Loren Data's SAM Daily™

FBO DAILY ISSUE OF JULY 20, 2011 FBO #3525
DOCUMENT

65 -- Dialysis system, VISN - Attachment

Notice Date

7/18/2011
 

Notice Type

Attachment
 

NAICS

334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing
 

Contracting Office

Department of Veterans Affairs;VA Midwest Health Care System;Attention: Justin Rose;708 S. THIRD ST., SUITE 200E;Minneapolis MN 55415
 

ZIP Code

55415
 

Solicitation Number

VA26311RP0373
 

Archive Date

8/17/2011
 

Point of Contact

Justin Rose
 

Small Business Set-Aside

N/A
 

Description

Introduction This request for proposal (RFP) outlines VISN 23's requirements for the Contractor to furnish and install Hemodialysis Machines and accompanying Dialysis Information Systems, herein referred to as Dialysis Care System or System. This contract shall include an unlimited, non-exclusive, non-transferable seven year license for the Dialysis Care System, all interface software licenses, interface hardware, and services as defined herein for all VISN 23 facilities identified in Section A.1.2. A phased approach will be utilized to maximize organizational learning and VA project management and technical resources. Each phase of the project will be coordinated with VISN 23's Primary COTR and will be discussed in detail with the successful Contractor during the pre-work orientation. Upon completion of the installation, testing and training, VISN 23 will have a state of the art Dialysis Care System. Contractor shall be responsible to provide all services associated with the furnishing and installation of this system. Contractor shall provide the most efficient means of optimizing training, system maintenance, and data exchange throughout each facility in VISN. By responding to this RFP, the Contractor acknowledges that he/she understands that VISN 23 has substantial interface requirements between the Dialysis Care System and the VHA hospital information system (VISTA CPRS), specifically the CP Hemo package. This is a critical component of this project. Summary of Product and Services Required Line ItemLine Item DescriptionQuantityUnit PriceExtended Price 1Dialysis Machine79 units 2Dialysis Information System6 units 3Clinical Training6 jobs 4Biomedical Training9 jobs 5Installation6 jobs Place of Performance The Dialysis Care Systems will be delivered and provide specified functionality to the following VISN 23 Health Care Systems. Fargo VA Health Care System2101 Elm Street Fargo, ND 58102 VA Black Hills Health Care System - Hot Springs Campus500 N 5th St Hot Springs, SD 57747 Iowa City VA Health Care System601 Highway 6 West Iowa City, IA 52246-2208 Omaha Division - VA Nebraska Western Iowa Health Care System4101 Woolworth Avenue Omaha, NE 68105 Minneapolis VA Health Care SystemOne Veterans Drive Minneapolis, MN 55417 Sioux Falls VA Health Care System2501 W. 22nd St Sioux Falls, SD 57117-5046 Summary of Equipment and Supplies Requested By Facility VISN 23 VA Dialysis ClinicDialysis Machines RequiredDialysis Information SystemsClinical Training Biomedical Training Fargo, ND7111 Hot Springs, SD9111 Iowa City, IA11112 Omaha, NE30112 Minneapolis, MN19112 Sioux Falls, SD3111 Total79669 Instructions to Offerors "Contractors shall provide statements for each required product and service in adequate detail to evaluate proposals. A description of the evaluation approach to be utilized is provided in Section E.1 52.212-2. The use of product brochures should be extremely limited, and when necessary, offeror's responses shall address the brochure by document title and page number. "Contractors shall complete the Manufactures Disclosure Statement for Medical Device Security Form and Pre-Procurement Risk Assessment. "Contractors shall provide a copy of Business Associate Agreement with the Department of Veterans Affairs, if already established. If not established, provide a statement so stating. "Contractor shall identify a single point of contact for all project management activities for the VA to correspond with throughout the installation and implementation process. Dialysis Machine Product Requirements Dialysate Delivery System The Hemodialysis Units shall provide a Dialysate Delivery System. The Dialysate Delivery System shall meet or exceed the following specifications: 1.Proportioning System = Volumetric, Servo-Controlled, or Balance Chamber Type 2.Temp Comfort Control ( °C) = 33 to 40 3.Temp Alarm Limit ( °C) = 35 to 41 4.Conductivity Range (mS/cm) = 11 to 17 (0.1 increments) 5.Flow (mL/min) = 300 to 800 6.Transmembrane Pressure (mmHg) = 300 to 800, Alarm if < 0 7.RX Dialysis - a.Bicarbonate - User Defined Profiling b.Sodium Therapy - User Defined Profiling 8.Ultrafiltration Removal Rate (L/Hr) = 0 to 4 in double needle. 9.pH Monitor - Optional 10.Filtering system to deliver Ultrapure dialysate 11.Dry bicarbonate online delivery system Consumables The Hemodialysis vendor shall provide cost estimates of the consumables used / required to treat the patients of VISN 23. Consumable cost estimates should be presented as "COST PER RUN". Consumables shall include but are not limited to: BiCarbonate, Acid Concentrate, Dialysate and Blood Circuit Tubing, In-Line Pre-filtration Systems, etc. Extracorporeal Blood Circuit The Hemodialysis Units shall provide an extracorporeal blood circuit. The blood circuit shall meet or exceed the following specifications: 1.Arterial Pressure (mmHg) = Min (-400 to -300), Max (+280 to +400) 2.Venous Pressure (mmHg) = Min (-60 to 0), Max (+390 to +520) 3.Blood Pump Range (mL/min) = Between 0 and 600 4.Heparin Pump Range (mL/hr) = Between 0 and 10 Blood Volume MonitoringThe Hemodialysis Units shall include an integrated system to continuously monitor blood volume and related parameters to include but not limited to: 1.Hematocrit 2.Oxygen saturation 3.Relative blood volume. 