Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 28, 2015 FBO #5026
DOCUMENT

Q -- NITRIC OXIDE GAS THERAPY - Attachment

Notice Date

8/26/2015
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;Ralph H. Johnson VA Medical Center;109 Bee Street;Charleston SC 29403-5799
 

ZIP Code

29403-5799
 

Solicitation Number

VA24715N1010
 

Response Due

9/2/2015
 

Archive Date

11/1/2015
 

Point of Contact

DARIUS CRANE
 

E-Mail Address

Contract Specialist
(darius.crane@va.gov)
 

Small Business Set-Aside

N/A
 

Description

Sources Sought Notice: Nitric Oxide Gas Therapy DESCRIPTION: This is a sources sought to determine the availability of potential sources having the skills and capabilities necessary to provide the Nitric Oxide Therapy Service. All interested vendors are invited to provide information to contribute to this market survey/sources sought including commercial market information. THIS IS NOT A SOLICITATION ANNOUNCEMENT. This is a sources sought synopsis only. Questions should be submitted by email to darius.crane@va.gov. Provide only the requested information below. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classifications (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub zone, 8(a), small, small disadvantaged, woman owned small business, FSS/GSA contract schedule holders or large business)) relative to NAICS 325412, Size Standard 100 employees. Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought synopsis, a solicitation announcement may be published on the FBO website. Responses to this sources sought synopsis are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the solicitation announcement in addition to responding to this sources sought announcement. SPECIFIED REQUIREMENT: Network Contracting Office 7, Charleston, SC is seeking sources for a potential contractor to perform the following type of Nitric Oxide Therapy Service, in accordance with Attachment 1. REQUESTED INFORMATION: (1) STATEMENT OF CAPABILITY: Submit a brief description, five (5) pages or less, that demonstrates how your company has the supervision, capabilities, software, labor and experience to perform the services described above. Include past experience in performing these services to the VA, other Government (Federal or State) agency, or for a private facility. If a FSS/GSA contract schedule holder, please provide contract schedule number. Please specify your availability to start date and your address. (2) BUSINESS SIZE AND SOCIO-ECONOMIC STATUS: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub-zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at https://www.sam.gov/portal/public/SAM/ and/or the VetBiz Registry at http://vip.vetbiz.gov/. If not, please (i) NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM and to receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry. Responses must be emailed to darius.crane@va.gov no later than 2:00PM EST, Monday, August 31, 2015. Your response should include both the STATEMENT OF CAPABILITY and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained above. Please place "Attention: Nitric Oxide Therapy" in the subject line of your email. This notice is to assist the VA in determining sources only. A SOLICITATION IS NOT CURRENTLY AVAILABLE. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. ? STATEMENT OF WORK NITRIC OXIDE THERAPY I.PURPOSE:To establish a policy, assign responsibility and to outline the steps in providing Nitric Oxide (NO) Therapy. II.SUPPORTIVE DATA: Nitric Oxide (NO), not to be confused with the anesthetic nitrous oxide, is a gas molecule with selective vasodilation properties. NO is the active metabolite of a number of other vasodilators, including sodium nitroprusside and nitroglycerin. It is also produced in all human organ systems, including the nasopharynx and lungs. In high concentration, NO is profoundly toxic and causes disease identical to Acute Respiratory Distress Syndrome (ARDS). In the presence of oxygen, NO is broken down to form nitrogen dioxide (N02). In the blood NO interacts with hemoglobin. The byproduct of this reaction produces increased levels of methemoglobin. Methemoglobin will not carry oxygen, and therefore, its level must be closely monitored during NO therapy. Inhaled NO provides selective vasodilatation of the pulmonary arterioles without systemic effect. Vasodilation of the pulmonary arterioles will provide a decrease in pulmonary vascular resistance (PVR) which should improve blood flow to the lung. The INOvent delivery system is an integrated, single unit, designed to administer and monitor inhaled NO. The INOvent delivery system connects to the inspiratory limb of the patient breathing circuit. It functions by measuring gas flow in the breathing circuit and injecting the required flow of NO to deliver the concentration set by the user in parts per million. Itis designed to deliver a constant concentration of NO, independent of ventilator flow patterns. INDICATIONS: oTo reduce pulmonary artery pressures due to pulmonary hypertension oTo reduce pulmonary vascular resistance oTo enhance oxygenation oAs adjunctive therapy in treatment of ARDS. CONTRAINDICATIONS: oAbsolute contraindications: 1. Patients with congenital or acquired methemglobinemia reductase deficiency oRelative contraindications: 1.Patients with a bleeding diathesis 2.Intracranial hemorrhage 3.Severe left ventricular failure HAZARDS/COMPLICATIONS: oElevated methemglobin levels oNitrogen dioxide (N02) toxicity oProlongation of PT/PTT oIncreased left