ATTACHMENT 1 PERFORMANCE WORK STATEMENT.docx

ATTACHMENT 1: PERFORMANCE WORK STATEMENT

Remote Level 1 Sleep Study Scoring

1. GENERAL:

1.1 Services/Resources Required

1.1 The Contractor shall provide remote Level 1 Sleep Scoring for the Department of Veterans Affairs (VA), Puget Sound Health Care System (PSHCS), American Lake Sleep Lab located at:

Puget Sound Health Care System Sleep Medicine Department, Building 81, Rm 309 ATTN: Tim Lamb 9600 Veterans Drive Lakewood, WA 98493-5000

1.2 The Contractor shall provide one firm fixed unit price in accordance with the Performance Work Statement (PWS) requirements for Scoring Level 1 Sleep studies using an all-inclusive firm fixed unit price. The All-Inclusive unit price shall be based on cost per report and will include ALL costs associated with the performance of services in accordance with performing the requirements of the PWS.

1.3 Estimated Quantities depicted in the schedule are based on prior weekly/monthly/annual ordering quantities from the VA Puget Sound Health Care System. Approximate estimate is 1500 studies per year.

1.4 Type of Contract: This contract shall be a (5) five-year Indefinite Delivery-Indefinite Quantity (IDIQ) Contract with annual ordering periods. Task Orders will be issued on an annual or as-needed basis.

1.5 Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

New Year’s Day President’s Day Martin Luther King’s Birthday Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas Any day specifically declared to be a national holiday.

2. SCOPE:

2.1 The VA Puget Sound Health Care System uses a VA approved cloud software, Somnoware, that is approved through the Federal Risk and Authorization management Program (FedRAMP) and was implemented in accordance with VA Memorandum dated 10/09/2020 per the Assistant Under Secretary for Health for Operations (10N), with the intent of improving time to diagnosis, increased provider capacity, and improvement with Veteran’s adherence to Continuous Positive Airway Pressure therapy. Somnoware platform enables sleep labs, pulmonary function testing facilities, and physicians to view results from various testing solutions.

2.2 Contractor shall be proficient with scoring polysomnogram data in Nihon Kohden and score in Somnoware.

2.3 Upon notification of a pending study, the Contractor shall acknowledge receipt within 24-hours. The Contractor shall score the sleep studies through the VA approved Cloud Software Somnoware and return the completed studies within 24-hours, but in no case, later than two business days.

2.3.1.1 Contractor’s staff is required to score VA’s polysomnogram data using Nihon Kohden and login remotely to the hosting application, Somnoware using an established national level virtual private network (VPN) connection.

2.3.1.2 Vendor will need to complete and submit a Business Associate Agreement (BAA) and create and maintain an Interconnection Security Agreements (ISA) and Memorandums of Understanding (MOU), as required, to establish the binding agreements and implementation of technical security controls between the external connecting parties. ISAs and MOUs protect the confidentiality, availability, integrity, and data ownership of VA information processed, stored, or transmitted between interconnecting parties as approved by the ESCC to allow access and transfer of patient data to the external company.

2.3.1.3 The VA Sleep Center will upload studies to contractor daily except weekend and holidays.

2.3.1.4 Vendor shall follow the American Academy of Sleep Medicine scoring manual format Version 3. Score sleep stages in 30-s sequential epochs commencing from the beginning of the study and assign a stage to each epoch.

2.4 The Summary Report shall have the following headings:

2.5 Hypnogram

2.6 EEG analysis

2.7 Limb movement analysis

2.8 Body position analysis

2.9 Respiratory tracing and event analysis

2.10 Oxygenation analysis

2.11 Positive airway pressure titrating analysis, if applicable

2.12 Electrocardiogram analysis

2.13 Contractor shall meet the requirements of the Privacy Act, Health Insurance Portability and Accountability Act of 1996 (HIPAA) and Department of Health and Human Services (HSS) final rules, and all confidentiality rights of patients.

2.14 Contractor shall include productivity and management methods such as quality assurance, progress/status reporting and program reviews, monthly and as requested. Provide the centralized administrative, clerical, documentation, and related functions.

3. DELIVERABLES:

3.1 The Contractor shall submit a comprehensive sleep study scoring report that shall be accompanied by the Patient-Reported information and collected raw data. The Contractor shall score the sleep studies through the VA approved Cloud Software Somnoware.

