SOW WPAT Updated.docx

Minneapolis Veterans Affairs Healthcare System 1 Veterans Way Minneapolis, MN 55417

Performance Work Statement Home Sleep Apnea Testing (HSAT) for Veteran Beneficiaries of the Minneapolis VA Healthcare System (MVAHCS) Purpose The purpose of this document is to communicate the Government requirements of potential contractors with regards to Home Sleep Apnea Testing devices and services. This document details requirements of the device, the service, and the potential contractor.

Background MVAHCS currently makes use of disposable HSAT devices from Zoll Itamar WatchPAT One Direct program. Devices are ordered from a manufacturer, who ships them directly to the Veteran beneficiary. The manufacturer contacts the beneficiary to provide instructions and support and uploads the test results to the Somnoware software platform where they are available to MVAHCS staff.

The Government wishes to continue it’s current, established process for HSAT, as this process has proven to benefit MVAHCS Veteran patients and reduce the cost of providing Sleep Clinic services at MVAHCS.

MVAHCS is currently limited in its ability to purchase HSATs due to Government Purchase Card (GPC) limits. Current purchases must be timed to meet the availability of purchase card funds rather than the needs of the Veteran. Pursuing the process under contract will allow the Government more flexibility in managing Sleep Clinic HSAT purchases and reduce the burden on Government purchase cards. We believe that this request is in line with the VA’s mission by placing the Veteran first.

Scope Quantities, costs, or amounts shown hereafter are estimates only and not guaranteed. Post-award Task Orders shall contain the final cost determination as agree upon by the Government and the Contractor.

The Contractor will ship Zoll Itamar WatchPAT One Direct or equal disposable HSATs to Veteran beneficiaries’ home address, provide tracking and proof of delivery, and provide Veteran beneficiaries with pre-paid shipping for the return of the disposable HSAT to the Contractor.

The Contractor will contact the Veteran beneficiary to provide instructions and support for operating the disposable HSAT. The Contractor will make multiple attempts to contact the Veteran beneficiary if the initial attempt is unsuccessful.

The Contractor’s disposable HSAT device shall include a web-based or mobile application for the retrieval of test scores and results.

The Contractor shall provide, at no additional cost to the Government, a non-disposable alternative HSAT for Veteran beneficiaries unable to use the Contractor’s web-based or mobile application or are otherwise not able to satisfactorily use a disposable HSAT.

The non-disposable HSATs shall be returned to the Contractor. The Contractor shall make test scores and results available to MVAHCS staff via the Somnoware software platform. Test scores and results shall be timely and complete.

The Contractor shall provide, for the life of the contract and at no charge to the government, HSATs that are compatible with the Somnoware software platform. HSATs must include a user’s manual and instructions for troubleshooting.

The Contractor shall repeat the Veteran beneficiary’s sleep apnea test for at no cost to the Government if:

· HSAT provides unsatisfactory results.

· HSAT fails to transmit or download information.

· Information is not retrievable through the Contractor’s web-based or mobile application.

· The Government, in good faith, deems the device damaged, defective, or substandard.

The Contractor shall provide reporting and analytics capabilities to MVAHCS suitable for the following audiences:

· Executive leadership

· Clinic providers and staff

· Management and program analysts

· Finance and billing specialists All costs for the devices and services covered in this PWS shall be included as a single invoiced line item and shall not be separately priced.

Equipment and supplies remain the property of Contractor; the Government shall neither stock nor store items on behalf of the Contractor.

The contract period of performance shall be one base year followed by two option years.

Place of Performance The contractor shall ship HSATs to the Veteran beneficiary’s home address. Test scores and results shall be retrieved remotely by the Contractor. Test scores and results shall be made available to the Government via the Somnoware software platform.

Equipment and Service Specifications Equipment Requirements

· Contractors shall provide the Zoll Itamar WatchPAT One Direct (product code CS2117002) or equal.

· Estimated yearly quantity is 2,500 disposable and non-disposable HSATs.

· Shall be lightweight and easy for Veteran beneficiaries to use.

· Captured sleep apnea results shall be available to be reviewed remotely in report form and raw data form.

· Shall be available as a disposable type IV peripheral arterial tone based home sleep apnea monitoring system AND a non-disposable returnable equivalent device for patients without access to an internet-connected smart device.

· Shall have U.S. Food and Drug Administration (FDA) approval.

· Shall be compatible with the Somnoware software platform.

· Shall provide date and timestamps on clinical reports.

· Shall have the capability of monitoring and recording central sleep apnea, obstructive sleep apnea, hypopnea, oximetry, heart rate, and snoring.

· Shall not require respiratory belts, airflow sensor, or need of additional monitoring sensors.