ventricular filling associated with rapid changes in pulmonary pressures. oRapid withdrawal of NO may result in rebound hypoxemia and pulmonary hypertension. PRECAUTIONS: oWhen given via mechanical ventilator, an increase in exhaled tidal volumes might be noted. This increase occurs as a result of additional gas flow from NO into the circuitry. For example, at 40 ppm NO setting, the INOvent delivery system will add 10% more gas to that delivered to the ventilator and 5% more for 20 ppm setting. oTrigger sensitivity of the ventilator might be compromised, especially if the patient is on an assisted mode of ventilation. oThe INOvent delivery system pulls gas from the breathing circuit via the gas sampling system at a flowrate of 230 ml/min. This may interfere with the patient's ability to trigger the ventilator if the patient is spontaneously breathing. oThe set Fi02 in the breathing circuit might be reduced with increases in the NO concentration. ASSESSMENT OF NEED: oHypoxia oIncreased pulmonary artery pressures oAcute Respiratory Distress Syndrome ASSESSMENT OF OUTCOME: oImproved oxygen saturation as measured by pulse oximetry oIncreased arterial oxygenation oReduced pulmonary artery pressures. MONITORING DURING NITRIC OXIDE THERAPY: oFi02 oTidal volume oPulse oximetry oArterial blood gases must be obtained at baseline and as follows: 1.Baseline (Pre initiation) 2.30 minutes Post initiation 3.Every day 4.30 minutes after each NO concentration adjustment 5.At any time when clinically indicated oMet Hemoglobin (Nursing) oPulmonary artery pressure (Nursing) oPlatelet count (Nursing) oN02 levels FREQUENCY OF SYSTEM CHECKS: oA ventilator INOvent system check should be done upon initiation of NO therapy. In addition to an initial check, the system should be checked: 1.Every two hours and PRN 2.Following any changes in ventilator and/or INOvent delivery system settings. 3.Following an acute deterioration of the patient's condition as a result of decreasing or increasing NO concentration. III.POLICY: Nitric Oxide Therapy via the INOvent is to be administered in the ICU and Cardiovascular Laboratory by a Respiratory Therapist that is trained and competent in the use of the INOvent delivery system. IV.DELEGATION OF AUTHORITY AND RESPONSIBILITIES: All Pulmonaiy/Respiratory Care Staff as designated by the Chief of Respiratory Care. V.PROCEDURE: EQUIPMENT AND SUPPLIES oINOvent delivery system with two 800 ppm Nitric Oxide gas cylinders oMechanical ventilation equipment oPulse oximetry oPulmonary artery catheter (when indicated) oArterial line (when indicated) oPurge and performance setup SET UP: oInitial connections 1.Connect regulator output hoses to the quick connect ports on the rear of the INOvent delivery system 2.Connect regulators (hoses) to the NO therapy gas cylinders 3.Confirm that the pressure in the NO gas cylinders is greater than 200 psi 4.Connect the INOvent delivery system power cord to an electrical outlet. Ensure that the green power light is illuminated. 5.Connect the injector module to the electrical cable and injector tube. Connect the electrical cable and injector tube to the front panel of the unit. 6.Connect the sample line to the INOvent delivery system and, if necessary, empty the fluid bottle and/or change the filter 7.Switch on the INOvent delivery system and wait for the start-up routine to complete. Confirm that both the buzzer and speaker sound. oCalibrations The INOvent delivery system calibration function allows for low range calibrations of the NO, N02 02 sensors. This calibration can occur without taking the patient off the ventilator. The high range calibration is individually calibrated with special calibration gas. WARNING: Ventilator changes should not be made while performing a low range calibration. oA low range calibration should be done initially and at least once per shift while in use. A low range calibration will zero the NO and N02 sensors and span the 02 sensor to 21% (room air). Follow calibration procedures in Operator's Manual: Section 4-1 to 4-6. oA high range calibration should be done at least once per month using the calibration kit provided. The procedure requires that each sensor be calibrated individually. Separate cylinders of NO and N02 are required. A high range calibration of the 02 cell can be performed using medical grade wall oxygen. Follow calibration procedures in Operator's Manual: Section 4-1 to 4-6. PRE-USE PROCEDURES: Note: Prior to using the INOvent delivery system to administer NO to a patient ensure that monthly maintenance procedures have been performed within the last 30 days. These steps MUST be performed prior to placing a patient on the INOvent delivery system. oInitial Connections and Leak Test 1.Connect the INOvent delivery system as described in the initial setup section. 2.Check cable and hoses for signs of wear or damage and replace as needed. 3.Switch the INOvent delivery system to ON and confirm that the buzzer and speaker sound. Wait for the start up routine to finish. 4.Tum each gas cylinder ON and confirm that there is at least 200 psi in each therapy gas cylinder. 5.Tum each cylinder valve off. Wait for 30 seconds and confirm that there is no decrease in the pressure reading on the regulator. Leave the cylinder valves off. oPurge and performance Test 1.Perform a low range calibration of the NO, N02, and 02 sensors. 