3.2 If it is determined by the PSHCS Director of Sleep Medicine that the comprehensive sleep study report is inadequate, the Contractor will be notified of the inadequacy and a repeat scoring will be completed within 24 hours of the notification at no additional cost to the PSHCS or patient.

3.3 Place(s) of Performance: Certified sleep technicians shall perform individual personalized scoring of VA sleep studies at the Contractor’s business location. Interpretation of returned scored studies will be performed by VA Physicians at the VA Puget Sound.

3.4 Contractor Personnel Qualifications: The Contractor’s employees providing services under this contract shall be fully certified as sleep study technicians.

3.5 The Contractor is required to maintain and provide records that document certifications and competency of their employees and sub-contractors providing services under this contract in accordance with the Joint Commission and other regulatory body requirements. The Contractor shall provide current copies of these records upon Contracting Officer's Representative (COR) request.

3.6 Mandatory Training: Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contractor’s physician(s) as required by the VA. A Training Management System (TMS) account will be established for each contractor employee who will be performing services under this contract by the COR prior to being given access to VA Information Systems.

3.7 The Contractor's certified sleep technician or individual approved shall be designated as a Key Person subject to the terms and conditions.

3.8 Joint Commission - where the contract does not require Joint Commission accreditation or other regulatory body requirements, the Contractor must perform the required work in accordance with JC standards. A copy of these standards may be obtained from the Joint Commission, One Renaissance Blvd., Oakbrook Terrace, IL 60181 or website JCR Publications | Joint Commission Resources (jcrinc.com).

4. KEY PERSONNEL AND TEMPORARY SUBSTITUTIONS

4.1 During the first (90) ninety days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the Contracting Officer, in writing, within (15) fifteen calendar days after the occurrence of any of these events and provide the information required under contract terms and conditions listed in the contract. After the initial 90-day period of the contract, the Contractor shall submit replacement employee information and all information required under other contract terms and conditions to the Contracting Officer at least 15 days prior to making any permanent substitutions.

4.2 The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes along with credentials, etc. for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The Key Personnel Listing (Attachment 3) will be updated to reflect any and approved changes of key personnel.

4.3 Conflict of Interest: The Contractor shall not propose any person who is also an employee of the PSHCS, if the employment of that person would create an appearance of a conflict of interest.

4.4 A Government employee who is employed by a Contractor is prohibited from participating personally and substantially on behalf of the Government through decision, approval, disapproval, recommendation, rendering of advice, certifying for payment or otherwise in that contract. No VA employee who is an employee, officer, director, or trustee of an affiliated university, or who has a financial interest in the contract, may lawfully participate in a VA contract or any other Government contract with the university. Authority: 18 U.S.C. § 208(a) and 38 U.S.C. § 8153; and 5 C.F.R. §§ 2635.402 and 2635.502. See VHA Handbook 1660.03, Transmittal Sheet, September 13, 2021.

5. MEDICAL RECORDS

5.1 Authorities: Contractor’s employee providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

5.2 Disclosure: Contractor employee may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Handbook 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

5.3 Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of Information Section shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer.

5.4 Investigation. A Tier 1, Low Risk/Non-sensitive investigation will be conducted on all key personnel. This investigation requires a National Agency Check with Inquiries (NACI). The vendor will have access to the patient’s name, date-of-birth, address, and social security number.

6. VENDOR ELECTRONIC INVOICE SUBMISSION METHODS

6.1 Invoices will be electronically submitted to the Tungsten Automation website at https://www.tungstenautomation.com/. Tungsten Automation direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During implementation (technical set-up) Tungsten Automation will confirm your Taxpayer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your certifying official for approval and payment. To successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten Automation to the VA-FSC should mirror the current submission of invoice. Clarification of additional requirements should be confirmed with your certifying official (your CO or buyer). Payments will only be made for actual services rendered. Payments shall be made monthly, in arrears. The VA-FSC requires specific information in compliance with the Prompt Pay Act and business requirements. The contractor shall be reimbursed upon receipt of a proper invoice. For additional information, please contact:

Tungsten Support Phone: 1-877-489-6135 Website: https://www.tungstenautomation.com/ Department of Veterans Affairs Financial Service Center https://www.fsc.va.gov/einvoice.asp