Page 5 of 6 This is a SOURCES SOUGHT announcement ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does no obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought announcement MUST be in writing. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified businesses. Responses to this notice shall include: Company Name Address Point of contact Phone, fax, and email DUNS number Cage Code Tax ID Number Socioeconomic Status: Service Disabled Veteran Owned Small Business Veteran Owned Small Business 8(a) HUB Zone Women Owned Small Business SBA Certified Small Disadvantaged Business SBA Certified 8(a) SBA Certified HUB-Zone Small Business Other than Small Business Notice to Potential Offerors: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought announcement. This announcement shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. STATEMENT OF WORK FOR NITRIC OXIDE (INOTHERAPY) REQUIREMENT Introduction and Background The VA New York Harbor Healthcare System is dedicated to providing quality health care to veterans using the abilities of all employees supported by our commitment to education and research. We are recognized locally, regionally, and nationally as a leader in quality patient care, positive customer service, medical/allied health education, health-related research and employment opportunities. We seek to be the provider of choice of veterans and the community by offering an efficient, integrated quality health care system capable of providing a full range of primary, specialty and chronic health care services in a system that is readily accessible and responsive to change. Respiratory Care Service provides a 24 hour 7 day coverage for inpatient Respiratory patients as well as multifaceted outpatient care. The care provided includes: Home Oxygen evaluation and follow-up Patient education on various respiratory equipment Cpap/Bipap clinic Sleep Clinic (unattended take home sleep studies, mask fitting, equipment setup and follow-up) EEG testing Pulmonary Function Testing Pulmonary Rehabilitation Role of Nitric Oxide in Respiratory Disease Inhaled nitric oxide is a selective pulmonary vasodilator that improves ventilation perfusion matching at low doses in patients with acute respiratory failure, potentially improving oxygenation and lowering pulmonary vascular resistance The anatomic target of inhaled nitric oxide (NO) is the vascular smooth muscle cells that surround the small resistance arteries in the lungs. As NO diffuses through the alveolar membrane, it reaches these smooth muscle cells, causing an increase in the levels of cyclic guanosine monophosphate that in turn sets off a chain of events resulting in the reduction of smooth muscle tone. Inhaled NO therapy is used in adult respiratory distress syndrome and persistent pulmonary hypertension of the neonate because it reduces pulmonary artery pressure and vasodilates the blood vessels in ventilated regions. This reduces the shunt fraction and simultaneously increases PaO2.. Ideal Treatment Goals for Inhaled Nitric Oxide Improved oxygenation Decreased pulmonary vascular resistance Decreased pulmonary edema Reduction or prevention of inflammation rebound phenomena may be avoided by withdrawing inhaled nitric oxide gradually. Despite these concerns, in large clinical studies of patients with ARDS, the abrupt discontinuation of inhaled nitric oxide has not caused a deterioration in oxygenation Cytoprotection Protection against infection Nitric oxide is most commonly administered to patients receiving mechanical ventilation, although it may also be given through a face mask or nasal cannulae. Limiting the mixing of nitric oxide and high concentrations of inspired oxygen reduces the risk of adverse effects resulting from the formation of nitrogen dioxide. This is minimized further by introducing the mixture of nitric oxide and nitrogen into the inspiratory limb of the ventilator tubing as near to the patient as possible and synchronizing injection of the mixture with inspiration. Objective/Requirements INOTHERAPY Pharmaceutical solutions INOMAX(nitric oxide) for inhalation Delivery device meeting criteria for the administration of the nitric oxide and needed items, accessories and disposables Support for maintenance/calibration requirements Training and 24/7 technical support The INOMAX Delivery System provides a constant dose of INOMAX into the inspiratory limb of the ventilator circuit. It uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas sensors (NO, NO2, and O2 sensors) and the user interface, including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring. This allows the monitoring system to shutdown INOMAX delivery, if it detects a fault in the delivery system. INOMAX drug is stored as a gas mixture of NO/N2 in an aluminum cylinder at a nominal pressure of 2000 psig. The cylinder is attached to a high pressure regulator, which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder regulator is attached via tubing to the INOmax delivery system using one of the two NO/ N2 quick connect inlets on the back of the machine. The INOmax DSIR checks the INOMAX cylinder for the correct expiration date and cylinder concentration. The INOMAX enters the back of the INOmax DSIR, passes through a filter, then a safety shutoff valve, which is open under normal operation. An injector module is placed in the ventilator gas flow between the ventilator inspiratory outlet