Test Scores and Results Requirements Following are the minimum acceptable requirement for scoring and resulting:

· Respiratory abnormalities

· Oxygen desaturations

· Snoring

· Body position

· Heart rate Contractor Requirements

· Shall receive orders from MVAHCS clinicians through Somnoware sleep and respiratory care diagnostics software.

· Shall drop ship orders placed through Somnoware to the patient’s residence.

· Shall send veteran a disposable type IV peripheral arterial tone-based HSAT. If the veteran does not have an internet-connected smart device, shall send veteran a non-disposable equivalent and prepaid return shipping.

· Shall provide all leads, probes, attachments, and batteries needed for HSAT to properly perform its intended function.

· Shall provide for all cleaning and maintenance of any reusable type IV peripheral arterial tone-based HSATs.

· Shall provide 24/7 troubleshooting and customer support. Support number shall be included with shipment to each veteran.

· Shall notify the Veteran beneficiary of the delivery date and time (e.g. four-hour window).

· Shall establish a sleep study date and time by contacting the Veteran beneficiary directly.

· Shall provide veteran written and video instructions on how to complete Type IV peripheral arterial tone-based HSAT using either the disposable or non-disposable device.

· Shall provide patient with return mailing instructions, shipping label, and packaging for any non-disposable HAST.

· Shall make test scores and results available through Somnoware platform upon completion of disposable HSAT or return of reusable HSAT.

· Shall follow up with multiple attempts with veteran to retrieve non-returned HSATs.

· Shall assume fiscal responsibility for lost/damaged/unreturned devices prior to delivery receipt provided by the carrier.

· Shall replace defective devices at no cost to the Government.

· Shall provide tracking information to authorized individuals.

· Shall invoice the Government via the Inpatient Prospective Payment System (IPPS) where the HSAT device and service shall be submitted as a single line item.

· Shall proactively provide regular reports and analysis suitable for monitoring at both a patient and device level.

· Shall proactively provide data in raw format (for example, .csv or .exls) to the COR or the COR’s alternative. This data should be sufficient to demonstrate at minimum, for each device, when it was ordered, shipped, received, returned with results, whether the results were valid.

· Shall proactively provide notification to the COR and manager of the remaining available HSTs for the ordering period.

Procedure and Workflow

1. MVAHCS staff place a consultation order using the Somnoware platform.

2. MVAHCS staff assigns the consultation for scheduling with the Contractor.

3. Contractor schedules delivery appointment with Veteran beneficiary.

· Prior to delivery, Contractor inspects HSAT to be in good condition and sanitized according to the Centers for Disease Control and Prevention (CDC) Guidelines for Disinfection and Sanitization.

· At the time of the appointment, the Contractor shall provide training on the use of the HSAT device, connection, operation, and web-based or mobile application.

4. Veteran beneficiary completes sleep apnea test and returns any non-disposable HSAT device using the pre-paid return shipping label.

5. Contractor’s certified sleep technician interprets the study results and records results in Somnoware.

Deliverables Contractor shall provide the following deliverables through the life of the contract:

· Integration Management Control Plan (IMCP) shall be provided prior to the commencement of services by the Contractor. The IMCP shall provide details demonstrating how the Contractor will integrate with the Government’s current sleep study procedures. Topics shall include, at a minimum, quality assurance, reporting, administrating and clerical functions, and documentation.

· Contract Management Plan (CMP) shall be provided prior to the commencement of services by the Contractor. The CMP shall provide details demonstrating the technical, organizational, and managerial controls that will be employed to meet the cost, schedule, and performance requirements of the contract.

· Financial Management Report (FMR) shall be provided monthly directly to the Contracting Officer’s Representative (COR). Shall be in raw format (e.g. .csv or .xlsx) and shall contain all data required for the reconciling of payment to the device-level detail.

· Clinician Status Report (CSR) shall be provided to MVAHCS Sleep Clinic staff monthly and as requested. Shall allow clinicians to understand the status of the program, as well as that of individual Veteran beneficiaries, in terms of their HSAT.

· Test Scores and Results (TSR) shall be uploaded to Somnoware software platform upon the completion of the Veteran beneficiary’s HSAT. Shall be interpreted by a Contractor employee meeting the performance and certification requirements of the contract.

· Invoices shall be submitted through IPPS.

Training and Technical Support Contractor shall provide training to each Veteran beneficiary. Training shall be conducted through written and video demonstration. Training material shall be in English and/or the primary language of the Veteran beneficiary. In the case where non-English material is required, the Contractor shall work with the Government in providing adequate instruction material.

Contractor shall provide troubleshooting and technical support for Contractor-supplied devices and services. Such support must be available 24 hours per day, 7 days per week via telephone.

Quality Measurement Quality assurance and surveillance will assess the following areas: Maintenance, Quality, and Staff Qualifications