Attachment 2_ Polysomnography System Tasks Final.docx

Attachment 1: Defense Health Agency (DHA) Polysomnography (PSG) Enterprise Capability

Background:

Polysomnography (PSG) is a test used to diagnose sleep disorders, such as obstructive sleep apnea (OSA), narcolepsy, and idiopathic hypersomnia (IH). A requirement for an enterprise network accredited PSG capability is needed to facilitate compliance with Combatant Command (COCOM) Deployment Fitness/Medical Suitability standards.

Challenges:

The Defense Health Agency (DHA) currently faces challenges in effectively diagnosing and managing sleep disorders due to lack of standards and limitations in its PSG capabilities. Specific issues:

1. Standardization: There is not a consistent PSG system across the 22 DHA-managed sleep laboratories. This inconsistency can lead to variations in data acquisition and analysis, potentially impacting diagnosis accuracy.

2. Network Inaccessibility: Existing PSG systems operate in isolated, "off-network" environments. This isolation prevents data transfer between facilities and upload to the enterprise electronic health record (EHR).

3. Data Exchange Obstacles: Due to the lack of network connectivity, sharing PSG data electronically becomes impossible. This hinders:

a. Collaboration between sleep specialists across different facilities.

b. Timely access to patient information for diagnosis and treatment.

c. Potential use of centralized data analysis for research purposes.

These limitations significantly hinder DHA’s ability to efficiently diagnose and manage sleep disorders such as obstructive sleep apnea (OSA), narcolepsy, and idiopathic hypersomnia (IH). Additionally, the lack of an enterprise network accreditation raises potential concerns about data security and compliance. These challenges contribute to suboptimal patient care and operational inefficiencies within the organization.

Objectives:

The high-level objectives of the requirements will aid the capability to:

1. Improve the accuracy and efficiency of sleep disorder diagnosis for active-duty personnel, retirees, and their dependents.

2. Enhance patient comfort and accessibility to PSG studies.

3. Integrate seamlessly with the existing DHA electronic health records (EHR).

4. Streamline data acquisition, analysis, and reporting processes by providing artificial intelligence (AI) tools.

5. Foster the Adoption of advanced PSG technologies to support future clinical needs.

Specific Tasks:

1.0 Business Requirements:

1. The capability MUST support bi-directional integrated data flow between the PSG system and the EHR.

2. The capability MUST support bi-directional integrated data flow between the Home Sleep Apnea Test (HSAT) system and the EHR.

3. The capability MUST support bi-directional integrated data flow between the actigraphy system and the EHR.

4. The capability MUST comply with COCOM and Service specific standards of individual deployment/operational (Diving, Aviation, etc.) status and overall readiness as related to a sleep disqualifying diagnosis.

5. The capability MUST meet the enterprise equipment requirements to provide standardization and interoperability.

6. The capability MUST be able to perform scoring and analysis in real-time processing to enable immediate clinical feedback during sleep studies.

7. The capability MUST comply with American Academy of Sleep Medicine (AASM) Standards.

8. The capability MUST have the ability to distribute, collect, and archive pre-screening questionnaires and other risk assessment tools to assist with the need for sleep testing.

9. The capability MUST perform quality care and audit functions to provide quality metrics.

a. The capability MUST/SHALL align to inter-scorer reliability (ISR) assessment standards set forth in the AASM.

10. The capability MUST/SHALL adhere to the National Archives and Records Administration (NARA) DHA approved disposition schedules to ensure the responsible legal management of records.

11. The capability MUST/SHALL store sleep study raw data from all sleep tests (including but not limited to PSG, Multiple Sleep Latency Test (MSLT), and HSAT) ensuring clinical accessibility for a minimum of five years.

2.0 Functional Requirements:

1. The capability MUST integrate reports, data and Digital Imaging and Communications in Medicine (DICOM) (images, video, audio files) with picture archiving and communication system (PACS) and MHS-EHR.

2. The capability MUST be able to measure various physiological activities during sleep.

a. The capability MUST provide integration and capture of Brain waves or electroencephalogram (EEG).

b. The capability MUST/SHALL provide integration and capture of Electrooculogram (EOG).

c. The capability MUST/SHALL provide integration and capture of Electromyogram (EMG).

d. The capability MUST/SHALL provide integration and capture of Rhythm electrocardiogram (ECG).

e. The capability MUST/SHALL provide Nasal and oral airflow sensors helping to diagnose sleep apnea and other breathing disorders.

f. The capability MUST/SHALL provide integration and capture of Nasal and oral airflow thermistor and pressure.

g. The capability MUST/SHALL provide integration and capture of actigraphy.

h. The capability MUST/SHALL provide integration and capture of blood oxygen levels (SpO2), or oxygen saturation in the blood which indicates potential oxygen deprivation during sleep.