4.kt/v monitoring real time Indicators/Display The Hemodialysis Units shall provide a full complement of displayed parameters. Display type shall be either LED Indicators or color LCD display. Displayed parameters shall include but are not limited to the following: 1.Dialysate Pressure 2.Transmembrane Pressure 3.Conductivity 4.Elapsed Time 5.Remaining Time 6.Prescribed Time 7.Ability to view Dialysis Information System 8.Fluid Target Removal and Current Volume Removed 9.Ultrafiltration (UF) and Sodium (Na) Profiles 10.Heparin Values 11.Blood Flow Rate 12.Dialysate Temp and Flow 13.Blood Pressure (Systolic, Diastolic, MAP) 14.Pulse Other displayed parameter preferred: 1.Touch Screen Navigation Disinfection The Hemodialysis Units shall provide an automated method to disinfect the equipment between patients. Method shall include both heat and chemical disinfection. Internal Microprocessor Functions The Hemodialysis Units shall provide microprocessor functions which include internal storage of the following critical data: 1.Treatment 2.Configuration 3.Failure Data/Logs 4.Service Menu/Auto-Test In addition, the Hemodialysis Units shall provide a data port/interface to an external dialysis workstation with compatible software. Clinical FunctionalityThe vendor shall describe features and functions of the dialysis unit proposed that improve the clinical efficiency and efficacy of hemodialysis treatment. Dialysis Information System Product Requirements: Dialysis Information System Dialysis Information System (continued) "Describe capabilities for centralizing the dialysis information system hardware, including required workstations, hardware, and LAN/WAN requirements. The Hemodialysis Units shall provide an interface to the Department of Veterans Affairs' developed application called CP-HEMO. The vendor is encouraged to provide as much detail as possible to describe the interface between the hemodialysis units and other dialysis workstations/central equipment, as well as the interface to the VA's CP-HEMO application. "Description of the interface(s) shall include but is not limited to the following: 1.Process Flow Diagram which demonstrates the work and steps necessary to move data/information between the Hemodialysis Unit(s) and the VA's electronic medical record (CPRS) specifically the CP Hemo application. 2.All Hardware and Software required shall be provided by the vendor. The vendor shall also provide a detailed description of the network requirements with diagram of the proposed configuration. 3.This contract shall include a non-transferable license for the Dialysis Care System, all interface software licenses, interface hardware, and services for a period of 7 years. 4.The vendor shall describe the operating system and hardware specifications of any central server/workstations required. Description shall include but is not limited to: microprocessor speed, hard drive size, memory, display, LAN connectivity, storage/back-up requirements and virus scanning applications. This equipment shall be vendor provided. 5.Interface to CP-HEMO package: a.Pre-Treatment and Post Treatment Tabs; it requires much data to be entered. Describe how the data within the Dialysis Machine/Server is populated into your companies interface to the VA's CP-HEMO application. b.Describe how the medications given at the dialysis machine during treatment are populated back into your companies interface to the VA's CP-HEMO application. c.Describe how an existing patient and treatment profile (order) are retained by the central server provided by your company. d.Provide a complete list of data fields currently mapped and exporting from the proposed dialysis system into your companies interface to the VA's CP-HEMO application. e.In some cases, Hemodialysis treatment is provided in the ICU at the various VISN 23 Medical Centers. Network (or LAN) connectivity is limited in these areas. Based on these conditions, describe how data gathered during a hemodialysis treatment can be uploaded into your companies interface to the VA's CP-HEMO application. "Describe known capabilities and/or issues with antivirus software, including antivirus software updates, and any necessary virus scanning exclusion lists for the dialysis information system. "Describe your licensing model including software obsolescence, major updates, and revisions, patches, and fixes for the dialysis information system. "Describe remote system support, including remote diagnostics via VPN/remote access. Contractor shall utilize the VA national Site-to-Site VPN, or the Contractor shall work with the Office of Cyber and Information Security and VISN23 Information Security Officers to establish a client-based VPN. "Describe operation with automatic critical OS updates on both the server and dialysis information systems client workstations. Electrical/Line Power The Hemodialysis Unit with workstation shall use existing electrical services of VISN 23. The system shall operate with a line power of 120 volts AC and current draw less than 20 amps. 1.Please describe the electrical requirements of your Dialysis Unit w/workstation. 