2.Follow the diagram below to set up circuitry for the Purge and Performance Test. 1.02 Flowmeter 2.02 Tubing 3.15Mx 4.5 mm Adapter 4.22M/l 5F x 22M/l 5F Adapter 5.Injector Module 6.300 mm of 22mm hose 7.Sample Tee 8.Inspiratmy Gas Sample Line 9.NO/N2 Injector Tube 10.Injector Module Electrical Cable Circuit connections for purge and performance test 3.Ensure one end of the sample line is connected to the front on the INOvent delivery system and connect the other end to the sample tee as shown. 4.To purge the system, set the oxygen flow to 15 lpm and set the NO concentration to its maximum setting (80 ppm). Ensure that the regulator pressures fall to zero; the INOvent delivery system has been purged., 5.Confirm that the "Low NO/N02 Pressure" and the "Delivery Failure" alarms sound to ensure the pressure has reached zero. This may take a few minutes depending on the NO supply gauges at the start of the test. 6.Once the alarms have sounded, turn on one NO cylinder. DO NOT TURN ON THE OTHER CYLINDER. The alarms will ·silence automatically. 7.Adjust the "SET NO" to 40 ppm, wait for 3 minutes or until the monitor readings are stable, and check that NO, N02, and 02 readings, are within acceptable ranges. Acceptable ranges are listed below: 02 % v/v ( ± 3% v/v) = 95 N02 ppm max = 1.5 NO ppm (min/max) = 32/48 NOTE: This table includes errors of the NO delivery system, the NO monitoring system, the calibration gas, and the NO therapy gas. If any of the monitor readings fall outside the ranges listed above, recalibrate the appropriate sensor. 8.Adjust the "SET NO" concentration to zero. 9.Enter the "ALARM HISTORY" page and clear the screen of any resolved alarms. oConnecting the INOvent to the patient ventilator 1.Perform all pre use procedures 2.Locate INOvent near the patient and ventilator 3.Connect the power cord to an emergency red outlet electrical supply. WARNING: If pre use procedures were performed more than 5 minutes prior to connecting to the patient's ventilator circuit, repeat the procedure to ensure that a high N02 is not delivered to the patient. 4.Connect the injector module to the inspiratory limb of the breathing circuit between the inspiratory outlet of the ventilator and the inspiratory inlet of the humidification chamber. 5.Insert the sample tee into the inspiratory limb of the patient's breathing circuit approximately 6" to 12" away from the patient wye. INITIATE NITRIC OXIDE THERAPY oPerform a TIMEOUT; verify patient's identification by name and SS#. oSet the ordered NO concentration to the desired level oSet the measured inspired NO, N02, and 02 measured alarm limit values. MAINTENANCE OF THE INOvent SYSTEM oChanging NO Therapy Cylinders 1. The NO therapy gas cylinders should be changed whenever the cylinder pressure falls below 200 psi. Replacement NO gas cylinders and supplies should be obtained from Ikaria. WARNING: You must purge the regulator assembly immediately before using a new NO cylinder to make sure the patient continues to receive the correct NO concentration and does not receive high N02 concentrations. oPurging the NO Therapy Cylinder 1. Use the purge manifold mounted on the cart located between the regulators in the back of the unit Inserting the low pressure hose quick-connect fitting into the purge manifold 2.Determine which regulator assembly is not being used and requires purging. 3.On the regulator assembly that requires purging, disconnect the low pressure hose quick connect fitting from the NO, N2 input on the rear of the INOvent delivery system. 4.Open the cylinder valve on the new NO therapy gas cylinder 5.Close the cylinder valve on the new NO therapy gas cylinder 6.Check for leaks at the cylinder valve outlet connection of the new cylinder with soapy water. 7.Insert the low pressure hose quick connect fitting into the purge manifold 8.Firmly push and hold the quick connect fitting in place while the pressure falls to zero on the regulator gauge. 9.After the pressure drops to zero, reconnect the low pressure quick connect fitting to the No/N2 input on the rear of the INOvent delivery system. 10.Open the cylinder valve on the new cylinder 11. Close the cylinder valve on the empty cylinder. 12. Replace the empty NO gas cylinder. Leave valve off. ROUTINE AND SCHEDULED MAINTENANCE/INFECTION CONTROL oBetween Patient Use 1.Change sample line 2.Remove the injector module. Package module for delivery to SPD for sterilization via steam autoclave. 3.Take INOvent to SPD for processing 4.Ensure the power cord is plugged into wall outlet to charge batteries at all times oDaily (During Patient Use) 1.Ensure that NO therapy gas cylinder supply pressure is greater than 200 psi 2.Perform low range calibration 3.Empty the fluid trap bottle between patient use or when bottle is half full 4.Replace the fluid trap filter cartridge between patient use oMonthly 1. A complete system calibration must be performed each month
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/ChaVAMC/VAMCCO80220/VA24715N1010/listing.html)
 

Document(s)

Attachment
 

File Name: VA247-15-N-1010 VA247-15-N-1010_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2279604&FileName=VA247-15-N-1010-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2279604&FileName=VA247-15-N-1010-000.docx

 

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

Place of Performance

Address: Department of Veterans Affairs;Ralph H. Johnson VA Medical Center;109 Bee Street;Charleston, SC

Zip Code: 29403-5799
 

Record

SN03856857-W 20150828/150826235803-30f5e0cfa510da9025b0e8a39724f673 (fbodaily.com)
 

Source

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

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