3. The capability MUST/SHALL provide/capture of Respiratory effort via respiratory inductive plethysmography.

a. The capability MUST/SHALL provide capture of Respiratory effort capturing chest-wall and abdominal movement.

b. The capability MUST/SHALL provide capture of Respiratory effort via endoesophageal pressure.

c. The capability MUST/SHALL provide capture of Respiratory effort via intercostal EMG.

d. The capability MUST/SHALL provide capture of Respiratory effort via Polyvinylidene Fluoride (PVDF).

e. The capability MUST/SHALL provide integration of impedance belt.

4. The capability MUST provide capture of audio/sound recording to measure quantitative and qualitative measures snoring.

5. The capability MUST provide capture of continuous video monitoring.

6. The capability SHOULD provide capture of core body temperature.

7. The capability MUST provide Type I - IV PSG testing to ensure all ranges of testing are achievable in both attended (Type I) and unattended (Types II-IV).

8. The capability MUST provide ability to DOCUMENT universally recognized sleep study scales.

a. The capability MUST provide ability to DOCUMENT universally recognized Epworth Sleepiness Scale.

b. The capability MUST provide ability to DOCUMENT universally recognized Insomnia Severity Index.

c. The capability MUST provide ability to DOCUMENT universally recognized Pittsburgh Sleep Quality Index.

9. The capability MUST provide ability to DOCUMENT apnea-hypopnea index (AHI).

a. The capability MUST provide ability to DOCUMENT the recommended hypopnea definition.

b. The capability MUST provide ability to DOCUMENT the optional hypopnea definition.

10. The capability MUST/SHALL provide ability to document Respiratory Disturbance Index (RDI).

11. The capability MUST/SHALL provide ability to capture and document events.

12. The capability MUST/SHALL provide ability to document events sleep disturbance risk factors. Such as, (1) excessive daytime sleepiness (2) impaired cognition (3) mood disorders (4) insomnia (5) hypertension (6) ischemic heart disease (7) stroke history.

13. The capability MUST/SHALL provide ability to capture, count and document respiratory events into industry standard categories.

a. The capability MUST/SHALL ensure AHI or Respiratory Disturbance Index (RDI) is equal to or less than 5 events per hour with a minimum of 10 events to be categorized as no significant sleep disordered breathing.

b. The capability MUST/SHALL ensure AHI or RDI is greater than or equal to 5 and less than or equal to 14.9 events per hour with a minimum of 10 events to be defined as mild.

c. The capability MUST/SHALL ensure AHI or RDI is greater than or equal to 15 and less than or equal to 29.9 events per hour with a minimum of 10 events to be defined as moderate.

d. The capability MUST/SHALL ensure AHI or RDI is greater than or equal to 30 events per hour with a minimum of 10 events to be defined as severe.

14. The capability MUST/SHALL integrate equipment data.

a. The capability MUST/SHALL integrate equipment compliance data for continuous positive airway pressure (CPAP) machine.

b. The capability MUST/SHALL integrate equipment compliance data for oral appliance. (Data Management)

c. The capability MUST/SHALL integrate equipment compliance data for implanted stimulators. (Data Management)

15. The capability MUST/SHALL generate a note.

a. The capability MUST/SHALL generate a PDF note to support study reports (test data results).

b. The capability MUST/SHALL generate a PDF note to support clinical visit notes (assessment).

c. The capability MUST/SHALL generate a PDF note to support therapy data reports (ex. CPAP).

16. The capability SHOULD autogenerate sleep study notes.

a. The capability MUST/SHALL have the ability to incorporate the data captured during standards and advanced modes of ventilation (Continuous Positive Airway Pressure (CPAP), Automatic Positive Airway Pressure (APAP), Bilevel, Adaptive Servo Ventilation (ASV), Average Volume-Assured Pressure Support (AVAPS)).

b. The capability MUST/SHALL have the ability to incorporate the data captured during oral appliance and implanted stimulators.

c. The capability MUST/SHALL have the ability to incorporate the data captured during seizure montage (i.e. EEG).

d. The capability MUST/SHALL have the ability to incorporate the data captured during neurofeedback, biofeedback, and quantitative EEG.