2.Please describe the electrical requirements of your Dialysis Information System. Clinical training requirements: On-Site User Training Clinical-User Training - The vendor providing the system will be responsible for training all clinical users on their application and use. The vendor prior to and at the time of installation shall provide staff education at each VAMC. On-Site or "Go-Live" training shall be a minimum of 30 hours per VISN 23 Health Care System. Four training manuals are to be provided to each facility. A clinical education professional shall administer the training. Education curriculum must include but is not limited to the following: 1.Operations and set-up 2.User maintenance 3.Safety 4.User Troubleshooting 5.Negotiating and understanding machine profiles to better serve the patient and staff 6.Clinical use of bedside charting features and functions Dialysis Information System Training Information System Super User Training- The vendor providing the system will be responsible for training at least two super users on the administrative use of the dialysis information system. An educational professional shall administer the training. Curriculum must include but is not limited to the following: 1.Theory of Operation 2.System administration 3.Utilization of reporting tools such as Treatment Flow Sheets 4.Workflow design with CP Hemo 5.Troubleshooting Biomed Training Requirements Biomedical Technical Training The vendor should address how they will provide technical training for maintenance and service for biomedical engineering personnel to include factory service training courses (If Applicable). 1.Please indicate details about each training session offered for the Dialysis units and the Dialysis Information System. 2.Training shall include tuition, hotel, meals, and travel expenses for 9 VISN 23 employees to attend each training session offered (i.e. Intermediate, Advanced, etc). 3.Vendor shall provide any special service tools and/or test equipment comparable with that provided to the OEM's service personnel. 4.Training should at minimum address the following topics. a.Theory of Operation b.Using schematics and circuit diagrams c.Using the Technical Service Mode d.Commissioning and Preventative Maintenance e.Calibration Procedures f.Troubleshooting g.Interpreting and correcting alarm conditions h.Spare parts Installation Services Installation and Implementation The vendor shall provide a description of the installation services offered specifically addressing each of the following requirements: 1.The vendor shall provide professional project management services to organize the trade-in, training, installation and go-live activities at each facility. 2.The vendor shall identify a single project manager to oversee the VISN 23 dialysis system installation, and include an organization chart identifying all installation team members. 3.The vendor shall be responsible for removing the existing equipment being replaced. 4.The vendor shall be responsible for testing the system at each facility to ensure that the system is functioning as defined by the SOW. 5.The vendor shall be responsible for managing all waste created by the product installation, including clean-up and disposal. 6.The vendor shall define all site preparation requirements of the VA in writing as part of the submittal package. This shall include high voltage electrical requirements, network requirements, and any other required utilities not explicitly specified. 7.Ongoing clinical applications support via telephone, for 6 months following the installation. Service Requirements Manuals The vendor shall provide the following documentation for the proposed system: 1.Three copies of the Operator Manuals per VISN 23 Health Care System. 2.Three copies of complete technical Service Manuals per VISN 23 Health Care System including troubleshooting guides, necessary diagnostic software and equipment, schematic diagrams, and parts lists. ServiceThe vendor shall address how they will meet the following service requirements: 1.Service during the guarantee period shall be provided within 1 hour of notification. A routine service request will be issued upon any failure which degrades system performance but does not prevent continuation of patient care. 2.Emergency service by qualified personnel must be provided within 1 hour via telephone communication and within 24 hours via onsite service. An emergency service request will be issued upon any failure which prevents systems operation and disrupts continued patient care. 3.Prior to and during the guarantee period, all services shall be performed at no charge to the Government. Describe remote system support, including remote diagnostics via VPN/remote access. Contractor shall utilize the VA national Site-to-Site VPN, or the Contractor shall work with the Office of Cyber and Information Security and VISN23 Information Security Officers to establish a client-based VPN. Post Warranty MaintenanceFor maintenance service after the warranty period, the vendor shall provide a service agreement proposal addressing at minimum the following items: 1.Guaranteed period of availability of replacement parts 2.Delivery time for replacement parts upon receipt of order 3.Normal service hours for field service 4.Qualified service personal should be available to respond onsite to issue within 24 hours from notification to each VISN 23 Health Care System. Warranty specifications: 1.At minimum vendor is to provide at minimum a one (1) year warranty after installation has been completed. Maintenance, to include preventative maintenance, during the warranty period will be at the cost of the manufacturer to include parts, labor and travel.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/MiVAMC618/MiVAMC618/VA26311RP0373/listing.html)
 

Document(s)

Attachment
 

File Name: VA-263-11-RP-0373 VA-263-11-RP-0373_1.doc (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=220034&FileName=VA-263-11-RP-0373-000.doc)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=220034&FileName=VA-263-11-RP-0373-000.doc

 

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

Record

SN02501523-W 20110720/110718235454-d08bba37c93c1548d38f85d50ca79e57 (fbodaily.com)
 

Source

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

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