Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 02, 2015 FBO #5031
DOCUMENT

65 -- (ACT) 436 BILLINGS ACTIVATION IMPEDANCE MANOMETRY PACKAGE - Attachment

Notice Date

8/31/2015
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office;NCO 19;4100 E. Mississippi Avenue, Suite 900;Glendale CO 80246
 

ZIP Code

80246
 

Solicitation Number

VA25915Q0611
 

Response Due

9/14/2015
 

Archive Date

9/29/2015
 

Point of Contact

Brooke Barker
 

Small Business Set-Aside

Total Small Business
 

Description

1.This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. 2.The solicitation number is: VA259-15-Q-0611, and it is issued as a request for quotation (RFQ). 3.The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-82. 4.This solicitation is set-aside for Small Business. NAICS: 339112. Contract Line Items: ITEMDESCRIPTIONQTY. 0001ULT1-H-TD: inSIGHT Ultima High Resolution Impedance Manometry System, OR EQUAL. Includes an inSIGHT Ultima Base unit, HRiM 2 Probe with 32 circumferential pressure sensors & 16 impedance channels (12 FR), BioVIEW Acquisition Software, calibration accessories and cables, computer, 19" Touch-Screen Monitor, Mobility Cart & Printer. Training included. ***See specifications below on page 4-6 ***1 EA 0002Z07-2000B-SB: ZepHr I2.5 Z/pH kit- Impedance/pH reflux monitoring kit OR EQUAL. Includes 1 ZepHr Z/pH recorder, software, calibration kit & accessories. ***See specifications below on page 7-8***1 EA 0003ZAN-BS-01: ComforTEC Z/pH Single-use Probe, 18cm Esophageal length non-infused, 6 impedance, 1 pH channel, Diameter 6.4FR/2.13mm; OR EQUAL5 EA 0004ZAN-BG-44: ComforTEC Z/pH Single use Probe, Gastric, non-infused, 18cm Esophageal length, 6 impedance 2 pH channels -15 & 0, Diameter 6.9FR/2.3mm; OR EQUAL5 EA Vendor must be able to provide all of the listed or equal items. The quoted items shall meet or exceed the items listed on the schedule. If an equal product is quoted the vendor shall submit documentation stating why/how their product meets or exceeds each item. Specifications are included on pages 4-8. 5.Delivery (FOB Destination) Department of Veterans Affairs Billings Majestic Clinic 1766 Majestic Lane Billings, MT 59102 6.The provision at 52.212-1, Instructions to Offerors - Commercial, applies to this acquisition. 7.The provision at 52.212-2, Evaluation - Commercial Items, does not apply to this acquisition. Evaluation will be made by LPTA. 8.Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications - Commercial Items, with the offer. 9.The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. 10.The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. 11.Any additional contract requirements or terms and conditions: FAR 52.203-99, FAR 52.232-40, FAR 52.247-34, VAAR 852.203-70, VAAR 852.211-73, VAAR 852.232-72, VAAR 852.246-70, VAAR 852.246-71. All Contractors must be registered in SAM.gov to do business with the federal government and annually ensure the information is current at https://www.sam.gov/. 12.The Defense Priorities and Allocations System (DPAS) does not apply. 13.Date and Time offers are due: September 14, 2015 by 1200 Mountain Time to brooke.barker@va.gov. 14.Name and telephone number of the individual to contact for information regarding the solicitation: Brooke Barker Contract Specialist Brooke.barker@va.gov inSIGHT, or equal, Specifications 1.inSIGHT Ultima Platform a.A single hardware platform that has the capability for multiple diagnostic testing modules, including: i.High Resolution Impedance Manometry (HRiM) ii.High Resolution Impedance Manometry Smal Idameter (HRiMSD) iii.High Resolution Manometry (HRM) iv.Anorectal Manometry 1.High Resolution Anorectal Manometry (HRAM) 2.Low Resolution Anorectal Manometry (Air-charged) v.Sphincter of Oddi Manometry (SOM) 1.Solid-state 2.Water perfused b.A single hardware platform capable of supporting multiple technology configurations, including: i.Solid-state ii.Water perfused iii.Air charged c.Catheter specific guided protocols with data acquisition software to guide the user through the study leading to reduced study complexity & optimized data consistency. d.Application specific system cart, including: i.Hydraulic movement allowing the user to stand when performing a study or in a seated position to analyze the study ii.Integrated power isolation transformer iii.Large lockable storage drawer iv.Printer shelf v.24" medical grade touch screen monitor e.Solid-State Catheter Configurations: i.High Resolution Impedance Manometry (HRiM): 1.12 FR, with at least 32 true