Q521--Portable Sleep Studies

STATEMENT OF WORK 1. Contract Title: Portable Sleep Studies-Brand name or Equal 52.211-6 2. Background: The Phoenix VA Health Care System (PVAHCS) 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 PVAHCS 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 brand name or equal 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. The device and software need to be compatible with National Somnoware program used for the VA for the interpretation by the reading providers. The Item is needs to be completely disposable. 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. 4. Minimum Salient Characteristics: WATCHPATONE via WATCHPAT DIRECT It is a diagnostic home sleep apnea (HSAT) test that utilizes the Peripheral Arterial Tone (PAT) signal. 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 HSATs 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. 5. Specific Tasks: This is to provide portable sleep studies. Direct mail to patient will be conducted from contractor. Address listings will be provided by Nadia Hasaneen, M.D., PVAHCS Sleep Medicine Clinic Director; Morgan Kula, Supervisory RRT, RPSGT; or designee to the VA assigned Contract Officer Representative (COR). Assigned COR provides the VA address listings to contractor point of contact Mr. Matthew Plummer. Results will go to Nadia Hasaneen, M.D., PVAHCS Sleep Medicine Clinic Director; Morgan Kula, Supervisory RRT, RPSGT; or designee. 5.1. Task 1 - Enterprise Management Controls. 5.1.1. 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. 5.1.2. 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. 5.2. Task 2 - Consultation sheet of patient to Pulmonary Department 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. 5.2.1. Subtask 1 VA address listing provided to Contractor to send wristband (WatchPATOne Direct or brand name or equal) to patient with instructions for proper usage. 5.2.2. Subtask 2 - Patient push button indicating sleep study complete to forward report to PVAHCS Pulmonary Department. Portable band is discarded by patient after test. 6. 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 CORs: Primary COR - Michael Sierra, Administrative Officer/FAC-COR III Alternate COR - Danette Venegas, Program Specialist/FAC-COR I 7. Performance Monitoring: Each study will be reviewed by the local VA physician and inadequate function of the product shall be reported. 8. 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, 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. 9. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI): VA logs into contractor WATCHPAT One Direct Database or equal Hospital and Specialty Medicine Service Line, Pulmonary Department Sleep Study Administrative Staff, Morgan Kula, Supervisory RRT, RPSGT; or designee, gives information. Pulmonary Department - Pulmonologist Nadia Hasaneen, M.D., or designee gets the results. There will be no GFE or GFI based on contactor sending disposable sleep study device via direct mail to patient. 10. 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. 11. Delivery Schedule: SOW TASK # Deliverable Title Format Number Calendar Days after CO Start 1 Sleep Study Interpretations Digital 1 Per Patient; various count per month Immediately upon completion study 2 Monthly Itemized Invoice OB 10 Tungsten - IPPS Once month billing Within 5 Days end of month 3 Sleep Study Results Verbal/Written EHR 1 Per Patient 45 Days of Interpretation 12. Holiday info: The following Federal holidays are observed by the Federal Government: The Contractor is not required to provide services on the following National Holidays, nor shall the contractor employee be paid for those days. Date Holiday Monday, January 01 New Year s Day Monday, January 15 Birthday of Martin Luther King, Jr. Monday, February 19 * Washington s Birthday Monday, May 27 Memorial Day Wednesday, June 19 Juneteenth National Independence Day Thursday, July 04 Independence Day Monday, September 02 Labor Day Monday, October 14 Columbus Day Monday, November 11 Veterans Day Thursday, November 28 Thanksgiving Day Wednesday, December 25 Christmas Day When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday. Also, included would be any other day specifically declared by the President of the United States to be a National Holiday. 13. INVOICE and PAYMENTS: Contractor shall submit monthly invoices in the arrears electronically via the Tungsten-Network System at the end of each month, for payment of the storage containers in that billing period. Contractor shall submit original invoice electronically to: Department of Veterans Affairs Financial Services Center http://www.tungsten-network.com (Toll-free telephone number: +1 (555) 000-0000) Payment shall be made monthly in the arrears upon receipt of properly prepared invoice. The invoice MUST be itemized to include the following information. Any information listed below that is not provided on an invoice, will render that invoice incomplete and the invoice will be returned for immediate correction. Dates of service. Description of services. Invoice number, date. Contract number. Obligation number Failure to comply with the above shall delay payment to the Contractor.