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Page 4 of 5 Page 1 of 3 INTENT TO SOLE SOURCE TO SDVOSB OEM DISTRIBUTOR TRILLAMED INTENT TO SOLE SOURCE: PROCUREMENT OF VYNTUS ONE PC System for PFT and CPET testing Page 5 of 5 Page 1 of 3 THIS IS NO... Page 4 of 5 Page 1 of 3 INTENT TO SOLE SOURCE TO SDVOSB OEM DISTRIBUTOR TRILLAMED INTENT TO SOLE SOURCE: PROCUREMENT OF VYNTUS ONE PC System for PFT and CPET testing Page 5 of 5 Page 1 of 3 THIS IS NOTICE OF INTENT TO SOLE SOURCE FOR VYNTUS ONE PC System for PFT and CPET testing: VAMC Providence, RI INTENT TO SOLE SOURCE FOR PURCHASE REQUISITION: This is not a request for competitive proposals. This is not a solicitation or request for offers. No solicitation package is available and telephone requests will not be honored. The Department of Veterans Affairs VA Medical Center intends to award a one-time, Firm Fixed Price, Sole Source contract for the VYNTUS ONE PC System for PFT and CPET testing for VAMC Providence, RI. Technology, knowledge, technical expertise, and servicing capabilities for the VYNTUS ONE PC System for PFT and CPET testing, are proprietary and peculiar to Vyaire Medical. Government distribution for this equipment is available only through the Service Disabled Veteran Owned Small Business (SDVOSB) Trillamed. A Sole Source Letter has been provided by the OEM describing the proprietary nature of the VYNTUS ONE PC System for PFT and CPET testing, establishing this product as being peculiar to Vyaire Medical. The letter states that only the OEM distributor is authorized distribute this product domestically. Per Vyaire Medical, no other vendors in any class, aside from the Trillamed are authorized to distribute this product as a distributor or a reseller in the US. The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901. This statute is implemented by for restricting competition on this procurement via FAR 8.405-6(a)(1)(i)(B). The intent is to procure these services on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 334510: Electromedical and Electrotherapeutic Apparatus Manufacturing. The most current Business Size Rating for this NAICS is 1250 employees. Capable parties may identify their interests and authorization to respond to this requirement by April 21st, at 10:00 AM (EDT). A determination by the Government not to compete this proposed award upon response to this notice is solely within the discretion of the Contracting Officer. STATEMENT OF WORK SCOPE OF WORK: The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to perform the following: Installation and implementation of a fully functional Vyaire Vyntus. Vyntus ONE will include complete pulmonary function testing, spirometry, DLCO, nitrogen washout lung volumes, LCI and MIP/MEP. It can be expanded to do cardiopulmonary stress testing. Clinical Training for Providence VA Medical Center staff. Technical Training for Providence VA Medical Center staff. 1. EQUIPMENT The following equipment shall be provided and installed by the Contractor in the space determined by the Government. All equipment installed by the Contractor shall be FDA approved for use, in new condition, and fully operational in accordance with manufacturer literature specifications. A minimum of two (2) copies of any associated operational and/or service manuals shall be provided for all equipment listed below as applicable. Vyntus ONE Pulmonary Function System has a modular design for an impressive array of features. Tests are more accurate, less intrusive and less stressful for patients. Modular design with 3 configuration options Factory Calibrated, Ultrasonic Flow Sensor with Double Shot Technology Innovative eDemand valve requiring less patient effort Tool free O2 cell exchange Mobile version for PFT testing outside the lab Cardiosoft ECG The Contractor shall provide all tools and equipment necessary to properly and safely perform the services set forth within this statement of work. This shall include, but is not limited, to all Personal Protective Equipment (PPE) which may be required for the work to be completed in a safe manner. The Contractor shall provide any equipment necessary for proper infection control measures during installation. 2. SALIENT CHARACTERISTICS The Contractor shall provide a fully functional system that meets the following characteristics: Salient Characteristics Ultrasonic flow sensor PFT application 1000 Hz, achieved by 2000 ultrasound transit time measurements Gas exchange CPET (physiological measurement) Volume sensor CPET DVT (physiological measurement) O2 analyzer CO2 analyzer Vyntus ECG Multigas analyzer (CO/CH4) Diffusion measurement Temperature sensor 10 to 50 °C (14 to 122 °F) ±0.5 °C at 20 °C (68 °F) ±1 °C at 10 to 34 °C (50 to 93.2 °F) Humidity sensor 0 100% relative humidity 4% relative humidity at 20 80% relative humidity Air pressure sensor 500 to 1100 hPa (375 to 825 mmHg) ±2.5 hPa (1.88 mmHg) at 700 to 1060 hPa (525 to 795 mmHg) Vyntus EC Meets latest ATS/ERS DLCO guidelines Validated, simple hygiene and maintenance routines PDF report creation and export 2. AREAS TO BE SERVICED (one or all as necessary and appropriate to this contract) Department of Veterans Affairs Providence VA Medical Center Respitory Department 830 Chalkstone Ave Providence, RI 02908 3. INSTALLATION a) The Contractor shall provide all labor, materials, tools, equipment etc. to prepare for and complete the installation of the equipment in the space determined by the Government. b) Project implementation meetings, if necessary, shall be coordinated with the COR. c) Installation and implementation dates are to be coordinated in advance with the Contractor and the COR. d) All employees of the Contractor and subcontractors shall comply with VA security management program and obtain the permission of the VA police, be identified by project and employer, and restricted from unauthorized access. e) All installation personnel shall be trained by the manufacturer on how to properly install the equipment. Resumes and certifications shall be submitted for review upon request by the Government. f) All installation personnel shall be trained by the manufacturer on safe and proper Personal Protective Equipment (PPE) usage and general infection control regulations and requirements relevant to the work outlined in the Scope of Work. g) The Contractor shall communicate to the Government the estimated downtime required to complete full installation and testing of Vyntus. If the Contractor is unable to install the equipment to its normal operational state within 24 hours the Contractor shall compensate the Government for the downtime by extending the warranty service in a period equivalent to the downtime of the equipment. h) The Contractor shall be responsible for the safe removal and disposal of all trade-in equipment as applicable. i) The Contractor shall be responsible for the safe removal and disposal of all packing materials and related waste generated during installation. 