circumferential pressure sensors spaced at 1cm intervals & 16 impedance channels spaced at 2cm intervals ii.Small Dianeter High Resolution Impedance Manometry (HRiMSD) 1.8 FR, with at least 32 directional pressure sensors spaced at 1cm intervals & 16 impedance channels spaced at 2cm intervals iii.High Resolution Manometry (HRM) 1.12 FR, with at least 32 true circumferential pressure sensors spaced at 1cm intervals iv.High Resolution Anorectal Manometry (HRAM) 1.12 FR, with at least 23 directional pressure sensors, including 5 rings with 4 sensors positioned Posterior, Left, Anterior, & Right v.High Resolution Anorectal Manometry (HRCA) 1.12 FR, with at least 6 circumferential pressure sensors, linear configuration spaced at 1cm intervals f.All solid state catheters should be protected against submersion in approved cleaning & disinfection g.The system should be upgradeable of other GI functional tests, including Biofeedback, Pudendal Nerve Latency Testing, antro-duodenal manometry h.System must have a computer using Microsoft Windows 7 OS 2.BioVIEW Software for inSIGHT, or equal a.For HRiM analysis, bolus transit should be able to be displayed either as a separate image or an overlay with the manometric findings b.The analysis software should include the capability to automatically analyze manometric data using the Chicago Classifications or Conventional Manometric Analysis functions c.Software must support real-time SyncVIEW using Wire Frame Multi-Dimensional Display Technology capable of showing "virtual esophagus" playback using advanced wire frame multi-dimensional display technology included as an integral element of both the acquisition & analysis software d.The report should contain a data table including all Chicago Classification analysis metrics, including IRP, DCI, CFV, Distal Latency & Peristatic Breaks e.The report should contact a data table including Conventional Manometry findings f.The report should provide LES Profile Data as well as Bolus Transit metrics (Impedance catheter only) g.The acquisition software should provide the capability of viewing using either HREPT (High Resolution Esophageal Pressure Topography), standard waveforms, SyncVIEW using Wire Frame Multi-Dimensional Display Technology h.Acquisition software should have catheter specific guided protocols to guide the user through the study leading to reduced study complexity & optimized data consistency i.Analysis software should be loadable on an unlimited number of PCs at no additional charge. No user license should be required j.Should provide free software updates for the life of the project k.During data acquisition, there should be a facility for pausing & restarting the recording, which should be automatically saved on the computer l.There should be facility for marking events like the type of swallow, the position of the catheter, respiration, cough/sneeze, catheter pull-through, etc. m.Operation requirement i.Ambient temperature: 10 to 40 degrees C ii.Altitude: -400 to 2200 meters MSL iii.Power specs: 100-230V; 50-60Hz n.Training i.Provide access to the following clinical training opportunities: 1.A comprehensive training program in a dedicated classroom environment to practice hands0on exercises 2.Cyber-coaching from a Registered Nurse experienced in motility 3.Online training program with downloadable teaching modules o.Comprehensive warranty i.Two years comprehensive hardware warranty ii.Spare parts & required consumables should be available for a period of at least 7 years from the date of purchase iii.The High Resolution Manometry Catheter should have a two-year/200 use warranty including repair of original catheter when warranted claim is validated iv.The equipment should follow international standards & safety requirement. Should be UD FDA approved p.Technical support i.The manufacturer should provide 24/7/365 technical support ii.The manufacturer should have on-line diagnostic capabilities for the system & software, free of charge to the end user ZepHr, or equal, Specification 1.ZepHr Reflux Recorder a.A single, portable recording hardware platform that must have the capability for multiple diagnostic testing modules, including: i.pH monitoring ii.Impedance/pH monitoring iii.Acid (pH) Laryngopharyngeal Reflux (LPR) monitoring iv.Impedance/pH LPR monitoring b.A single, portable, recording hardware platform capable of supporting multiple catheter technology configurations, including, but not limited to: i.1 distal esophageal pH channel, internal reference, infused or not infused