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Department of Veterans Affairs Medical Center (562) ERIE, PA. 16504 STATEMENT OF NEED (SON) TITLE: VYNTUS SPIROS SYSTEMS INTRODUCTION: The Department of Veterans Affairs Medical Center, Erie, Pa 16504... Department of Veterans Affairs Medical Center (562) ERIE, PA. 16504 STATEMENT OF NEED (SON) TITLE: VYNTUS SPIROS SYSTEMS INTRODUCTION: The Department of Veterans Affairs Medical Center, Erie, Pa 16504, Medical Service has determined a Brand Name Only need to purchase five (5) VYNTUS Spirometer Systems for the associated Community Out Based Clinics (CBOCS) HISTORY/BACKGROUND/PURPOSE: The purpose of this purchase is to provide diagnostic lung/pulmonary screening for our Veterans in the Community Based Outpatient Clinics. Providing this service in the community will increase the number of Veterans that can be seen due to the shorter commutes to the clinics rather than to The Erie VA Medical Center. The implementation of the Spirometry Program at the Community-Based Outpatient Clinics will greatly enhance the care we are providing for our Veterans. It will make it easier for the Pulmonologist to follow disease processes in cases of asthma and reactive airway disease and observe the efficacy of treatment and patient compliance with medication. DETAILED DESPRIPTION/REQUIREMENTS: Erie Veterans Affairs Medical Center (station 562) located at 135 East 38th St. Erie, PA 16504 is completing Action Item V4AI-VH-10961 to refresh, replace, or expand remote telemetry spirometry with Brand Name Only in the community-based outpatient clinics. The Brand Name Only Requirement for the Vyntus Spiro is required because it uses the SentrySuite Software which is already in use with the Vyntus One and Vyntus Body Pulmonary Function System at the Erie VA Medical Center. The requirements for this action item will be setting up a Vyntus Spiro System in the following clinics: Ashtabula, OH CBOC Crawford, PA CBOC Venango, PA CBOC Warren, PA CBOC McKean, PA CBOC SALIENT CHARACTERSTICS: To ensure compliance and completion of Action Item V4AI-VH-10961, Erie VA Medical Center is requesting a Brand Name Only purchase of five (5) VYNTAS Spirometer Systems compatible with the main PFT lab in Erie. The Vyntus Spiro is a small hand-held spirometer that comes complete with a stand and laptop. Reasons for choosing this item include: Its 100 % compatible with SentrySuite the main Erie VAMC (562) PFT lab It is compact and easily stored The easy-to-use SentrySuite software produces comprehensive reports for the pulmonologist to review. The Vyntus Spirometer System has proven sensor technology that is easy to clean Technical Specifications Flow measurement Type: High-quality pneumotach Range: 0.1 to ± 16 L/s Resolution: 1 mL/s Accuracy: 0.1 to 14 L/s: ± 5% of reading or 0.2 L/s, whichever is greater Resistance: < 0.05 kPa/L/s (0.51 cmH2O/L/s) at 10 L/s Volume integration Type: Software volume integration of flow signal Range: 30 L (software limited) Resolution: 1 mL Accuracy: 0.5 to 8 L: ± 3% of reading or 0.05 L, whichever is greater Ambient Temperature: +10 °C to +34 °C (+50 °F to 93.2 °F) Relative humidity: 20 to 80 % RH, non-condensing Ambient pressure: 700 to 1060 hPa (525 to 795 mmHg) Altitude: 3000 m Classification of applied parts Type: applied part B Category according to MDD 93/42/EEC (2007) Complete system: Active class IIa medical product Standards, directives and market clearances Standards: EN 60601-1, EN 60601-1-2, EN 62304, EN 62366, EN ISO 14971, EN ISO 10993-1 Directives: 93/42/EEC amended by 2007/47/EC; RoHS 2011/65/EU compliant Market clearances: CE, FDA 510(k) clearance Basic Cart Dimension tota:l 96 cm W × 73 cm D × 117 cm H (37.8 × 28.7 × 46.1 ) Weight total: 32.6 kg (72 lbs) REQUIREMENTS: QTY UNIT ITEM CODE DESCRIPTION 5 Ea V-859142-13 Vyntus Basic Cart 5 Ea 34571-001 Laptop Lock-Keyed 5 Ea 25626-001 Vyntus Spiro Laptop 5 Ea 29225-001 Kit, HP Office Jet 5 Ea 720254 Syringe 3 Lite Manual Calibration 5 Ea 34491-104 Service-VYN Spiro-Protect Basic 4-years 5 Ea 34558-132 Service-RDX-SM Device PFT Fundmtls Trg-2 Days-Live Web Based 5 Ea 33120-001 Vyntus Spiro Pneumotach/Elbow Kit 5 Ea V-378560 USB Ambient Module 1 Ea 34588-101 Service-RDX-SM Device Field Install-1st Device 4 Ea 34588-102 Service-RDX-SM Device Field Install-Addl Devive 5 Ea 28567-001 SES Client 1 Ea 33285-001 Sentrysuite Workflow Advanced 6 Ea V-577201-100 Sentryconnect Seat License for SES IF Vendor will be on station: Contractor will be on station to provide service and therefore required to take the generalized privacy training: Privacy Training for Personnel Without Access to VA Computer Systems or Direct Access to or the Use of VA Sensitive Information. Copies to be maintained by COR. DELIVERABLES/INSTALLATION/INCEDENTAL SERVICES: Please deliver to: Erie VA Medical Center 135 E. 38th Street Erie, PA 16504 8am 4pm Monday through Friday except holidays. Deliveries to CBOC shall be coordinated with Will Taylor (814) 860-2344 Government Furnished Information or Material: a. This acquisition does not include Government-furnished property (GFP), identify in the Statement of Need all available information on GFP to be provided, including the make, model, bar code number and serial number, if available, of all accountable assets with an acquisition cost of $500 or more. b. This acquisition does not include Contractor-acquired property (CAP). c. "No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification." 5. Period of Service: Delivery shall occur within 30 days of receipt of contract or must occur within the timeframe designated by the Federal Government. 6. Security/National Agency Check Requirements: No special security requirements are anticipated. Influenza Vaccination: VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical, and administrative, paid, and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VA Medical Center s. Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation: - Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination. - Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine. The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities is in compliance with VHA Directive 1192. Tuberculosis Prevention: Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually. COVID 19: Contractor shall provide evidence of vaccination records or a negative COVID testing result within 72 hours of planned onsite visitation. This is to include installation, training, maintenance, and repairs. Emergency repairs will be evaluated on a case-by-case situation. HIPAA Training Certificates: If Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the COR listed in the awarded contract. Smoking: All VA Medical Center s property is smoke-free. Contractor personnel will comply with VA Medical Center s smoking policies. Violations will result in a warning and possible citation.