17. The capability SHOULD contain auto generation note capturing.

18. The capability SHOULD accept notes generated from all PSG equipment.

19. The capability SHOULD contain an AI-powered sleep analysis and reporting system to automate scoring, analyze sleep patterns and events, and generate comprehensive reports with high rate of accuracy and reliability across multiple populations (OSA, elderly, young). (MUST meet accuracy >80%, Cohen’s Kappa>0.75, N3 and REM sensitivity > 80%, wake sensitivity >85%, N1 sensitivity >30%, with F1 score >0.80 for AHI calculations, and model SNR >10dB.).

a. The capability SHOULD provide explainable AI to analyze multi-channel/time series sleep biosignal data. Hypnodensity plots should be callable into report formats, should be displayed with each data collection, and allow for evaluation of certainty of staging with mouse-over capabilities.

b. The capability SHOULD analyze EEG, EMG, EOG, SpO2, airflow, and other PSG data streams using AI algorithms.

c. The capability SHOULD be able to automatically classify sleep stages (wake, NREM 1-3, REM).

d. The capability SHOULD detect and quantify sleep-related events (apneas, hypopneas, arousals, Periodic Limb Movements (PLMs)) with high sensitivity and specificity.

e. The capability SHOULD identify individual sleep patterns and trends based on the analysis of multiple parameters.

f. The capability SHOULD contain AI-powered sleep coaching tools for personalized sleep improvement strategies.

g. The capability SHOULD integrate all AI generated data with existing PSG information systems.

h. The AI capability MUST be compliant with the risk management framework standards established by the National Institute of Standards and Technology (NIST), and the American Academy of Sleep Medicine Autoscoring Software Certification.

20. The capability MUST support wearable at-home short-term monitoring to assess sleep and circadian concerns for patients.

a. The capability MUST utilize devices equipped with the following measurement technologies: 1) Photoplethysmography (PPG), 2) Accelerometer, 3) Gyroscope, 4) Skin Temperature, 5) Skin Conductance, 6) Ambient Light, and 7) Forehead EEG.

b. The capability MUST use devices that have public data demonstrating validation against clinical polysomnography for the detection of a) sleep/wake states and b) apnea/hypoxia events.

c. The capability MUST ensure that all utilized devices have demonstrated a Cohen's Kappa >= 0.7 and an F1 score >= 0.7 in their validation studies.

d. The capability MUST provide a device option for sophisticated, multi-sensor (except EEG) monitoring (wrist or finger worn) that can collect data continuously for at least 3 days and 3 nights, utilizing all seven technologies listed in 20.a.

e. The capability MUST have a device download capability that displays the sleep and circadian raw data and also statistics graphically over 3-4 days with the capability to view EEG tracings and plot hypnograms.

f. The capability MUST have a tabulated data output that is customizable based upon needs of the provider and viewable/importable into the patient record.

g. The capability MUST have high resolution raw or near-raw data export features in standard formats

21. The capability MUST support wearable at-home longitudinal monitoring to assess sleep and circadian processes requiring extended monitoring and/or emission-free devices.

a. The capability MUST utilize devices equipped with the following measurement technologies: 1)accelerometry, 2)gyroscope, 3)temperature, 4)ambient light.

b. The capability MUST use devices that have public data demonstrating validation against clinical polysomnography for the detection of sleep/wake states

c. The capability MUST ensure that all utilized devices have demonstrated a Cohen's Kappa >= 0.7 and an F1 score >= 0.7 in their validation studies.

d. The capability MUST provide a device option for simplified, long-duration monitoring that can collect data continuously for up to 3 weeks without recharge using a minimum of accelerometry, temperature, and ambient light sensors with local storage.

e. The capability MUST have a device download capability that displays sleep and circadian raw data and also statistics graphically over 3-4 weeks with single and double 24hr visualization.

f. The capability MUST have a tabulated data output that is customizable based upon needs of the provider and viewable/importable into the patient record.

22. The capability MUST support wearable Home Sleep Test (HST) with a FDA cleared device that can provide options for both EEG and respiratory channels

a. The capability MUST use devices that have public data demonstrating validation against clinical polysomnography for the detection of a) sleep/wake states and b) apnea/hypoxia events.

b. The capability MUST ensure that all utilized devices have demonstrated a Cohen's Kappa >= 0.7 and an F1 score >= 0.7 in their validation studies.

c. The capability MUST export viewable data for automated AI scoring and easy review of interpretation, meeting criteria set in item 19.

3.0 Department of War (DoW) Cybersecurity & Risk Management Framework (RMF) Requirements:

1. Vendor MUST provide products that already possess a current Authorization to Operate (ATO) or fully commit to undergoing the DHA RMF approval process.

2. Vendors MUST affirm compliance with all cybersecurity, Health Insurance Portability and Accountability Act (HIPAA), and Business-to-Business (B2B) requirements.

3. Vendor SHALL maintain RMF Approval for the entire Term of Support (minimum 6 years) including:

a. OS updates

b. Third-party component patching

c. Security upgrades

d. Vulnerability remediation

4. Cybersecurity maintenance MUST be included during warranty and remain available post-warranty.