ii.1 distal esophageal pH channel, internal reference, with impedance, infused or non-infused iii.1 proximal esophageal pH & 1 distal esophageal pH channels, with impedance, infused or non-infused iv.1 distal esophageal pH & 1 1 gastric pH channel, internal reference, with or without impedance v.Single branch LPR catheters with distal & proximal pharyngeal impedance sensors surrounding a pH channel in addition to esophageal impedance & pH channels c.Portable recorder must be able to directly interface with a Lower Esophageal Sphincter locator working with disposable Infused pH or Infused Impedance/pH catheters to accurately locate the proximal border of the Lower Esophageal Sphincter (LES) for pH Sensor placement d.Portable recorder device must have at least 3 programmable buttons for patient-specific symptoms, in addition to dedicated buttons for start/stop meals & dedicated buttons for upright/supine positions e.Portable recorder device must operate on 2 AA-cell batteries for at least 24 hours f.Portable recorder must interface with catheters, which allow data analysis for reporting gastric acid analysis, distal acid/non-acid analysis & proximal (LPR) acid/non-acid analysis g.Recorded data should be stored on a SD memory card to allow for rapid "turn-over" between patient studies h.The system should operate on a PC using Microsoft Windows 7 OS 2.BioVIEW Analysis Software, or equal a.The analysis software must include the capability to automatically analyze pH & impedance/pH data to identify Reflux Events using advanced neuronet architecture b.The analysis software must include the capability to associate Reflux Events with Symptoms automatically, including the Symptom Index & Symptom Association Probability data. c.The analysis software must allow printed reports in multiple formats, including MS Word & PDF files d.Report must contain a data table for Acid, Weakly Acidic, & Non-Acidic Reflux Events, as well as a data table for correlating reflux events with symptoms e.Acquisition software should have catheter specific guided protocols to guide the user through the study leading to reduced study complexity & optimized data consistency f.The system must have the ability to detect incompatibility between catheter & study protocol g.The acquisition software should provide the capability of viewing using either standard waveforms, color contour mapping or Wire Frame Multi-Dimensional Display Technology h.Software must support real-time SyncVIEW using Wire Frame Multi-Dimensional Display Technology capable of showing "virtual esophagus" playback using advanced wire frame multi-dimensional display technology included as an integral element of the analysis software program i.Raw data must be loadable on an unlimited number of PCs at no additional charge. No user license should be required j.Updates to analysis software should be provided free of charge for the life of the product k.Operation requirement: i.Ambient temperature: 10 to 40 degrees C ii.Altitude: -400 to 2200 meters MSL iii.Power specs: 100-230V; 50-60Hz l.Training i.Provide access to the following clinical training opportunities: 1.A comprehensive training program in a dedicated classroom environment to practice hands0on exercises 2.Cyber-coaching from a Registered Nurse experienced in motility 3.Online training program with downloadable teaching modules m.Comprehensive warranty i.Two years comprehensive hardware warranty ii.Spare parts & required consumables should be available for a period of at least 7 years from the date of purchase iii.The equipment should follow international standards & safety requirement. Should be UD FDA approved n.Technical support i.The manufacturer should provide 24/7/365 technical support ii.The manufacturer should have on-line diagnostic capabilities for the system & software, free of charge to the end user
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VARMCCC/VARMCCC/VA25915Q0611/listing.html)
 

Document(s)

Attachment
 

File Name: VA259-15-Q-0611 VA259-15-Q-0611.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2289133&FileName=VA259-15-Q-0611-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2289133&FileName=VA259-15-Q-0611-000.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;Billings Clinic;1766 Majestic Lane;Billings, MT 59012

Zip Code: 59012
 

Record

SN03863842-W 20150902/150831235610-7cb98eed25d57cbb2d120100864cc4f1 (fbodaily.com)
 

Source

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

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