation only when the site is ready for installation to proceed.

2.10.4. The contractor shall coordinate all deliveries, installation, and parking arrangements with the COR.

2.10.5. Delivered materials will arrive in manufacturer’s original sealed containers with the associated purchase order number listed on the outside of the box.

2.10.6. The contractor shall conduct a joint inspection with the COR upon delivery of the equipment and shall provide the COR with a list of missing or damaged items found upon inspection.

2.10.7. The contractor shall remove all related shipping debris and packing from the VAMHCS facilities.

3. INSPECTION AND ACCEPTANCE

3.1. The contractor shall conduct a joint inspection with the COR upon delivery equipment.

3.2. The contractor shall provide the VA COR with a list of missing and /or damaged items found upon inspection and have those items replaced at no cost to the Government.

3.3. The COR shall ensure all work is completed satisfactorily prior to acceptance.

Disputes shall be resolved by the VA Contracting Officer.

4. DELIVERABLES

4.1. Operation and Maintenance Manuals

4.1.1. Delivery compilation of all manufacturers recommended maintenance schedules and operation materials packaged upon delivery. Manuals shall be made available in an electronic format.

5. OPERATOR TRAINING

5.1. Onsite education and training by a vendor service trained representative will be provided to VAMHCS clinical staff, facilities and engineering staff, and the biomedical engineering staff. The scheduling of operator training shall be coordinated with the VAMHCS clinical staff after delivery and installation.

6. PROTECTION OF PROPERTY

6.1. The contractor shall protect all items from damage. The contractor shall take precautions against damage to the building(s), grounds and furnishings. The contractor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Contractor.

7. SECURITY REQUIREMENTS

7.1. The contractor must have a photo ID available when performing work at the VA

Medical Center and be willing to present it to VA staff.

7.2. The contractor is responsible for providing any personal protective equipment

(PPE) that is deemed necessary to complete tasks stated in this requirement.

7.3. The contractor must follow the VA Maryland Health Care Systems current COVID- 19 guidance for entry to any medical center or Community Based Outpatient Clinic

(CBOC).

8. WARRANTY

8.1. At a minimum the vestibular testing system must include a 1-year warranty on all parts and labor at no cost to the Government. Additional years are highly recommended as added value to the government.

8.2. The warranty shall begin upon completion of validation testing.

8.3. Warranty shall include onsite repairs and over-the-phone support.

8.4. Contractor shall provide routine maintenance service program during warranty period.

8.5. All repairs shall be performed by a vendor or contractor which has been certified by the vendor to perform the repairs.

8.6. The warranty shall include all travel and shipping costs associated with any warranty repair.

12. Period Of Performance: Delivery is expected within 60 days ARO.

13. Contract Type: Firm-Fixed Price.

14. Evaluation Factors:

• Brand name or equal to Natus IAW SOW.

• OEM distributor/authorization letter from the manufacturer is required for all quoters, if no OEM letter is supplied the quoter will be considered non-responsive and vendor will be disqualified at the time RFI will close,

• Must complete the Buy American Certificate (FAR 52.225-2), included in the solicitation.

• Agency’s intention to provide price preference for domestic end products. The offerors who will provide domestic end products will receive a price preference in evaluation for award. Buy American Supplies (FAR 52.225-1), included in the solicitation.

• Price.