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This Statement of Need document details the VA Pittsburgh Healthcare System's requirement for four Neuroptics NPi-300 Pupillometer Systems for use in Critical Care units. The Critical Care Service Line seeks to purchase these devices to provide more reliable and objective measurements of pupillary size, symmetry, and reactivity, addressing the limitations of manual pupillary assessments. The NPi Pupillometer is designed to accurately measure pupillary light reflex across various neurological conditions, including traumatic brain injury, cerebral edema, and post-operative scenarios.

The document specifies delivery within 60 days of contract award to the North Loading Dock at University Drive C., Pittsburgh, PA, with normal operating hours Monday through Friday from 7:30 am to 3:00 pm, excluding federal holidays. The procurement is planned as a sole-source order under FAR 13.106-1, with Neuroptics of Irvine, CA as the sole provider. Additional device characteristics include quantitative infrared technology, a comfortable ergonomic design, an incorporated barcode scanner, an easy-to-read touchscreen LCD, and the ability to store 168 bilateral pupil measurements. The end user contact is Andrea Ploof, Executive Assistant for the Critical Care Service Line.

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Statement of Need

VA Pittsburgh Healthcare System

Neuroptics NPi-300 Pupillometer

Background

The Critical Care Service Line (CCSL) is requesting four Neuroptics NPi-300 Pupillometer systems for use in the Critical Care units. Routine neurological examinations are required for critically ill patients with impaired consciousness. Manual pupillary assessment is subject to compounded sources of inaccuracies and error and can result in inter-examiner variability. A variety of factors affect the reliability of manual assessment and increase inter-examiner disagreement.

Justification:

The Critical Care department at VA Pittsburgh Healthcare System is requesting to purchase four Neuroptics NPi-300 Pupillometer Systems to provide more reliable and objective measurements of pupillary size, symmetry, and reactivity. Accurate neurological and pupillary assessment are critical for detection of trauma related neurological deterioration as well as prognostication. The NPi Pupillometer provides an objective means of assessing and trending pupillary reactivity across a broad spectrum of neurological conditions including traumatic brain injury (TBI), cerebral edema, herniation syndrome, and post-operative scenarios. The NPi Pupillometer is now the recommended method for pupillary assessment because it could improve detection of neurologic deterioration, serving as an early indicator of worsening intracranial pathology and clinical deterioration. VAs throughout the country have adopted this method of practice and the specific Neuroptics NPI-300 Pupillometer Systems are in use at the VA Long Beach Healthcare System, Charlie Norwood VA Medical Center, Michael E. DeBakey VA Medical Center, and currently pending CPRC approval at the VA Palo Alto Health care System. The NPi-300 Pupillometer and expendable supplies have already been approved by the Clinical Product Review Committee (CPRC) at VA Pittsburgh. The CPRC is a team that reviews any new product that touches a patient that the hospital proposes to introduce in to use. The VA requires a CPRC request entered through the CPRC portal that requests detailed justification and documents, that is subsequently reviewed by the committee members (logistics, biomed, property management, infection prevention, etc.) who vote whether the item can be used or not.

Item Product Part Product Description Quantity 1 NPi-300-SYS-PROMO NPi-300 Pupillometer System 4

Salient Characteristics/Requirements

• Neurological Pupil index (NPi)

• Accurately Measures and trends pupil size and reactivity

• Measures the entire Pupillary Light Reflex (PLR)

• Incorporates all 7 components of the PLR using analysis of the waveform measured by the NPi Pupillometer

• Pupillary measurement parameter remains unaffected by many ICU medications and intoxicants

• Quantitative infrared technology

• Comfortable ergonomic design

• Incorporated barcode scanner

• Easy-to-read touchscreen LCD

• SmartGaurd storage of 168 Bilateral Pupil Measurements

• Trend for changes in NPi and size over time

Period of Performance

• Delivery no more than 60 days after contract award.

DELIVERY

• Delivery will be made to VAPHS locations:

o North Loading Dock | University Drive C., Pittsburgh, PA 15240

• Normal hours of operation are Monday through Friday from 7:30am am to 3:00 pm, excluding holidays.

• Federal Holidays observed by the VAMC are:

New Years’ Day Labor Day Martin Luther King Day Columbus Day Presidents’ Day Veterans’ Day Memorial Day Christmas Day Juneteenth Thanksgiving Day

Independence Day o Logistics will receive these items, PPM will place EE tags, and BioMedical Engineering will need to perform a safety check and enter the equipment into the system for annual Preventive Maintenance (PM) checks.

REPAIR AND MAINTENANCE

• The vendor/distributor and/or the manufacturer must provide all necessary procedure manuals, troubleshooting manuals and operator manuals.

End User/Contact:

Andrea Ploof, Executive Assistant, Critical Care Service Line VA Pittsburgh Healthcare system Andrea.Ploof@va.gov Office: 412-360-3718 Cell: 412-419-9383 mailto:Andrea.Ploof@va.gov

File details come from the government source that posted it. Updated .