SPECIAL NOTICE
65 -- Intent to Sole Source brand name only requirement for two Pulmonary Function Measurement Systems plus one MS-IOS SES 614-21-4-560-0200 - PULMONARY FUNCTIION MEASUREMENT SYSTEM Logistics (90)
- Notice Date
- 8/16/2021 6:27:22 AM
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 249-NETWORK CONTRACT OFFICE 9 (36C249) MURFREESBORO TN 37129 USA
- ZIP Code
- 37129
- Solicitation Number
- 36C24921Q0521
- Archive Date
- 08/31/2021
- Point of Contact
- Martha Warren, Contract Specialist, Contract Specialist, Phone: 615-225-6454
- E-Mail Address
-
Martha.Warren1@va.gov
(Martha.Warren1@va.gov)
- Awardee
- null
- Description
- The Department of Veterans Affairs, Network Contracting Office 09, hereby provides notice of its intent to award a sole source, firm-fixed price contract for two pulmonary function measurement systems and one MS-IOS Oscillometry System for the Memphis VA Medical Center, 1030 Jefferson Ave., Memphis, TN 38104, to Carefusion 211, Inc., 22745 Savi Ranch Parkway, Yorba Linda, CA 92887. The contract is expected to be awarded under the authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 13.106-1(b) Soliciting from a Single Source. A Justification for Single Source Awards for Other Than Full and Open Competition has been prepared. The anticipated award date is September 7, 2021. The contractor will provide two pulmonary function measurement systems for the Memphis VA Medical Center, 1030 Jefferson Ave., Memphis, TN 38104. NAICS code: 339112 Surgical and Medical Instrument Manufacturing (SBA Size Standard 1,000 Employees) PSC: 6515 - Medical and Surgical Instruments, Equipment, and Supplies THIS NOTICE OF INTENT IS NOT A SOLICITATION OR REQUEST FOR COMPETITIVE QUOTES. However, interested parties may identify their interest and capability to respond to this requirement within seven calendar days after publication of this notice. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement. The Department of Veterans Affairs will NOT be responsible for any costs incurred by interested parties in responding to this notice of intent. Only written responses will be considered. All responses from responsible sources will be fully considered. As a result of analyzing responses to this notice of intent, the Government shall determine if a solicitation will be issued. Any prospective contractor must be registered in the System for Award Management (SAM) to be eligible for award and must submit a current authorized distributor letter from the manufacturer. All Service-Disabled Veteran Owned and Veteran Owned Small Businesses must submit a self-certifying statement that their company meets all criteria established IAW 13 CFR 121.406(b)(1)(i) through (b)(1)(iii) thus demonstrating compliance with the Non-Manufacturer Rule. Interested parties are encouraged to furnish information by email only with RESPONSE TO INTENT TO SOLE SOURCE 36C24921Q0521 in the subject line. All documents submitted will not be returned. All interested parties shall submit clear and convincing documentation demonstrating their capabilities to satisfy the requirements listed above to Martha Warren, Contract Specialist, by email at Martha.Warren1@va.gov NO LATER THAN August 23, 2021 @ 1:00pm CST. The capability documentation should include general information and technical background describing in detail the prospective contractor's capabilities and experience that will demonstrate the ability to support these requirements. Pulmonary Function Lab Specifications Equipment List One MS-IOS Oscillometry Systems Two Vyntus Body Diffusion PFT Plethysmography Systems Training Requirements The company will conduct a 4-day training session at the company. The company must provide a qualified trainer. The training must provide CEU s for 3 attendees provided the attendees attend all sessions and complete the written exam. The training session will provide proper instruction on how to use the equipment. Also, the company will provide an additional 2-day onsite training for follow-up at the Memphis VA Medical Center. Manufacturer s Warranty All new equipment must come with a standard one-year manufacturer s warranty. Software Requirements The software shall be the same for all testing devices. All data needs to reside in one common database with the ability to review and edit the data from any system. Existing patient data needs to be compatible with this software. In general, the software will have the following features: Compliance with ATS/ERS guidelines including the 2017 DLCO and Reporting guidelines. Digital Questionnaire can be integrated in to patient record. Mobile review application to allow physicians to interpret testing from any computer. Digital signature for reports Report output format selectable as print, monitor view, PDF, TIFF, RTF, JPG Online coaching for technician and patient Quality feedback based on ATS/ERS guidelines GLI reference sets implemented along with