SOURCES SOUGHT
65 -- WatchPATOne Direct Disposable Device
- Notice Date
- 10/27/2021 1:18:27 PM
- Notice Type
- Sources Sought
- NAICS
- 333914
— Measuring, Dispensing, and Other Pumping Equipment Manufacturing
- Contracting Office
- 257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
- ZIP Code
- 76006
- Solicitation Number
- 36C25722Q0042
- Response Due
- 11/1/2021 7:00:00 AM
- Archive Date
- 11/16/2021
- Point of Contact
- david.simmons@va.gov, David Simmons, Phone: david.simmons@va.gov
- E-Mail Address
-
david.simmons@va.gov
(david.simmons@va.gov)
- Awardee
- null
- Description
- This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for Market Research. This is a Request for Information only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Department of Veterans Affairs Dallas Texas VA Medical Center in Dallas, Texas intends to award a brand name or equal only contract award for the purchase of a below items. The Government is conducting a market survey to help determine the availability and technical capability of qualified service-disabled veteran-owned small businesses, veteran-owned small businesses, small businesses, HUBZone small businesses and/or other large businesses capable of serving the needs identified below. This notice of intent is for open market as well as Federal Supply Schedule items. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women owned small business, HUB Zone, 8(a), small business or large business, relative to NAICS 33914 with a size standard of 750 employees. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on Federal Business opportunities website http://www.fbo.gov or GSA E-Buy at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Please advise if you carry the products for this requirement. Please submit all information to David Simmons via e-mail: david.simmons@va.gov by Monday, 1 Nov 2021 9am CST. Items OPERATING SUPPLIES: CS2116045 1 12 WatchPAT ONE Direct Disposable Device 300 EA CS2116046 2 WATCHPAT ONE DIRECT SERVICES 300 EA DESCRIPTION/SPECIFICATIONS/WORK STATEMENT Watch PAT ONE Direct Disposable Device CONTRACTING OFFICERS TECHNICAL REPRESENTATIVE (COTR): VANTHCS will appoint one (1) COTR for this contract. When service is requested, the contractor will always contact the COTR Tamira Dyers at (404) 775-7402 SCHEDULING ARRANGEMENTS: Except by special alternative arrangement, scheduled delivery will be provided only during Contractor s normal working hour s local site time. Upon acceptance of this contract, the Contractor shall immediately contact the COTR Tamira Dyers at 404-775-7402, to schedule mutually agreeable delivery times. SCOPE OF WORK: Delivery and set up of Watch PAT ONE Direct Disposable Device for the Dallas VA Sleep Clinic, 4500 South Lancaster Rd. Dallas, TX 75216-9982. Delivery activities shall consist of the following: Setup. Delivery of all items necessary to install the Watch PAT ONE Direct Disposable Device or operation. Post installation inspection. COTR will verify that required specifications are met and testing will be performed as necessary to meet VA and vendor requirements. ` C. Item will be installed by Dallas VA Bio - medical team with the assistance of vendors. Upon receiving a maintenance and repair call from VANTHCS, the Contractor shall make a return telephone call for within 2 hours. The Contractor will restore the equipment to FULL PERFORMANCE within forty-eight (48) hours of the original call. The Contractor shall notify the COTR of the existence or development of any defects in the equipment covered under this contract which the Contractor considers he/she is not responsible for under the terms of the contract (such as operator misuse). Training and support and preventative maintenance and educational courses to be provided on-site as indicated. Watch PAT ONE Direct Disposable Device The raw data is downloaded and auto-scored differentiating obstructive and central events, providing AHi, ROI and ODI based upon True Sleep Time and Sleep Staging. Both the AHi and ROI derived from the PAT were clinically validated with an 89% correlation to PSG.2 The PAT signal is an approved measure in the 2017 MSM HSAT Clinical Practice Guidelines for Adults with OSA.3 Measures 7 channels (PAT signal, heart rate, oximetry, actigraphy, body position, snoring and chest motion) via three points of contact Must provide True Sleep Time. The Watch PAT uses its advanced actigraphy to differentiate between wake and sleep periods to calculate True Sleep Time. A simple smartphone app transmits the study data to the cloud. As soon as the study is completed, the clinician can review the automated study results. Ease of Use Fully Disposable. Fully Reliable. Same Watch PAT Simplicity, Accuracy and Reliability NO Return Shipment, NO Cleaning, Downloading or Charging, NO Infection Risk Immediate access to sleep data for interpretation Data interpretation anytime, anywhere with Cloud based solution Clinical Efficacy Hypopnea Index (AHI) and Respiratory Disturbance Index (RDI) Vendor must be willing to receive and ship document to patients American Academy of Sleep Medicine (AASM)/ Centers for Medicare & Medicaid Services (CMS) compliant Immediate study results Three consecutive nights of reporting time capacity 24/7 tech support for patients and healthcare providers Chain of custody option for occupational health (police, trucking) and gov t/military applications reflect a patient s condition because a regular diet and normal activities can be maintained. - Patient Satisfaction Among all patient educational levels of understanding with single button operation. EXCLUSIONS (unless otherwise quoted): Modifications or corrections to the work scope dictated by concealed conditions encountered in the performance of the work and not indicated by the drawings, or specifications. Modification or corrections to installation room or supplied power. PERSONNEL CLEARANCES AND PRIVACY CONSIDERATIONS: The Contractor will ensure that their personnel and subcontractor personnel meet the privacy standards as set forth by HIPAA (Health Insurance Portability and Accountability Act of 1996) with respect personal and confidential information that they may come upon, while servicing medical equipment. PATIENT HEALTH INFORMATION (PHI) AND INDIVIDUALLY IDENTIFIABLE INFORMATION (III): This system does contain Patient Health Information (PHI) and Individually Identifiable Information (III). No VA data will leave the VA Facility. If a hard drive or any other electronic storage device needs to be replaced, the device will be given to the ISO. After destruction of the data by degaussing, the device may be returned to the vendor for inventory control if so requested. The repair of this system will be supervised by a VA employee in BioMed to assure data does not leave the facility. The COTR is responsible to assure that no VA data leaves the facility and an employee supervises repair. No Security & privacy training is needed by the vendor because the repair will be supervised. No other security statement is needed. a. Contractors and any subcontractors must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996. This includes both the Privacy and Security Rules published by the Department of Health and Human Services (HHS). b. