S02 - SOW - Honolulu Pkg 6 - Pulmonary Analyzer - v2.1 2.23.2023.docx

VA Pacific Islands Health Care System Initial Outfitting, Transition & Activation Statement of Work Analyzer, Pulmonary Function (JSN: M0720)

VA Pacific Islands Health Care System New Akaka VA Clinic 91-1051 Franklin D. Roosevelt Avenue Kapolei, Hawaii 96707 Version 2.1 Dated 2/23/2023 Introduction The VA Pacific Islands Health Care System has a requirement to purchase Analyzer, Pulmonary Function (JSN: M0720) with an authorized vendor to supply and deliver the item(s) identified in Table 1 below. See salient characteristics below. This is a Brand Name or equal Requirement. This requirement is in support of the activation of New Akaka VA Clinic. The new Akaka VA Clinic has the need for 1 – pulmonary function tester and body box to use at the facility. Vyaire Medical equipment is the basis for design.

Table 1 – Package Items Summary

Additional Item Requirements The vendor will provide service manuals that includes theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA Biomed Department.

Date of manufacture must not be greater than 2 years before the purchase order date. The equipment must not be used or refurbished and must have the latest manufacturer’s software/hardware updates installed. Any batteries provided with the unit will not be manufactured more than 12 months before the purchase order issue date.

General Conditions Site Address The address of the Akaka VA Clinic is provided below.

91-1051 Franklin D. Roosevelt Avenue Kapolei, Hawaii 96707

Delivery Schedule Items shall be delivered no earlier than the estimated delivery start date and no later than the delivery end date listed in Table 2 below.

Table 2 – Anticipated Building Outfitting Schedule

Schedule and Order Management The above delivery schedule is based upon the current construction schedule due to the nature of activation efforts and construction timelines and dates may vary and shift. Delivery dates need to be flexible. The delivery of items for installation are dependent upon the completion of applicable areas within the building. If there is a delay, the Contractor may be required to adjust the delivery date at no cost to the Government. The Contractor will coordinate with the on-site POC’s before delivery.

The awardees actual delivery dates will be confirmed by VA upon award.

Post-award, the vendor will coordinate delivery identified in this document with the VA prior to beginning any work (See Section 2.4). Once the dates have been confirmed, modifications to the schedule are subject to written approval by the CO, COR, and the vendor.

Delivery and Receiving Delivery and receipt of the proposed items is anticipated to be directed to the location identified below. Confirmation of delivery location will be provided post-award. To coordinate delivery, contact VA POC, TBD.

☒ Akaka VA Clinic (Direct Delivery to address detailed in paragraph 2.1) There is no loading dock available. All delivery vehicles must be equipped with a “Tommy Gate” type lift to facilitate unloading to ground level.

☐ IOT&A Contractor Provided warehouse: Address TBD The vendor is required to define the need for a staging area to accommodate item delivery, if needed. Post-award, this information will be confirmed with the vendor.

The delivery of items identified in this document shall take place during normal loading dock business hours which are defined as: 8:15 AM to 3:00 PM Hawaii Standard Time, Monday through Friday, and excluding Federal Holidays.

Delivery trucks will not be permitted to remain at the receiving area. Trucks shall be unloaded, moved from the receiving area, and then brought back to the receiving area if required to haul out any waste, tools, or excess materials.

Labeling of delivered items shall include the VA facilities contract number and VA purchase order number for identification and reference upon receipt of product.

NOTE: Due to the COVID19 situation, the vendor must follow VA guidelines when on VA property. Any individuals who need to enter the building for installation &/or training will be required to wear a mask and be screened by the site staff prior to entry. Please allow time for this in your schedule.

Clean Up and Disposal There are no dumpsters available for vendor use.

The removal of waste and/or excess material shall be conducted through the loading dock area.

Assembly, Installation, and Calibration Required (Yes ☐ No ☒) The vendor is not required to manage and coordinate installation at the Akaka VA Clinic with the COR or his representative and the IOT&A POC.

Training Required (Yes ☒ No ☐)

2.7.1 The vendor is required to provide live clinical training on set up, operation, shut down, and troubleshooting procedures to clinical staff.

2.7.2 The vendor shall coordinate training dates with the on-site Project Manager. Post-award, these dates will be confirmed with the vendor to meet the clinical schedule. Proposed training date will occur after installation of equipment.

Current timeframe of training is March 2024.

FY23-006 JSN: M0720 Analyzer, Pulmonary Function

2.7.3 The vendor shall provide documentation and/or certification to each staff member that has successfully completed training.

Statement of Work Page 1 of 8

Confidentiality and Non-Disclosure This equipment does connect to a VA network. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist, block 6, the C&A requirements do apply to this requirement, and a Security Accreditation Package is required.

This equipment does hold or store patient information. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist block 7, Appendix B and C provisions do apply.

Appendix B: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

Appendix C: VA will own this equipment. If vendor needs access during delivery, assembly, install or repair, the contractor shall be escorted by a VA employee to ensure there is no exposure to VA sensitive information. If the contractor is required to be on site for more than two consecutive days, VHA Privacy Training, TMS Course VA10203, is required and available at https://www.tms.va.gov/SecureAuth35/. The contractor will provide all consumable supplies necessary for training and competency assessment of hospital staff. Proof of training will be provided to the COR upon request.

Salient Characteristics Analyzer, Pulmonary Function, w/Computer (JSN: M0720) Total Quantity: 4 ☒ Network Required if Checked ☐ Manufacturer Certified Installation Required if Checked ☒ BMET Training Required if Checked ☒ End User Training Required if Checked

Basis of Design is Vyaire - VYNTUS ONE-PFT PC System; MFG P/N: 31783-001 Brand Name Requirement Salient Characteristics:

· Power shall be 110V

· Include gasses for initial startup / calibration

· Include hospital grade power cord

· Include pressurized chamber (aka Body Box) with bench for performing tests not to exceed 36.7” W x 31.5” D x 72.8” H exterior dimensions

· Include training for four staff

· Include Service costs for one year

· Minimum Measurement capabilities:

· Complete Spirometry [Forced Vital Capacity (FVC), Slow Vital Capacity (SVC), Maximal Voluntary Ventilation (MVV)] pre/post dilator

· Bronchial Challenge Testing

· Lung Volumes, Functional Residual Capacity (FRC) by Nitrogen (N2) Washout

· Body Plethysmography (FRC pleth, Raw)

· Single-Breath (SB) Diffusing Capacity

· SB Diffusing Capacity, Intrabreath

· Maximal Inspiratory Pressure (MIP)/Maximal Expiratory Pressure (MEP)

· Impulse Oscillometry (IOS)

· Cardio-Pulmonary Exercise Test (CPET), breath-by-breath

· Re-Expansion Edema (REE), mask

· Electrocardiogram (ECG), Rest & Stress

· Includes mobile cart

· Provides intuitive, single screen user interface

· Provides immediate Quality Check feedback

· Provides customizable settings, data tables, and parameters

· Provides unlimited Patient Trending and comparison reports

· Includes Global Lung Index (GLI) reference value equations

· Meets current ATS DLCO Guidelines for reporting

· Supports document uploads from other programs for any patient visit image2.jpeg