648 VA Portland OR Home Sleep Testing Services Requirement RFQ

VA Portland Health Care System (VAPORHCS) is seeking a contract for Home Sleep Apnea Testing. American Academy of Sleep Medicine (AASM) and VA Prioritization for Expanding Outpatient Consultations, Procedures, and Appointments recommend use of completely disposable home sleep testing. VAPORHCS does not currently own any completely disposable devices. VAPORHCS anticipates continued & increased emphasis for home sleep apnea testing as we transition clinical programs involving greater use of alternatives to face-to-face medicine. Pertinent excerpt of referenced communication:

“Non-urgent pulmonary/sleep procedures should be deferred to minimize unnecessary risk to patients. These include, but are not limited to pulmonary function testing, 6-minute walk tests, methacholine challenge testing, surveillance bronchoscopy, in-person pulmonary rehabilitation, lung cancer screening, and polysomnography. Providers should consider empiric treatments and alternative diagnostic modalities that do not require in-person visits (e.g., HSAT) while these procedures are deferred.”

To assist as we shift to alternatives to high-bandwidth, face-to-face care with limited staff, the contractor shall provide VAPORHCS as ordered, direct to home disposable HSAT to our Veteran population through a mail order service. The contractor shall prepare the ordered/requested HSAT kit per instructions of the sleep provider and then ship it to the patient. The contractor shall provide phone service to support the Veteran in the use of the HSAT kit on the scheduled test day to review test instructions. After the patient completes the HSAT in their own home, the data from the device is uploaded to a VA approved cloud -based platform for interpretation by VA providers.  

The HSAT device must provide comprehensive home-based sleep disorder screening and monitoring services for patients suspected of obstructive sleep apnea (OSA), central sleep apnea (CSA), and related breathing disorders. The system must enable healthcare providers to conduct Type III sleep studies in the patient’s natural sleep environment, eliminating the need for in-laboratory polysomnography in appropriate clinical scenarios. The purchased device will be shipped directly from the vendor to the patient. The vendor must be able to provide 24/7 vendor support to the patient rather than depending on VAPORHCS staff to provide troubleshooting support. The patient wears the device and upon completion of the test the data is sent via patients previously downloaded phone app to a secure portal for VA physician review. The device is disposable or sent back to the contractor for reuse or recycling.

The device must perform multi-parameter physiological monitoring throughout the sleep period, capturing respiratory airflow patterns, chest and abdominal respiratory effort (or equivalent), snoring, blood oxygen saturation levels, heart rate variability, arrhythmia detection, and body positioning detection. It must generate automated scoring algorithms for apnea-hypopnea index (AHI) or respiratory event index (REI), and central apnea index (CAI) calculations.

1. Technical Requirements and Characteristics:
   
   1. Wireless data transmission capabilities with secure encrypted patient data protection.
   2. Battery life that is sufficient for at least one full night of continuous monitoring (minimum 8-10 hours per session).
   3. Lightweight, ergonomic design weighing less than 100 grams for patient comfort.
   4. FDA-cleared sensors including pulse oximetry, respiratory inductance plethysmography belts and nasal pressure transducers or wristband with built in peripheral arterial tone (PAT) sensor.
   5. FDA-cleared to identify Atrial fibrillation events and premature beats.
   6. Real-time data quality monitoring with automatic artifact detection.
   7. Cloud-based data storage and analysis platform with HIPAA-compliant security protocols.
   8. Compatibility with existing electronic health record systems.
   9. User-friendly interface requiring minimal patient training.
   10. Disposable sensor components to prevent cross-contamination.
   11. Temperature and humidity resistant housing for various environmental conditions.
   12. The system must demonstrate clinical validation equivalent to laboratory-based sleep studies for diagnostic accuracy in detecting moderate to severe sleep-disordered breathing events.
   13. FDA-validated to score obstructive and central sleep apnea events and be able to identify Cheyne Stokes Respirations.
   14. Ability to detect positional data and therefore able to provide a supine AHI/REI vs non-supine AHI/REI.
   15. The device must have integrated questionnaires (E.g. within an accompanying smartphone app) to collected Epworth sleepiness data and patient reported weight and height to calculate body mass index (BMI).
   16. In the event that the veteran does not have a smartphone or access to internet in their bedroom, the company must have capabilities to send an alternative HSAT device that able to store data internally without use of smartphone or internet (typically the veteran ships the device back to the company so that data can be uploaded). The company’s devices must produce all reports on the same could platform so VAPORHCS physicians can interpret raw data and produce a report. This way veterans with and without smartphone/internet can complete studies through the same platform.
   17. Device must be able to report AASM hypopnea scoring rule (3% desaturation).
   18. The company must be able to provide customizable reports per the preferences of VHAPORHCS staff.