4. TRAINING The Contractor shall provide a comprehensive onsite training program for the operating clinicians. This training program shall include at the minimum the following sessions: (i) Technical Training, (ii) Operational Training, (iii) Administrative Training, and (iv) Hardware and Software Trouble-shooting. Training shall occur onsite during normal business hours, 7:00am-3:30pm, Monday through Friday. Competency assessments shall be provided with the training. Onsite training is to be scheduled in advance with the Providence VA Medical Center through the COR. The Contractor shall provide onsite general overview technical training for Clinical Engineering personnel as requested. Training shall include a technical overview of the mechanics, electronics, and general operations of the system. Training shall cover detailed instruction regarding the preventative maintenance, troubleshooting, and general maintenance of the equipment. 5. INSPECTION AND ACCEPTANCE a) The Contractor shall conduct a joint inspection with the COR upon delivery of equipment. b) Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s). c) The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer. 6. WARRANTY a) The contractor shall provide a one year manufacturer s warranty on all parts and labor. b) The warranty shall include all travel and shipping costs associated with any warranty repair. 7. TASK FREQUENCY AND INSTRUCTIONS The work set forth in the Scope of Work shall be completed in a single visit, be it a single day or multiple days as required for appropriate completion. All work is to be scheduled in advance with the COR. Equipment delivery shall not precede installation by more than 20 days. Installation and implementation must be immediately followed by clinical user training including go live support. Implementation and integration with VistA CPRS shall not exceed 90 days from date of award. 8. SPECIAL WORK REQUIREMENTS The Contractor shall comply with any and all Infection Control Risk Assessment requirements deemed appropriate by the Providence VA Medical Center during all portions of the work set forth in the Scope of Work. The Contractor must comply with security, privacy, and safety issues in accordance to VA standards, policies, and directives set forth at all times while providing the work outlined in the Scope of Work. 9. PROPERTY DAMAGE The contractor shall take all necessary precautions to prevent damage to any government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (e.g. trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the government, upon approval of the Contracting Officer. 10. ATTACHMENTS None. 11. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS The contractor's employees shall wear visible identification at all times while on the premises of the VA property. It is the responsibility of the contractor to park in the appropriate desig¬nated park¬ing areas. Information on parking is available from the VA Police-Security Service. The VA will not invalidate or make reimbursement for parking viola¬tions of the con¬tractor under any con-ditions. Smoking is prohibited inside any buildings at the VA. Cellular phones and two way radios are not to be used within six feet of any medical equipment. Posses¬sion of weapons is prohibited. Enclosed containers, including tool kits, shall be sub¬ject to search. Violations of VA regulations may result in a citation answer¬able in the United States (Federal) Dis¬trict Court, not a local district state, or municipal court. 12. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD The contractor shall comply with the Federal OSHA Blood borne Pathogens Standard. The contractor shall: A. Have methods by which all employees are educated as to risks associated with blood borne pathogens. B. Have policies and procedures which reduce the risk of employee exposure to blood borne pathogens. C. Have mechanisms for employee counseling and treatment following exposure to blood borne pathogens. D. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, and mouthpieces for the employee during performance of the contract. 13. INFORMATION SECURITY LANGUAGE VA HANDBOOK 6500.6 APPENDIX C C-1 VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 6. SECURITY INCIDENT INVESTIGATION a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-10 compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 7. LIQUIDATED DAMAGES FOR DATA BREACH a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C C-11 (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 8. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day s notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. VA HANDBOOK 6500.6 MARCH 12, 2010 APPENDIX C C-12 9. TRAINING a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. 14. Records Management Language for Statement of Work (SOW): The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract: 1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. 2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. 3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. 4. 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 by the Freedom of Information Act. 5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. 6. The Government Agency owns the rights to all data/records produced as part of this contract. 7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. 8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. 9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. 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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information