SOW WatchPatv2.docx

Statement of Work

1. Contract Title: Portable Sleep Studies via WatchPATONE Direct with WatchPATOne Direct Services, IDIQ

2. Background: The VA Puget Sound Health Care System (PSHCS) is seeking a 1 Year contract with 2 1-year Option periods. Consistent with a COVID-19-related communication that we received on 19 March 2020 from the Office of the Deputy Under Secretary of Health for Operations and Management (DUSHOM), the Sleep Program of the PSHCS Pulmonary Service has discontinued conducting in-hospital sleep studies, both in-lab and home sleep apnea testing. PSHCS anticipates continued and increased emphasis for home sleep testing as we transition clinical programs involving greater use of alternatives to face-to-face medicine. The pertinent excerpt of the referenced communication is below:

“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. home sleep apnea testing) while these procedures are deferred.”

To assist as we shift to alternatives to face-to-face clinical care, the contractor shall provide the PSHCS as ordered, direct to home disposable sleep studies to our Veteran population through a mail order service known as WatchPAT Direct. The contractor shall prepare a WatchPATOne kit Product code CS2116045 per the instructions of the patient’s provider and then ship it to the patient. The contractor shall provide phone service to support the Veteran in the use of the WatchPAT kit on the scheduled test day in order to review test instructions. After the patient completes the test in their own home, the Veteran will ship the device back to Contractor the next day using a contractor-provided prepaid shipping label. Once the device is returned, the contractor shall upload the test results to a cloud-based server, where the referring physician can retrieve it for evaluation.

Amounts are provided for estimates only and are not guaranteed, quantities will be listed on funded task orders as needed.

3 Scope: The purchased units will be shipped directly from the vendor to the patient with 24/7 vendor support to the patient. The patient wears the device on the wrist and upon completion of the test the data is sent via the patients previously downloaded phone app to a secure portal for VA physician review. The device is disposable per contractor.

3. Minimum Salient Characteristics: WATCHPATONE via WATCHPAT DIRECT It is a diagnostic home sleep apnea test that utilizes the Peripheral arterial signal (PAT) It measures up to 7 channels (PAT signal, heart rate, oximetry, actigraphy, body position, snoring and chest motion) via three points of contact. Within one ‐minute post‐study the raw data is downloaded and auto‐scored identifying all types of apnea events. Sending the HSTs to patients’ home, providing 24‐hour assistance, also will provide help with scoring the studies. These disposable systems will allow the VA to decrease the waiting time and will ease the veterans that live far away by having them shipped to their homes.

4. Specific Tasks: This is to provide portable sleep studies during COVID-19 Isolation. Direct mail to patient will be conducted from contractor. Address listings will be provided by the VAMC assigned COR to contractor point of contact ________________. Results will go to VAMC – Sleep Medicine Clinic Director Brian Palen, MD.

4.1. Task 1 - Enterprise Management Controls.

4.1.1. Subtask 1 - Integration Management Control Planning. Provide the technical and functional activities at the required level for integration of all tasks specified within this SOW. Include productivity and management methods such as quality assurance, progress/status reporting and program reviews. Provide the centralized administrative, clerical, documentation and related functions.

4.1.2. Subtask 2 - Contract Management. Prepare a Contract Management Plan describing the technical approach, organizational resources and management controls to be employed to meet the cost, performance and schedule requirements throughout Contract execution. Provide a monthly status report monitoring the quality assurance, progress/status reporting and program reviews applied to this contract.

4.2. Task 2. Consultation sheet of patient to Pulmonary Dept for patient to be tested. 1) Sleep Study Interpretations - digital 2) Monthly Itemized Invoice – OB 10 Tungsten IPPS 3) Sleep Study Results - Verbal / Written CPRS – see deliverable schedule details at bottom of statement of work.

4.2.1. Subtask 1. VA address listing provided to Contractor to send wristband (WatchPATOne Direct) to patient with instructions for proper usage.

4.2.2. Subtask 2. Patient push button indicating sleep study complete to forward report to Pulmonary Dept, VA. Portable band is discarded by patient after test.

5. Deliverables: Sleep Study Report per patient with monthly invoicing for all Sleep Studies mailed out, returned by patient and uploaded to the VA. Certifier of Invoices – Assigned VA COR ___________________

6. Performance Monitoring: Each study will be reviewed by the local VA physician and inadequate function of the product shall be reported.

7. Security Requirements: From VA Project Special Forces: This acquisition has been reviewed and is categorized as a Software-as-a-Service (SaaS) by PSF. Additionally, no VA Enterprise Center (VAEC) or Technical Reference Model (TRM) approval is required. Critical Decision 1 approved on 4/22/2020 VIPR #: V20-04292-001.

This SaaS Product processes: No VA Data SaaS product has no direct connections or interfaces to VA systems or network Users consent to share their data (which may include PII and PHI) directly with the SaaS provider. SaaS provider must have published terms and conditions for user consent. VA providers access data in a view-only mode, or with limited functionality per the user’s consent. All data processed by SaaS provider shall be owned by SaaS provider/user.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI): VA logs into contractor Watchpat One Direct Database –Hospital and Specialty Medicine Service Line, Pulmonary Dept, Sleep Study Administrative Staff ________________ gives information, Pulmonary Department -Pulmonologist -Dr. Brain Palen gets the results. There will be no GFE or GFI based on contactor sending disposable sleep study device via direct mail to patient.

9. Packaging, Packing and Shipping Instructions: Direct shipping to the patient is implicit. The packing slip will be received by the patient. Must include return shipping instructions and postage.

10. Delivery Schedule:

Sleep Study Interpretations

count per month Immediately upon completion study

Invoice

end of month