and the humidifier. Based on the ventilator flow, the INOMAX cylinder concentration and set INOMAX dose, the proportional solenoid valve delivers 800 ppm INOMAX into the ventilator circuit via the injector module where it mixes with the breathing circuit gas flow to achieve the set dose. This allows the INOmax DSIR to deliver a constant dose of INOMAX regardless of the ventilator flow pattern or breathe rate. A flow sensor inside the INOmax DSIR also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DSIR drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading. Gas Monitoring - The INOmax DSIR gas monitoring system provides monitored values for inspired NO, NO , and O . The sample gas is withdrawn from the breathing circuit and goes through a water trap, a zero valve, a sample pump and finally a sample flow sensor to the gas monitoring sensors. The zero valve allows the gas sensors to be zeroed (during low calibration) without having to disconnect the sample line from the breathing circuit. The pump and sample flow sensor ensure a sample gas flow rate is maintained to the monitoring sensors. The gas monitoring sensors are electrochemical; they are specific to each gas and provide an electronic signal which is proportional to the concentration of the gas present. Backup Delivery - If the delivery system does go into shutdown, the INOmax DSIR has an integrated backup function which provides a fixed flow of INOMAX (250 mL/min) into the injector module using a pneumatic on/off switch and a restrictor built into the delivery side of the system. This fixed flow of INOMAX will provide 20 ppm of NO when the continuous ventilator gas flow is 10 L/min. The backup is only for short term use until a replacement delivery system can be obtained. An alarm will warn the user if the backup system is turned on while the main delivery system is in use for INOMAX delivery. The INOblender® can also be used as a backup. Other Requirements All medical gases shall conform to specifications prescribed in the United States Pharmacopeia and the National Formulary. All medical gas manufacturers and fillers of medical gases shall be registered with the FDA; and all medical gases shall be manufactured, processed, packed, transported, and stored according to the FDA s Current Good Manufacturing Practice (CGMP) regulations and Title 21, Code of Federal Regulations, Parts 210, 211 and 201 for labeling. All products, equipment, and services provided under the contracts awarded under this solicitation shall be in compliance with all applicable Federal, state, and local regulations. Delivery and Quantity Requirements The contract items will be ordered and delivered according the needs of the New York Harbor Healthcare System (NYHHS). Quantities shall be specified by the COR or designee from the NYHHS Respiratory Service. All delivery charges such as hazardous material fees, delivery fees and other surcharges shall be included in the price of the contract. Place of Delivery The product will be delivered to VA NYHHS Respiratory Service, New York Campus, 423 East 23rd Street, New York, NY 11010 Training Of Operating personnel The price quoted shall include contractor responsibility for providing on-site orientation and training for all using personnel in operation and care of the equipment furnished. This training shall include actual demonstration and operation of the equipment, preventative maintenance, and any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action shall in no way jeopardize the Government's rights under contract guarantee clause. Upon completion of delivery, this training shall be given by qualified contractor representatives on a date to be determined by the using service POC. Operator and maintenance training shall not be conducted concurrently. Vendor shall submit training materials and training videos (prepared in CD or DVD format) on each piece of equipment for operation and maintenance. Any available training videos shall be for operation and maintenance and shall not be combined. These training materials and videos shall demonstrate the operation and maintenance of the equipment and any adjustments or other actions that may be undertaken by VA operating personnel in the event of failure of equipment. These training materials and videos shall be submitted to the responsible operations official or his designee prior to beginning of training. The Vendor shall consult with the Contracting Officer Representative or person acting in that capacity regarding the time this training will begin. These officials will be responsible for arranging for the presence of personnel to be trained. All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM) located on the web at www.sam.gov. It is desirable that any Offeror to have completed their business Online Representations and Certifications Application (ORCA). Additionally, all Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to this announcement must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at https://www.vip.vetbiz.gov/.  All interested Offerors should submit information by e-mail (preferred) to
[email protected] and include the RFQ (RFI) number, title of the project (Automatic Swing Doors Operator), and company name in the email subject heading. All responses are to be received NO LATER THAN Monday, 2-13-2017, 9:00am EST. Please refrain from telephone communication. Page 6 of 6 Page 6 of 6