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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 01, 2018 FBO #5942
DOCUMENT

65 -- Nitric Oxide inhalation Gas - Attachment

Notice Date

2/27/2018
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 2;James J. Peters VA Medical Center;130 West Kingsbridge Road;Bronx NY 10468-3904
 

ZIP Code

10468-3904
 

Solicitation Number

36C24218Q9111
 

Response Due

3/13/2018
 

Archive Date

4/12/2018
 

Point of Contact

Safa Shleiwet
 

E-Mail Address

Safa.Shleiwet@va.gov
(safa.shleiwet@va.gov)
 

Small Business Set-Aside

N/A
 

Description

Please note that this is NOT a request for quotes or proposals. The Government is seeking Information for market research purposes only. The Department of Veterans Affairs, VISN 2, Network Contracting Office (NCO2) is currently conducting a market survey for firms capable of providing the following: Nitric Oxide inhalation Gas for VA New York Harbor Healthcare System. 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 followup) 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 breath 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. The North American Industry Classification Systems (NAICS) is 325412 Responses to this notice must be submitted in writing via email and must be received not later than Tuesday, March 13, 2018 10:00 AM EST. No telephone inquiries will be accepted. 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, HUB Zone, 8(a), small business or large business), relative to NAICS 325412. Responses to this notice will be used by the Government to make appropriate acquisition decisions. Responses to this notice should include company/individual name, a service capability statement, examples of similar facilities for which you have provided services to, proof of capably, certification. DUNS number, address, point of contact and social-economic category (ex:SBVOSB, VOSB, 8(a), HUBZone, WOSB, EDWOSB, Small Business). If your firm is a Service-Disabled Veteran Owned or Veteran Owned Small Business, you must be CERTIFIED in VetBiz (see internet site: http://vip.vetbiz.gov). Contractor must be registered in System for Award Management (SAM), formerly CCR (see internet site: http://www.sam.gov). Responses to this notice must be submitted in writing, and received not later than Tuesday, March 13, 2018 10:00 AM EST. All interested parties must respond to any related solicitation announcement separately from the responses to this announcement. Email: safa.shleiwet@va.gov. No telephone inquiries will be accepted.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BroVANAP/VAMD/36C24218Q9111/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24218Q9111 36C24218Q9111.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4111819&FileName=36C24218Q9111-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4111819&FileName=36C24218Q9111-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04836732-W 20180301/180227231737-6a697d8403f47f56d2a472fd84c6a521 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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