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities, Veterans Health Administration (VHA). In accordance with HIPAA, the contractor may be required to enter into a Business Associate Agreement (BAA) with VHA. c. Business associates must follow VHA privacy policies and practices when applicable. All contractors and business associates must receive privacy training annually. d. For contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually Identifiable Health Information as determined by VHA. e. For contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required upon request. DOCUMENTATION: Contractor will provide the COTR with individual written reports which describe the maintenance and repair service performed on the equipment under warranty in sufficient detail so as to be acceptable by field inspectors of the Joint Commission and other inspecting bodies. This shall include a list of all parts replaced, all service performed as well as a statement that the equipment is operating per manufacturer s specifications after repair. The service report will be signed by the contractor s service technician, and by designated VANTHCS personnel. Prior to award, bidder must have a facility to include personnel, test equipment, parts inventory, training certificates, licenses and technical documentation available for inspection by VA Medical Center personnel and be able to show written evidence to technical qualifications of personnel, test equipment (and calibration documentation) licenses and availability of parts. Parts availability must be written documentation from either the equipment manufacturer or authorized parts supplier. In either case, bidder must be able to show the availability of parts to him/her within 24 hours after initial call. For contracts for maintenance and repair services form other than the original manufacturer or a designated representative, the Contractor will be fully responsible for obtaining all technical documentation necessary to fulfill contractual obligations. The Contractor warrants that the services to be performed under this contract will be performed in a good workmanship manner and shall conform to the standards of the industry. This warranty is given expressly and in place of all other warranties, expressed or implied, statutory or otherwise, and is the only warranty given by the Contractor. Warranty items that expire during the contract period will be added to the contract as appropriate. 9. NEGLIGANCE CLAUSE: When services and parts are required as a result of accident, abuse, misuse or negligence by other than the Contractor or his representative, and are not included as a part of PM inspection or service calls, such needs will be reported to the Contracting Officer s representative along with estimates of charges. The Contracting Officer and Representative will evaluate these needs and authorize appropriate action. The parts will be installed under the terms of the contact and each invoice is to include a legible itemized list of labor charges and parts costs. The government will incur no charges for service and parts including glassware due to accident, abuse, misuse or negligence by the contractor or his representative. 10. RECORDS MANAGEMENT: 1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. 3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. 4. VA North Texas Health Care System and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA North Texas Health Care System or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA North Texas Health Care System. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA North Texas Health Care System control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). 6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA North Texas Health Care System guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. 7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA North Texas Health Care System policy. 8. The Contractor shall not create or maintain any records containing any non-public VA North Texas Health Care System information that are not specifically tied to or authorized by the contract. 9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. 10. The VA North Texas Health Care System owns the rights to all data and record produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA North Texas Health Care System shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. 11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training 11. HD Statement: Electronic storage devices (ESD) of all forms containing any VA data shall not be removed from VA control. If the ESD needs to be replaced, the failed ESD shall be given to the facility Information Security Officer (ISO) for sanitization. Following sanitization of the ESD and at the request of the vendor, the sanitized ESD may be returned to the vendor for inventory purposes. If the equipment/system must be taken off VA premises for service or at the end of a lease, the ESD shall be removed by the vendor without cost to the VA and left at the VA for reinstallation or sanitization. Questions can be referred to the ISO. 12. SECURITY STATEMENT: No remote access. Chaperoned on site! 13. END OF CONTRACT: Contractor guarantees that all equipment covered in this contract shall meet or exceed manufacturer s performance specifications at the contract expiration date. Salient Characteristic Watchpat ONe Disposable Equipment Intuitive design with improved patient comfort Improved workflow with rapid download time and one-step processing 7 Channels with 4 respiratory indices 89% Correlation to PSG Accurate diagnosis with true sleep time and sleep staging 98% study success rate Scalable cost effective solution for high volume workflow with an automated report for immediate diagnosis and treatment decision Central Sleep Apnea (CSA) identification Percentage of Cheyne-Stokes Respiration WatchPAT calculates AHI and RDI using the patient s True Sleep Time rather than the recorded time used in most commercially available HSAT s True Sleep Time reduces the risk of misdiagnosis and misclassification that has been reported up to 20% with using total recording time WatchPAT s clinically validated Sleep Architecture provides information on sleep staging including sleep efficiency, sleep latency and REM latency4-5. It also provides the added value of detecting REM related sleep apnea with REM and non-REM AHI. WatchPAT has been clinically proven to detect all types of apnea events. The Central PLUS Module enables specific identification of Central Sleep Apnea (CSA) and Percent of Sleep Time with Cheyne-Stokes Respiration.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/4886b01dadf2434db9694d1769eb6141/view)
- Place of Performance
- Address: DEPARTMENT OF VETERANS AFFAIRS Dallas VA Medical Center 4500 S. Lancaster Rd Dallas, Texas 75216, USA
- Zip Code: 75216
- Country: USA
- Zip Code: 75216
- Record
- SN06165981-F 20211029/211027230110 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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