many others and the ability to create custom user sets and equations. Different patient types for BIO QC, QM validation and BIO controls to help keep Internal quality control data separated from patient data. Software automated exercise protocol suggestion due to reference values and spirometry data. User-specific post exercise test evaluation workflow steps. Centralized network administration and monitoring. Role Based Security Active directory integration for password management HL7 messaging and the ability to interface with CPRS Vista Enable TLS/HTTPS for all connected services TLS 1.2 Support unique application keys for all services Hygiene All devices must have a validated bacterial/viral applicable filter to include complete hygiene documentation and concept. The entire inside of the Plethysmography devices must be able to be surfaced wiped without having to enter the cabin and closing the door. Salient Characteristics MS IOS Oscillometry System Testing Capabilities: Spirometry Forced Vital Capacity (FVC, FEV1, Flow Volume Loop) and Slow Vital Capacity (SVC, ERV, IC) with the IOS system Must have a Maximum Voluntary Ventilation (MVV). Must have a Pre and post medication testing for therapy control. Bronchial Challenge Testing Quiet breathing Airways resistance (R5, R20 R5-R20%, AX, Fres, and X5) Must have technician/user manual over-ride of best selection of range of impedance Hardware Specifications: Must be able to utilize the same software as the Vyntus Body PFT systems and integrate with the same SES SQL database. Heated Pneumotach Must have a validated bacterial/viral applicable filter to include complete hygiene documentation and concept Vyntus Body Diffusion PFT Plethysmograph Systems Testing Capabilities: Spirometry Forced Vital Capacity (FVC, FEV1, Flow Volume Loop) and Slow Vital Capacity (SVC, ERV, IC) Must have a Maximum Voluntary Ventilation (MVV). CO-Diffusion SB Real-time: with continuous, high speed gas analysis for calculation of DLCO, VA, DL/VA. Contain a CO Diffusion Intrabreath or equal: an alternative diffusion method with a non-breath hold maneuver with continuous, high speed gas analysis for calculation of DLCO, VA, DL/A etc. Lung Volumes: using the N2 washout method for FRCN2, ERV, RV, TLC, VC, IC and determination of the Lung Clearance Index (LCI). Must have a Pre and post medication testing for therapy control. Maximal Inspiratory and Expiratory Pressures (MIP/MEP) Bronchial Challenge Testing Contain Lung Volumes and Airway Resistance by Body Plethysmography programs (TLC, FRC, sRaw.) Provide Resistance Volume loops Hardware Specifications: System must be made of glass cabin with open vision on all four sides to monitor patient safety Contain at least a 1100L Volume Cabin Door must contain an Electromagnetic door closure that does not require any gas pressure to seal cabin. Door must be capable of being opened by patient via release button inside the cabin Handgrip must be stable for safety of the patient to allow easy entry and exit Bench must be capable of withstanding at a minimum of 551lbs. Flexible, telescoping arm that extends 25 outside the cabin to test patients in wheelchairs or for whatever reason cannot enter the cabin. Low entry step must be is less than 3 for patient safety Contain a Digital Pressure Compensation Must have a minimum of 3 frequency calibration Contain a LED status lights for durability Fast Multigas analyzer (CO/CH4) for the Diffusion measurements with response time <150ms. Fully digital, high speed CO2 analyzer, based on infrared absorption for accuracy Must have single gas tank, as space is limited in the facility. Automatic temperature compensation during FRC measurement (to eliminate any thermal drift) Must contain an USB ambient module for continuously reading ambient data temperature, humidity, and barometric pressure. Factory Calibrated Ultrasonic sensor with 1000Hz sampling rate and double shot technology. Volume accuracy of 2.5%, meeting 2017 ATS/ERS DLCO guidelines. Ultrasonic flow sensor must be waterproof for cleaning and disinfection. Magnetically controlled shutter system must reduce dead space to meet ATS standards. Shutter system must be free of balloons Must have a validated bacterial/viral applicable filter to include complete hygiene documentation and concept Keyboard and mouse must be sealed so that it can be cleaned and disinfected. The information identified above is intended to be descriptive, not restrictive and to indicate the quality that will be satisfactory. The interested parties bear full responsibility to ensure their submission demonstrates to the government that they can provide the brand name or equal to supplies being requested.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/6189bf7bf2364d399bb8b62dd81db032/view)
- Record
- SN06097853-F 20210818/210816230113 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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